nct_id
string | updated_at
timestamp[us] | brief_title
string | official_title
string | acronym
string | study_type
string | overall_status
string | study_first_submit_date
timestamp[ms] | start_date
timestamp[ms] | primary_completion_date
timestamp[ms] | completion_date
timestamp[ms] | phases
sequence | enrollment_count
float64 | minimum_age
float64 | maximum_age
float64 | sex
string | healthy_volunteers
bool | brief_summary
string | detailed_description
string | eligibility_criteria
string | lead_sponsor_name
string | lead_sponsor_class
string | org_study_id_info
dict | why_stopped
string | expanded_access_info
dict | last_update_submit_qc_date
timestamp[ms] | last_update_post_date_struct
dict | study_first_post_date_struct
dict | std_ages
sequence | study_population
string | sampling_method
string | oversight_has_dmc
bool | design_info
dict | conditions
sequence | keywords
string | interventions
null | locations
list | collaborators
list | arm_groups
null | outcomes
dict | overall_officials
list | study_references
string | misc_info_module
string | condition_browse_module
dict | intervention_browse_module
dict | mesh_terms
dict |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00295126 | null | REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla | Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla. | None | INTERVENTIONAL | TERMINATED | 2006-02-20T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 20 | 18 | null | ALL | false | This is a randomized open label trial that evaluates the efficacy of an autologous platelet concentrate (APC) in pre-implantation reconstruction of maxilla.
The sinus occlusion will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.
The side selection will be determined by the randomization. | Rational
Maxillary Edentulous is one of the more frequent handicaps that cause many problems for dental prosthesis. Dental implants are currently the most convenient solution but require sufficient bone sinus height.
The filling of the sinus can be made by two ways :
* Either with autologous bone removed from hipbone or cranial bone. This method has several drawbacks such as the multiplicity of the surgery sites.
* Or with alloplasty materials that are subject to uncertain osseointegration and that are very expensive.
The aim of this study is to show the interest of an autologous platelet concentrate (APC) in this surgery. We will use the osteogenic property of platelets associated with a small quantity of spongy bone removed from the surgery site.
It has been previously demonstrated that platelets contain growth factors, in particular PDGF (platelet derivated growth factors), TGF-α1 and 2 (transforming growth factors) and IGF-1 (insulin like growth factor). These molecules have receptors on spongy bone, enhance mitosis, osteoblast differentiation, angiogenesis and induce the inhibition of osteoclats.
Method :
The sinus filling will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.
The side selection will be determined by the randomization. For each patient a waiting period of 6 months is required before dental implants.
Twenty patients will be enrolled in this single-centre study with a follow-up of one year.
Main objective :
- To demonstrate that the osteogenesis with APC mixed with a small quantity (1 to 2 cm2) of autologous bone tissue removed from the surgery site, has a sufficient quality to allow the dental implants.
Secondary Objectives :
* To compare the osteogenesis with the current procedure (hipbone transplant)
* To estimate the kinetic of osteogenesis using successive radiography. | Inclusion Criteria:
* Age above 18 years
* ASA1 class of anesthetic risk
* SA3 or SA4 of the Misch classification
Exclusion Criteria:
* Smoker
* Progressive sinusal lesion or previous history of maxillary sinusitis
* Previous history of maxillary surgery
* Hemopathy
* Contraindication to cytapheresis
* Progressive cardiopathy
* Severe cerebellar arteriopathy
* Infectious state
* Thrombopenia \< 150 g/l controlled by citrate
* Serology : antibody anti-HVC, anti-HIV 1 \& 2, anti HTLV 1 \& 2 positive | University Hospital, Grenoble | OTHER | {
"id": "DCIC 01 12",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-02-20T00:00:00 | {
"date": "2008-03-14",
"type": "ESTIMATED"
} | {
"date": "2006-02-22",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Jaw, Edentulous",
"Tooth Loss",
"Maxillary Diseases"
] | ["Edentulous", "Tooth Loss", "APC", "Autologous platelet concentrate"] | null | [
{
"city": "Grenoble",
"country": "France",
"facility": "University Hospital of Grenoble",
"geoPoint": {
"lat": 45.16667,
"lon": 5.71667
},
"state": "Isere"
}
] | [
{
"class": "OTHER",
"name": "Etablissement Français du Sang"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Radiological outcome measure : the bone height under the sinus on the two sides.",
"timeFrame": null
}
],
"secondary": [
{
"description": null,
"measure": "Radiological outcome measure : the bone density",
"timeFrame": null
},
{
"description": null,
"measure": "Clinical outcome measure : assessment of the alveolar crest quality, possible orals complications, and complications at the removal site.",
"timeFrame": null
},
{
"description": null,
"measure": "Histological outcome measures : with bone core boring at the implant site.",
"timeFrame": null
},
{
"description": null,
"measure": "All these measurements will be matched for each patient on both sides.",
"timeFrame": null
}
]
} | [
{
"affiliation": "Univesity Grenoble Hospital, Stomatology Department",
"name": "Georges Bettega, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "12022097", "type": "BACKGROUND", "citation": "Robiony M, Polini F, Costa F, Politi M. Osteogenesis distraction and platelet-rich plasma for bone restoration of the severely atrophic mandible: preliminary results. J Oral Maxillofac Surg. 2002 Jun;60(6):630-5. doi: 10.1053/joms.2002.33107."}, {"pmid": "11212572", "type": "BACKGROUND", "citation": "Carlson ER. Bone grafting the jaws in the 21st century: the use of platelet-rich plasma and bone morphogenetic protein. Alpha Omegan. 2000 Aug-Sep;93(3):26-30."}, {"pmid": "11063400", "type": "BACKGROUND", "citation": "Kassolis JD, Rosen PS, Reynolds MA. Alveolar ridge and sinus augmentation utilizing platelet-rich plasma in combination with freeze-dried bone allograft: case series. J Periodontol. 2000 Oct;71(10):1654-61. doi: 10.1902/jop.2000.71.10.1654."}, {"pmid": "10859754", "type": "BACKGROUND", "citation": "Lebeau J, Savariaux C, Perrier P, Bettega G, Raphael B. [Functional evaluation of intraoral reconstructive surgery. A valuable tool: articulatory evaluation of the acoustic signal]. Rev Stomatol Chir Maxillofac. 2000 Apr;101(2):60-4. French."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009059",
"term": "Mouth Diseases"
},
{
"id": "D009057",
"term": "Stomatognathic Diseases"
},
{
"id": "D014076",
"term": "Tooth Diseases"
},
{
"id": "D010510",
"term": "Periodontal Diseases"
},
{
"id": "D007571",
"term": "Jaw Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC07",
"name": "Mouth and Tooth Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
}
],
"browseLeaves": [
{
"asFound": "Edentulous",
"id": "M12026",
"name": "Mouth, Edentulous",
"relevance": "HIGH"
},
{
"asFound": "Jaw, Edentulous",
"id": "M10605",
"name": "Jaw, Edentulous",
"relevance": "HIGH"
},
{
"asFound": "Tooth Loss",
"id": "M18823",
"name": "Tooth Loss",
"relevance": "HIGH"
},
{
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"id": "M11422",
"name": "Maxillary Diseases",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12019",
"name": "Mouth Diseases",
"relevance": "LOW"
},
{
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"id": "M12017",
"name": "Stomatognathic Diseases",
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},
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"asFound": null,
"id": "M16831",
"name": "Tooth Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13419",
"name": "Periodontal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10601",
"name": "Jaw Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007575",
"term": "Jaw, Edentulous"
},
{
"id": "D008439",
"term": "Maxillary Diseases"
},
{
"id": "D009066",
"term": "Mouth, Edentulous"
},
{
"id": "D016388",
"term": "Tooth Loss"
}
]
} | null | {
"conditions": [
{
"id": "D007575",
"term": "Jaw, Edentulous"
},
{
"id": "D008439",
"term": "Maxillary Diseases"
},
{
"id": "D009066",
"term": "Mouth, Edentulous"
},
{
"id": "D016388",
"term": "Tooth Loss"
}
],
"interventions": null
} |
NCT02914626 | null | Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study | Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study | None | INTERVENTIONAL | UNKNOWN | 2016-09-22T00:00:00 | null | null | null | [
"PHASE3"
] | 28 | 18 | null | ALL | false | Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order to decrease VEGF formation. The investigators postulate that the use of anti-VEGF intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma. | This is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (Lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma.
28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- University of Sao Paulo Medical School General Hospital. A complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study.
Patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. Two injections will be performed 30 days apart. The patients will be followed for 6 months. | Inclusion Criteria:
* IOP greater than 24 mmHg
* Iris or anterior chamber neovascularization
* At least 120 degrees of opened anterior chamber angle
Exclusion Criteria:
* Visual acuity worse than counting fingers in the fellow eye
* No light perception in the treated eye
* Any ocular infectious disease
* Use of systemic steroids
* Lack of media transparency precluding laser photocoagulation
* Thromboembolic disease
* Known hypersensitivity to ranibizumab
* Female participants at childbearing age not using oral contraceptives
* Use of intravitreal anti-VEGF over the last 30 days. | University of Sao Paulo General Hospital | OTHER | {
"id": "USaoPauloGH 294.326",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-09-23T00:00:00 | {
"date": "2016-09-27",
"type": "ESTIMATED"
} | {
"date": "2016-09-26",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Glaucoma, Neovascular",
"Ranibizumab"
] | ["Glaucoma, Neovascular", "Ranibizumab", "Intraocular pressure", "anti-VEGF", "intravitreal injection"] | null | null | [
{
"class": "INDUSTRY",
"name": "Novartis"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Intraocular pressure",
"timeFrame": "6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Anterior segment neovascularization",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Best corrected visual acuity",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Number of drugs needed for IOP control",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Need for IOP control surgery",
"timeFrame": "6 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009798",
"term": "Ocular Hypertension"
},
{
"id": "D005128",
"term": "Eye Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC11",
"name": "Eye Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
}
],
"browseLeaves": [
{
"asFound": "Glaucoma",
"id": "M9013",
"name": "Glaucoma",
"relevance": "HIGH"
},
{
"asFound": "Glaucoma, Neovascular",
"id": "M18043",
"name": "Glaucoma, Neovascular",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10024",
"name": "Hypertension",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12731",
"name": "Ocular Hypertension",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8271",
"name": "Eye Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D005901",
"term": "Glaucoma"
},
{
"id": "D015355",
"term": "Glaucoma, Neovascular"
}
]
} | {
"ancestors": [
{
"id": "D020533",
"term": "Angiogenesis Inhibitors"
},
{
"id": "D043924",
"term": "Angiogenesis Modulating Agents"
},
{
"id": "D006133",
"term": "Growth Substances"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D006131",
"term": "Growth Inhibitors"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
}
],
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Air",
"id": "M472",
"name": "Ranibizumab",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M22318",
"name": "Angiogenesis Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9231",
"name": "Growth Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000069579",
"term": "Ranibizumab"
}
]
} | {
"conditions": [
{
"id": "D005901",
"term": "Glaucoma"
},
{
"id": "D015355",
"term": "Glaucoma, Neovascular"
}
],
"interventions": [
{
"id": "D000069579",
"term": "Ranibizumab"
}
]
} |
NCT03216226 | null | A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus | A Phase 3, Randomized, Double-Blind, Parallel Group Safety Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen® Administered Subcutaneously in Patients With Type 1 Diabetes Mellitus (T1DM) | None | INTERVENTIONAL | COMPLETED | 2017-07-07T00:00:00 | null | 2018-02-13T00:00:00 | 2018-02-13T00:00:00 | [
"PHASE3"
] | 112 | 18 | 70 | ALL | false | The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon\* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon and GlucaGen.
\*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207 | Patients with T1DM were randomly assigned in a 1:1 ratio to receive 3 SC injections of either dasiglucagon (0.6 mg) or GlucaGen (1 mg), with 1 week between doses. Patients were followed for 15 weeks from the day of the first dose to assess the immune response. Patients with previous exogenic glucagon exposure were not excluded from the trial, but the information on previous glucagon administration was recorded to enable subgroup analyses. It was expected that 112 patients in total would be randomly assigned to treatment groups and treated. A total of 90 patients were expected to complete the trial (45 in each treatment arm). To qualify as completed, the patient had to be dosed according to the procedure described in the protocol and to have blood drawn for the antidrug antibody analyses as scheduled. | Inclusion Criteria:
* Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
* Availability for the entire trial period
* Age between 18 and 70 years, both inclusive
* Male or female patients with T1DM for at least 1 year. Diagnostic criteria as defined by the American Diabetes Association
* Hemoglobin A1c (HbA1c) \<10%
* Stable anti-diabetic treatment for at least 1 month (e.g. within 10% insulin dose adjustment)
Exclusion Criteria:
* Previous administration of dasiglucagon (previously referred to as ZP4207)
* Known or suspected allergy to trial medication(s) or related products
* History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
* Previous participation (randomization) in this trial
* Females who are pregnant according to a positive pregnancy test, actively attempting to get pregnant, or are lactating
* Patients on a closed loop artificial pancreas
* Receipt of any investigational drug within 3 months prior to screening
* Active malignancy within the last 5 years
* Congestive heart failure, New York Heart Association class II-IV
* Inadequately treated blood pressure as defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥90 mmHg at screening
* Current bleeding disorder, including use of anticoagulant treatment
* Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin-secreting pancreas tumor)
* Known or suspected HIV infection
* Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial
* Use of systemic corticosteroids, anti-inflammatory biological agents, kinase inhibitors or other immune modulating agents within the last 3 months prior to screening
* Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening
* A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women.
* Surgery or trauma with significant blood loss within the last 2 months prior to screening
* Use of prescription or non-prescription medications known to cause QT prolongation | Zealand Pharma | INDUSTRY | {
"id": "ZP4207-16136",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-07-10T00:00:00 | {
"date": "2021-05-04",
"type": "ACTUAL"
} | {
"date": "2017-07-13",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Hypoglycemia",
"Diabetes Mellitus, Type 1"
] | ["Glucagon", "Dasiglucagon"] | null | [
{
"city": "Orlando",
"country": "United States",
"facility": "Compass Research",
"geoPoint": {
"lat": 28.53834,
"lon": -81.37924
},
"state": "Florida"
},
{
"city": "Meridian",
"country": "United States",
"facility": "Advanced Clinical Research",
"geoPoint": {
"lat": 43.61211,
"lon": -116.39151
},
"state": "Idaho"
},
{
"city": "Graz",
"country": "Austria",
"facility": "CRC - Clinical Research Center, Medizinische Universität Graz",
"geoPoint": {
"lat": 47.06667,
"lon": 15.45
},
"state": null
},
{
"city": "Barrie",
"country": "Canada",
"facility": "LMC Manna Research",
"geoPoint": {
"lat": 44.40011,
"lon": -79.66634
},
"state": null
},
{
"city": "Calgary",
"country": "Canada",
"facility": "LMC Calgary",
"geoPoint": {
"lat": 51.05011,
"lon": -114.08529
},
"state": null
},
{
"city": "Toronto",
"country": "Canada",
"facility": "LMC Diabetes & Manna Research",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": null
},
{
"city": "Hamburg",
"country": "Germany",
"facility": "Diabeteszentrum Hamburg West, Gemeinschaftspraxis für Innere Medizin",
"geoPoint": {
"lat": 53.57532,
"lon": 10.01534
},
"state": null
}
] | [
{
"class": "INDUSTRY",
"name": "SynteractHCR"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Percentage of Patients With ADA",
"timeFrame": "104 days after the first dose"
}
],
"secondary": [
{
"description": null,
"measure": "Percentage of Patients With Treatment-induced ADA",
"timeFrame": "104 days after the first dose"
},
{
"description": null,
"measure": "Percentage of Patients With Treatment-boosted ADA",
"timeFrame": "104 days after the first dose"
},
{
"description": null,
"measure": "Characterization of ADA Response - Neutralizing Activity",
"timeFrame": "104 days after the first dose"
},
{
"description": null,
"measure": "Characterization of ADA Response - Titer of Neutralizing Activity",
"timeFrame": "104 days after the first dose"
},
{
"description": null,
"measure": "Characterization of ADA Response - Cross-reactivity",
"timeFrame": "104 days after the first dose"
},
{
"description": null,
"measure": "Characterization of ADA Response - Timing",
"timeFrame": "104 days after the first dose"
},
{
"description": null,
"measure": "Characterization of ADA Response - Duration",
"timeFrame": "104 days after the first dose"
},
{
"description": null,
"measure": "Pharmacokinetics - Area Under the Plasma Concentration Curve",
"timeFrame": "0-30 minutes"
},
{
"description": null,
"measure": "Pharmacokinetics - Area Under the Plasma Concentration Curve",
"timeFrame": "0-90 minutes"
},
{
"description": null,
"measure": "Pharmacokinetics - Maximum Plasma Concentration",
"timeFrame": "90 minutes"
},
{
"description": null,
"measure": "Pharmacokinetics - Time to Maximum Plasma Concentration",
"timeFrame": "90 minutes"
},
{
"description": null,
"measure": "Pharmacodynamics - Area Under the Effect Curve",
"timeFrame": "0-30 minutes"
},
{
"description": null,
"measure": "Pharmacodynamics - Area Under the Effect Curve",
"timeFrame": "0-90 minutes"
},
{
"description": null,
"measure": "Pharmacodynamics - Change From Baseline Plasma Glucose",
"timeFrame": "90 minutes"
},
{
"description": null,
"measure": "Pharmacodynamics - Time to Maximum Plasma Glucose Concentration",
"timeFrame": "90 minutes"
},
{
"description": null,
"measure": "Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment",
"timeFrame": "30 minutes"
}
]
} | [
{
"affiliation": "Zealand Pharma A/S",
"name": "Christina Sylvest, MSc Pharm",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D044882",
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},
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"id": "D004700",
"term": "Endocrine System Diseases"
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{
"id": "D001327",
"term": "Autoimmune Diseases"
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{
"id": "D007154",
"term": "Immune System Diseases"
}
],
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{
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"term": "Diabetes Mellitus, Type 1"
},
{
"id": "D007003",
"term": "Hypoglycemia"
}
]
} | {
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}
],
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]
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],
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} |
NCT04071626 | null | Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure | The EMMED-HF Study: Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure | EMMED-HF | INTERVENTIONAL | TERMINATED | 2019-08-26T00:00:00 | null | 2023-01-11T00:00:00 | 2023-01-11T00:00:00 | [
"PHASE4"
] | 9 | 18 | 75 | ALL | false | This clinical trial will determine if subjects with heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes mellitus (DM2) receiving sodium-glucose cotransporter 2 (SGLTi2) inhibitor therapy (ertugliflozin) alters cardiac metabolism compared to placebo in a single blinded (to subject), randomized, parallel group, active controlled, single center experimental design. | The results of recent sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy clinical trials demonstrate clinically significant reductions in cardiovascular endpoints (myocardial infarction, cardiac death, heart failure hospitalization). SGLT2 inhibition appears to exert cardiovascular protection through pleiotrophic effects involving both the myocardium and peripheral organs but the primary pathway of risk reduction of heart failure incidents has not been elucidated. SGLT2 inhibitors induce a loss of 50-100 grams of glucose through urinary excretion daily. There is a compensatory increase in ketone body production in the liver after initiation of SGLT inhibition. Ketone bodies are the most energy efficient myocardial fuel source and reduce myocardial oxidative stress when consumed as the primary energy substrate. Inducing a shift to ketone body metabolism to improves cardiac diastolic performance suggests a unifying paradigm of direct myocardial effect and peripheral metabolic flexibility through which SGLT2 inhibition mediates myocardial protection in HFpEF.
Specific Aims Aim 1: Determine if 12 weeks of SGLTi2 therapy improves peak exercise oxygen uptake compared to placebo. We will perform cardiac MRI exercise testing (CPET-ExMR) before and \& post 12 weeks of therapy to measure cardiopulmonary fitness by metabolic cart gas exchange and left ventricular myocardial mass.
Aim 2: Evaluate the short term (12 weeks effect of SGLTi on metabolic flexibility in HFpEF compared to baseline function and control group. We will measure glucose and lipid metabolism response to SGLT2 inhibition. Serum samples of glucose and ketone bodies (β-hydroxybutyrate) will be assessed before \& post 12 weeks of therapy. Serial serum samples will allow us to generate metabolomics profiles before and after treatment. This experimental design will provide insight into ketone body production, peripheral glucose flux, and circulating lipoparticles in response to SGLTi therapy. | Inclusion Criteria:
* Age \> 18 years old but \< 75 years old
* No HF hospitalization within 6 months
* Overweight or Obesity defined as BMI \> 29 but \< 42
* History of insulin resistance or T2DM and on oral diabetes agents other than SGLT2i (HgbA1c \> 5.8% and \< 10.5%)
* EF calculated based on a recent echo/cath/nuclear study at screening (pre-enrollment) \> 50%
* Stable HFpEF (HF with preserved ejection fraction) medications use of 3 months with no plans to changes or add medications for at least 12 weeks course of the study)
Exclusion Criteria:
* Acute HFpEF hospitalization within 6 months of enrollment.
* CKD stage 4 or 5 (eGFR \< 30 ml/min by CKD-EPI equation).
* Other known causes of HF including poorly controlled hypertension (SBP \>160 mm Hg) or ischemic cardiomyopathy (etc).
* Anemia (Hgb \< 11.0 mg/dL for women and \< 12.0 mg/dL for men) or severe thrombocytopenia (platelets \< 50,000 mm3)
* Anticipated changing of HF medication during anticipated study period.
* HFREF (LV EF \< 50%).
* Acute coronary syndrome, transient ischemic attack, CVA or critical limb ischemia during the last 6 months or coronary/peripheral revascularization within the last 3 months. Severe life threatening illness or live expectancy \< 6 months.
* Contraindications to MRI (metallic implants, severe claustrophobia) or treadmill exercise (limb amputation, severe osteoarthritis or equivalent functional mechanical limitation). | University Hospitals Cleveland Medical Center | OTHER | {
"id": "STUDY20190016",
"link": null,
"type": null
} | Lack of enrollment | {
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"nctId": null,
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} | 2019-08-26T00:00:00 | {
"date": "2023-12-13",
"type": "ACTUAL"
} | {
"date": "2019-08-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
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} | [
"Heart Failure, Diastolic",
"Diabetes Mellitus, Type 2"
] | ["ertugliflozin", "SGLT2 inhibtion", "Cardiovascular Diseases", "Sodium-Glucose Transporter 2 Inhibitors", "Glucose Metabolism Disorders", "Physiological Effects of Drugs", "Diabetes Mellitus", "Diabetes Mellitus, Type 2", "Endocrine System Diseases"] | null | [
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"city": "Cleveland",
"country": "United States",
"facility": "University Hospitals Cleveland Medical Center",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio"
}
] | null | null | {
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"primary": [
{
"description": null,
"measure": "Peak VO2, ml/kg/Min, as Measured by Metabolic Gas Exchange",
"timeFrame": "12 weeks"
}
],
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{
"description": null,
"measure": "Left Ventricular Mass Index (gm/m2), as Measured by Cardiac MRI",
"timeFrame": "12 weeks"
},
{
"description": null,
"measure": "Serum Ketone Bodies (Betahydroxybutyrate)",
"timeFrame": "12 weeks"
}
]
} | [
{
"affiliation": "University Hospitals Cleveland Medical Center",
"name": "Trevor L Jenkins, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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],
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"term": "Diabetes Mellitus"
},
{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
}
]
} | {
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}
],
"interventions": [
{
"id": "C570288",
"term": "Ertugliflozin"
}
]
} |
NCT03568526 | null | Sensorimotor Rehabilitation Program in Improving Quality of Life in Patients With Early Stage Breast Cancer | The Effects of a Sensorimotor Rehabilitation Program on the Upper and Lower Limbs of Persons With Cancer Following Taxane-Based Chemotherapy for Early Stage Breast Cancer | None | INTERVENTIONAL | COMPLETED | 2018-03-20T00:00:00 | null | 2018-02-08T00:00:00 | 2022-09-14T00:00:00 | [
"NA"
] | 36 | null | null | ALL | false | This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life. | PRIMARY OBJECTIVES:
I. To investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer.
OUTLINE:
Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks. | Inclusion Criteria:
* Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities
* Taxane-based chemotherapy for early stage breast cancer
* Diagnosis of early stage breast cancer
Exclusion Criteria:
* Individuals with late stage breast cancer | Ohio State University Comprehensive Cancer Center | OTHER | {
"id": "OSU-14219",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-06-20T00:00:00 | {
"date": "2022-10-12",
"type": "ACTUAL"
} | {
"date": "2018-06-26",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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"maskingDescription": null,
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},
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"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Peripheral Neuropathy",
"Stage I Breast Cancer AJCC v7",
"Stage IA Breast Cancer AJCC v7",
"Stage IB Breast Cancer AJCC v7",
"Stage II Breast Cancer AJCC v6 and v7",
"Stage IIA Breast Cancer AJCC v6 and v7",
"Stage IIB Breast Cancer AJCC v6 and v7"
] | null | null | [
{
"city": "Columbus",
"country": "United States",
"facility": "Ohio State University Comprehensive Cancer Center",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire",
"timeFrame": "Up to 2 years"
},
{
"description": null,
"measure": "Evaluate patients using post-test scores on the CIPN-20",
"timeFrame": "Up to 2 years"
},
{
"description": null,
"measure": "Assess the differences in patients post-test scores on the Disability of Arm Hand and Shoulder scores",
"timeFrame": "Up to 2 years"
}
],
"secondary": null
} | [
{
"affiliation": "Ohio State University Comprehensive Cancer Center",
"name": "Amy Darragh, PhD, OTR/L",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Breast Diseases"
},
{
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},
{
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"term": "Neuromuscular Diseases"
},
{
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}
],
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"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
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"name": "Nervous System Diseases"
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"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
}
],
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},
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},
{
"id": "D010523",
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]
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"term": "Breast Neoplasms"
},
{
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],
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} |
NCT02341326 | null | Defective FGFR2 Signaling in the Small Airway Basal Progenitor Cells in COPD | Defective FGFR2 Signaling in the Small Airway Basal Progenitor Cells in COPD | None | OBSERVATIONAL | COMPLETED | 2014-07-16T00:00:00 | null | 2024-10-29T00:00:00 | 2024-10-29T00:00:00 | null | 111 | 18 | null | ALL | true | Early changes associated with the development of smoking-induced diseases, e.g., COPD and lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells necessary for generation of differentiated airway epithelium. Based on our preliminary observations on SAE BC cells and FGFR2 signaling, we hypothesized that suppression of FGFR2 signaling in the SAE BC stem/progenitor cells by cigarette smoking renders these cells less potent in generating and maintaining normally differentiated SAE, shifting these cells towards a COPD associated phenotype. To test this, SAE basal cells will be isolated from cultured cells obtained through bronchoscopic brushings and analyzed through in vitro assays for their stem/progenitor capacities. | Changes within the small airways of the lungs represent the key element in the mechanism of COPD, as they precede the development of emphysema and contribute to the progressive decline in expiratory airflow. One of the key features of COPD is the remodeling of the small airway epithelium (SAE), and COPD SAE phenotypes are often induced by smoking and broad gene expression changes in the SAE. Many of the specific mechanisms for maintenance and regeneration of small airways and differentiated SAE in adult human lungs are largely unknown, but smoking associated defects in the maintenance of the SAE may be an early event of COPD. Preliminary data from murine studies have indicated that fibroblast growth factor receptor 2 (FGFR2) signaling is critical for lung architecture and development, and preliminary evidence has shown the FGFR2 pathway is down regulated within the small airway epithelium (SAE) of smokers and smokers with COPD. We hypothesize that the suppression of FGFR2 signaling in SAE BC stem cells by cigarette smoking causes these cells to become less potent, shifting the expression of normally differentiated SAE towards the COPD-associated small airway phenotype and therefore affecting the generation and maintenance of these cells. Using technologies established in our laboratories, pure populations of BC will be isolated from the SAE of healthy nonsmokers, healthy smokers, and COPD smokers. The stem/progenitor cell capacities of the SAE BC of each group will then be analyzed through the use of 3D modeling. The basic mechanisms of COPD will be tested by focusing on the phenotypes present in the lungs of COPD patients and comparison to their nonsmoker and healthy smoker counterparts. The 3 aims will be assessed in parallel, with all aims sharing in the biologic samples:
Aim 1 (n=60). To determine whether BC from the SAE of COPD smokers have reduced capacity to generate normally differentiated SAE, e.g initiate airway branching and repair in response to injury in vitro but generate airway epithelium with the phenotype similar to that present in SAE of COPD smokers in vivo.
Aim 2 (n=20). To test the hypothesis that FGFR2 signaling is necessary for normal SAE BC stem cell function and suppression of FGFR2 caused by inhibitors and smoking associated factors (EGF and TGF- beta) leads an altered stem cell functional phenotype similar to SAE BC from COPD smokers with reduced capacity as characterized by Aim 1.
Aim 3 (n=40). To assess the hypothesis that increasing FGFR2 signaling and suppressing smoking induced EGF receptors and TGF-beta pathways will restore the FGFR2 expression and normalize the capacity of SAE BC stem cells to generate and maintain normally differentiated SAE. | Samples from newly recruited research subjects will be collected under the IRB approved protocol "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies" (IRB # 1204012331) or may have been collected under previous IRB approved collection protocols: #0005004439, #0005004440, and #0905010391.
Inclusion Criteria:
* Must be capable of providing informed consent
* Males and females, age 18 or older
* Nonsmoking, matched with other groups by age, sex, ethnic/racial group
* Good overall health without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease
* Normal physical examination
* Normal routine laboratory evaluation, including general hematologic studies, general serologic/ immunologic studies, general biochemical analyses, and urine analysis
* Negative HIV serology
* Normal chest X-ray (PA and lateral)
* Normal electrocardiogram
* Females - not pregnant
* No history of allergies to medications to be used in the bronchoscopy procedure
* Not taking any medications relevant to lung disease or having an effect on the airway epithelium
* Willingness to participate in the study
Exclusion Criteria:
* Unable to meet the inclusion criteria
* Pregnancy
* Current active infection or acute illness of any kind
* Current alcohol or drug abuse
* Evidence of malignancy within the past 5 years | Weill Medical College of Cornell University | OTHER | {
"id": "1311014509",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-01-13T00:00:00 | {
"date": "2025-03-11",
"type": "ACTUAL"
} | {
"date": "2015-01-19",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | New York Metropolitan area residents | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"COPD",
"Smoking",
"Lung Disorder"
] | ["Lung", "COPD", "smoking", "Non-smoker"] | null | [
{
"city": "New York",
"country": "United States",
"facility": "Weill Cornell Medicine",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
}
] | [
{
"class": "NIH",
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Expression of FGFR2 and related pathways in SAE BC",
"timeFrame": "5 Years"
}
],
"secondary": null
} | [
{
"affiliation": "Weill Cornell Medical College, NY",
"name": "Renat Shaykhiev, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
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],
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} | {
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NCT03498326 | null | Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer | Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer | GCRP | INTERVENTIONAL | RECRUITING | 2018-04-02T00:00:00 | null | 2023-03-31T00:00:00 | 2030-03-31T00:00:00 | [
"PHASE2"
] | 480 | 18 | 90 | ALL | false | The prognosis of pancreatic cancer is extremely poor, even in those patients who had underwent surgery, the 5-year survival is still less than 10%. Current guidelines recommend Gemcitabine monotherapy for R0 resection of pancreatic cancer. Inflammation plays an critical role in the development and progression of pancreatic cancer. Here we intend to assess the synergistic effect of using celecoxib in combination with gemcitabine on the treatment of R0 resection of pancreatic cancer. | We choose those patients who had underwent the R0 resection of pancreatic ductal adenocarcinoma patients, and divided them into two groups randomly, one group patients were given gemcitabine only according the current guidelines, while the other group patients were given gemcitabine combined with the anti-inflammation agent Celecoxib. The disease free survivals, drugs related side effects, overall survivals and other endpoints events were recorded and analyzed, to assess the celecoxib could or couldn't synergist the gemcitabine anti tumor effect on R0 resection pancreatic cancer patients. | Inclusion Criteria:
1. 18 years old and above.
2. Surgery for R0 resection.
3. The gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies.
4. Eastern Cooperative Oncology Group score 0-2 points.
5. Blood routine: The neutrophil count is at least 1.5\*10\^9/ml, and the platelet count is at least 100\*10\^9/ml.Hemoglobin is at least 80g/L.
6. Liver function: bilirubin does not exceed 1.5 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase does not exceed the upper limit of normal 3 times; kidney function: creatinine ≤ 1.2 mg/dL.
Exclusion Criteria:
1. Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma).
2. Surgery for pancreatic cancer fails to reach the R0 resection criteria.
3. Pancreatic cancer received radiotherapy before surgery.
4. Malignant brain metastases.
5. There are other serious cancer history.
6. Active infection, severe diarrhea.
7. Others: Those who are allergic to celecoxib; or who are intolerant to celecoxib, require continuous aspirin or Non-steroidal anti-inflammatory drugs; similar chemical or biological components and sulfa drugs that constitute the study drug History of allergies; allergies, asthma, and rubella after taking aspirin or non-steroidal anti-inflammatory drugs; pregnancy or breastfeeding; active gastrointestinal ulcer/hemorrhage/perforation; Severe mental illness; severe heart failure; past serious cardiovascular thrombotic adverse events, severe hypertensive patients. | Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER | {
"id": "SAHZhejiangU-GCRP",
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} | 2018-04-07T00:00:00 | {
"date": "2018-05-30",
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"date": "2018-04-13",
"type": "ACTUAL"
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} | [
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"Chemotherapy Effect"
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"facility": "the second affiliated hospital of Zhejiang University",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
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],
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},
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"description": null,
"measure": "Carbohydrate antigen 19-9",
"timeFrame": "Up to approximately 36 months"
},
{
"description": null,
"measure": "Quality of Life",
"timeFrame": "Up to approximately 60 months"
},
{
"description": null,
"measure": "Common Toxicity Criteria for Adverse Effects",
"timeFrame": "Up to approximately 12 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"id": "D009371",
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NCT04377126 | null | Unacylated Ghrelin to Improve Functioning in PAD | Unacylated Ghrelin to Improve Functioning in PAD: The GIFT Trial Phase II | GIFTII | INTERVENTIONAL | COMPLETED | 2020-05-04T00:00:00 | null | 2025-01-23T00:00:00 | 2025-01-23T00:00:00 | [
"PHASE2"
] | 25 | 55 | null | ALL | true | GIFT is a pilot, randomized, double-blinded clinical trial that will examine the effects of unacylated ghrelin on walking ability in people with peripheral artery disease (PAD) compared to placebo. Preliminary evidence suggests that unacylated ghrelin may improve blood flow to the extremities and promote improved skeletal muscle growth and energy use.
A total of 30 participants with PAD will be randomized to one of two groups: unacylated ghrelin injections or placebo injections . Participants will self-administer the study drug or placebo subcutaneously once daily for four months. The primary outcome is change in six-minute walk distance between baseline and 4-month follow-up | Work from the McDermott research team and that of other investigators shows that patients with lower extremity peripheral artery disease (PAD) have greater functional impairment, faster functional decline, and higher rates of mobility loss compared to people without PAD. In patients with PAD, ischemia results in calf muscle injury that includes myofiber loss and calf muscle mitochondrial dysfunction. Therapies to regenerate calf skeletal muscle cells, improve mitochondrial function, and increase calf muscle capillary density may improve functioning and prevent mobility loss in people with PAD. Yet few effective therapies currently exist for patients with PAD.
This pilot study will investigate the therapeutic potential of unacylated ghrelin to promote capillary growth, increase calf muscle perfusion, and reverse PAD-related skeletal muscle abnormalities, thereby improving PAD-related functional impairment. Ghrelin is a peptide and hormone that circulates in acylated and unacylated forms. Unacylated ghrelin promotes skeletal muscle cell regeneration, improves mitochondrial function, and increases muscle capillary density. Unlike acylated ghrelin, unacylated ghrelin does not increase appetite, or cause insulin resistance.
The proposed GIFT Trial will provide preliminary data to test the hypothesis that unacylated ghrelin improves walking performance and prevents mobility loss in older patients with PAD. Furthermore, the investigators hypothesize that the favorable effect of unacylated ghrelin will be mediated by increased myofiber regeneration, increased muscle capillary density, and improved muscle mitochondria function. If preliminary data support these hypotheses, results will be used to design a large randomized trial of unacylated ghrelin therapy, in subsequent study, to improve functioning and prevent mobility loss in older people with PAD.
Investigators will conduct a pilot randomized trial in 30 participants age 55 and older with PAD, to gather preliminary evidence about whether daily subcutaneously administered unacylated improves the six-minute walk distance (primary outcome), maximal treadmill walking time(secondary outcome), and calf muscle perfusion (secondary outcome), compared to placebo. Investigators will also perform calf muscle biopsies at baseline and follow up to determine whether unacylated ghrelin increases Type 1 skeletal muscle myofibers, satellite cell number, capillary density, and succinate dehydrogenase (SDH) mitochondrial activity in calf skeletal muscle, compared to placebo. If these hypotheses are correct, results will be used to design a large, definitive randomized trial of unacylated ghrelin to improve lower extremity functioning and prevent mobility loss in the large and growing number of older people who are disabled by PAD. | Inclusion Criteria:
1. 55 years and older
2. Presence of peripheral artery disease defined as either:
1. An ankle-brachial index (ABI) of less than or equal to 0.90 at the baseline study visit
2. Vascular lab evidence of PAD or angiographic evidence of PAD with ischemic leg symptoms during the six-minute walk and/or treadmill exercise stress test.
Exclusion Criteria:
1. Above- or below-knee amputation.
2. Critical limb ischemia.
3. Wheelchair-bound or requiring a cane or walker to ambulate.
4. Walking is limited by a symptom other than PAD.
5. Current ulcer on bottom of foot. The participant may become eligible after the ulcer heals.
6. Significant liver or kidney impairment defined as two or more hepatic function enzymes \> 3.0 times the upper limit of normal and/or eGFR \< 20. \[NOTE: participants who meet this criterion may undergo a re-test of hepatic function tests to determine whether initially elevated hepatic enzymes represented a transient or spurious phenomenon.\]
7. Unwilling or unable to self-administer study drug.
8. Failure to successfully complete the study run-in.
9. Planned lower extremity revascularization or other major surgery during the next four months.
10. Lower extremity revascularization, major orthopedic surgery, cardiovascular event, coronary revascularization, or other major surgery in the previous three months.
11. Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who only use oxygen at night may still qualify.\]
12. Mini-Mental Status Examination (MMSE) score \< 23
13. Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\]
14. Currently taking study drug(s) or has taken study drug(s) in past six months.
15. Increase in angina in last month or angina at rest.
16. Non-English speaking.
17. Visual impairment that limits walking ability.
18. Women who are pregnant or who are pre-menopausal will not be eligible.
19. Potential participants who recently participated in or are currently participating in a supervised treadmill exercise and those planning to begin a supervised treadmill exercise regimen will become eligible four months after their participation in the supervised treadmill exercise program has ended.
20. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
21. The potential participant does not have adequate refrigeration for storing study drug.
Vulnerable populations (fetuses, pregnant women, children, prisoners, and institutionalized persons) and adults unable to consent will not be included in the study. | Northwestern University | OTHER | {
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"date": "2025-04-29",
"type": "ACTUAL"
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"date": "2020-05-06",
"type": "ACTUAL"
} | [
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NCT03662126 | null | KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment | A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT 232 in Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera MF (Post-PV-MF), Or Post Essential Thrombocythemia MF (Post-ET-MF) Who Are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment | BOREAS | INTERVENTIONAL | RECRUITING | 2018-09-05T00:00:00 | null | 2023-12-31T00:00:00 | 2025-12-31T00:00:00 | [
"PHASE2",
"PHASE3"
] | 385 | 18 | null | ALL | false | This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.
This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. | null | Inclusion Criteria:
* Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
* High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
* Failure of prior treatment with JAK inhibitor
* ECOG ≤ 2
Exclusion Criteria:
* Prior splenectomy
* Splenic irradiation within 3 months prior to randomization
* History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
* History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
* Prior MDM2 inhibitor therapy or p53-directed therapy
* Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
* History of major organ transplant
* Grade 2 or higher QTc prolongation (\> 480 milliseconds per NCI-CTCAE criteria, version 5.0) | Kartos Therapeutics, Inc. | INDUSTRY | {
"id": "KRT-232-101",
"link": null,
"type": null
} | Unknown | {
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} | 2018-09-05T00:00:00 | {
"date": "2023-04-28",
"type": "ACTUAL"
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"date": "2018-09-07",
"type": "ACTUAL"
} | [
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} | null | [{"pmid": null, "type": "BACKGROUND", "citation": "Al-Ali, H.K.; Delgado, R.G.; Lange, A.; Pluta, A.; McLornan, D.; Vachhani, P.; Damaj, G.L.; Jost, P.J.; Rejto, L.; Hus, M.; et al. KRT-232, A First-In-Class, Murine Double Minute 2 Inhibitor, for Myelofibrosis Relapsed or Refractory to Janus-Associated Kinase Inhibitor Treatment. Eha. Libr. 2020, 295035, S215"}] | {"versionHolder": "2025-06-18"} | {
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NCT00709826 | null | APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer | APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer | None | INTERVENTIONAL | COMPLETED | 2008-07-01T00:00:00 | null | null | null | [
"PHASE2"
] | 109 | 18 | null | ALL | false | This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer. | This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only. | Inclusion Criteria:
1. Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
2. Life expectancy greater than or equal to 3 months.
3. Patients must have measurable disease by RECIST.
4. ECOG PS of 0, 1, or 2.
5. Negative serum pregnancy test at the time of first dose for women of childbearing potential.
Exclusion Criteria:
1. Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
2. RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
3. Evidence of New York Heart Association class III or greater cardiac disease.
4. History of myocardial infarction, stroke, ventricular arrhythmia.
5. Symptomatic central nervous system metastases.
6. Pregnant or nursing women.
7. Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
8. History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
9. Previous anti-EGFR kinase therapy. | Tragara Pharmaceuticals, Inc. | INDUSTRY | {
"id": "TP2001-203",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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"date": "2012-11-07",
"type": "ESTIMATED"
} | {
"date": "2008-07-03",
"type": "ESTIMATED"
} | [
"ADULT",
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] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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} | [
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"Metastatic Pancreatic Cancer"
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] | null | null | {
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],
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} | [
{
"affiliation": "Tragara Pharmaceuticals, Inc.",
"name": "Tracy Parrott",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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NCT05600426 | null | A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202) | A Phase III Randomized Trial Comparing Unrelated Donor Bone Marrow Transplantation With Immune Suppressive Therapy for Newly Diagnosed Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202) | TransIT | INTERVENTIONAL | RECRUITING | 2022-10-20T00:00:00 | null | null | null | [
"PHASE3"
] | 234 | 0 | 25 | ALL | false | Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant. Regular treatment for patients with aplastic anemia who have a matched sibling (brother or sister), or family donor is a bone marrow transplant. Patients without a matched family donor normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone marrow transplant (BMT) is used as a secondary treatment in patients who did not get better with IST, had their disease come back, or a new worse disease replaced it (like leukemia).
This trial will compare time from randomization to failure of treatment or death from any cause of IST versus URD BMT when used as initial therapy to treat SAA.
The trial will also assess whether health-related quality of life and early markers of fertility differ between those randomized to URD BMT or IST, as well as assess the presence of marrow failure-related genes and presence of gene mutations associated with MDS or leukemia and the change in gene signatures after treatment in both study arms.
This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for treatment of SAA. | This study is a multi-center randomized phase III trial to compare the failure free survival between those randomized to IST vs 9-10/10 HLA matched URD BMT. The study will also address patient-reported outcomes and gonadal function in each arm and explore critical biological correlates including assessing germline genetic mutations associated with pediatric SAA that may lead to a predisposition to the disease and the risk of development of clonal hematopoiesis following IST vs BMT in pediatric and young adult SAA.
This clinical trial will randomize 234 children/AYA over 3.3-4.7 years at a 1:1 ratio between initial treatment with immune suppression therapy (IST) with horse ATG (hATG)/cyclosporine (CsA) versus well- matched (9-10/10 allele) unrelated donor (URD) bone marrow transplantation (BMT) using a regimen of rabbit ATG (rATG)/fludarabine/cyclophosphamide and 200 cGy TBI. Duration of subject participation for all study procedures in this study will be up to 2 years after treatment; a single later timepoint between 3 and 5 years will be collected to follow patients for specific protocol defined late effects and survival. | Inclusion Criteria:
To be eligible to participate in the randomized trial, an individual must meet all the following criteria:
1. Provision of signed and dated informed consent form for the randomized trial by patient and/or legal guardian.
2. Age ≤25 years old at time of randomized trial consent.
3. Confirmed diagnosis of idiopathic SAA, defined as:
1. Bone marrow cellularity \<25%, or \<30% hematopoietic cells.
2. Two of three of the following (in peripheral blood): neutrophils \<0.5 x 10\^9/L, platelets \<20 x 10\^9/L, absolute reticulocyte count \<60 x 10\^9/L or hemoglobin \<8 g/dL.
4. No suitable fully matched related donor available (minimum 6/6 match for HLA-A and B at intermediate or high resolution and DRB1 at high resolution using DNA based typing).
5. At least 2 unrelated donors noted on NMDP search who are well matched (9/10 or 10/10 for HLA-A, B, C, DRB1, and DQB1 using high resolution).
6. In the treating physician's opinion, no obvious contraindications precluding them from BMT or IST.
Exclusion Criteria:
1. Presence of Inherited bone marrow failure syndromes (IBMFS). The diagnosis of Fanconi anemia must be excluded by diepoxybutane (DEB) or equivalent testing on peripheral blood or marrow. Telomere length testing should be sent on all patients to exclude Dyskeratosis Congenita (DC), but if results are delayed or unavailable and there are no clinical manifestations of DC, patients may enroll. If patients have clinical characteristics suspicious for Shwachman-Diamond syndrome, this disorder should be excluded by pancreatic isoamylase testing or gene mutation analysis (note: pancreatic isoamylase testing is not useful in children \<3). Other testing per center may be performed to exclude IBMFS.
2. Clonal cytogenetic abnormalities or Fluorescence In-Situ Hybridization (FISH) pattern consistent with pre- myelodysplastic syndrome (pre-MDS) or MDS on marrow examination.
3. Known severe allergy to ATG.
4. Prior allogeneic or autologous stem cell transplant.
5. Prior solid organ transplant.
6. Infection with human immunodeficiency virus (HIV).
7. Active Hepatitis B or C. This only needs to be excluded in patients where there is clinical suspicion of hepatitis (e.g., elevated LFTs).
8. Female patients who are pregnant or breast-feeding.
9. Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ.
10. Disease modifying treatment prior to study enrollment, including but not limited to use of androgens, eltrombopag, romiplostim, or immune suppression. Note: Supportive care measures such as G-CSF, blood transfusion support and antibiotics are allowable | Boston Children's Hospital | OTHER | {
"id": "IRB-2020-0438",
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"hasExpandedAccess": false,
"nctId": null,
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} | 2022-10-26T00:00:00 | {
"date": "2025-05-07",
"type": "ACTUAL"
} | {
"date": "2022-10-31",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | true | {
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"interventionModel": "PARALLEL",
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"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
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"observationalModel": null,
"primaryPurpose": "TREATMENT",
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{
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"name": "National Institutes of Health (NIH)"
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{
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"primary": [
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"description": null,
"measure": "The primary endpoint of this trial is time from randomization to treatment failure or death from any cause.",
"timeFrame": "Randomization to 2 years post-randomization"
}
],
"secondary": [
{
"description": null,
"measure": "Comparison of subjects with failure of IST or BMT before or at 2 years",
"timeFrame": "Randomization to 2 years post-randomization"
},
{
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"timeFrame": "Randomization to 2 years post-randomization"
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{
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"timeFrame": "Randomization to 2 years post-randomization"
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{
"description": null,
"measure": "Estimate the time from randomization to initiation of IST or BMT.",
"timeFrame": "Randomization through Day 100"
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{
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"timeFrame": "Randomization through Day 100"
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{
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"timeFrame": "Randomization through two years post randomization"
},
{
"description": null,
"measure": "Estimate the median time to T- and B-cell immune reconstitution the first year for the URD BMT Arm",
"timeFrame": "Initiation of therapy (Day 0) to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Comparison of overall survival at 1 and 2 years from randomization in both arms.",
"timeFrame": "Randomization to one year, randomization to two years"
},
{
"description": null,
"measure": "Comparison of treatment-related mortality (TRM) at 1 and 2 years from randomization in both arms.",
"timeFrame": "Randomization to 1 year, randomization to 2 years"
},
{
"description": null,
"measure": "Comparison of the median time from randomization to and rates of neutrophil recovery on both arms",
"timeFrame": "Randomization to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Comparison of the median time from randomization to and rate of platelet recovery on both arms",
"timeFrame": "Randomization to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Comparison of the median time from randomization to and rates of red blood cell recovery on both arms",
"timeFrame": "Randomization to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Comparison of the median time from initiation of therapy to and rates of neutrophil recovery on both arms",
"timeFrame": "Initiation of therapy to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Comparison of the median time from initiation of therapy to and rate of platelet recovery on both arms",
"timeFrame": "Initiation of therapy to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Comparison of the median time from initiation of therapy to and rates of red blood cell recovery on both arms.",
"timeFrame": "Randomization to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Estimate the rates of engraftment in patients who are randomized to URD BMT.",
"timeFrame": "Randomization to 3-5 years"
},
{
"description": null,
"measure": "Estimate the rates of primary graft failure in patients who are randomized to URD BMT .",
"timeFrame": "Randomization to 3-5 years"
},
{
"description": null,
"measure": "Estimate the rates of secondary graft failure in patients who are randomized to URD BMT .",
"timeFrame": "Randomization to 3-5 years"
},
{
"description": null,
"measure": "Estimate the rates of grade II-IV acute GVHD in patients who are randomized to URD BMT .",
"timeFrame": "Randomization to 3-5 years"
},
{
"description": null,
"measure": "Estimate the rates of grade III-IV acute GVHD in patients who are randomized to URD BMT.",
"timeFrame": "Randomization to 3-5 years"
},
{
"description": null,
"measure": "Estimate the rates of severe chronic GVHD in patients who are randomized to URD BMT.",
"timeFrame": "Randomization to 3-5 years"
},
{
"description": null,
"measure": "Estimate the rates of response of patients randomized to IST",
"timeFrame": "Randomization to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Estimate the rates of failure of patients randomized to IST",
"timeFrame": "Randomization to 100 days, 180 days, 1 year and 2 years"
},
{
"description": null,
"measure": "Describe the secondary therapies given and outcomes achieved for patients failing initial therapy",
"timeFrame": "Randomization to 3-5 years"
},
{
"description": null,
"measure": "Comparison of rates of secondary MDS, AML, other subsequent neoplasms, and development of Paroxysmal Nocturnal Hemoglobinuria in both treatment arms for the duration of the trial.",
"timeFrame": "Randomization to 3-5 years"
},
{
"description": null,
"measure": "Comparison of HR-QoL score between patients randomized to both arms",
"timeFrame": "Randomization to 2 years post-randomization, randomization to up to 5 years post-randomization"
},
{
"description": null,
"measure": "Comparison of gonadal function values between patients randomized to both arms",
"timeFrame": "Randomization to 1 year post-randomization, randomization to 2 years post-randomization, and randomization to up to 5 years post-randomization"
}
]
} | [
{
"affiliation": "Boston Children's Hospital",
"name": "David Williams, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "University of Utah",
"name": "Michael Pulsipher, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "CIBMTR/Medical College of Wisconsin (MCW)",
"name": "Bronwen Shaw, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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NCT05749926 | null | Immunogenicity and Reactogenicity of the Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine | Immunogenicity and Reactogenicity of the Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine: A Non-inferiority Multicenter Single-blinded, Randomized Trial | CoviBOOST 2 | INTERVENTIONAL | UNKNOWN | 2023-02-28T00:00:00 | null | 2023-07-12T00:00:00 | 2024-07-12T00:00:00 | [
"PHASE3"
] | 248 | 18 | null | ALL | true | The objective of this trial is to compare the immunogenicity and the safety of the Beta-variant recombinant protein booster vaccine (VidPrevtyn® Beta, Sanofi) to a bivalent mRNA vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in adults previously vaccinated with at least 3 doses of COVID-19 mRNA vaccine. The results will provide important data for the future COVID 19 vaccine strategy.
A biobank will also be set up to evaluate the protection conferred by one or other of these vaccines as booster in the event of the emergence of new variants in the future. | The efficacy of COVID 19 vaccines for reducing the risk of severe COVID-19 infection is demonstrated in real life.
However, data currently available on the persistence of immunity after vaccination on the one hand and the emergence of viral variants with reduced sensibility to vaccine immunity on the other, raise the need to administer boosters to maintain the protection and to compare different strategies as bivalent mRNA vaccines but also others platforms.
The vaccines currently recommended as boosters in France are mRNA bivalent vaccines, adapted to better match the circulating variants of SARS-CoV-2 and expected to provide broader protection against Omicron sub variants (19). However, the rapid antigenic evolution of SARS-CoV-2 and the antigenic imprinting against the initial Hu-1 strain could reduce their effectiveness.
More recently, the Beta-variant recombinant protein booster vaccine (VidPrevtyn Beta, Sanofi) obtained European authorization and is recommended in France as booster as an alternative to the bivalent mRNA vaccines (21, 22). However, in the absence of comparative data with the bivalent mRNA vaccines, VidPrevtyn Beta is recommended as second line.
It has been shown with vectored vaccines that a heterologous vaccination scheme could be more immunogenic than a homologous scheme (23). Our group previously showed that VidPrevtyn Beta, administered as a third vaccine dose, induces higher immune response than the mRNA BNT162b2 vaccine (Comirnaty, BioNTech-Pfizer), against Beta variant but also others variants of concern (VOC) including Omicron BA1 (20) and Omicron BA4/5 (data submitted for publication). The data available at 3 and 6 months after the boost, show that VidPrevtyn Beta could be also of interest in term of durability of the response (data not published). The hypothesis is that a Beta variant protein recombinant vaccine could enlarge the protection against the variants by overpassing antigenic imprinting and the adjuvant improve the duration of immune response and protection. Moreover, the Beta-variant recombinant protein vaccine could bring an advantage in terms of reactogenicity, acceptability, cost and accessibility.
In this context, as recently pointed by the HAS, comparative data on immunogenicity and reactogenicity between a bivalent mRNA vaccine and the Beta-variant recombinant protein, both administered as boosters, are needed to better adapt the COVID 19 vaccine recommendations for the future.
This study is Comparative, non-inferiority, single-blinded, multicenter, randomized trial.
Randomization in a 1:1 ratio, will be stratified by age (18-60 years and ≥ 60 years of age) and history of SARS-CoV-2 infection | Inclusion Criteria:
1. Male or female aged 18 years and over
2. Adult in a healthy condition or with a stable health status, determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health. Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment can be included at the discretion of the investigator.
3. For women of childbearing age: a negative highly sensitive pregnancy urinary test during the inclusion visit
4. Confirmed receipt of at least three doses of COVID-19 mRNA vaccine the last dose at least 6 months prior to study vaccine
5. Understands and agrees to comply with the study procedures
6. Written informed consent signed by both the participant and the investigator
7. Subject affiliated to the French Social Security System.
Exclusion Criteria:
1. Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 within the previous 28 days
2. Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection \< 3 months prior to the study vaccine dose.
3. Immunosuppressive therapy such as corticosteroids \> 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies.
4. Treatment with immunoglobulins or other blood derivatives within 3 months prior to inclusion or scheduled administration of immunoglobulins or blood derivatives before the end of the study.
5. Any medical condition, such as cancer, that might impair the immune response.
6. Use of experimental immunoglobulins, experimental monoclonal antibodies or convalescent plasma is not permitted during the study.
7. Pregnancy or breastfeeding currently ongoing
8. History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-COV-2 vaccine at the time of the first vaccine injection:
9. Any bleeding disorder considered as a contraindication to an intramuscular injection,
10. Participation in other interventional research involving humans within 4 weeks prior to the inclusion visit, or participation in any other vaccine trial excepted for those with mid or long term follow up when vaccination was made at least 4 weeks before the injection in the study. In this case no delay is required after the end of the study participation".
11. Subject under legal protection (e.g. guardianship) | Assistance Publique - Hôpitaux de Paris | OTHER | {
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NCT03630757 | null | Effects of Manual Therapy in Fibromyalgia Syndrome | Effects of Manual Therapy on Pain, Spinal Mobility, Quality of Sleep and Emotional Status in Fibromyalgia Syndrome | Fibromyalgia | INTERVENTIONAL | COMPLETED | 2018-08-07T00:00:00 | null | 2018-04-05T00:00:00 | 2018-07-07T00:00:00 | [
"NA"
] | 40 | 30 | 50 | FEMALE | false | Fibromyalgia syndrome (FMS) is among the most difficult diseases that restrict physical functions of patients due to persistent aches,sleep problems,psychological problems and decrease the quality of life. The aim of this study was to investigate the efficacy of manual therapy (MT) in the treatment of FMS patients. | Fibromyalgia syndrome (FMS) etiology is a chronic musculoskeletal system characterized by widespread pain and hyperalgesia in the body that is not yet known. At the same time, FMS patients are accompanied by functional emotional disorders including persistent muscle soreness, muscle spasms, mood disorders such as chronic fatigue, sleep disturbances, paresthesia, morning stiffness, depression, and cognitive disorders. The prevalence in the general population in the world between 2-4%, but reaching up to 7% between 50-80 years of age the prevalence of a study conducted in Turkey were found to be 3.6%. Frequently seen in women between the ages of 40-60, the quality of life of patients with FMS falls because of generalized pain in their bodies, accompanied by stress in 30-45% of patients.
According to Chaitow, there are 3 factors in the etiology of the dysfunctional model of FMS syndrome (biochemical, biomechanical, psychosocial) : (1) Negative emotional state may cause specific biochemical change, weakening of immune functions and change in muscle tone (2) Hyperventilation, blood oxygenation at the neural level, general anxiety and anxiety state, change in the structural components of the thoracic and cervical region (3) Chemical changes in blood flow may cause emotional and structural changes. The neuroendocrine hypothalamic pituitary that controls primer stress response may have abnormal release of corticotropin releasing hormone, adrenocorticotropic hormone, and cortisol, which are part of the adrenal axis. Hypothalamic corticotropin releasing hormone delays corticotropin release by insufficiency of interleukin-6 regulation in the neuronal function defect. Although the pathophysiology is not yet fully understood, it is thought to be related to environmental and genetic factors. The basal autonomic status of FMS patients is characterized by increased sympathetic system and reduced parasympathetic system. The most basic complaints of patients are generalized pain. For this reason, peripheral and central nociceptive pathways are dominant in the view of being active in FMS patients. Intramuscular connective tissue dysfunction, myofascial tissue inflammation and fibroblasts and release of pro-inflammatory cytokines cause chronic peripheral sensitization in these patients. Some authors have reported that trigger points have central sensitization-inducing effects, while others have indicated that such a situation is not the case because the patient with each trigger point is not FMS. In recent biopsy studies, it has been found that the level of collagen in the endomyositis of the FMS muscles is increased, the production of N-carboxymethylsine, which is the oxidative stress marker, is increased, and the tissue damage is increased and the CD-68 positive macrophage levels in the interstitial tissue are increased in the muscles. The disturbance in the peripheral and central mechanisms leads to impairment of the postural control and therefore the increase in the frequency of falls with equilibrium losses. In the treatment of these symptoms, it was reported that the application of myofascial relaxation techniques had positive effects on patients' quality of life, sleep patterns, joint stiffness, neck and back pain.
Myofascial release therapy Myofascial relaxation restores pain relief by restoring soft-touch dysfunctions. Behind the therapeutic effects of myofascial relaxation is the effect on the connective tissue, that is, the fascia, one of the structures that play a fundamental role in the musculoskeletal functions. According to this theory, the facial system makes a great contribution to the different functions spreading from head to foot and to the dynamic movements of the body through its ability to move. Hardened and shortened facial tissue (due to recurrent micro trauma or acute injury), loss of functional capacity and pain due to reduced ability to shear. Myofascial relaxation therapy can also restore the mobility and pain sensation in the joints by stretching, loosening to the myofascial tissue. Myofascial relaxation therapy is a combination of manual traction and long stretching maneuvers to open facial adhesions. There are two basic myofascial release techniques, direct and indirect. In the direct relaxation technique, the therapist uses a hand or device to apply slight pressures (for 90-120 seconds) directly on the restricted tissue. The direct technique also includes self myofascial relaxation techniques. In the indirect technique, the myofascial complex is extended for a longer time under less load. With myofascial relaxation, normalization of the morphological and inflammatory responses of fibroblasts injured in the context of recurrent strains is possible.
The aim of this study was to investigate the efficacy of myofascial relaxation and mobilization techniques in the treatment of FMS patients on pain, trigger point number, FMS effect score, spinal mobility, sleep quality, anxiety and depression. | Inclusion Criteria:
* Between the ages of 30 and 50
* No remission during the last 48 months
* Do not have regular physical activity
* Have had a daily activity limit of at least 1 day within 30 days
Exclusion Criteria:
* Cardiac, renal, hepatic insufficiency
* Severe physical disability
* Comorbid conditions (interstitial cystitis, inflammatory diseases)
* Chronic viral infection
* Fever
* Rheumatoid arthritis, herpes lupus
* Multiple sclerosis, polio, epilepsy
* Hypertension and hypotension
* Respiratory deficiencies during treatment
* Skin lesions
* Psychiatric disorders
* Past surgical history | Istanbul Bilgi University | OTHER | {
"id": "2018-40016-69",
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"type": null
} | Unknown | {
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"nctId": null,
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} | 2018-08-10T00:00:00 | {
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} | {
"date": "2018-08-15",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Patients were randomly divided into 2 groups of 20 people. A randomized list is prepared in a computer environment by a statistician for randomization. In this list, the odd numbers for the control group and the MT group were given double numbers. The group identification is printed on sequentially numbered cards placed in sealed envelopes. After enrollment, the numbered envelope was opened by the patient and the blind investigator. For the study group, manual therapy (MT) was given and the home exercise program was given and for the control group only home exercise program was given. In the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk). The treatment program has been implemented by a physiotherapist who specializes in this area.",
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"Manual Therapies"
] | ["Fibromyalgia syndrome", "Manual Therapies", "Pain"] | null | [
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"facility": "Istanbul Bilgi University",
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} | [
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"name": "TOMRIS DUYMAZ",
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"term": "Neuromuscular Diseases"
},
{
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}
],
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
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"name": "All Conditions"
},
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
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}
],
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"relevance": "HIGH"
},
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"id": "M12161",
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"relevance": "HIGH"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
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"id": "M12411",
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}
],
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"term": "Fibromyalgia"
},
{
"id": "D009209",
"term": "Myofascial Pain Syndromes"
}
]
} | null | {
"conditions": [
{
"id": "D005356",
"term": "Fibromyalgia"
},
{
"id": "D009209",
"term": "Myofascial Pain Syndromes"
}
],
"interventions": null
} |
NCT06251557 | null | Effects of Lumbopelvic Massage and Exercise Training in Children With Lower Urinary Tract Dysfunction | Additional Effects of Lumbopelvic Massage and Exercise Training to Standard Urotherapy and Biofeedback Therapy in Children With Lower Urinary Tract Dysfunction | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-02-01T00:00:00 | null | null | null | [
"NA"
] | 68 | 7 | 15 | ALL | false | Lower urinary tract dysfunctions (LUTD) are common in the pediatric population and include symptoms related to functional disorders. LUTD limits children and their parents socially, physically, and financially; leads to secondary comorbidities in the long term and negatively affects quality of life. Therefore, effective treatment of LUTD is important. Treatment options in children with LUTD include standard urotherapy, physiotherapy and rehabilitation practices, pharmacologic approaches, and Botulinum toxin type A injections. Pharmacologic treatment and invasive approaches have high side effect rates and compliance problems; therefore, conservative treatment methods should be completed first. The literature focuses on standard urotherapy, pharmacologic approaches and biofeedback therapy. However, to the best of our knowledge, there is no study in this population that comprehensively addresses the anatomical structures closely related to the pelvic floor with a more holistic perspective beyond the standard patient education and pelvic floor. Therefore, The aim of our study is to demonstrate the additional effects of massage therapy and exercise training for the lumbopelvic area in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design. | Pediatric lower urinary tract dysfunction (LUTD) is a common and multifactorial health problem. A holistic perspective is required in treatment. Therefore, the aim of our study is to demonstrate the additional effects of massage therapy and exercise training for the lumbopelvic area in children with LUTD compared to standard urotherapy and pelvic floor biofeedback therapy in a randomized controlled design. At the beginning of our study, sample size was estimated using the G Power 3.1.9.7 program. Estimating that a 30% difference between the two groups is clinically significant (80% improvement in the score in the research arm and 50% in the control arm), with 80% power and a margin of error of 0.05 in the one-way hypothesis design, the minimum number of samples that should be included in the study was determined for each A total of 62 volunteers were calculated for the group, 31 of which were volunteers. Anticipating a 10% loss rate in volunteers during the study period, the final sample size was calculated as 68 individuals in total, 34 individuals for each research arm. The study will include 68 volunteer children aged 7-15 years with symptoms associated with functional LUTD, accompanied by their parents. Children will be randomly assigned to 2 separate groups according to an online computer generated, gender stratified block randomization list. Group 1 will receive lumbopelvic massage and exercise training in addition to standard urotherapy and pelvic floor EMG biofeedback therapy. Group 2 will receive only standard urotherapy and pelvic floor EMG biofeedback therapy. The treatments will be applied 2 days a week for 6 weeks. Children will be evaluated at the beginning of the study and at the end of the treatment (6th week). The primary outcome measure is the "Dysfunctional Voiding and Incontinence Score". Secondary outcome measures are 3-day voiding and defecation diaries data, uroflowmetry parameters and residual urine volume after voiding by pelvic ultrasound. SPSS program will be used for data analysis. SPSS program will be used for data analysis. In the comparison of numerical data between 2 independent groups, "Independent Groups T Test" will be used when parametric assumptions are met and "Mann-Whitney U test" will be used when parametric assumptions are not met. In the analysis of change within the dependent group, "Significance Test of the Difference Between Two Pairs" will be used when parametric assumptions are met and "Wilcoxon Test" will be used when parametric assumptions are not met. In the examination of the change in outcome measurements over time, the effect of the treatments in both groups on the dependent variables in all evaluations (In-group factor, Time; pre-treatment and post-treatment) will be tested with "Repeated Measures of Anova" using Treatment Group\*Time (2\*2) factors. Type-1 error level for statistical significance will be based on 5%. | Inclusion Criteria:
* Children between the ages of 7 and 15
* Presence of symptoms of functional lower urinary tract dysfunction
* Do not have a condition (such as autism, ADHD-Attention Deficit and Hyperactivity Disorder) that would prevent cooperation with the assessments and interventions in the study
* Consented to participate in the study by their parents
Exclusion Criteria:
* Symptomatic urinary tract infection,
* A neurological disease,
* Neurogenic bladder/bowel diagnosis,
* Monosymptomatic enuresis,
* Anatomical anomaly that may affect bladder/bowel function,
* Fecal incontinence,
* Disruption of skin integrity or open wound at the massage site and
* An orthopedic problem that would prevent them from performing the exercises in the study | Hacettepe University | OTHER | {
"id": "KA-23059",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-02-01T00:00:00 | {
"date": "2024-03-04",
"type": "ACTUAL"
} | {
"date": "2024-02-09",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Lower Urinary Tract Symptoms"
] | ["Children", "Lumbopelvic massage therapy", "Lumbopelvic exercise", "Biofeedback therapy", "Urotherapy"] | null | [
{
"city": "Ankara",
"country": "Turkey",
"facility": "Burcu Sert",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Symptom score",
"timeFrame": "Change in symptom score from baseline up to end of 6th week"
}
],
"secondary": [
{
"description": null,
"measure": "Frequency of voiding, incontinence and defecation",
"timeFrame": "Change in frequency of voiding, incontinence and defecation from baseline up to end of 6th week"
},
{
"description": null,
"measure": "Uroflowmeter parameters",
"timeFrame": "Change in uroflowmeter parameters from baseline up to end of 6th week"
},
{
"description": null,
"measure": "Residual urine volume after voiding",
"timeFrame": "Change in residual urine volume after voiding from baseline up to end of 6th week"
}
]
} | null | [{"pmid": "25772695", "type": "BACKGROUND", "citation": "Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14."}, {"pmid": "15711352", "type": "BACKGROUND", "citation": "Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6."}, {"pmid": "31366055", "type": "BACKGROUND", "citation": "Morgan KE, Leroy SV, Corbett ST, Shepard JA. Complementary and Integrative Management of Pediatric Lower Urinary Tract Dysfunction Implemented within an Interprofessional Clinic. Children (Basel). 2019 Jul 30;6(8):88. doi: 10.3390/children6080088."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D020924",
"term": "Urological Manifestations"
}
],
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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},
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"id": "M22659",
"name": "Urological Manifestations",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D059411",
"term": "Lower Urinary Tract Symptoms"
}
]
} | null | {
"conditions": [
{
"id": "D059411",
"term": "Lower Urinary Tract Symptoms"
}
],
"interventions": null
} |
NCT00739557 | null | A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair. | A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair. | None | OBSERVATIONAL | WITHDRAWN | 2008-08-19T00:00:00 | null | null | null | null | 0 | 18 | null | ALL | false | The purpose of this study is to look at the systemic inflammatory response caused when patients undergo thoracoabdominal aortic aneurysm repair (TAAA). In addition, this study will look at how the inflammatory response affects the post operative healing process and post operative complications. | Patients will be invited to participate in this study prior to the TAAA repair procedure. Prior to the surgery, baseline blood and saliva samples will be collected. Following the surgery, blood and saliva samples will be collected for 48 hours. In addition, hemodynamic data (i.e. vital signs) will be collected for the first 48 hours. The patient data will be reviewed for the first 30 days for morbidity and mortality assessment. | Inclusion Criteria:
* Elective TAAA repair
Exclusion Criteria: | The University of Texas Health Science Center, Houston | OTHER | {
"id": "07-0257",
"link": null,
"type": null
} | Investigator left the institution, another PI has not been named. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-08-20T00:00:00 | {
"date": "2015-12-07",
"type": "ESTIMATED"
} | {
"date": "2008-08-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | patients entering the hospital for elective TAAA repair | NON_PROBABILITY_SAMPLE | false | {
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"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": null,
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Aortic Aneurysm, Thoracic",
"Systemic Inflammatory Response Syndrome"
] | ["elective TAAA repair"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "to evaluate the effects of TAAAA repair on pro-inflammatory mediators and the anti-inflammatory mediators IL-1 receptor antagonist and IL-10.",
"timeFrame": "30 days"
}
],
"secondary": [
{
"description": null,
"measure": "To characterize the inflammatory response after TAAA repair and delineate any association to post-operative morbidity",
"timeFrame": "30 days"
}
]
} | [
{
"affiliation": "Univ. of Texas Health Science Center at Houston",
"name": "Kenneth S Helmer, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D001018",
"term": "Aortic Diseases"
},
{
"id": "D007249",
"term": "Inflammation"
},
{
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"term": "Pathologic Processes"
},
{
"id": "D012769",
"term": "Shock"
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{
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"term": "Aortic Aneurysm, Abdominal"
}
],
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
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],
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},
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},
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"id": "M17400",
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"relevance": "LOW"
},
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},
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"name": "Inflammation",
"relevance": "LOW"
},
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"name": "Shock",
"relevance": "LOW"
},
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"id": "M19800",
"name": "Aortic Aneurysm, Abdominal",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000783",
"term": "Aneurysm"
},
{
"id": "D001014",
"term": "Aortic Aneurysm"
},
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"term": "Aortic Aneurysm, Thoracoabdominal"
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"term": "Aortic Aneurysm, Thoracic"
},
{
"id": "D018746",
"term": "Systemic Inflammatory Response Syndrome"
}
]
} | null | {
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"term": "Aneurysm"
},
{
"id": "D001014",
"term": "Aortic Aneurysm"
},
{
"id": "D000094624",
"term": "Aortic Aneurysm, Thoracoabdominal"
},
{
"id": "D017545",
"term": "Aortic Aneurysm, Thoracic"
},
{
"id": "D018746",
"term": "Systemic Inflammatory Response Syndrome"
}
],
"interventions": null
} |
NCT03994757 | null | Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder | Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder | None | INTERVENTIONAL | UNKNOWN | 2018-12-24T00:00:00 | null | null | null | [
"NA"
] | 40 | 3 | 9 | ALL | false | Autism Spectrum Disorder (ASD) mainly has social and interaction related problems, and repetitive behaviors or interests. In recent years, studies showed that Routine-Based Early Intervention(RBEI) could increase children's development and enhance skills maintenance. Using the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) to assess children can identify different factors under systematic analysis, then improving children's physical functions and self-care abilities. Therefore, this study will design RBEI programs for autistic children, and use ICF-CY to assess the efficacy of RBEIin body function, body structure, and participation for children with autism. | Study will enroll 30-40 children with ASD, aged 3-9 years. Children will receive subjective and objective assessment for pre-test, post-test and three-monthfollow-up after treatment. After pre-test, children will be randomized and assigned to either the experimental group or the control group. The experimental group willreceive RBEI and the control group willreceive traditional therapy. The treatment period is 12 weeks, 1-2 times a week, 1-2hours each time, and homework is given during the treatment period, allowing parents to do treatment at home. Post-test will be conducted immediately after the end of treatment period, and homework will continue until three-month follow-up conducts. It is expected that after intervention, the physical function, activities and participation, quality of life of the experimental group will improve and significantly different from the control group. | Inclusion Criteria:
* Parents are willing to sign written consent form
* Diagnosed as ASD by doctor
* No neurological disease
Exclusion Criteria:
* Active medical condition
* Progressive or degenerative symptoms or illness | Chang Gung Memorial Hospital | OTHER | {
"id": "201602004A3",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-06-20T00:00:00 | {
"date": "2019-08-01",
"type": "ACTUAL"
} | {
"date": "2019-06-21",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Autism Spectrum Disorder"
] | ["Autism Spectrum Disorder", "Routine-Based Early Intervention"] | null | [
{
"city": "Taoyuan",
"country": "Taiwan",
"facility": "Chang Gung Memorial Hospital",
"geoPoint": {
"lat": 24.95233,
"lon": 121.20193
},
"state": null
}
] | null | null | {
"other": null,
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"description": null,
"measure": "Goal Attainment Scale(GAS)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)",
"timeFrame": "baseline, up to 24hours,3-month FU"
}
],
"secondary": [
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"description": null,
"measure": "Childhood Asperger Syndrome Test(CAST)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "The Children Autism Rating Scale Second Edition(CARS-2)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Clancy Behavior Scale",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Social Responsiveness Scale(SRS)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Theory of Mind Inventory-2(ToMI-2)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "The Berry-Buktenica Developmental Test of Visual-Motor Integration(VMI)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Preschool Language Impaired Scale(PLS)/ Language Impaired Scale(LS)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Peabody Picture Vocabulary Test-Revised(PPVT-R)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Assessment of preschool children's participation(APCP) / Children Assessment of Participation and Enjoyment andPreferences for Activity of Children(CAPE)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Functional Independence Measure for Children(WeeFIM)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "TNO-AZL Preschool children Quality of Life(TAPQOL)/TNO-AZL Quality of Life Questionnaire(TACQOL)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Sensory Profile(SP)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Parenting Stress Index(PSI)",
"timeFrame": "baseline, up to 24hours,3-month FU"
},
{
"description": null,
"measure": "Swanson, Nolan, and Pelham Questionnaire(SNAP)",
"timeFrame": "baseline, up to 24hours,3-month FU"
}
]
} | [
{
"affiliation": "Chang Gung Memorial Hospital",
"name": "Chia-Ying Chung, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D065886",
"term": "Neurodevelopmental Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
"browseBranches": [
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
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"name": "All Conditions"
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],
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},
{
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"id": "M5903",
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},
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"asFound": null,
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"name": "Developmental Disabilities",
"relevance": "LOW"
},
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M4815",
"name": "Mental Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001321",
"term": "Autistic Disorder"
},
{
"id": "D000067877",
"term": "Autism Spectrum Disorder"
},
{
"id": "D002659",
"term": "Child Development Disorders, Pervasive"
}
]
} | null | {
"conditions": [
{
"id": "D001321",
"term": "Autistic Disorder"
},
{
"id": "D000067877",
"term": "Autism Spectrum Disorder"
},
{
"id": "D002659",
"term": "Child Development Disorders, Pervasive"
}
],
"interventions": null
} |
NCT00070057 | null | Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer | An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer | None | INTERVENTIONAL | COMPLETED | 2003-10-03T00:00:00 | null | null | null | [
"PHASE1"
] | 75 | 18 | null | FEMALE | false | This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. | PRIMARY OBJECTIVES:
I. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.
SECONDARY OBJECTIVES:
I. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.
II. Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients.
III. Determine whether any observed biological effect of this drug is dose-dependent in these patients.
IV. Identify collateral targets (COX-2-independent) of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
Arm II: Patients receive a higher dose of oral celecoxib as in arm I.
Arm III: Patients do not receive treatment.
All patients undergo definitive surgery.
PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years. | Inclusion Criteria:
* Histologically confirmed invasive breast carcinoma
* Tumor at least 1 cm by radiologic estimate or physical exam
* No disease limited to ductal carcinoma in situ only
* Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center
* Hormone receptor status:
* Not specified
* Female
* Postmenopausal as defined by at least 1 of the following:
* No menstrual period within the past 12 months
* Prior bilateral oophorectomy
* No known liver disease
* No renal insufficiency
* No congestive heart failure
* No coronary artery disease
* No history of documented peptic ulcer disease
* No gastritis
* No medical condition that would preclude definitive surgery
* No allergy to NSAIDs or sulfa-containing drugs
* No connective tissue diseases, including any of the following:
* Systemic lupus erythematosus
* Reynaud's disease
* Scleroderma
* More than 3 months since prior chemotherapy
* More than 2 weeks since prior hormone replacement therapy
* More than 2 weeks since prior tamoxifen
* More than 2 weeks since prior aromatase inhibitors
* More than 2 weeks since prior raloxifene
* More than 2 weeks since prior steroids
* More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
* More than 1 week since prior cyclooxygenase (COX)-2 inhibitors
* No concurrent warfarin
* No concurrent thiazide or loop diuretics
* No concurrent COX-2 inhibitors
* No concurrent NSAIDs | National Cancer Institute (NCI) | NIH | {
"id": "NCI-2012-01441",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2003-10-06T00:00:00 | {
"date": "2016-12-29",
"type": "ESTIMATED"
} | {
"date": "2003-10-07",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Stage I Breast Cancer",
"Stage II Breast Cancer",
"Stage IIIA Breast Cancer",
"Stage IIIB Breast Cancer",
"Stage IIIC Breast Cancer"
] | null | null | [
{
"city": "New York",
"country": "United States",
"facility": "Memorial Sloan-Kettering Cancer Center",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in aromatase activity levels",
"timeFrame": "From baseline to post-surgery"
}
],
"secondary": [
{
"description": null,
"measure": "Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry",
"timeFrame": "From baseline to post-treatment"
},
{
"description": null,
"measure": "Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens",
"timeFrame": "At post-treatment/surgery"
},
{
"description": null,
"measure": "Effect of treatment vs. no treatment on gene expression (mRNA) profile by microarray, kinase activities (PI3, AKT and ERK1/2 MAP kinases) and PGE2 levels",
"timeFrame": "At post-treatment/surgery"
}
]
} | [
{
"affiliation": "Memorial Sloan Kettering Cancer Center",
"name": "Elisa Port",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D001941",
"term": "Breast Diseases"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Breast Cancer",
"id": "M5220",
"name": "Breast Neoplasms",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5218",
"name": "Breast Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001943",
"term": "Breast Neoplasms"
}
]
} | {
"ancestors": [
{
"id": "D000894",
"term": "Anti-Inflammatory Agents, Non-Steroidal"
},
{
"id": "D018712",
"term": "Analgesics, Non-Narcotic"
},
{
"id": "D000700",
"term": "Analgesics"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D000893",
"term": "Anti-Inflammatory Agents"
},
{
"id": "D018501",
"term": "Antirheumatic Agents"
},
{
"id": "D052246",
"term": "Cyclooxygenase 2 Inhibitors"
},
{
"id": "D016861",
"term": "Cyclooxygenase Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
}
],
"browseBranches": [
{
"abbrev": "Infl",
"name": "Anti-Inflammatory Agents"
},
{
"abbrev": "ARhu",
"name": "Antirheumatic Agents"
},
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Size",
"id": "M277",
"name": "Celecoxib",
"relevance": "HIGH"
},
{
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"id": "M4217",
"name": "Anti-Inflammatory Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4218",
"name": "Anti-Inflammatory Agents, Non-Steroidal",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4032",
"name": "Analgesics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20786",
"name": "Analgesics, Non-Narcotic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20604",
"name": "Antirheumatic Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27009",
"name": "Cyclooxygenase 2 Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19209",
"name": "Cyclooxygenase Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000068579",
"term": "Celecoxib"
}
]
} | {
"conditions": [
{
"id": "D001943",
"term": "Breast Neoplasms"
}
],
"interventions": [
{
"id": "D000068579",
"term": "Celecoxib"
}
]
} |
NCT03245957 | null | HDL Dysfunction During the Acute Stage of Stroke | HDL Dysfunction During the Acute Stage of Stroke | RUSH | OBSERVATIONAL | UNKNOWN | 2017-08-08T00:00:00 | null | null | null | null | 112 | 18 | null | ALL | false | The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes. | MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke.
Plasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3 cases.
The investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent marker of early stage of ischemic stroke.
Plasma MPO levels could also be discriminant regarding the mimick strokes in patient exhibiting stroke clinical picture. | Inclusion Criteria:
Patients with less than 12 hours stroke clinical signs:
* hemiparesis or hemiplegia
* unilateral sensitivity disorder
* language impairment
* balance disorder
* dizziness, bilateral or monocular vision totally or partially lost
Exclusion Criteria:
* Pregnancy
* head trauma since the last 3 months
* stroke since the last 3 months
* myocardial infarction since the last 3 months
* patient disagrees to be enrolled in the study | Centre Hospitalier Universitaire de la Réunion | OTHER | {
"id": "2016/CHU/06",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-08-08T00:00:00 | {
"date": "2019-03-07",
"type": "ACTUAL"
} | {
"date": "2017-08-10",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Adult patients with clinical picture of early stage of stroke with the first signed lasting for less than 12 hours | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Stroke, Acute"
] | null | null | [
{
"city": "Saint-Pierre",
"country": "Réunion",
"facility": "Chu Reunion Island",
"geoPoint": {
"lat": -21.3393,
"lon": 55.47811
},
"state": "Reunion Island"
}
] | [
{
"class": "OTHER_GOV",
"name": "Institut National de la Santé Et de la Recherche Médicale, France"
}
] | null | {
"other": [
{
"description": null,
"measure": "HDL dysfunction",
"timeFrame": "Through study completion, an average of 6 hours"
}
],
"primary": [
{
"description": null,
"measure": "Plasma MPO concentrations",
"timeFrame": "Through study completion, an average of 6 hours"
}
],
"secondary": [
{
"description": null,
"measure": "HDL-MPO concentrations",
"timeFrame": "Through study completion, an average of 6 hours"
}
]
} | [
{
"affiliation": "Centre Hpospitalier Universitaire de La REUNION",
"name": "David COURET, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D002561",
"term": "Cerebrovascular Disorders"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Stroke",
"id": "M22306",
"name": "Stroke",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5810",
"name": "Cerebrovascular Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5204",
"name": "Brain Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5742",
"name": "Central Nervous System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T170",
"name": "Acute Graft Versus Host Disease",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D020521",
"term": "Stroke"
}
]
} | null | {
"conditions": [
{
"id": "D020521",
"term": "Stroke"
}
],
"interventions": null
} |
NCT02950857 | null | A Study of EPEG in Beta Thalassemia Patients | A Phase Ib, Open-label, Repeat Dose, Study of EPEG in Beta Thalassemia Patients With Non-transfusion Dependent Thalassemia (β NTDT) | None | INTERVENTIONAL | COMPLETED | 2016-10-27T00:00:00 | null | 2017-09-27T00:00:00 | 2017-09-27T00:00:00 | [
"PHASE1"
] | 6 | 18 | 65 | ALL | false | An open-label study in which 6 patients will receive once-weekly subcutaneous injections of EPEG for 4 weeks. Final visit will occur 60 days after study entry | Following the provision of informed consent, screening visit procedures to be performed will include: a detailed medical history (including concomitant medications), physical exam, vital signs (non-invasive systolic and diastolic arterial blood pressure, heart rate, and respiratory rate, temperature, and oxygen saturation by pulse oximetry,), laboratory testing of blood samples collections for safety (hematology and chemistry), and urinalysis (dipstick and microscopy, if necessary). A serum pregnancy test for all female patients (of child-bearing potential) will be measured during the Screening Visit. Urine pregnancy test for all female patients (of child-bearing potential) will be measured at each dosing visit prior to dosing.
Eligible patients will receive either subcutaneous injection of EPEG (0.9 µg/kg, 1.2 µg/kg, and 1.5 µg/kg,) for four weeks followed by follow up for 5-6 weeks after 4th dose of IP.
Vital signs will be recorded for study documentation at 1 hour after dosing and at discharge of the day (to occur 2 hours after the time of dosing). All patients will receive standard of care as per investigative site standard practice. | Inclusion Criteria:
1. Male or female
2. Age 18 - 65 years of age
3. Confirmed diagnosis of Non-Transfusion Dependent β-thalassemia (β-NTDT)
4. Hemoglobin 6.0-10.0 g/dL
5. Signed and dated informed written consent by the subject
6. Able to receive subcutaneous injections of study drug
7. Female patients must be non-lactating
8. Female patients of reproductive potential must have a negative serum pregnancy (β-HCG) test at screening.
Exclusion Criteria:
1. In the judgment of the investigator the patient is not a good candidate for the study
2. Blood transfusion within the last 30 days
3. Any of the following medical conditions:
1. Severe kidney insufficiency, defined as use of hemodialysis or serum creatinine at levels greater than 2.5 mg/dL at the time of screening
2. Cardiac disease with adjustment of cardiac medications in the 60 days before study entry
3. Symptomatic coronary artery disease, as indicated by a history of chest pain, angina, claudication, or surgery to treat coronary artery disease in the 1 year before study entry
4. Stroke, defined as a new focal neurological deficit lasting more than 24 hours in the 45 days before study entry
5. New diagnosis of pulmonary embolism by ventilation-perfusion scan, angiography, or any other technique in the 90 days before study entry
6. History of retinal detachment or retinal hemorrhage in the 180 days before study entry
7. Use of nitrate-based vasodilators, prostacyclin (inhaled, subcutaneous, or intravenous)
8. Acute asthma exacerbation requiring use of prednisone in the 60 days before study entry
9. Initiation or dosage increase of calcium channel blockers in the 30 days before study entry
10. Initiation of any other cardiac or pulmonary medication in the 90 days before study entry
4. Presence of any other condition, which in the opinion of the investigator, would make the person unsuitable for enrollment or could interfere with compliance in the study, including but not limited to alcohol or drug abuse
5. Any prior treatment with Erythropoiesis-stimulating Agents (ESA) within 90 days of study treatment;
6. History of hypersensitivity to erythropoietin or any related drug. | Prolong Pharmaceuticals | INDUSTRY | {
"id": "PETH-001",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-10-31T00:00:00 | {
"date": "2018-05-25",
"type": "ACTUAL"
} | {
"date": "2016-11-01",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Beta-Thalassemia"
] | null | null | [
{
"city": "Chiang Mai",
"country": "Thailand",
"facility": "Faculty of Medicine, Chiang Mai University",
"geoPoint": {
"lat": 18.79038,
"lon": 98.98468
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of participants in each treatment arm with abnormal laboratory values and/or adverse events that are related to treatment.",
"timeFrame": "60 days"
}
],
"secondary": [
{
"description": null,
"measure": "Change in the Hemoglobin from Baseline to the Final Visit",
"timeFrame": "60 Days"
},
{
"description": null,
"measure": "A mean increase in Hematocrit (Hct) from Baseline to the Final Visit",
"timeFrame": "60 Days"
},
{
"description": null,
"measure": "A mean increase in reticulocyte count from Baseline to the Final Visit",
"timeFrame": "60 Days"
},
{
"description": null,
"measure": "Change in clinical signs and symptoms of β-NTDT from Baseline to the Final Visit",
"timeFrame": "60 Days"
}
]
} | [
{
"affiliation": "Prolong Pharmaceuticals",
"name": "Rosa Real, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D000745",
"term": "Anemia, Hemolytic, Congenital"
},
{
"id": "D000743",
"term": "Anemia, Hemolytic"
},
{
"id": "D000740",
"term": "Anemia"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D006453",
"term": "Hemoglobinopathies"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
}
],
"browseBranches": [
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Thalassemia",
"id": "M16557",
"name": "Thalassemia",
"relevance": "HIGH"
},
{
"asFound": "Beta Thalassemia",
"id": "M19408",
"name": "beta-Thalassemia",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4070",
"name": "Anemia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4073",
"name": "Anemia, Hemolytic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9547",
"name": "Hemolysis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4075",
"name": "Anemia, Hemolytic, Congenital",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9490",
"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9539",
"name": "Hemoglobinopathies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": "Thalassemia",
"id": "T5622",
"name": "Thalassemia",
"relevance": "HIGH"
},
{
"asFound": "Beta Thalassemia",
"id": "T737",
"name": "Beta-thalassemia",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D013789",
"term": "Thalassemia"
},
{
"id": "D017086",
"term": "beta-Thalassemia"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Hemat",
"name": "Hematinics"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M314",
"name": "Epoetin Alfa",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D013789",
"term": "Thalassemia"
},
{
"id": "D017086",
"term": "beta-Thalassemia"
}
],
"interventions": []
} |
NCT04760457 | null | Mandibular Overdentures Retained by Mini Implants: a Clinical Trial Comparing Different Surgical and Loading Protocols | One-piece TiZr Mini Implants With Miniaturized Carbon-based Coating Prosthetic Connection for Mandibular Overdentures: a Factorial, Randomized Clinical Trial Testing the Outcomes of Immediate/Delayed Loading and Flapped/Flapless Surgery | SMIS | INTERVENTIONAL | COMPLETED | 2021-01-27T00:00:00 | null | 2022-11-30T00:00:00 | 2022-11-30T00:00:00 | [
"NA"
] | 74 | null | null | ALL | false | This study aims to test the combined effects of different loading protocols and surgical approaches on clinical and patient-reported outcome measures (PROMs) following the use of four mini implants for mandibular overdenture retention.
The main study hypotheses are:
1. There are significant improvements in PROMs following implant intervention compared to baseline measures;
2. Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol.
3. Flapless surgery has similar post-insertion outcomes compared to flapped surgery. | This study aims to test the combined effects of different loading protocols and surgical approaches on clinical and patient-reported outcome measures (PROMs) following the use of four mini implants for mandibular overdenture retention.
Main study hypotheses:
1. There are significant improvements in PROMs following implant intervention compared to baseline measures;
2. Immediately loaded mini implants have similar failure rates compared to mini implants receiving a delayed 6-week protocol;
3. Flapless surgery has similar post-insertion outcomes compared to flapped surgery.
Statement of clinical relevance:
Mini implants are an alternative to standard implants for overdentures. They are suitable for insertion in narrow ridges, are less invasive, simpler, less costly, and faster to perform, and are especially advantageous for older and frail patients who would benefit from more conservative and less burdensome treatments. Although previous studies reported favorable outcomes regarding patient oral comfort and function, there is a need for implant/attachment systems with higher predictability on implant survival and retention performance in the long-term. This study aims to provide clinical evidence on the newly developed 2.4mm one-piece TiZr mini implant with a miniaturized carbon-based coating attachment.
Methods:
This is a randomized clinical trial using a factorial design, to test the effectiveness of a mandibular overdenture retained by four mini implants. Participants will be randomized using a 2×2 factorial design: immediate/delayed loading (factor 1) and flapless/flapped surgery (factor 2). New conventional complete dentures will be provided as the baseline treatment. Next, eligible participants will be those who completed a 6-month period of denture usage, and are in need of implants to improve the function of the mandibular denture. Imaging exam should present a minimum of 5.4 mm of ridge width in the interforaminal region (recommended for flapless surgery).
Included subjects to take part in the RCT will be randomized to the treatment groups according to the combined study factors - loading protocols: immediate (IL) or delayed (DL); and surgical approaches: flapless (FLS) or flapped (FPS) surgery. Hence, the combined factors will results in four groups:
* IL/FLS (Group I)
* IL/FPS (Group II)
* DL/FLS (Group III)
* DL/FPS (Group IV) Considering the patient's perspective this study design assumed a "worst" protocol (delayed and flapped - Group IV) and a "best" protocol (flapless and immediate - Group I) and two other intermediary conditions (flapped/immediate and flapless/delayed).
All participants will receive four Straumann® Mini Implant System (one-piece Tissue Level implants) with an Optiloc® prosthetic connection and PEEK matrix inserts. Surgery will follow the workflow for the surgical procedure for the Straumann® Mini Implant System concerning preoperative planning, implant bed preparation and implant insertion. For the prosthetic procedures, we will perform a chairside incorporation of the retentive inserts to convert the existing well-fitting and well-functioning lower denture into an overdenture with the Optiloc® Retentive System/Straumann® Mini Implants.
Outcomes will include short-term outcomes (Patient perceived burdens in surgery, postoperative swelling and pain, consumption of analgesics and surgical time) and long-term - 1-year (implant survival and success, peri-implant marginal bone level changes, PROMs, retention force, prosthodontic events) outcomes. Sample size calculation resulted in a total of 74 participants, 18 in each of the four groups. Data analysis will include descriptive and bivariate analyses, Kaplan-Meier curves and regression models using Generalized Estimating Equations (GEE) for longitudinal data. | Inclusion Criteria:
* No contraindications for implant surgery (mainly related to uncontrolled systemic diseases);
* Enough bone height in the interforaminal area for an implant length of at least 10 mm;
* Ability to understand and answer the questionnaires used in the study and agree to participate by providing a written informed consent.
Exclusion Criteria:
* Noncompliant participants;
* Disagreement to be randomly allocated to the treatment study groups;
* Signs of untreated temporomandibular disorders or uncontrolled systemic or oral conditions that require additional treatments. | Universidade Federal de Goias | OTHER | {
"id": "PI04011-2019",
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"type": null
} | Unknown | {
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"statusForNctId": null
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"date": "2023-05-10",
"type": "ACTUAL"
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"date": "2021-02-18",
"type": "ACTUAL"
} | [
"CHILD",
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"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "A factorial experiment of two factors is planned, each with two possible values or \"levels\", and whose experimental units take on all possible combinations of these levels across all such factors (2×2 factorial design), allowing the study to determine the effect of each factor on the response variable, as well as the effects of interactions between factors on the response variable. The tested factors will be: loading protocol (immediate or delayed), and surgical approach (flapped or flapless), resulting in a factorial experiment with four treatment combinations in total. Hence, the design is denoted a 2² factorial, which identifies the number of factors (n=2) and how many levels each factor has (n=2) there are in the design (2²=4).",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The assessment of longitudinal outcomes will be performed by an assessor blinded to the surgical/loading protocols",
"whoMasked": [
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
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"Complete Edentulism"
] | ["Overdenture", "Mini implant", "Flapless surgery", "Dental implant", "Implant loading protocol"] | null | [
{
"city": "Goiânia",
"country": "Brazil",
"facility": "School of Dentistry, Federal University of Goias",
"geoPoint": {
"lat": -16.67861,
"lon": -49.25389
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"state": "Goias"
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] | [
{
"class": "OTHER",
"name": "ITI International Team for Implantology, Switzerland"
},
{
"class": "INDUSTRY",
"name": "Institut Straumann AG"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Patient-perceived burdens",
"timeFrame": "Twenty-four hours after implant surgery."
},
{
"description": null,
"measure": "Implant survival and success",
"timeFrame": "Incidence thoughout the 12-month follow-up after implant placement."
},
{
"description": null,
"measure": "Postoperative pain and discomfort",
"timeFrame": "Assessed 24 hours after implant placement."
},
{
"description": null,
"measure": "Postoperative pain and discomfort",
"timeFrame": "Assessed 72 hours after implant placement."
},
{
"description": null,
"measure": "Postoperative pain and discomfort",
"timeFrame": "Assessed 1 week after implant placement."
},
{
"description": null,
"measure": "Consumption of analgesics",
"timeFrame": "Assessed until 1 week after implant placement."
},
{
"description": null,
"measure": "Patient Satisfaction",
"timeFrame": "Assessed at baseline (before implant surgery)"
},
{
"description": null,
"measure": "Patient Satisfaction",
"timeFrame": "Assessed at the 3-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Patient Satisfaction",
"timeFrame": "Assessed at the 6-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Patient Satisfaction",
"timeFrame": "Assessed at the 12-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Oral health-related quality of life (OHRQoL)",
"timeFrame": "Assessed at baseline (before implant surgery)."
},
{
"description": null,
"measure": "Oral health-related quality of life (OHRQoL)",
"timeFrame": "Assessed at the 3-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Oral health-related quality of life (OHRQoL)",
"timeFrame": "Assessed at the 6-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Oral health-related quality of life (OHRQoL)",
"timeFrame": "Assessed at the 12-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Prosthodontic maintenance events",
"timeFrame": "Throughout 12 months after overdenture delivery."
},
{
"description": null,
"measure": "Surgical time",
"timeFrame": "Procedure (Assessed during the clinical visit of implant placement and overdenture delivery or denture adaptation.)"
}
],
"secondary": [
{
"description": null,
"measure": "Masticatory Performance",
"timeFrame": "Assessed at baseline (before implant surgery)."
},
{
"description": null,
"measure": "Masticatory Performance",
"timeFrame": "Assessed at the 3-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Masticatory Performance",
"timeFrame": "Assessed at the 6-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Masticatory Performance",
"timeFrame": "Assessed at the 12-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Maximum voluntary bite force",
"timeFrame": "Assessed at baseline (before implant surgery)."
},
{
"description": null,
"measure": "Maximum voluntary bite force",
"timeFrame": "Assessed at the 3-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Maximum voluntary bite force",
"timeFrame": "Assessed at the 6-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Maximum voluntary bite force",
"timeFrame": "Assessed at the 12-month follow-up visit after implant placement."
},
{
"description": null,
"measure": "Peri-implant bone change",
"timeFrame": "Peri-implant bone loss at the 3-month follow-up compared to initial stage (1-week rediograph)."
},
{
"description": null,
"measure": "Peri-implant bone change",
"timeFrame": "Peri-implant bone loss at the 6-month follow-up compared to initial stage (1-week rediograph)."
},
{
"description": null,
"measure": "Peri-implant bone change",
"timeFrame": "Peri-implant bone loss at the 12-month follow-up compared to initial stage (1-week rediograph)."
},
{
"description": null,
"measure": "Bleeding on probing",
"timeFrame": "Assessed at 6-month post-insertion"
},
{
"description": null,
"measure": "Bleeding on probing",
"timeFrame": "Assessed at 12-month post-insertion"
},
{
"description": null,
"measure": "Probing depth",
"timeFrame": "Assessed at 6-month post-insertion"
},
{
"description": null,
"measure": "Probing depth",
"timeFrame": "Assessed at 12-month post-insertion"
},
{
"description": null,
"measure": "Suppuration",
"timeFrame": "Assessed at 6-month post-insertion"
},
{
"description": null,
"measure": "Suppuration",
"timeFrame": "Assessed at 12-month post-insertion"
}
]
} | [
{
"affiliation": "Universidade Federal de Goias",
"name": "Claudio R Leles, DDS, PhD",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "9870539", "type": "BACKGROUND", "citation": "Awad MA, Feine JS. Measuring patient satisfaction with mandibular prostheses. Community Dent Oral Epidemiol. 1998 Dec;26(6):400-5. doi: 10.1111/j.1600-0528.1998.tb01978.x."}, {"pmid": "8006237", "type": "BACKGROUND", "citation": "de Grandmont P, Feine JS, Tache R, Boudrias P, Donohue WB, Tanguay R, Lund JP. Within-subject comparisons of implant-supported mandibular prostheses: psychometric evaluation. J Dent Res. 1994 May;73(5):1096-104. doi: 10.1177/00220345940730051201."}, {"pmid": "26024379", "type": "BACKGROUND", "citation": "Demain S, Goncalves AC, Areia C, Oliveira R, Marcos AJ, Marques A, Parmar R, Hunt K. Living with, managing and minimising treatment burden in long term conditions: a systematic review of qualitative research. PLoS One. 2015 May 29;10(5):e0125457. doi: 10.1371/journal.pone.0125457. eCollection 2015."}, {"pmid": "27009835", "type": "BACKGROUND", "citation": "Enkling N, Saftig M, Worni A, Mericske-Stern R, Schimmel M. Chewing efficiency, bite force and oral health-related quality of life with narrow diameter implants - a prospective clinical study: results after one year. Clin Oral Implants Res. 2017 Apr;28(4):476-482. doi: 10.1111/clr.12822. Epub 2016 Mar 24."}, {"pmid": "31021481", "type": "BACKGROUND", "citation": "Enkling N, Haueter M, Worni A, Muller F, Leles CR, Schimmel M. A prospective cohort study on survival and success of one-piece mini-implants with associated changes in oral function: Five-year outcomes. Clin Oral Implants Res. 2019 Jun;30(6):570-577. doi: 10.1111/clr.13444. Epub 2019 May 8."}, {"pmid": "27492988", "type": "BACKGROUND", "citation": "Kanazawa M, Feine J, Esfandiari S. Clinical guidelines and procedures for provision of mandibular overdentures on 4 mini-dental implants. J Prosthet Dent. 2017 Jan;117(1):22-27. doi: 10.1016/j.prosdent.2016.04.020. Epub 2016 Aug 1."}, {"pmid": "24660189", "type": "BACKGROUND", "citation": "Klein MO, Schiegnitz E, Al-Nawas B. Systematic review on success of narrow-diameter dental implants. Int J Oral Maxillofac Implants. 2014;29 Suppl:43-54. doi: 10.11607/jomi.2014suppl.g1.3."}, {"pmid": "7560392", "type": "BACKGROUND", "citation": "Leao A, Sheiham A. Relation between clinical dental status and subjective impacts on daily living. J Dent Res. 1995 Jul;74(7):1408-13. doi: 10.1177/00220345950740071301."}, {"pmid": "8634892", "type": "BACKGROUND", "citation": "Leao A, Sheiham A. The development of a socio-dental measure of dental impacts on daily living. Community Dent Health. 1996 Mar;13(1):22-6."}, {"pmid": "27888049", "type": "BACKGROUND", "citation": "Lemos CA, Verri FR, Batista VE, Junior JF, Mello CC, Pellizzer EP. Complete overdentures retained by mini implants: A systematic review. J Dent. 2017 Feb;57:4-13. doi: 10.1016/j.jdent.2016.11.009. Epub 2016 Nov 22."}, {"pmid": "29125652", "type": "BACKGROUND", "citation": "Marcello-Machado RM, Faot F, Schuster AJ, Nascimento GG, Del Bel Cury AA. Mini-implants and narrow diameter implants as mandibular overdenture retainers: A systematic review and meta-analysis of clinical and radiographic outcomes. J Oral Rehabil. 2018 Feb;45(2):161-183. doi: 10.1111/joor.12585. Epub 2017 Dec 2."}, {"pmid": "24033878", "type": "BACKGROUND", "citation": "Reissmann DR, Semmusch J, Farhan D, Smeets R, Heiland M, Heydecke G. Development and validation of the Burdens in Oral Surgery Questionnaire (BiOS-Q). J Oral Rehabil. 2013 Oct;40(10):780-7. doi: 10.1111/joor.12092. Epub 2013 Aug 27."}, {"pmid": "29852211", "type": "BACKGROUND", "citation": "Reissmann DR, Enkling N, Moazzin R, Haueter M, Worni A, Schimmel M. Long-term changes in oral health-related quality of life over a period of 5 years in patients treated with narrow diameter implants: A prospective clinical study. J Dent. 2018 Aug;75:84-90. doi: 10.1016/j.jdent.2018.05.019. Epub 2018 May 28."}, {"pmid": "30328192", "type": "BACKGROUND", "citation": "Schiegnitz E, Al-Nawas B. Narrow-diameter implants: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:21-40. doi: 10.1111/clr.13272."}, {"pmid": "17919248", "type": "BACKGROUND", "citation": "Souza RF, Patrocinio L, Pero AC, Marra J, Compagnoni MA. Reliability and validation of a Brazilian version of the Oral Health Impact Profile for assessing edentulous subjects. J Oral Rehabil. 2007 Nov;34(11):821-6. doi: 10.1111/j.1365-2842.2007.01749.x."}, {"pmid": "18332753", "type": "BACKGROUND", "citation": "Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059."}] | {"versionHolder": "2025-06-18"} | {
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* Male or female patients aged at least 18 years, with RA for a minimum of 6 months
* Has been receiving methotrexate treatment (stable for 8 weeks)
* Has active disease classified as ACR functional class of I, II or III
Exclusion Criteria:
* Has previously discontinued DMARD therapy due to hepatic intolerance
* Has received any DMARD in addition to methotrexate during the 4 weeks prior to randomisation
* Is receiving more than 2 DMARDs in addition to methotrexate at the time of screening
* Is receiving or has received Gold, leflunomide or biological agents including TNF/IL-1 inhibitors within the 8 weeks prior to randomisation
* Has previously failed 2 or more DMARDS | Dainippon Sumitomo Pharma Europe LTd. | INDUSTRY | {
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NCT00300157 | null | Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent | French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not | None | INTERVENTIONAL | COMPLETED | 2006-03-07T00:00:00 | null | null | null | [
"PHASE3"
] | 155 | 18 | null | ALL | false | The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not. | Coronary artery bypass graft is the reference treatment of left main coronary artery disease. With the advancements of technology and particularly drug-eluting stents, in-stent restenosis has dramatically decreased and now it is possible to extend indications of complexes lesions such as left main coronary artery stenoses. In these particular situations,some centers performed percutaneous coronary angioplasty (PCI) with drug-eluting stents with acceptable results in terms of safety and efficacy. However, these procedures are performed at isolated sites and are not evaluated in multicenter trial.The aim of this study is to assess the safety and efficacy of this PCI with Taxus-stent in a french multicenter trial and to evaluate clinical and angiographic outcome of these patients at long-term follow-up. | Inclusion Criteria:
* The patient must be \> or = 18 years of age
* Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee
* Aspirin + Clopidogrel \> or = 12 hours before percutaneous coronary intervention (PCI)
* Documented evidence of ischemic heart disease (clinical,biological or ECG) with unprotected left main coronary artery stenosis \> or = 50% associated to other coronary lesions or not responsible of stable or unstable coronary syndrome above 48 hours
* The target reference vessel diameter must be \> or = 2.5 mm
* Unprotected left main coronary artery disease eligible by coronary stenting
Exclusion Criteria:
* Restenosis lesion in left main coronary artery
* Known allergies to the following: aspirin, clopidogrel,ticlopidine,contrast agent or drug similar to paclitaxel
* Acute coronary syndrome \< 48 hours
* Impaired renal function (creatinine \> 180 ùmol/l) at the time of treatment
* Life expectancy less than 36 months
* Female of childbearing potential without reliable birth control
* Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints | French Cardiology Society | OTHER | {
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NCT04707157 | null | Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain | Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3556050 for the Treatment of Diabetic Peripheral Neuropathic Pain | None | INTERVENTIONAL | TERMINATED | 2021-01-12T00:00:00 | null | 2022-06-13T00:00:00 | 2022-06-13T00:00:00 | [
"PHASE2"
] | 68 | 18 | null | ALL | false | This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol (H0P-MC-CPMP) which is a protocol to accelerate the development of new treatments for chronic pain. | null | Inclusion Criteria:
* Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening.
* Have a history of daily pain for at least 12 weeks based on participant report or medical history.
* Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive).
* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
* Are willing to discontinue all pain medications taken for chronic pain conditions for the duration of the study.
* Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
* Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
* Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
* Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion Criteria:
* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
* Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
* Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
* Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
* Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have a positive human immunodeficiency virus (HIV) test result at screening.
* Have an intolerance to acetaminophen or paracetamol or any of its excipients.
* Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
* Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
* Have known hereditary motor, sensory or autonomic neuropathies.
* Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
* Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
* Are taking metformin therapy. Metformin Exception Limited dosages of metformin are allowed in this study. Additional exclusion criteria for participants taking metformin.
* Have a history or presence of lactic acidosis.
* Have a history or presence of severe hepatic disease including cirrhosis.
* Have uncontrolled or unstable congestive heart failure.
* Are taking carbonic anhydrase inhibitors if also taking metformin.
* Have had a change in metformin therapy in the last 12 weeks.
* Have not maintained a stable dose of glucose-lowering agents other than metformin before randomization.
* Are pregnant or breastfeeding.
* Have fibromyalgia. | Eli Lilly and Company | INDUSTRY | {
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NCT06904157 | null | Investigation of Shoulder Position, Upper Extremity Proprioception, and Function in Adolescents With Idiopathic Scoliosis Using Braces | Investigation of Shoulder Head Position, Upper Extremity Proprioception, and Upper Extremity Function in Adolescents With Idiopathic Scoliosis Using Braces | None | OBSERVATIONAL | NOT_YET_RECRUITING | 2025-02-27T00:00:00 | null | 2025-05-30T00:00:00 | 2025-06-30T00:00:00 | null | 30 | 10 | 18 | ALL | true | This study aims to investigate the effects of brace use on shoulder position, upper extremity proprioception, and upper extremity function in adolescents with idiopathic scoliosis. Participants will be assessed under both in-brace and out-brace conditions. The control group's upper extremity proprioception and upper extremity function will be assessed under out-brace condition. Shoulder position will be evaluated using a photographic method, while upper extremity proprioception (angular deviation) will be measured with the Laser Pointer-Assisted Angle Reproduction Test. Upper extremity function will be assessed through muscle strength tests, the Closed Kinetic Chain Upper Extremity Stability Test, the Medicine Ball Throw Test, the Finger-to-Nose Test, the Nellson Hand Reaction Test, and the Minnesota Manual Dexterity Test. Adolescents diagnosed with idiopathic scoliosis who have been prescribed brace treatment and have no history of spinal surgery or neurological/musculoskeletal conditions affecting upper extremity function will be included. Individuals with congenital or neuromuscular scoliosis, previous spinal surgery, neurological disorders affecting proprioception, or those unable to comply with study assessments will be excluded. This study aims to provide insights into the impact of bracing on proprioception and upper extremity function, contributing to the development of rehabilitation strategies for scoliosis management. | Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional spinal deformity characterized by lateral curvature and vertebral rotation, affecting postural alignment, musculoskeletal function, and neuromuscular control. AIS can lead to asymmetrical loading of the spine and trunk, potentially altering proprioception, postural stability, and functional capacity. Bracing is a widely used conservative treatment aimed at preventing curve progression and maintaining spinal alignment during skeletal growth. However, its effects on upper extremity function, proprioception, and shoulder biomechanics remain underexplored.
Proprioception, the body's ability to sense movement and position, plays a critical role in motor control and stability. In AIS, spinal asymmetry and altered postural alignment may disrupt proprioceptive feedback mechanisms, leading to compensatory movement strategies and potential impairments in upper extremity coordination and function. Additionally, bracing may impose external constraints that influence neuromuscular activation patterns and joint positioning, further affecting movement efficiency and functional performance.
This study aims to investigate the impact of brace use on shoulder position, upper extremity proprioception, and functional performance in adolescents with idiopathic scoliosis. Participants will be assessed in both braced and unbraced conditions to determine how brace-related mechanical constraints influence proprioceptive accuracy, postural adaptation, and functional motor skills. Shoulder position will be analyzed through photographic assessment, while proprioception will be measured using the Laser Pointer-Assisted Angle Reproduction Test. Upper extremity function will be evaluated using standardized clinical assessments, including strength tests, stability and coordination measures, and reaction time assessments.
Understanding the effects of bracing on upper extremity proprioception and function is essential for optimizing rehabilitation strategies in AIS. This study seeks to provide evidence that can inform clinical decision-making regarding brace design, therapy interventions, and functional training approaches to minimize movement restrictions and enhance musculoskeletal performance in adolescents undergoing brace treatment. | Inclusion Criteria:
- Inclusion criteria for the patient group;
* To have a diagnosis of adolescent idiopathic scoliosis (AIS),
* Be using Cheneau Type corset for at least one month,
* Having a primary thoracic or thoracolumbar curve,
* Cobb angle of 20 degrees or more,
* The dominant hand is the right hand,
* Volunteering to participate in the study,
* Parental consent was required. Inclusion criteria for the control group;
* Individuals between the ages of 10-18
* Dominant Hand is the Right Hand
* Volunteering to Participate in the Study
Exclusion Criteria:
Exclusion Criteria for Patient Group;
* Having a diagnosis of Congenital Scoliosis,
* Becoming a Professional Athlete,
* Neuromuscular, Rheumatologic, Renal Except Scoliosis, Any History of Vestibular, Pulmonary or Cardiovascular Disease Finding
* History of Surgical Intervention on the Spine. Exclusion Criteria for Control Group;
* Neuromuscular, Rheumatologic, Renal, Vestibular, Pulmonary Or History of any Cardiovascular Disease
* History of Spine Surgery,
* Being a Professional Athlete. | Hacettepe University | OTHER | {
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"description": null,
"measure": "Open Kinetic Chain Upper Extremity Power (Medicine Ball Throw Test)",
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]
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NCT00361257 | null | Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults | Phase II, Randomized, Placebo-Controlled, Double-Blind Study of Minocycline in the Treatment of HIV-Associated Cognitive Impairment | None | INTERVENTIONAL | TERMINATED | 2006-08-04T00:00:00 | null | null | null | [
"PHASE2"
] | 107 | 18 | 65 | ALL | false | The purpose of this study is to determine the effectiveness of minocycline, an antibiotic, in lessening the decreased mental function sometimes caused by anti-HIV drugs. | Cognitive impairment, including disabling cognitive, behavioral, and social dysfunction, continues to be a major problem faced by HIV-infected people taking antiretroviral therapy (ART). Research is needed to develop treatment that can be given alongside ART to prevent or lessen cognitive impairment caused by ART. Minocycline, an antibiotic commonly used for the treatment of acne and rheumatoid arthritis, has demonstrated anti-inflammatory and neuroprotective properties in previous studies. This study will evaluate the effectiveness of 24-week therapy with minocycline in lessening the cognitive impairment of HIV infected adults taking ART.
This study will last at least 24 weeks and has two steps. Patients will be stratified by HIV viral load and their neurocognitive state at study screening. In Step I, patients will be randomly assigned to one of two groups. Group 1 participants will receive twice-daily minocycline for 24 weeks; Group 2 participants will receive placebo. At the end of Phase I, study participants will be offered to enter Step II; all participants in Step II will receive twice-daily minocycline for an additional 24 weeks.
There will be a total of 8 study visits: 5 visits for Step I (including the entry visit) and 3 visits for Step II. Medical history will occur at all visits. Blood collection will occur at all visits. Participants who have positive nonreactive rapid plasma regain (RPR) values at screening will have mandatory lumbar punctures; for those with negative serum RPR results lumbar punctures are optional. Participants who test positive for syphilis will also have a lumbar puncture at their discretion to determine if syphilis has affected the brain. A neurological exam, other neuropsychological, dementia, and depression scale assessments, and urine collection will occur at most visits. Patients will be asked to complete a questionnaire on daily living at study entry and Weeks 12 and 24. Patients who have a lumbar puncture at Week 24 will receive a phone call 2 to 5 days after the procedure to report any adverse effects. Some participants may also have an electrocardiogram (ECG) during the study. For participants not on atazanavir some procedures and sample collections are optional. | Inclusion Criteria:
* HIV infected
* Currently on a stable ART regimen for at least 16 consecutive weeks prior to study entry. Participants whose regimens have changed with respect to dose or formulation are eligible, but patients who have changed to different drugs in the same class are not eligible. Participants taking atazanavir must also be taking ritonavir or a ritonavir-boosted drug to be eligible for this study. More information on this criterion can be found in the protocol.
* Plan to stay on current ART regimen between study screening and Week 24
* AIDS Dementia Scale (ADC) Stage greater than 0
* Cognitive impairment, as evidenced by neuropsychological tests administered at screening
* Progressive neurocognitive decline. More information on this criterion can be found in the protocol.
* Estimated premorbid IQ of 70 or higher indicated by an age-corrected scaled score of 5 or higher on the vocabulary section of the Wechsler Adult Intelligence Scale Revised (WAIS-R) administered at study screening
* Karnofsky performance score of 60 or higher
* Ability to sit and stand for at least 2 hours and swallow medications with an 8-ounce glass of water
* Willing to use acceptable methods of contraception
* Willing to adhere to study schedule
Exclusion Criteria:
* Current cancers. Patients with basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or cancer not requiring systemic chemotherapy are not excluded.
* Severe premorbid psychiatric illness, including schizophrenia and major depression, which, in the opinion of the investigator, may interfere with the study
* Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry
* Previous or current confounding neurological disorders. More information on this criterion can be found in the protocol.
* Central nervous system infections or cancers. More information on this criterion can be found in the protocol.
* Systemic lupus
* Thyroid disease diagnosed within 24 weeks of study entry
* Active drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
* Serious illness requiring systemic treatment or hospitalization. Patients who complete therapy or are clinically stable on therapy are not excluded.
* Investigational agents within 45 days prior to study entry. Patients taking expanded access drugs or drugs used in an ACTG protocol for HIV treatment or for HIV-associated complications that are not prohibited by this protocol are not excluded.
* History of allergy/sensitivity to minocycline or other tetracyclines and their formulations
* Any esophageal or other condition that would interfere with a patient's ability to swallow study medication
* Participation in a previous clinical drug research trial of HIV-associated cognitive impairment. Patients who have had an objective decline in performance as defined by the protocol are not excluded.
* Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the study
* Certain medications
* Certain abnormal laboratory values. Patients who test positive on nonreactive rapid plasma reagin tests (RPR)are not excluded.
* Inability to undergo lumbar punctures
* Breastfeeding | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | NETWORK | {
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"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia"
},
{
"city": "Chicago",
"country": "United States",
"facility": "Northwestern University CRS",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois"
},
{
"city": "Baltimore",
"country": "United States",
"facility": "Johns Hopkins School of Medicine",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland"
},
{
"city": "Boston",
"country": "United States",
"facility": "Massachusetts General Hospital, Division of Infectious Diseases",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts"
},
{
"city": "Detroit",
"country": "United States",
"facility": "Henry Ford Hosp. CRS",
"geoPoint": {
"lat": 42.33143,
"lon": -83.04575
},
"state": "Michigan"
},
{
"city": "St. Louis",
"country": "United States",
"facility": "Washington University",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri"
},
{
"city": "New York",
"country": "United States",
"facility": "NYU Med Ctr, Dept of Medicine",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
},
{
"city": "Rochester",
"country": "United States",
"facility": "1101 University of Rochester Medical Center, Division of Infectious Diseases",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York"
},
{
"city": "Chapel Hill",
"country": "United States",
"facility": "University of North Carolina, AIDS Clinical Trials Unit",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina"
},
{
"city": "Portland",
"country": "United States",
"facility": "The Research and Education Group - Portland CRS",
"geoPoint": {
"lat": 45.52345,
"lon": -122.67621
},
"state": "Oregon"
},
{
"city": "Philadelphia",
"country": "United States",
"facility": "University of Pennsylvania, ACTU",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania"
},
{
"city": "Richmond",
"country": "United States",
"facility": "Virginia Commonwealth Univ. Medical Ctr. CRS",
"geoPoint": {
"lat": 37.55376,
"lon": -77.46026
},
"state": "Virginia"
},
{
"city": "Seattle",
"country": "United States",
"facility": "Univ of Washington, Harborview Medical Ctr",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington"
}
] | [
{
"class": "NIH",
"name": "National Institute of Allergy and Infectious Diseases (NIAID)"
},
{
"class": "OTHER",
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}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in Cognitive Performance Compared to Baseline",
"timeFrame": "At baseline and week 24"
}
],
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{
"description": null,
"measure": "Change in Global Deficit Z-Score (GDS)",
"timeFrame": "At baseline and week 24"
},
{
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"measure": "Change in Investigator's Clinical Global Impression Score (ICGIS)",
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},
{
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},
{
"description": null,
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},
{
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},
{
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},
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"measure": "Change in Information Processing Function Domain Z-Score",
"timeFrame": "At baseline and week 24"
},
{
"description": null,
"measure": "Change in Verbal Memory Domain Z-Score",
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},
{
"description": null,
"measure": "Change in Frontal Systems Function Domain Z-Score",
"timeFrame": "At baseline and week 24"
},
{
"description": null,
"measure": "Change in Karnofsky Performance Score",
"timeFrame": "At baseline and week 24"
},
{
"description": null,
"measure": "Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks)",
"timeFrame": "At baseline and weeks 24"
},
{
"description": null,
"measure": "Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks)",
"timeFrame": "At baseline and week 24"
},
{
"description": null,
"measure": "Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms",
"timeFrame": "Throughout study up to week 48"
},
{
"description": null,
"measure": "Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load",
"timeFrame": "At baseline and week 24"
},
{
"description": null,
"measure": "Changes in Instrumental Activities of Daily Living Questionnaire",
"timeFrame": "At baseline and week 24"
},
{
"description": null,
"measure": "Changes in Medication Management Test (Modified)",
"timeFrame": "At baseline and weeks 24"
},
{
"description": null,
"measure": "Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only)",
"timeFrame": "At pre-entry and Week 24"
},
{
"description": null,
"measure": "Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only)",
"timeFrame": "At pre-entry and Week 24"
},
{
"description": null,
"measure": "Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only)",
"timeFrame": "At pre-entry and Week 24"
},
{
"description": null,
"measure": "Changes in Neurotransmitter Levels (Unit = uM Only)",
"timeFrame": "At pre-entry and Week 24"
},
{
"description": null,
"measure": "Changes in Alternate Psychomotor Function Z-Score",
"timeFrame": "At baseline and week 24"
},
{
"description": null,
"measure": "Changes in Alternate Verbal Memory Z-Score",
"timeFrame": "At baseline and week 24"
},
{
"description": null,
"measure": "Changes in Alternate Frontal Systems Z-Score",
"timeFrame": "At baseline and week 24"
}
]
} | [
{
"affiliation": "Department of Neurology, Johns Hopkins Bayview Medical Center",
"name": "Ned Sacktor, MD",
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] | [{"pmid": "15569045", "type": "BACKGROUND", "citation": "Bell JE. An update on the neuropathology of HIV in the HAART era. Histopathology. 2004 Dec;45(6):549-59. doi: 10.1111/j.1365-2559.2004.02004.x."}, {"pmid": "16471077", "type": "BACKGROUND", "citation": "Ferrari S, Vento S, Monaco S, Cavallaro T, Cainelli F, Rizzuto N, Temesgen Z. Human immunodeficiency virus-associated peripheral neuropathies. Mayo Clin Proc. 2006 Feb;81(2):213-9. doi: 10.4065/81.2.213."}, {"pmid": "15855434", "type": "BACKGROUND", "citation": "Zink MC, Uhrlaub J, DeWitt J, Voelker T, Bullock B, Mankowski J, Tarwater P, Clements J, Barber S. Neuroprotective and anti-human immunodeficiency virus activity of minocycline. JAMA. 2005 Apr 27;293(16):2003-11. doi: 10.1001/jama.293.16.2003."}, {"pmid": "21900636", "type": "RESULT", "citation": "Sacktor N, Miyahara S, Deng L, Evans S, Schifitto G, Cohen BA, Paul R, Robertson K, Jarocki B, Scarsi K, Coombs RW, Zink MC, Nath A, Smith E, Ellis RJ, Singer E, Weihe J, McCarthy S, Hosey L, Clifford DB; ACTG A5235 team. Minocycline treatment for HIV-associated cognitive impairment: results from a randomized trial. Neurology. 2011 Sep 20;77(12):1135-42. doi: 10.1212/WNL.0b013e31822f0412. Epub 2011 Sep 7."}, {"pmid": "25377444", "type": "RESULT", "citation": "Sacktor N, Miyahara S, Evans S, Schifitto G, Cohen B, Haughey N, Drewes JL, Graham D, Zink MC, Anderson C, Nath A, Pardo CA, McCarthy S, Hosey L, Clifford D; ACTG A5235 team. Impact of minocycline on cerebrospinal fluid markers of oxidative stress, neuronal injury, and inflammation in HIV-seropositive individuals with cognitive impairment. J Neurovirol. 2014 Dec;20(6):620-6. doi: 10.1007/s13365-014-0292-0. Epub 2014 Nov 7."}] | {"versionHolder": "2025-06-18"} | {
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{
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{
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"term": "Enzyme Inhibitors"
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{
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],
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{
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],
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"term": "Minocycline"
},
{
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"term": "Tetracycline"
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]
} |
NCT06771557 | null | Evaluation of Usage and Efficacy of the 656 Online Platform for Reducing Caregiver Stress in Chinese Caregivers | Evaluation of Usage and Efficacy of the 656 Online Platform for Reducing Caregiver Stress in Chinese Caregivers: Longitudinal Open-trial Study | None | INTERVENTIONAL | COMPLETED | 2025-01-08T00:00:00 | null | 2022-08-31T00:00:00 | 2022-08-31T00:00:00 | [
"NA"
] | 287 | 18 | null | ALL | false | This study aimed to assess the efficacy of a new online platform, 656 Online Platform, in Hong Kong in reducing caregiver stress and enhancing caregiver preparedness and competence of caring for older adults with stroke, dementia, and fracture, investigate the factors influencing the usage of the online platform, and examine user satisfaction and engagement. | The informal caregivers of older adults with serious health problems, especially for stroke, dementia, and fracture, are facing numerous caregiving stress. The online platform can be a cost-effective way to support caregivers and reduce their caregiving stress.
A new online platform, the 655 Online Platform, was developed by St. James Settlement in Hong Kong, to provide caregivers with appropriate information and support, attempting to reduce their pressure. Therefore, this study was launched to evaluate the efficacy of a new online platform in reducing caregiver stress and enhancing caregiver preparedness and competence in caring for older adults with stroke, dementia, and fracture, investigate the factors influencing the usage of the online platform, and examine user satisfaction and engagement.
A longitudinal open-trial study design was applied (N=287) with outcome measures administered at baseline, 3-month follow-up, and 15-month follow-up. Primary outcomes included changes in caregiver stress, caregiver preparedness, and competence. The user profile was explored by comparing the characteristics of participants in user group and non-user group. User satisfaction and engagement were also reported. | Inclusion Criteria:
* Family caregivers who are Chinese citizens aged 18 or above and provide care for elderly individuals aged 65 or above diagnosed with stroke, dementia, or fall-related fractures
Exclusion Criteria:
* Family caregivers who have been diagnosed with severe mental or physical illness or have impairments in cognitive function, such as comprehension, memory, observation, and other related abilities | Hong Kong Metropolitan University | OTHER | {
"id": "1-2021-39-E",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-01-08T00:00:00 | {
"date": "2025-01-13",
"type": "ACTUAL"
} | {
"date": "2025-01-13",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A longitudinal open-trial study design was applied (N=287) with outcome measures administered at baseline, 3-month follow-up, and 15-month follow-up. Primary outcomes included changes in caregiver stress, caregiver preparedness, and competence. The user profile was explored by comparing the characteristics of participants in user group and non-user group. User satisfaction and engagement were also reported.",
"maskingInfo": {
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},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Stoke",
"Dementia",
"Fall and Fractures Prevention"
] | ["Online Platform", "Caregivers", "Caregiver stress"] | null | [
{
"city": "Hong Kong",
"country": "Hong Kong",
"facility": "Hong Kong Metropolitan University",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "City University of Hong Kong"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Caregiver stress",
"timeFrame": "From the baseline survey to the second follow-up survey at 15 months"
},
{
"description": null,
"measure": "Preparedness for caregiving",
"timeFrame": "From the baseline survey to the second follow-up survey at 15 months"
},
{
"description": null,
"measure": "Caregiver competence",
"timeFrame": "From the baseline survey to the second follow-up survey at 15 months"
}
],
"secondary": null
} | [
{
"affiliation": "Hong Kong Metropolitan University",
"name": "Yuen Ha WONG",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
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"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D019965",
"term": "Neurocognitive Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
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"abbrev": "BC26",
"name": "Wounds and Injuries"
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"abbrev": "All",
"name": "All Conditions"
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"name": "Nervous System Diseases"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
}
],
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"id": "M26370",
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"relevance": "LOW"
},
{
"asFound": "Dementia",
"id": "M6904",
"name": "Dementia",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5204",
"name": "Brain Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5742",
"name": "Central Nervous System Diseases",
"relevance": "LOW"
},
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"asFound": null,
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"name": "Neurocognitive Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4815",
"name": "Mental Disorders",
"relevance": "LOW"
},
{
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"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003704",
"term": "Dementia"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
},
{
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"name": "All Drugs and Chemicals"
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}
],
"meshes": null
} | {
"conditions": [
{
"id": "D003704",
"term": "Dementia"
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],
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} |
NCT03673657 | null | Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer | A Prospective, Single-arm, Phase II Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer | None | INTERVENTIONAL | COMPLETED | 2018-09-05T00:00:00 | null | 2020-03-16T00:00:00 | 2023-08-31T00:00:00 | [
"PHASE2"
] | 67 | 18 | 75 | ALL | false | This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer. | This single-arm phase II prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.
Patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks after its completion. Weekly counseling sessions, conducted by both doctors and nurses, aimed to educate patients on regulating their regular dietary intake to meet specific energy, protein, and other macronutrient requirements. Dietary advice provided precise instructions on food type and quantity, meal frequency, and calorie or protein intake to ensure a daily energy intake of approximately 30 kcal/kg. All patients received definitive thoracic radiotherapy with total radiation doses of 60-68 Gy, concurrent with weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡). | Inclusion Criteria:
* Confirmed unresectable stage IIIA-IIIC non-small cell lung cancer.
* Recieved definitive concurrent chemoradiotherapy.
* Pretreatment PG-SGA score A or B.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Estimated life expectancy of at least 6 months.
* Without contraindication for chemoradiotherapy.
Exclusion Criteria:
* Severe impairment of intestinal function, or intolerance of enteral nutrition.
* Severe vomiting, gastrointestinal bleeding, or intestinal obstruction.
* Severe malnutrition, or intolerance of chemoradiotherapy. | Sun Yat-sen University | OTHER | {
"id": "GASTO-1041",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-09-14T00:00:00 | {
"date": "2023-12-08",
"type": "ACTUAL"
} | {
"date": "2018-09-17",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"maskingInfo": {
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"maskingDescription": null,
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Local Advanced Non-small Cell Lung Cancer"
] | ["Local Advanced Non-small Cell Lung Cancer", "Chemoradiotherapy", "Early nutritional intervention"] | null | [
{
"city": "Guangzhou",
"country": "China",
"facility": "Sun yat-sen University Cancer Center",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong"
}
] | null | null | {
"other": [
{
"description": null,
"measure": "Exploratory endpoint",
"timeFrame": "From the start to the end of CCRT"
}
],
"primary": [
{
"description": null,
"measure": "The incidence of weight loss ≥5% during the treatment",
"timeFrame": "From the start to the end of CCRT"
}
],
"secondary": [
{
"description": null,
"measure": "Nutrition-related parameters",
"timeFrame": "up to 6 months after radiotherapy"
},
{
"description": null,
"measure": "EORTC Quality of Life Questionnaire C30 (QLQ-C30)",
"timeFrame": "up to 6 months after radiotherapy"
},
{
"description": null,
"measure": "Scored Patient-Generated Subjective Global Assessment",
"timeFrame": "up to 6 months after radiotherapy"
},
{
"description": null,
"measure": "Toxicities",
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NCT01401257 | null | Phase II, Randomized, Placebo-controlled Trial in Patients With Charcot-marie-tooth Disease Type 1A | A Phase II, Randomized, Placebo-controlled Trial of the Safety, Efficacy, Pharmacodynamics and Pharmacokinetics of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A. | None | INTERVENTIONAL | COMPLETED | 2011-07-20T00:00:00 | null | null | null | [
"PHASE2"
] | 80 | 18 | 65 | ALL | false | The present trial is a randomized, placebo-controlled study evaluating 3 different doses of PXT3003 in patients with CMT1A disease. | In addition to the safety and tolerability of the treatment, clinical, electrophysiological and biological endpoints (PMP22 mRNA, skin biopsy histology and plasma biomarkers) will be assessed. Standard laboratory tests and drug plasma concentrations will also be measured. Because of the slow progression of the disease and the nature of the observed symptoms, a minimum duration of 12 months of treatment is required in order to observe a potential improvement in any of the efficacy parameters. | Inclusion Criteria:
* DNA proven CMT1A
* Muscle weakness in at least foot dorsiflexion (clinical assessment)
* Age between 18 and 65 years
* Male or non pregnant, non breastfeeding female
* CMT neuropathy score at screening ≤ 20
* Agrees to perform electrorophysiological studies and two cutaneous biopsies for determination of PMP22 expression and histology
* Providing signed written informed consent to participate in the study and willing and able to comply with all study procedures and scheduled visits
Exclusion Criteria:
* Patients with another neurological disease
* Patients using unauthorized concomitant treatments, ascorbic acid, opioids, levothyroxine and potentially neurotoxic drugs. Patients who can/agree to stop these medications 4 weeks before randomization can be included
* Patients who have participated in another trial of investigational drug within the past 30 days
* Concomitant major systemic disease
* Clinically significant history of unstable medical illness over the last 30 days (unstable angina...)
* History of significant hematologic, kidney, liver disease, or insulin-dependent diabetes
* Clinically significant abnormalities on the prestudy laboratory evaluation, physical evaluation, electrocardiogram (ECG)
* ASAT/ALAT levels above the upper limit of normal (ULN). However, patients with an isolated elevation of either ASAT or ALAT (\<1.5 ULN) can be included at investigators" discretion if the remaining liver function tests are normal and if ASAT or ALAT value is stable at 2 distinct evaluations in the month prior to inclusion
* Serum creatinine levels above the upper limit of normal
* Limited mental capacity or psychiatric disease rendering the subject unable to provide written informed consent or comply with evaluation procedures
* History of recent alcohol or drug abuse or non-adherence with treatment or other experimental protocols
* Female of childbearing potential (apart of patient using adequate contraceptive measures), pregnant or breast feeding
* Suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom follow-up evaluation is not assured)
* Limb surgery in the six months before randomization or planned before completion of the trial
* Known hypersensitivity to any of the individual components of PXT3003
* Porphyria | Pharnext S.C.A. | OTHER | {
"id": "CLN-PXT3003-01",
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"type": null
} | Unknown | {
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"type": "ESTIMATED"
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"Hereditary Neuropathy With Liability to Pressure Palsies",
"Genetic Disorders"
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"facility": "Groupe Hospitalier Pitié-Salpétrière",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null
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] | null | null | {
"other": null,
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"description": null,
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"timeFrame": "Screening, randomization, 1-, 3-, 6-, 9-, 12-month treatment and 1-month follow-up"
}
],
"secondary": [
{
"description": null,
"measure": "To Obtain Preliminary Data on the Efficacy of PXT3003 on Clinical Scores and Functional Tests",
"timeFrame": "Screening, randomization, 3-, 6-, 9- and 12-months treatment"
},
{
"description": null,
"measure": "To Assess the Pharmacodynamic Effect of PXT3003 on PMP22 mRNA Levels and Intra-epidermal Axon Density in Cutaneous Biopsy",
"timeFrame": "Randomization and 12-month treatment"
},
{
"description": null,
"measure": "To Assess the Pharmacodynamic Effect of PXT3003 on Selected Neurophysiological Parameters",
"timeFrame": "Screening, randomization, 3-, 6-, 9- and 12-month treatment"
},
{
"description": null,
"measure": "To Assess the Pharmacodynamic Effect of PXT3003 on a Series of Biochemical Biomarkers",
"timeFrame": "Randomization and 3-month treatment"
},
{
"description": null,
"measure": "To Assess the Plasma Concentrations of PXT3003",
"timeFrame": "Randomization, 1-, 6- and 12-month treatment"
}
]
} | [
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"affiliation": "Hôpital La Timone",
"name": "Shahram ATTARIAN, MD",
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"affiliation": "Pharnext S.C.A.",
"name": "Viviane BERTRAND, PhD",
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] | [{"pmid": "25519680", "type": "DERIVED", "citation": "Attarian S, Vallat JM, Magy L, Funalot B, Gonnaud PM, Lacour A, Pereon Y, Dubourg O, Pouget J, Micallef J, Franques J, Lefebvre MN, Ghorab K, Al-Moussawi M, Tiffreau V, Preudhomme M, Magot A, Leclair-Visonneau L, Stojkovic T, Bossi L, Lehert P, Gilbert W, Bertrand V, Mandel J, Milet A, Hajj R, Boudiaf L, Scart-Gres C, Nabirotchkin S, Guedj M, Chumakov I, Cohen D. An exploratory randomised double-blind and placebo-controlled phase 2 study of a combination of baclofen, naltrexone and sorbitol (PXT3003) in patients with Charcot-Marie-Tooth disease type 1A. Orphanet J Rare Dis. 2014 Dec 18;9:199. doi: 10.1186/s13023-014-0199-0."}] | {"versionHolder": "2025-06-18"} | {
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],
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"term": "Hereditary Sensory and Motor Neuropathy"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
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]
} | null | {
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NCT03156257 | null | The Role of the Space Environment on Vascular Endothelial and Smooth Muscle Cell Processes | OR-DRPD-SRI/CASIS2016: The Role of the Space Environment on Vascular Endothelial and Smooth Muscle Cell Processes | OR-DRPD-SRI | OBSERVATIONAL | COMPLETED | 2017-05-15T00:00:00 | null | 2020-01-06T00:00:00 | 2020-01-06T00:00:00 | null | 4 | 21 | 50 | ALL | true | By studying the affect of the space environment on vascular cell types, our goal is to elucidate the mechanism of vascular cell damage in the space environment by exposing vascular cells to space flight. In this pilot study, The study team propose to assess changes in transcriptomics of vascular cell types in space compared to those in a ground based study. | Under conditions of simulated microgravity, it is well known that normal cellular processes of vascular cells are altered. While these studies provide important information about these alterations in cells, it is likely not a complete picture due to the limitations of ground based simulated microgravity. It is our hypothesis that real microgravity, as is experienced in space, will reveal changes in EC and SMC phenotype and function that alters cell-cell communication. The study team will test our hypothesis by culturing mature endothelial cells, as well as stem cell derived endothelial cells, and mature smooth muscle cells in low Earth orbit (LEO) on the International Space Station (ISS) U.S. National Laboratory. The specific aims the Study team have proposed are the following:
Specific Aim #1: Preflight isolation and characterization of circulating stem cell derived endothelial cells. Specifically, the Study team will isolate CSCs from whole blood then direct them down an EC pathway. Once differentiated the study team will characterize their phenotype.
Specific Aim #2: Culture mature ECs, SMCs, and CSC derived ECs under conditions of low Earth orbit (LEO) aboard the ISS. Specifically, The study team will use advanced flight hardware to establish an active cell culture on the ISS. The cells will be cultured for a duration of 3 and 10 days, at which time the cells will be frozen for subsequent analysis. Simultaneously, the study team will culture the same populations in a ground based microgravity simulator as well as a normal gravity control.
Specific Aim #3: Assess the morphologic and genetic changes in cells after 3 and 10 days of space flight. Specifically, upon return to Earth, a transcriptome analysis will be completed from the frozen cell samples to assess changes in the cells molecular machinery.
This proposed study builds upon the abundant literature, including our own, surrounding the effects of ground based simulated microgravity on vascular endothelial cells. However, the study team include the less studied populations of smooth muscle cells and stem cell derived ECs. The goal of this work is to leverage conditions on the ISS, a powerful one-of-a-kind microgravity research platform in low Earth orbit, to study these cells and their cellular processes as it relates to cardiovascular disease (CVD) and cardiovascular deconditioning. This work seeks to reveal currently unknown changes in vascular cell health that lead to these diseases. The impact of this work is broad and can lead to new treatment options for millions of people who suffer from CVD including neointimal hyperplasia. | Inclusion Criteria:
* Self-reported healthy individuals
* Willingness to have 50mls of whole blood collected
Exclusion Criteria:
* Unwillingness to have blood used in stem cell research | University of Florida | OTHER | {
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} | [
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"timeFrame": "within 1 year of collecting cells"
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"affiliation": "University of Florida",
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} |
NCT00062257 | null | Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer | A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer | None | INTERVENTIONAL | COMPLETED | 2003-06-05T00:00:00 | null | null | null | [
"PHASE2"
] | null | 18 | null | ALL | false | RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer. | OBJECTIVES:
* Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.
* Determine the toxicity profile of this drug in these patients.
* Determine the overall survival of patients treated with this drug.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9 months. | DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed gastric adenocarcinoma
* Recurrent or metastatic disease
* Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction
* Measurable disease
* At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* More than 3 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No active disseminated intravascular coagulation
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases)
* Alkaline phosphatase no greater than 5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No other uncontrolled concurrent illness that would preclude study participation
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* Must have central or peripherally inserted central catheter
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa
Chemotherapy
* No prior chemotherapy for recurrent or metastatic disease
* Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior radiotherapy and recovered
Surgery
* Not specified
Other
* No other concurrent investigational or commercial agents or therapies for the malignancy
* No concurrent combination antiretroviral therapy for HIV-positive patients | National Cancer Institute (NCI) | NIH | {
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NCT01289457 | null | Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome | Phase I/II Randomized Study of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome | None | INTERVENTIONAL | COMPLETED | 2011-02-02T00:00:00 | null | 2017-06-28T00:00:00 | 2017-06-28T00:00:00 | [
"PHASE1",
"PHASE2"
] | 282 | 18 | 60 | ALL | false | The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinations will also be studied. | The Study Drugs:
Clofarabine is designed to interfere with the growth and development of cancer cells.
Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of cells). This may cause the cancer cells to die.
Cytarabine and Fludarabine are designed to insert themselves into the DNA of cancer cells and stop the DNA from repairing itself.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of 6 participants will be enrolled in the Phase I portion of the study. Up to 280 participants will be enrolled in Phase II.
Phase I:
If you are enrolled in the Phase I portion, the dose of clofarabine you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of clofarabine. Each new group will receive a higher dose of clofarabine than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of clofarabine is found.
All participants will receive the same dose level of idarubicin and cytarabine.
Phase II:
If you are enrolled in the Phase II portion, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:
* If you are in Group 1, you will receive clofarabine, idarubicin, and cytarabine. You will receive clofarabine at the highest dose that was tolerated in the Phase I portion.
* If you are in Group 2, you will receive fludarabine, idarubicin, and cytarabine.
Study Drug Administration:
Study drug(s) will be given in what are called "cycles." Each cycle is 28 days.
Phase I:
On Days 1-5:
* You will receive clofarabine by vein over about 1 hour.
* You will receive cytarabine by vein over about 2 hours.
* On Days 1-3 only, you will receive idarubicin by vein over about 30 minutes.
Phase II (Induction):
The first cycle of study drugs is called Induction. If the doctor thinks it is needed, you will have up to 2 Induction cycles.
If you are in Group 1:
On Days 1-5 of each cycle:
* You will receive clofarabine by vein over about 1 hour.
* You will receive cytarabine by vein over about 2 hours.
* On Days 1-3 only, you will receive idarubicin by vein over about 30 minutes.
If you are in Group 2:
On Days 1-5 of each cycle:
* You will receive fludarabine by vein over about 30 minutes.
* You will receive cytarabine by vein over about 2 hours.
* On Days 1-3 only, you will receive idarubicin by vein over about 30 minutes.
If the doctor thinks it is needed, you may receive less than 5 days of treatment in the induction cycle.
If the doctor thinks it is needed, your dose level will be reduced after Induction.
Phase II (Consolidation):
If the disease responds to the study drugs, you may receive up to 6 more cycles of study drugs. This is called Consolidation.
If you are in Group 1:
On Days 1-3 of each cycle :
* You will receive clofarabine by vein over about 1 hour.
* You will receive cytarabine by vein over about 2 hours.
* After 1 to 2 hours of receiving cytarabine on Days 1-2 only, you will receive idarubicin by vein over about 30 minutes.
If you are in Group 2:
On Days 1-3 of each cycle:
* You will receive fludarabine by vein over about 30 minutes
* You will receive cytarabine by vein over about 2 hours.
* After 1 to 2 hours of receiving cytarabine on Days 1-2 only, you will receive idarubicin by vein over about 30 minutes
If the cancer does not completely respond after Cycle 1, you may repeat induction (Cycle 1). If the cancer completely responds, you will begin the consolidation cycles.
If the doctor thinks it is needed, you may receive less than 3 days of treatment in the consolidation cycles.
Study Visits:
You will have a physical exam, including measurement of your vital signs before the start of each cycle. Blood (about 2 teaspoons) will be drawn for routine tests every 3-7 days.
On Day 28 of every 2-3 cycles (+/- 7 days), if the doctor thinks it is needed, you will have a bone marrow aspirate to check the status of the disease. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest or up to 8 total cycles. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over once you have completed the long-term follow-up.
Long-Term Follow-up:
Every 3 months for 1 year after you are off study, you will be called and asked how you are feeling, about any side effects you may be having, and about any other drugs you may be taking. These calls should last about 5 minutes each.
This is an investigational study. Cytarabine and Idarubicin are FDA approved and commercially available for the treatment of AML. Fludarabine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL). Clofarabine is FDA approved and commercially available for the treatment of acute lymphoblastic leukemia (ALL). The combination of these study drugs is investigational.
Up to 292 patients will take part in Phase I and Phase II of this study. All will be enrolled at MD Anderson. | Inclusion Criteria:
1. Sign an Institutional Review Board (IRB)-approved informed consent document.
2. Age 18 to 60. Patients above the age of 60 only with principal investigator (PI) approval
3. Diagnosis of newly diagnosed AML \[other than acute promyelocytic leukemia (APL)\] or high-risk (intermediate-2 or high by International Prostate Symptom Score (IPSS) or \> 10% blasts, including CMML) MDS. Prior therapy with hydrea and the use of a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use up to 24 hours prior to start of study therapy is allowed. Prior therapy for MDS or other AHD is not allowed.
4. Eastern Cooperative Oncology Group (ECOG) performance status of \</= 3 at study entry.
5. Organ function as defined below (unless due to leukemia): Serum creatinine \</= 3 mg/dL Total bilirubin \</= 2.5 mg/dL , Alanine aminotransferase (ALT) (SGPT) \</= 3 \* upper limit of normal (ULN) or \</= 5 \* ULN if related to disease.
6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and must agree to practice acceptable contraceptive methods. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
7. Cardiac ejection fraction \>/= 40% (by either cardiac echo or multiple gated acquisition scan (MUGA) scan). Documentation of recent (\</= 6 months from screening) outside reports is acceptable.
Exclusion Criteria:
1. Breast feeding females
2. Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
3. Patients with active secondary malignancy will not be eligible. | M.D. Anderson Cancer Center | OTHER | {
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] | [{"pmid": "29702001", "type": "DERIVED", "citation": "Morita K, Kantarjian HM, Wang F, Yan Y, Bueso-Ramos C, Sasaki K, Issa GC, Wang S, Jorgensen J, Song X, Zhang J, Tippen S, Thornton R, Coyle M, Little L, Gumbs C, Pemmaraju N, Daver N, DiNardo CD, Konopleva M, Andreeff M, Ravandi F, Cortes JE, Kadia T, Jabbour E, Garcia-Manero G, Patel KP, Futreal PA, Takahashi K. Clearance of Somatic Mutations at Remission and the Risk of Relapse in Acute Myeloid Leukemia. J Clin Oncol. 2018 Jun 20;36(18):1788-1797. doi: 10.1200/JCO.2017.77.6757. Epub 2018 Apr 27."}] | {"versionHolder": "2025-06-18"} | {
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M4214",
"name": "Anti-Infective Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4222",
"name": "Anti-Bacterial Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4224",
"name": "Antibiotics, Antitubercular",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003561",
"term": "Cytarabine"
},
{
"id": "C024352",
"term": "Fludarabine"
},
{
"id": "D015255",
"term": "Idarubicin"
},
{
"id": "D000077866",
"term": "Clofarabine"
}
]
} | {
"conditions": [
{
"id": "D007938",
"term": "Leukemia"
},
{
"id": "D011289",
"term": "Preleukemia"
},
{
"id": "D007951",
"term": "Leukemia, Myeloid"
},
{
"id": "D015470",
"term": "Leukemia, Myeloid, Acute"
},
{
"id": "D009190",
"term": "Myelodysplastic Syndromes"
}
],
"interventions": [
{
"id": "D003561",
"term": "Cytarabine"
},
{
"id": "C024352",
"term": "Fludarabine"
},
{
"id": "D015255",
"term": "Idarubicin"
},
{
"id": "D000077866",
"term": "Clofarabine"
}
]
} |
NCT00712257 | null | Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis | A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis. | SALVAGE | INTERVENTIONAL | TERMINATED | 2008-07-03T00:00:00 | null | null | null | [
"NA"
] | 27 | 18 | 89 | ALL | false | A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis | null | Inclusion Criteria:
* Subject or subject's legal representative informed of the study nature.
* Subject understands the duration of the study and its follow up visit requirements.
* Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
* Subject able to walk unassisted.
* Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.
Exclusion Criteria:
* Life expectancy less than 12 months
* Myocardial infarction less than 3 months prior to procedure
* Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
* Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
* Uncontrolled hypercoagulability | VIVA Physicians | OTHER | {
"id": "SALVAGE - 00106-661",
"link": null,
"type": null
} | Due to safety concerns | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-07-08T00:00:00 | {
"date": "2014-06-04",
"type": "ESTIMATED"
} | {
"date": "2008-07-09",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Restenosis"
] | ["treatment of superficial femoral artery instent restenosis"] | null | [
{
"city": "Columbus",
"country": "United States",
"facility": "Gary Ansel, MD",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio"
}
] | [
{
"class": "INDUSTRY",
"name": "W.L.Gore & Associates"
},
{
"class": "INDUSTRY",
"name": "Spectranetics Corporation"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis.",
"timeFrame": "12 months"
}
],
"secondary": [
{
"description": null,
"measure": "Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure.",
"timeFrame": "12 month follow up"
}
]
} | [
{
"affiliation": "Presbyterian Heart Institute",
"name": "Tony Das, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": [
{
"id": "D000925",
"term": "Anticoagulants"
},
{
"id": "D005343",
"term": "Fibrinolytic Agents"
},
{
"id": "D050299",
"term": "Fibrin Modulating Agents"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
}
],
"browseBranches": [
{
"abbrev": "FiAg",
"name": "Fibrinolytic Agents"
},
{
"abbrev": "AnCoag",
"name": "Anticoagulants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Learning",
"id": "M9579",
"name": "Heparin",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M46053",
"name": "Calcium heparin",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4244",
"name": "Anticoagulants",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8473",
"name": "Fibrinolytic Agents",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006493",
"term": "Heparin"
}
]
} | {
"conditions": null,
"interventions": [
{
"id": "D006493",
"term": "Heparin"
}
]
} |
NCT02616757 | null | Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing | Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing | None | INTERVENTIONAL | WITHDRAWN | 2015-11-25T00:00:00 | null | 2021-01-06T00:00:00 | 2021-01-06T00:00:00 | [
"NA"
] | 0 | 2 | 21 | ALL | true | Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone lesions. Literature to date describes little agreement between clinicians on specific prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given its association with the mechanical properties of bone. There has been further exploration into the use of quantitative ultrasound to assess bone density by measuring the velocity of the ultrasound transmission over the bone. To determine whether the QUS can provide prognostic information with respect to cyst healing, recurrence or fracture with a SBC, further study is needed. | null | Arm 1 - Simple Bone Cyst Patients
Inclusion Criteria
1. Patients ≥ 2 and ≤ 21 years
2. Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration
3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria
1. Patients with implants to stabilize the bone where the cyst is located.
2. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
3. Patients who are pregnant or breastfeeding
4. Patients with a simple bone cyst crossing the growth plate
Arm 2 - Healthy Controls
Inclusion Criteria
1. Patients ≥ 2 and ≤ 21 years
2. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria
1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
3. Patients who are pregnant or breastfeeding
Arm 3 - Fracture patients
Inclusion Criteria
1. Patients ≥ 2 and ≤ 21 years
2. Patients who have undergone any type of casting or surgical treatment for their fracture
3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria
1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
3. Patients who are pregnant or breastfeeding | The Hospital for Sick Children | OTHER | {
"id": "1000049774",
"link": null,
"type": null
} | Ultrasound machine was no longer approved for use by Health Canada therefore study was closed prior to patients being enrolled on study. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-11-25T00:00:00 | {
"date": "2021-04-21",
"type": "ACTUAL"
} | {
"date": "2015-11-30",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Simple Bone Cyst"
] | null | null | [
{
"city": "Toronto",
"country": "Canada",
"facility": "The Hospital for Sick Children",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Z-scores obtained using quantitative ultrasound",
"timeFrame": "2 years"
}
],
"secondary": [
{
"description": null,
"measure": "Bone specific alkaline phosphatase",
"timeFrame": "2 years"
}
]
} | [
{
"affiliation": "The Hospital for Sick Children",
"name": "Andrew Howard, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Nuffield Orthopaedic Centre",
"name": "James G. Wright, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D020763",
"term": "Pathological Conditions, Anatomical"
},
{
"id": "D001847",
"term": "Bone Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
}
],
"browseLeaves": [
{
"asFound": "Cyst",
"id": "M6765",
"name": "Cysts",
"relevance": "HIGH"
},
{
"asFound": "Bone Cysts",
"id": "M5124",
"name": "Bone Cysts",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M22519",
"name": "Pathological Conditions, Anatomical",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5126",
"name": "Bone Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003560",
"term": "Cysts"
},
{
"id": "D001845",
"term": "Bone Cysts"
}
]
} | null | {
"conditions": [
{
"id": "D003560",
"term": "Cysts"
},
{
"id": "D001845",
"term": "Bone Cysts"
}
],
"interventions": null
} |
NCT05112757 | null | Effective Conversion of Individuals at Risk | Effective Conversion of Individuals at Risk | None | INTERVENTIONAL | TERMINATED | 2021-10-19T00:00:00 | null | 2022-12-08T00:00:00 | 2022-12-08T00:00:00 | [
"NA"
] | 77 | 18 | null | ALL | true | This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis | The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system. | Inclusion Criteria:
* High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health
* 18 years or older, with sufficient English language skills
* Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11\<)
* Able to download and handle an app on a smartphone
* Willing and able to give informed consent
Exclusion criteria:
* Diagnosed with OSA and/or AFib
* Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)
* Pregnancy/breast feeding | Philips Electronics Nederland B.V. acting through Philips CTO organization | INDUSTRY | {
"id": "ICBE-S-000283",
"link": null,
"type": null
} | Very low recruitment success and all recruitment options were exhausted | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-11-04T00:00:00 | {
"date": "2022-12-12",
"type": "ACTUAL"
} | {
"date": "2021-11-09",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Obstructive Sleep Apnea",
"Atrial Fibrillation"
] | ["OSA", "AFib"] | null | [
{
"city": "Sioux Falls",
"country": "United States",
"facility": "Sandford Health",
"geoPoint": {
"lat": 43.54997,
"lon": -96.70033
},
"state": "South Dakota"
}
] | [
{
"class": "OTHER",
"name": "Sanford Health"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Effective conversion",
"timeFrame": "6 months after consent"
}
],
"secondary": null
} | [
{
"affiliation": "Philips Healthcare",
"name": "Tim Weysen, MSc",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001145",
"term": "Arrhythmias, Cardiac"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D012891",
"term": "Sleep Apnea Syndromes"
},
{
"id": "D001049",
"term": "Apnea"
},
{
"id": "D012120",
"term": "Respiration Disorders"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D020919",
"term": "Sleep Disorders, Intrinsic"
},
{
"id": "D020920",
"term": "Dyssomnias"
},
{
"id": "D012893",
"term": "Sleep Wake Disorders"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
}
],
"browseLeaves": [
{
"asFound": "Atrial Fibrillation",
"id": "M4586",
"name": "Atrial Fibrillation",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4361",
"name": "Apnea",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15694",
"name": "Sleep Apnea Syndromes",
"relevance": "LOW"
},
{
"asFound": "Obstructive Sleep Apnea",
"id": "M22010",
"name": "Sleep Apnea, Obstructive",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4453",
"name": "Arrhythmias, Cardiac",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16355",
"name": "Syndrome",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14957",
"name": "Respiration Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22242",
"name": "Parasomnias",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22654",
"name": "Sleep Disorders, Intrinsic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22655",
"name": "Dyssomnias",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15696",
"name": "Sleep Wake Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D020181",
"term": "Sleep Apnea, Obstructive"
},
{
"id": "D001281",
"term": "Atrial Fibrillation"
}
]
} | null | {
"conditions": [
{
"id": "D020181",
"term": "Sleep Apnea, Obstructive"
},
{
"id": "D001281",
"term": "Atrial Fibrillation"
}
],
"interventions": null
} |
NCT01730157 | null | Radioembolization and Ipilimumab in Treating Patients With Uveal Melanoma With Liver Metastases | Pilot Study of Sequential Hepatic Radioembolization and Systemic Ipilimumab in Patients With Uveal Melanoma Metastatic to Liver | None | INTERVENTIONAL | TERMINATED | 2012-11-12T00:00:00 | null | null | null | [
"EARLY_PHASE1"
] | 6 | 18 | null | ALL | false | This pilot clinical trial studies radioembolization and ipilimumab in treating patients with uveal melanoma with liver metastases. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radioembolization together with ipilimumab may kill more tumor cells in patients with uveal melanoma | PRIMARY OBJECTIVE:
I. To estimate the safety and efficacy of sequential hepatic radioembolization and systemic ipilimumab in patients with uveal melanoma metastatic to liver.
SECONDARY OBJECTIVES:
I. To evaluate effects on regulators of tumor immunity.
OUTLINE:
Patients undergo radioembolization with yttrium Y 90 glass microspheres via hepatic arterial infusion on day 1. Beginning on day 29, patients also receive ipilimumab intravenously (IV) over 90 minutes. Treatment with ipilimumab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years. | Inclusion Criteria:
* Histologic diagnosis of metastatic uveal melanoma; the tumor biopsy/aspiration must be available for review
* Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
* Patients must have liver metastasis
* No more than one prior systemic therapeutic regimen; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting
* No concomitant therapy with any of the following: interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids; must have been discontinued \> 4 weeks
* Patients with prior hepatic embolization procedures are eligible as long as they are candidates for repeat procedures and they have demonstrated progressive disease
* No infection with human immunodeficiency virus (HIV); due to the mechanism of action of ipilimumab, activity and side effects in an immune compromised patient are unknown
* No active infection with hepatitis B
* No active or chronic infection with hepatitis C
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Women must not be pregnant or breast-feeding due to unknown effects of treatments on the unborn fetus; all women of childbearing potential must have a blood test within 72 hours prior to randomization to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception; women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
* White blood cell (WBC) \>= 2000/uL
* Absolute neutrophil count (ANC) \>= 1500/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \>= 8 g/dL
* Creatinine =\< 3.0 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN
* Bilirubin =\< 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
* Albumin \>= 3 g/dL
Exclusion Criteria:
* Patients are excluded if they have liver tumor volume \> 50%
* Patients are excluded if they have any history of central nervous system (CNS) metastases
* Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
* Patients are excluded if they have a history of autoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain- Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy
* Patients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
* Patients are excluded if they have a history of prior treatment with ipilimumab or prior tumor necrosis factor receptor superfamily, member 9 (CD137) agonist or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor or agonist
* Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to four weeks (28 days) prior to or after any dose of ipilimumab
* Patients are excluded if they have any concurrent medical condition requiring the use of systemic steroids (the use of inhaled or topical steroids is permitted)
* Patients are excluded if they have a functional organ transplant | Case Comprehensive Cancer Center | OTHER | {
"id": "CASE1612",
"link": null,
"type": null
} | Research Cancelled | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-11-15T00:00:00 | {
"date": "2016-03-10",
"type": "ESTIMATED"
} | {
"date": "2012-11-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Ciliary Body and Choroid Melanoma, Medium/Large Size",
"Ciliary Body and Choroid Melanoma, Small Size",
"Extraocular Extension Melanoma",
"Iris Melanoma",
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NCT04421157 | null | Exercises in Adolescent Idiopathic Scoliosis | The Effectiveness of Two Different Exercises in Adolescent Idiopathic Scoliosis: A Single-blind Study | None | INTERVENTIONAL | COMPLETED | 2020-05-12T00:00:00 | null | 2020-01-28T00:00:00 | 2020-03-03T00:00:00 | [
"NA"
] | 28 | 10 | 18 | ALL | false | The purpose of this study was to investigate the effectiveness of two different exercises in adolescent idiopathic scoliosis. In total, 28 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: Schroth (n = 14) and stabilization group (n = 14). The Schroth group received Schroth exercises in addition to traditional rehabilitation, and the stabilization group received core stabilization in addition to traditional rehabilitation for 10 weeks. The outcome measures were based on Cobb angle, angle of trunk rotation, spinal mobility, cosmetic trunk deformity, muscle strength, and quality of life. | Adolescent idiopathic scoliosis (AIS) is a progressive growth disease with unknown etiology, characterized by a three-dimensional deformity of the spine (frontal translation, sagittal modification, and torsion of the spinous processes on the concave side of the scoliotic curve on radiographs).
In patients with AIS, in addition to curve progression there are many problems commonly occur such as; muscular imbalance, functional limitations, altered posture, gait deviations, reduced flexibility of the spine, back pain, negative physico-social, body image effects, and in severe cases pulmonary symptoms. The asymmetry of the trunk and pelvis are affected related to the shape and angle of scoliosis, and the weight distribution position changes depending on the shape and the Cobb angle of scoliosis. To deal with these complications and more, various treatment approaches have been proposed for AIS, including exercise, bracing, casting, traction, biofeedback, surgery, and simple observation to prevent, correct or halt the progression of the deformity. Conservative treatment methods including physiotherapy and bracing are accepted in Central Europe.
In literature, exercises are recommended to decrease progression, to improve spine and thoracic cage flexibility, muscle strengths, and elasticity, to correct postural behavior, and neuro-motor control, spine stability. In general, traditional exercises (TE) including postural training, stretching, and strengthening exercises for spinal musculature, respiratory exercises have been used for many years for scoliosis. Except for the traditional exercises, there are several exercise concepts including Schroth, Side Shift, Dobomed methods... etc. Schroth exercises are asymmetric scoliosis-specific postural exercises that aim to improve the curve, function, posture, self-image, and pain. Schroth exercises target strength and endurance training of the back, abdominal, and leg muscles. Also one of the aim of Schroth exercises is to improve motor control of the posture by repeating corrective movements with progressively less feedback. Schroth exercises are the most studied scoliosis exercises but there are limited randomized controlled studies on Schroth exercises.
Recently general physiotherapeutic exercises including, Core stabilization (CS) exercises, Pilates have been used in the conservative treatment of idiopathic scoliosis. CS exercises are described as therapy techniques that improve postural control, and functional stability through increasing neuromuscular control, the strength of trunk stabilization muscles, the endurance of postural muscles around the spine, the balance between pelvis and spine. However, limited studies are determining CS exercises' effect on patients with AIS. In a study CS exercises found to be more effective in reducing pain and rotational deformity than traditional exercises in the conservative rehabilitation of AIS.
A recent systematic review showed that therapeutic exercise had been effective to reduce symptoms, Cobb's angle, trunk rotation, craniovertebral angle, and body asymmetries, and to improve muscular endurance, pulmonary function, and functional capacity of patients with AIS. Corrective, therapeutic exercises appear to have positive effects by improving function and reducing symptoms, as well as various angles and body asymmetries. However, further studies with better methodological quality are required to confirm these outcomes and detect the best therapeutic exercise intervention. And also there is a need for randomized controlled studies on different methods of exercise to choose the most effective exercise in clinical practice.
There was no research compared to the effects of the Schroth method and CS exercises in patients with AIS. And also there was no research examining the effects of the Schroth method on peripheral muscle strengths. This study aimed to investigate the effects of the Schroth versus CS exercises in addition to traditional exercises, on Cobb angle, trunk rotation, peripheral muscle strengths, spine mobility, cosmetic deformity, and health-related quality of life in patients with AIS. | Inclusion Criteria:
* Having a diagnosis of adolescent idiopathic scoliosis,
* A Cobb angle of 10 to 30 degrees
* Having Lenke type 1 curve
* No other treatment which might affect scoliosis
Exclusion Criteria:
* Non-idiopathic scoliosis
* Prescribed brace
* Surgical correction history
* Who were unable to participate in the supervised sessions,or those who refused to follow treatment were excluded.
* Contraindications to exercise -Accompanying mental problems, neurological- muscular or rheumatic diseases, | Karamanoğlu Mehmetbey University | OTHER | {
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"date": "2020-11-30",
"type": "ACTUAL"
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"date": "2020-06-09",
"type": "ACTUAL"
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Each patient selected a number in a closed envelope, which was sorted via the 'Research Randomiser' program for the randomisation process, and the patients were separated into the following two groups; Schroth group (n=14) and stabilization group (n=14)",
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} | [
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] | ["Adolescent Idiopathic Scoliosis, Scoliosis, Exercise"] | null | [
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Disabil Rehabil. 2008;30(10):772-85. doi: 10.1080/09638280801889568."}, {"pmid": "28033399", "type": "BACKGROUND", "citation": "Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016."}, {"pmid": "31286903", "type": "BACKGROUND", "citation": "Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Patients with adolescent idiopathic scoliosis perceive positive improvements regardless of change in the Cobb angle - Results from a randomized controlled trial comparing a 6-month Schroth intervention added to standard care and standard care alone. SOSORT 2018 Award winner. BMC Musculoskelet Disord. 2019 Jul 8;20(1):319. doi: 10.1186/s12891-019-2695-9."}, {"pmid": "30824243", "type": "BACKGROUND", "citation": "Thompson JY, Williamson EM, Williams MA, Heine PJ, Lamb SE; ACTIvATeS Study Group. Effectiveness of scoliosis-specific exercises for adolescent idiopathic scoliosis compared with other non-surgical interventions: a systematic review and meta-analysis. Physiotherapy. 2019 Jun;105(2):214-234. doi: 10.1016/j.physio.2018.10.004. Epub 2018 Oct 27."}, {"pmid": "30016036", "type": "BACKGROUND", "citation": "Ceballos Laita L, Tejedor Cubillo C, Mingo Gomez T, Jimenez Del Barrio S. Effects of corrective, therapeutic exercise techniques on adolescent idiopathic scoliosis. A systematic review. Arch Argent Pediatr. 2018 Aug 1;116(4):e582-e589. doi: 10.5546/aap.2018.eng.e582. English, Spanish."}, {"pmid": "27134403", "type": "BACKGROUND", "citation": "Kim G, HwangBo PN. 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"id": "T433",
"name": "Tannic Acid",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D012600",
"term": "Scoliosis"
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],
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} |
NCT00172757 | null | Association of Colorectal Cancer With Nutrition, Diet, Obesity, Diabetes Mellitus, and Genetic Alterations in Taiwan | Risk Factors of Colorectal Cancer in Taiwan-With Special Reference to the Association With Nutrition, Diet, Obesity, Diabetes Mellitus, and Genetic Alterations | None | OBSERVATIONAL | UNKNOWN | 2005-09-12T00:00:00 | null | null | null | null | 1,000 | 0 | null | ALL | true | We will explore the genetic (including APC, k-ras, p53, MSI, etc.) and environmental (including family history, life style, diet, nutritional status, DM, serum IGF-I, IGFBP-3, etc.) risk factors of colorectal tumorigenesis. We will accrue approximately 1000 patients as experimental group. The control group consists of 2000 individuals who were confirmed without colorectal cancer or polyps by colonoscopy. We estimated the statistical power of this study will reach more than 90%. In the second year, we will explore the association between various environmental risk factors with the epigenetic changes of various oncogenes and tumor suppressor genes. Firstly, we will study the correlation between hypermethylation of promoter region of hMLH1 gene with various environmental factors. Next, we will explore the genetic polymorphisms of promoter of E-cadherin gene. Recently, it has been reported that the C→A genetic polymorphism in the promoter region of E-cadherin gene in prostate cancer. Since this phenomenon has not been reported in colorectal cancer, it is mandatory for us to extend our research to the E-cadherin polymorphisms of colorectal cancer. Moreover, this project will focus on exploration of the association between the genetic polymorphisms of promoter of TS gene with chemosensitivity to 5-Fu-based therapy. We speculated that the better prognosis in colorectal tumors with MSI is related to their expression of TS gene. In summary, the second year of this project will extend our accumulated experience in the study of genetic polymorphisms to further clarify the association between genetic polymorphisms of TS gene with the prognosis of colorectal cancers after chemotherapy. We believe that this project will facilitate: (1) the further clarification of colorectal cancer tumorigenesis; (2) the establishment of domestic epidemiological data of colorectal cancer of Taiwan, and (3) the improvement of the quality of clinical management of patients with colorectal cancer. | This is a two-year hospital-based case control study. In the fist year, we will set up solid database of our laboratory regarding the molecular genetics of colorectal cancer. We will explore the genetic (including APC, k-ras, p53, MSI, etc.) and environmental (including family history, life style, diet, nutritional status, DM, serum IGF-I, IGFBP-3, etc.) risk factors of colorectal tumorigenesis. During the whole 2-year period of this project, we will accrue approximately 1000 patients as experimental group. The control group consists of 2000 individuals who were confirmed without colorectal cancer or polyps by colonoscopy. We estimated the statistical power of this study will reach more than 90%. In the second year, we will explore the association between various environmental risk factors with the epigenetic changes of various oncogenes and tumor suppressor genes. It has been well known that epigenetic changes of various oncogene and tumor suppressor genes was related to the intrinsic and extrinsic environmental alterations. Firstly, we will study the correlation between hypermethylation of promoter region of hMLH1 gene with various environmental factors. Next, we will explore the genetic polymorphisms of promoter of E-cadherin gene. It has been well known that E-cadherin plays a major role in the maintenance of cellular structure. Recently, it has been reported that the C→A genetic polymorphism in the promoter region of E-cadherin gene in prostate cancer. The experimental method was feasible in our laboratory. Since this phenomenon has not been reported in colorectal cancer, it is mandatory for us to extend our research to the E-cadherin polymorphisms of colorectal cancer. Moreover, this project will focus on exploration of the association between the genetic polymorphisms of promoter of TS gene with chemosensitivity to 5-Fu-based therapy. Recent reports indicated that colorectal tumors with MSI have better prognosis. Moreover, some authors indicated that the genetic polymorphisms of TS genes was related to chemosensitivity. Therefore, we speculated that the better prognosis in colorectal tumors with MSI is related to their expression of TS gene. In summary, the second year of this project will extend our accumulated experience in the study of genetic polymorphisms to further clarify the association between genetic polymorphisms of TS gene with the prognosis of colorectal cancers after chemotherapy. We believe that this project will facilitate: (1) the further clarification of colorectal cancer tumorigenesis; (2) the establishment of domestic epidemiological data of colorectal cancer of Taiwan, and (3) the improvement of the quality of clinical management of patients with colorectal cancer. | Inclusion Criteria:
* Consecutive cases of sporadic colorectal cancer in NTUH.
Exclusion Criteria:
* FAP and HNPCC. | National Taiwan University Hospital | OTHER | {
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"date": "2005-09-15",
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"city": "Taipei",
"country": "Taiwan",
"facility": "Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.",
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"name": "Jin-Tung Liang, M.D., Ph.D.",
"role": "PRINCIPAL_INVESTIGATOR"
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] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Endocrine System Diseases"
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"term": "Gastrointestinal Neoplasms"
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"term": "Neoplasms by Site"
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"term": "Digestive System Diseases"
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"term": "Gastrointestinal Diseases"
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"term": "Colonic Diseases"
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"term": "Intestinal Diseases"
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"term": "Rectal Diseases"
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],
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"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
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NCT01121757 | null | Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma | A Phase 2 Study Evaluating the Efficacy of Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma | None | INTERVENTIONAL | TERMINATED | 2010-02-11T00:00:00 | null | null | null | [
"PHASE2"
] | 11 | 18 | null | ALL | false | The purpose of this study is to evaluate the response and safety in subjects receiving the drugs lenalidomide and azacitidine when each drug is given by itself and when the drugs are taken together. This study is open for patients with relapsed or refractory follicular or marginal zone lymphoma. | This will be a prospective, non-randomized, un-blinded, phase 2 efficacy trial using an Immunomodulatory derivatives of thalidomide (IMiD™)compound and a hypomethylating agent for epigenetic targeted therapies in patients with relapsed/refractory follicular and marginal zone lymphoma. There will be two parts to the trial. Each patient will progress through each part of the study.
Part 1: Sequential single agent therapy with azacitidine and lenalidomide. Each agent will be given for four-six 28-day cycles.
Subjects with less than a complete response (CR) after 4 cycles of study drug in Part 1a or 1b should proceed to the next study drug(s) after the prescribed washout period.
Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.
There will be a 1-6 week 'washout' period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient's best interest. There will be no washout period required between Part 1 and Part 2.
Part 2: Combination therapy with azacitidine and lenalidomide given in 28-day cycle for up to 13 cycles in subjects who have stable disease or better. | Inclusion Criteria:
1. Histologically or cytologically confirmed Follicular or Marginal Zone Lymphoma
2. Refractory disease defined as persistence of evaluable disease after therapy or have relapsed disease to at least one prior treatment regimen
3. Understand and voluntarily sign an informed consent form
4. Age \> or = to 18 years
5. Able to adhere to the study requirements
6. A frozen tumor sample must be available for microarray analysis. This may either be a previously collected sample if it was properly prepared or a new biopsy may be obtained.
o At least 1 core biopsy specimen using at least a 16 gauge needle, which corresponds to roughly 25 mg of tissue. An equivalent amount of biopsy material from previously performed procedures, as long as it was fresh frozen, can be used. Sample obtained with leukapheresis is acceptable in subjects with a white blood cell count (WBC) of 100,000 or greater.
7. Eastern Cooperative Oncology Group (ECOG) performance status of \< or = to 2
8. Laboratory test results within ranges specified by the protocol.
9. Disease free of prior malignancies for \> or = to 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast or superficial melanoma only requiring excision or prostate cancer with a prostate specific antigen (PSA) that has not increased for at least 3 months.
10. All study participants must be willing to be registered into the mandatory RevAssist® program, and comply with the requirements of RevAssist®.
11. Females of childbearing potential (FCBP) must comply with pregnancy testing requirements. Men and women must use approved birth control methods during the study.
12. Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine.
13. If at high risk for thrombotic event (such as on steroids or history of deep vein thrombosis), subjects must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid may use warfarin or low molecular weight heparin)
Exclusion Criteria:
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
4. Use of any other experimental drug or therapy within 28 days of baseline.
5. Known hypersensitivity to thalidomide or mannitol.
6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
7. Any prior use of lenalidomide or azacitidine
8. Concurrent use of other anti-cancer agents or treatments
9. Known positive for HIV or infectious hepatitis, type B or C
10. No chemotherapy, biologics or immunotherapy within 2 weeks prior to registration as specified in the protocol. Subjects must have recovered from all therapy-related non-hematological toxicities to \< grade 1 or to baseline if patient started with \> grade 1 toxicity. There is no time limit with regards to radiation prior to registration.
11. No radioimmunotherapy within 2 months prior to registration. Subjects must have recovered from all therapy-related toxicities to \< grade 1 or to baseline if patient started with \> grade 1 toxicity.
12. No prior allogeneic stem cell transplantation unless allogeneic engraftment is \<2%
13. Subjects receiving chronic, systemic treatment with corticosteroids equivalent to \>20mg of prednisone per day | Duke University | OTHER | {
"id": "Pro00019069",
"link": null,
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} | The study closed temporarily in February 2012 pending analysis of samples collected. In October, 2012, Celgene requested closure of the study. | {
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"date": "2010-05-12",
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{
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"country": "United States",
"facility": "Duke University Medical Center",
"geoPoint": {
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"lon": -78.89862
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"state": "North Carolina"
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] | [
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"name": "Celgene"
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"description": null,
"measure": "Serum Markers Measured on the First Day of Cycle 1 and on the First Day of Cycle 3",
"timeFrame": "Within 4 months of taking single agent and 6 months of taking the combination"
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],
"primary": [
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"description": null,
"measure": "Response Predicted by Molecular Signatures Compared to True Response",
"timeFrame": "approximately one year"
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"description": null,
"measure": "Overall Response",
"timeFrame": "Response will be assessed after at least 4 months on first study drug."
},
{
"description": null,
"measure": "Overall Response",
"timeFrame": "Response will be assessed after at least 4 months on second drug."
},
{
"description": null,
"measure": "Overall Response",
"timeFrame": "Response will be assessed after at least 6 months on combination drug."
}
],
"secondary": [
{
"description": null,
"measure": "Number of Participants With Grade 3 and 4 Toxicities",
"timeFrame": "While taking the study drug and 30 days after the last dose"
}
]
} | [
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"affiliation": "Duke University Medical Center Durham, NC USA",
"name": "Anne W. Beaven, MD",
"role": "PRINCIPAL_INVESTIGATOR"
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"term": "Lenalidomide"
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} |
NCT06865157 | null | Healthy Food Subsidy Project in Chile | Bolsillo Saludable: Feasibility of a Healthy Food Subsidy on Healthy Eating in Low-Income Households in Chile | None | INTERVENTIONAL | COMPLETED | 2024-11-21T00:00:00 | null | 2024-08-19T00:00:00 | 2024-10-30T00:00:00 | [
"NA"
] | 30 | null | null | ALL | true | Feasibility Study
Objective:
The objective of this feasibility study is to develop and evaluate the feasibility and acceptability of a healthy food subsidy program within the Chilean context. The program, called Healthy Wallet, is a smartphone app-based initiative aimed at incentivizing low-income families to purchase fruits and vegetables at open markets. The findings from this study are intended to inform and potentially accelerate the implementation of similar policies in other countries.
Methods:
This study assessed the feasibility of implementing the Healthy Wallet subsidy program, designed to promote healthy eating habits among low-income families. The program incentivized the purchase of fruits and vegetables at local ferias (open markets) and was delivered through a smartphone application. The research adopted a community-based approach, leveraging existing social support systems to identify eligible beneficiaries and streamline the distribution of benefits. Open markets served as redemption sites for the subsidies.
The study engaged 30 families and 8 vendors in an 8-week pilot program conducted from June to August 2024. Data collection included pre- and post-implementation surveys, as well as focus group discussions: three with participating families and one with vendors. These methods aimed to evaluate the app's effectiveness, user experience, and overall feasibility of the program. Insights from the study will guide recommendations for scaling the initiative to a national level and beyond. | Study Design:
This study employed an eight-week feasibility approach (Healthy Wallet) utilizing a mixed-methods assessment. The quantitative component consisted of a pre-post single-arm study, while the qualitative component involved focus group discussions with both vendors and participants.
Intervention:
The Healthy Wallet program is a mobile-based initiative aimed at promoting healthy eating habits among low-income families by incentivizing the purchase of fruits and vegetables at open markets. The program provides a monthly electronic transfer of 16,000 CLP (approximately 17 USD) for each eligible household member, including children under 18, students under 25, and individuals with disabilities. The primary food purchaser in each household receives the transfer, which is exclusively redeemable at registered stalls in the open market.
To ensure seamless transactions, registered vendors display a distinctive Healthy Wallet identification sign with a unique code. Beneficiaries use the mobile application to view available funds and complete purchases by entering the vendor's stall code. A separate vendor application tracks sales and maintains transaction records for efficient invoicing.
Sample:
The program engaged 30 families, who received monthly benefits for two consecutive months to use at 6 participating stalls within the Juan Pinto Durán open market.
Eligibility Criteria:
Eligibility aligned with Chile's existing social protection framework, leveraging the Emergency Family Wallet government subsidy established to address rising food prices during the COVID-19 pandemic. Households that participated in the Emergency Family Wallet program (2023-2024) were eligible.
The designated household representative, responsible for receiving and managing the benefit, had to meet the following criteria:
Be at least 18 years old (legal age). Be a parent or guardian of a child aged 0-5 years. Be responsible for household grocery purchases. Vendors operating at the Juan Pinto Durán open market were excluded from household eligibility.
Subsidy Delivery Platform:
A private mobile application, originally developed for university food benefits, was adapted for this pilot program. A private company managed the entire process, including loading benefits into participants' accounts, facilitating their use at the Juan Pinto Durán open market, and ensuring payment to vendors. This company provided its services pro bono, offering technical expertise and logistical support at no cost.
Ethical Considerations:
The study was conducted in accordance with the Declaration of Helsinki. The protocol and informed consent forms were approved by the Ethics Committee of the Faculty of Medicine, University of Chile. | Inclusion Criteria:
Households that are beneficiaries of the Bolsillo Familiar Electrónico program in 2023-2024 and have children under 5 years of age.
Availability to shop at the local open-air market (feria libre).
Exclusion Criteria:
Individuals who are market vendors (feria vendors). | University of Chile | OTHER | {
"id": "5128637",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-03-03T00:00:00 | {
"date": "2025-03-07",
"type": "ACTUAL"
} | {
"date": "2025-03-07",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The Healthy Wallet program is a mobile-based initiative designed to promote healthy eating among low-income families by incentivizing the purchase of fruits and vegetables at open markets. Over the course of two months, 30 families received monthly benefits redeemable at participating stalls within the Juan Pinto Durán open market in Santiago, Chile. Registered vendors prominently displayed a distinctive Healthy Wallet identification sign with a unique code, ensuring easy identification. Beneficiaries used the mobile app to check their available funds and complete purchases by entering the stall code. Meanwhile, vendors utilized their own app to track sales and maintain transaction records, streamlining the invoicing process.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Feasibility Studies",
"Food Security"
] | ["Chile", "Fruit and vegetables subsidy", "Feasibility study"] | null | [
{
"city": "Santiago",
"country": "Chile",
"facility": "Feria Libre Juan Pinto Durán",
"geoPoint": {
"lat": -33.45694,
"lon": -70.64827
},
"state": "Macul"
}
] | [
{
"class": "OTHER",
"name": "Bloomberg Philanthropies"
}
] | null | {
"other": [
{
"description": null,
"measure": "Self-reported monthly expenditure on all fruits purchased from the open market, based on a questionnaire",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "Self-reported monthly expenditure on all vegetables purchased at the open market, based on a questionnaire",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "Self-reported monthly expenditure on all fruits and vegetables combined, purchased from the open market, based on a questionnaire",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "Self-reported monthly combined fruit and vegetable purchases (in kilograms) from the open market, based on a questionnaire",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "Self-reported monthly fruit purchases (in kilograms) at the open market, based on a questionnaire",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "Self-reported monthly vegetable purchases (in kilograms) at the open market, based on a questionnaire",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "Self-reported monthly vegetable purchases (in units) at the open market, based on a questionnaire",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "The Global Dietary Recommendations (GDR) score from the Diet Quality Questionnaire (DQQ), range 0-18",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "The Non-Communicable Disease-protect (NCD-protect) score from the Diet Quality Questionnaire (DQQ), range 0-9",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "The Non-Communicable Disease-risk (NCD-risk) score from the Diet Quality Questionnaire (DQQ), range 0-9",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
},
{
"description": null,
"measure": "The Food Group Diversity Score (FGDS) from the Diet Quality Questionnaire (DQQ), range 0-10",
"timeFrame": "At baseline and at the end of the study (0 and 2 months of follow-up)"
}
],
"primary": [
{
"description": null,
"measure": "Percentage of the monetary subsidy spent daily by each household, based on the records from the subsidy delivery platform.",
"timeFrame": "Daily throughout the two months of follow-up"
},
{
"description": null,
"measure": "Percentage of households that used the monetary subsidy at least once per month, based on the records from the subsidy delivery platform",
"timeFrame": "Weekly throughout the two months of follow-up"
},
{
"description": null,
"measure": "Perceived utility of the subsidy program among beneficiaries, evaluated through online surveys",
"timeFrame": "At the end of the study, at two months of follow-up"
},
{
"description": null,
"measure": "Perceived utility of the subsidy program among vendors, evaluated through online surveys",
"timeFrame": "At the end of the study, at two months of follow-up"
},
{
"description": null,
"measure": "Self-reported satisfaction of the subsidy program among beneficiaries, evaluated through focus groups",
"timeFrame": "At the end of the study, at two months of follow-up"
},
{
"description": null,
"measure": "Self-reported satisfaction of the subsidy program among vendors, evaluated through focus groups",
"timeFrame": "At the end of the study, at two months of follow-up"
},
{
"description": null,
"measure": "Perceived utility of the subsidy platform among beneficiaries, evaluated through online surveys",
"timeFrame": "At the end of the study, at two months of follow-up"
},
{
"description": null,
"measure": "Perceived utility of the subsidy platform among vendors, evaluated through online surveys",
"timeFrame": "At the end of the study, at two months of follow-up"
},
{
"description": null,
"measure": "Self-reported satisfaction of the subsidy platform among beneficiaries, evaluated through focus groups",
"timeFrame": "At the end of the study, at two months of follow-up"
},
{
"description": null,
"measure": "Self-reported satisfaction of the subsidy platform among vendors, evaluated through focus groups",
"timeFrame": "At the end of the study, at two months of follow-up"
}
],
"secondary": null
} | [
{
"affiliation": "Institute of Nutrition and Food Technology, University of Chile",
"name": "Camila Corvalan, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "38453385", "type": "BACKGROUND", "citation": "Huangfu P, Pearson F, Abu-Hijleh FM, Wahlich C, Willis K, Awad SF, Abu-Raddad LJ, Critchley JA. Impact of price reductions, subsidies, or financial incentives on healthy food purchases and consumption: a systematic review and meta-analysis. Lancet Planet Health. 2024 Mar;8(3):e197-e212. doi: 10.1016/S2542-5196(24)00004-4."}, {"pmid": "35648401", "type": "BACKGROUND", "citation": "Andreyeva T, Marple K, Moore TE, Powell LM. Evaluation of Economic and Health Outcomes Associated With Food Taxes and Subsidies: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Jun 1;5(6):e2214371. doi: 10.1001/jamanetworkopen.2022.14371."}, {"pmid": "34379125", "type": "BACKGROUND", "citation": "Berkowitz SA, Curran N, Hoeffler S, Henderson R, Price A, Ng SW. Association of a Fruit and Vegetable Subsidy Program With Food Purchases by Individuals With Low Income in the US. JAMA Netw Open. 2021 Aug 2;4(8):e2120377. doi: 10.1001/jamanetworkopen.2021.20377."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT03171857 | null | Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses | Role of Doppler Ultrasound in Evaluation of Superficial Soft Tissue Masses | None | OBSERVATIONAL | UNKNOWN | 2017-05-28T00:00:00 | null | 2019-06-01T00:00:00 | 2019-09-01T00:00:00 | null | 40 | null | null | ALL | false | A wide variety of superficial soft tissue masses may be seen in clinical practice. Superficial soft tissue masses can generally be categorized as mesenchymal tumors, skin appendage lesions, metastatic tumors, other tumors and tumor-like lesions, or inflammatory lesions. The investigators will use doppler ultrasound in evaluation of superficial soft tissue masses characterization. | There are many examples for these benign superficial soft tissue lesions as lipoma, ganglion, Baker's cyst, giant cell tumor, lymphangioma, hernia, abscess, epidermoid cyst, hematoma, muscle rupture, glomus tumor, fibromatosis, lymphadenitis hemangioma, exostosis, fibroma, neurofibroma and schwannoma. Malignant lesions also could be seen as lymphoma, metastasis, osteogenic sarcoma, liposarcoma , leiomyosarcoma, rhabdomyosarcoma and synovial sarcoma.
Nowadays, High resolution ultrasound has a high sensitivity in detecting superficial soft tissue masses through the grey-scale grading that compose an image range from pure black at the weakest intensity to pure white at the strongest that can be used to evaluate its structure, some aspects of its function and to determine the nature of a mass lesion (cystic or solid) and with Doppler ultrasound which is an excellent imaging modality to determine the vascularity of superficial soft tissue masses that can be characterized in terms of their echogenicity, margin, shape, composition, acoustic transmission, size, the grading of color Doppler ultrasound , and resistive index in spectral Doppler as spectral Doppler will be applied in lesions with positive color flow signals. | Inclusion Criteria:
* Patients in different age groups with superficial soft tissue lesions
Exclusion Criteria:
* If the patient undergo previous operations at the same mass that could change the criteria of that mass or if the mass is recurrent at the same site. | Assiut University | OTHER | {
"id": "DUSSSTM",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-05-30T00:00:00 | {
"date": "2017-05-31",
"type": "ACTUAL"
} | {
"date": "2017-05-31",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | All patients that have superficial soft tissue masses in different age groups that referred from the outpatient clinics of the general or orthopaedic surgery, Assiut University Hospital to the Diagnostic Radiology Department | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Mass of Soft Tissue"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Patients diagnosed as superficial soft tissue lesions by doppler ultrasound.",
"timeFrame": "2 years"
}
],
"secondary": null
} | null | [{"pmid": "12386768", "type": "BACKGROUND", "citation": "Brkljacic B, Kuzmic AC, Dmitrovic R, Rados M, Vidjak V. Doppler sonographic renal resistance index and resistance index ratio in children and adolescents with unilateral hydronephrosis. Eur Radiol. 2002 Nov;12(11):2747-51. doi: 10.1007/s00330-001-1259-0. Epub 2002 Feb 2."}, {"pmid": "19473494", "type": "BACKGROUND", "citation": "Taurino M, Rizzo L, Stella N, Mastroddi M, Conteduca F, Maggiore C, Faraglia V. Doppler ultrasonography and exercise testing in diagnosing a popliteal artery adventitial cyst. Cardiovasc Ultrasound. 2009 May 27;7:23. doi: 10.1186/1476-7120-7-23."}, {"pmid": "23996840", "type": "BACKGROUND", "citation": "Toprak H, Kilic E, Serter A, Kocakoc E, Ozgocmen S. Doppler US in rheumatic diseases with special emphasis on rheumatoid arthritis and spondyloarthritis. Diagn Interv Radiol. 2014 Jan-Feb;20(1):72-7. doi: 10.5152/dir.2013.13127."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT05207657 | null | Lentiviral Gene Therapy for p47 AR-CGD | Phase I/II, Non-randomised, Single-centre, Open-label Study of pCHIM-p47 (Lentiviral Vector Transduced CD34+ Cells) in Patients With p47 Autosomal Recessive Chronic Granulomatous Disease | None | INTERVENTIONAL | RECRUITING | 2021-06-24T00:00:00 | null | 2029-04-01T00:00:00 | 2029-04-01T00:00:00 | [
"PHASE1",
"PHASE2"
] | 5 | 23 | null | ALL | false | Chronic Granulomatous Disease (CGD) is a rare inherited disorder in which patients suffer from severe infection and inflammation. The first indications of disease usually appear in early childhood. The basic defect has been found to be lie in specialised white blood cells called phagocytic cells, which are responsible for engulfing and destroying germs. In CGD, there is a defect in an enzyme (known as the NADPH-oxidase) that is responsible for generating bleach like substances that are important for killing some important germs. In one form of the disease known as p47 AR-CGD (which accounts for 30% of patients), there are defined mistakes in a gene called NCF1. This gene is needed to form a key component of NADPH-oxidase.
In many cases, patients can be protected from infection by constant intake of antibiotics. However, in others potentially life-threatening infections break through. In some cases patients also develop serious inflammation requiring high doses of drugs such as steroids. CGD can be cured by bone marrow transplant and the best results are available when a matched sibling donor is available. Transplant from unmatched donors have a much worse outcome and as a result alternative treatments for patients without a matched donor are highly desirable.
Gene therapy of p47 AR-CGD is performed by introducing a normal copy of the human NCF-1 gene into the blood forming stem cells in the patients' bone marrow by using a gene carrier (in this study called a lentiviral vector). After treatment of the bone marrow cells in a specialised laboratory they are given back to the patient and will grow into functional phagocytic cells. There have been no previous clinical trials for patients with p47 AR-CGD however there have been previous gene therapy clinical trials conducted in the UK for patients with the most common form of CGD, known as X-CGD. | null | Inclusion Criteria:
1. p47 AR-CGD patients \> 23 months of age
2. Molecular diagnosis confirmed by Deoxyribonucleic acid (DNA) sequencing and supported by laboratory evidence for absent or reduction \> 95% of the biochemical activity of the NAHPD-oxidase
3. At least one prior, ongoing or refractory severe infection and/or inflammatory complications requiring hospitalisation despite conventional therapy
4. No 10/10 human leukocyte antigen (HLA)-matched donor available after initial search of National Marrow Donor Program (NMDP) registries performed within the last year
5. No co-infection with Human Immunodeficiency Virus (HIV) or hepatitis B virus (HBsAg positive) or hepatitis C virus (HCV ribonucleic acid (RNA) positive), Cytomegalovirus (CMV), adenovirus, parvovirus B 19 or toxoplasmosis
6. Written informed consent for adult patient
7. Parental/guardian and, where appropriate, child's signed consent/assent
Exclusion Criteria:
1. Age ≤ 23 months or \> 35 kg body weight
2. 10/10 HLA identical (A,B,C,DR,DQ) family or unrelated adult donor unless there is deemed to be an unacceptable risk associated with an allogeneic procedure
3. Contraindication for leukapheresis (Haemoglobin \<8g/dl, cardiovascular instability, severe coagulopathy)
4. Appropriate organ function as outlined below must be observed within 8 weeks of entering this trial.
a) Haematologic i) Anaemia (hemoglobin \< 8 g/dl). ii) Neutropenia (absolute granulocyte count \<1,000/mm3 iii) Thrombocytopenia (platelet count \< 150,000/mm3). iv) Prothrombin Time (PT) or Partial thromboplastin time (PTT) \> 2 X the upper limits of normal (ULN) (patients with a correctable deficiency controlled on medication will not be excluded).
v) Cytogenetic abnormalities known to be associated with haematopoietic defect on peripheral blood or bone marrow.
b) Infectious i) Evidence of infection with HIV-1 and -2, hepatitis B, Hepatitis C, adenovirus, parvovirus B 19 or toxoplasmosis within 8 weeks prior to mobilisation/pheresis or bone marrow harvest. CMV infection is allowable as long as the infection is under control.
c) Pulmonary i) Resting O2 saturation by pulse oximetry \< 90% on room air. d) Cardiac i) Abnormal electrocardiogram (ECG) indicating cardiac pathology. ii) Uncorrected congenital cardiac malformation with clinical symptomatology. iii) Active cardiac disease, including clinical evidence of congestive heart failure, cyanosis, iv) Hypotension. v) Poor cardiac function as evidenced by Left Ventricular Ejection Fraction (LVEF) \< 40% on echocardiogram.
e) Neurologic i) Significant neurologic abnormality by examination. ii) Uncontrolled seizure disorder. f) Renal i) Renal insufficiency: serum creatinine greater than or equal to 1.5 mg/dl, or greater than or equal to 3+ proteinuria ii) Abnormal serum sodium, potassium, calcium, magnesium at grade III or IV according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 g) Hepatic/GI: i) Serum transaminases \> 5X the upper limit of normal (ULN). ii) Serum Bilirubin \> 2X ULN. iii) Serum Glucose \> 1.5x ULN. h) Oncologic i) Evidence of active malignant disease
5. General
1. Expected survival \< 6 months.
2. Major congenital anomaly.
3. Ineligible for autologous Haematopoietic Stem Cell Transplant (HSCT) by the criteria at the clinical site.
4. Contraindication for administration of conditioning medication
5. Known sensitivity to Busulfan
6. Administration of gamma-interferon within 30 days before the infusion of transduced, autologous CD34+ cells
7. Participation in another experimental therapeutic protocol within 6 months prior to baseline and during the study period
8. Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful study completion
9. Patient/Parent/Guardian unable or unwilling to comply with the protocol requirements. | Great Ormond Street Hospital for Children NHS Foundation Trust | OTHER | {
"id": "19IC05",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-01-13T00:00:00 | {
"date": "2023-05-16",
"type": "ACTUAL"
} | {
"date": "2022-01-26",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"P47-Phox, Deficiency of"
] | null | null | [
{
"city": "London",
"country": "United Kingdom",
"facility": "Great Ormond Street Hospital",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To evaluate the safety of p47 LV transduced autologous CD34+ cells treatment in p47 AR-CGD patients.",
"timeFrame": "6 months to 1 year"
},
{
"description": null,
"measure": "To evaluate the efficacy of p47 LV transduced autologous CD34+ cells treatment in p47 AR-CGD patients.",
"timeFrame": "6 months to 1 year"
}
],
"secondary": null
} | [
{
"affiliation": "UCL Great Ormond Street Institute of Child Health",
"name": "Claire Booth",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M9208",
"name": "Granulomatous Disease, Chronic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T1304",
"name": "Chronic Granulomatous Disease",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
"interventions": null
} |
NCT05977257 | null | VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL） | VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL） | VITAL | OBSERVATIONAL | NOT_YET_RECRUITING | 2023-07-10T00:00:00 | null | 2025-10-30T00:00:00 | 2028-10-30T00:00:00 | null | 89 | 18 | null | ALL | false | This study is an observational study to evaluate the long-term safety and effectiveness of the valve system. | This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system. | Inclusion Criteria:
* Must meet 1, 2, 3, 4 or 1, 5 to be selected:
1. Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions\*;
2. Be able to get in touch with the patient or his legal guardian/relative;
3. Patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information;
4. Sign the informed consent form;
5. Patients who are known to have died.
* 4 research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital.
Exclusion Criteria:
1. Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;
2. The investigator judges that the patient's compliance is poor and the study cannot be completed as required. | Shanghai MicroPort CardioFlow Medtech Co., Ltd. | INDUSTRY | {
"id": "VITAL-2023-192R",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-07-28T00:00:00 | {
"date": "2023-08-04",
"type": "ACTUAL"
} | {
"date": "2023-08-04",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Aortic Valve Disease",
"Aortic Valve Stenosis"
] | null | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Fuwai CVD Hospital of Chinese Academy of Medical Sciences",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": null
},
{
"city": "Chengdu",
"country": "China",
"facility": "West China Hospital, Sichuan University",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": null
},
{
"city": "Hangzhou",
"country": "China",
"facility": "The Second Affiliated Hospital Zhejiang University School of Medicine",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": null
},
{
"city": "Shanghai",
"country": "China",
"facility": "Zhongshan Hospital Fudan University",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "All cause mortality",
"timeFrame": "7years after the operation"
}
],
"secondary": [
{
"description": null,
"measure": "Cardiac death",
"timeFrame": "6 years, 7 years, 8 years, 9 years and 10 years after the operation"
},
{
"description": null,
"measure": "Stroke",
"timeFrame": "6 years, 7 years, 8 years, 9 years and 10 years after the operation"
},
{
"description": null,
"measure": "valve-related rehospitalization",
"timeFrame": "6 years, 7 years, 8 years, 9 years and 10 years after the operation"
},
{
"description": null,
"measure": "Serious Adverse Event",
"timeFrame": "6 years, 7 years, 8 years, 9 years and 10 years after the operation"
},
{
"description": null,
"measure": "Blood pressure",
"timeFrame": "6 years, 7 years, 8 years, 9 years and 10 years after the operation"
},
{
"description": null,
"measure": "The 12-Item Short Form Health Survey (SF-12)",
"timeFrame": "6years, 7years, 8 years, 9 years and 10 years after the operation"
},
{
"description": null,
"measure": "Mean transvalvular pressure gradient",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "Effective orifice area",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "Peak velocity",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "class of Paravalvular leak",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "class of Aortic regurgitation",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "New York Heart Association Class for heart function",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "Kansas City Cardiomyopathy Questionnaire",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "Natriuretic peptide tests ( NT Pro-BNP or BNP)",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "moderate and severe structural valve deterioration SVD",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "bioprosthetic valve failure，BVF",
"timeFrame": "7years,and 10 years after the operation"
},
{
"description": null,
"measure": "All cause mortality",
"timeFrame": "6 years, 8 years, 9 years and 10 years after the operation"
}
]
} | [
{
"affiliation": "Fudan University",
"name": "Daxin Zhou",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D006349",
"term": "Heart Valve Diseases"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D014694",
"term": "Ventricular Outflow Obstruction"
}
],
"browseBranches": [
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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"id": "M2379",
"name": "Aortic Valve Disease",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6475",
"name": "Constriction, Pathologic",
"relevance": "LOW"
},
{
"asFound": "Aortic Valve Stenosis",
"id": "M4340",
"name": "Aortic Valve Stenosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M9437",
"name": "Heart Valve Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17440",
"name": "Ventricular Outflow Obstruction",
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},
{
"asFound": "Aortic Valve Stenosis",
"id": "T449",
"name": "Aortic Valve Stenosis",
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}
],
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{
"id": "D001024",
"term": "Aortic Valve Stenosis"
},
{
"id": "D000082862",
"term": "Aortic Valve Disease"
}
]
} | null | {
"conditions": [
{
"id": "D001024",
"term": "Aortic Valve Stenosis"
},
{
"id": "D000082862",
"term": "Aortic Valve Disease"
}
],
"interventions": null
} |
NCT06629857 | null | A Cross Sectional Study Evaluating the Mean Levels of Alpha Fetoprotein in Patients of Hepatocellular Carcinoma and Its Correlates in Pakistan | Clinical Correlation of Alpha-Fetoprotein in Hepatocellular Carcinoma: a Cross-Sectional Study from Southeast Asia | None | OBSERVATIONAL | COMPLETED | 2024-10-04T00:00:00 | null | 2023-03-01T00:00:00 | 2023-03-01T00:00:00 | null | 94 | 27 | 80 | ALL | false | This study aims to explore the levels of alpha-fetoprotein (AFP), a protein often elevated in liver cancer, in patients with hepatocellular carcinoma (HCC). The goal is to determine whether AFP levels vary based on the size of the liver tumor or other health conditions like hepatitis B, hepatitis C, and obesity. By analyzing data from 94 patients, the study seeks to identify factors that influence AFP levels, which may help in understanding liver cancer progression and improving diagnosis and treatment approaches. | null | Inclusion Criteria:
* Aged between 27 to 80 years.
* Diagnosed with hepatocellular carcinoma (HCC) within the last three months.
* Diagnosis confirmed by relevant investigations (e.g., imaging, liver biopsy).
* Able to provide informed consent.
Exclusion Criteria:
* Elevated alpha-fetoprotein levels due to tumors other than HCC.
* Presence of secondary liver metastases from other primary sites.
* Any significant comorbid conditions that could interfere with study assessments.
* Pregnancy or breastfeeding. | Darul Sehat Hospital | OTHER | {
"id": "M-000037/22",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-10-04T00:00:00 | {
"date": "2024-10-08",
"type": "ACTUAL"
} | {
"date": "2024-10-08",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | The study population will consist of a total of 94 adult patients diagnosed with hepatocellular carcinoma (HCC) who are receiving care at Dar ul Sehat Hospital, Karachi, Pakistan. Participants will be recruited from outpatient, emergency, and inpatient departments. Eligible individuals will be aged between 27 to 80 years and must have been diagnosed with HCC within the last three months, confirmed by relevant investigations. The study aims to reflect a diverse population that includes various tumor sizes and underlying liver disease etiologies, such as hepatitis B, hepatitis C, non-alcoholic steatohepatitis, and cirrhosis. Patients will be excluded if they have elevated alpha-fetoprotein levels due to tumors other than HCC or have secondary liver metastases from other primary sites. This approach ensures that the findings are specific to HCC and its correlates, aiding in the assessment of AFP levels in this population. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
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"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Carcinoma, Hepatocellular"
] | ["Hepatocellular carcinoma (HCC)", "Alpha-fetoprotein (AFP) levels", "Liver cancer biomarkers", "Tumor size and AFP correlation", "Hepatitis B and C in liver cancer", "Non-alcoholic steatohepatitis (NASH)", "AFP as a diagnostic tool", "Liver tumor progression markers"] | null | [
{
"city": "Karachi",
"country": "Pakistan",
"facility": "Darul Sehat Hospital",
"geoPoint": {
"lat": 24.8608,
"lon": 67.0104
},
"state": "Sindh"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Mean Alpha-Fetoprotein (AFP) Levels in HCC Patients",
"timeFrame": "Baseline measurement at time of diagnosis."
}
],
"secondary": [
{
"description": null,
"measure": "Correlation Between AFP Levels and Tumor Size",
"timeFrame": "At baseline (upon diagnosis)."
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D000230",
"term": "Adenocarcinoma"
},
{
"id": "D008113",
"term": "Liver Neoplasms"
},
{
"id": "D004067",
"term": "Digestive System Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D008107",
"term": "Liver Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
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"asFound": null,
"id": "M11113",
"name": "Liver Neoplasms",
"relevance": "LOW"
},
{
"asFound": "Carcinoma",
"id": "M5534",
"name": "Carcinoma",
"relevance": "HIGH"
},
{
"asFound": "Carcinoma, Hepatocellular",
"id": "M9613",
"name": "Carcinoma, Hepatocellular",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M8375",
"name": "Fatty Liver",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9592",
"name": "Hepatitis A",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9595",
"name": "Hepatitis B",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9591",
"name": "Hepatitis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20559",
"name": "Disease Progression",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12320",
"name": "Neoplasms, Glandular and Epithelial",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12315",
"name": "Neoplasms by Histologic Type",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3585",
"name": "Adenocarcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8886",
"name": "Gastrointestinal Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7256",
"name": "Digestive System Neoplasms",
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},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11107",
"name": "Liver Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T4202",
"name": "Oculocerebral Syndrome With Hypopigmentation",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T5868",
"name": "Visceral Steatosis",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D006528",
"term": "Carcinoma, Hepatocellular"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Hemat",
"name": "Hematinics"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M11110",
"name": "Liver Extracts",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D006528",
"term": "Carcinoma, Hepatocellular"
}
],
"interventions": []
} |
NCT03297957 | null | Fluorescence Imaging in Head and Neck Cancer | Evaluation of Fluorescence Imaging in Head and Neck Cancer | None | INTERVENTIONAL | TERMINATED | 2017-09-26T00:00:00 | null | 2019-04-15T00:00:00 | 2019-04-15T00:00:00 | [
"NA"
] | 28 | 18 | null | ALL | false | Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of time required to perform the SLNB procedure.
Regarding parathyroid identification, this technology has the potential to identify these very small glands during procedures they are at risk. These glands are not only at risk of inadvertent removal if not adequately identified, but may also be at risk if devascularized by manipulation during the surgical procedure. Therefore, early and accurate identification may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. This is not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery where the anatomic region these glands are located are often resected to remove at risk lymph nodes from cancer spread. Therefore, identifying these glands may help preserve parathyroid function in this patient population as well. | null | Inclusion Criteria:
* Adults aged 18 years or older will be considered eligible.
* Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma. Patients with central neck pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms undergoing surgical resection.
* Candidates for sentinel lymph node biopsy or central neck surgery
* Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy.
* Not pregnant or breast feeding.
* Able to understand and willing to sign an IRB-approved written informed consent document.
* Able to understand written or spoken English.
Exclusion Criteria:
* History of allergy to iodide drugs or shellfish (iodine allergy)
* Pregnant or breast feeding
* Do not fit age criteria
* Prisoners
* Unable to provide written consent
* Contraindications for surgery
\*Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agents | Washington University School of Medicine | OTHER | {
"id": "201708068",
"link": null,
"type": null
} | Low accrual | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-09-26T00:00:00 | {
"date": "2020-01-18",
"type": "ACTUAL"
} | {
"date": "2017-09-29",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Head and Neck Cancer",
"Cancer of the Head and Neck"
] | null | null | [
{
"city": "Saint Louis",
"country": "United States",
"facility": "Washington University School of Medicine",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure",
"timeFrame": "Up to 1 week after surgery"
},
{
"description": null,
"measure": "Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure",
"timeFrame": "Up to 1 week after surgery"
},
{
"description": null,
"measure": "Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure",
"timeFrame": "Up to 1 week after surgery"
},
{
"description": null,
"measure": "Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure",
"timeFrame": "Up to 1 week after surgery"
},
{
"description": null,
"measure": "Ability of the hands-free goggle system to identify parathryoid glands during central neck surgeries",
"timeFrame": "Up to 1 week after surgery"
}
],
"secondary": [
{
"description": null,
"measure": "Determine if there is contrast between SLN and surrounding tissues using the novel fluorescence imaging device",
"timeFrame": "Up to 1 week after surgery"
}
]
} | [
{
"affiliation": "Washington University School of Medicine",
"name": "Ryan S Jackson, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
}
],
"browseBranches": [
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"abbrev": "BC04",
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{
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"name": "All Conditions"
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],
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"asFound": "Head and Neck Cancer",
"id": "M9348",
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"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D006258",
"term": "Head and Neck Neoplasms"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M13194",
"name": "Parathyroid Hormone",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D006258",
"term": "Head and Neck Neoplasms"
}
],
"interventions": []
} |
NCT00506857 | null | Phase I/II Trial of Fludarabine Plus Busulfan and Allogeneic Progenitor Cell Support | Phase I/II Trial of Fludarabine in Combination With Intravenous Busulfan and Allogeneic Progenitor Cell Support for Patients With Hematologic Malignancies | None | INTERVENTIONAL | COMPLETED | 2007-07-23T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 82 | null | 75 | ALL | false | Objectives:
1. To determine the relative toxicities, engraftment potential, kinetics of engraftment, degree of chimerism and disease control achieved with the combination of fludarabine and busulfan at different dose levels and different dose schedules in patients undergoing allogeneic stem cell transplant (SCT).
2. Determine pharmacokinetics, and toxicity of intravenous busulfan given at equal total dose levels given four times daily, or once daily.
3. In vivo determination of fludarabine inhibitory effects on DNA repair. | Treatment: Participants will have blood tests and bone marrow tests as well as tests to check lung, heart, kidney, and liver functions. Participants will receive busulfan by vein for 2 to 4 days depending on their age and medical condition. All participants will receive fludarabine which will be given over 4 days. Participants undergoing unmatched or matched unrelated donors will receive ATG over 4 days to help with the engraftment of the donor progenitor cells. All drugs are given through the vein daily.
The donor blood cells will be taken from the donor through a process known as apheresis. This will occur after the donor has received 2 days of granulocyte colony stimulating factor (G-CSF) to increase her/his white cell count. The G-CSF will also increase the number of very immature (stem cells) that are to be collected. Apheresis is similar to a platelet donation, but white cells and stem cells are collected instead. About 3 to 5 apheresis procedures will be needed to get enough cells for infusion. If apheresis is not used, donor bone marrow will be taken under general anesthesia.
After the participants receives the donor stem cells, the stem cells divide and reconstitute bone marrow function, blood function, and immunity. The donor stem cells are given after the chemotherapy to shorten the period of low blood counts. They are also given at this time to achieve an antileukemic effect whereby the donor immune cells will recognize the participant's leukemia as "foreign" and prevent its recurrence. A small amount of donor cells will be kept for infusion on a future date (usually 3 and 6 months post transplant) to try to prevent the disease from coming back.
During the 4 to 8 weeks following blood cell infusion, participants will need frequent blood tests to monitor their counts and blood chemistries. Participants will need frequent blood transfusion and may have to be admitted to the hospital to receive antibiotics if they develop fever. Bone marrow will be examined frequently beginning four weeks after treatment to check response. Participants that achieve normal bone marrow and blood counts will be evaluated to determine the most appropriate form of future therapy. Participants who fail to respond to treatment will be offered other therapies.
This is an investigational study. All through all drugs are commercially available. Up to 140 participants will take part in this study. All will be enrolled at UT MD Anderson Cancer Center. | Inclusion Criteria:
1. Less than physiologic 75 years of age.
2. Interferon resistant late chronic phase CML not eligible for a protocol of higher priority.
3. Accelerated/Blastic Phase CML.
4. Acute leukemia or Intermediate to High Risk MDS according to the IPPS.
5. Any Lymphoma or Myeloma beyond CR1 ineligible for a protocol of higher priority.
6. Patients must have an HLA compatible donor willing to donate either peripheral blood or bone marrow progenitor cells.
7. Both patients and donor must sign written informed consents.
Exclusion Criteria:
1. Uncontrolled infection
2. Bilirubin \>3.0
3. Creatinine \>2.5
4. Performance Status \>Zubrod 2 | M.D. Anderson Cancer Center | OTHER | {
"id": "DM99-251",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2007-07-23T00:00:00 | {
"date": "2012-02-28",
"type": "ESTIMATED"
} | {
"date": "2007-07-25",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
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} | [
"Hematologic Malignancies"
] | ["Hematologic Malignancies", "Blood And Marrow Transplantation", "Leukemia", "MDS", "Lymphoma", "Myeloma", "Fludarabine", "Fludara", "Fludarabine Phosphate", "Busulfan", "Busulfex", "Myleran", "Progenitor Cell Transplantation", "Granulocyte colony stimulating factor", "G-CSF", "Apheresis", "Blood cell infusion"] | null | [
{
"city": "Houston",
"country": "United States",
"facility": "UT MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Maximum Tolerated Dose (MTD)",
"timeFrame": "1 month"
}
],
"secondary": [
{
"description": null,
"measure": "Number of Participants With Graft Versus Host Disease (GVHD)",
"timeFrame": "5 years"
}
]
} | [
{
"affiliation": "UT MD Anderson Cancer Center",
"name": "Richard E. Champlin, MD, BS",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
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"term": "Neoplasms by Site"
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{
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],
"browseBranches": [
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"abbrev": "BC04",
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{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M12058",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M27588",
"name": "Neoplasms, Plasma Cell",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10945",
"name": "Leukemia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11220",
"name": "Lymphoma",
"relevance": "LOW"
},
{
"asFound": "Hematologic Malignancies",
"id": "M21314",
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"relevance": "HIGH"
},
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"asFound": null,
"id": "M9490",
"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T3947",
"name": "Multiple Myeloma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T3543",
"name": "Lymphosarcoma",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D019337",
"term": "Hematologic Neoplasms"
}
]
} | {
"ancestors": [
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D000964",
"term": "Antimetabolites, Antineoplastic"
},
{
"id": "D000963",
"term": "Antimetabolites"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D007166",
"term": "Immunosuppressive Agents"
},
{
"id": "D007155",
"term": "Immunologic Factors"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D000477",
"term": "Alkylating Agents"
},
{
"id": "D018906",
"term": "Antineoplastic Agents, Alkylating"
},
{
"id": "D019653",
"term": "Myeloablative Agonists"
}
],
"browseBranches": [
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
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{
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"name": "All Drugs and Chemicals"
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],
"browseLeaves": [
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"id": "M283230",
"name": "Fludarabine",
"relevance": "HIGH"
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{
"asFound": null,
"id": "M1945",
"name": "Lenograstim",
"relevance": "LOW"
},
{
"asFound": "Stretching",
"id": "M5336",
"name": "Busulfan",
"relevance": "HIGH"
},
{
"asFound": "Twice daily",
"id": "M225513",
"name": "Fludarabine phosphate",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4281",
"name": "Antimetabolites",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10212",
"name": "Immunosuppressive Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10201",
"name": "Immunologic Factors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3820",
"name": "Alkylating Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20942",
"name": "Antineoplastic Agents, Alkylating",
"relevance": "LOW"
}
],
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"term": "Fludarabine"
},
{
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},
{
"id": "D002066",
"term": "Busulfan"
}
]
} | {
"conditions": [
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D019337",
"term": "Hematologic Neoplasms"
}
],
"interventions": [
{
"id": "C024352",
"term": "Fludarabine"
},
{
"id": "C042382",
"term": "Fludarabine phosphate"
},
{
"id": "D002066",
"term": "Busulfan"
}
]
} |
NCT01449357 | null | Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors | A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors | None | INTERVENTIONAL | WITHDRAWN | 2011-09-29T00:00:00 | null | null | null | [
"PHASE2"
] | 0 | 18 | null | ALL | false | A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors. | null | Inclusion Criteria:
* Patients must have documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST).
Exclusion Criteria:
* Estimated life expectancy of less than 3 months.
* Received the following treatments within 2 weeks prior to Visit 2:
* Cytotoxic or cytostatic anti-cancer chemotherapy
* Total resection or irradiation of the target lesion
* Any investigational agent | Genmab | INDUSTRY | {
"id": "GEN210",
"link": null,
"type": null
} | Trial never initiated | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-10-07T00:00:00 | {
"date": "2011-10-10",
"type": "ESTIMATED"
} | {
"date": "2011-10-10",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
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"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Non-small Cell Lung Cancer"
] | ["NSCLC", "Zalutumumab", "Efficacy", "Safety"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months.",
"timeFrame": "within 6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months.",
"timeFrame": "within 6 months"
}
]
} | [
{
"affiliation": "H. Lee Moffitt Cancer Center, Tampa, Florida, USA",
"name": "Not applicable, Study cancelled",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012142",
"term": "Respiratory Tract Neoplasms"
},
{
"id": "D013899",
"term": "Thoracic Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D002283",
"term": "Carcinoma, Bronchogenic"
},
{
"id": "D001984",
"term": "Bronchial Neoplasms"
}
],
"browseBranches": [
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"abbrev": "BC04",
"name": "Neoplasms"
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"abbrev": "BC08",
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},
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"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
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"relevance": "HIGH"
},
{
"asFound": "Non-small Cell Lung Cancer",
"id": "M5546",
"name": "Carcinoma, Non-Small-Cell Lung",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M20559",
"name": "Disease Progression",
"relevance": "LOW"
},
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"asFound": null,
"id": "M5534",
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"relevance": "LOW"
},
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"id": "M14979",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M16658",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5540",
"name": "Carcinoma, Bronchogenic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5260",
"name": "Bronchial Neoplasms",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008175",
"term": "Lung Neoplasms"
},
{
"id": "D002289",
"term": "Carcinoma, Non-Small-Cell Lung"
}
]
} | {
"ancestors": [
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"id": "D000074322",
"term": "Antineoplastic Agents, Immunological"
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{
"id": "D000970",
"term": "Antineoplastic Agents"
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],
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"abbrev": "All",
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}
],
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{
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"term": "Zalutumumab"
}
]
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}
],
"interventions": [
{
"id": "C546618",
"term": "Zalutumumab"
}
]
} |
NCT05117957 | null | Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study | Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study | None | INTERVENTIONAL | ENROLLING_BY_INVITATION | 2021-10-21T00:00:00 | null | 2024-10-31T00:00:00 | 2025-12-31T00:00:00 | [
"PHASE2"
] | 50 | 20 | null | ALL | false | To investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced HCC. | Sorafenib (Soranib Tablet) will be administered orally at a dose of 600mg daily without food for patients who have been treated with prior systemic therapy for advanced HCC. The study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent, or study closure.
Response to sorafenib should be assessed at least every 8 weeks (± 7 days) by either CT scan or MRI.
After the treatment phase, subjects will undergo follow up for survival and the use of other anticancer treatments and/or therapies every 12 weeks (± 7 days) from the last dose and the survival follow up will be performed for at least 12 months after the enrollment of the last subject. | Inclusion Criteria:
1. Signed written informed consent
2. Age of 20 or more
3. Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center
4. Locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies
5. Intolerant to or progressed on at least 1 prior systemic treatment for HCC
6. Having at least one measurable target lesion (per RECIST v1.1)
- Patients who received prior local therapy (e.g., radiofrequency ablation, transarterial chemoembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1.
7. Child-Pugh class A or B7
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
9. Life expectancy of at least 16 weeks
10. Adequate hematologic and hepatic function (should be obtained within 14 days prior to initiation of study treatment):
11. Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 5 months (women) and 7 months (men) after the last study drug administration.
Exclusion Criteria:
1. Fibrolamellar carcinoma or sarcomatoid carcinoma
2. Having active brain metastasis or leptomeningeal metastasis
3. Moderate to severe or intractable ascites
4. Presence of hepatic encephalopathy
5. Presence of active bacterial infection
6. Uncontrolled severe medical comorbidity
7. Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years)
8. Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study | National Cancer Center, Korea | OTHER_GOV | {
"id": "SOPT study 2021",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-11-02T00:00:00 | {
"date": "2022-10-24",
"type": "ACTUAL"
} | {
"date": "2021-11-11",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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} | [
"Advanced Hepatocellular Carcinoma"
] | ["HCC", "Sorafenib"] | null | [
{
"city": "Seoul",
"country": "Korea, Republic of",
"facility": "National Cancer Center, Korea",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Progression-free survival (PFS)",
"timeFrame": "Until 12 months after the last patient was enrolled"
},
{
"description": null,
"measure": "Safety (Adverse events)",
"timeFrame": "Until 12 months after the last patient was enrolled"
}
],
"secondary": [
{
"description": null,
"measure": "Overall survival (OS)",
"timeFrame": "Until 12 months after the last patient was enrolled"
},
{
"description": null,
"measure": "Time to progression (TTP)",
"timeFrame": "Until 12 months after the last patient was enrolled"
},
{
"description": null,
"measure": "Objective response rate (ORR)",
"timeFrame": "Until 12 months after the last patient was enrolled"
},
{
"description": null,
"measure": "Disease control rate (DCR)",
"timeFrame": "Until 12 months after the last patient was enrolled"
}
]
} | [
{
"affiliation": "National Cancer Center, South Korea",
"name": "Bo Hyun Kim, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D000230",
"term": "Adenocarcinoma"
},
{
"id": "D008113",
"term": "Liver Neoplasms"
},
{
"id": "D004067",
"term": "Digestive System Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
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"term": "Liver Diseases"
}
],
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"abbrev": "BC04",
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],
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"name": "Carcinoma, Hepatocellular",
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},
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"name": "Neoplasms by Histologic Type",
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},
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},
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},
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},
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"relevance": "LOW"
},
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"relevance": "LOW"
},
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"relevance": "LOW"
}
],
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"term": "Carcinoma"
},
{
"id": "D006528",
"term": "Carcinoma, Hepatocellular"
}
]
} | {
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"term": "Antineoplastic Agents"
},
{
"id": "D047428",
"term": "Protein Kinase Inhibitors"
},
{
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},
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],
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"abbrev": "ANeo",
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],
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"relevance": "LOW"
}
],
"meshes": [
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"id": "D000077157",
"term": "Sorafenib"
}
]
} | {
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],
"interventions": [
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]
} |
NCT01295957 | null | Alzheimer's Disease Reminiscence Quality of Life | Phase 4 Study of a Reminiscence Program to Improve Quality of Life of Alzheimer's Disease Long Term Care Residents Using a Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2011-02-14T00:00:00 | null | null | null | [
"PHASE4"
] | 135 | 65 | 87 | ALL | true | The effectiveness of reminiscence for dementia has been claimed as an effective tool, but scientific validation and systematic assessment of this method is needed. Materials and Methods: A randomized controlled trial (RCT) was conducted to search whether a reminiscence program is associated with improvement of quality of life of demented long term care residents. The trial had three arms: interventional, comparison and control. The reminiscence program was modeled within a life-story approach, while comparison group received informal counseling to control for changes in quality of life resulting from social contacts. The Social Engagement Scale (SES) and Self-rated Quality of Life Index (SRQoL) were the outcome measures. The results were examined at baseline (T0), twelve weeks (T1), and 6 months (T2) after intervention. The sample had 135 subjects \[intervention group (N=45), comparison group (N=45) and control group (N=45)\]. | A total number of 135 residents will be recruited from two private funded long term nursing homes, which shared equal structural and functional characteristics. Subjects were randomly assigned to one of the three groups (intervention, comparison and control). The subjects admitted for the study are diagnosed as having Alzheimer's disease according to the DSM-IV are able to communicate with a Holden Communication Scale scores\>25 and have a Folstein mental Exam score above 10. Exclusion criteria are active major psychiatric disorders (schizophrenia, major affective disorders); acute or unstable chronic medical conditions including cardiac or lung diseases; blindness and deafness, even with hearing aids, both assessed with the RAI blindness and deafness scales.
Power and sample size calculation. Sample size will be estimated taking into account that the study had to test a null hypothesis whether the different participating groups were similar or different. It is assumed that a significant change in dementia nursing home resident quality of life (QoL) from baseline would be of half a standard deviation, which equals to 3 points, as found in a previous longitudinal study10. With this predicted effect size of QoL, a power of 80% and a type I error for independent groups of 0.01, the estimated sample size was 143 participants in the total study population.
Methods and materials The intervention was designed as an individual treatment condition in which each participating subject received 24 bi-weekly sessions of reminiscence therapy, lasting one hour each one, over a period of 12 weeks. The latter refers to the use of images, sentences or memorabilia which help to focus on specific segments of the life history of an individual, and stimulates the emergence of affect-laden personal recalls, which are later verbalized in the context of guided conversations. The term story life is intended to highlight samples of meaningful events of the subject's life rather than a historically structured biography. The control group was administered counseling and informal social contacts in bi-weekly sessions of one hour, but they didn't participate in reminiscence sessions. This was intended to rule out the possibility that improvement in quality of life was due only to attention received and social stimulation. The comparison group received unstructured social contacts, again in bi-weekly sessions of one hour each one. Remaining features in the design of the three arms were similar with the only exception being the structured reminiscence program participation. The study was approved by the local Ethics Review Committee. This study adopted a single-blinded, parallel-group (one intervention, one comparison, and one control \[no-intervention\] group) design to address the following hypothesis: a) residents with Alzheimer's disease submitted to a reminiscence program intervention will show a better quality of life as a consequence of greater sense of self identity regarding groups with no specific therapeutic intervention, b) this quality of life improvement will be sustained beyond actual therapeutic intervention, due to consolidation of self identity and the reinforcing effects of increased competence, efficacy and personal involvement in everyday activities, associated with higher sense of self.
Demographic and clinical data of residents, including age, gender, marital status, level of education, religion, length of dementia, length of stay in the nursing home, associated medical problems, Mini-mental State Examination (MMSE) score, Cognitive Performance Scale level (CPS)15, ability to communicate, functional abilities, use of psychotropic medications, fitness programs, physical restrictions, number of visits per month from families and friends, and caregiver burden with the Burden Interview (short version ) will be collected. The severity of dementia will be staged with the CDR. The functional performance of the residents will be assessed using an index of physical function for level of independence in eating, dressing, toileting, transferring, and walking by using magnitude estimation weights. Each level of disability on each activity is given a weight, rather than a simple count. The resulting score ranges from 0 (no limitation) to 3.77 (completely disabled on five activities of daily living) and has ratio scale properties. To assess physical restraints the investigators used an indicator of daily use of full bed rails, trunk or limb restraints, or a chair that prevents rising. Physical restraints are not an aspect of the individual resident, but they are a clinical care process that is modifiable by the facility. Restraint use is considered an indicator of poor quality of care and an infringement on individual autonomy that diminishes QOL. Cognitive performance was assessed with the CPS. This is a clinically derived scale to predict MMSE and Test for Severe Impairment scores18. While MMSE has a floor effect with minimal scores suggesting questionable validity for more cognitively impaired elders, the TSI achieves meaningful variations, minimizes reliance on language skills and permitting subjects to answer correctly through nonverbal as well as verbal responses. Is composed of twenty-one items covering six cognitive areas: well-learned motor performance, language comprehension, language production, immediate and delayed memory, conceptualization, and general knowledge. The best score is 24, the lower is zero. For persons with an MMSE score of 11 or more, they will have TSI scores of 22 or higher. The CPS is composed by five items: 1-short-term memory, 2-cognitive skills for daily decision making, 3-coma (or persistent vegetative state), 4-making self understood and 5-eating. The scale has an average inter-rater reliability of 0.85 and a sensibility of 0.92 and specificity of 0.87. The CPS classifies residents into seven cognitive performance levels, from level 0 (Intact) with a mean MMSE score of 25, to Level 6 (Very Severe Impairment) with a near to zero. CPS Levels 2 and 3 (Mild and Moderate Impairment) corresponds to a MMSE score of 10 or higher, averaging 10.3 and 13.8, and to a TPI of 21 (SD=3.6). The Social Engagement Scale19 rates the resident status during the last seven days in areas such as ease interaction with others and doing planned or structured activities. Each item is ranked on a binary basis, as yes (1) or no (0) by the caregiver. The highest score is 6 and the lowest is 0. It has high internal consistency (intra-class correlation: 0.51-0.64), and the items shows reliability across different groups of residents with variable levels of functional and cognitive status. The resident self-reported SRQoL was measured using a multidimensional self-report instrument20. It measures 11 dimensions of QOL relative to a resident's experience: comfort, functional competence, privacy, dignity, autonomy, meaningful activities, relationships, food enjoyment, spiritual well-being, security, and individuality. Each dimension is scored on a 4-point Likert scale, with 4 meaning often, 3 sometimes, 2 rarely and 1 never. Residents unable to use the 4-point scale could answer ''generally yes'' or ''generally no.'' These responses are scored as 3.8 and 1.5, respectively, based on a z score approximation method. Reliability scores range between Cronbach's alpha values of 0.78 and 0.8521. Anxiety will be assessed using the Rating of Anxiety in Dementia (RAID): an 18-item scale with scores \>11 indicating significant anxiety symptoms. Depression will be ruled out using the Minimum Data Set Depression Rating Scale. This is a standardized screening instrument for detecting depression among nursing home residents. Its comprises seven core Minimum Data Set mood items with a sensibility of 69% and a sensitivity of 91%, and a Cronbach α measure of internal consistency of 0,75. It has a score range of 0-14 with a cut-off point of 3. The Burden Interview short version (ZBI)24 will be used to measure the strain and burden experienced by caregivers on a 12 items scale, each one is scored on a 5 point Likert scale from 0 (never) to 4 (always). It has a range of results from 0 to 48, a Cronbach's alpha of 0.88, and a cutoff score of 17. Well being of residents will be assessed using the Well-being/Ill-being Scale (WIB)25 which includes positive components such as "being able to express wishes in an acceptable way," "bodily relaxation," and "creative self expression" (such as singing, dancing or painting), and negative ones such as "unattended sadness or grief," "sustained anger" or "anxiety." The WIB scale rates each category of behavior observed every five minutes for a minimum of six hours. After five minutes, the rater quantifies the nature of the observed behavior category by assigning a WIB value to it. The six-point WIB scale ranges from very negative to very positive (-5, -3, -1, +1, +3, +5). Values will be calculated at the end of the observation period to extract a mean score. | Inclusion Criteria:
* Alzheimer's disease
* Able to communicate
Exclusion Criteria:
* Active major psychiatric disorders
* Acute or unstable chronic medical conditions
* Blindness
* Deafness | Universidad Nacional de Rosario | OTHER | {
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"date": "2011-02-15",
"type": "ESTIMATED"
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] | null | null | false | {
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},
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} | [
"Alzheimer's Disease"
] | null | null | [
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"city": "Rosario",
"country": "Argentina",
"facility": "Faculty of Psychology",
"geoPoint": {
"lat": -32.94682,
"lon": -60.63932
},
"state": "Santa Fe"
}
] | null | null | {
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"description": null,
"measure": "self rated quality of life",
"timeFrame": "12 weeks"
}
],
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"description": null,
"measure": "Social engagement scale",
"timeFrame": "12 weeks"
}
]
} | [
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"affiliation": "faculty of psychology",
"name": "daniel jl serrani azcurra, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "12948999", "type": "BACKGROUND", "citation": "Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248."}, {"pmid": "23429813", "type": "DERIVED", "citation": "Serrani Azcurra DJ. A reminiscence program intervention to improve the quality of life of long-term care residents with Alzheimer's disease: a randomized controlled trial. Braz J Psychiatry. 2012 Dec;34(4):422-33. doi: 10.1016/j.rbp.2012.05.008."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Dementia"
},
{
"id": "D001927",
"term": "Brain Diseases"
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{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D024801",
"term": "Tauopathies"
},
{
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"term": "Neurodegenerative Diseases"
},
{
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"term": "Neurocognitive Disorders"
},
{
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"term": "Mental Disorders"
}
],
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"abbrev": "BC10",
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"name": "All Conditions"
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],
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"relevance": "HIGH"
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},
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},
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},
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}
],
"meshes": [
{
"id": "D000544",
"term": "Alzheimer Disease"
}
]
} | null | {
"conditions": [
{
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"term": "Alzheimer Disease"
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],
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} |
NCT04604457 | null | Impact of Predictive Modeling on Time to Palliative Care in an Outpatient Primary Care Population | Impact of Predictive Modeling on Time to Palliative Care in an Outpatient Primary Care Population | None | INTERVENTIONAL | COMPLETED | 2020-10-14T00:00:00 | null | 2021-05-31T00:00:00 | 2021-05-31T00:00:00 | [
"NA"
] | 127,070 | 18 | null | ALL | false | A machine learning algorithm will be used to accurately identify patients in certain primary care units who may benefit from palliative care consults. | A machine learning algorithm will be used to accurately identify patients in certain primary care units who may benefit from palliative care consults. These patients will be presented weekly to a palliative care specialist in a custom user interface. The palliative care specialist will reach out to primary care teams if she determines that the patient would benefit from palliative care. If the primary care provider agrees, he/she would write a palliative care consult order for the patient. The goal is to reduce the time to palliative care for these patients, who may not have been identified as quickly without the algorithm. | Inclusion Criteria:
* Adult patient assigned to a primary care unit from July 2020 to June 2021.
* Weekly the palliative care specialists will select patients by looking at patients in sorted order starting with the highest score and proceeding down the list and evaluating each patient for exclusion criteria.
Exclusion Criteria:
* Patients that have been seen by Palliative care will be excluded for 75 days
* Patients under the age of 18 years.
* Patients currently enrolled with hospice | Mayo Clinic | OTHER | {
"id": "20-005977",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-10-21T00:00:00 | {
"date": "2021-06-16",
"type": "ACTUAL"
} | {
"date": "2020-10-27",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Step-wedge design with 7 wedges: the first wedge has all primary care teams in the standard of care arm; every six weeks one or two care teams switch to the intervention arm.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
} | [
"Palliative Care"
] | ["machine learning", "predictive model", "palliative care"] | null | [
{
"city": "Rochester",
"country": "United States",
"facility": "Mayo Clinic in Rochester",
"geoPoint": {
"lat": 44.02163,
"lon": -92.4699
},
"state": "Minnesota"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Timely identification for need of palliative care",
"timeFrame": "Through study completion, an average of 1 year"
}
],
"secondary": [
{
"description": null,
"measure": "Number of palliative care consults",
"timeFrame": "Through study completion, an average of 1 year"
},
{
"description": null,
"measure": "Number of advanced care planning notes documented in the EHR",
"timeFrame": "Through study completion, an average of 1 year"
},
{
"description": null,
"measure": "Number of billing codes for palliative care",
"timeFrame": "Through study completion, an average of 1 year"
},
{
"description": null,
"measure": "Positive predictive value of screened patients",
"timeFrame": "Through study completion, an average of 1 year"
},
{
"description": null,
"measure": "Percent of patients who are eligible for ECH based palliative care",
"timeFrame": "Through study completion, an average of 1 year"
},
{
"description": null,
"measure": "Percent agreement between Palliative Care and Primary Care and average time between Primary Care Contact and Response",
"timeFrame": "Through study completion, an average of 1 year"
}
]
} | [
{
"affiliation": "Mayo Clinic",
"name": "Rachel Havyer, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT00193557 | null | Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma | Phase I Trial of Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma | None | INTERVENTIONAL | COMPLETED | 2005-09-12T00:00:00 | null | null | null | [
"PHASE2"
] | 40 | 18 | null | ALL | false | This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib | Upon determination of eligibility, patients will be receive:
* Bortezomib | Inclusion Criteria:
To be included in this study, you must meet the following criteria:
* Multiple Myeloma
* Received no more than 2 previous treatment regimens for multiple Myeloma
* ECOG performance status 0, 1, or 2
* Serum creatinine \< 2.0mg/dL
* calculated or measured creatinine clearance \> 30ml/minute
* Measurable or evaluable disease
* Provide written informed consent prior to receiving protocol therapy.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Moderate or severe peripheral neuropathy
* Other serious medical conditions
* Other active malignancies
* history of treatment for other invasive cancers
* Women who are pregnant or lactating
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. | SCRI Development Innovations, LLC | OTHER | {
"id": "SCRI MM 06",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2005-09-12T00:00:00 | {
"date": "2010-06-29",
"type": "ESTIMATED"
} | {
"date": "2005-09-19",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Multiple Myeloma"
] | null | null | [
{
"city": "Fort Myers",
"country": "United States",
"facility": "Florida Cancer Specialists",
"geoPoint": {
"lat": 26.62168,
"lon": -81.84059
},
"state": "Florida"
},
{
"city": "Nashville",
"country": "United States",
"facility": "Tennessee Oncology, PLLC",
"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee"
}
] | [
{
"class": "INDUSTRY",
"name": "Millennium Pharmaceuticals, Inc."
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "objective response rate",
"timeFrame": null
}
],
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"description": null,
"measure": "progression-free survival",
"timeFrame": null
},
{
"description": null,
"measure": "overall survival",
"timeFrame": null
},
{
"description": null,
"measure": "Safety",
"timeFrame": null
}
]
} | [
{
"affiliation": "SCRI Development Innovations, LLC",
"name": "John D. Hainsworth, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "18543319", "type": "RESULT", "citation": "Hainsworth JD, Spigel DR, Barton J, Farley C, Schreeder M, Hon J, Greco FA. Weekly treatment with bortezomib for patients with recurrent or refractory multiple myeloma: a phase 2 trial of the Minnie Pearl Cancer Research Network. Cancer. 2008 Aug 15;113(4):765-71. doi: 10.1002/cncr.23606."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
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},
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},
{
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"term": "Vascular Diseases"
},
{
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"term": "Cardiovascular Diseases"
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{
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"term": "Paraproteinemias"
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"term": "Blood Protein Disorders"
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"term": "Hematologic Diseases"
},
{
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"term": "Hemorrhagic Disorders"
},
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"term": "Immunoproliferative Disorders"
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}
],
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"abbrev": "BC04",
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},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
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],
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},
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},
{
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"name": "Blood Coagulation Disorders",
"relevance": "LOW"
},
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},
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},
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"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
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"relevance": "LOW"
},
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},
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"asFound": null,
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},
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"asFound": null,
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},
{
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}
],
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{
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"term": "Multiple Myeloma"
},
{
"id": "D054219",
"term": "Neoplasms, Plasma Cell"
}
]
} | {
"ancestors": [
{
"id": "D000970",
"term": "Antineoplastic Agents"
}
],
"browseBranches": [
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
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}
],
"meshes": [
{
"id": "D000069286",
"term": "Bortezomib"
}
]
} | {
"conditions": [
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"term": "Multiple Myeloma"
},
{
"id": "D054219",
"term": "Neoplasms, Plasma Cell"
}
],
"interventions": [
{
"id": "D000069286",
"term": "Bortezomib"
}
]
} |
NCT02805257 | null | Ahmed Glaucoma Valve Surgery With Mitomycin-C | Ahmed Glaucoma Valve Surgery With Mitomycin-C | AMCT | INTERVENTIONAL | COMPLETED | 2016-06-15T00:00:00 | null | null | null | [
"PHASE2"
] | 119 | 18 | 85 | ALL | true | This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment. | Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such as Ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively. | Inclusion Criteria:
* Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg.
* Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.
* For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.
Exclusion Criteria:
* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
* Pregnant or nursing women.
* Previous cyclodestruction or glaucoma drainage device (GDD) surgery.
* Patients with nanophthalmos.
* Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
* No light perception vision.
* VA \<20/200 in non-study eye.
* Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
* Previous scleral buckling procedure or silicone oil present.
* Uveitic glaucoma. | University of California, San Francisco | OTHER | {
"id": "IRB#16-18935",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-06-16T00:00:00 | {
"date": "2022-05-31",
"type": "ACTUAL"
} | {
"date": "2016-06-17",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Glaucoma",
"Primary Open Angle Glaucoma",
"Secondary Glaucoma",
"Neovascular Glaucoma"
] | null | null | [
{
"city": "San Francisco",
"country": "United States",
"facility": "University of California, San Francisco",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California"
},
{
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"facility": "Zhongshan Ophthalmic Center",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong"
},
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"facility": "Shri Ganesh Vinayak Eye Hospital",
"geoPoint": {
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"lon": 81.63333
},
"state": "Chhattisgarh"
},
{
"city": "Mexico City",
"country": "Mexico",
"facility": "Asociación para Evitar la Ceguera en México (APEC)",
"geoPoint": {
"lat": 19.42847,
"lon": -99.12766
},
"state": null
}
] | [
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},
{
"class": "OTHER",
"name": "University of North Carolina"
},
{
"class": "OTHER",
"name": "University of Colorado, Denver"
},
{
"class": "OTHER",
"name": "University of Maryland"
},
{
"class": "OTHER",
"name": "Zhongshan Ophthalmic Center, Sun Yat-sen University"
},
{
"class": "OTHER",
"name": "Asociación para Evitar la Ceguera en México"
},
{
"class": "OTHER_GOV",
"name": "Hospital Central Militar"
},
{
"class": "OTHER",
"name": "Shri Ganesh Vinayak Eye Hospital"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Intraocular Pressure After Surgery",
"timeFrame": "1 year"
}
],
"secondary": [
{
"description": null,
"measure": "Intraocular Pressure After Surgery",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Number of Medications Postoperatively",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Visual Acuity",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Number of Medications Postoperatively",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Number of Participants With Intraoperative Complications",
"timeFrame": "Day of Surgery"
},
{
"description": null,
"measure": "Visual Acuity",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Number of Participants With Postoperative Complications",
"timeFrame": "1 Year"
}
]
} | [
{
"affiliation": "University of California, San Francisco",
"name": "Ying Han, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009798",
"term": "Ocular Hypertension"
},
{
"id": "D005128",
"term": "Eye Diseases"
}
],
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"abbrev": "BC04",
"name": "Neoplasms"
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{
"abbrev": "BC23",
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"abbrev": "All",
"name": "All Conditions"
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"abbrev": "BC11",
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"abbrev": "BC14",
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}
],
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},
{
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},
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},
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},
{
"asFound": null,
"id": "M8271",
"name": "Eye Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D005901",
"term": "Glaucoma"
},
{
"id": "D005902",
"term": "Glaucoma, Open-Angle"
},
{
"id": "D015355",
"term": "Glaucoma, Neovascular"
}
]
} | {
"ancestors": [
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"id": "D000903",
"term": "Antibiotics, Antineoplastic"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
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{
"id": "D000477",
"term": "Alkylating Agents"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
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{
"id": "D019384",
"term": "Nucleic Acid Synthesis Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
}
],
"browseBranches": [
{
"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M21860",
"name": "Pharmaceutical Solutions",
"relevance": "LOW"
},
{
"asFound": "Infiltration",
"id": "M11903",
"name": "Mitomycins",
"relevance": "HIGH"
},
{
"asFound": "Infiltration",
"id": "M19053",
"name": "Mitomycin",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4222",
"name": "Anti-Bacterial Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4224",
"name": "Antibiotics, Antitubercular",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3820",
"name": "Alkylating Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008937",
"term": "Mitomycins"
},
{
"id": "D016685",
"term": "Mitomycin"
}
]
} | {
"conditions": [
{
"id": "D005901",
"term": "Glaucoma"
},
{
"id": "D005902",
"term": "Glaucoma, Open-Angle"
},
{
"id": "D015355",
"term": "Glaucoma, Neovascular"
}
],
"interventions": [
{
"id": "D008937",
"term": "Mitomycins"
},
{
"id": "D016685",
"term": "Mitomycin"
}
]
} |
NCT03483857 | null | Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa | Peer Navigation to Improve Engagement in Care for HIV-Positive Men Who Have Sex With Men in Ehlanzeni, South Africa | None | INTERVENTIONAL | COMPLETED | 2017-10-24T00:00:00 | null | 2018-06-29T00:00:00 | 2018-06-29T00:00:00 | [
"NA"
] | 103 | 18 | null | MALE | false | This protocol describes the Cohort Assessment phase of an R34 pilot intervention trial of a Peer Navigation (PN) intervention tailored to the needs of HIV-positive MSM in rural Mpumalanga province South Africa. The PN intervention to be adapted, I-Care, has been implemented among HIV-positive men and women in the general population in North West province, South Africa, by members of this research team. | null | Inclusion Criteria:
* Biological male;
* Age \>=18 years;
* Self-identify as a gay or bisexual man, or a transgender woman;
* Have male sexual partners within the prior six months
* Resident in the Ehlanzeni District Municipality for at least six months of the year;
* Be physically present in Ehlanzeni for at least two weeks per month
* Self-disclosed receiving an HIV-positive diagnosis in the last 5 years;
* Consent to all serological testing for HIV antibodies, ART analytes, and HIV RNA
* Consent for study staff to review participants' clinical records;
* Consent to the randomization process.
Exclusion Criteria:
* Inability to provide written informed consent for participation, including being under the influence of alcohol or drugs.
* Inability to provide laboratory or documentary evidence of HIV diagnosis. | University of California, San Francisco | OTHER | {
"id": "1R34MH109395-01",
"link": "https://reporter.nih.gov/quickSearch/1R34MH109395-01",
"type": "NIH"
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-03-23T00:00:00 | {
"date": "2020-02-05",
"type": "ACTUAL"
} | {
"date": "2018-03-30",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two arm study assessing to determine feasibility and acceptability of a pilot PN intervention among 100 HIV-positive MSM. We will explore associations between PN participation and continuum of care outcomes in a cohort of 55 HIV-positive MSM receiving PN, as compared to a cohort of 48 HIV-positive MSM receiving standard-of-care clinical referral, in preparation for a full-scale multi-site behavioral efficacy trial.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Hiv"
] | ["Peer Navigation"] | null | [
{
"city": "Nelspruit",
"country": "South Africa",
"facility": "Anova Health Institute",
"geoPoint": {
"lat": -25.47448,
"lon": 30.97033
},
"state": "Mpumalanga"
}
] | [
{
"class": "UNKNOWN",
"name": "ANOVA Health Institute"
},
{
"class": "NIH",
"name": "National Institutes of Health (NIH)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Viral Suppression",
"timeFrame": "6 months"
}
],
"secondary": null
} | [
{
"affiliation": "University of California, San Francsico",
"name": "Sheri Lippman, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D015658",
"term": "HIV Infections"
},
{
"id": "D000086982",
"term": "Blood-Borne Infections"
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{
"id": "D003141",
"term": "Communicable Diseases"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D015229",
"term": "Sexually Transmitted Diseases, Viral"
},
{
"id": "D012749",
"term": "Sexually Transmitted Diseases"
},
{
"id": "D016180",
"term": "Lentivirus Infections"
},
{
"id": "D012192",
"term": "Retroviridae Infections"
},
{
"id": "D012327",
"term": "RNA Virus Infections"
},
{
"id": "D014777",
"term": "Virus Diseases"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D007153",
"term": "Immunologic Deficiency Syndromes"
},
{
"id": "D007154",
"term": "Immune System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M18250",
"name": "HIV Infections",
"relevance": "LOW"
},
{
"asFound": "HIV-Positive",
"id": "M9742",
"name": "HIV Seropositivity",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M3522",
"name": "Acquired Immunodeficiency Syndrome",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2593",
"name": "Blood-Borne Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15558",
"name": "Sexually Transmitted Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17933",
"name": "Sexually Transmitted Diseases, Viral",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18640",
"name": "Lentivirus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15026",
"name": "Retroviridae Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17522",
"name": "Virus Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15149",
"name": "RNA Virus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
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"relevance": "LOW"
},
{
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{
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"id": "M10200",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006679",
"term": "HIV Seropositivity"
}
]
} | null | {
"conditions": [
{
"id": "D006679",
"term": "HIV Seropositivity"
}
],
"interventions": null
} |
NCT00612157 | null | Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP) | Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Effect of Eszoplicone on Initial Continuous Positive Airway Pressure (CPAP) Compliance | CPAPASAP | INTERVENTIONAL | COMPLETED | 2008-01-29T00:00:00 | null | null | null | [
"PHASE4"
] | 154 | 18 | 64 | ALL | false | The purpose of this study is to assess the efficacy of Eszopiclone in improving short and intermediate-term compliance with continuous positive airway pressure (CPAP) in patients newly diagnosed with obstructive sleep apnea (OSA). | CPAP is the treatment of choice for patients with OSA. However, patients are frequently intolerant of this therapy initially. After continued use, tolerance is achieved. However, this initial discomfort or intolerance frequently leads to a patient-initiated discontinuation of therapy. It has been shown that CPAP use at 1 month predicts use at 6 months and 1 year. Patients who initially struggle with or are intolerant of CPAP frequently abandon therapy and are unlikely to use it long term. To prevent this, sleep physicians often prescribe short courses of sedatives to help improve initial tolerance and promote better compliance with therapy. However, the effectiveness of this practice has not been validated in a clinical trial. Compliance, in reference to this study is the willingness of the patients to follow the prescribed course of treatment. | Inclusion Criteria:
* Adult patients
* Newly diagnosed with OSA who are prescribed CPAP therapy
Exclusion Criteria:
* Patients \< 18 years old
* Patients over 65 years
* Pregnant women
* Patients with chronic liver disease
* Patients who abuse alcohol
* Patients taking narcotics or using sedative-hypnotic agents such as Ambien, Klonopin or Benadryl | Walter Reed Army Medical Center | FED | {
"id": "WRAMC07-17022",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-02-08T00:00:00 | {
"date": "2009-02-26",
"type": "ESTIMATED"
} | {
"date": "2008-02-11",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Obstructive Sleep Apnea"
] | ["Obstructive Sleep Apnea", "Continuous Positive Airway Pressure", "CPAP Compliance", "Non-benzodiazepine hypnotics"] | null | [
{
"city": "Washington",
"country": "United States",
"facility": "Walter Reed Army Medical Center",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
},
"state": "District of Columbia"
}
] | [
{
"class": "INDUSTRY",
"name": "Sumitomo Pharma America, Inc."
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Short term CPAP Compliance",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Intermediate CPAP Compliance",
"timeFrame": "1 year"
}
],
"secondary": [
{
"description": null,
"measure": "Quality of Life Issue - Prostate Symptoms for men",
"timeFrame": "1 month, 3 months, 6 months, 9 months, 12 months"
},
{
"description": null,
"measure": "Quality of Life Issue - Erectile Dysfunction for men",
"timeFrame": "1 month, 3 months, 6 months, 9 months, 12 months"
},
{
"description": null,
"measure": "Quality of Life Issue - Sleepiness",
"timeFrame": "1 month, 3 months, 6 months, 9 months, 12 months"
},
{
"description": null,
"measure": "Quality of Life Issue - Fatigue",
"timeFrame": "1 month, 3 months, 6 months, 9 months, 12 months"
},
{
"description": null,
"measure": "Quality of Life Issue - Subjective Sleep Quality",
"timeFrame": "1 month, 3 months, 6 months, 9 months, 12 months"
}
]
} | [
{
"affiliation": "Walter Reed Army Medical Center",
"name": "Christopher J Lettieri, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "17564406", "type": "BACKGROUND", "citation": "Lettieri CJ, Eliasson AH, Andrada T, Khramtsov A, Raphaelson M, Kristo DA. Obstructive sleep apnea syndrome: are we missing an at-risk population? J Clin Sleep Med. 2005 Oct 15;1(4):381-5."}, {"pmid": "7917771", "type": "BACKGROUND", "citation": "Quera-Salva MA, McCann C, Boudet J, Frisk M, Borderies P, Meyer P. Effects of zolpidem on sleep architecture, night time ventilation, daytime vigilance and performance in heavy snorers. Br J Clin Pharmacol. 1994 Jun;37(6):539-43. doi: 10.1111/j.1365-2125.1994.tb04301.x."}, {"pmid": "11165310", "type": "BACKGROUND", "citation": "Feinberg I, Maloney T, Campbell IG. Effects of hypnotics on the sleep EEG of healthy young adults: new data and psychopharmacologic implications. J Psychiatr Res. 2000 Nov-Dec;34(6):423-38. doi: 10.1016/s0022-3956(00)00038-8."}, {"pmid": "8269446", "type": "BACKGROUND", "citation": "Blois R, Gaillard JM, Attali P, Coquelin JP. Effect of zolpidem on sleep in healthy subjects: a placebo-controlled trial with polysomnographic recordings. Clin Ther. 1993 Sep-Oct;15(5):797-809."}, {"pmid": "9927363", "type": "BACKGROUND", "citation": "Ballester E, Badia JR, Hernandez L, Carrasco E, de Pablo J, Fornas C, Rodriguez-Roisin R, Montserrat JM. Evidence of the effectiveness of continuous positive airway pressure in the treatment of sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med. 1999 Feb;159(2):495-501. doi: 10.1164/ajrccm.159.2.9804061."}, {"pmid": "19920270", "type": "DERIVED", "citation": "Lettieri CJ, Shah AA, Holley AB, Kelly WF, Chang AS, Roop SA; CPAP Promotion and Prognosis-The Army Sleep Apnea Program Trial. Effects of a short course of eszopiclone on continuous positive airway pressure adherence: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):696-702. doi: 10.7326/0003-4819-151-10-200911170-00006."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012120",
"term": "Respiration Disorders"
},
{
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"term": "Respiratory Tract Diseases"
},
{
"id": "D012818",
"term": "Signs and Symptoms, Respiratory"
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{
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{
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],
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"abbrev": "BC08",
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{
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"name": "All Conditions"
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{
"abbrev": "BXM",
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],
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],
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{
"id": "D020181",
"term": "Sleep Apnea, Obstructive"
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]
} | {
"ancestors": [
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{
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},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
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],
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],
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}
],
"interventions": [
{
"id": "D000069582",
"term": "Eszopiclone"
}
]
} |
NCT04933357 | null | Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy  | Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging | MART | INTERVENTIONAL | UNKNOWN | 2021-06-15T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 75 | 18 | null | ALL | false | This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC. | null | Inclusion Criteria:
* More than or equal to 18 years old. ECOG Performance Scale (0-2). Histological confirmation of SCC of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx.
Clinical stage II-IVB (AJCC, 8th edition). Multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (CCRT).
Informed consent obtained, signed and dated before specific protocol procedures.
Exclusion Criteria:
* Stage I/II glottic cancer. Patients who underwent surgery for the primary tumor location. Distant metastases. Inability to undergo PET-CT or MRI. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule. | National Cancer Institute, Egypt | OTHER | {
"id": "RO2010-30912",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-06-15T00:00:00 | {
"date": "2021-06-21",
"type": "ACTUAL"
} | {
"date": "2021-06-21",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Head and Neck Cancer"
] | null | null | [
{
"city": "Cairo",
"country": "Egypt",
"facility": "National Cancer Institute",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Loco-regional control of HNSCC patients.",
"timeFrame": "2 years loco-regional control."
}
],
"secondary": [
{
"description": null,
"measure": "Acute radiation toxicity",
"timeFrame": "During treatment and up to 6 months post treatment."
},
{
"description": null,
"measure": "Comparison between different parameters of PET/CT and fMRI in assessing response to treatment.",
"timeFrame": "2-4 weeks after start of treatment"
},
{
"description": null,
"measure": "Overall survival",
"timeFrame": "2 years overall survival"
}
]
} | [
{
"affiliation": "National Cancer Institute (NCI)",
"name": "Tarek Shouman",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"id": "M9348",
"name": "Head and Neck Neoplasms",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D006258",
"term": "Head and Neck Neoplasms"
}
]
} | null | {
"conditions": [
{
"id": "D006258",
"term": "Head and Neck Neoplasms"
}
],
"interventions": null
} |
NCT03872557 | null | Modulating Glucose Tolerance With Dietary Tyrosine | Modulating Glucose Tolerance With Dietary Tyrosine | None | INTERVENTIONAL | COMPLETED | 2019-03-11T00:00:00 | null | 2020-01-24T00:00:00 | 2020-01-24T00:00:00 | [
"NA"
] | 10 | 18 | 65 | ALL | true | Metabolic or Bariatric surgery is an effective treatment for type 2 diabetes mellitus (T2DM) diabetes associated with obesity. There remain some questions about the biochemical mechanism that drive how these surgeries work to reverse hyperglycemia. In the proposed human studies, the investigators will test the hypothesis that the amino acid tyrosine is a key metabolite in regulating blood sugar levels and that manipulation of the amount tyrosine supplied by nutrition is able to achieve some of the metabolic benefits seen in the early post-surgical period following bariatric surgery. The central hypothesis is that that the tyrosine content of the meal challenge affects post-prandial intestinal and plasma dopamine and levodopa and L-3,4-dihydroxyphenylalanine (L-DOPA) levels, which, in turn, impact β-cell insulin secretion and glucose excursions. The investigators now propose to characterize the possible effects of manipulating dopamine and L-DOPA levels in the gut and plasma on glucose tolerance, insulin secretion, and insulin sensitivity in healthy volunteers with a range of body mass indexes (BMIs). | Several biochemical mechanisms explaining how Roux-en-Y Gastric Bypass (RYGB) provides an effective treatment for obesity associated type 2 diabetes mellitus (T2DM) and improves hyperglycemia independently of weight loss have been proposed. Two are of particular interest; a) the hindgut hypothesis suggesting that nutrient delivery to the distal intestine drives the production of "incretins" which enhance insulin secretion (e.g. glucagon-like peptide-1 (GLP-1)), and b) the foregut hypothesis, positing that foregut bypass reduces the secretion of factors (i.e. anti-incretins) that normally defend against hypoglycemia. The investigators have been actively investigating this topic and have developed a hypothesis based on past studies that they wish to test in a limited human clinical study. In addition, preclinical data suggest that there exists a gut-to-beta cell pathway, responsive to nutritional tyrosine, regulating insulin secretion, and this pathway provides a mechanism for the early postoperative improvements in hyperglycemia observed in RYGB. | i. Inclusion Criteria
1. Capable of giving written as well as oral informed consent.
2. A fasting plasma glucose level (FPG) \< 126 mg/dL (\< 7.0 mmol/L) and an Hb1ac in the 5.7-6.4 % range.
3. BMI in the range of 18-45 kg/m2.
4. Normal Complete blood count (CBC), renal and liver function tests.
ii. Exclusion Criteria:
1. Any diabetes medication within previous three (3) months.
2. Fasting plasma Glucose (FPG) \>126 mg/dl or HbA1c \> 6.4%
3. Current use (or within 6 months) of antipsychotic, anti-anxiety, or antidepressant medications (e.g. monoamine oxidase (MAO) inhibitors, 5-Hydroxytryptophan (5HT) inhibitors, tricyclic antidepressants, L-DOPA), reserpine, β-2-receptor agonists (e.g., terbutaline), steroids, weight loss medication, anticoagulant medication, over-the-counter nutritional supplements other than standard vitamin and mineral supplements
4. History of Phenylketonuria or other inherited disorders of amino acid metabolism.
5. History of movement disorder such as Parkinson's disease or Huntington's disease
6. Cardiovascular, renal, pulmonary, gastrointestinal, migraines or other medical conditions deemed significant by investigators
7. History of/ or psychiatric illness such as major depression, bipolar disease, anxiety or schizophrenia.
8. History of bariatric surgery with the exception of gastric band if the band has been removed
9. Female of child-bearing age, currently pregnant, breastfeeding or not using a form of birth control.
10. Previous or current use of cocaine, methamphetamine, ecstasy (3-4 methylenedioxymethamphetamine (MDMA))
11. Current daily intake of caffeine \>500 mg/day (\>4-5 cups of coffee; \>10 12-oz cans of soda)
12. Consumption of more than 1 alcoholic drink per day or smoking more than 5 cigarettes/day.
13. Systolic Blood Pressure (SBP) \> 150 mmHg; Diastolic Blood Pressure (DBP) \> 100 mmHg.
14. Recent history (in the past three months) of more than a 3% gain or loss in body wt.
15. Difficulty in swallowing capsules.
16. Concurrent use of antacids or proton pump inhibitors (e.g.,Prilosec Prevacid, dexilant, Aciphex, Protonix, Nexium, Vimovo, Zegerid) | Columbia University | OTHER | {
"id": "AAAS2124",
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"type": null
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"nctId": null,
"statusForNctId": null
} | 2019-03-11T00:00:00 | {
"date": "2021-05-05",
"type": "ACTUAL"
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"date": "2019-03-13",
"type": "ACTUAL"
} | [
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"OLDER_ADULT"
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} | [
"Glucose Tolerance"
] | ["Glucose tolerance", "Tyrosine"] | null | [
{
"city": "New York",
"country": "United States",
"facility": "Columbia University Irving Medical Center",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
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"state": "New York"
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] | [
{
"class": "NIH",
"name": "National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Whole blood glucose level",
"timeFrame": "Up to 120 minutes from baseline"
},
{
"description": null,
"measure": "Plasma insulin concentration",
"timeFrame": "Up to 120 minutes from baseline"
},
{
"description": null,
"measure": "Plasma dopamine concentration",
"timeFrame": "Up to 120 minutes from baseline"
},
{
"description": null,
"measure": "Plasma L-DOPA concentration",
"timeFrame": "Up to 120 minutes from baseline"
},
{
"description": null,
"measure": "L-tyrosine concentration",
"timeFrame": "Up to 120 minutes from baseline"
},
{
"description": null,
"measure": "Plasma glucagon concentration",
"timeFrame": "Up to 120 minutes from baseline"
},
{
"description": null,
"measure": "Plasma GLP-1 concentration",
"timeFrame": "Up to 120 minutes from baseline"
}
],
"secondary": null
} | [
{
"affiliation": "Columbia University",
"name": "Judith Korner, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "30876866", "type": "BACKGROUND", "citation": "Korner J, Cline GW, Slifstein M, Barba P, Rayat GR, Febres G, Leibel RL, Maffei A, Harris PE. A role for foregut tyrosine metabolism in glucose tolerance. Mol Metab. 2019 May;23:37-50. doi: 10.1016/j.molmet.2019.02.008. Epub 2019 Feb 27."}] | {"versionHolder": "2025-06-18"} | null | {
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NCT01078857 | null | Small-fiber Neuropathy in Chronic Kidney Disease | Small-fiber Neuropathy in Chronic Kidney Disease | None | INTERVENTIONAL | UNKNOWN | 2010-02-28T00:00:00 | null | null | null | [
"NA"
] | 120 | 18 | null | ALL | false | Neurological dysfunction is a common complication of late stage chronic kidney disease (CKD) and peripheral nerve system is often involved in such complication. Sensory disturbances such as paresthesia and hypoesthesia are the predominant symptoms in uremic polyneuropathy and it is traditionally thought the uremic polyneuropathy mainly involve large-diameter sensory nerves. However in uremic patients the abnormal thermal thresholds, the sensory symptoms like numbness, burning, paradoxical heat, cold or freezing, and pain, and the frequent symptoms of autonomic dysfunction suggest that small-fiber neuropathy should be a clinical entity in patients of CKD. But there are still few investigations with emphasis on the changes of small-fiber nerves in CKD, and little is known about the characteristics and mechanism of small-fiber neuropathy in CKD. Skin biopsy with evaluation of epidermal nerve density and the morphology of epidermal nerves and the subepidermal nerve plexus is an effective and minimally invasive test for assessment of small-fiber neuropathy. Contact heat evoked potential (CHEP) recording the brain responses evoked by contact heat stimuli on the skin is a non-invasive technique to investigate the thermo-nociceptive pathways mediated by small-fiber nerves. In the current study, we will use an integrated approach by combining the skin biopsy, quantitative sensory testing, autonomic function tests, and CHEP to investigate the pathological, psychophysical and physiological aspects of small-fiber neuropathy in patients of CKD. The aims of the current study is to address the following issues: (1) the changes of small fiber nerves in uremia and CKD of different stage; (2) the correlation of skin innervation with clinical manifestations, thermal thresholds, and autonomic function; (3) the influence of dialysis therapy, the type of dialysis therapy, or renal transplantation on the small fiber neuropathy in uremia; (4) the roles of blood chemical substances, metals, and endocrine profiles on the development of small-fiber neuropathy; (5) the relationship between the small-fiber neuropathy and pruritus or restless leg syndrome; and (6) the pathological and physiological correlates of painful symptoms by skin biopsy and CHEP in CKD related neuropathy. The results of the study will provide important insights in the understanding of the pathogenesis, and the prevention and new treatments of small-fiber neuropathy in CKD. | null | Inclusion Criteria:
* The patients should fulfill the criteria of CKD according to renal function study and the patients of end-stage renal disease should receive regular dialysis therapy and follow-up at outpatient clinics.
* For disease comparison, patients with peripheral neuropathy of variable etiologies will also be recruited.
Exclusion Criteria:
* Poor control DM,
* Severe heart failure,
* Bleeding tendency,
* Severe lung disease with respiratory distress,
* Severe infection,
* Alcoholism,
* Amyloidosis,
* Poor wound healing history. | National Taiwan University Hospital | OTHER | {
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} | 2010-03-01T00:00:00 | {
"date": "2010-03-02",
"type": "ESTIMATED"
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"date": "2010-03-02",
"type": "ESTIMATED"
} | [
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} | [
"Small-Fiber Neuropathy",
"Chronic Kidney Disease"
] | ["Chronic kidney disease", "Small-fiber neuropathy", "Skin biopsy", "Contact heat evoked potential", "Autonomic neuropathy", "Neuropathy in late stage chronic kidney disease"] | null | [
{
"city": "Taipei",
"country": "Taiwan",
"facility": "National Taiwan University Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "The pathology of skin biopsy",
"timeFrame": "within 3 months after inclusion"
},
{
"description": null,
"measure": "Intraepidermal fiber density",
"timeFrame": "within 3 months after inclusion"
},
{
"description": null,
"measure": "Autonomic function",
"timeFrame": "within 3 months after inclusion"
}
],
"secondary": [
{
"description": null,
"measure": "Function of small-fiber sensory nerve",
"timeFrame": "within 3 months after inclusion"
}
]
} | [
{
"affiliation": "National Taiwan University Hospital",
"name": "Sung-Tsang Hsieh",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Urogenital Diseases"
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{
"id": "D052801",
"term": "Male Urogenital Diseases"
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{
"id": "D051437",
"term": "Renal Insufficiency"
},
{
"id": "D002908",
"term": "Chronic Disease"
},
{
"id": "D020969",
"term": "Disease Attributes"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D009468",
"term": "Neuromuscular Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
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"abbrev": "BXS",
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"name": "All Conditions"
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"abbrev": "BC10",
"name": "Nervous System Diseases"
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"name": "Rare Diseases"
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"id": "M697",
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"relevance": "HIGH"
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{
"asFound": "Neuropathy",
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"asFound": "Chronic Kidney Disease",
"id": "M26717",
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"relevance": "HIGH"
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{
"asFound": null,
"id": "M26718",
"name": "Renal Insufficiency",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17319",
"name": "Urologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
"name": "Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27093",
"name": "Female Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14127",
"name": "Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8399",
"name": "Female Urogenital Diseases and Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27095",
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"relevance": "LOW"
},
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"id": "M6147",
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"relevance": "LOW"
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{
"asFound": null,
"id": "M22700",
"name": "Disease Attributes",
"relevance": "LOW"
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"relevance": "LOW"
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"id": "T1303",
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"relevance": "HIGH"
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],
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} | {
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{
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{
"asFound": null,
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{
"asFound": null,
"id": "T473",
"name": "Vitamin B7",
"relevance": "LOW"
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"meshes": null
} | {
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],
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} |
NCT01009957 | null | Everolimus on CKD Progression in ADPKD Patients | Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients | None | INTERVENTIONAL | TERMINATED | 2009-11-06T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 71 | 18 | null | ALL | false | The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients. | Considering the inhibitor activity of Everolimus on mTOR, our hypothesis is to evaluate its possible utility on the progression of CKD in ADPKD patients by reducing the rate of increase of renal cysts. | Inclusion Criteria:
1. Subjects over 18 years of both genders
2. Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
3. GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
4. Previous follow up of two years, with a creatinine evaluation at least once a year
5. GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)
Exclusion Criteria:
1. Pregnancy, lactating, males and females without adequate contraception
2. Leucopenia (\< 3,000 leucocytes/mm3) or thrombocytopenia (\< 100,000 platelets/mm3)
3. Dyslipidemia (cholesterol or triglycerides \> 260 mg/dl with treatment)
4. Urinary tract infection
5. Patients who cannot undergoing NMR | A. Manzoni Hospital | OTHER | {
"id": "PolEver",
"link": null,
"type": null
} | After primary completition date, experimental drug was no longer available | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-11-06T00:00:00 | {
"date": "2015-06-23",
"type": "ESTIMATED"
} | {
"date": "2009-11-09",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Polycystic Kidney Diseases"
] | ["ADPKD", "CKD", "Renal disease progression", "Everolimus"] | null | [
{
"city": "Brescia",
"country": "Italy",
"facility": "A.O. Spedali Civili Di Brescia",
"geoPoint": {
"lat": 45.53558,
"lon": 10.21472
},
"state": null
},
{
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"lon": 9.39704
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"lon": 14.26811
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"lon": 9.69342
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"lon": 7.68682
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"facility": "Ospedale Civile San Bortolo Vicenza",
"geoPoint": {
"lat": 45.54672,
"lon": 11.5475
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Reduction of GFR (according to MDRD formula) during a two-year follow up",
"timeFrame": "Two year-followup"
}
],
"secondary": [
{
"description": null,
"measure": "reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up",
"timeFrame": "Two year-followup"
},
{
"description": null,
"measure": "changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study",
"timeFrame": "Two year-followup"
},
{
"description": null,
"measure": "safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events",
"timeFrame": "Two year-followup"
},
{
"description": null,
"measure": "evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point",
"timeFrame": "Two year-followup"
}
]
} | [
{
"affiliation": "Nephrology and Dialysis Department - A. Manzoni Hospital",
"name": "Francesco Locatelli, MD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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{
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"term": "Abnormalities, Multiple"
},
{
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"term": "Congenital Abnormalities"
},
{
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},
{
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}
],
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},
{
"abbrev": "All",
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"abbrev": "BC16",
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NCT03507257 | null | Longitudinal Early-onset Alzheimer's Disease Study Protocol | Longitudinal Early-onset Alzheimer's Disease Study Protocol | LEADS | OBSERVATIONAL | RECRUITING | 2018-04-04T00:00:00 | null | 2026-05-31T00:00:00 | 2026-05-31T00:00:00 | null | 850 | 40 | 64 | ALL | true | The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EOnonAD) participants, and (3) cognitively normal (CN) control participants. | The LEADS study is a non-randomized, natural history, non-treatment study. Enrolled participants must be 40 - 64 (inclusive) years of age, with MCI due to AD or probable AD dementia (cognitively impaired participants) or have no significant memory impairment (cognitively normal \[CN\] participants).
Approximately 850 participants with cognitive impairment (650 with early onset Alzheimer's Disease \[EOAD\] and 200 with early onset non-Alzheimer's Disease \[EOnonAD\]) and 100 CN participants will be enrolled at approximately 20 sites in the United States. At approximately 5 sites outside of the United States, approximately 400 cognitively impaired participants and 10 CN participants will be enrolled. Cognitively impaired participants will take part in the study for 48+ months; CN participants will take part in the study for 24+ months.
Participants will undergo longitudinal clinical and cognitive assessments, computerized cognitive tests, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI brain scans, and optional cerebrospinal fluid (CSF) collection. Participants will be invited to consider autopsy brain donation
The primary objectives of the LEADS study are to:
* collect longitudinal assessments and biomarker data in individuals with early onset cognitive impairment (EOAD / EOnonAD) and cognitively normal (CN) controls;
* to compare baseline and longitudinal cognitive and functional characteristics, between EOAD and CN, and EOAD and Late Onset Alzheimer's Disease (LOAD) from the Alzheimer's Disease Neuroimaging Initiative (ADNI); and
* to study the associations of longitudinal clinical and cognitive assessments with multimodal imaging and biofluid markers that capture different elements of the AD pathophysiological cascade | Inclusion Criteria for Cognitively Impaired (EOAD and EOnonAD) Cohorts Only:
1. Meets NIA-AA criteria for MCI due to AD or probable AD dementia
2. Have a global CDR score ≤ 1.0
3. Have capacity to provide informed consent (IC) or has a legal authorized representative or guardian who provides IC
4. Age between 40-64 years (inclusive) at the time of consent
5. Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends at least 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI
6. Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure
7. Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
8. Fluent in English or Spanish if enrolled in the U.S.
9. Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s).
Inclusion Criteria for Cognitively Normal (CN) Cohort Only:
1. Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
2. Have a global CDR score = 0
3. Have capacity to provide informed consent
4. Have a Mini-Mental State Exam score between 26-30 (inclusive). Exceptions may be made for participant with less than 8 years of education at the discretion of the Site PI
5. Age between 40-64 years (inclusive) at the time of consent
6. Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI
7. Willing and able to complete longitudinal study procedures aside from LP which is an optional procedure
8. Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
9. Fluent in English or Spanish if enrolled in the U.S.
10. Fluent in English, Spanish, Dutch or Swedish for sites outside the U.S., according to site's spoken language(s).
Exclusion Criteria for all (EOAD, EOnonAD and CN) cohorts:
1. Meets core clinical criteria for non-AD dementia
2. Two or more first degree relatives with a history of early-onset dementia suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2, MAPT, GRN and C9ORF72 have been excluded
3. Known CLIA certified mutation in an ADAD gene (APP, PSEN1, PSEN2), or other autosomal dominant genes associated with other neurodegenerative disorders (MAPT, GRN, C9ORF72)
4. Contraindications to 3T MRI (e.g., claustrophobia, pacemaker, select aneurismal clip, artificial heart valve, select ear implants, select stents incompatible with 3T MRI, metal fragments or foreign objects in the eyes, skin or body, etc.)
5. Lifetime medical history of a brain disorder other than the disorder causing dementia except for headache (exceptions are allowed at the discretion of the Site PI - e.g., seizure disorder thought to be due to EOAD).
6. MRI scan with evidence of infection or focal lesions, cortical strokes, multiple lacunes (single lacune is allowable unless it meets criteria for strategic lacune affecting cognition)
7. Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)
8. Research radiation exposure will be assessed by the study physician. If the candidate participant has had more than one nuclear medicine study in the prior 12 months for research-related purposes, study inclusion will require approval from the PET Core
9. Investigational agents are prohibited 30 days prior to entry
10. Previous enrollment in a therapeutic trial targeting amyloid or tau.
11. Participation in other clinical studies with neuropsychological measures, with the exception of participants who are co-enrolled in the NACC Uniform Data Set (UDS) protocol (Note: This criterion is intended to reduce repeat measures effects during neuropsychological testing. Exceptions are allowed at the discretion of the Site PI)
12. Lifetime history of schizophrenia spectrum disorders (DSM-5 criteria)
13. Current history (in previous 12 months) of DSM-5 diagnosis of mania, bipolar disorder with or without psychotic features
14. Current history (in previous 6 months) of moderate or severe substance abuse (nicotine or caffeine is allowed)
15. Suicidal behaviors in the past 12 months or active suicidal ideations
16. Residing in a 24-hour care skilled nursing facility (at the time of screening)
17. (For optional lumbar puncture procedure only):
a. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be not clinically significant by the Site PI i. Platelet count \<100,000/ml ii. INR\>1.2 iii. Abnormal PT or PTT at screening b. Contraindications to the procedure, including but not limited to severe degenerative joint disease, deformity of the spine, history of a bleeding disorder c. Suspected elevated intracranial pressure, Arnold Chiari malformation or mass lesion d. Use of the anticoagulant medications such as but not limited to warfarin, rivaroxaban, dabigatran
18. Deemed ineligible by the Site PI for any other reason | Indiana University | OTHER | {
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"date": "2025-05-30",
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] | Cognitively Impaired Participants (ie: Early Onset Alzheimer's Disease (EOAD) and Early Onset non-Alzheimer's Disease (EOnonAD)) and Cognitively Normal (CN) Control Participants | PROBABILITY_SAMPLE | true | {
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"name": "National Institute on Aging (NIA)"
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"other": null,
"primary": [
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"measure": "Rate of change in cognition as measured by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13)",
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"measure": "Rate of change in cognition as measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB)",
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},
{
"description": null,
"measure": "Change in tau deposition as measured by flortaucipir (18F-AV-1451) Positron Emission Tomography (PET) imaging",
"timeFrame": "Month 0, Month 12 (EOAD only), Month 24 (EOAD only) and Month 36 (EOAD and EOnonAD amyloid positive participants only)"
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"timeFrame": "CN participants: Month 0, Month 12 and Month 24; EOAD/EOnonAD participants: Month 0, Month 12, Month 24, Month 36 and Month 48"
}
]
} | [
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"affiliation": "Indiana University",
"name": "Liana Apostolova, MD",
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] | [{"pmid": "19474427", "type": "BACKGROUND", "citation": "Savva GM, Wharton SB, Ince PG, Forster G, Matthews FE, Brayne C; Medical Research Council Cognitive Function and Ageing Study. Age, neuropathology, and dementia. N Engl J Med. 2009 May 28;360(22):2302-9. doi: 10.1056/NEJMoa0806142."}, {"pmid": "17568013", "type": "BACKGROUND", "citation": "Schneider JA, Arvanitakis Z, Bang W, Bennett DA. Mixed brain pathologies account for most dementia cases in community-dwelling older persons. Neurology. 2007 Dec 11;69(24):2197-204. doi: 10.1212/01.wnl.0000271090.28148.24. Epub 2007 Jun 13."}, {"pmid": "21345175", "type": "BACKGROUND", "citation": "Szigeti K, Doody RS. Should EOAD patients be included in clinical trials? Alzheimers Res Ther. 2011 Feb 8;3(1):4. doi: 10.1186/alzrt63."}, {"pmid": "21911656", "type": "BACKGROUND", "citation": "Wingo TS, Lah JJ, Levey AI, Cutler DJ. Autosomal recessive causes likely in early-onset Alzheimer disease. Arch Neurol. 2012 Jan;69(1):59-64. doi: 10.1001/archneurol.2011.221. Epub 2011 Sep 12."}, {"pmid": "20061618", "type": "BACKGROUND", "citation": "Koedam EL, Lauffer V, van der Vlies AE, van der Flier WM, Scheltens P, Pijnenburg YA. Early-versus late-onset Alzheimer's disease: more than age alone. J Alzheimers Dis. 2010;19(4):1401-8. doi: 10.3233/JAD-2010-1337."}, {"pmid": "22871906", "type": "BACKGROUND", "citation": "Mendez MF, Lee AS, Karve SJ, Shapira JS. Nonamnestic presentations of early-onset Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2012 Sep;27(6):413-20. doi: 10.1177/1533317512454711. Epub 2012 Aug 7."}, {"pmid": "17941342", "type": "BACKGROUND", "citation": "Snowden JS, Stopford CL, Julien CL, Thompson JC, Davidson Y, Gibbons L, Pritchard A, Lendon CL, Richardson AM, Varma A, Neary D, Mann D. Cognitive phenotypes in Alzheimer's disease and genetic risk. Cortex. 2007 Oct;43(7):835-45. doi: 10.1016/s0010-9452(08)70683-x."}, {"pmid": "8035918", "type": "BACKGROUND", "citation": "Jacobs D, Sano M, Marder K, Bell K, Bylsma F, Lafleche G, Albert M, Brandt J, Stern Y. Age at onset of Alzheimer's disease: relation to pattern of cognitive dysfunction and rate of decline. Neurology. 1994 Jul;44(7):1215-20. doi: 10.1212/wnl.44.7.1215."}, {"pmid": "8559362", "type": "BACKGROUND", "citation": "Koss E, Edland S, Fillenbaum G, Mohs R, Clark C, Galasko D, Morris JC. Clinical and neuropsychological differences between patients with earlier and later onset of Alzheimer's disease: A CERAD analysis, Part XII. Neurology. 1996 Jan;46(1):136-41. doi: 10.1212/wnl.46.1.136."}, {"pmid": "23411393", "type": "BACKGROUND", "citation": "Xia CF, Arteaga J, Chen G, Gangadharmath U, Gomez LF, Kasi D, Lam C, Liang Q, Liu C, Mocharla VP, Mu F, Sinha A, Su H, Szardenings AK, Walsh JC, Wang E, Yu C, Zhang W, Zhao T, Kolb HC. 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NCT05583357 | null | Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 | A Single Center, Randomized, Open-labeled, Blind Endpoint Evaluation, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 as a Booster Dose in Participants Aged 18 Years and Older Vaccinated 2-dose or 3-dose Inactivated COVID-19 Vaccine | COVID-19 | INTERVENTIONAL | UNKNOWN | 2022-10-13T00:00:00 | null | 2022-09-13T00:00:00 | 2023-08-10T00:00:00 | [
"EARLY_PHASE1"
] | 40 | 18 | null | ALL | true | It is a single center, randomized, open-labeled, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster. | null | Inclusion Criteria:
* Adults aged 18 years and older at time of consent, male or female;
* Normal body temperature;
* Meet either of the following conditions:
1. Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago;
2. Received completed 3 doses of CoronaVac 5-9 months ago;
* Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
* Be able and willing to complete the study during the entire study and follow-up period;
* Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.
Exclusion Criteria:
* Serious chronic diseases or uncontrolled diseases;
* Uncontrolled neurological disorders, epilepsy;
* Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
* Patients with congenital or acquired immunodeficiency;
* History of severe allergy or be allergic to any components of the test vaccines;
* History of hereditary hemorrhagic tendency or coagulation dysfunction;
* Patients with malignant tumors and other patients have a life expectancy less than 1 year;
* Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
* History of previous COVID-19 infection;
* Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
* Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
* Those considered by the investigator as inappropriate to participate in the study. | Livzon Pharmaceutical Group Inc. | INDUSTRY | {
"id": "V-01D-351-Booster-03",
"link": null,
"type": null
} | Unknown | {
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"measure": "RBD antibody level",
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"measure": "Specific cytokine secretion levels",
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{
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"measure": "AEs",
"timeFrame": "30 minutes, 0-7 days, 0-28 days after vaccination"
},
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}
]
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NCT04001257 | null | 18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) and Grading Glioma | Role of 18F-Fluoro-Ethyl-Tyrosine (FET) Positron Emission Tomography (PET) for Grading Glioma | GLIOFET | OBSERVATIONAL | COMPLETED | 2019-06-21T00:00:00 | null | 2019-09-17T00:00:00 | 2019-09-17T00:00:00 | null | 60 | 18 | null | ALL | false | Role of 18F-FET PET for grading gliomas according to 2016 WHO classification: value of quantitative and qualitative data obtained by 18F-FET PET for differentiating low grade glioma (WHO II) versus high grade gliomas (WHO III and IV) | The management and prognosis of patients with glioma is highly dependent on the tumour grade according to the new 2016 classification of the World Health Organization (WHO), which incorporates molecular characteristics. Standard magnetic resonance imaging (MRI) enhanced by contrast is the basis of imaging primary brain tumours including gliomas. Nevertheless MRI specificity to type glioma is limited. Recently, positron emission tomography (PET) molecular imaging using radiolabeled amino acids or their analogues has been recommended by the Neuro-Oncology Response Assessment (RANO) working group for differential diagnosis of brain lesions, non-invasive classification of glial tumours, prognostic value, tumour delineation, stereotactic biopsy radiotherapy planification and treatments follow-up, to provide additional informations beyond MRI on biological processes such as cell proliferation, membrane biosynthesis, glucose consumption and absorption of amino acid analogues. Among the radiotracers used in PET, radiolabeled amino acids or their analogues are increasingly used in clinical routine for glioma imaging. Although most previous PET studies focused on brain gliomas used L-\[methyl- 11 C\] -methionine (11C-MET), the fluorinated amino acid analogue O - (2-\[ 18 F\] fluoroethyl) -L-tyrosine (18F-FET) appeared to be a favorable marker for clinical routine due to his longer half-life than Carbone 11. Recent european guidelines attempt to provide some guidance on the performance and interpretation of molecular imaging. The authors recommend a static (20-40 mn after injection (Pi)) or dynamic PET acquisition (40-50 mn from injection). A visual analysis can be completed by a quantitative analysis which consists to measure mean and maximal tumour activity uptake values (SUVmean and SUVmax) and their respective tumour to background ratios (TBRmean and TBRmax). Although the mean physiological brain activity uptake is well defined, the measurement of mean glioma activity uptake is less clear. Indeed, TBRmean depends on the delineation of the tumour ROI and/or VOI. Most often previously, VOI was determined by a 3D contouring process using a tumour-to-brain ratio of at least 1.6 at the beginning of the scan, threshold defined on a brain gliomas biopsy-controlled study. Moreover, Albert et al. emphasized the interest of early TBRmax.To our knowledge, none study evaluated others parameters as SUVmax, SUVmean and TBRmean in early period. In this context, the aim of this study was to compare quantitative and qualitative PET parameters between Low Grade Glioma and High Grade Glioma. | Inclusion Criteria:
* glial tumor
* patient underwent 18F-FET PET at Brest University Hospital
* no opposite to participate
Exclusion Criteria:
* patient Under 18 years old
* opposite to participate | University Hospital, Brest | OTHER | {
"id": "GLIOFET (29BRC19.0140)",
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"type": "ACTUAL"
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"facility": "CHRU de Brest",
"geoPoint": {
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"lon": -4.48628
},
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}
] | null | null | {
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"timeFrame": "3 months"
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{
"description": null,
"measure": "quantitative criteria (TBRmax) between 2 groups (glioma II vs glioma III-IV)",
"timeFrame": "3 months"
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"measure": "quantitative criteria (SUVmean) between 2 groups (glioma II vs glioma III-IV)",
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},
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"measure": "quantitative criteria (TBRmean) between 2 groups (glioma II vs glioma III-IV)",
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},
{
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"measure": "quantitative criteria (SUVpeak) between 2 groups (glioma II vs glioma III-IV)",
"timeFrame": "3 months"
},
{
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"measure": "quantitative criteria (métabolic tumoral volume MTV) between 2 groups (glioma II vs glioma III-IV)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "quantitative criteria (Total Lesion Glycolysis TLG) between 2 groups (glioma II vs glioma III-IV)",
"timeFrame": "3 months"
},
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],
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"timeFrame": "3 months"
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{
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"timeFrame": "3 months"
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{
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"measure": "diagnostic accuracy of biological criteria (as MGMT mutation or IDH status or 1p19q codeletion, ATRX status) to discriminate the 2 groups of glioma",
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{
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"timeFrame": "3 months"
},
{
"description": null,
"measure": "prognostic value of F-FET PET data on PET Baseline on PFS",
"timeFrame": "2 years and 3 months"
},
{
"description": null,
"measure": "prognostic value of F-FET PET data on PET Baseline on OS",
"timeFrame": "2 years and 3 months"
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"measure": "prognostic value of variation of quantitative PET data (SUVmax, TBRmax, SUVmean, TBRmean, SUVpeak, SUVmin, MTV, TLG) (for example deltaSUVmax between PET Baseline and PET 3 months) on PFS",
"timeFrame": "2 years and 3 months"
},
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"description": null,
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"timeFrame": "2 years and 3 months"
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]
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"affiliation": "CHRU Brest",
"name": "solene querellou, MD",
"role": "STUDY_CHAIR"
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] | null | {"versionHolder": "2025-06-18"} | {
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NCT04100057 | null | Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia | Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia | None | INTERVENTIONAL | RECRUITING | 2019-09-19T00:00:00 | null | 2025-08-30T00:00:00 | 2025-08-30T00:00:00 | [
"NA"
] | 150 | 50 | 90 | ALL | false | Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD)
This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD.
This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout the sleep manipulation to assess week-to-week changes following an increasing number of CBT-I sessions. Wristwatch actigraphy will be acquired from baseline to the end of the sleep manipulation at week 11. Neuropsychiatric symptoms and sleep will be assessed again at six months post-manipulation. | null | Inclusion Criteria:
* Males and females of any racial or ethnic group, aged 50-90 (inclusive)
* Subjective complaint of insomnia associated with daytime impairment or distress (ISI ≥ 10)
* Subjective complaint of sleep disturbance ≥ 3 months in duration
* Subjective complaint of Neuropsychiatric symptoms (Self-Report NPI distress total score ≥ 4 on any measure other than the sleep domain OR current symptoms from Study Partner NPI ≥ 1
* Able to verbalize understanding of involvement in the research and provide written informed consent or provide assent co-signed by a LAR
* Fluent and literate in English
* Written, informed consent
* Medications (including any dementia-related meds) stable for at least 4 weeks prior to study baseline
* Research diagnosis of memory impairment based on the following:
i) Global Clinical Dementia Rating (CDR) of 0.5 or 1.0. OR a diagnosis of memory impairment from the Stanford/VA AD Center
* MRI safety screen passed , as assessed by the attached MRI safety screening form from the Stanford CNI, excluding mild claustrophobia that will be further screened at the in-person screening session per the screening protocol
* Have a caregiver or study partner willing to aid in facilitating the protocol and ratings
* Reside within approximately 60 miles of Stanford University
Exclusion Criteria:
* less than 20 on the Mini-Mental State Examination (MMSE)
* Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (\> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if \< 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders (with the exception of mild AD) such as Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months; unstable adult onset diabetes as defined by treatment regimen changes in the prior 3 months.
* Use of medication specifically prescribed for sleep disturbance or nighttime-only, low dose anti-depressants (e.g., doxepin, amitriptyline, trazodone used only at sub-therapeutic anti-depressant doses and taken only at bedtime) specifically prescribed for sleep disturbance and unwilling or unable to discontinue \> two weeks (anti-depressants) or \>1 week (sleep medications) prior to baseline data collection.
* Current or lifetime history of bipolar disorder
* History of psychosis preceding onset of memory impairments
* Substance abuse or dependence
* Excessive alcohol consumption (\>14 drinks per week or \> 4 drinks per occasion)
* Current exposure to trauma, or exposure to trauma within the past 3 months
* Presence of suicidal ideations representing high risk as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). Individuals are considered high risk if they have endorsement of either of the following:
1. A score of 4 or more for the past month on the C-SSRS
2. ) A positive endorsement, relative to the past 90 days, in the "Suicide Behavior" section of item #6 (Have you ever done anything, started to do anything, or prepared to do anything to end your life?)
* History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities OR traumatic brain injury in the past two months
* Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
* Current or expected cognitive behavior therapy or other evidence based psychotherapies; therapy for another condition (e.g. Depression)
* History of falling and/or severe mobility impairment
* Individuals who are not CPAP adherent or have untreated severe OSA (AHI \>= 30).CPAP adherence being defined as using the CPAP machine 70% of nights for a minimum of 4 hours per night.
* Received Cognitive Behavior Therapy for Insomnia (CBT-I) or Desensitization Therapy for Insomnia (DTI) within the past year
* Are not fully vaccinated for COVID-19 (e.g. 2 doses of Moderna or BioNTech, Pfizer vaccines; or 1 for Johnson and Johnson) and unwilling, if asked, to provide proof (e.g., CDC COVID-19 Vaccination Card, e-Health record, etc.) | Stanford University | OTHER | {
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} | 2019-09-20T00:00:00 | {
"date": "2024-08-13",
"type": "ACTUAL"
} | {
"date": "2019-09-23",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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"Mild Cognitive Impairment",
"Neuropsychiatric Symptoms",
"Sleep Disturbance"
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"city": "Palo Alto",
"country": "United States",
"facility": "Andrea Goldstein-Piekarski, PhD",
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"name": "National Institute of Mental Health (NIMH)"
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"description": null,
"measure": "Fronto-limbic function",
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"description": null,
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"timeFrame": "6 weeks"
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"description": null,
"measure": "Insomnia symptoms",
"timeFrame": "6 weeks"
}
],
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"affiliation": "Stanford University",
"name": "Andrea Goldstein-Piekarski, PhD",
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NCT01091857 | null | Mediators and Moderators of Exercise Behavior Change | Mediators and Moderators of Exercise Behavior Change | COSTRIDE | INTERVENTIONAL | COMPLETED | 2010-03-22T00:00:00 | null | null | null | [
"NA"
] | 238 | 18 | 45 | ALL | true | Rates of cancer and cardiovascular disease have shown very little improvement over the past two decades, and the incidence of Type II diabetes mellitus is increasing at an alarming rate. Recent reports estimate that approximately 30% of total cancer deaths are related to poor exercise and nutrition, and other reports have suggested that, when taking into consideration both cardiovascular disease and cancer, inactivity contributes to as many as 250,000 premature deaths per year (Booth et al., 2002). Despite the benefit of regular physical activity in the prevention of cancer and other debilitating illnesses, 75% of the U.S. population do not get the recommended amount of physical activity as defined by 30 minutes of moderate intensity physical activity 5 or more days per week (CDC, 2001), and 40% of the population is completely sedentary (USDHHS, 19960. The objective of the proposed research is to understand the mediators and moderators of a well-tested individually tailored, print-based intervention to increase exercise behavior among sedentary adults. Using a randomized, controlled intervention ton trial, the proposed study will address three primary and one secondary hypotheses: 1) A previously tested and validated exercise promotion intervention (c.f., Marcus et al., 1998) is successful at helping sedentary individuals initiate and maintain a moderate intensity physical activity regimen, as compared to a health and wellness control intervention, 2) Increases in positive attitudes, perceived normative support, self-efficacy, and intentions to exercise will mediate the effectiveness of the intervention, 3) That increased positive mood, and better temperature, stress, and lactate regulation immediately after exercise challenge (assessed in the laboratory) will moderate the effectiveness of the intervention, and 4) Secondarily, we will test whether gender, race/ethnicity, and two recently suggested genetic factors (BDNF and OPRM1) moderate the effectiveness of the intervention. The rigorous assessment of how and for whom an exercise promotion intervention is effective will provide information for future development of intervention strategies and content, as well as allow the targeting of exercise content to individuals for whom it is most likely to be effective. | null | Inclusion Criteria:
* All participants were required to exercise less than 90 minutes per week on average, have a body mass index (BMI) between 18 and 37.5, be physically capable of engaging in moderate-intensity physical activity, have a regular menstrual cycle (if female), be willing to be randomly chosen for one of the two interventions, and give informed consent.
Exclusion Criteria:
* Individuals were excluded if they smoked cigarettes, were on a restricted diet, taking psychotropic medications, receiving treatment for any psychiatric disorder, diabetic, had a history of cardiovascular or respiratory disease, had the flu or illness in the previous month, or were pregnant (if female). | University of New Mexico | OTHER | {
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"Validate STRIDE Exercise Intervention in Sedentary Individuals",
"Increase Positive Attitudes, Perceived Normative Support, Self-efficacy, and Intentions",
"Increase Self-reported Physical Activity"
] | ["Exercise", "Transdisciplinary", "Physiology", "Mood", "Motivation"] | null | [
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} | null | [{"pmid": "24359456", "type": "DERIVED", "citation": "Bryan AD, Magnan RE, Hooper AE, Ciccolo JT, Marcus B, Hutchison KE. Colorado stride (COSTRIDE): testing genetic and physiological moderators of response to an intervention to increase physical activity. Int J Behav Nutr Phys Act. 2013 Dec 21;10:139. doi: 10.1186/1479-5868-10-139."}, {"pmid": "23088712", "type": "DERIVED", "citation": "Magnan RE, Kwan BM, Bryan AD. Effects of current physical activity on affective response to exercise: physical and social-cognitive mechanisms. Psychol Health. 2013;28(4):418-33. doi: 10.1080/08870446.2012.733704. Epub 2012 Oct 23."}, {"pmid": "22398432", "type": "DERIVED", "citation": "Magnan RE, Kwan BM, Ciccolo JT, Gurney B, Mermier CM, Bryan AD. Aerobic capacity testing with inactive individuals: the role of subjective experience. J Phys Act Health. 2013 Feb;10(2):271-9. doi: 10.1123/jpah.10.2.271. Epub 2012 Feb 29."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT06186557 | null | Automated Detection of Patient Ventilator Asynchrony Using Pes Signal | Automated Detection of Patient Ventilator Asynchrony Using Pes Signal A Feasibility Study Towards a Detection Algorithm | None | OBSERVATIONAL | RECRUITING | 2023-03-01T00:00:00 | null | 2024-12-31T00:00:00 | 2025-04-30T00:00:00 | null | 50 | 18 | 100 | ALL | false | Rationale: Patient-ventilator asynchrony (PVA) in mechanical ventilation is associated with adverse patient outcome such as a prolonged stay in the ICU and even mortality. The prevalence of asynchronies is, however, difficult to quantify. It is common to use only the pressure and flow signal of the ventilator to detect asynchronies. The detection method is often based on definitions. The investigators will use new techniques (esophageal pressure signal and machine learning (ML)) to improve detection and quantification of patient-ventilator asynchronies. The hypothesis is that an algorithm which uses the Pes signal and ML to detect and quantify asynchronies is superior to previous techniques.
Objective: 1. To develop an asynchrony detection algorithm based on pressure, flow and Pes signal using ML. 2. To develop a second algorithm with the same ML technique based on pressure an flow signal only. 3. To compare the performance of these models in comparison with an expert team and with each other.
Study design: The investigators will collect internal data from the ventilator connected to patients on mechanical ventilation (population described below). First, the investigators will, with a dedicated expert team, identify and annotate the asynchronies based on visual inspection of the pressure, flow and Pes signal. Second, the investigators will develop an ML algorithm which will be trained with the annotated data from the visual inspection. Third, the performance of the AI algorithm will be compared with the performance of the expert panel using newly obtained data. Fourth, the performance of the AI algorithm will be compared with the second algorithm which uses the pressure and flow signal only.
Study population: All patients admitted to the adult ICU of the LUMC on mechanical ventilation who are ventilated \> 24 hours and are equipped with an esophageal balloon catheter.
Intervention (if applicable): None.
Main study parameters/endpoints: The performance of the detection algorithm. | 1. INTRODUCTION AND RATIONALE Mechanical ventilation should unload the respiratory muscles, provide adequate gas exchange and should be safe, i.e., harm due to mechanical ventilation should be reduced to a minimum. To achieve this the interaction between the ventilator and the patient is preferentially synchronous. Ventilator settings not being synchronized with patient respiratory drive or activity is a phenomenon known as patient-ventilator asynchrony (PVA). PVA may induce several deleterious effects.1 Studies have shown asynchronies to be associated with patient discomfort, increased work of breathing, prolonged weaning, and in one study, even increased mortality.
Monitoring PVA however is difficult. Clinicians often have to rely on physical examination of the patient as well as visual inspection of pressure, flow and volume waveforms to identify an asynchrony.6 The sensitivity and positive predictive value of analyzing breath-to-breath waveforms are very low (22% and 32%, respectively).1 Artifacts such as cardiac oscillation may mimic asynchronies, and there are times when clinicians standing at the bedside are unable to distinguish between asynchronies and artifacts with certainty.6 Furthermore, detection of PVA is dependent of bedside examination. This challenge leads to the desire of developing effective automated PVA recognition algorithms.7 Various automated algorithms have been developed, however with a variable performance.1 For a correct analysis of asynchronies, the use of an esophageal balloon catheter, which measures the esophageal pressure (Pes), or a catheter which measures the electrical activity of the diaphragm, is necessary.1 Since the use of Pes catheters, it is possible to describe other forms of PVA, such as reverse triggering, which is an asynchrony in which the ventilator triggers the patient.8 Until recently, however, the esophageal catheter has not been routinely used in daily practice but more as a research tool. Since the introduction of personalized medicine, clinicians have gained interest in esophageal manometry to better titrate care to the unique physiology of a patient.9 There are in the current literature no reports of PAV detection algorithms that use the Pes signal for detection.
In the LUMC the investigators use the esophageal catheter in all patients admitted with acute respiratory failure and in patients ventilated for more than 48 hours per protocol. The esophageal signal gives the opportunity to detect asynchronies more easily than without. The investigators therefore hypothesize that an algorithm based on the esophageal signal will perform better than an algorithm that only uses other ventilator waveforms.
2. OBJECTIVES 2.1 Primary Objective The primary objective of this study is to develop an asynchrony detection algorithm based on pressure, flow and Pes signals of patient data using ML.
2.2 Secondary Objectives Secondary objectives are to validate the detection algorithm by comparing its performance with the assessment of the expert panel and to compare its performance with the performance of a second algorithm which is based on pressure- and flow signals only.
3. STUDY DESIGN This study will take place at the Intensive Care Unit of the LUMC. First, internal data of adult ICU patients on mechanical ventilation because of acute respiratory failure or with a ventilation duration of at least 24 hours and that are equipped with an esophageal balloon catheter will be collected from the ventilator. The data of interest include pressure, flow and Pes signals of the ventilation. It is necessary to collect as much data as possible as this is required for the development of the algorithm. A minimum of 50 patients will be included with from each a ventilation recording between 4 and 8 hours, which amounts to 200 - 400 hours of mechanical ventilation recording.
The following labels will be assigned to the data:
* Trigger asynchrony (early (reversed), false, failed)
* Cycle (early, late )
* Double trigger (combination of trigger and cycle problem)
The data will be checked for regions of interest. Regions of interest are regions in which a lot of asynchronies can be visually detected. These regions of interest will be annotated and labeled by three independent experts with a lot of experience in the field. If two of the three experts agree on a asynchrony label than the breath cycle will be included for construction of the model. An equivalent amount of normal breaths will also be used to train the algorithm.
The data will be separated in two datasets. The first set will contain the first half of the patients, i.e. the patients with an odd research number. The second set will contain the second half of the patients (patients with an even research number). Research numbers are allocated consecutively to patients after consent.
The machine learning (ML) technique that will be used is a Convolutional Neural Network which will be developed in cooperation with the Technical University of Delft (Technical Medicine and Dr. D.M.J. Tax). The algorithm will be developed based on this training data and the purpose is that the algorithm learns to generalize from the training set.
The algorithm will be validated on the test data for the detection of PAV. The test data will also be annotated by the expert panel. The algorithm's detection performance will be compared with the annotation of the expert panel on the same data.
Together with the development of the main algorithm, which is based on three signals (flow, pressure and esophageal pressure (Pes)), another algorithm based on two signals (flow and pressure) will be developed with the same AI technique. This second algorithm has most in common with previous described algorithms in the current literature. The performance of the first algorithm will be compared with the second algorithm using the test data (second part of the data) in order to investigate if addition of the Pes signal is superior in the detection of asynchronies. | Inclusion Criteria:
* admission to the ICU of the LUMC;
* age of 18 years or older;
* intubated and receiving mechanical ventilation because of acute respiratory failure or with a ventilation duration of at least 24 hours; and
* equipped with an esophageal balloon catheter
Exclusion Criteria:
* after recent pneumectomy or lobectomy;
* no informed consent | Leiden University Medical Center | OTHER | {
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"ADULT",
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] | [{"pmid": "32457175", "type": "BACKGROUND", "citation": "Esperanza JA, Sarlabous L, de Haro C, Magrans R, Lopez-Aguilar J, Blanch L. Monitoring Asynchrony During Invasive Mechanical Ventilation. Respir Care. 2020 Jun;65(6):847-869. doi: 10.4187/respcare.07404."}, {"pmid": "31236639", "type": "BACKGROUND", "citation": "Shi ZH, Jonkman A, de Vries H, Jansen D, Ottenheijm C, Girbes A, Spoelstra-de Man A, Zhou JX, Brochard L, Heunks L. Expiratory muscle dysfunction in critically ill patients: towards improved understanding. Intensive Care Med. 2019 Aug;45(8):1061-1071. doi: 10.1007/s00134-019-05664-4. Epub 2019 Jun 24."}, {"pmid": "29771711", "type": "BACKGROUND", "citation": "Doorduin J, Roesthuis LH, Jansen D, van der Hoeven JG, van Hees HWH, Heunks LMA. Respiratory Muscle Effort during Expiration in Successful and Failed Weaning from Mechanical Ventilation. Anesthesiology. 2018 Sep;129(3):490-501. doi: 10.1097/ALN.0000000000002256."}, {"pmid": "24070493", "type": "BACKGROUND", "citation": "Gilstrap D, MacIntyre N. Patient-ventilator interactions. Implications for clinical management. Am J Respir Crit Care Med. 2013 Nov 1;188(9):1058-68. doi: 10.1164/rccm.201212-2214CI."}, {"pmid": "25693449", "type": "BACKGROUND", "citation": "Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Lujan M, Garcia-Esquirol O, Chacon E, Estruga A, Oliva JC, Hernandez-Abadia A, Albaiceta GM, Fernandez-Mondejar E, Fernandez R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM. Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19."}, {"pmid": "30919393", "type": "BACKGROUND", "citation": "Rehm GB, Han J, Kuhn BT, Delplanque JP, Anderson NR, Adams JY, Chuah CN. Creation of a Robust and Generalizable Machine Learning Classifier for Patient Ventilator Asynchrony. Methods Inf Med. 2018 Sep;57(4):208-219. doi: 10.3414/ME17-02-0012. Epub 2018 Sep 24."}, {"pmid": "23187649", "type": "BACKGROUND", "citation": "Akoumianaki E, Lyazidi A, Rey N, Matamis D, Perez-Martinez N, Giraud R, Mancebo J, Brochard L, Richard JM. Mechanical ventilation-induced reverse-triggered breaths: a frequently unrecognized form of neuromechanical coupling. Chest. 2013 Apr;143(4):927-938. doi: 10.1378/chest.12-1817."}] | {"versionHolder": "2025-06-18"} | {
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NCT05381857 | null | Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment | Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment | MI-V3 | OBSERVATIONAL | COMPLETED | 2022-05-16T00:00:00 | null | 2022-10-13T00:00:00 | 2022-10-13T00:00:00 | null | 415 | 30 | 79 | ALL | true | Effects of aging, genetics and environmental exposures on immune variation in a previously well-defined healthy population (NCT03905993). | Susceptibility to infections, disease severity, and response to medical therapies and vaccines are highly variable from one individual to another.
Individual heterogeneity in the immune response can have an enormous impact on the likelihood to respond to therapy or the development of side effects secondary to vaccine administration. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that constitute a healthy immune system and its natural occurring variability.
The overall aim of the Milieu Intérieur study (NCT03905993) is to define the parameters that characterise a healthy immune response and its natural variation across individuals, and in doing so, inform clinical strategies for managing disease. To achieve this, in 2012, a total of 1000 healthy volunteers, descendants of mainland French persons for at least three generations, split equally by sex (1:1 sex ratio) and stratified across five-decades of life were recruited.
With the first data collection (clinical study), key fundamental insights were gained. The project has also established a rich sample and data repository, supporting ongoing integrative research in systems immunology and personalized medicine.
To provide a longitudinal assessment of the immune variation observed in the Milieu Intérieur cohort, this research aim to perform a follow-up study of the cohort, 10 years after the initial study. | Inclusion Criteria:
* Any individual that provided samples for the initial Milieu Intérieur study (NCT03905993)
* Ability to give their informed consent in writing
* Subjects who, according to the investigator, can and will comply with the requirements of the protocol.
* Affiliated to the French social security or assimilated regimens
Exclusion Criteria:
* Individuals benefiting from a legal protection measure
* Individuals unable to express informed consent for participation
* Pregnant and breastfeeding women | Institut Pasteur | INDUSTRY | {
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"date": "2022-05-19",
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"ADULT",
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] | ["Immune response", "Immune system", "genotype-to-phenotype association", "genetic variability", "reference-based population"] | null | [
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"affiliation": "Institut Pasteur",
"name": "Lluis QUINTANA MURCI, PhD",
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] | [{"pmid": "25562703", "type": "BACKGROUND", "citation": "Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. The Milieu Interieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3."}, {"pmid": "24656047", "type": "BACKGROUND", "citation": "Duffy D, Rouilly V, Libri V, Hasan M, Beitz B, David M, Urrutia A, Bisiaux A, Labrie ST, Dubois A, Boneca IG, Delval C, Thomas S, Rogge L, Schmolz M, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Functional analysis via standardized whole-blood stimulation systems defines the boundaries of a healthy immune response to complex stimuli. Immunity. 2014 Mar 20;40(3):436-50. doi: 10.1016/j.immuni.2014.03.002."}, {"pmid": "29476184", "type": "BACKGROUND", "citation": "Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jonsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Mar;19(3):302-314. doi: 10.1038/s41590-018-0049-7. Epub 2018 Feb 23."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT00634257 | null | Spirituality/Religiosity in Patients and Caregivers | A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers | None | OBSERVATIONAL | COMPLETED | 2008-02-25T00:00:00 | null | 2022-02-10T00:00:00 | 2022-02-10T00:00:00 | null | 193 | 18 | null | ALL | true | Primary Objective:
-To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.
Secondary Objectives:
* To examine the associations between self-rated spirituality/religiosity and physical (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among palliative care patients.
* To examine the association between patient's self-reported spirituality/religiosity, and primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire, FACIT-sp).
* To determine the frequency (self-rated spiritual pain scale when score is more or equal than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the palliative care setting and to explore the association between spiritual pain, and negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment questionnaire).
* To examine the association between primary caregivers' spirituality/religiosity (Appendix H, first question), religious coping strategies (Brief-RCOPE) and psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second question). | Questionnaires:
If you are found to be eligible to take part in this study and you agree to take part, you will complete 9 questionnaires.
The first 2 questionnaires ask about your demographic information (such as your education level and age) and the symptoms of cancer you may be experiencing.
The 6 other questionnaires ask questions about several subjects. You will be asked about your religious/spiritual beliefs, such as your way of coping with cancer and whether you have focused on religion/spirituality or other strategies in order to stop worrying. You will also be asked whether you feel religious/spiritual beliefs are important in your everyday life, how hopeful you may feel, and the level of spiritual pain you may feel. (Some people experience spiritual pain as a deep pain in the "soul" or "being" that is not physical pain.)
The last questionnaire asks about any symptoms of anxiety or depression you may feel. In total, these questionnaires should take about 40 minutes to complete.
Length of Study Participation:
After completing the questionnaires, your participation in this study will be over.
This is an investigational study. Up to 100 patients and 100 caregivers will take part in this study. All will be enrolled at M. D. Anderson. | Inclusion Criteria:
1. (Patients) Advanced cancer patients seen in palliative care outpatient clinic and palliative care mobile team and inpatient unit at M.D. Anderson Cancer Center
2. (Patients) Patients aged 18 years or over
3. (Patients) Karnofsky performance status score of more than 40 at time of inclusion into study. (Patients with Karnofsky score less than 40 may not be able to complete the measures).
4. (Patients) Able to provide informed consent and comply with study procedures
5. (Caregivers) Spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living
6. (Caregivers) Having the patient's consent to be contacted.
7. (Caregivers) Caregiver is 18 years or over
8. (Caregivers) Able to provide informed consent and comply with study procedures
9. (Patients) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.
10. (Caregivers) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.
11. (Patients) Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
Exclusion Criteria:
N/A | M.D. Anderson Cancer Center | OTHER | {
"id": "2007-0678",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-03-04T00:00:00 | {
"date": "2023-03-27",
"type": "ACTUAL"
} | {
"date": "2008-03-12",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients with advanced cancer receiving palliative care and their primary caregivers. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Advanced Cancer",
"Solid Tumors"
] | ["Advanced Cancer", "Solid Tumors", "Spirituality", "Religiosity", "Symptom Distress", "Quality of Life", "Caregivers", "Questionnaire", "Survey"] | null | [
{
"city": "Houston",
"country": "United States",
"facility": "University of Texas MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Association between self-rated spirituality/religiosity and coping strategies",
"timeFrame": "Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms."
}
],
"secondary": null
} | [
{
"affiliation": "M.D. Anderson Cancer Center",
"name": "Eduardo Bruera, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
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"name": "All Conditions"
}
],
"browseLeaves": [
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"asFound": null,
"id": "T6034",
"name": "Quality of Life",
"relevance": "LOW"
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],
"meshes": null
} | null | {
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NCT02131857 | null | The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic | The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic | Mindfulness | INTERVENTIONAL | UNKNOWN | 2014-04-28T00:00:00 | null | null | null | [
"NA"
] | 24 | 8 | 65 | ALL | true | Hypothesis 1: Mindfulness is a feasible tool for use within a cystic fibrosis (CF) clinic
Hypothesis 2: Participants in the mindfulness intervention will show an increased level of quality of life post intervention with the Mindfulness course
Hypothesis 3. Levels of mindfulness:
Participants in the mindfulness intervention will report increased mindfulness levels post-program completion as compared to pre-program completion
Hypothesis 4. Levels of stress:
Participants in the mindfulness intervention will report lower levels of stress post-program completion as compared with pre-program commencement.
Hypothesis 5. Levels of residual depressive symptoms post-mindfulness intervention program: Residual symptoms of depression are a risk factor for relapse of depression. Post -program participants of mindfulness will purport fewer residual depressive symptoms compared with pre-program.
Hypothesis 6. CF is associated with severe neutrophilic inflammation of the airways. As mindfulness intervention has been shown to modulate immune system it may improve physical aspects of CF including markers of inflammation and markers of lung disease (lung function tests and rate of pulmonary exacerbations) and nutritional state. | The study will be an active interventional program for approximately six months in duration. All participants will initially undergo an initial assessment interview. Personnel trained and certified in mindfulness-based stress reduction (MBSR) will run mindfulness-based groups in 6-8 weekly 1 1/2 hour sessions (the staff group will comprise of 6 sessions and the parents' and patients' groups will be 8 sessions long). Participants will learn and engage in various formal and informal meditation practices during experiential learning of skills, including concentration, mindfulness of thoughts, emotions, feelings and bodily sensations, decentering, and letting go. Each group will include both practical exercises and a psycho-educational component. Daily homework, an essential aspect of the course, will include meditation practices together with exercises designed to integrate application of awareness skills into daily life. On day 0, participants will complete a battery of questionnaires as well as tests of the physical status of CF disease. This battery will be repeated at 8 weeks, and again at 6 months. | Inclusion Criteria:
1. Diagnosis of CF clinically and by sweat test and/ or genetic testing and/ or nasal potential difference
2. Treatment with one or more chronic medications or regimes;
3. Willingness by patient or parent to sign consent form;
4. Parents capable of complying with the program requirements including completing self-report questionnaires pre and post intervention completion.
Exclusion Criteria:
1. Having significant developmental delay or a mental health diagnosis of psychosis;
2. Transplant patients;
3. Participation in other interventional studies within 2 weeks of recruitment or during the study period - | Rabin Medical Center | OTHER | {
"id": "RMC-0321-12-ctil",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-05-04T00:00:00 | {
"date": "2014-05-06",
"type": "ESTIMATED"
} | {
"date": "2014-05-06",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Cystic Fibrosis"
] | ["Mindfulness", "stress reduction"] | null | [
{
"city": "Petah Tikva",
"country": "Israel",
"facility": "Schneider Children's Medical Center of Israel",
"geoPoint": {
"lat": 32.08707,
"lon": 34.88747
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Score on the Mindful Attention Awareness Scale (MAAS)",
"timeFrame": "8 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "score on the Perceived Stress Scale (PSS)",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Level of depression as assessed by the Beck Depression Inventory (BDI)",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Pulmonary function as assessed by spirometry: forced expiratory volume in one second (FEV1), forced expiratory flow 25-75% (FEF25-75), and forced vital capacity (FVC)",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "CF related inflammation",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Rate of pulmonary exacerbations",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Score on the Mindful Attention Awareness Scale (MAAS)",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "score on the Perceived Stress Scale (PSS)",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Level of depression as assessed by the Beck Depression Inventory (BDI)",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Pulmonary function as assessed by spirometry: forced expiratory volume in one second (FEV1), forced expiratory flow 25-75% (FEF25-75), and forced vital capacity (FVC)",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "CF related inflammation",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "Rate of pulmonary exacerbations",
"timeFrame": "8 weeks"
}
]
} | [
{
"affiliation": "Rabin Medical Center",
"name": "Hannah Blau, MBBS",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D010182",
"term": "Pancreatic Diseases"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
},
{
"id": "D007232",
"term": "Infant, Newborn, Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
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"id": "M6755",
"name": "Cystic Fibrosis",
"relevance": "HIGH"
},
{
"asFound": "Fibrosis",
"id": "M8485",
"name": "Fibrosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M13102",
"name": "Pancreatic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
"name": "Lung Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10276",
"name": "Infant, Newborn, Diseases",
"relevance": "LOW"
},
{
"asFound": "Cystic Fibrosis",
"id": "T1710",
"name": "Cystic Fibrosis",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D003550",
"term": "Cystic Fibrosis"
},
{
"id": "D005355",
"term": "Fibrosis"
}
]
} | null | {
"conditions": [
{
"id": "D003550",
"term": "Cystic Fibrosis"
},
{
"id": "D005355",
"term": "Fibrosis"
}
],
"interventions": null
} |
NCT06264557 | null | Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment | A Multicenter, Prospective, Comparative, Randomized, Independent Rater-blind, Superiority Clinical Trial to Compare the Safety and Efficacy of the Cognitive Therapy Software 'SUPERBRAIN DEX' With a Control Group for Patients With MCI | SB-DEX | INTERVENTIONAL | RECRUITING | 2024-02-08T00:00:00 | null | 2025-03-31T00:00:00 | 2025-06-30T00:00:00 | [
"NA"
] | 140 | 50 | 85 | ALL | false | Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment | A multicenter, prospective, comparative, randomized, independent rater-blind, superiority, pivotal clinical trial to compare the safety and efficacy of the Cognitive therapy software 'SUPERBRAIN DEX' for improving cognitive function with a control group for patients with mild cognitive impairment | Inclusion Criteria:
1. 50 - 85years old
2. Those who meet all of the National Institute on Aging-Alzheimer's Association (NIA-AA) key clinical criteria below that may suspect mild cognitive impairment caused by Alzheimer's disease as of the screening date
* Concern of the subject or guardian about the deterioration of cognitive function compared to before
* More than one cognitive impairment
* Maintaining the independence of overall daily life functions
* It's not dementia
3. In at least one of the following neuropsychological tests conducted within one year of the screening date, the delayed recall score in the memory area was 'average -1' according to the standard score table corrected for education level and age.
* Seoul Neuropsychological Screening Battery 2nd edition (SNSB-II)
* Korean version of Consortium to Establish a Registry for Alzheimer's Disease (CERAD-K)
* Literacy Independent Cognitive Assessment (LICA)
4. A person whose Korea-Mini Mental State Examination-2 (K-MMSE-2) score corresponds to "Average-1.5 standard deviation or higher" according to the standard score table corrected for education level and age as of the screening date
5. Those with a Global Clinical Dementia Rating (CDR) score of 0.5 and a memory item score of 0.5 or 1 as of the screening date
6. A person who has a guardian in regular contact with the subject
* Defined to be able to support subjects during the clinical trial (compliance supervision and subject status reporting) and spend at least 8 hours per week with subjects
7. A person who is taking drugs (donepezil, galantamine, ribastigmine, memantine) for the purpose of improving cognitive function is taking drugs stably for at least 12 weeks as of the screening date
8. Those who have no difficulty using tablet PCs
9. A person who voluntarily decides to participate in this clinical trial and agrees to the subject's explanation and consent in writing
10. Those who are willing to comply with the clinical trial plan
Exclusion Criteria:
1. Those diagnosed with dementia (including Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., Human Immunodeficiency Virus (HIV), syphilis, etc.), Creutzfeld-Jacob disease (Creutzfeld-Jacob disease), Pick disease, Huntington's disease, Parkinson's disease, etc.) as of the screening date
2. Those who have a history of diagnosing significant neurological diseases affecting cognitive function within one year of the screening date (e.g., stroke, multiple sclerosis, severe head trauma with loss of consciousness, normal cerebral hydrocephalus, epilepsy, brain tumors, cerebral infarction, spinal cord infarction or central nervous system infection)
3. Based on the screening date, major depressive disorder, bipolar disorder, schizophrenia, A person diagnosed with a serious mental illness such as drug addiction and alcoholism
4. Laboratory and/or vital signs tests as of the date of screening, any of the following
* Those diagnosed with infectious or metabolic diseases that may cause cognitive decline in the subject (e.g., hypothyroidism, vitamin B12 deficiency, folate deficiency, neurotoxin, HIV)
* Those with liver dysfunction (AST, ALT ≥ 3x upper limit of normal range) and/or renal dysfunction (serum creatinine ≥ 2x upper limit of normal range)
* Those with uncontrolled hypertension (SBP \> 180 mmHg) and/or diabetes (HbA1c \> 11%)
5. Those who have severe or unstable cardiovascular disease (e.g., myocardial infarction, unstable angina, class III or IV heart failure by classification of the New York Heart Association (NYHA) within 24 weeks of the screening date)
6. Where the tester determines that he/she has a medical condition that may interfere with the completion of the clinical trial due to a serious or unstable physical condition (e.g., a history of malignant tumors within five years of the screening date (e.g., basal cell cancer and squamous cell carcinoma of the skin considered to have been completely resected and cured, cervical intraepithelial carcinoma, non-transparent prostate cancer, acute and severe asthma, active peptic ulcers, etc.)
7. If you can't walk, A person who can move using walking aids (e.g. walkers, canes, wheelchairs, etc.)
8. an illiterate patient who is unschooled (defined as unadmitted to a regular school)
9. Where the tester determines that a person does not have sufficient vision, hearing, language skills, motor skills, and comprehension to follow the examination procedures related to clinical trials
10. a person who is pregnant or nursing
11. For women of childbearing age, who do not agree with the medically permitted contraceptive method during the clinical trial
* Hormonal contraception, intrauterine device (IUD) or intrauterine system (IUS), oviduct ligation, double blocking (male condom, female condom, cervical cap, a combination of contraceptive septum, contraceptive sponge-like blocking methods), a single blocking method with a combination of an alveolar agent
12. Those who are currently participating in other clinical trials or who have participated in other clinical trials within 90 days of screening
13. Other, ethical or clinical trial outcomes may be impacted and deemed inappropriate by the tester | Rowan | INDUSTRY | {
"id": "RW-MCI-01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-02-15T00:00:00 | {
"date": "2024-10-31",
"type": "ACTUAL"
} | {
"date": "2024-02-20",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Mild Cognitive Impairment",
"MCI"
] | ["SUPERBRAIN", "SUPERBRAIN DEX", "DEX", "MCI", "Digital Therapeutics"] | null | [
{
"city": "Guri-si",
"country": "Korea, Republic of",
"facility": "Hanyang University Guri Hospital",
"geoPoint": {
"lat": 37.5986,
"lon": 127.1394
},
"state": "Gyeonggi-do"
},
{
"city": "Busan",
"country": "Korea, Republic of",
"facility": "Inje University Haeundae Paik Hospital",
"geoPoint": {
"lat": 35.10278,
"lon": 129.04028
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"state": null
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"city": "Incheon",
"country": "Korea, Republic of",
"facility": "Inha University Hospital",
"geoPoint": {
"lat": 37.45646,
"lon": 126.70515
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"state": null
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"city": "Incheon",
"country": "Korea, Republic of",
"facility": "Gachon University Gil Medical Center",
"geoPoint": {
"lat": 37.45646,
"lon": 126.70515
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"state": null
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"country": "Korea, Republic of",
"facility": "Chonnam National University Hospital",
"geoPoint": {
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"country": "Korea, Republic of",
"facility": "Ewha Womans University Seoul Hospital",
"geoPoint": {
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"country": "Korea, Republic of",
"facility": "Korea University Anam Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
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"state": null
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{
"city": "Seoul",
"country": "Korea, Republic of",
"facility": "The Catholic University of Korea, Seoul St. Mary's Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null
},
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"city": "Suwon",
"country": "Korea, Republic of",
"facility": "Ajou University Hospital",
"geoPoint": {
"lat": 37.29111,
"lon": 127.00889
},
"state": null
},
{
"city": "Suwon",
"country": "Korea, Republic of",
"facility": "The Catholic University of Korea, St. Vincent's Hospital",
"geoPoint": {
"lat": 37.29111,
"lon": 127.00889
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "K-RBANS",
"timeFrame": "Baseline, 16 weeks after treatment"
}
],
"secondary": [
{
"description": null,
"measure": "K-RBANS",
"timeFrame": "Baseline, 8 weeks after treatment"
},
{
"description": null,
"measure": "K-MMSE-2",
"timeFrame": "Baseline, 8 weeks after treatment, and 16 weeks after treatment"
},
{
"description": null,
"measure": "CDR-SB",
"timeFrame": "Baseline, 8 weeks after treatment, and 16 weeks after treatment"
},
{
"description": null,
"measure": "K-IADL",
"timeFrame": "Baseline, 8 weeks after treatment, and 16 weeks after treatment"
},
{
"description": null,
"measure": "PRMQ",
"timeFrame": "Baseline, 8 weeks after treatment, and 16 weeks after treatment"
},
{
"description": null,
"measure": "GDS-15",
"timeFrame": "Baseline, 8 weeks after treatment, and 16 weeks after treatment"
},
{
"description": null,
"measure": "QOL-AD",
"timeFrame": "Baseline, 8 weeks after treatment, and 16 weeks after treatment"
},
{
"description": null,
"measure": "ADAS-Cog14",
"timeFrame": "Baseline, 16 weeks after treatment"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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{
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"term": "Mental Disorders"
}
],
"browseBranches": [
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"name": "All Conditions"
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"relevance": "LOW"
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],
"meshes": [
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"term": "Cognitive Dysfunction"
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} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "Derm",
"name": "Dermatologic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M6263",
"name": "Coal Tar",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D060825",
"term": "Cognitive Dysfunction"
}
],
"interventions": []
} |
NCT04883957 | null | Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies | A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Bcl-2 Inhibitor BGB-11417 in Adult Patients With Mature B-cell Malignancies | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2021-05-07T00:00:00 | null | null | null | [
"PHASE1"
] | 64 | 18 | null | ALL | false | The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types. | This study will have 3 cohorts for determining a monotherapy MTD and ramp-up schedule: Cohort A, participants with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL); Cohort B, participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with low tumor burden; Cohort C, participants with R/R CLL/SLL with high tumor burden. | Key Inclusion Criteria:
1. Confirmed diagnosis of only one of the following:
Cohort A
a. Marginal Zone Lymphoma
i. R/R extranodal, splenic or nodal disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for MZL is available per investigator's assessment.
ii. Active disease requiring treatment.
b. Follicular Lymphoma
i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that has relapsed after, or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for FL is available per investigator's assessment.
ii. Active disease requiring treatment.
c. Diffuse Large B-cell Lymphoma
i. R/R DLBCL defined as disease that relapsed after, or been refractory to, at least one line of anti-CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for DLBCL is available per investigator's assessment.
ii. Active disease requiring treatment.
d. Transformed indolent B-cell NHL
i. Any lymphoma otherwise eligible for Cohort A that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Cohort A.
ii. Active disease requiring treatment.
Cohorts B and C
a. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria:
i. R/R disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of standard therapy for ≥ 2 consecutive cycles, and no effective standard therapy is available per investigator's assessment.
ii. Requiring treatment based on IWCLL criteria.
2. Measurable disease by computed tomography/magnetic resonance imaging, defined as:
1. CLL: At least 1 lymph node \> 1.5 centimeters (cm) in longest diameter and measurable in 2 perpendicular dimensions. For Cohort B, participants should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C.
2. DLBCL, FL, MZL, SLL: At least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions. For MZL isolated splenomegaly is considered to indicate measurable disease for this study. For SLL, participants in Cohort B should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C.
Key Exclusion Criteria:
1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
2. Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results.
3. Known central nervous system involvement by lymphoma/leukemia.
4. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome.
5. Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric cell therapy unless ≥ 6 months after cell infusion.
6. Prior allogeneic stem cell transplant. | BeiGene | INDUSTRY | {
"id": "BGB-11417-102",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2021-05-07T00:00:00 | {
"date": "2024-11-29",
"type": "ACTUAL"
} | {
"date": "2021-05-12",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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"allocation": "NON_RANDOMIZED",
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} | [
"Mature B-cell Malignancies"
] | ["BGB-11417", "Bcl-2", "Pharmacokinetics", "RP2D", "MTD"] | null | [
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"city": "Beijing",
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"facility": "Peking University First Hospital",
"geoPoint": {
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"facility": "Hunan Cancer Hospital",
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"facility": "The First Affiliated Hospital of Soochow University",
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"city": "Shanghai",
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"facility": "Affiliated Zhongshan Hospital of Fudan University",
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"state": "Shanghai"
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{
"city": "Hangzhou",
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"facility": "The First Affiliated Hospital, Zhejiang University School of Medicine",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
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"state": "Zhejiang"
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] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "MTD Of BGB-11417 As Recommended By The Bayesian Logistic Regression Model Or The MAD",
"timeFrame": "Approximately 3 years"
},
{
"description": null,
"measure": "RP2D Of BGB-11417",
"timeFrame": "Approximately 3 years"
},
{
"description": null,
"measure": "Incidence And Severity Of Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events (AEs) Leading To Discontinuation, And Dose-Limiting Toxicities (DLTs)",
"timeFrame": "Approximately 3 years"
},
{
"description": null,
"measure": "Incidence And Severity Of Tumor Lysis Syndrome-relevant Events",
"timeFrame": "Approximately 3 years"
}
],
"secondary": [
{
"description": null,
"measure": "Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Time To Maximum Observed Plasma Concentration (tmax) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Terminal Half-life (t1/2) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Apparent Total Clearance Of Drug From Plasma After Oral Administration (CL/F) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Apparent Volume Of Distribution (Vz/F) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To Last Measurable Concentration At Steady State (AUClast,ss) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Trough Concentration At Steady State (Ctrough,ss) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "PK As Assessed By Time To Maximum Observed Plasma Concentration At Steady State (tmax,ss) Of BGB-11417",
"timeFrame": "Up to 24 hours postdose"
},
{
"description": null,
"measure": "Overall Response Rate (ORR) Of BGB-11417 Monotherapy",
"timeFrame": "Approximately 3 years"
}
]
} | [
{
"affiliation": "BeiGene (Suzhou) Co., Ltd.",
"name": "Lu Zhang, M.D.",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"meshes": [
{
"id": "D009369",
"term": "Neoplasms"
}
]
} | null | {
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{
"id": "D009369",
"term": "Neoplasms"
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],
"interventions": null
} |
NCT05991557 | null | Peroneus Longus Graft :Effect in Foot and Ankle Function | Peroneus Longus Autograft Use in Knee, Shoulder, Elbow Ligaments Reconstruction Surgery : Effect On Ankle And Foot Function | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2023-08-06T00:00:00 | null | null | null | [
"NA"
] | 54 | 18 | 50 | ALL | false | The purpose of this study is to report the ankle and foot functions via American orthopedic foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments reconstruction. | Using a Peroneus longus tendon (PLT) as an autograft is a common procedure and has been used previously for deltoid ligament reconstruction in flatfoot deformity correction . Recently, (PLT) is gaining popularity as a graft option in primary anterior cruciate ligament (ACL) reconstruction surgeries with biomechanical studies showing tensile strength and clinical outcomes comparable to quadrupled hamstring grafts.
In addition to using PLT for isolated (ACL), it is also used in posterior cruciate ligament (PCL) reconstruction, medial collateral ligament reconstruction, posterolateral corner reconstruction of the knee, or knee multiple ligament injuries . The partial-thickness of the tendon has been used variably in knee ligament surgery..
Being a powerful muscle in plantar flexion and eversion of the foot, there might be associated ankle functional impairment. To the authors knowledge, there is a gap in science evaluating donor site morbidity. The aim of this study is to report the clinical and functional outcome of the donor site for better explanation of the cons and pros of using PLT as a graft in joint ligamentous injury . | Inclusion Criteria:
1. clinical and radiological diaginsis of joint ligament injury and needs to ligament reconstruction .
2. people with asymptomatic ankle and foot pre and post injury
Exclusion Criteria:
1. Associated ankle and/or foot fractures.
2. Associated hip or pelvic fractures
3. Abnormal ankle function pre-injury.
4. Contralateral limb fractures
5. Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care;
6. Presence of neurological condition that result in spasticity or any abnormal lower limb muscles tone.
7. Any condition that would preclude the ability to comply with post-operative guidelines. | Assiut University | OTHER | {
"id": "peroneus longus graft",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-08-06T00:00:00 | {
"date": "2023-08-16",
"type": "ACTUAL"
} | {
"date": "2023-08-14",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | null | {
"allocation": "NA",
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Ligament Injury"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "peronei muscle strength testing using handheld dynamometer",
"timeFrame": "preoperative, three months postoperative and six months postoperative"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT01901757 | null | Single-dose, 2-way Crossover Open Study to Evaluate the Food Effect on the PK of HCP1201 in Healthy Volunteers | An Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of HCP1201 Tablet in Healthy Volunteers | None | INTERVENTIONAL | COMPLETED | 2013-07-07T00:00:00 | null | null | null | [
"PHASE1"
] | 12 | 20 | 55 | MALE | true | To investigate the effect of food in healthy male volunteers who receive HCP1201 tablet in fed versus fasted condition | An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteers | Inclusion Criteria:
1. Healthy male volunteer, age 20\~55 years
2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4. Subject who has the ability and willingness to participate the whole period of trial
Exclusion Criteria:
1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
3. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
4. Systolic Blood Pressure: lower than 90mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
5. History of relevant drug allergies or clinically significant hypersensitivity reaction.
6. History of drug abuse or positive drug screening.
7. Participation in other drug studies within 60days prior to the drug administration.
8. Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
9. Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
10. Subjects who took medicines(e.g. proton pump inhibitor, rifampicin, oriental medicines, etc.) within 30days that can affect absorption, distribution, metabolism, elimination of metformin/rosuvastatin.
11. Intake of more than 140g of alcohol per week or who can't abstain from alcohol during the trial.
12. Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
13. Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
14. Genetic myopathic disorder or related family history, medical history of myopathic disorder caused by medication.
15. Clinically inappropriate laboratory test result.
16. Clinically inappropriate electrocardiogram result.
17. Subjects who judged ineligible by the investigator. | Hanmi Pharmaceutical Company Limited | INDUSTRY | {
"id": "HM-MERO-102",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-07-14T00:00:00 | {
"date": "2013-08-13",
"type": "ESTIMATED"
} | {
"date": "2013-07-17",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Diabetes Mellitus"
] | null | null | [
{
"city": "Seoul",
"country": "Korea, Republic of",
"facility": "Samsung Medical Center",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Metformin, rosuvastatin Cmax, AUClast",
"timeFrame": "pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h"
}
],
"secondary": [
{
"description": null,
"measure": "Metformin, rosuvastatin Tmax",
"timeFrame": "pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h"
},
{
"description": null,
"measure": "Metformin, rosuvastatin T1/2",
"timeFrame": "pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h"
},
{
"description": null,
"measure": "Metformin, rosuvastatin AUCinf",
"timeFrame": "pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h"
},
{
"description": null,
"measure": "Metformin, rosuvastatin CL/F",
"timeFrame": "pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h"
},
{
"description": null,
"measure": "Metformin, rosuvastatin Vd/F",
"timeFrame": "pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h"
}
]
} | [
{
"affiliation": "Samsung Medical Center",
"name": "Jung Ryul Kim, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
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"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
},
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"abbrev": "All",
"name": "All Conditions"
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"name": "Diabetes Mellitus",
"relevance": "LOW"
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],
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NCT03356457 | null | Development of Agents to Diminish the Risk of Hypoglycemia-induced Brain Injury in Type 1 Diabetes | Development of Agents to Diminish the Risk of Hypoglycemia-induced Brain Injury in Type 1 Diabetes | None | INTERVENTIONAL | COMPLETED | 2017-11-09T00:00:00 | null | 2019-03-20T00:00:00 | 2019-03-20T00:00:00 | [
"EARLY_PHASE1"
] | 21 | 18 | 65 | ALL | true | To determine the effect of re-activation of brain glucose metabolism induced by dichloroacetate (DCA) on cognitive function and counterregulatory hormone responses in patients with type 1 diabetes (T1DM) with recurrent hypoglycemia. | This will be a single center, placebo-controlled, cross-over, randomized clinical pilot study. The screening will take place at the Yale New Haven Hospital Research Unit (HRU) 10th floor, East Pavilion at 20 York St., New Haven, CT. At the screening visit informed consent will be obtained. Medical history and documents will be reviewed to screen potential subjects by inclusion and exclusion criteria. Subjects will receive a physical examination and laboratory blood work (BUN/creatinine, electrolytes, lipid profile, liver function, and HbA1c) as well as urine toxicology screens (to confirm self-report of alcohol, and drug information) to ensure good physical health. | Inclusion Criteria:
Group 1:
* Diagnosed C-peptide-negative T1DM, \> 5 years duration, HbA1c of \< 7.5%
* Intensive management, defined by frequent self-monitoring of glucose values and by the administration of 3 or more insulin injections each day (or the use of insulin pump therapy).
* History of severe hypoglycemia and hypoglycemia unawareness as assessed by the Guy's and Thomas' Minimally Modified Clarke Hypoglycemia Survey, the Gold Score and the Edinburgh Hypoglycemia Survey (see Appendix 1)
* Willingness to fast and to reduce insulin therapy for a limited time period
Group 2:
* Age, weight, and gender matched to group 1 subjects
* HbA1c \<6%
* Good general health as evidenced by medical history and blood screening
* Willing to fast for a limited time period
Exclusion Criteria:
General criteria:
* Known allergic reactions to components of the study product(s)
* Participants carrying polymorphisms known to slow DCA metabolism (e.g. KGM or EGM allele \[10\])
* Treatment with another investigational drug or other intervention
* Active infection including hepatitis C, hepatitis B, HIV
* Any past or current history of alcohol or substance abuse
* Psychiatric or neurological disorders, including need for medications, including anxiolytics, and antidepressants
* Baseline Hgb \< 10.5 g/dL in females, or \< 12.5 g/dL in males. Blood donation within 30 days of the study
* History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
* Co-existing cardiac, liver, and kidney disease
* Abnormal liver function tests
* GI disorders potentially interfering with the ability to absorb oral medications
* Women that are post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
* Any medical condition that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
* Any medication assumed less than 30 days before the study sessions that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes.The list of medications to be avoided includes - but is not limited to - drugs known to influence metabolic and endocrine function (other than insulin in Group 1) and neuroactive medications.
Group 1:
* Detectable C-peptide;
* Untreated proliferative retinopathy;
* Creatinine ≥1.5 mg/dl, urinary albumin levels . 300 mg/day
* Autonomic neuropathy; painful peripheral neuropathy | Yale University | OTHER | {
"id": "2000029203",
"link": null,
"type": null
} | Unknown | null | 2017-11-22T00:00:00 | {
"date": "2021-01-22",
"type": "ACTUAL"
} | {
"date": "2017-11-29",
"type": "ACTUAL"
} | [
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"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Once stable hypoglycemia is reached, a cognitive testing battery will be administered by a study co-investigator who will be blinded to the treatment assignment.",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Hyperglycaemia (Diabetic)"
] | null | null | [
{
"city": "New Haven",
"country": "United States",
"facility": "Yale New Haven Hospital",
"geoPoint": {
"lat": 41.30815,
"lon": -72.92816
},
"state": "Connecticut"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "• Measurement of hormone changes during hypoglycemia",
"timeFrame": "1 day"
}
],
"secondary": [
{
"description": null,
"measure": "cognitive function",
"timeFrame": "1 day"
}
]
} | [
{
"affiliation": "Yale University",
"name": "Raimund Herzog, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D044882",
"term": "Glucose Metabolism Disorders"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
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"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D006259",
"term": "Craniocerebral Trauma"
},
{
"id": "D020196",
"term": "Trauma, Nervous System"
},
{
"id": "D014947",
"term": "Wounds and Injuries"
}
],
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"abbrev": "BC18",
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{
"abbrev": "BC10",
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"asFound": null,
"id": "M7117",
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"asFound": "Hypoglycemia",
"id": "M10053",
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"asFound": "Hyperglycemia",
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NCT05299957 | null | Usefulness of Integrated PET/MRI in Oropharyngeal Squamous Cell Carcinoma Evaluation | Usefulness of Integrated PET/MRI in Oropharyngeal Squamous Cell Carcinoma Evaluation | None | OBSERVATIONAL | COMPLETED | 2022-03-07T00:00:00 | null | 2018-10-31T00:00:00 | 2021-12-31T00:00:00 | null | 233 | 18 | 75 | ALL | false | Head and neck cancer (HNC) continues to be a significant health care problem in Taiwan and oropharyngeal squamous cell carcinoma (SCC) is the common subtype. With the concern of organ preservation in recent years, concurrent chemoradiation is the major treatment modality for oropharyngeal SCC, while endoscopy with biopsy serves as the main diagnostic tools. With the advance of MRI technology, whole body MRI is now possible, and functional techniques become more feasible in the head and neck region, including diffusion-weighted imaging (DWI) which comprises of monoexponential DWI, intravoxel incoherent motion (IVIM) model and Kurtosis (biexponential or non-Gaussian fitting), and dynamic contrast-enhanced perfusion weighted MRI (DCE-PWI) become feasible. Therefore, MRI can evaluate distant site status of HNC in the single examination session and provide biologic information of tumors. Positron emission tomography/CT (PET/CT) is another common imaging modality to evaluate HNC, because of its ability to provide whole-body anatomic and metabolic information.
Integrated PET/MRI is a novel imaging technology that combines PET and MRI in one single scanner. In this 3-year prospective study, the investigators will take the advantages of integrated PET/MRI scanner with DWI (including monoexponential, kurtosis and IVIM modes) and DCE-PWI to evaluate our 160 patients with oropharyngeal SCC subjected to chemoradiation. Non-contrast chest CT will also be performed on the same day. The investigators aim to determine whole-body staging/restaging accurately, to predict treatment response and prognosis, and to determine necessity of noncontrast chest CT. The investigators expect that this project will offer the validation of usefulness of integrated PET/MRI in tumor staging/restaging of oropharyngeal SCC and resultant clinical impact. The role of noncontrast chest CT in the workup with our PET/MRI protocol can be defined. It will also provide evidence about how and to what extent the various simultaneously acquired MRI and PET functional parameters can help prediction of treatment response and prognosis of oropharyngeal SCC subjected to chemoradiation, which are important in timely modification of treatment regimen. | In this three-year prospective project, a total of 160 patients with histologically proven oropharyngeal SCC subjected to chemoradiation will be enrolled. Exclusion criteria include previous head or neck malignant tumor, a second malignant tumor, distant metastasis, contraindications to MRI (renal insufficiency, cochlear implant, cardiac pacemaker, or intracranial aneurysmal ferromagnetic clips), and serum glucose level \>200 mg/dl. Each enrolled patients will undergo detail clinical examination, including human papillomavirus test. The participants will undergo low dose chest CT on the same day before PET/MRI. In the posttreatment period, baseline whole body MRI will be obtained 3 months after chemoradiation. Thereafter, the participants will then be followed up also with alternative extend-field CT and whole body MRI by every 6 months. If tumor recurrenceis confirmed or highly suspected, PET/MRI will also be performed for tumor re-staging.
The three-years planning Adequate cases number and follow-up duration are essential for statistical analysis and outcome determination of oropharyngeal SCC treated with chemoradiation. The investigators plan to accomplish this study in 3 years.
In the first year, the works of the this project in the first year will design the data bank categories, set up the workflow and optimize the imaging protocols, determine the diagnostic capability of MRI component, PET component, integrated PET/MRI in tumor staging, determinate any added diagnostic value of noncontrast chest CT in integrated PET/MRI, and study the early treatment response and the patterns of residual tumor.
In the second year, the investigators will continue to the first-year works, and further include the following works to determinate incidence and predictors of treatment failure of oropharyngeal SCC, and to study the patterns of treatment response and early recurrence. In the third year, the investigators will continue to do previous work and will also get sufficient sample size to perform statistical analysis of the relationship between the imaging parameters and patient outcomes, attain comprehensive imaging about patterns of tumor recurrence and posttreatment changes/complications, investigate to what extent biologic imaging parameters may affect outcome and patient selection for chemoradiation, and analysis the accuracy, pitfalls and cost effectiveness of the PET/MRI alone and PET/MRI with noncontrast chest CT in evaluating in patients with oropharyngeal SCC.
PET/MRI data will be acquired on the integrated PET/MRI scanner , which acquires simultaneous PET and MR data with a 3.0-T magnet. The examination protocol will combined a whole-body scan with a dedicated examination of the head and neck area. All participants will fast for 6 h before the scan. At 50-70 min post injection of 370 MBq of FDG, the patient will be placed on the PET/MRI scanner bed. After fast-view T1-weighted MR localizer sequence for scout imaging and Dixon VIBE sequence for attenuation correction, a whole-body PET scan will be performed in 5 bed positions to cover from the head to the proximal thigh, with an acquisition time of 4 min per bed position. Simultaneously, whole body MR image acquisition will be performed for the corresponding 5 bed positions with the axial HASTE sequence and coronal STIR sequence as well as the sagittal T1-weighted Turbo spine echo(TSE) and STIR sequence.
Afterwards, regional PET and MRI images will be simultaneously performed. Regional PET will be performed with an acquisition time of 10 min, while a dedicated MRI of the head and neck region will be acquired in the axial and coronal projections with T1-weighted TSE sequence and T2-weighted TSE sequence with fat saturation. Axial DWI will be performed using a single shot spin-echo echo-planar technique with modified Stejskal-Tanner diffusion gradient pulsing scheme. A total of 10 b values will be used for the reconstruction of IVIM and kurtosis imaging, which are: 0, 20, 40, 80, 100, 200, 400, 800, 1200, 1500 sec/mm2. DCE-PWI at the head and neck region will be acquired by using a 3D T1-weighted spoiled gradient-echo sequence. A spatial saturation slab will be implanted inferior to the acquired region to minimize the inflow effect from the carotid arteries. Before the contrast agent administration, baseline longitudinal relaxation time values will be calculated from image acquired with different flip angles. Then, the dynamic series will be acquired using the same sequence with a 15° flip angle, after intravenous administration of paramagnetic contrast agent at 3 ml/s. Thereafter, dedicated regional MRI will be obtained with T1-weighted TSE sequence with fat saturation in the axial and coronal projections. Finally, whole body axial VIBE with fat saturation will be performed. The total acquisition time is about 42 min, and the mean in-room time for PET/MR will be approximately 60 min.
Non-enhanced low-dose chest CT Spiral low-dose chest CT without contrast material enhancement will be performed before PET/MRI on the same examination day. Acquisition parameters include peak voltage of 120 kVp, mAs of 50, collimation of 64x0.5 mm and reconstruction interval of 3-mm.
Data analysis Readers are aware that patients have oropharyngeal SCC, and they will be blinded to the results of other studies and to PET/MR data. The PET, MRI and chest CT images will be first interpreted independently. All images will be then reviewed together and compared. A checklist of various distributions of tumor extension, nodal spread and distant metastasis will be recorded. The clinical and imaging findings will be discussed jointly by the Head-and-Neck research team. Endoscopic biopsy, ultrasonographic guided fine needle aspiration or CT-guided biopsy will be performed in any lesions suspicion for malignancy if possible. If biopsy of the lesion of interest is not feasible, or yields a negative result, close clinical and imaging follow-up will be pursued. All participants will be followed up for at least 12 months. The clinical and functional imaging data will be collected and analyzed for predicting treatment response and prognosis. For the diffusion MRI, regions of interest will be manually placed on the lesions on ADC map to encompass as much of the solid tumor area as possible. The signal intensities measured on the images acquired at different b-values S(b) will be numerically fitted against the model, S(b)=S0 e-b\*ADC, where S0 and Sb are signal intensities at different b values, For IVIM imaging, the relationship between signal intensities and b values can be expressed by the equation: Sb/S0 = (1-f )．exp(-bD) + f．exp\[-b( D + D＊)\] where f is a microvascular volume fraction representing the fraction of the diffusion linked to microcirculation, D represents pure diffusion coefficient, and D\* is perfusion-related incoherent microcirculation. For the DKI, the relationship between signal intensities and b values can be expressed by the equation: ln\[S(b)\] = ln\[S(0)\] - b x Dapp + 1/6b2 x Dapp2 x Kapp where S is the signal intensity (arbitrary units), b is the b-value (s/mm2), Dapp is the apparent diffusion coefficient (10-3 mm2/s), and Kapp is the apparent kurtosis coefficient denoting thedeviation from a Gaussian distribution. We will also perform monoexponential fitting by using Kapp=0 in the equation, yielding ADCmono. For the DCE-PWI MRI, the change in contrast agent concentration over time, Ct(t), will be determined in each voxel in the tumor, and the compartmental tracer kinetic model will be applied to each voxel by using an arterial input function, Cp(t), measured in each individual: Ct (t)=VpCp(t) + Ktrans ∫0 t Cp(t' ) exp(Ktrans(t-t') /Ve )dt' where t' is the time (in minutes) as an integration variable, and Cp(t') is the concentration of contrast agent in the blood plasma as a function of time.
For PET imaging parameters, SUV and MTV of the target lesions will be measured from attenuation-corrected 18F-FDG PET images by drawing the boundaries drawn large enough to include the lesions. An SUV threshold of 2.5 will be used to delineate the MTV. The TLG is calculated as the product of the mean SUV and the MTV. | Inclusion Criteria:
* histologically proven oropharyngeal SCC subjected to chemoradiation
Exclusion Criteria:
* previous head or neck malignant tumor, a second malignant tumor, distant metastasis, contraindications to MRI (renal insufficiency, cochlear implant, cardiac pacemaker | Chang Gung Memorial Hospital | OTHER | {
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NCT05323357 | null | Bern Human Organoid-Study to Study Host-microbe Interaction | Establishment of Human Organoid Lines as a Tool to Dissect Molecular Pathways of Host-microbiota Interactions | humorg | OBSERVATIONAL | RECRUITING | 2022-04-04T00:00:00 | null | 2025-03-30T00:00:00 | 2026-03-30T00:00:00 | null | 100 | 18 | 80 | ALL | false | The human body inhabits a complex consortium of different microbes which together form the microbiota. Virtually every surface of the human body is colonized by a distinct microbiota, forming complex communities. An increasing number of research results indicates that changes in the microbiota can have vast effects on the health of its host.
Most studies investigating the microbiota were conducted on animals, as many interventions and investigations cannot be performed on humans due to ethical considerations. This raises the question if findings from experimental studies are translational and can benefit patients. That becomes especially apparent when trying to dissect molecular mechanisms involved in this fine-tuned interplay between nutrients, the microbiota, and its host.
By establishing human organoid cultures from the large and small intestine that can be exposed to microbes and/or microbial products with subsequent transcriptomic, epigenetic and immunological analysis, the investigators aim to generate findings with high translational potential with new insights into the complex interaction of the microbiota, the host and its immune system. | * Data obtained from participants will be recorded in the database Redcap to ensure high-quality data recording
* Establishment of human organoid cultures are standardized by published protocols (Pleguezuelos-Manzano et al. 2020) | Inclusion Criteria:
* Signed informed consent
* Indication for upper or lower endoscopic procedure
* Ability to understand and follow study procedures and understand informed consent
* Age 18-80 years
* Negative pregnancy test result prior to study enrollment of female study participants (test will be performed prior to enrollment)
* BMI between 18.5 and 30 kg/m2
Exclusion Criteria:
* Disease known to chronically affect gut microbiota, gut epithelium or gut-associated immune system, namely inflammatory bowel disease, diverticulitis, microscopic colitis, liver cirrhosis, malignancy within the digestive tract, systemic sclerosis, coeliac disease, common-variable immunodeficiency, diabetes mellitus
* Medication with immunosuppressants (e.g. corticoids, biological therapy)
* Current diagnosis of a hematological disorder (e.g. anemia with hemoglobin \<7 g/dl, leukemia) or any other absolute contraindication for blood draw
* Women who are pregnant
* Serious coagulation disorder, relevant thrombocytopenia (\<50'000/ul), double platelet-inhibition, oral anticoagulation (ASS therapy is possible)
* Known or suspected non-compliance, drug, or alcohol abuse
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees, and other dependent persons
* Inability or unwillingness to provide blood samples and tissue samples (biopsies)
* Participants taking oral anticoagulant or with bleeding disorders who would be at much higher risk of bleeding after biopsy samples or who are contraindicated for an endoscopic examination
* Patients unable to give informed consent
* Patients that have been under antibiotic therapy in the last 4 weeks
* Participation in other clinical study interfering with study procedures
* Potential study participants that wish not to be informed about random results acquired during the study (e.g., during endoscopy or genetic analysis) relevant for their health and for prevention of diseases | Insel Gruppe AG, University Hospital Bern | OTHER | {
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NCT05245357 | null | Impact of Foods on Bile Acids, Metabolites, and Inflammation | Therapeutic Impacts of Dietary Pulses on Bile Acids | None | INTERVENTIONAL | UNKNOWN | 2022-01-31T00:00:00 | null | null | null | [
"NA"
] | 24 | 18 | 65 | ALL | true | Dietary incorporation of pulse crops may be an effective way to lower unhealthy elevations in serum bile acids. These elevations play a direct role in promoting obesity-related diseases estimated to be present in about one third of the US adult population, including non-alcoholic fatty liver disease and type 2 diabetes. The overarching hypothesis for this study is that pulse consumption increases bile acid secretion and excretion, which will decrease toxicity linked to excess accumulation of bile in the liver, improve metabolism, and lower resulting levels of bile acids in the serum. In direct alignment with the USDA-AFRI Food, Safety, Nutrition, and Health priority to address obesity and related chronic disease with increased fruit and vegetable consumption and also with the American Pulse Association call to investigate the impact of regular pulse consumption on human physical well- being, the long-term research goal of this study is to establish effective and practical therapeutic strategies utilizing dietary incorporation of pulse crops to prevent or reverse obesity driven diseases. The specific objectives in this proposal are to:
1. determine the impact of acute lentil ingestion on serum postprandial bile acid responses and composition in a human cohort with obesity, and
2. determine the impact of daily lentil consumption for 12 weeks on serum fasting and postprandial bile acid concentrations and composition in an overweight or obese cohort with elevated postprandial triglycerides.
This proposal is being submitted in response to the American Pulse Association commodity board sponsored topic of investigating the impact pulse crop consumption on health. | The approach for Objective 1 is to enroll a population of overweight/obese individuals (n=24) in a two-armed (LENTIL and CONTROL), randomized, crossover trial in which each individual participant serves as his/her own control to compare postprandial serum bile acid responses between isocaloric meals with the same amount of fat with (LENTIL) and without (CONTROL) lentils. Isocaloric meals with the same total fat content in LENTIL and CONTROL study arms will provide the same stimulus to induce increased postprandial serum bile acids. The randomized crossover design with half of the participants starting in the LENTIL arm and the other half starting in the CONTROL arm will eliminate potential order effects. Block randomization with 3 blocks of two equally numbered levels (total of 8 per block) will be created. Having each person serve as their own control in a crossover trial will eliminate the influence of inter-individual variation. The MSU Nutrition Research team has extensive experience with postprandial testing protocols and dietary manipulation and will utilize this experience to perform the proposed protocol with appropriate pre-test standardization, uniformity of meal preparation, precise timing of blood collection, and established procedures for processing and analyzing blood samples. Bile acids, including all primary and secondary forms, will be analyzed from samples collected before the meal and at 30-minute intervals for 4 hours after the meal. Established methods in the MSU Proteomics, Metabolomics, and Mass Spectrometry Facility will be used to compare total and individual bile acids between LENTIL and CONTROL conditions.
The approach for Objective 2 will leverage banked samples from a highly synergistic ongoing clinical trial comparing 12 weeks of daily lentil consumption to control. This study utilizes a randomized, parallel research design to compare the impact of ingesting 140 g of lentils per day to 0 g per day for 12 weeks on serum triglyceride and inflammation responses to a high-fat meal. High fat meals induce the largest serum bile acid responses so the current proposal augments this study by adding assessment of the impact of prolonged lentil consumption on the appearance of bile acids in the systemic circulation under fasting and postprandial conditions. In contrast to Objective 1, which focuses on the acute impact of incorporating lentils into a meal, Objective 2 will measure the impact of adaptations to lentil ingestion that improve enterohepatic function. These changes may be facilitated by changes to the composition of the gut microbiome, enhanced bile acid excretion, or other mechanisms independent of having lentils in the challenge meal. Data from the ongoing trial will be analyzed to determine whether lentils induced changes in the composition of the gut microbiome. This proposal will analyze whether lentil consumption increases excretion of bile acids by analyzing bile acid composition of stool samples collected before and after lentil supplementation. In sum, adding analysis of serum and stool bile acids from samples collected and banked in an ongoing clinical trial, will allow the determination of whether lentil consumption over time improves enterohepatic health in a way that reduces appearance of bile acids in serum and or increases excretion of bile acids. | Inclusion Criteria:
* 18 - 65 years of age
* Body Mass Index greater than 27 kg/m\^2
Exclusion Criteria:
* taking medication that will influence cholesterol, lipids, or inflammation
* a gallbladder condition or have had the gallbladder removed
* allergy to wheat, dairy, or legumes
* pregnant or lactating
* have been on a ketogenic or paleo diet in the past 6 weeks
* have been on antibiotics in the past 90 days | Montana State University | OTHER | {
"id": "AFRI Grant 2021-67028-34103",
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"Hyperlipidemias",
"Bile Acid Malabsorption"
] | null | null | [
{
"city": "Bozeman",
"country": "United States",
"facility": "Nutrition Research Laboratory",
"geoPoint": {
"lat": 45.67965,
"lon": -111.03856
},
"state": "Montana"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Postprandial Bile Acid Response to High-Fat Meal",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Peak Bile Acid Response to High-Fat Meal",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Postprandial Triglyceride Response to High-Fat Meal",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Peak Triglyceride Response to High-Fat Meal",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Postprandial Serum Inflammatory Cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) Response to High-fat Meal",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Postprandial Serum Metabolite Response (untargeted) to a High-Fat Meal",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Fasting Serum Metabolite Response (untargeted) to a High-Fat Meal",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Gut Microbiome Composition",
"timeFrame": "1 day"
}
],
"secondary": [
{
"description": null,
"measure": "Body Composition",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Visceral Adipose Tissue",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Body Mass Index",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Habitual Diet",
"timeFrame": "1 month"
},
{
"description": null,
"measure": "Acute Diet",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Acute Physical Activity",
"timeFrame": "1 day"
}
]
} | [
{
"affiliation": "Montana State University",
"name": "Mary P Miles, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D050171",
"term": "Dyslipidemias"
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{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
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"term": "Gastrointestinal Diseases"
},
{
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"term": "Digestive System Diseases"
}
],
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{
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}
],
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"relevance": "HIGH"
},
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"id": "M11639",
"name": "Metabolic Diseases",
"relevance": "HIGH"
},
{
"asFound": "Hyperlipidemia",
"id": "M10000",
"name": "Hyperlipidemias",
"relevance": "HIGH"
},
{
"asFound": "Hypertriglyceridemia",
"id": "M17932",
"name": "Hypertriglyceridemia",
"relevance": "HIGH"
},
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"id": "M11278",
"name": "Malabsorption Syndromes",
"relevance": "HIGH"
},
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},
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"relevance": "LOW"
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"relevance": "LOW"
},
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"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
}
],
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"term": "Malabsorption Syndromes"
},
{
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"term": "Hyperlipidemias"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
},
{
"id": "D015228",
"term": "Hypertriglyceridemia"
},
{
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"term": "Lipid Metabolism Disorders"
},
{
"id": "D007249",
"term": "Inflammation"
}
]
} | {
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"term": "Metabolic Diseases"
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"term": "Hypertriglyceridemia"
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],
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NCT03251157 | null | Dietary Intake in Adults From the GA2LEN Folow-up Survey | Dietary Intake, Allergy and Respiratory Diseases in European Adults From the GA2LEN Follow-up Survey | None | OBSERVATIONAL | COMPLETED | 2017-08-12T00:00:00 | null | 2010-12-31T00:00:00 | 2010-12-31T00:00:00 | null | 3,500 | 15 | 75 | ALL | null | The Nutrition Study of the GA2LEN Follow-Survey was designed to investigate the association between usual dietary intake and allergic and respiratory outcomes in adults across Europe. Within this framework, a food frequency questionnaire (FFQ) was designed to ascertain usual dietary intake of 250 food items, which was translated into the languages of the participant centres. Information on daily intake of foods, nutrients, and flavonoids was derived. | Within the GA2LEN Follow-up Survey, the Nutrition Survey was aimed at assessing dietary intake in adults across European countries and its association with various outcomes of allergy and respiratory health. In absence of an internationally comparable dietary questionnaire to ascertain usual dietary intake, a single and standardized food frequency questionnaire (FFQ) was design to be used as a common instrument in all participant countries. The FFQ is comprised of 32 food sections and 250 food items. The FFQ sections were designed following the recommendations by the EFCOSUM Group, which facilitate international comparisons of dietary intake. It also included several staple foods to capture locally representative dietary intake.
Participants reported how often they had consumed each of the foods over the previous month, using eight predefined options (rarely or never, 1-3 times per month, once, 2-4, or 5-6 times per week, once, 2-3 times per day). Standard food portion sizes were used to quantify the intake following the recommendations from the UK's Food Standards Agency. Daily intake of foods (g) were estimated and macro- and micronutrient and flavonoid intakes were derived. The GA2LEN FFQ was validated in five EU countries, namely Finland, UK, Portugal, Germany, Poland, and Greece, and demonstrated to be a good tool to assess mid-term intake of foods, specifically essential polyunsaturated fatty acids (PUFAs). The instrument has also been demonstrated to be an accurate tool to assess dietary sources of flavonoids.
Various approaches were planned to derive dietary exposures and to examine their association with respiratory and allergic outcomes. These included the use of dietary patterns derived from Principal Component Analysis (PCA), a dietary inflammatory index (DII), as well as single antioxidants, and individual food items. | Inclusion Criteria:
Participants aged 15-75 years old, who had responded to the GA2LEN Baseline survey and who met the definition of cases or controls (as described below)
Exclusion Criteria:
Participants who did not answer the baseline survey | Johns Hopkins Bloomberg School of Public Health | OTHER | {
"id": "GA2LEN Nutrition Survey",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-08-15T00:00:00 | {
"date": "2017-08-16",
"type": "ACTUAL"
} | {
"date": "2017-08-16",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | The GA2LEN follow-up study was a multi-center case-control study with participants selected from the respondents to an initial cross-sectional survey of a general population of adults aged 15-74 years living in 17 European cities and completed between June 2007 and May 2009. A random sample of eligible participants who indicated a willingness to be re-contacted was selected based on their responses to the initial postal survey. The cases were participants who either had asthma, sinusitis or both and the controls (who lived in the same areas) were those who reported having neither. Each center recruited up to 120 cases each of patients with asthma only, CRS only, controls and 40 patients with both asthma and CRS based on the responses to the initial cross-sectional survey. | PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Asthma",
"Lung Function Decreased",
"Food Allergy",
"Allergic Sensitisation",
"Allergic Rhinitis",
"COPD",
"Atopy"
] | ["Asthma", "Adults", "Europe", "Lung function", "Allergy", "Atopy", "IgE", "Sensitisation", "Diet", "Dietary patterns", "Dietary antioxidants", "Flavonoids", "Fruits and vegetables", "Food frequency questionnaire (FFQ)", "Fatty acids"] | null | [
{
"city": "Baltimore",
"country": "United States",
"facility": "Johns Hopkins Bloomberg School of Public Health",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland"
}
] | [
{
"class": "OTHER",
"name": "Imperial College London"
},
{
"class": "OTHER",
"name": "Helsinki University Central Hospital"
},
{
"class": "OTHER",
"name": "Medical University of Lodz"
},
{
"class": "OTHER",
"name": "Karolinska Institutet"
},
{
"class": "OTHER",
"name": "University Ghent"
},
{
"class": "OTHER",
"name": "University of Wuerzburg"
},
{
"class": "OTHER",
"name": "Medical University of Silesia"
},
{
"class": "OTHER",
"name": "University of Coimbra"
},
{
"class": "OTHER",
"name": "Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"
},
{
"class": "OTHER",
"name": "University of Southern Denmark"
},
{
"class": "OTHER",
"name": "Uppsala University"
},
{
"class": "OTHER",
"name": "Umeå University"
},
{
"class": "OTHER",
"name": "Charite University, Berlin, Germany"
},
{
"class": "OTHER",
"name": "University of Southampton"
},
{
"class": "OTHER",
"name": "Göteborg University"
},
{
"class": "OTHER",
"name": "Jagiellonian University"
},
{
"class": "OTHER",
"name": "Odense University Hospital"
}
] | null | {
"other": [
{
"description": null,
"measure": "Asthma",
"timeFrame": "Last 12 months"
},
{
"description": null,
"measure": "IgE sensitisation",
"timeFrame": "1 day"
}
],
"primary": [
{
"description": null,
"measure": "Asthma score",
"timeFrame": "Last 12 months"
},
{
"description": null,
"measure": "Chronic rhinosinusitis (CRS)",
"timeFrame": "Last 12 weeks"
},
{
"description": null,
"measure": "Lung function",
"timeFrame": "Day"
},
{
"description": null,
"measure": "Atopy",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Allergic rhinitis",
"timeFrame": "Last month"
}
],
"secondary": null
} | [
{
"affiliation": "Imperial College London",
"name": "Peter GJ Burney, MD PhD",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "19392994", "type": "BACKGROUND", "citation": "Bousquet J, Burney PG, Zuberbier T, Cauwenberge PV, Akdis CA, Bindslev-Jensen C, Bonini S, Fokkens WJ, Kauffmann F, Kowalski ML, Lodrup-Carlsen K, Mullol J, Nizankowska-Mogilnicka E, Papadopoulos N, Toskala E, Wickman M, Anto J, Auvergne N, Bachert C, Bousquet PJ, Brunekreef B, Canonica GW, Carlsen KH, Gjomarkaj M, Haahtela T, Howarth P, Lenzen G, Lotvall J, Radon K, Ring J, Salapatas M, Schunemann HJ, Szczecklik A, Todo-Bom A, Valovirta E, von Mutius E, Zock JP. GA2LEN (Global Allergy and Asthma European Network) addresses the allergy and asthma 'epidemic'. Allergy. 2009 Jul;64(7):969-77. doi: 10.1111/j.1398-9995.2009.02059.x. Epub 2009 Apr 7."}, {"pmid": "28149501", "type": "BACKGROUND", "citation": "Garcia-Larsen V, Arthur R, Potts JF, Howarth PH, Ahlstrom M, Haahtela T, Loureiro C, Bom AT, Brozek G, Makowska J, Kowalski ML, Thilsing T, Keil T, Matricardi PM, Toren K, van Zele T, Bachert C, Rymarczyk B, Janson C, Forsberg B, Nizankowska-Mogilnicka E, Burney PGJ. Is fruit and vegetable intake associated with asthma or chronic rhino-sinusitis in European adults? Results from the Global Allergy and Asthma Network of Excellence (GA2LEN) Survey. Clin Transl Allergy. 2017 Jan 27;7:3. doi: 10.1186/s13601-016-0140-9. eCollection 2017."}, {"pmid": "21427744", "type": "BACKGROUND", "citation": "Garcia-Larsen V, Luczynska M, Kowalski ML, Voutilainen H, Ahlstrom M, Haahtela T, Toskala E, Bockelbrink A, Lee HH, Vassilopoulou E, Papadopoulos NG, Ramalho R, Moreira A, Delgado L, Castel-Branco MG, Calder PC, Childs CE, Bakolis I, Hooper R, Burney PG; GA2LEN-WP 1.2 'Epidemiological and Clinical Studies'. Use of a common food frequency questionnaire (FFQ) to assess dietary patterns and their relation to allergy and asthma in Europe: pilot study of the GA2LEN FFQ. Eur J Clin Nutr. 2011 Jun;65(6):750-6. doi: 10.1038/ejcn.2011.15. Epub 2011 Mar 23."}] | {"versionHolder": "2025-06-18"} | {
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},
{
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"term": "Respiratory Hypersensitivity"
},
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"term": "Hypersensitivity, Immediate"
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{
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"term": "Immune System Diseases"
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"term": "Infections"
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{
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"name": "Diseases and Abnormalities at or Before Birth"
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"name": "Rare Diseases"
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],
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"name": "Hypersensitivity",
"relevance": "HIGH"
},
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"id": "M8636",
"name": "Food Hypersensitivity",
"relevance": "HIGH"
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"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
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"name": "Respiration Disorders",
"relevance": "LOW"
},
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"id": "M4556",
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"relevance": "LOW"
},
{
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"id": "M15049",
"name": "Rhinitis",
"relevance": "HIGH"
},
{
"asFound": "Allergic Rhinitis",
"id": "M30545",
"name": "Rhinitis, Allergic",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M27555",
"name": "Multiple Acyl Coenzyme A Dehydrogenase Deficiency",
"relevance": "LOW"
},
{
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"id": "M14967",
"name": "Respiratory Hypersensitivity",
"relevance": "LOW"
},
{
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"id": "M10020",
"name": "Hypersensitivity, Immediate",
"relevance": "LOW"
},
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"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
},
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"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
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"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
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"id": "M14978",
"name": "Respiratory Tract Infections",
"relevance": "LOW"
},
{
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"id": "M12604",
"name": "Nose Diseases",
"relevance": "LOW"
},
{
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"id": "M12961",
"name": "Otorhinolaryngologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T2548",
"name": "Glutaric Acidemia Type II",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D012220",
"term": "Rhinitis"
},
{
"id": "D065631",
"term": "Rhinitis, Allergic"
},
{
"id": "D006967",
"term": "Hypersensitivity"
},
{
"id": "D005512",
"term": "Food Hypersensitivity"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
}
],
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"asFound": null,
"id": "M4292",
"name": "Antioxidants",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18331",
"name": "Ganciclovir",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M340476",
"name": "Ganciclovir triphosphate",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D012220",
"term": "Rhinitis"
},
{
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"term": "Rhinitis, Allergic"
},
{
"id": "D006967",
"term": "Hypersensitivity"
},
{
"id": "D005512",
"term": "Food Hypersensitivity"
}
],
"interventions": []
} |
NCT05851157 | null | A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548 | A Phase 1, Randomized, Open-label, Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of VX-548 in Healthy Adults | None | INTERVENTIONAL | COMPLETED | 2023-04-28T00:00:00 | null | 2023-10-30T00:00:00 | 2023-11-08T00:00:00 | [
"PHASE1"
] | 73 | 18 | 65 | ALL | true | The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 in healthy participants. | This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.). | Key Inclusion Criteria:
* Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m\^2)
* A total body weight greater than (\>) 50 kilogram (kg)
Key Exclusion Criteria:
* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Participants of childbearing potential
Other protocol defined Inclusion/Exclusion criteria may apply. | Vertex Pharmaceuticals Incorporated | INDUSTRY | {
"id": "VX22-548-016",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-04-28T00:00:00 | {
"date": "2024-03-20",
"type": "ACTUAL"
} | {
"date": "2023-05-09",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Pain"
] | null | null | [
{
"city": "Salt Lake City",
"country": "United States",
"facility": "ICON Salt Lake City",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite",
"timeFrame": "Pre-dose up to Day 35 Post-dose"
},
{
"description": null,
"measure": "Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-548 and its Metabolite",
"timeFrame": "Pre-dose up to Day 35 Post-dose"
},
{
"description": null,
"measure": "Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite",
"timeFrame": "Pre-dose up to Day 35 Post-dose"
}
],
"secondary": [
{
"description": null,
"measure": "Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)",
"timeFrame": "From Day 1 up to Day 44"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
"interventions": null
} |
NCT00333957 | null | Capsule Endoscopy in Cystic Fibrosis | Capsule Endoscopy in Cystic Fibrosis-Screening for Small Bowel Disease in Cystic Fibrosis Patient. | None | OBSERVATIONAL | COMPLETED | 2006-06-05T00:00:00 | null | null | null | null | 200 | 10 | null | ALL | false | Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy will be used to photograph the entire bowel. | The capsule endoscope system (Given Imaging, Ltd.) consists of 3 elements: a disposable capsule (PillCamTM SB) that acquires video images during natural propulsion through the digestive system.
The video-capsule PillCamTM SB has been cleared by the FDA for use in patients over 10 years of age for the detection of small intestinal disorders. It has been used in patients under age 10 and has been placed with the use of a gastroscope in patients unable to swallow the capsule. In fact, a new delivery device has been introduced recently that facilitates placement of the video-capsule in pediatric patients.For the purposes of this study, only patients over age 10 years who are able to swallow the capsule would be enrolled.
There are approximately 450 CF patients in the registry in Israel, with about 300 above the age of 10. Study subjects would be enrolled from this registry population and would be screened for the presence of the contraindications noted above. Patients would be assessed for symptoms of possible small bowel lesions at the time of enrollment including gastrointestinal bleeding, palpable abdominal mass, weight loss, diarrhea, and abdominal pain. Markers of inflammation including stool calprotectin will be assessed in all patients. These data would be recorded for further analysis.
Page | Inclusion Criteria:
Inclusion criteria would include those subjects with known CF who are able to give informed consent to undergo capsule endoscopy and whose guardians provide consent as well, if applicable. -
Exclusion Criteria
Subjects would be excluded if they were felt to be poor surgical candidates as patients may need to undergo surgery in the rare event of retention of the capsule. Patients genotype and lung function will be noted; patients will be excluded if FEV1 \< 40%.
- | Hadassah Medical Organization | OTHER | {
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"date": "2018-05-04",
"type": "ACTUAL"
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"date": "2006-06-06",
"type": "ESTIMATED"
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] | ["capsule endoscopy"] | null | [
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{
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} | [
{
"affiliation": "Hadassah Medical Organization",
"name": "Michael Wilschanski, MBBS",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D010335",
"term": "Pathologic Processes"
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"id": "D010182",
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NCT05771857 | null | Obesity: an Underappreciate Risk Factor for Severe Form of COVID-19 | Obesity: an Underappreciate Risk Factor for Severe Form of COVID-19: Retrospective Cohort Study of 415 Cases | None | OBSERVATIONAL | COMPLETED | 2023-03-14T00:00:00 | null | 2021-09-30T00:00:00 | 2021-10-01T00:00:00 | null | 415 | 18 | 80 | ALL | true | Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19. | Introduction: COVID 19 pandemic continues to progress with a considerable mortality and morbidity throughout the world since its emergence in December 2019. Many studies were conducted to identify the predictive factors of mortality of those infected with the virus. The previous studies noticed that obesity seems to be associated with severe form of respiratory distress syndrome. Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.
Methods: investigators led a retrospective monocentric, descriptive and analytic study, in the department of anesthesia and intensive care unit of the university hospital of Mohamed VI Oujda, in Morocco, from March 2020 to October 2021, including all the patients tested positive for the infection. | Inclusion Criteria:
* All patients presenting an infection with SARS-CoV-2 that were hospitalized in the intensive care unit.
Exclusion Criteria:
* None | Mohammed VI University Hospital | OTHER | {
"id": "Service anesthesie Reanimation",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2023-03-15T00:00:00 | {
"date": "2023-03-16",
"type": "ACTUAL"
} | {
"date": "2023-03-16",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | investigators have included all the patients presenting an infection with SARS-CoV-2 (1069 patients) diagnosed following the regarding of the world health organization (WHO), confirmed by a PCR of a nasopharyngeal swap, or highly suspected images on thoracic CT scans, that were hospitalized in the intensive care unit. | NON_PROBABILITY_SAMPLE | null | {
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} | [
"COVID-19 Pandemic",
"Obesity"
] | null | null | [
{
"city": "Berkane",
"country": "Morocco",
"facility": "younes Oujidi",
"geoPoint": {
"lat": 34.92,
"lon": -2.32
},
"state": null
}
] | null | null | {
"other": null,
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"description": null,
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"timeFrame": "in all the 22 mounths"
},
{
"description": null,
"measure": "Risk factor for severe form of COVID-19",
"timeFrame": "in all the 22 mounths"
}
],
"secondary": null
} | null | [{"pmid": "32271993", "type": "BACKGROUND", "citation": "Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10."}, {"pmid": "32409499", "type": "BACKGROUND", "citation": "Gao F, Zheng KI, Wang XB, Sun QF, Pan KH, Wang TY, Chen YP, Targher G, Byrne CD, George J, Zheng MH. Obesity Is a Risk Factor for Greater COVID-19 Severity. Diabetes Care. 2020 Jul;43(7):e72-e74. doi: 10.2337/dc20-0682. Epub 2020 May 14. No abstract available."}, {"pmid": "33358523", "type": "BACKGROUND", "citation": "Yu W, Rohli KE, Yang S, Jia P. Impact of obesity on COVID-19 patients. J Diabetes Complications. 2021 Mar;35(3):107817. doi: 10.1016/j.jdiacomp.2020.107817. Epub 2020 Nov 26."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D011024",
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"term": "Body Weight"
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{
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],
"interventions": null
} |
NCT05992857 | null | Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty | Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula. | PACOMARCO | INTERVENTIONAL | NOT_YET_RECRUITING | 2023-08-08T00:00:00 | null | null | null | [
"NA"
] | 150 | 18 | null | ALL | false | To assess the efficacy of complete covering using retromesenteric omentoplasty vs. partial covering or no covering of peripancreatic arteries in decreasing incidence of grade B+C post-pancreatectomy hemorrhage (PPH), i.e. treated by transfusion and / or radiological or surgical hemostasis after PD in patients with high risk of POPF. | Grade B+C postpancreatectomy hemorrhage (PPH) is a severe complication following pancreaticoduodenectomy (PD), more frequently observed in patients with high-risk of postoperative pancreatic fistula (POPF). To date no randomized controlled trial has assessed the impact of an omentoplasty covering all arteries exposed during PD on the prevention of clinically relevant postpancreatectomy hemorrhage (PPH) in patients with high-risk of POPF (fistula risk score between 7 to 10)
In the standard technique, no omental flap is used or an omental flap is only interposed between the pancreatic anastomosis and the hepatic artery, and/or the round ligament wraps the hepatic artery only. An orignal approach is proposed using a J-shaped omental flap created by the mobilization of the greater omentum and ascended through the retromesentric route to cover all the peri-pancreatic arteries at risk of bleeding after pancreatic resection.
Patient fulfilling eligibility criteria will be enrolled during a selection visit (V0) which may take place 45 days and up to 1 day prior PD surgery. Patient will be randomized intra-operatively either in the experimental arm or the control arm for allocation the omental covering technique.
After surgery, the following visits will be planned for the patient follow up:
* V2: End of hospitalization visit which can be done up to 1 day prior discharge.
* V3: POD 45 (±15) days which will take place at the hospital.
* Vai: Additional visit which may take place if the patient is readmitted for postoperative complication. Those visits may take place between V2 and V4 up to 1 day prior discharge.
* V4: POD 90 (±15) days is the end of study visit. It will take place at the hospital.
During those visits, data will be collected to validate the primary and secondary endpoints of the trial. | Inclusion Criteria:
* Age ≥ 18 years
* Patients requiring a pancreaticoduodenectomy (PD) for any indication
* Open approach
* Affiliation to the French public healthcare insurance
* Fistula risk score (FRS) ≥ 7 confirmed intraoperatively
* Ability to understand and to comply with the study protocol
* Reconstruction with PJ and external pancreatic stent
* Signed written informed consent
* Inclusion is allowed for patients:
* On curative or long-term anticoagulation or aspirin (indicated for previous thromboembolic complications, heart disease, previous history of stroke)
* Undergoing PD with venous resection
Exclusion Criteria:
* Presence of distant tumor deposits (liver and peritoneal metastases, and/or para-aortic lymph nodes metastases) reveals during intraoperative exploration for patient with malignant pancreatic or periampullary tumor.
* Patients with previous abdominal surgery compromising completion of retromesenteric omentoplasty
* PD with arterial resection (i.e. resection of hepatic artery, splenic artery, superior mesenteric artery, or celiac axis)
* Laparoscopic or robotic PD
* Reconstruction wih pancreatico-gastrostomy
* Total pancreatectomy
* Emergency procedure
* Pregnant women
* Patient under guardianship and curatorship
* Participation in another interventional study evaluating complication after pancreaticoduodenectomy or patient still being in the exclusion period at the end of a previous study evaluating drugs. | Assistance Publique - Hôpitaux de Paris | OTHER | {
"id": "APHP220823",
"link": null,
"type": null
} | Unknown | {
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} | 2023-08-08T00:00:00 | {
"date": "2024-02-16",
"type": "ACTUAL"
} | {
"date": "2023-08-15",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "National, Phase IIIb multicenter, centrally randomized open-label trial with two parallel arms. Participants will be distributed between the two arms at a ratio (1:1).\n\nRandomization will be built by block of unequal size stratified by center and the prophylactic use of somatostatin/octreotide-Yes/No",
"maskingInfo": {
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} | [
"Pancreatectomy",
"Complication of Surgical Procedure"
] | ["Pancreaticoduodenectomy", "Post-pancreatectomy haemorrhage", "Omentoplasty", "Post-operative pancreatic fistula"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)",
"timeFrame": "From surgery to post-operative day 90"
}
],
"secondary": [
{
"description": null,
"measure": "Mortality",
"timeFrame": "From surgery to post-operative day 90"
},
{
"description": null,
"measure": "Overall Morbidity",
"timeFrame": "From surgery to post-operative day 90"
},
{
"description": null,
"measure": "Rate of grade B+C post-operative pancreatic fistula",
"timeFrame": "From post-operative day 3 to post-operative day 90"
},
{
"description": null,
"measure": "Rate of grade A post-pancreatectomy haemorrhage",
"timeFrame": "From surgery to post-operative day 90"
},
{
"description": null,
"measure": "Hospital readmission",
"timeFrame": "From end of initial hospital stay to post-operative day 90"
},
{
"description": null,
"measure": "Total duration of hospital stay",
"timeFrame": "From surgery to post-operative day 90"
},
{
"description": null,
"measure": "Rate of arterial pseudoaneurysm",
"timeFrame": "Performed at post-operative day 90"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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],
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]
} | null | {
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],
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} |
NCT00167557 | null | Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive Treatment | Tacrolimus Monotherapy in OLT Recipients With HCV Under Preemptive Treatment With Interferon and Ribavirin | None | INTERVENTIONAL | WITHDRAWN | 2005-09-09T00:00:00 | null | null | null | [
"PHASE4"
] | 0 | 18 | 70 | ALL | false | After a liver transplant, the hepatitis C virus (which destroyed one's own liver) eventually comes back. In many patients, this will eventually cause the loss of the new liver and can also confuse the doctors taking care of them because it is hard to tell the difference between one's body rejecting the new liver and hepatitis. This can cause serious treatment errors that can lead to more severe hepatitis or to rejection of the liver. Some of the drugs used to prevent rejection of one's new liver can cause the hepatitis to come back in a more severe form. This is especially true for the drugs known as corticosteroids.
Right now, the only effective treatment against hepatitis C is a combination of two drugs called interferon and ribavirin. These drugs act by strengthening one's immune system to fight the virus and by directly reducing the reproduction of the virus. Because the treatment with these drugs is associated with many side effects, there is little experience with treating patients after liver transplantation with them.
In the investigators' transplant program, they have decided to treat all patients with hepatitis C as early as possible after transplantation and to follow them closely for the development of hepatitis and side effects of the treatment. The investigators treat one's hepatitis as early as possible, before any actual damage has occurred in the new liver. This approach has been tried before but it has been hard to tell if it has worked or not. The main reason for failure was that many patients could not complete the treatment due to side effects. The investigators' purpose is to treat those side effects aggressively so that most patients can complete the treatment course.
The purpose of this study is to collect all the data regarding the investigators' treatment protocol so that they will be able to learn if this form of treatment is beneficial.
The study includes performing liver biopsies at scheduled times after one's liver transplant and for scheduled blood tests to see how much virus is still in the blood. If patients show signs that they are not responding to treatment they will be removed from the study. | HCV recurs in the transplanted liver almost invariably. The clinical course is variable and ranges from no hepatitis to severe aggressive hepatitis with cirrhosis. Factors that affect outcome are high viral load prior to OLT, genotype, and immunosuppressive regimen. Recent studies indicate that the severity of recurrence is increasing with longer follow up, and longevity of both graft and patient is compromised by HCV. Viral load appears to be particularly affected by corticosteroids. The impact of mycophenolate mofetil and tacrolimus is not certain. The results of re-transplantation are generally poor and seem to be a non-cost beneficial way to deal with recurrence HCV cirrhosis. Additionally, re-transplantation deprives other patients from getting OLT in a timely fashion.
Recent studies have shown that with intensive alpha interferon and ribavirin treatment, up to 40% of patients can be cleared of virus as measured by PCR. Thus, despite the cost and side effects of this treatment, it appears justified to treat recurrence preemptively.
Due to the deleterious effects of high dose Corticosteroids it seems logical to attempt to withdraw them as soon as possible from treatment. MMF is often incompatible with interferon and ribavirin treatment due to leukopenia and anemia. The same is true for sirolimus. Thus, most patients will eventually be treated with Tacrolimus monotherapy. Presently, numerous patients end up being treated with Tacrolimus monotherapy as part of the reduction in immune suppression, which occurs over time. There is, however, very little prospective data regarding Tacrolimus monotherapy and almost no data on the specific issue of monotherapy in HCV patients. Even less is known with respect to this type of treatment while using interferon and ribavirin.
Our purpose in this protocol is to examine both the effect of preemptive antiviral treatment on recurrent HCV and the effect of Tacrolimus monotherapy in this setting. This may be important as more and more programs are turning to preemptive anti viral treatment and the issue of appropriate immune suppression becomes seminal to this discussion.
Aims
1. To determine the safety and efficacy of PEG interferon and ribavirin in the treatment of HCV recurrence after OLT.
2. To determine the effectiveness and safety of maintenance dose of PEG interferon to delay progression of fibrosis and histologic damage, in non-responders to the initial regimen of PEG interferon and ribavirin.
3. To determine the effect of early prednisone withdrawal in the rate of response to treatment with PEG interferon and ribavirin.
4. To assess the feasibility of Tacrolimus monotherapy in patients undergoing treatment for HCV recurrence post transplant. | Inclusion Criteria:
1. Adult male or female patients between 18 and 70 years of age
2. All liver transplant patients with a positive HCV RNA by PCR within 30 days after transplant.
3. No evidence of acute or chronic rejection within 4 weeks of enrollment
4. Compensated liver disease according to the following criteria:
* Hemoglobin \> 10 gm/dL;
* Neutrophil count \> 1,000/mm3;
* Platelet count \> 50,000/mm3;
* Serum creatinine \< 2.0 mg/dL.
5. Documentation of adequate contraception in females and males sexually active or of childbearing potential.
Exclusion Criteria:
1. Hypersensitivity to alpha interferon and/or ribavirin
2. Previous treatment with interferon and/or ribavirin post liver transplantation
3. HIV
4. Autoimmune hepatitis
5. Active alcohol or substance abuse
6. Non compliance
7. Hemoglobinopathies or hemolytic anemia
8. Clinical significant retinal abnormalities
9. Decompensated cardio-vascular, endocrine, pulmonary, renal, immune, metabolic, dermatologic or psychiatric illness
10. Re-transplantation | The University of Texas Health Science Center, Houston | OTHER | {
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"link": null,
"type": null
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"class": "INDUSTRY",
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NCT01727557 | null | Anesthetic Technique for AV Fistulae Creation | null | None | INTERVENTIONAL | TERMINATED | 2012-06-08T00:00:00 | null | 2016-07-15T00:00:00 | 2016-07-15T00:00:00 | [
"NA"
] | 10 | 21 | 70 | ALL | false | This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques. | The primary objectives of the study are:
1. To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula.
2. To evaluate the immediate (within 3 days) and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia.
The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia). | Inclusion Criteria:
* Age 21-70 years old
* Able to give informed consent
* Creation of first time AV fistula
* Possible 3 month follow up visit
* ASA-I-IV
Exclusion Criteria:
* BMI ≥40
* Repeated AV fistula creation,
* ASA -V,
* Allergic to local anesthetic agents,
* Significant lung and cardiac disease,
* Infection at the site of regional anesthesia,
* Pre-existing peripheral nerve damage,
* Significant bleeding disorders, | Montefiore Medical Center | OTHER | {
"id": "11-08-302",
"link": null,
"type": null
} | Low Accural Rate | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-11-15T00:00:00 | {
"date": "2018-03-05",
"type": "ACTUAL"
} | {
"date": "2012-11-16",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"End Stage Renal Failure on Dialysis"
] | ["Hemodialysis and AV fistula"] | null | [
{
"city": "Bronx",
"country": "United States",
"facility": "Montefiore Medical Center",
"geoPoint": {
"lat": 40.84985,
"lon": -73.86641
},
"state": "New York"
}
] | null | null | {
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{
"description": null,
"measure": "AV fistula success rate",
"timeFrame": "Three months from the day of creation"
}
],
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"description": null,
"measure": "Short term comfort level",
"timeFrame": "Within three days of procedure"
},
{
"description": null,
"measure": "Short term safety, number of post operative complications",
"timeFrame": "Three days after the creation"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"id": "D051437",
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{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
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"name": "All Conditions"
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"abbrev": "BC14",
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],
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NCT06641557 | null | A Phase I Dosing Study of IkT-148009. | A Phase I, 7-Day Dosing Study of 200 Mg IkT-148009 to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers | None | INTERVENTIONAL | COMPLETED | 2024-09-12T00:00:00 | null | 2023-03-21T00:00:00 | 2023-04-19T00:00:00 | [
"PHASE1"
] | 6 | 45 | 70 | ALL | true | This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules. | This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.
This is a single arm study with subjects to treatment with IkT-148009 only. The study will consist of a total of up to 15 visits over a period of up to 29 days prior to dosing, 7 days of dosing and 14 days of follow up.
Subjects will receive a single daily dose of study drug with a meal for a period of up to 7 days. A full breakfast must be consumed prior to receiving the dose study drug. Subjects will be confined to the unit for approximately 12 days. | Inclusion Criteria:
* 1. Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
2. Men or women aged 45 to 70 years at screening (both inclusive) of any race. 3. Subjects must be otherwise healthy and ambulatory, with no history or evidence of clinically relevant medical disorders 4. Mini Mental State Examination (MMSE) ≥ 28 5. Physical examination, clinical laboratory values, vital signs, and the electrocardiogram (ECGs) are clinically acceptable to the Investigator. Body weight ≥ 45 kg. Body Mass Index (BMI) ≥ 18 and ≤33 kg/m2.
6. Female subjects must be postmenopausal or surgically sterile or sterile for other medical reason.
7. Male subjects must agree to practice an acceptable method of highly effective birth control.
8. Males must be willing to abstain from sperm donation from the screening visit, while on study and through 30 days after receiving the last dose of study drug.
Exclusion Criteria:
* 1. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits.
2. Clinically significant abnormal findings on physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits.
3. Significant history (within six months prior to receiving the study drug) and/or presence of clinically significant medical, surgical or psychiatric disorder in the judgement of the investigator.
4. History of clinically significant problems in the retina as reported by a subject
5. eGFR \< 60 mg/mL
6. Creatinine, Amylase and/or Lipase \> ULN
7. Any malignancy in the 5 years prior to screening excluding basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.
8. Any subject with a history, presence and/or current evidence of serologic positive result for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies 1 or 2. Subjects considered to be cured for hepatitis C will be eligible.
9. Recent history (within previous six months prior to screening) of alcohol or drug abuse (as judged by the investigator) or has consumed \> 2 alcohol drinks/day during the last three months prior to screening.
10. Any subject with known hypersensitivity to IkT-148009. 11. Donation of blood, plasma, or acute loss of blood within 60 days prior to screening visit.
12. Use of tobacco or nicotine-containing products during the 60 days prior to screening and for the duration of the study.
13. Any subject who has received treatment with an investigational drug during the 30 days prior to screening.
14. Investigative site personnel or their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
15. Any subject unwilling or unable to comply with study procedures. | ABLi Therapeutics, Inc. | INDUSTRY | {
"id": "IkT-148009-102",
"link": null,
"type": null
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"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-10-10T00:00:00 | {
"date": "2025-03-11",
"type": "ACTUAL"
} | {
"date": "2024-10-15",
"type": "ACTUAL"
} | [
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"OLDER_ADULT"
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"maskingDescription": null,
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"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Healthy"
] | null | null | [
{
"city": "Lincoln",
"country": "United States",
"facility": "Celerion",
"geoPoint": {
"lat": 40.8,
"lon": -96.66696
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"state": "Nebraska"
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Participant Safety",
"timeFrame": "Through study completion, an average of 50 days"
},
{
"description": null,
"measure": "Participant Safety - vital signs",
"timeFrame": "Through study completion, an average of 50 days"
},
{
"description": null,
"measure": "Participant Safety - clinical lab values",
"timeFrame": "Through study completion, an average of 50 days"
},
{
"description": null,
"measure": "Participant Safety",
"timeFrame": "Through study completion, an average of 50 days"
},
{
"description": null,
"measure": "Participant Safety",
"timeFrame": "Through study completion, an average of 50 days"
},
{
"description": null,
"measure": "Participant Tolerability",
"timeFrame": "Through study completion, an average of 50 days"
},
{
"description": null,
"measure": "Assess the pharmacokinetics (PK) of IkT-148009",
"timeFrame": "Through study completion, an average of 50 days"
},
{
"description": null,
"measure": "Assess the pharmacokinetics (PK) of IkT-148009",
"timeFrame": "Through study completion, an average of 50 days"
},
{
"description": null,
"measure": "Assess the pharmacokinetics (PK) of IkT-148009",
"timeFrame": "Through study completion, an average of 50 days"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT05154357 | null | The Effect of Elastic Sac on Feeding | The Effect Of Elastic Sac On Physıological Characteristic And Feeding Performance In Preterm Infants | None | INTERVENTIONAL | COMPLETED | 2021-11-05T00:00:00 | null | 2022-05-03T00:00:00 | 2022-07-05T00:00:00 | [
"NA"
] | 26 | 32 | 40 | ALL | true | The study will be conducted using the crossover randomized controlled method. Preterm infants who began oral feeding from the neonatal intensive care unit will be divided into two groups through randomization in the computer environment. Following the randomization, infants in Group 1 will be fed by applying ''elastic sac'' at the first feeding hour after they are included in the study and in the next feeding they will be fed without performing any application. Infants in Group 2 will be fed without performing any application at the first feeding hour after they are included in the study and they will be fed at the second feeding hour by applying ''elastic sac''. Infants in both groups will be fed by the researcher with a bottle in a semi-fowler right lateral position during feeding hours. During feeding, the effect of the elastic sac on the infant's feeding status and physiological parameters will be evaluated. | Swaddling method is a method which can be used for preserving thermoregulation, decreasing stress and maintaining comfort in term and preterm infants during painful procedures. The effect of the ''elastic sac'' method which is thought to imitate the uterus environment, on physiological parameters and feeding performance of infants during feeding will be evaluated. The ''elastic sac'' method will be applied with 100% cotton and elastic fabric. The single-use elastic and cotton fabric was sewed as a U-shaped sac for each infant included in the study. The infant will be placed in the sac during the feeding hour and will be placed in a position in which he/she can move easily, maintain the flexion posture and feel safe contrary to traditional swaddling. The purpose of the study is to evaluate stress-associated physiological parameters and feeding status during oral feeding in preterm infants starting oral feeding. The study will be conducted using the crossover randomized controlled method. The sample size of the study was determined via the power analysis in accordance with the results obtained from studies conducted via a similar research method. According to the results of the analyses, a total of 26 preterm infants including 13 for each group will be included in the study group. After informing the families of infants meeting the inclusion criteria both in written and oral forms, the study will be conducted with mothers who agree to participate in the study and their infants.
Application Stages GROUP 1
1. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen saturation will be recorded in the observation form. The infant will be placed in the ''elastic sac'' and the angle of the incubator bed will be elevated 45 degrees. He/she will be laid in the right lateral position within the nest and will be allowed to take a rest within the ''elastic sac'' until the feeding time (30 minutes). Giving priority to breast milk, formula milk at optimum temperature will be prepared for infants without breast milk. The nutrient amount ordered by the doctor will be put in the bottle. Ten minutes before the feeding time, the infant's heart rate and oxygen saturation will be recorded in the observation form every two minutes. At the feeding time, the bottle will be approached to the infant's mouth for feeding in the semi-fowler right lateral position at 45 degrees without making any change in his/her posture. As soon as the infant begins to suck, the chronometer will be started and the infant's heart rate and oxygen saturation will be recorded by another observer nurse every two minutes throughout feeding. When the infant shows signs of fatigue (Spo2 less than 90, HR higher than 160), the feeding will be discontinued and when the infant's HR fall below 160 and spO2 increases above 90, the feeding will continue. The time of feeding will be limited to a maximum of 30 minutes. When the infant stops feeding, the chronometer will be stopped, the feeding will be terminated and the infant will be allowed to take a rest. His/her heart rate and oxygen saturation will be recorded in the observation form every two minutes for ten minutes. Then, the ''elastic sac'' application will be terminated and an onesie will be put on the infant in line with the care procedures of the clinic and he/she will be allowed to take a rest until the next feeding hour. The amount (cc) of milk the infant receives from the ordered amount of the milk and the amount of nutrient he/she receives in a minute will be calculated and recorded in the observation form.
2. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen saturation will be recorded in the observation form. The angle of the incubator bed will be elevated 45 degrees. Only an onesie will be put on the infant in line with the care procedures of the clinic and no other application will be performed. He/she will be laid in the right lateral position within the nest and will be allowed to take a rest until the feeding time. In order to feed him/her the same nutrient at both feeding hours, the same nutrient prepared at the previous feeding hour will be prepared at optimum temperature. The nutrient amount ordered by the doctor will be put in the bottle. Ten minutes before the feeding hour, the infant's heart rate and oxygen saturation will be recorded in the observation form every two minutes. At the feeding hour, the bottle will be approached to the infant's mouth for feeding in the semi-fowler right lateral position at 45 degrees without making any change in his/her position. As soon as the infant begins to suck, the chronometer will be started and the infant's heart rate and oxygen saturation will be recorded by another observer nurse every two minutes throughout feeding. When the infant shows signs of fatigue (Spo2 less than 90, HR higher than 160), the feeding will be discontinued and when the infant's HR falls below 160 and spO2 increases above 90, the feeding will continue. The time of feeding will be limited to a maximum of 30 minutes. When the infant stops feeding, the chronometer will be stopped, the feeding will be terminated and the infant will be allowed to take a rest. His/her heart rate and oxygen saturation will be recorded in the observation form every two minutes for ten minutes. The infant will be allowed to take a rest in line with the care procedures of the clinic. The amount (cc) of milk the infant receives from the ordered amount of the milk and the amount of nutrient he/she receives in a minute will be calculated and recorded in the observation form.
GROUP 2
1. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen saturation will be recorded in the observation form. The angle of the incubator bed will be elevated 45 degrees. Only an onesie will be put on the infant in line with the care procedures of the clinic and no other application will be performed. He/she will be laid in the right lateral position within the nest and will be allowed to take a rest until the feeding time (30 minutes). Giving priority to breast milk, formula milk at optimum temperature will be prepared for infants without breast milk. The nutrient amount ordered by the doctor will be put in the bottle. Ten minutes before the feeding hour, the infant's heart rate and oxygen saturation will be recorded in the observation form every two minutes. At the feeding hour, the bottle will be approached to the infant's mouth for feeding in the semi-fowler right lateral position at 45 degrees without making any change in his/her position. As soon as the infant begins to suck, the chronometer will be started and the infant's heart rate and oxygen saturation will be recorded by another observer nurse every two minutes throughout feeding. When the infant shows signs of fatigue (Spo2 less than 90, HR higher than 160), the feeding will be discontinued and when the infant's HR falls below 160 and spO2 increases above 90, the feeding will continue. The time of feeding will be limited to a maximum of 30 minutes. When the infant stops feeding, the chronometer will be stopped, the feeding will be terminated and the infant will be allowed to take a rest. His/her heart rate and oxygen saturation will be recorded in the observation form every two minutes for ten minutes. The infant will be allowed to take a rest until the next feeding hour in line with the care procedures of the clinic. Amount (cc) of milk the infant receives from the ordered amount of the milk and the amount of nutrient he/she receives in a minute will be calculated and recorded in the record form.
2. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen saturation will be recorded in the observation form. The infant will be placed in the ''elastic sac'' and the angle of the incubator bed will be elevated 45 degrees. He/she will be laid in the right lateral position within the nest and will be allowed to take a rest within the elastic sac until the feeding time. In order to feed him/her the same nutrient at both feeding hours, the same nutrient prepared during the previous feeding hour will be prepared at optimum temperature. The nutrient amount ordered by the doctor will be put in the bottle. Ten minutes before the feeding time, the infant's heart rate and oxygen saturation will be recorded in the observation form every two minutes. At the feeding time, the bottle will be approached to the infant's mouth for feeding in the semi-fowler right lateral position at 45 degrees without making any change in his/her position. As soon as the infant begins to suck, the chronometer will be started and the infant's heart rate and oxygen saturation will be recorded by another observer nurse every two minutes throughout feeding. When the infant shows signs of fatigue (Spo2 less than 90, HR higher than 160), the feeding will be discontinued and when the infant's HR falls below 160 and spO2 increases above 90, the feeding will continue. The time of feeding will be limited to a maximum of 30 minutes. When the infant stops feeding, the chronometer will be stopped, the feeding will be terminated and the infant will be allowed to take a rest. His/her heart rate and oxygen saturation will be recorded in the observation form every two minutes for ten minutes. Then, the ''elastic sac'' application will be terminated and he/she will be allowed to take a rest in line with the care procedures of the clinic. The amount (cc) of milk the infant receives from the ordered amount of the milk and the amount of nutrient he/she receives in a minute will be calculated and recorded in the observation form. | Criteria Inclusion Criteria
* Parent agreeing to take part in the study
* Infant starting oral feeding by the doctor in the neonatal intensive care unit and tolerating it
* Infant born at 26-36+6 gestational week specified according to the last menstruation date of the mother
* Infant being at 32-39+6 postmenstrual week
* Infant having a body weight of 1500 grams and above
* Infant being fed orally once before and tolerating it
* Infant having no health problem except for being a preterm
Exclusion Criteria
* Infant having a gastrointestinal, neurological or genetic illness (such as necrotizing enterocolitis, intracranial bleeding, hydrocephaly, omophalocele, down's syndrome, gastroschisis) and other illnesses
* Infant having no obstacle to oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial anomaly)
* Infant being on oxygen support | Istanbul University - Cerrahpasa | OTHER | {
"id": "E-74555795-050.01.04-88001",
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"Oxygen Saturation",
"Heart Rate",
"Nutritional Status"
] | ["Heart rate", "Oxygen Saturation", "Preterm Infants", "Safe Swaddling"] | null | [
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"facility": "Istanbul University, Cerrahpaşa",
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NCT01731457 | null | Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function | Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function | None | INTERVENTIONAL | COMPLETED | 2012-11-15T00:00:00 | null | null | null | [
"PHASE2"
] | 94 | 18 | null | ALL | false | The aims of this study are:
1. assessment of ischemia injury of kidney retrieved from standard and expanded criteria deceased donor before transplantation
2. assessment of efficacy of kidney ischemia injury decreasing
3. assessment of influence of kidney ischemia injury decreasing on its function after transplantation For the purpose of this research one hundred kidney will be retrieved from deceased donors (standard and expanded criteria deceased donors) for transplantation. All kidneys before transplantation will be stored in machine perfusion in hypothermia with continuous flow - Organ Recovery Systems LifePort - each single kidney in self-contained perfusion system.
For the kidney allograft assessment will be used measurements performed during machine perfusion in hypothermia: renal flow, resistance, lactate dehydrogenase, lactates and ischemia injury markers measured in the fourth hour of perfusion in perfusion fluid.
For kidney ischemia injury assessment such markers will be measured: tumour necrosis factor (TNF alfa), interleukin 2 (IL-2), interleukin 6 (IL-6), high sensitivity C-reactive protein (hsCRP), platelet-derived growth factor (PDGF), cystatin C, kidney Injury Molecule (KIM-1), neutrophil Gelatinase-associated Lipocalin (NGAL), complement component C3, caspase 3.
Every time from pair of retrieved kidneys each kidney will be randomise for one of the group:
* group 1) - 50 kidneys - examined group - "cured" with etanercept (ENBREL) in the first hour of perfusion by adding drug to perfusion fluid,
* group 2) - 50 kidneys - control group - without intervention. Ischemia injury markers will be measured in perfusion fluid by kidney two times (in the first and fourth hour of perfusion) for assessment of efficacy kidney ischemia injury decreasing.
Results of measurements of kidney ischemia injury before transplantation, parameters during machine perfusion in hypothermia and donor parameters will be correlated with kidney allograft function post transplantation.
Immediate, delayed and slow graft function, primary non-function, kidney function assessed by creatinine concentration and creatinine clearance at one day, seven days, two weeks, 1, 6 and 12 months post transplantation and kidney graft survival 6 and 12 months post transplantation will be analysed. | null | Inclusion Criteria:
DONOR STAGE
* donor after brain death
* seronegative HCV (hepatitis C virus)
* procurement of two kidneys from the same donor
* donor center distance up to 220 kilometres from Warsaw
* availability of fluid KPS-1 and cartridge of Organ Recovery System
RECIPIENT STAGE
* recipient of kidneys from deceased donor
* at least eighteen recipient
* expression of informed consent
Exclusion Criteria:
DONOR STAGE
* live kidney donor
* seropositive HCV (hepatitis C virus)
* get only one from the kidneys
* "doubtful" donor - e.g. need for biopsy because of proteinuria or due to histological lesions (e.g. tumor)
* donor center distance above 220 kilometres from Warsaw
* lack of fluid KPS-1 and cartridge of Organ Recovery System
RECIPIENT STAGE
* recipient of kidney form living donor
* minor recipient
* no expression of informed consent
* multiple organ recipient
* recipient "EN BLOC" kidneys or two kidneys
* recipient of kidney from donor under 14 years old
* a need of atypical urinary diversion in kidney recipient
* participation in another study at least in the last 30 days | Medical University of Warsaw | OTHER | {
"id": "N N403 589338-WUM-PD-Poland",
"link": null,
"type": null
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} | 2012-11-15T00:00:00 | {
"date": "2017-05-10",
"type": "ACTUAL"
} | {
"date": "2012-11-21",
"type": "ESTIMATED"
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"Transplanted Kidney Ischemia Reperfusion Injury"
] | ["ischemia, reperfusion, kidney, transplantation"] | null | [
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"country": "Poland",
"facility": "Department of General Surgery and Transplantation",
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"lat": 52.22977,
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"state": "Mazowieckie"
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"description": null,
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"timeFrame": "one week"
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{
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"measure": "12 months graft survival",
"timeFrame": "12 months"
}
],
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"measure": "acute rejection",
"timeFrame": "12 months"
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{
"description": null,
"measure": "kidney ischemia injury assessment",
"timeFrame": "4 hours"
}
]
} | [
{
"affiliation": "Medical University of Warsaw",
"name": "Piotr Domagala, MD, PhD",
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NCT03983057 | null | Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer | Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial | None | INTERVENTIONAL | UNKNOWN | 2019-06-05T00:00:00 | null | 2023-12-01T00:00:00 | 2024-12-01T00:00:00 | [
"PHASE3"
] | 830 | 18 | 70 | ALL | false | The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with borderline resectable and locally advanced pancreatic cancer. | Investigators chose borderline resectable and locally advanced pancreatic cancer patients. The planned treatment was given to the participants after randomization. Response rate, recurrence-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with borderline resectable and locally advanced pancreatic cancer. | Inclusion Criteria:
* Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
* No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
* Initial assessment for definitive borderline resectable or locally advanced tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2019 first edition standard).
* ECOG score 0 or 1.
* Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
* ALT and AST are less than 2 x ULN.
* If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.
* Leukocyte count (\> 3.5 x 10\^6 /mL), neutrophil count (\> 1.5 x 10\^6 /mL), platelet count (\> 80 x 10\^6 /mL), hemoglobin (\> 9 g/dL).
* Signed informed consent.
Exclusion Criteria:
* History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
* History of participation of other clinical trails within 4 weeks
* History of immunotherapy within 4 weeks
* History of receiving chemotherapy, radiotherapy and molecular target therapy within 2 weeks
* Tumor is a local recurrent lesion.
* Imaging confirmed severe portal hypertension / cavernous transformation.
* Ascites
* Gastric outlet obstruction
* Respiratory failure requires supplementation of oxygen.
* Immune deficiency syndrome, such as active tuberculosis and HIV infection.
* Hematological precancerous diseases, such as myelodysplastic syndromes.
* Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
* Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
* Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
* Preexisting neuropathy \> 1 (NCI CTCAE).
* Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
* Severe serious wounds, ulcers or fractures.
* Confirmed coagulant disease.
* Clinical evaluation is unacceptable. | Zhejiang University | OTHER | {
"id": "CISPD-4",
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"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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"date": "2023-06-13",
"type": "ACTUAL"
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"date": "2019-06-12",
"type": "ACTUAL"
} | [
"ADULT",
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} | [
"Pancreatic Cancer"
] | ["Pancreatic cancer", "PD-1", "FOLFIRINOX", "combination therapy"] | null | [
{
"city": "Hangzhou",
"country": "China",
"facility": "the First Affiliated Hospital, School of Medicine, Zhejiang University",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
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"state": "Zhejiang"
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] | null | null | {
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"description": null,
"measure": "Progression-free survival",
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],
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"timeFrame": "Through the study peirod, for 3 years"
},
{
"description": null,
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"timeFrame": "Through the study peirod, for 3 years"
},
{
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},
{
"description": null,
"measure": "Disease control rate",
"timeFrame": "Through the study peirod, for 3 years"
},
{
"description": null,
"measure": "Overall survival",
"timeFrame": "Through the study peirod, for 3 years"
},
{
"description": null,
"measure": "EORTC QLQ - PAN26 score",
"timeFrame": "Through the study peirod, for 3 years"
},
{
"description": null,
"measure": "Adverse effects",
"timeFrame": "Through the study peirod, for 3 years"
},
{
"description": null,
"measure": "Carbohydrate antigen 19-9",
"timeFrame": "Through the study peirod, for 3 years"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT03440957 | null | Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed | Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed Pilot Study | OSTEO | INTERVENTIONAL | COMPLETED | 2018-02-15T00:00:00 | null | 2020-02-02T00:00:00 | 2020-02-02T00:00:00 | [
"NA"
] | 22 | 18 | null | ALL | false | Staying confined in the bed is frequent at the end of life. The cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. This pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . The non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients. | null | Inclusion Criteria:
* Man or woman
* Aged 18 years or older
* Having signed informed consent to participate in the study
* Patient affiliated to a social security scheme
* Patient with pain affecting the musculoskeletal system following prolonged bed rest
* Capable to understand French
* Capable of completing self-assessment scales
Exclusion Criteria:
* Patients with bone metastases at risk for the use of osteopathy
* Patients under legal protection measures
* Patients with cognitive impairment preventing self-evaluation
* Patient who is considered too fragile or with a clinical condition too unstable by the doctor refer to be included in the study
* Patients in the pre-agonic or agonic phase | Hospices Civils de Lyon | OTHER | {
"id": "69HCL17_0723",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-02-15T00:00:00 | {
"date": "2022-07-14",
"type": "ACTUAL"
} | {
"date": "2018-02-22",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Cancer Patient Confined in the Bed"
] | ["advanced cancer", "osteopathy", "pain", "bedridden"] | null | [
{
"city": "Pierre-Bénite",
"country": "France",
"facility": "Hôpital Lyon Sud",
"geoPoint": {
"lat": 45.7009,
"lon": 4.82511
},
"state": null
}
] | null | null | {
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"primary": [
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"description": null,
"measure": "Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session",
"timeFrame": "15 days"
}
],
"secondary": [
{
"description": null,
"measure": "Decrease in analgesic consumption for pain related to immobilization",
"timeFrame": "15 days"
},
{
"description": null,
"measure": "Decreased 2 points of intensity of other symptoms associated before and after session measured with Edmonton Symptom Assessment System (ESAS).",
"timeFrame": "15 days"
}
]
} | [
{
"affiliation": "Hospices Civils de Lyon",
"name": "Marilène FILBET, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Pain"
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],
"meshes": [
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"id": "D000072716",
"term": "Cancer Pain"
}
]
} | null | {
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"id": "D000072716",
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NCT05124457 | null | DETERMINE: Detemir vs NPH | A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study | DETERMINE | INTERVENTIONAL | RECRUITING | 2021-10-25T00:00:00 | null | null | null | [
"PHASE2"
] | 336 | 18 | null | ALL | false | The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use. | Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions. | Inclusion Criteria:
* Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
Exclusion Criteria:
1. Multiple Gestation
2. Type 1 Diabetes mellatus
3. Age \< 18
4. Known or suspected hypersensitivity to NPH or insulin detemir
5. Known fetal major malformations
6. Chronic renal or hepatic insufficiency
7. Known to be HIV, Hepatitis B, or Hepatitis C positive
8. Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
9. Insulin dependent before conception | University of California, Los Angeles | OTHER | {
"id": "DETERMINE",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-11-05T00:00:00 | {
"date": "2023-09-26",
"type": "ACTUAL"
} | {
"date": "2021-11-18",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
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"maskingInfo": {
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} | [
"Gestational Diabetes",
"Diabetes Mellitus, Type 2"
] | null | null | [
{
"city": "Los Angeles",
"country": "United States",
"facility": "University of California, Los Angeles",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California"
}
] | null | null | {
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"description": null,
"measure": "Neonatal Hypoglycemia",
"timeFrame": "Within the first 24 hours of life"
},
{
"description": null,
"measure": "Prolonged neonatal hypoglycemia",
"timeFrame": "Neonatal hypoglycemia after the 1st 24 hours of life but before discharge"
}
],
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"description": null,
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"timeFrame": "At birth"
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"description": null,
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"timeFrame": "At birth"
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{
"description": null,
"measure": "Neonatal insulin level",
"timeFrame": "At birth"
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"measure": "Neonatal leptin level",
"timeFrame": "At birth"
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"description": null,
"measure": "Rates of pregnancy induced hypertension",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Mode of delivery",
"timeFrame": "At delivery"
},
{
"description": null,
"measure": "Gestational Age at delivery",
"timeFrame": "At delivery"
},
{
"description": null,
"measure": "Maternal glycemic control",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Total daily insulin",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Fetal anomolies",
"timeFrame": "At birth"
},
{
"description": null,
"measure": "Macrosomia",
"timeFrame": "At birth"
},
{
"description": null,
"measure": "Polyhydramnios",
"timeFrame": "At birth"
},
{
"description": null,
"measure": "Neonatal weight",
"timeFrame": "At birth"
},
{
"description": null,
"measure": "Need for supplemental oxygen",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Need for dextrose infusion in neonate",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Rates of respiratory distress syndrome",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "5 Minute APGAR",
"timeFrame": "At birth"
}
]
} | [
{
"affiliation": "University of California, Los Angeles",
"name": "Christina Han, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "University of California, Los Angeles",
"name": "Michael Richley, MD",
"role": "STUDY_DIRECTOR"
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] | [{"pmid": "26810997", "type": "BACKGROUND", "citation": "Coton SJ, Nazareth I, Petersen I. A cohort study of trends in the prevalence of pregestational diabetes in pregnancy recorded in UK general practice between 1995 and 2012. BMJ Open. 2016 Jan 25;6(1):e009494. doi: 10.1136/bmjopen-2015-009494."}, {"pmid": "28669379", "type": "BACKGROUND", "citation": "Melchior H, Kurch-Bek D, Mund M. The Prevalence of Gestational Diabetes. Dtsch Arztebl Int. 2017 Jul 16;114(24):412-418. doi: 10.3238/arztebl.2017.0412."}, {"pmid": "22851598", "type": "BACKGROUND", "citation": "Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brondsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. doi: 10.2337/dc11-2264. Epub 2012 Jul 30."}, {"pmid": "32396624", "type": "BACKGROUND", "citation": "Hirsch IB, Juneja R, Beals JM, Antalis CJ, Wright EE. The Evolution of Insulin and How it Informs Therapy and Treatment Choices. Endocr Rev. 2020 Oct 1;41(5):733-55. doi: 10.1210/endrev/bnaa015."}, {"pmid": "26070699", "type": "BACKGROUND", "citation": "Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9."}, {"pmid": "11924935", "type": "BACKGROUND", "citation": "Dalgic N, Ergenekon E, Soysal S, Koc E, Atalay Y, Gucuyener K. Transient neonatal hypoglycemia--long-term effects on neurodevelopmental outcome. J Pediatr Endocrinol Metab. 2002 Mar;15(3):319-24. doi: 10.1515/jpem.2002.15.3.319."}, {"pmid": "28156005", "type": "BACKGROUND", "citation": "O'Neill SM, Kenny LC, Khashan AS, West HM, Smyth RM, Kearney PM. Different insulin types and regimens for pregnant women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD011880. doi: 10.1002/14651858.CD011880.pub2."}, {"pmid": "31498869", "type": "BACKGROUND", "citation": "Kadakia R, Talbot O, Kuang A, Bain JR, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM, Lowe WL; HAPO Study Cooperative Research Group. Cord Blood Metabolomics: Association With Newborn Anthropometrics and C-Peptide Across Ancestries. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4459-4472. doi: 10.1210/jc.2019-00238."}, {"pmid": "28637888", "type": "BACKGROUND", "citation": "Lowe WL Jr, Bain JR, Nodzenski M, Reisetter AC, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM; HAPO Study Cooperative Research Group. Maternal BMI and Glycemia Impact the Fetal Metabolome. Diabetes Care. 2017 Jul;40(7):902-910. doi: 10.2337/dc16-2452."}, {"pmid": "33865836", "type": "BACKGROUND", "citation": "Fishel Bartal M, Ward C, Blackwell SC, Ashby Cornthwaite JA, Zhang C, Refuerzo JS, Pedroza C, Lee KH, Chauhan SP, Sibai BM. Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial. Am J Obstet Gynecol. 2021 Jul;225(1):87.e1-87.e10. doi: 10.1016/j.ajog.2021.04.223. Epub 2021 Apr 15."}, {"pmid": "31168280", "type": "BACKGROUND", "citation": "Chun J, Strong J, Urquhart S. Insulin Initiation and Titration in Patients With Type 2 Diabetes. Diabetes Spectr. 2019 May;32(2):104-111. doi: 10.2337/ds18-0005."}] | {"versionHolder": "2025-06-18"} | {
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NCT06085157 | null | EMA and Content Analysis for Alcohol Marketing in Hong Kong In-school Adolescents | Snapshot Your Drinking: Ecological Momentary Assessment and Content Analysis for Alcohol Marketing in Hong Kong In-school Adolescents | None | OBSERVATIONAL | NOT_YET_RECRUITING | 2023-09-21T00:00:00 | null | 2025-05-31T00:00:00 | 2025-08-31T00:00:00 | null | 661 | 13 | 18 | ALL | true | The proposed study aims to assess adolescents' exposure to alcohol marketing and its effect on drinking attitudes and drinking behaviors.
The three main research questions:
1. Is exposure to alcohol marketing associated with drinking attitude (perceive popularity, perceive social approval, positive expectancies)?
2. What are the contents of alcohol marketing that establish the brand capital of alcohol beverages in Hong Kong?
3. Does the brand capital of alcohol beverages mediate the relationship between (a) exposure to alcohol marketing and drinking attitudes? (b) exposure to alcohol marketing and alcohol consumption? | Study design
The proposed project is a combination of a time-based system-triggered ecological momentary assessment (EMA), which will collect real-time exposure to alcohol marketing and alcohol consumption, and a longitudinal survey. Consented participants will first complete a baseline questionnaire, followed by completing 3 regularly prompted EMA surveys via smartphone application (APP) every day for 21 consecutive days. The EMA will include questions of self-report exposure, brand capital (marketing receptivity and brand recognition), and alcohol consumption. One month after the EMA period, a telephone follow-up will be conducted to understand participants' drinking attitude and alcohol consumption.
Setting and subjects
The inclusion criteria will include (1) aged 13 to 18, (2) studying in secondary schools, (3) own a mobile smartphone with internet access, (4) stay in Hong Kong during the EMA study period, and (5) being able to read and write Chinese. To increase statistical power in analyzing alcohol consumption, we will recruit one-third (about 220) of the participants who are ever drinkers. To avoid seasonal variation in the ad exposure and drinking pattern (i.e. more ads and drinking in festivals), the recruitment will be evenly distributed within a year.
Sample size determination
The sample size calculation is based on the multilevel modelling of the estimated effect of alcohol marketing exposure on alcohol consumption and drinking attitude, and the mediation effect of brand capital (Figure 1 in Appendix 1). The R package simsem, MASS and lavaan were used for sample size calculation with Monte Carlo simulation run for 1000 times. Parameters of the multilevel modeling used for simulation was based on our pilot study, which showed that 210 participants will be needed to reach the threshold of 80% power, the comparative fit index and the Tucker Lewis Index larger than 0.90, the standardized root mean square residual less than 0.08 and the root mean square error of approximation less than 0.05.32 We conservatively assume that one in three students will report any exposure to alcohol marketing, therefore we need 636 (210/0.33) students to join the study. According to our first pilot study, the dropout rate of the EMA was 3.9% (2/51). Hence, 661 participants will be needed.
Recruitment procedures
The investigators will conduct both offline and online recruitment. The investigators have collaborated with the Hong Kong Council on Smoking and Health (COSH) to organize the leadership training (the Smokefree Teen project) annually since 2015. The investigators will promote the study to the secondary school students (n=200) participating in this training camp. The investigators will also send invitation letters to the 451 government and subsidized secondary schools. After receiving the schools' consent to join the study, our research assistant will contact these schools to plan the recruitment methods, including the distribution of recruitment posters and leaflets to the students with the help from the cooperators, organization of talks or recruitment booths to recruit participants in those schools. In addition, online recruitment advertisements will be disseminated in online discussion boards and social media (e.g., Facebook, Instagram) that Hong Kong adolescents usually visit. Volunteer participants can directly contact our research staff via telephone, email or submit an online application form via a Quick Response (QR) code. First, all volunteer participants will receive a web link for eligibility screening. Then our research assistant will contact eligible students via a phone call, and invite them for a face-to-face or virtual meeting via WhatsApp or Zoom. If they choose virtual meeting, the research assistant will mail a package including an invitation letter, consent form, and a pre-stamped return envelope, and request them to send back the signed consent form with the participant's and parent's signature. Afterwards, the research assistant will assist them in completing the baseline questionnaire, app installation and using the app in the virtual meeting. If participants choose the face-to-face meeting, the research assistant will complete all study procedures in the meeting, and request the participants to send their parent's signed consent after the meeting. Our second pilot study found that both virtual and face-to-face meeting are feasible in secondary school students.
EMA App
An EMA app will be developed in both iPhone operating system (IOS) and Android platform to administer the regular prompts automatically. Our research assistant will assist participants to install the EMA App in their own smartphone after obtaining study consent. To protect the privacy of participants, no personal information will be collected via the app. Participants only need to impute a 5-digit case number (such as last 5 digits of phone number) as an identifier. Participants will use the App to complete 3 time-based EMA each day for 21 consecutive days. Two systematic reviews on the length of the study period of EMA in the underage showed that compliance can be optimal when participants were prompted to complete about 3 EMA per day within 1 week or more. Once the App is installed and logged in, the participants will be asked to choose a start date for the 21-day EMA study. To facilitate the EMA on school days when they cannot use smartphone all the time, participants can create custom schedule of the 3 EMA prompts. The time gap between any two prompts must be longer than 3 hours to capture more information within the participants' waking hours. The first, second, and third prompt must range from 11:00 am and 1:00 pm, 4:00 pm to 6:00 pm, and 9:00 pm to 11:00 pm, respectively. All data will be uploaded to our server at home office immediately after each EMA completion for further analysis. Only the project administrators can access the datasets in the server with login name and password.
Follow-up
To reduce reactive effect from EMA, all participants will be followed up via telephone 1 month after completing the EMA survey. The survey includes drinking attitude and alcohol consumption. Participants are also requested to rate their satisfaction on EMA App, frequency and content of the EMA survey by a 5-point Likert scale at the follow up.
Consent
Participation in the study is voluntary. The recruitment staff will first explain the project's details to the potential subjects who agree to join the study before seeking consent. The potential subjects will be assured that they can withdraw from the study anytime without any prejudice, and all the information will be kept confidential and results will be reported in an aggregate format. For participants who choose to complete the recruitment procedures virtually, a research assistant will mail them a package including an invitation letter, consent form, and a pre-stamped return envelope, and request that they send back the signed consent form with the theirs and their parent's signature. For participants who choose to complete the recruitment procedures face-to-face, the research assistant will obtain their signed consent in the meeting, and request that they send their parent's signed consent after the meeting.
Statistical analysis
In the 1st research question, ordered logistic regression will be used to examine the association between alcohol marketing exposure from EMA and drinking attitudes from the follow-up survey. In the 2nd research question, descriptive statistics about the themes of alcohol marketing content will be computed. Structural equation modeling will be conducted to examine the research question 3a and 3b. In research question 3a, we will use alcohol marketing exposure and brand capital from EMA, and drinking attitude from 1-month follow-up in the model. In research question 3b, We will use alcohol marketing exposure, brand capital, and alcohol consumption from the EMA in the model. To avoid reversal causality between alcohol marketing exposure and alcohol consumption in research question 3b, the lagged alcohol consumption will be regressed on the alcohol marketing exposure in the previous EMA. In models for 3a and 3b, autocorrelation will be detected and controlled for in this model. 95% confidence interval will be estimated by using bootstrapping with size 10,000. Chi-square (χ2), root mean square error of approximation (RMSEA), comparative Fit Index (CFI), and Tucker-Lewis Index (TLI) will be used to evaluate model fit. Rules of thumb guidelines are that p-value for χ2\>0.05, RMSEA≤.05, CFI≥0.95, and TLI≥0.95 represent a good fitting model. All data analysis will be conducted by using R (version 1.3.1073). All significant tests were two-sided with a 5% level of significance. | Inclusion Criteria:
1. aged 13 to 18
2. studying in secondary schools
3. own a mobile smartphone with internet access
4. stay in Hong Kong during the EMA study period
5. being able to read and write Chinese. | The University of Hong Kong | OTHER | {
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"timeFrame": "1 month follow-up"
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"measure": "Perceived social approval",
"timeFrame": "1 month follow-up"
},
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"description": null,
"measure": "Positive expectancies",
"timeFrame": "1 month follow-up"
},
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"measure": "Marketing receptivity",
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"measure": "Brand recognition",
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NCT05480657 | null | Safety, Tolerability, and Efficacy of Immunomodulation With AT-1501 in Combination With Transplanted Islet Cells in Adults With Brittle T1D | AT-1501-I206: An Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Transplanted Islet Cells and AT-1501 Immunomodulation in Adults With Brittle Type 1 Diabetes | None | INTERVENTIONAL | WITHDRAWN | 2022-07-27T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 0 | 18 | 65 | ALL | false | This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant. | This study will evaluate the safety, tolerability and efficacy of transplantation of experimental islet cells as a potential treatment for brittle type 1 diabetes mellitus. It will also assess the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with brittle T1D undergoing an islet cell transplant. This is a single arm open-label study and up to 6 participants will be recruited at a single center in the United States.
The objectives include:
* To assess the safety and tolerability of transplanted islet cells and immunomodulation with AT-1501, in combination (AT+) with rabbit anti-thymoglobulin (ATG), etanercept and mycophenolate mofetil (MMF/EC-MPS) in adults with T1D undergoing islet cell transplant.
* To assess the efficacy of transplanted islet cells and immunomodulation with AT-1501 in adults with brittle T1D undergoing islet cell transplant.
The duration of treatment may vary from participant to participant and could be up to 2 years. Participants may receive up to 2 islet cell transplants. | Inclusion Criteria:
* Men and women 18-65 years of age
* A diagnosis of T1D ≥5 years with onset of disease at \<40 years of age
* Involvement in appropriate diabetes management in accordance with the standard of care, as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to Screening; using an insulin pump or multiple daily injection (MDI) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of unexplained SHEs
* At least 3 unexplained SHEs not secondary to a missed meal or dosing error, in the 12 months prior to Screening
* Glycosylated hemoglobin (HbA1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive
* Absence of stimulated C peptide (\< 0.3 ng/mL) in response to a mixed meal tolerance test (MMTT) measured at 60 and 90 minutes after the start of consumption
* Impaired awareness of hypoglycemia (IAH) as defined by a Clarke Score \[Clarke 1995\] of 4 or more at the time of Screening, during the Screening period, and within the last 6 months prior to the transplant
Exclusion Criteria:
* Any previous solid organ or islet allotransplant
* Body mass index (BMI) \>30 kg/m2
* Insulin requirement \>1.0 unit/kg/day or \<15 units/day | Eledon Pharmaceuticals | INDUSTRY | {
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"date": "2022-07-29",
"type": "ACTUAL"
} | [
"ADULT",
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"facility": "University of Chicago",
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"state": "Illinois"
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"other": null,
"primary": [
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"description": null,
"measure": "Safety - Adverse Events (AE) and Adverse Events of Special Interest (AEoSI)",
"timeFrame": "Accessed from date of transplant through Day 364 post final transplant for approximately 2 years"
},
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"description": null,
"measure": "Efficacy - Insulin independence",
"timeFrame": "Date of transplant through Day 364 post- final transplant"
}
],
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"description": null,
"measure": "Efficacy - HbA1c",
"timeFrame": "Date of transplant through Day 364 post-final transplant"
},
{
"description": null,
"measure": "Efficacy - Graft failure",
"timeFrame": "Proportion of participants with graft failure at Day 364 post final transplant"
},
{
"description": null,
"measure": "Efficacy - Durability of insulin independence",
"timeFrame": "Date of transplant through Day 364 post final transplant"
},
{
"description": null,
"measure": "Efficacy - Durability of insulin independence - long term",
"timeFrame": "2 and 3 years after discontinuation of AT- 1501"
}
]
} | [
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"affiliation": "Eledon Pharmaceuticals",
"name": "Jeff Bornstein, MD",
"role": "STUDY_DIRECTOR"
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NCT03056157 | null | Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure | Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure | None | INTERVENTIONAL | COMPLETED | 2017-01-31T00:00:00 | null | 2021-11-30T00:00:00 | 2022-02-28T00:00:00 | [
"NA"
] | 174 | 18 | null | ALL | false | The aim of this study was to determine the efficacy of Adaptive Disclosure for Moral Injury and Loss (AD-MIL), a combat-specific psychotherapy for war-related PTSD stemming from Moral Injury (MI) and traumatic loss (TL) with Iraq and Afghanistan War Veterans with PTSD. AD-MIL will be compared to Present Centered Therapy (PCT). AD-MIL is a modified version of Adaptive Disclosure (AD), which has been modified and extended to solely treat MI and TL by targeting psychological and behavioral obstacles to occupational, relationship, and family functioning, as well as quality of life. PCT is a manualized evidenced-based PTSD treatment used to address functioning problems in several large-scale PTSD trials. The primary end-point was psychosocial functioning (improvements in social, educational and occupational functions). Secondary end-points included PTSD, depression, moral emotions (anger, shame, and guilt), alcohol use, self-compassion, and mindful/valued living. | The investigators conducted a multi-site randomized trial comparing Adaptive Disclosure for Moral Injury and Loss (AD-MIL; an expanded version of Adaptive Disclosure) for war-related PTSD stemming from Moral Injury (MI) and traumatic loss (TL) to Present Centered Therapy (PCT; Frost et al., 2014). The primary endpoint was psychosocial functioning. The investigators had six hypotheses:
A: Functional and behavioral changes:
A.1. Immediately post-treatment, and 3- and 6-months post-treatment, Veterans with PTSD randomized to AD-MIL will have greater reductions in social, educational, and occupational disability.
A.2. COVID-19 aim. In the extended time period for the trial, at the post-treatment, or post-treatment and 3-months post-treatment intervals (depending on when the participant was randomized), Veterans with PTSD randomized to AD-MIL will have greater reductions in social, educational and occupational disability (the investigators also explored whether there would be greater PTSD and depression symptom reduction in this interval).
B: Mental health changes:
B.3. AD-MIL will lead to greater reductions in PTSD symptom severity and a smaller percentage of PTSD cases.
B.4. AD-MIL will lead to greater reductions in depressive symptoms. B.5. AD-MIL will lead to greater reductions in shame and guilt B.6. AD-MIL will lead to greater reductions in psychological distress.
Exploratory hypotheses: AD-MIL will lead to greater reductions in aggressive behaviors, suicidal ideation, and alcohol use, and greater increases in compassion for the self and others and social connectedness.
BACKGROUND PTSD is a functionally disabling condition among war Veterans. Approximately 20% of Veterans of post-9-11 operations have clinically significant PTSD and suffer from a variety of co-morbid mental and physical health conditions. They also have extensive functional impairments, aggressive and risky behaviors, and reduced quality of life. Although considerable gains have been made in the VA's dissemination of PTSD treatments that are highly effective with civilian trauma, these therapies have been shown to work considerably less well for war trauma. The investigators have argued that this is partly due to a lack of attention to the military culture and warrior ethos and the unique harms of war trauma, namely, moral injury (MI) and traumatic loss (TL). In addition, PTSD treatments have failed to demonstrate an impact on functioning and quality of life, problems that are no less impacted by the warzone trauma. Instead, symptom change is typically the sole metric of success, and functional deficits are rarely considered. The investigators argue that PTSD symptoms should be conceptualized and targeted as part of the fabric of the whole Veteran and his or her context. The investigators aimed to fill a care-gap in the VA by creating an evidence-based treatment for war-related PTSD stemming from MI and TL, focusing on improving psychosocial functioning. The investigators extended Adaptive Disclosure to treat MI and TL (AD-MIL) by: (1) facilitating emotional-processing of TL and MIs and a healing and action plan by letter writing tasks to the lost person or, depending on the nature of the MI, the person or persons harmed by transgressive acts (MI stemming from personal actions or the failure to act) or the person or persons who were the transgressors (MI stemming from being the victim of others' transgressions or bearing witness to grave transgressive acts); (2) skills training and behavioral contracting to improve functioning and targeting MI- and TL-related psychological and behavioral obstacles to habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. If found to be effective, AD-MIL will fill a care-gap in the VA, reduce PTSD patients' suffering, and help Veterans reclaim or establish positive relationships, work roles, and self-care routines.
METHOD Overview: The VA sites were Boston, Minneapolis, San Francisco, San Diego, and Central Texas. The coordinating/lead site was VA Boston led by the study PI, Brett Litz, PhD. The trial followed the consensus recommendations for clinical trials in the VA (VA ORD, 2008): (1) clearly defined target symptoms: functional and clinical outcomes were operationalized; (2) reliable and valid measures: assessment tools were selected for their content relevance and psychometric properties; (3) use of blind evaluators of outcome: the evaluator was independent and blind to treatment condition. This assessor reminded participants to help maintain their blind; (4) assessor training: the independent evaluator was carefully trained to criteria and monitored on an ongoing basis; (5) manualized, replicable, specific treatment programs; (6) there was unbiased assignment to treatment arms and (7) treatment adherence: sessions were be recorded, and a random percentage was used to assess treatment integrity. Adherence to the therapy manuals was monitored by senior supervisors. The investigators followed the CONSORT guidelines for randomization and participant tracking.
Participants: The trial required 148 Veterans (including women and members of diverse ethnic and racial groups) with PTSD as a result of military trauma.
Recruitment: Veterans were recruited and treated at the Minneapolis, San Diego, San Francisco, and Waco VAs. Co-Investigators (Co-Is): (a) provided materials describing the nature of the study and the target populations sought, distributing said materials via formal (e.g., staff meetings) and informal (e.g., bulletin boards) channels; (b) attended clinical staff meetings; (c) gave talks to describe various treatments in staff grand rounds and other contexts (e.g., to trainees); and (d) provided feedback to staff about referred patients.
Assessor Training and Adherence: A co-investigator, Dr. Matt Gray (University of Wyoming) trained the assessors prior to beginning enrollment. Training included reading and viewing training materials, observation of CAPS-5 administration, and supervised administration of at least three CAPS-5s. Dr. Gray has expertise in CAPS-5 training and fidelity monitoring. The assessor was considered trained on CAPS-5 when they matched Dr. Gray on three interviews. To establish matching, Dr. Gray co-rated interviews conducted by the assessor. A match occurred when the assessor and Dr. Gray agreed on the diagnosis and were within 2 severity points on all of the symptom clusters (PTSD criteria B, C, D, and E).
All assessments were audiotaped to ensure that a standardized approach was used across patients (provided that the participant consents). Dr. Gray reviewed a random 10% of the assessments. All recordings were stored on a restricted-access encrypted drive. Selected recordings were transported to Dr. Gray via Federal Express that allows tracking.
Random Assignment: Veterans were assigned to PCT or AD-MIL based on a randomized permuted block scheme, blocked by gender and minority status. Block size for gender and minority status was based on the distribution of these variables at each site. The Boston site used constrained randomization (i.e., biased coin design) if unexpected imbalance arose in gender and minority distribution across treatment groups.
Treatment Fidelity Monitoring: Half-time therapists with Ph.Ds. in clinical or counseling psychology and VA internship experiences treating Veterans with PTSD were trained to deliver AD-MIL and PCT. Training involved a review of the respective manuals and supporting materials, intensive one-on-one training and supervision, and weekly and ad hoc supervision (Dr. Litz for AD-MIL; Dr. Harris for PCT). All sessions were audiotaped. Two random session recordings from a random 20% of the cases were rated to ensure fidelity to each treatment approach.
ANALYSES Data Analysis: The longitudinal and clustered nature of the design produced a multilevel or nested data structure (Raudenbush \& Bryk, 2002), with a likelihood of between-subject variability in treatment trajectory over time (e.g., random slopes). In this study, Veterans and therapists were nested (clustered) within performance sites. The lower level (level-1) data consisted of the repeated measures for each individual at each assessment. Level-1 data is nested within upper level (level-2) person-level variables (e.g., study site).
Using SAS 9.4 and R/R Studio, the investigators explored the change trajectory of endpoints over the course of pre-treatment, during-treatment, and post-treatment time intervals. Specifically, the investigators used the linear mixed model regression framework to assess the differential treatment effects of endpoint symptom burden over time. The investigators examined observed measurement scores and specified linear mixed models that best fit the time-change trends (e.g., linear, piecewise). The investigators tested for the presence of random variation, such as between-site cluster effects and between-subject random slopes of treatment effect. The investigators determined the best fit linear mixed effects model as a combination of most appropriate representation of time and empirically-evidenced random and fixed effects.
The linear mixed effects models incorporated clinically relevant time-invariant and time-varying predictors and used Maximum Likelihood Estimation to produce estimates that were unbiased in the presence of random missingness and dropout. These provided an Intent-To-Treat (ITT) analysis that incorporated all available data. Per-protocol and "completer" subset analyses were performed under the same paradigm. Additionally, a subset of subjects who began therapy during the COVID-19 pandemic were identified and analyzed separately; they comprised subjects which began therapy following December 31st, 2020. The tenability of the "At-Random" missingness assumption was assessed and a sensitivity analysis of the results was conducted to determine robustness of the inferences.
Clinical significance: The investigators used a variation of the two-stage Jacobson \& Truax (J\&T; 1991) method to establish a reasonable cutoff between dysfunctional and functional scores. The investigators first established the cutoff A, defined as the point 2 SDs beyond the range of the pre-therapy mean (cutoff A = M(baseline) - 2 SD(baseline)). Next, the investigators generated a reliable change index (RCI) for each participant to ensure that changes were not due to artifact of measurement error (\[x2 - x1\]/Sdiff where x1 represents the participant's pre-treatment total score, x2 represents the participant's post-treatment or follow-up total score, and Sdiff is the standard error of difference between the two test scores. Sdiff was calculated from the test-retest reliability of measures. An RCI larger than 1.96 reflects real change. Individuals were classified as recovered (passed both cutoff A and RC criteria), improved (passed RC criterion but not cutoff A), unchanged (passed neither criterion), or deteriorated (passed RC criterion but symptom scores increased) for each follow-up interval. Chi-square analyses were used to compare proportions per arm at each follow-up. | Inclusion Criteria:
1. Served in an active-duty role within the military since September 2001 (Veterans may be eligible whether or not they were deployed to a warzone)
2. Met the DSM-5 diagnostic criteria for PTSD as a result of military trauma (per Clinician Administered PTSD Scale for DSM-5 \[CAPS-5\]) and reported non-negligible levels of associated functional impairment (Sheehan Disability Scale \[SDS\] score = 10)
3. Prospective enrollees must have been willing to commit to 12 consecutive weekly therapy sessions lasting up to 90 minutes in duration and to complete assessment materials.
Exclusion Criteria:
1. Bipolar or psychotic disorders.
2. Current drug or alcohol dependence (other than caffeine or tobacco dependence). Prospective enrollees who had maintained sobriety for at least 6 weeks immediately prior to the time of enrollment may have been eligible.
3. Evidence of traumatic brain injury severe enough to influence the ability to understand and respond to study procedures
4. Suicidal or homicidal ideation severe enough to warrant immediate attention
5. Concurrent enrollment in any treatment that involves: (1) systematic disclosure of troubling trauma-related memories or (2) present-focused psychosocial skills training for PTSD or (3) supportive therapy/case management on a \> monthly basis or (4) any individual therapy or (5) newly (\< 6 weeks) prescribed pharmacological treatment. | VA Office of Research and Development | FED | {
"id": "D2135-I",
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"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2017-02-16T00:00:00 | {
"date": "2024-07-03",
"type": "ACTUAL"
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"date": "2017-02-17",
"type": "ACTUAL"
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"ADULT",
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"allocation": "RANDOMIZED",
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{
"city": "San Diego",
"country": "United States",
"facility": "VA San Diego Healthcare System, San Diego, CA",
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"state": "California"
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{
"class": "FED",
"name": "San Diego Veterans Healthcare System"
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{
"class": "OTHER",
"name": "Central Texas Veterans Health Care System"
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"other": [
{
"description": null,
"measure": "Change in Overall Self-Compassion Assessed Through the Self Compassion Scale (SCS)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in State Anger Assessed Through the Dimensions of Anger Reactions (DAR)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in Use of Psychologically Aggressive Behavior Assessed Through the Psychological Aggression Subscale of the Revised Conflict Tactics Scale (CTS2)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in Use of Physically Aggressive Behavior Assessed Through the Physical Assault Subscale on the Revised Conflict Tactics Scale (CTS2)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in Suicidality Across Assessed Through the Depressive Symptoms Index - Suicidality Subscale (DSI-SS)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after posttreatment."
},
{
"description": null,
"measure": "Change in Alcohol Consumption Assessed Through the Quick Drinking Screen (QDS)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in Social Connectedness Assessed Through the Social Connectedness Scale (SCS)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in Compassion for Humanity Assessed Through The Santa Clara Brief Compassion Scale (SCBSC)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
}
],
"primary": [
{
"description": null,
"measure": "Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)",
"timeFrame": "Assessments occurred at baseline, every treatment session, post treatment, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Pre-to-Post-Treatment Clinically Significant Change (CSC) in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)",
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{
"description": null,
"measure": "Change in Psychosocial Functioning Assessed Through the Brief Inventory of Psychosocial Functioning (B-IPF)",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort",
"timeFrame": "Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort",
"timeFrame": "Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment."
},
{
"description": null,
"measure": "Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) for the COVID-19 Cohort",
"timeFrame": "Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment."
},
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"description": null,
"measure": "Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort",
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],
"secondary": [
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},
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"description": null,
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"description": null,
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},
{
"description": null,
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"description": null,
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"timeFrame": "Baseline and post treatment."
},
{
"description": null,
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},
{
"description": null,
"measure": "Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the (Lack of) Justification Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief)",
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Depress Anxiety. 2001;13(3):132-56. doi: 10.1002/da.1029."}, {"pmid": "24768777", "type": "BACKGROUND", "citation": "Batterham PJ, Fairweather-Schmidt AK, Butterworth P, Calear AL, Mackinnon AJ, Christensen H. Temporal effects of separation on suicidal thoughts and behaviours. Soc Sci Med. 2014 Jun;111:58-63. doi: 10.1016/j.socscimed.2014.04.004. Epub 2014 Apr 8."}, {"pmid": "15253097", "type": "BACKGROUND", "citation": "Forbes D, Hawthorne G, Elliott P, McHugh T, Biddle D, Creamer M, Novaco RW. A concise measure of anger in combat-related posttraumatic stress disorder. J Trauma Stress. 2004 Jun;17(3):249-56. doi: 10.1023/B:JOTS.0000029268.22161.bd."}, {"pmid": "2002127", "type": "BACKGROUND", "citation": "Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12."}, {"pmid": null, "type": "BACKGROUND", "citation": "Kubany ES, Haynes SN, Abueg FR, Manke FP, Brennan JM, & Stahura C. Development and validation of the Trauma-Related Guilt Inventory (TRGI). Psychological Assessment. 1996; 8(4): 428-444."}, {"pmid": null, "type": "BACKGROUND", "citation": "Lee RM, Robbins SB. Measuring belongingness: The social connectedness and the social assurance scales. Journal of Counseling Psychology. 1995; 42(2): 232-241."}, {"pmid": null, "type": "BACKGROUND", "citation": "Marx BP. Development & validation of a PTSD-related impairment scale. Boston VA Research Institute."}, {"pmid": null, "type": "BACKGROUND", "citation": "Metalsky GI, Joiner TE. The hopelessness depression symptom questionnaire. Cognitive Therapy and Research. 1997; 21(3): 359-384."}, {"pmid": null, "type": "BACKGROUND", "citation": "Neff KD. The development and validation of a scale to measure self-compassion. Self and identity. 2003; 2(3): 223-250."}, {"pmid": null, "type": "BACKGROUND", "citation": "\u00d8ktedalen T, Hagtvet KA, Hoffart A, Langkaas TF, Smucker M. The Trauma Related Shame Inventory: Measuring trauma-related shame among patients with PTSD. Journal of Psychopathology and Behavioral Assessment. 2014; 36(4): 600-615."}, {"pmid": null, "type": "BACKGROUND", "citation": "Raudenbush SW, Bryk AS. Hierarchical linear models: Applications and data analysis methods (Vol 1). Sage; 2002."}, {"pmid": null, "type": "BACKGROUND", "citation": "Sheehan DV. (1983). The Anxiety Disease. New York: Charles Scribner and Sons."}, {"pmid": "8923116", "type": "BACKGROUND", "citation": "Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996 Jun;11 Suppl 3:89-95. doi: 10.1097/00004850-199606003-00015."}, {"pmid": "14743950", "type": "BACKGROUND", "citation": "Sobell LC, Agrawal S, Sobell MB, Leo GI, Young LJ, Cunningham JA, Simco ER. Comparison of a quick drinking screen with the timeline followback for individuals with alcohol problems. J Stud Alcohol. 2003 Nov;64(6):858-61. doi: 10.15288/jsa.2003.64.858."}, {"pmid": null, "type": "BACKGROUND", "citation": "Straus MA, Hamby SL, Boney-McCoy SU, Sugarman DB. The revised conflict tactics scales (CTS2) development and preliminary psychometric data. Journal of family issues. 1996; 17(3): 283-316."}, {"pmid": "28493729", "type": "BACKGROUND", "citation": "Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11."}, {"pmid": null, "type": "BACKGROUND", "citation": "Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd.va.gov. 2013; 10(4): 206."}, {"pmid": "10689649", "type": "BACKGROUND", "citation": "Blais MA, Lenderking WR, Baer L, deLorell A, Peets K, Leahy L, Burns C. Development and initial validation of a brief mental health outcome measure. J Pers Assess. 1999 Dec;73(3):359-73. doi: 10.1207/S15327752JPA7303_5."}, {"pmid": null, "type": "BACKGROUND", "citation": "Wilson, K. G., Sandoz, E. K., Kitchens, J., & Roberts, M. (2010). The Valued Living Questionnaire: Defining and measuring valued action within a behavioral framework. The Psychological Record, 60(2), 249-272. https://doi.org/10.1007/BF03395706"}, {"pmid": null, "type": "BACKGROUND", "citation": "Hwang, J.Y., Plante, T. & Lackey, K. The development of the Santa Clara Brief Compassion Scale: An abbreviation of Sprecher and Fehr's Compassionate Love Scale. Pastoral Psychol 56, 421-428 (2008). https://doi.org/10.1007/s11089-008-0117-2"}] | {"versionHolder": "2025-06-18"} | {
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NCT06516757 | null | A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health. | A Single Group Study to Evaluate the Effects of a Boric Acid Suppository on Vaginal Health. | None | INTERVENTIONAL | COMPLETED | 2024-07-11T00:00:00 | null | 2024-07-05T00:00:00 | 2024-07-05T00:00:00 | [
"NA"
] | 40 | 18 | null | FEMALE | false | This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8). | null | Inclusion Criteria:
* Female at birth
* Aged 18+
* Interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal pH levels
* Regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating
* Willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period
* Has used a boric acid suppository before
* Willing to avoid the use of any intra-vaginal products during the study product use
* Willing and able to follow the study protocol
Exclusion Criteria:
* Surgeries or invasive treatments in the last six months or planned during the study period
* Introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks
* Known allergies to the product ingredients
* Diagnosed with chronic health conditions impacting participation
* Pregnant, breastfeeding, or trying to conceive
* History of substance abuse
* Current or former smoker within the past six months
* Unwilling to follow the study protocol
* Currently participating in any other clinical trial or perception study | Love Wellness | INDUSTRY | {
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"date": "2024-07-24",
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"city": "Santa Monica",
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"description": null,
"measure": "Vaginal Health and Balance",
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"description": null,
"measure": "Participant Perception of Product Convenience",
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} | null | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D001424",
"term": "Bacterial Infections"
},
{
"id": "D001423",
"term": "Bacterial Infections and Mycoses"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D014627",
"term": "Vaginitis"
}
],
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "Bacterial Vaginosis",
"id": "M18971",
"name": "Vaginosis, Bacterial",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17371",
"name": "Vaginal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8943",
"name": "Genital Diseases, Female",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
"name": "Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27093",
"name": "Female Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14127",
"name": "Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8399",
"name": "Female Urogenital Diseases and Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4722",
"name": "Bacterial Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12136",
"name": "Mycoses",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4721",
"name": "Bacterial Infections and Mycoses",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17375",
"name": "Vaginitis",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D016585",
"term": "Vaginosis, Bacterial"
}
]
} | null | {
"conditions": [
{
"id": "D016585",
"term": "Vaginosis, Bacterial"
}
],
"interventions": null
} |
NCT03431857 | null | Multi Centre Study on TESS V2 Shoulder System | Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System | None | OBSERVATIONAL | COMPLETED | 2018-01-29T00:00:00 | null | 2015-12-31T00:00:00 | 2019-12-31T00:00:00 | null | 106 | 18 | null | ALL | false | This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System. | The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship. | Inclusion Criteria:
* Except in special cases, the "anatomic" type is indicated for:
* Centered osteoarthritis of the shoulder
* Humeral head fractures
* Rheumatoid arthritis (with intact rotator cuff)
* Avascular necrosis of the humeral head
* Except in special cases, the "reversed" type is indicated for:
* Offset osteoarthritis of the shoulder
* Massive and non-repairable rotator cuff tears
* Rheumatoid arthritis (with degenerative rotator cuff)
* Revision in cases of:
* Replacement of an "anatomic" prosthesis with a "reversed" prosthesis
* Conversion of a hemi-arthroplasty into a total arthroplasty
* Increasing the size of the stem (length and/or diameter)
* Replacing a glenoid prosthesis
* Replacing a competitor's prosthesis
* In rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis
* Additional inclusion criteria include
* Patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements)
* Willing to return for follow-up evaluations
Exclusion Criteria:
* Local or systemic infections.
* Severe muscular, neurological, or vascular deficiency of the affected joint.
* Bone destruction or poor bone quality liable to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
* Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.
* Any concomitant complaint likely to affect the functioning of the implant.
* Allergy to any of the implant components.
* Local bone tumors.
* Patient over 18 under law supervision | Zimmer Biomet | INDUSTRY | {
"id": "ORTHO.CR.E13",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-02-12T00:00:00 | {
"date": "2021-10-19",
"type": "ACTUAL"
} | {
"date": "2018-02-13",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients in need of Total Shoulder Arthroplasty (primary or revision) who receive the TESS V2 and who meet all of the inclusion and none of the exclusion criteria. | PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
} | [
"Osteoarthritis Shoulder",
"Fracture",
"Rheumatoid Arthritis",
"Avascular Necrosis",
"Rotator Cuff Tear",
"Revision"
] | ["Shoulder arthroplasty", "Medical device", "Shoulder prosthesis", "Performance"] | null | [
{
"city": "Sint-Niklaas",
"country": "Belgium",
"facility": "Orthokliniek Waasland",
"geoPoint": {
"lat": 51.16509,
"lon": 4.1437
},
"state": null
},
{
"city": "Berck",
"country": "France",
"facility": "Institut Calot",
"geoPoint": {
"lat": 50.4,
"lon": 1.6
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Constant Shoulder Score",
"timeFrame": "Pre-operative, 5 years follow-up"
}
],
"secondary": [
{
"description": null,
"measure": "Active Anterior Elevation",
"timeFrame": "Pre-operative, 5 years follow-up"
},
{
"description": null,
"measure": "Active Lateral Elevation",
"timeFrame": "Pre-operative, 5 years follow-up"
},
{
"description": null,
"measure": "Active External Rotation RE1",
"timeFrame": "Pre-operative, 5 years follow-up"
},
{
"description": null,
"measure": "Active External Rotation RE2",
"timeFrame": "Pre-operative, 5 years follow-up"
},
{
"description": null,
"measure": "Passive Elevation",
"timeFrame": "Pre-operative, 5 years follow-up"
},
{
"description": null,
"measure": "Passive External Rotation",
"timeFrame": "Pre-operative, 5 years follow-up"
},
{
"description": null,
"measure": "Radiographic Evaluation",
"timeFrame": "Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up."
},
{
"description": null,
"measure": "Survivorship",
"timeFrame": "5 years follow-up"
}
]
} | [
{
"affiliation": "Zimmer Biomet",
"name": "Paola Vivoda",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D012421",
"term": "Rupture"
},
{
"id": "D014947",
"term": "Wounds and Injuries"
},
{
"id": "D000070599",
"term": "Shoulder Injuries"
},
{
"id": "D013708",
"term": "Tendon Injuries"
}
],
"browseBranches": [
{
"abbrev": "BC26",
"name": "Wounds and Injuries"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M26370",
"name": "Fractures, Bone",
"relevance": "LOW"
},
{
"asFound": "Necrosis",
"id": "M12284",
"name": "Necrosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12926",
"name": "Osteoarthritis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15241",
"name": "Rupture",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4476",
"name": "Arthritis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4480",
"name": "Arthritis, Rheumatoid",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22785",
"name": "Lacerations",
"relevance": "LOW"
},
{
"asFound": "Rotator Cuff Tears",
"id": "M624",
"name": "Rotator Cuff Injuries",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17685",
"name": "Wounds and Injuries",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M602",
"name": "Shoulder Injuries",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16479",
"name": "Tendon Injuries",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009336",
"term": "Necrosis"
},
{
"id": "D000070636",
"term": "Rotator Cuff Injuries"
}
]
} | null | {
"conditions": [
{
"id": "D009336",
"term": "Necrosis"
},
{
"id": "D000070636",
"term": "Rotator Cuff Injuries"
}
],
"interventions": null
} |
NCT05211557 | null | Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer | A Single-Arm, Open-Label Study to Evaluate Safety and Efficacy of Fully Human B7H3 CAR-T in Treating Patients With Recurrent Malignant Ovarian Cancer | None | INTERVENTIONAL | RECRUITING | 2022-01-13T00:00:00 | null | 2023-08-31T00:00:00 | 2026-08-31T00:00:00 | [
"PHASE1",
"PHASE2"
] | 15 | 18 | 70 | FEMALE | false | This is single center, open-label phase I, non-randomized study which will enroll patients with recurrent advanced ovarian cancer to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T cells (fhB7H3.CAR-Ts) via using a '3+3+3' dose escalation design. In the dose expansion cohort, six patients will be enrolled to further assess their efficacy with the optimal dosage. | The purpose of this study is to test the safety and efficacy of a newly developed fully human scFv-armed B7H3 targeting chimeric antigen receptor T cells (fhB7H3.CAR-Ts), which are supposed to attack and eliminate B7H3-positive cancer cells. The patients who have been diagnosed as recurrent or relapsed malignant ovarian cancer, especially ovarian cancer patients with refractory ascites, will be potentially enrolled after assessing the expression of B7H3 antigen in tumor tissue by immunohistochemistry staining or ascitic tumor cells by flow cytometry.
After enrollment, participants' peripheral blood mononuclear cells will be collected and used to manufacture fhB7H3.CAR-Ts. Before infusion, the patients will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for three consecutive days. Two days later after lymphodepletion, the fhB7H3.CAR-Ts would be given through an abdominal catheter for intraperitoneal infusion. From the day of infusion, participants' peripheral blood and ascites will be collected twice a week in the first month for monitoring the survival of fhB7H3.CAR-Ts and evaluating the therapeutic efficacy. Additional follow-up and examination will be performed monthly for the first three month and then trimonthly until one year. Thereafter, annual follow-up will be completed for 5 years.
In addition, since the fhB7H3.CAR-Ts containing a RQR8 safety-switch which could be targeted and removed by Rituximab. Participants who experience life-threatening toxicities caused by uncontrollable proliferation of fhB7H3.CAR-Ts will receive infusion of Rituximab (Rituxan or Ruxience or Halpryza) to assess the ability of RQR8 safety-switch to eliminate infused fhB7H3.CAR-Ts.
This is an investigator-initiated clinical study to assess first-line clinical performance of novel fhB7H3.CAR-Ts which may help other advanced and recurrent ovarian cancer patients in the future. | Inclusion Criteria:
1. Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production
2. Written informed consent and authorization for release of personal health information
3. Subject has adequate performance status as defined by ECOG score of ≤ 2.
4. Expected life expectancy is no less than 12 weeks.
5. Subjects must have histologically or cytologically confirmed ovarian cancer. And cancer tissue or ascitic cancer cells are measured positive for B7H3 expression.
6. Subjects must have recurrent or refractory disease after or during first-line treatment.
Defined as:
Radiographic progression or Continuous Elevation of CA125.
7. Subjects must have evaluable disease - defined as:
Measurable disease with tumor length ≥ 10mm or enlarged lymph nodes ≥ 15mm according to RECIST v1.1 criteria.
8. Adequate organ function - defined as:
1. Blood routine:
white blood cell count ≥ 3 × 10\^9 / L; neutrophil count ≥ 1.5 × 10\^9 / L; hemoglobin ≥ 9g/dL; platelet count ≥ 80 × 10\^9 / L; INR\< 1.5 × ULN; PT, APTT\< 1.5 × ULN
2. The liver, kidney, lung and cardiopulmonary function:
Urea and serum creatinine ≤ 1.5 × ULN; Left ventricular ejection fraction ≥ 40%; Baseline oxygen saturation ≥ 95%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN.
9. Not pregnant with negative serum pregnancy test within 3 days prior to enrollment.
10. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of highly effective methods of contraception from the time of informed consent until 8 weeks after study treatment discontinuation.
-
Exclusion Criteria:
1. Subject has primary immunodeficiency syndrome or history of severe allergic reaction.
2. Subject has active infection with HIV, HTLV, HBV, HCV.
3. Subject has severe, uncontrolled intercurrent bacterial, viral or fungal infection.
4. Subject has a history of gastrointestinal perforation, clinical and/or radiographic evidence of bowel obstruction, or intra-abdominal abscess within 3 months prior to starting treatment.
5. Subject has active malignancy under treatment other than ovarian cancer.
6. Subject has Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention.
7. Subject is current using of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent.
8. Subject has not recovered from toxicity of previous anti-tumor treatment (CTCAE 5.0).
9. Subject is pregnant or breastfeeding.
10. Unwilling or unable to provide consent/assent for participation in the study. - | The Affiliated Hospital of Xuzhou Medical University | OTHER | {
"id": "XYFY2021-KL184-01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-01-25T00:00:00 | {
"date": "2022-01-27",
"type": "ACTUAL"
} | {
"date": "2022-01-27",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Ovarian Cancer"
] | ["Fully Human B7H3 CAR-T", "Recurrent Ovarian Cancer"] | null | [
{
"city": "Xuzhou",
"country": "China",
"facility": "The Affiliated Hospital of Xuzhou Medical University",
"geoPoint": {
"lat": 34.18045,
"lon": 117.15707
},
"state": "Jiangsu"
}
] | [
{
"class": "OTHER",
"name": "Xuzhou Medical University"
},
{
"class": "UNKNOWN",
"name": "IIT MediTech (Jiangsu) Co. Ltd"
}
] | null | {
"other": [
{
"description": null,
"measure": "Progress free survival (PFS)",
"timeFrame": "up to 5 years"
},
{
"description": null,
"measure": "Overall survival (OS)",
"timeFrame": "up to 5 years"
}
],
"primary": [
{
"description": null,
"measure": "Dose limiting toxicity of fully human B7H3 CAR-T cells",
"timeFrame": "1 month"
},
{
"description": null,
"measure": "Objective response of fully human B7H3 CAR-T cells",
"timeFrame": "1 month"
}
],
"secondary": [
{
"description": null,
"measure": "In vivo persistence of fully human B7H3 CAR-T cells",
"timeFrame": "1 month"
}
]
} | [
{
"affiliation": "The Affiliated Hospital of Xuzhou Medical University, Xuzhou Medical University",
"name": "Junnian Zheng, M.D., Ph.D.",
"role": "STUDY_DIRECTOR"
},
{
"affiliation": "The Affiliated Hospital of Xuzhou Medical University",
"name": "Longzhen Zhang, M.D., Ph.D.",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Xuzhou Medical University",
"name": "Gang Wang, Ph.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D004701",
"term": "Endocrine Gland Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D010049",
"term": "Ovarian Diseases"
},
{
"id": "D000291",
"term": "Adnexal Diseases"
},
{
"id": "D005831",
"term": "Genital Diseases, Female"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D005833",
"term": "Genital Neoplasms, Female"
},
{
"id": "D014565",
"term": "Urogenital Neoplasms"
},
{
"id": "D000091662",
"term": "Genital Diseases"
},
{
"id": "D004700",
"term": "Endocrine System Diseases"
},
{
"id": "D006058",
"term": "Gonadal Disorders"
},
{
"id": "D002277",
"term": "Carcinoma"
},
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M14850",
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"relevance": "LOW"
},
{
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"name": "Ovarian Neoplasms",
"relevance": "HIGH"
},
{
"asFound": "Ovarian Cancer",
"id": "M1704",
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"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5534",
"name": "Carcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7863",
"name": "Endocrine Gland Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12972",
"name": "Ovarian Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3643",
"name": "Adnexal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8943",
"name": "Genital Diseases, Female",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
"name": "Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M27093",
"name": "Female Urogenital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14127",
"name": "Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8399",
"name": "Female Urogenital Diseases and Pregnancy Complications",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8945",
"name": "Genital Neoplasms, Female",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17315",
"name": "Urogenital Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7862",
"name": "Endocrine System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9163",
"name": "Gonadal Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12320",
"name": "Neoplasms, Glandular and Epithelial",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12315",
"name": "Neoplasms by Histologic Type",
"relevance": "LOW"
},
{
"asFound": "Ovarian Cancer",
"id": "T4352",
"name": "Ovarian Cancer",
"relevance": "HIGH"
},
{
"asFound": "Ovarian Cancer",
"id": "T4354",
"name": "Ovarian Epithelial Cancer",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D010051",
"term": "Ovarian Neoplasms"
},
{
"id": "D000077216",
"term": "Carcinoma, Ovarian Epithelial"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "ARhu",
"name": "Antirheumatic Agents"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M283230",
"name": "Fludarabine",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6727",
"name": "Cyclophosphamide",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M225513",
"name": "Fludarabine phosphate",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D010051",
"term": "Ovarian Neoplasms"
},
{
"id": "D000077216",
"term": "Carcinoma, Ovarian Epithelial"
}
],
"interventions": []
} |
NCT03513757 | null | Dexmedetomidine and Propofol for Pediatric MRI Sedation | An Observer-blinded Randomized Study of Propofol Infusion vs Bolus Dexmedetomidine and Propofol Sedation for Pediatric Magnetic Resonance Imaging | None | INTERVENTIONAL | COMPLETED | 2018-02-04T00:00:00 | null | 2018-08-21T00:00:00 | 2018-10-21T00:00:00 | [
"PHASE4"
] | 40 | 12 | 60 | ALL | false | The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).
The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan.
The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018. | The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).
Recent studies and the FDA have raised concerns that anesthesia for longer than three hours may have effects on behavior and learning. Although investigators do not know if these effects are caused by drugs or the medical condition a child is being treated for, in December 2016, the FDA published the information below regarding anesthesia for children:
General anesthetic and sedation drugs are used to put people into a deep sleep so they do not feel pain during surgery or procedures.
These drugs are usually injected into a vein or breathed in through a mask. General anesthetic and sedation drugs are widely used to ensure the health, safety, and comfort of children and adults undergoing surgery or other procedures.
Recent studies in children suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. More research is still needed to fully understand how anesthetics might affect brain development, especially longer or repeated exposures and in more vulnerable children. Anesthetic and sedation drugs are necessary for infants, children, and pregnant women who require surgery or other painful and stressful procedures. https://www.fda.gov/Drugs/DrugSafety/ucm532356.htm Research in neonatal and infant animals has demonstrated that sedative and anesthetic agents, like propofol, produce adverse effects on brain development, including loss of brain cells resulting in long-term, possibly permanent changes in learning and behavior. These adverse effects appear to occur mostly after prolonged periods of sedation or anesthesia (generally greater than 3 hours) and when brain development is occurring at a rapid rate (which roughly occurs in children under 3 years of age). It is not known if similar adverse effects occur in humans. Study participants should be advised that the drugs used to accomplish the procedure may have the potential to increase the loss of nerve cells in the developing brain of young child and that the clinical significance of any such changes is not known. There are some animal studies that suggests dexmedetomidine may be better for a growing infant's brain. However, the effects of dexmedetomidine alone or in combination with propofol on the developing brain have not been thoroughly tested to date." The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. Investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, investigators will administer whatever is necessary. At the end of the study, an observer will record the time it takes for spontaneous eye opening, to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that investigators learn in the following day or two how the participant behaved at home; whether eating, behavior and sleeping were unusual. For that reason, the investigator will call the participant a day or so following the MRI scan.
The investigators expect to recruit 70 children between the ages of 12 and 72 months for the study and hope to have the study completed in 2018. | Inclusion Criteria:
* All children scheduled for outpatient MRI scans with expected duration of scan between 30 minutes and 75 minutes.
Exclusion Criteria:
* Inpatient status, airway abnormalities, allergy to any study medications, eggs and soy, and mitochondrial disorders.
* All subjects with any cardiac disease or history of cardiac arrhythmias will be excluded. | Medical College of Wisconsin | OTHER | {
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NCT04334057 | null | Post-Marketing Surveillance (Use-results Surveillance) With Esperoct® | Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®. A Multi-centre, Prospective, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Esperoct® in Haemophilia A Patients Under Routine Clinical Practice Conditions in Japan | None | OBSERVATIONAL | COMPLETED | 2020-04-02T00:00:00 | null | 2023-11-30T00:00:00 | 2023-11-30T00:00:00 | null | 23 | null | null | ALL | null | The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant. | null | Inclusion Criteria:
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* Diagnosis of haemophilia A in males or females, no age limitation.
* New patients who have not previously been exposed to Esperoct®.
Exclusion Criteria:
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Known or suspected hypersensitivity to study product or related products.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. | Novo Nordisk A/S | INDUSTRY | {
"id": "NN7088-4484",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-04-02T00:00:00 | {
"date": "2025-06-02",
"type": "ACTUAL"
} | {
"date": "2020-04-03",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Haemophilia A patients in routine clinical practice in Japan | NON_PROBABILITY_SAMPLE | false | {
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"country": "Japan",
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"other": null,
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"timeFrame": "From baseline (week 0) to end of study (week 104)"
}
],
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{
"description": null,
"measure": "Number of serious adverse events (SAEs) reported during the observation period",
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{
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"measure": "Number of serious adverse reactions (SARs) reported during the observation period",
"timeFrame": "From baseline (week 0) to end of study (week 104)"
},
{
"description": null,
"measure": "Number of patients who have confirmed inhibitory antibodies against FVIII during the observation period",
"timeFrame": "From baseline (week 0) to end of study (week 104)"
},
{
"description": null,
"measure": "Number of bleeding episodes requiring treatment for patients using Esperoct® during the observation period assessed by annual bleeding rate (ABR)",
"timeFrame": "From baseline (week 0) to end of study (week 104)"
},
{
"description": null,
"measure": "Evaluation of the haemostatic response of Esperoct® measured as number of successes for treatment requiring bleeds",
"timeFrame": "From baseline (week 0) to end of study (week 104)"
},
{
"description": null,
"measure": "Evaluation of the haemostatic response of Esperoct® measured as number of successes in treatment of bleeds in perioperative management during surgical procedures",
"timeFrame": "From baseline (week 0) to end of study (week 104)"
}
]
} | [
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NCT00417157 | null | Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH | Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation | None | OBSERVATIONAL | COMPLETED | 2006-12-22T00:00:00 | null | null | null | null | 135 | 20 | 50 | FEMALE | true | The purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment. | Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by performing IVF during a natural menstrual cycle. However, the main problem with a natural cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC offers no realistic chances of pregnancy prior to oocyte donation. In this study we will re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF outcome in patients with known previous poor response prior to oocyte donation. | Inclusion Criteria:
* Regular menstrual cycle (21-35 days)
* Basal FSH\>12 IU/ml
* One or more failed IVF attempts (\<3 oocyte retrieved)
Exclusion Criteria:
* PCOS
* Normal responders | Eugonia | OTHER | {
"id": "MNC",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-12-28T00:00:00 | {
"date": "2013-12-16",
"type": "ESTIMATED"
} | {
"date": "2006-12-29",
"type": "ESTIMATED"
} | [
"ADULT"
] | Women undergoing IVF treatment | NON_PROBABILITY_SAMPLE | null | {
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} | [
"Infertility",
"Premature Ovarian Failure"
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"country": "Greece",
"facility": "Eugonia",
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"lat": 37.97945,
"lon": 23.71622
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}
] | null | null | {
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"description": null,
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"timeFrame": "live birth"
}
],
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"description": null,
"measure": "Biochemical pregnancy per started cycle",
"timeFrame": "positive hCG test 14 days post oocyte retrieval"
},
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"description": null,
"measure": "Clinical pregnancy per started cycle",
"timeFrame": "presence of fetal sac and heart beat at 7 weeks of gestation"
},
{
"description": null,
"measure": "Cycle cancellation rates",
"timeFrame": "cycles not reaching oocyte retrieval"
},
{
"description": null,
"measure": "Ongoing pregnancy rates per started cycle",
"timeFrame": "presence of fetal sac and heart beat at 12 weeks of gestation"
}
]
} | [
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"affiliation": "Eugonia",
"name": "Tryfon Lainas, PhD",
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}
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{
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NCT01113957 | null | A Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Ovarian Cancer | A Phase 2 Randomized Clinical Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Subjects With Recurrent High Grade Serous Ovarian Cancer | None | INTERVENTIONAL | COMPLETED | 2010-02-26T00:00:00 | null | null | null | [
"PHASE2"
] | 168 | 18 | 99 | FEMALE | false | The purpose of this study is to determine the objective response rate of ABT-888 when given in combination with temozolomide versus pegylated liposomal doxorubicin (PLD) alone in subjects with recurrent high grade serous ovarian cancer. | Safety assessments and tolerability will be assessed through electrocardiograms (ECG). clinical laboratory tests, vital signs, Adverse Event assessments, and physical exams. Baseline radiographic tumor assessments, including CT scans of the chest, abdomen and pelvis will be obtained. Radiologic assessments and CA-125 measurements will also be performed every 8 weeks during dosing and following completion of dosing until disease progression. Study visits will be conducted weekly for the first 2 cycles and on Day 1 of each subsequent cycle, at the Final Visit and 30 day Follow-up Visit. Study visits will include physical examination, complete blood count (CBC) and chemistries. A urinalysis tests will be performed at Screening and Final Visit. An ECG will be performed at Screening, Cycle 1 Day 1 and at the Final Study Visit. A left ventricular ejection fraction (LVEF) will be measured by Echocardiogram or Multiple Gated Acquisition (MUGA) scan on all subjects at Screening. Subjects randomized to the PLD arm will have an echocardiogram or MUGA performed at the Final Study Visit and at the discretion of the Investigator throughout the study. Adverse events will be assessed at every visit. | Inclusion Criteria:
* Subject must have histologically (or cytologically) confirmed recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
* Subjects must have had at least 1 platinum containing chemotherapy regimen and no more than a total of 3 DNA damaging or cytotoxic regimens in the last 5 years. Less than a full dose of a DNA damaging agent, possibly due to reasons such as toxicity or documented allergic reaction are allowed. Previous treatments with biologics (including catumaxomab, tigatuzumab, abagovomab, and bevacizumab), vaccines, immunostimulants, hormonal agents, and signal transduction inhibitors (e.g., pazopanib, sorafenib, sunitinib, temsirolimus) are allowed and are not counted towards the limit of 3.
* Subjects who are resistant to platinum-based therapy; or sensitive to but are unable to tolerate platinum-based therapy (i.e., deemed toxic or have a documented platinum allergy). Subjects must have at least a \> 3 month treatment free interval from the last dose of platinum based therapy.
* Subject must be eligible for PLD treatment.
* Subject has either:
* Measurable disease, defined as at least 1 unidimensionally measurable lesion on a computed tomography (CT) scan as defined by response evaluation criteria in solid tumors (RECIST) version 1.1 OR
* Non-measurable disease with an elevation of serum CA-125 level by Gynecologic Cancer Intergroup (GCIG) criteria (baseline sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment).
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
* Subject must have adequate hematologic, renal and hepatic function as follows:
* Bone Marrow: Absolute neutrophil count (ANC ≥ 1,500/mm3 (1.5 x 109/L); Platelets ≥ 100,000/mm3 (100 x 109/L); Hemoglobin ≥ 9.5 g/dL (1.4 mmol/L);
* Renal function: Serum creatinine ≤ 1.5 x upper normal limit of institution's normal range OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal;
* Hepatic function: Aspartate aminotransferase (AST) and/or alanine transaminase (ALT) ≤ 2.5 x the upper normal limit of institution's normal range. For subjects with liver metastases, AST and/or ALT \< 5 x the upper normal limit of institution's normal range; Bilirubin ≤ 1.5 x the upper normal limit of institution's normal range;
* Partial thromboplastin time (PTT) must be ≤ 1.5 x the upper normal limit of institution's normal range and international normalized ratio (INR) \< 1.5. Subjects on anticoagulant (such as Coumadin) are allowed on study and will have PTT and INR as determined by the Investigator
* Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to initiation of treatment and a negative urine pregnancy test on Cycle 1 Day 1. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Exclusion Criteria:
* Subject has previously received a poly-ADP-ribose)-polymerase (PARP) inhibitor except a single dose from Cancer Therapy Evaluation Program (CTEP) Phase 0 (A06-161) study.
* Subjects who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin hydrocloride (HCL) or the components of PLD.
* The subject has received an anticancer agents or an investigational agent within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
* Subject has undergone major surgery within the previous 28 days prior to study drug administration.
* Subjects with prior radiotherapy to any portion of the abdominal cavity and pelvis, unless for the treatment of ovarian, primary peritoneal or fallopian tube cancer. Subject must have completed radiation at least 28 days prior to study drug administration and have measurable disease outside the radiation field or documented progression of lesions within a previously radiated field.
* Subjects with a known history of brain metastases.
* Clinically significant and uncontrolled major medical condition(s) including but not limited to:
* Active uncontrolled infection
* Symptomatic congestive heart failure
* Unstable angina pectoris or cardiac arrhythmia
* Psychiatric illness/social situation that would limit compliance with study requirements
* Any medical condition, which is in the opinion of the Study Investigator, places the subject at an unacceptably high risk for toxicities
* Subject is pregnant or lactating.
* Subjects who requires parenteral nutrition, or tube feeding or has evidence of partial bowel obstruction or perforation.
* The subject has had another active malignancy within the past five years except for any cancer in situ considered cured or non-melanoma carcinoma of the skin. Questions regarding the inclusion of individual subject should be directed to the Abbott Medical Monitor.
* Subject has previously received a poly-ADP-ribose)-polymerase (PARP) inhibitor except a single dose from Cancer Therapy Evaluation Program (CTEP) Phase 0 (A06-161) study. - Subjects who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin hydrocloride (HCL) or the components of PLD.
* The subject has received an anticancer agents or an investigational agent within 28 days prior to study drug administration. Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to previous anticancer treatment are excluded.
* Subject has undergone major surgery within the previous 28 days prior to study drug administration.
* Subjects with prior radiotherapy to any portion of the abdominal cavity and pelvis, unless for the treatment of ovarian, primary peritoneal or fallopian tube cancer. Subject must have completed radiation at least 28 days prior to study drug administration and have measurable disease outside the radiation field or documented progression of lesions within a previously radiated field.
* Subjects with a known history of brain metastases.
* Clinically significant and uncontrolled major medical condition(s) including but not limited to:
* Active uncontrolled infection
* Symptomatic congestive heart failure
* Unstable angina pectoris or cardiac arrhythmia
* Psychiatric illness/social situation that would limit compliance with study requirements
* Any medical condition, which is in the opinion of the Study Investigator, places the subject at an unacceptably high risk for toxicities
* Subject is pregnant or lactating.
* Subjects who requires parenteral nutrition, or tube feeding or has evidence of partial bowel obstruction or perforation.
* The subject has had another active malignancy within the past five years except for any cancer in situ considered cured or non-melanoma carcinoma of the skin. Questions regarding the inclusion of individual subject should be directed to the Abbott Medical Monitor. | AbbVie | INDUSTRY | {
"id": "M10-757",
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} | 2010-04-29T00:00:00 | {
"date": "2018-06-06",
"type": "ACTUAL"
} | {
"date": "2010-04-30",
"type": "ESTIMATED"
} | [
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"OLDER_ADULT"
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Ovarian Cancer"
] | ["Ovarian Cancer"] | null | [
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"country": "United States",
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{
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"country": "United States",
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"measure": "Objective response rate between the two treatment arms (ABT-888 + temozolomide versus the PLD) will be based on tumor measurements and CA-125 levels.",
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}
],
"secondary": [
{
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},
{
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},
{
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"timeFrame": "Screening to survival follow-up (every 3 months for 3 years)."
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NCT01084057 | null | Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer | Phase I Trial of Ixabepilone and Vorinostat in Metastatic Breast Cancer | None | INTERVENTIONAL | COMPLETED | 2010-03-08T00:00:00 | null | 2012-11-12T00:00:00 | 2019-09-27T00:00:00 | [
"PHASE1"
] | 56 | 18 | null | ALL | false | RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing or by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with vorinostat may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and best dose of vorinostat when given together with ixabepilone in treating patients with breast cancer that has spread to another place in the body. | PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of the combination of vorinostat with ixabepilone.
II. To determine the best schedule for delivery of this drug combination. III. To recommend a phase II dose of vorinostat in combination with ixabepilone.
SECONDARY OBJECTIVES:
I. To determine the objective response rate and/or clinical benefit rate. II. To assess the toxicity profile.
TERTIARY OBJECTIVES:
I. Collecting circulating tumor cells pre and post-treatment to study its deoxyribonucleic acid (DNA) somatic mutation and methylation assay after the introduction of histone deacetylases (HDAC) inhibitors and ixabepilone.
II. To determine whether administration of vorinostat with ixabepilone will alter the pharmacokinetics of vorinostat.
OUTLINE: This is a phase I, dose-escalation study of vorinostat. Patients are randomized to 1 of 2 treatment arms.
Arm I (Cohort A): Patients receive oral vorinostat once daily on days 1-14 and ixabepilone intravenously (IV) over 3 hours on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (Cohort B): Patients receive oral vorinostat once daily on days 1-7 and 15-21. Patients also receive ixabepilone IV over 3 hours on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically. | Inclusion Criteria:
* Patients must have histologically or cytologically confirmed stage IV adenocarcinoma of the breast; stable brain metastasis is allowed (not on anti-seizure or steroids for at least three months); if histological or cytological confirmation is not available/not done, patients who demonstrate metastatic disease as documented by computed tomography (CT) scan or magnetic resonance imaging (MRI), or Bone Scan may continue on study, if in the investigators clinical opinion this represents metastatic disease; also, skin disease that has not been biopsied may be used if in the investigators clinical opinion this represents metastatic disease
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral CT scan
* Multiple prior chemotherapy regimens (including trastuzumab containing regimens in human epidermal growth factor receptor 2 \[Her-2\] positive patients) for metastatic disease are allowed; prior radiation therapy and/or prior hormonal therapy (will need 2 weeks wash out period prior to enrollment) are allowed
* Life expectancy of greater than 6 months
* Performance status: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Hemoglobin \>= 9.0 g/dl
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Total bilirubin =\< 1.0 times upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 times the ULN
* Creatinine =\< 1.5 times ULN
* The effects of vorinostat and ixabepilone on the developing human fetus at the recommended therapeutic dose are unknown; women of childbearing potential must have a negative serum pregnancy test performed within 7 days of registration; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately and the patient will be withdrawn from the study
* Female patient of childbearing potential is willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with visit 1 through 30 days after the last dose of study drug; adequate contraceptive methods include for example, intra-uterine device, diaphragm with spermicide, cervical cap with spermicide, or female condom with spermicide; spermicides alone are not an acceptable method of contraception
* Male patient agrees to use an adequate method of contraception starting with the first dose of study drug through 30 days after the last dose of study drugs
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have had chemotherapy, radiotherapy (must not include \>= 30% of major bone marrow containing area) or any systemic anti-cancer drugs within 4 weeks (2 weeks for Hormonal therapy) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks
* Patients may not be receiving any other investigational agents
* Patients with unstable brain metastases (requirement of steroids or active seizures) are excluded from this clinical trial; patients with neurological symptoms must undergo a CT scan/MRI of the brain to asses brain metastasis
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (\> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2), symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, or psychiatric illness/social situations that would limit compliance with study requirements
* Prior ixabepilone and/or vorinostat are not allowed
* Prior valproic acid treatment for epilepsy will need 30 days wash out period prior to enrollment
* Pregnant women are excluded from this study because of unknown potential teratogenesis
* Human immunodeficiency virus (HIV)-positive patients are ineligible because of the potential for pharmacokinetic interactions with study drugs through the protease inhibition of the cytochrome P450 3A4 (CYP3A4); in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
* Patients with chronic hepatitis B or C are also excluded from this study
* Any condition that impairs patient's ability to swallow whole pills
* Any malabsorption problem
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in the study (e.g. ixabepilone, cremaphor)
* Any \> grade I neuropathy is contraindicated | City of Hope Medical Center | OTHER | {
"id": "08166",
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"type": null
} | Unknown | {
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} | 2010-03-08T00:00:00 | {
"date": "2019-11-05",
"type": "ACTUAL"
} | {
"date": "2010-03-10",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
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} | [
"Male Breast Cancer",
"Recurrent Breast Cancer",
"Stage IV Breast Cancer"
] | null | null | [
{
"city": "Duarte",
"country": "United States",
"facility": "City of Hope",
"geoPoint": {
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"lon": -117.97729
},
"state": "California"
},
{
"city": "South Pasadena",
"country": "United States",
"facility": "South Pasadena Cancer Center",
"geoPoint": {
"lat": 34.11612,
"lon": -118.15035
},
"state": "California"
}
] | null | null | {
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"description": null,
"measure": "Dose limiting toxicity defined as any treatment-related grade 3 or greater non-hematologic toxicity, grade 4 febrile neutropenia, thrombocytopenia or grade 4 neutropenia as a result of unresolved toxicity",
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}
],
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},
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"description": null,
"measure": "Toxicity profile",
"timeFrame": "Cohort A every 3 weeks during treatment, Cohort B every 4 weeks during treatment."
}
]
} | [
{
"affiliation": "City of Hope Medical Center",
"name": "Yuan Yuan, MD, PhD",
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}
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NCT00214357 | null | The Effects of Mindfulness Training on School Staff | The Effects of Mindfulness Training on School Staff Emotions, Attention, and Stress | None | INTERVENTIONAL | COMPLETED | 2005-09-15T00:00:00 | null | null | null | [
"NA"
] | 19 | 18 | null | ALL | true | The primary research objective is to investigate psychological, behavioral, and physiological changes in school staff as a result of undergoing meditation and stress reduction training. Specifically, we hypothesize that school staff undergoing meditation and stress reduction training will show decreased emotional distress on self-report measures, increased sustained attention on a behavioral task, and decreased stress levels as indexed by salivary cortisol. | null | Inclusion Criteria:
* Staff from Madison, WI area elementary school
Exclusion Criteria:
* N/A | University of Wisconsin, Madison | OTHER | {
"id": "M-2004-1277",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2005-09-15T00:00:00 | {
"date": "2015-10-05",
"type": "ESTIMATED"
} | {
"date": "2005-09-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Teachers"
] | null | null | [
{
"city": "Madison",
"country": "United States",
"facility": "University of Wisconsin",
"geoPoint": {
"lat": 43.07305,
"lon": -89.40123
},
"state": "Wisconsin"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Self-report; behavioral task; diurnal cortisol",
"timeFrame": null
}
],
"secondary": [
{
"description": null,
"measure": "Self-report measures",
"timeFrame": null
}
]
} | [
{
"affiliation": "University of Wisconsin, Madison",
"name": "Donal G MacCoon, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT04289857 | null | Neurodynamics to Improve Jump Functionality in Trampoline Jump Gymnasts | Efficacy of a Physiotherapy Intervention by Means of Neurodynamic Technique to Improve the Functionality of the Jump in Trampoline Jump Gymnasts. A Randomized Clinical Study. | None | INTERVENTIONAL | WITHDRAWN | 2020-02-27T00:00:00 | null | 2020-05-20T00:00:00 | 2020-06-10T00:00:00 | [
"NA"
] | 0 | 18 | 30 | MALE | true | The goal of neurodynamics is to restore homeostasis of peripheral nerves. In the current context there is varied evidence that links neurodynamics with clinical pain treatments or different pathologies, but little evidence regarding changes in the functionality of athletes, which could be related to improvements in performance.
The main objective of the study is to determine if the neurodynamic technique is effective in increasing the range of hip mobility and in increasing the jump with counter movement.
Randomized, simple blind clinical study. 15 trampoline jumping gymnasts will be randomized to the two study groups: experimental (active sciatic neurodynamics techniques) and control (without intervention). The intervention will last 4 weeks, with 3 weekly sessions of approximately 5 minutes each. The study variables will be the range of hip flexion movement (goniometry) and the countermove jump (My Jump® application). A descriptive statistical analysis will be performed calculating the main statistical characteristics. The sample distribution will be calculated using a Shapiro-Wills analysis. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
It is intended to observe improvement in the range of hip flexion movement and in the jump with countermovement. | null | Inclusion Criteria:
* Trampoline jumping gymnasts
* Male
* Aged between 18 and 30 years
* Who train at least 2 days a week
* Federated in the Madrid Gymnastics Federation
Exclusion Criteria:
* Subjects who have a medical diagnosis of musculoskeletal pathology at the time of beginning the study
* Neural pathology in the last 6 months
* With cognitive deficit that prevents them from understanding physical tests and questionnaires
* Have not signed the informed consent | Investigación en Hemofilia y Fisioterapia | NETWORK | {
"id": "Neuro",
"link": null,
"type": null
} | COVID-19 Lockdown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-02-27T00:00:00 | {
"date": "2021-09-02",
"type": "ACTUAL"
} | {
"date": "2020-02-28",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
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},
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"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Athlete Foot"
] | ["Gymnastics trampoline", "Neurodynamics", "Jump", "Range of motion", "Randomized clinical trial"] | null | [
{
"city": "Madrid",
"country": "Spain",
"facility": "Universidad Europea de Madrid",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": "Comunity Of Madrid"
}
] | null | null | {
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"description": null,
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"timeFrame": "Screening visit, within the first seven days after treatment and after one month follow-up visit"
}
],
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"description": null,
"measure": "Change from baseline jump height with counter movement after treatment and at month",
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}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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