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float64 | maximum_age
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dict | why_stopped
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NCT04574466 | null | Scaling-up Psychological Interventions With Syrian Refugees in Switzerland (STRENGTHS_CH): RCT | Scaling-up Psychological Interventions With Syrian Refugees in Switzerland: RCT | None | INTERVENTIONAL | COMPLETED | 2020-09-16T00:00:00 | null | 2022-12-31T00:00:00 | 2022-12-31T00:00:00 | [
"NA"
] | 54 | 18 | null | ALL | false | The current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological well-being, as well as on the healthcare systems of countries hosting refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the specific psychological treatment due to a lack of specialists. To address this problem the WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people in communities affected by adversity. The effectiveness and implementation of PM+ has never been examined in Switzerland before, this is the aim of the current randomized controlled trial. | Recent crises in the Middle East have resulted in an unprecedented increase in the worldwide number of refugees and asylum seekers. Switzerland (CH) is strongly affected by this crisis too.There are currently about 19'000 Syrian refugees and asylum seekers in Switzerland. A similar number of other Arabic-speaking individuals have applied for asylum in Switzerland since 2011. Due to the ongoing war in the MENA region, it is unlikely that this kind of migration and flight will resolve within the next years.
Refugees have typically been exposed to multiple stressors related to war and displacement including loss of family members, destruction of homes and livelihoods and human rights violations such as sexual violence or torture. They have often undertaken a risky and stressful flight leaving their homes for an unknown future. Accordingly, various studies have shown that refugees are at considerable risk of developing common mental disorders, including depression, anxiety, posttraumatic stress disorder (PTSD) and related somatic health symptoms.
According to the UNHCR, 85% of all displaced persons are hosted in third-world countries where appropriate mental health care is often not available. However, Western health systems are also often unable to appropriately cover the needs of this particularly vulnerable population regarding prevention and treatment of mental health problems. As a response to this situation, the WHO developed the low-intensity Problem Management Plus (PM+) programs, a new generation of short, resource-sparing, trans-diagnostic (i.e., not specifically aimed at treating a certain mental disorder) programs to reduce common mental health symptoms and improve psychosocial functioning. PM+ is based on the WHO treatment guidelines for conditions related to stress. PM+ is a 5-sessions intervention aimed at reducing symptoms of depression, anxiety, PTSD, and related conditions, is delivered by trained non-specialized workers or lay people, and is available in individual and group delivery formats for both children and adults. It comprises evidence-based techniques of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. PM+ has been successfully tested for effectiveness in Kenya and Pakistan.
The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study aims at evaluating the effectiveness and implementation of PM+ with Syrian refugees in different settings in low- and high-resource countries. The study consortium includes international experts in the domains of trauma and public mental health as well as representatives of WHO and UNHCR. The Zürich study site has been consigned to examine PM+ with adult refugees in an individual treatment setting in Switzerland. At the same time, similar studies in other countries will be undertaken. Despite the objective of these studies to implement and evaluate the effectiveness of PM+ in refugees, each research institution acts independently. Moreover, the other studies will be completed in different treatment settings - i.e., in children and adolescents (Lebanon), in groups (Turkey and Netherlands), and internet-delivered PM+ (Germany and Egypt).
To date, the effectiveness and implementation of PM+ has not been investigated in a highly industrialized country, such as Switzerland.
In the present study, the investigators will evaluate the effectiveness and implementation of PM+ in Arabic speaking refugees in Switzerland. | Inclusion Criteria:
* Male and female Arabic-speaking refugees or asylum seekers who entered Switzerland after March 2011
* ≥ 18 years of age
* Arabic-speaking (Levantine Arabic)
* Signed Informed Consent after being informed
* Increased psychological distress (K10 \> 15)
* Reduced psychological functioning (WHODAS 2.0 \> 16)
Exclusion Criteria:
* Inability to follow the procedures of the study
* Previous enrolment into the current study phase
* Participants under tutelage
* Acute or severe psychiatric (e.g. schizophrenia) or neurological illness (e.g. dementia)
* Imminent suicide risk | University of Zurich | OTHER | {
"id": "BASEC-2017-01175-rct",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-10-01T00:00:00 | {
"date": "2023-05-09",
"type": "ACTUAL"
} | {
"date": "2020-10-05",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The definitive RCT will inform us about the effectiveness and implementation of the intervention.\n\nAfter the baseline assessment, three hundred eighty participants (N = 380) will be involved in the exploratory RCT (assigned to either the PM+ intervention (n=190) or the ETAU control condition (n=190)).",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "All instruments and questions will be administered using tablets by trained research staff blind to the allocation status of the participants.",
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]
},
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"primaryPurpose": "TREATMENT",
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} | [
"Distress",
"PTSD",
"Anxiety",
"Depression",
"Trauma",
"Functional Disabilities",
"Common Mental Health Problems"
] | ["Problem Management Plus", "Distress", "Mental Health Care", "Low-intensity", "Refugees"] | null | [
{
"city": "Zürich",
"country": "Switzerland",
"facility": "Klinik für Konsiliarpsychiatrie und Psychosomatik",
"geoPoint": {
"lat": 47.36667,
"lon": 8.54999
},
"state": null
}
] | null | null | {
"other": [
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"description": null,
"measure": "Assessment of change in self-reported problems",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "Exposure to traumatic events",
"timeFrame": "Measured at baseline assessment and 12-months follow up only"
},
{
"description": null,
"measure": "Reduction of post-migration stressors",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "Somatization and somatic symptoms",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "Level of integration",
"timeFrame": "Screening, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "General Self-Efficacy",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "Attitudes towards mental health",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "Impact of COVID-19 pandemic",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "Cost of Care",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "Access to health care services",
"timeFrame": "Baseline assessment"
},
{
"description": null,
"measure": "Assessing the extent to which the strategies taught in PM+ are used before and after the study participation with the Reducing Tension Checklist",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment."
}
],
"primary": [
{
"description": null,
"measure": "Change in psychological distress",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
}
],
"secondary": [
{
"description": null,
"measure": "Change in posttraumatic stress disorder symptoms",
"timeFrame": "Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
},
{
"description": null,
"measure": "Change in functional disability",
"timeFrame": "Screening, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment"
}
]
} | [
{
"affiliation": "Klinik für Konsiliarpsychiatrie und Psychosomatik",
"name": "Naser Morina, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29163867", "type": "BACKGROUND", "citation": "Sijbrandij M, Acarturk C, Bird M, Bryant RA, Burchert S, Carswell K, de Jong J, Dinesen C, Dawson KS, El Chammay R, van Ittersum L, Jordans M, Knaevelsrud C, McDaid D, Miller K, Morina N, Park AL, Roberts B, van Son Y, Sondorp E, Pfaltz MC, Ruttenberg L, Schick M, Schnyder U, van Ommeren M, Ventevogel P, Weissbecker I, Weitz E, Wiedemann N, Whitney C, Cuijpers P. Strengthening mental health care systems for Syrian refugees in Europe and the Middle East: integrating scalable psychological interventions in eight countries. Eur J Psychotraumatol. 2017 Nov 7;8(sup2):1388102. doi: 10.1080/20008198.2017.1388102. eCollection 2017."}, {"pmid": "26407793", "type": "BACKGROUND", "citation": "Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available."}, {"pmid": "19654388", "type": "BACKGROUND", "citation": "Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M. Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA. 2009 Aug 5;302(5):537-49. doi: 10.1001/jama.2009.1132."}, {"pmid": "30948286", "type": "BACKGROUND", "citation": "Rahman A, Khan MN, Hamdani SU, Chiumento A, Akhtar P, Nazir H, Nisar A, Masood A, Din IU, Khan NA, Bryant RA, Dawson KS, Sijbrandij M, Wang D, van Ommeren M. Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1733-1744. doi: 10.1016/S0140-6736(18)32343-2. Epub 2019 Apr 1."}, {"pmid": "28809935", "type": "BACKGROUND", "citation": "Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug."}, {"pmid": "15823380", "type": "BACKGROUND", "citation": "Fazel M, Wheeler J, Danesh J. Prevalence of serious mental disorder in 7000 refugees resettled in western countries: a systematic review. Lancet. 2005 Apr 9-15;365(9467):1309-14. doi: 10.1016/S0140-6736(05)61027-6."}, {"pmid": "26510473", "type": "BACKGROUND", "citation": "Bogic M, Njoku A, Priebe S. Long-term mental health of war-refugees: a systematic literature review. BMC Int Health Hum Rights. 2015 Oct 28;15:29. doi: 10.1186/s12914-015-0064-9."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D001526",
"term": "Behavioral Symptoms"
}
],
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"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
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NCT05756166 | null | Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer | Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2023-02-23T00:00:00 | null | 2025-04-08T00:00:00 | 2025-12-30T00:00:00 | [
"PHASE1",
"PHASE2"
] | 5 | 18 | null | ALL | false | This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer. | PRIMARY OBJECTIVE:
I. To evaluate the safety profile of modified CKM (celecoxib, rintatolimod and interferon alpha-2b) regimen (replacement of INTRON \[registered trademark\] A, using alternative source of interferon alpha-2b \[IFNalpha2b\]) combined with pembrolizumab therapy in metastatic triple negative breast cancer patients.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of the CKM in combination with pembrolizumab in patients with metastatic triple negative breast cancer (mTNBC) as compared to historic outcomes of pembrolizumab and other anti-PD1/PD-L1 therapies alone, as determined by secondary measures of efficacy including:
Ia. Progression-free survival (PFS); Ib. Overall survival (OS); Ic. Overall response rate (ORR) to the combination therapy using Immune Modulated Response Evaluation Criteria in Solid Tumors (iRECIST); Id. Disease control rate (DCR) using iRECIST.
EXPLORATORY OBJECTIVES:
I. Examine the immune analysis profile of CKM and pembrolizumab combination:
Ia. Examine the relationship of infiltrating CD4+ and CD8+ T cells and other immune and genetic markers, and their associated PD-1, CD45RA or CD45RO levels; Ib. Correlate PD-L1 expression within both neoplastic and nonneoplastic stromal elements of the tumor microenvironment to PFS, OS, ORR and adverse events (AEs); Ic. Correlate immune panel results with ORR, PFS, OS and AEs.
II. Comparison of response assessment criteria for a prospective analysis:
IIa. Response evaluation criteria in solid tumors (RECIST) 1.1 response assessment; IIb. iRECIST response assessment.
OUTLINE: This is a phase I dose escalation study of interferon alpha-2b followed by a phase II study. Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive rintatolimod intravenously (IV), celecoxib orally (PO), interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) at screening and follow-up and undergo blood sample collection during screening and on study.
COHORT II: Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up. | Inclusion Criteria:
* Age \>= 18 years of age
* Have pathologically confirmed diagnosis of PDL-1-negative or PDL1 positive unresectable or metastatic TNBC with no curative treatment options
* Have been informed of other treatment options
* Patient has lesion that can be biopsied and is willing to undergo the procedure as part of the protocol. Note: For cohort 1 and cohort 2: Patient with accessible tumor will be offered optional pre-treatment and post-treatment biopsies. Biopsies are mandatory for cohort 3
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Ability to swallow and retain oral medication
* Have measurable disease per RECIST 1.1 criteria present
* Any line of therapy allowed, radiologically confirmed progression
* No cancer-directed therapy for at least 3 weeks prior to study treatment (bone-directed therapies are allowed)
* Platelets \>= 100,000/uL
* Hemoglobin \>= 9.0 g/dL
* Absolute neutrophil count (ANC) \>= 1500/uL
* Total bilirubin =\< institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional ULN
* Creatinine \< ULN or, creatinine clearance \>= 50 mL/min per Cockcroft-Gault equation for patients with creatinine levels greater than ULN
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Patients currently treated with systemic immunosuppressive agents, including steroids (greater than equivalent of 10 mg daily of prednisone), are ineligible until 3 weeks after removal from immunosuppressive treatment. (Inhaled steroids are allowed.)
* Patients with active autoimmune disease or history of transplantation
* Pregnant or nursing female participants
* Unwilling or unable to follow protocol requirements
* Patients with known serious mood disorders. (Major depression diagnosis is an exclusion. Other stable mood disorders on stable therapy for \> 6 months or not requiring therapy may be allowed after consultation with the principal investigator.)
* Cardiac risk factors including:
* Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent. While our published clinical studies involving short-term CKM did not indicate increased risk of cardiac events, the CKM can induce flu-like symptoms, providing justification for its avoidance in patients with recent cardiac events
* Patients with a New York Heart Association classification of III or IV
* Patients with a history of stroke
* History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years
* Prior allergic reaction or hypersensitivity to nonsteroidal antiinflammatory drug (NSAIDs) or any drugs administered on protocol
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
* Any patients with a positive antinuclear antibodies test will be excluded from study
* Has a known history of human immunodeficiency virus (HIV) infection
* Concurrent active hepatitis B (defined as hepatitis B antigen \[HBsAg\] positive and/or detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\]) and hepatitis C virus (defined as anti-hepatitis C virus \[HCV\] antibody \[Ab\] positive and detectable HCV ribonucleic acid \[RNA\]) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection | Roswell Park Cancer Institute | OTHER | {
"id": "I-3010822",
"link": null,
"type": null
} | Unknown | null | 2023-02-23T00:00:00 | {
"date": "2025-04-27",
"type": "ACTUAL"
} | {
"date": "2023-03-06",
"type": "ACTUAL"
} | [
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"allocation": "NON_RANDOMIZED",
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"maskingInfo": {
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"Anatomic Stage IV Breast Cancer AJCC v8",
"Metastatic Triple-Negative Breast Carcinoma",
"Unresectable Triple-Negative Breast Carcinoma"
] | null | null | [
{
"city": "Buffalo",
"country": "United States",
"facility": "Roswell Park Cancer Institute",
"geoPoint": {
"lat": 42.88645,
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"state": "New York"
}
] | [
{
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Incidence of adverse events",
"timeFrame": "Up to 2 years"
}
],
"secondary": [
{
"description": null,
"measure": "Progression-free survival",
"timeFrame": "From the start of post-chemokine modulation (CKM) therapy therapy until disease progression, death, or lst follow-up, assessed up to 2 years"
},
{
"description": null,
"measure": "Overall response rate",
"timeFrame": "From the start of study treatment until end of treatment or disease progression/recurrence, assessed up to 2 years"
},
{
"description": null,
"measure": "Overall survival",
"timeFrame": "From the start of post-CKM therapy until death due to any cause or last follow up, assessed up to 2 years"
},
{
"description": null,
"measure": "Disease control rate",
"timeFrame": "Up to 2 years"
}
]
} | [
{
"affiliation": "Roswell Park Cancer Institute",
"name": "Ellis Levine, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
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{
"id": "D009369",
"term": "Neoplasms"
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"term": "Neoplasms by Site"
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{
"asFound": "Triple Negative Breast Cancer",
"id": "M30373",
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],
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"term": "Breast Neoplasms"
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{
"id": "D064726",
"term": "Triple Negative Breast Neoplasms"
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]
} | {
"ancestors": [
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"id": "D000074322",
"term": "Antineoplastic Agents, Immunological"
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{
"id": "D000970",
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"id": "D000082082",
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NCT03498066 | null | Beta Blocker Interruption After Uncomplicated Myocardial Infarction | Assessment of βeta Blocker Interruption After Uncomplicated mYocardial Infarction on Safety and Symptomatic Cardiac Events Requiring Hospitalization: The AβYSS Study | AβYSS | INTERVENTIONAL | COMPLETED | 2018-03-21T00:00:00 | null | 2023-10-31T00:00:00 | 2023-10-31T00:00:00 | [
"PHASE4"
] | 3,700 | 18 | null | ALL | false | ABYSS is a national, multicenter, randomised, open label trial using the PROBE study design, that will evaluate the non-inferiority of the interruption of ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint or death, MI, Stroke and rehospitalization for others cardiovascular reasons. | Despite the outstanding progress made in cardiac care over the last few years, cardiovascular diseases remain the leading cause of morbidity and mortality in developed countries.
After the initial clinical event, patients are considered to have a chronic disease which combined with the increasing actual life expectancy patients with CAD are a major source of expenses due to their life-long treatment and follow-up.
ΒB are prescribed during the initial hospitalisation for MI and in the post-MI phase. European (European Society of Cardiology, ESC) and American (ACC/AHA) guidelines initially gave βB therapy a class I recommendation for MI or acute coronary syndrome (ACS) for the first year of treatment and extended such recommendation without solid data up to 3 years after MI , . However, there has been no recent clinical trial to evaluate safety and efficacy of long term ΒB therapy in the contemporary therapeutic era. Taking such lack of evidence in account and acknowledging that clinical practice has changed, the latest ESC STEMI (2014) and NSTEMI (2015) Guidelines degraded the recommendation for the use of ΒB in post MI patients (Class IIa B) during the hospitalization period and they question the validity of its use after the initial stabilization phase. This was confirmed in the 2017 STEMI Guidelines.
The primary objective of the ABYSS trial is to demonstrate the non-inferiority of the interruption of ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint.
The primary endpoint of the study will be evaluated, with one-year minimum follow-up, and will be the composite of Major Adverse Cardiovascular Events (MACE) measured at the longest follow-up including:
* All-cause death
* Stroke
* Myocardial infarction Hospitalisation for other cardiovascular (CV) reason.
It is expected that the interruption of βB therapy will not alter the prognosis of patients and improve safety and quality of life of patients and considerably reduce healthcare direct or indirect costs. | Inclusion criteria
Subjects meeting all of the following criteria will be considered for enrolment into the study:
1. Male or female +/=18 years of age
2. Current treatment with βB whatever the drug or the dose used
3. Prior acute myocardial infarction 6 months or more before randomisation defined either by:
AβYSS protocol, version 3.0 of 25/05/2021 Page 32 / 65
* An episode of ST elevation MI with ST segment elevation (STEMI) and/or the presence of Q wave (Type I MI)
* an episode of Non ST Elevation MI (NSTEMI) with preferably at least one of the followings:
* i) a documented hypokinetic or akinetic segment on echo or any other imaging technique
* ii) segmental hypoperfusion Thallium or any other imaging technique
* iii) segmental aspect of necrosis on MRI
* An episode of silent MI discovered on ECG or Cardiac Imaging. Importantly = The mention of an MI on a report is enough to be considered as a prior MI and it is not necessary to retrieve the source document and/or documentation of this prior MI .
4. Patient affiliated to Social Security
5. Informed consent obtained in writing at enrolment into the study
Exclusion Criteria:
* Subjects presenting with any of the following will not be included in the study:
1. Uncontrolled arterial hypertension according to investigator decision
2. Prior episode of heart failure in the past two years of follow-up and/or low left ventricular ejection fraction \<40% requiring the use of βB;
3. New ACS (in the past 6 months) including UA/NSTEMI and STEMI;
4. Persistent angina or ischemia (\>10% viable myocardium) requiring the use of βB;
5. Prior episode of ventricular or supraventricular arrhythmia in the past year of follow-up requiring the use of ΒB;
6. Treatment with other investigational agents or devices within the previous 30 days, or previous enrolment in this trial.
7. Pregnant Women or breast feeding women
8. Patient under legal protection (protection of the court, or in curatorship or guardianship). | Assistance Publique - Hôpitaux de Paris | OTHER | {
"id": "P150946J",
"link": null,
"type": null
} | Unknown | {
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} | 2018-04-06T00:00:00 | {
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"type": "ACTUAL"
} | {
"date": "2018-04-13",
"type": "ACTUAL"
} | [
"ADULT",
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] | null | null | true | {
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} | [
"Myocardial Infarction"
] | ["Myocardial Infarction", "Beta-Blockers", "Stable Coronary Artery Disease"] | null | [
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"city": "Paris",
"country": "France",
"facility": "Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière",
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},
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"description": null,
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}
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}
],
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"timeFrame": "Through study completion, with a minimum of 1 year"
}
]
} | [
{
"affiliation": "APHP / Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris (APHP) / ACTION Study Group / Sorbonne Université Paris-France",
"name": "Johanne SILVAIN, MD-PhD",
"role": "STUDY_CHAIR"
}
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} |
NCT06282666 | null | Lumbar ESPB in Hip Replacement Surgery | Comparison of Continuous Lumbar Erector Spinae Plane Block to Continuous Epidural Analgesia in Patients Undergoing Hip Replacement Surgery | ESPB_HIP | INTERVENTIONAL | RECRUITING | 2024-02-12T00:00:00 | null | 2025-02-01T00:00:00 | 2025-08-01T00:00:00 | [
"NA"
] | 60 | 18 | 100 | ALL | false | In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed. | This is a prospective trial in patients undergoing elective hip replacement surgery.
Written informed consent will be obtained from each patient, and our study will be conducted following the tenets of the Declaration of Helsinki for medical research involving human subjects.
Before the surgery, preoperative pain severity, chronic pain severity, and ability to sit, stand, and walk will be assessed.
Each participant will be anesthetized with spinal technique and randomly allocated patients according to postoperative analgesia to the continuous epidural (Epidural) group and the continuous lumbar erector spinae plane block (ESPB) group. Both regional techniques will be continued during the first day. Investigators will measure postoperative oxycodone consumption with a patient-controlled analgesia (PCA) pump. At several points, the patients' pain at rest and during activity will be evaluated on the visual analog scale (VAS, 0-10), their quadriceps femoris muscle strength on the Lovett scale (0-5), and their ability to sit, stand upright, and walk on the Timed Up and Go test. Moreover, the patient's recovery will be assessed through the Quality of Recovery 40 (QoR-40) questionnaire on the first postoperative day.
After the patient's discharge, information regarding acute and chronic pain severity and quality of recovery will be collected during the phone interview. | Inclusion Criteria:
* primary hip replacement surgery due to coxarthrosis
* anesthetized with spinal technique
* able to use PCA pump
* having access to phone
Exclusion Criteria:
* patients taking painkillers not related to coxarthrosis;
* having active cancer,
* dementia or challenging contact with the patient;
* suffering from depression or other psychiatric disorders that required antidepressant treatment;
* consuming alcohol or recreational drug addiction;
* contraindications to the regional block. | Medical University of Lublin | OTHER | {
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"link": null,
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} | Unknown | {
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} | {
"date": "2024-02-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two groups will be randomly allocated to Epidural and ESPB (1:1)",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation.\n\nPhysiotherapists assessing outcomes will not be aware of patient allocation.",
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]
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} | [
"Coxarthrosis",
"Pain, Postoperative",
"Pain, Acute",
"Pain, Chronic",
"Postoperative Pain, Chronic",
"Analgesia",
"Quality of Life",
"Anesthesia",
"Spinal"
] | ["erector spinae plane block", "epidural analgesia", "quality of recovery", "patient-controlled analgesia", "Timed Up and Go test", "visual analog scale", "neuropathic pain symptom inventory", "Lovett scale", "spinal anesthesia"] | null | [
{
"city": "Lublin",
"country": "Poland",
"facility": "II Department of Anesthesia and Intensive Care",
"geoPoint": {
"lat": 51.25,
"lon": 22.56667
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Opiod consumtion with PCA",
"timeFrame": "From the admission to the postoperative care unit to the next postoperative day for 24 hours."
}
],
"secondary": [
{
"description": null,
"measure": "Pain at rest",
"timeFrame": "24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation"
},
{
"description": null,
"measure": "Pain upon activity",
"timeFrame": "24 hours before the surgery, after the surgery immediately in the postoperative care unit, 4, 8, 24, and 48 hours following the operation"
},
{
"description": null,
"measure": "Lovett test",
"timeFrame": "24 hours before the surgery, 24 and 48 hours after the operation"
},
{
"description": null,
"measure": "TUG",
"timeFrame": "24 hours before the surgery, 24 and 48 hours after the operation"
},
{
"description": null,
"measure": "QoR-40",
"timeFrame": "It will be measured 24 hours, 30 days, and three months following the surgery."
},
{
"description": null,
"measure": "NPSI",
"timeFrame": "24 hours before the surgery and 3 and 6 months following the operation"
}
]
} | [
{
"affiliation": "Medical University of Lublin",
"name": "Paweł Piwowarczyk, M.D., Ph.D.",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "38084571", "type": "BACKGROUND", "citation": "Hanych A, Kutnik P, Pasiak P, Zakrzewska-Szalak A, Wichowska O, Jednakiewicz M, Nogalski A, Piwowarczyk P, Borys M. Continuous lumbar erector spinae plane block as an alternative to epidural analgesia in pain treatment in patients undergoing hip replacement surgery - a prospective pilot study. Anaesthesiol Intensive Ther. 2023;55(4):272-276. doi: 10.5114/ait.2023.132517."}] | {"versionHolder": "2025-06-18"} | {
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NCT05243966 | null | Myriad™ Augmented Soft Tissue Reconstruction Registry | Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures | MASTRR | OBSERVATIONAL | RECRUITING | 2022-02-08T00:00:00 | null | null | null | null | 800 | 18 | null | ALL | false | This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention. | This is an observational, multi-center, single arm, Phase IV study, designed to evaluate the safety and clinical outcomes of Matrix and Morcells in soft tissue reconstruction procedures.
The study is a registry study and will enroll participants who are undergoing a surgical procedure, and where the attending physician will use Myriad Matrix™ and/or Morcells™ as part of the surgical intervention.
Participants enrolled in the study will be undergoing a range of surgical procedures involving the reconstruction of soft tissues, including but not limited to:
* Abdominal dehiscence
* Necrotizing soft tissue infection (NSTI)
* Lower extremity complex non-healing wounds (limb salvage)
* Pilonidal sinus disease
* Anal fistula
* Hidradenitis suppurativa reconstruction
* Pressure injury reconstruction
Other procedure types may be included at the discretion of the Investigator/Research Team.
Participants that are being enrolled in the study would otherwise be undergoing their surgical procedure with either of the Myriad™ devices as part of Standard of Care (SoC).
The pre-operative care and preparation of the surgical site (prior to the application of Myriad™ devices) shall be undertaken at the discretion of the attending physician and per their institutional protocols and procedures. Surgical technique for the participants reconstruction is at the discretion of the attending physician. Use of Myriad Matrix™ or Morcells as part of the surgery shall be per the products Instructions for Use. Myriad Matrix™ devices may be implanted or used for dermal regeneration as part of the participants surgical procedure. Myriad Morcells™ may be used for dermal regeneration and in combination with the Myriad Matrix™ devices. The participants post-operative care is at the discretion of the attending physician.
Early and late-stage healing outcomes will be assessed as part of the study and as part of standard of care.
Through the course of treatment and following up care de-identified patient data (quantitative qualitative assessment measures and digital images) will be captured and from the basis of the registry dataset. | Inclusion Criteria:
* Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
* Male or female patients aged 18 years or above
* Patients where Matrix and/or Morcells were used as part of their soft tissue reconstruction procedure
* Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule
Exclusion Criteria:
* Patients with known sensitivity to ovine (sheep) derived material
* Patients with full thickness ('third degree') burns
* Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)
* Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study
* Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
* Pregnant or lactating women
* Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study | Aroa Biosurgery Limited | INDUSTRY | {
"id": "CIP.SUR.001",
"link": null,
"type": null
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"nctId": null,
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} | 2022-02-08T00:00:00 | {
"date": "2025-03-07",
"type": "ACTUAL"
} | {
"date": "2022-02-17",
"type": "ACTUAL"
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"Necrotizing Soft Tissue Infection",
"Lower Extremity Wound",
"Pilonidal Sinus",
"Anal Fistula",
"Hidradenitis Suppurativa",
"Pressure Injury"
] | ["Soft tissue reconstruction", "Limb salvage", "Extracellular matrix", "Soft tissue reinforcement", "Wound reconstruction", "Regenerative medicine"] | null | [
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"state": "Ohio"
},
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"city": "West Reading",
"country": "United States",
"facility": "Tower Health Reading Hospital",
"geoPoint": {
"lat": 40.3337,
"lon": -75.94743
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"other": null,
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{
"description": null,
"measure": "Proportion of participants with treatment emergent adverse events during the study",
"timeFrame": "3 years"
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],
"secondary": [
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"measure": "Percentage of surgical complications",
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"measure": "Time (weeks) to 100% granulation",
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"timeFrame": "1 week post application"
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"name": "Tracee Short, MD",
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NCT05831566 | null | Expertise Asthma COPD Program with Digital Support | Expertise Asthma COPD Program with Digital Support | EXACT@home | INTERVENTIONAL | RECRUITING | 2022-12-20T00:00:00 | null | 2025-04-30T00:00:00 | 2026-04-30T00:00:00 | [
"PHASE3"
] | 138 | 18 | null | ALL | false | The aim EXACT@Home is to create an evidence-based health program using e.g. questionnaires, a digital health platform and multiple digital devices to further improve the assessment of patients diagnosed with severe asthma. By better charting treatable traits (e.g. poor adherence, physical inactivity, dysfunctional breathing), we expect to improve the indication for the use of biologics. One the devices that will be used is also a medicinal product: a digital inhaler, which monitors adherence and inhaler technique through its connected application and aims to improve adherence and inhaler technique with reminders and notifications. Next to this an activity tracker, hand-held spirometer and FeNO measuring device will be used. The information of the devices will be collected in a Personal Digital Healthcare Environment (PDHE). Patients diagnosed with severe asthma according to the regional asthma Multi-Disciplinary Team Meeting (MDTM) eligible for a treatment with biologics will be included. Half of the patients will immediately receive a biologic. The other half will first undergo the systematic assessment including home monitoring (=EXACT@home) and afterwards a treatment will be chosen based on this evaluation: optimization of treatable traits when present and/or biologics. The chosen treatment of both, the intervention and control group, will be evaluated during 11-12 months. | Rationale:
Asthma is a common multifactorial disease with chronic inflammation of the lower airways, which is in most cases adequately treated by inhalation medication. 17% of asthma patients have difficult-to-treat asthma, which is uncontrolled despite of an optimal treatment with medication due to the presence of 'treatable traits'. Examples of treatable traits are poor adherence to ICS/LABA therapy and inhaler technique, dysfunctional breathing, physical inactivity and behavior. Severe and refractory asthma is a subtype of difficult-to-treat asthma and only occurs if the asthma is uncontrolled despite optimized treatment with medication and addressing of treatable traits, which occurs in only 3.7% of all asthma patients. This group of patients is responsible for a high burden of overall disease, as well as large healthcare costs.Treatment options with biologics have fundamentally changed the care for patients with severe asthma by giving a relevant improvement in asthma control, the number of asthma exacerbations and quality of life. On the other hand, these drugs are also very expensive and must be given for the correct indication.
The Centre of Excellence for severe Asthma, Franciscus Gasthuis \& Vlietland, Rotterdam organizes a weekly Multi-Disciplinary Team Meeting (MDTM) for hospitals in the South-West of the Netherlands to discuss their patients with problematic asthma and to start a treatment with biologics approved for severe asthma (in this document further called biologics). Despite maximal efforts of all stakeholders, the complete overview of a patient and the treatable traits is often hampered by the complexity and heterogeneity of severe asthma.
The aim of the EXACT@Home (Expertise Asthma COPD program with digital support) study is to further improve the assessment of treatable traits using ehealth before considering treatment with biologics.
Objectives:
Primary objective: To investigate if the EXACT@home program results in a reduced percentage of patients treated with biologics by means of systematically targeting treatable traits measured after 6 months of follow up.
Secondary objectives: To determine whether the use of EXACT@home results in a reduced percentage of patients treated with biologicals after 11-12 months. Next to this it will be investigated if EXACT@home has an influence on quality of life, asthma control, dyspnea perception, lung function, exacerbation frequency, prednisolone use, direct healthcare consumption, self-management skills, patient satisfaction, adherence to ICS/LABA therapy and inhaler technique, physical activity, sleep and vital parameters. Next to this, breath pattern analysis will be performed with the electronic nose (eNose). Moreover, the safety of the Digital inhaler (BF-Digihaler-DS from Teva) and eNose (Spironose from Breathomix) and the course of the treatment in each patient will also be investigated.
Study design:
Open-label, randomized controlled trial with a superiority design.
Study population:
Patients aged ≥ 18 years, in which the diagnosis severe and refractory asthma and eligibility for treatment with biologics was determined at the regional asthma MDTM will be asked to participate in this project.
Intervention (if applicable):
Patients will be randomized in 2 groups (intervention - and control group). The intervention group participates in a holistic assessment called EXACT@home consisting of a period of 6 weeks addressing diagnosis, asthma phenotype and treatable traits using e.g. questionnaires and digital devices measuring airway obstruction, eosinophilic airway inflammation, adherence to ICS/LABA therapy, inhalation technique, movement, vital parameters and sleep. The information of the devices and all other information concerning the patient will be stored in an 'Personal Digital Healthcare Environment (PDHE)'. Afterwards the collected data will be evaluated. Based on this evaluation and the degree of asthma control the type of treatment will be determined: optimization of 'treatable traits' or start of treatment with biologics. The control group will immediately start the treatment with biologics. The chosen treatment of both, the intervention and control group, will be evaluated during 11-12 months.
Main study parameters/endpoints:
Study parameter primary outcome:
Difference between the intervention and control group in the percentage of patients treated with biologicals after 6 months of follow up.
Study parameters secondary outcome:
The percentage of patients treated with biologicals after 11-12 months of follow up, quality of life, asthma control, dyspnea perception, lung function, exacerbation frequency, prednisolone use, direct healthcare consumption, self-management skills, patient satisfaction, adherence to ICS/LABA therapy, inhaler technique, physical activity, slap, vital parameters, breath pattern analysis with the eNose, safety of the digital inhaler and eNose and the course of the treatment in each patient.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The possible burden of the intervention group is temporarily postponing an effective treatment with biologics in favour of in depth extensive assessment in patients with a severe disease for a short period of at least 6 weeks. On the other hand, the patient could benefit from the EXACT@home assessment possibly leading to a personalized treatment, in which a treatment with biologics might not be necessary anymore. Next to this, another possible minor burden is 1 extra visit in addition to standard care. | Inclusion criteria:
* Confirmed asthma diagnoses (≥12% and \>200 ml reversibility in FEV1 or positive histamine/methacholine provocation test or FeNO ≥50) according to the asthma guidelines
* Diagnosed with severe, refractory asthma with eligibility for treatment with specific asthma biologics (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) as determined at the regional asthma MDTM according to the asthma guidelines
* Age ≥ 18 years.
* Previous prescribed asthma biologics have to be ceased ≥ 4 times the half-life of that specific biologic.
* The patient has be relatively stable. The onset of an asthma exacerbation and/or a respiratory infection has to be ≥ 4 weeks ago.
Exclusion criteria:
* Primary COPD diagnosis.
* History of cancer:
* Current basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the start of the study.
* Current other malignancies. Patients are eligible to participate in the study provided that curative therapy was completed at least 5 years prior to the start of the study.
* Inability to sufficiently understand and read the Dutch language.
* Being unable to engage in a remote monitoring and coaching program through the use of a smartphone.
* Being unable to engage in physical activity (e.g. physical disability).
* Current pregnancy.
* Current breastfeeding.
* A liaison with the coordinating or (principal) investigator, which could likely influence the decision to participate in this study voluntarily (in concordance with the WMO - article 5). | Franciscus Gasthuis | OTHER | {
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NCT04610866 | null | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat | Evaluation of the Safety,Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2020-10-30T00:00:00 | null | 2028-02-28T00:00:00 | 2028-02-28T00:00:00 | [
"PHASE1",
"PHASE2"
] | 15 | 18 | 70 | ALL | false | Background:
Sickle cell disease (SCD) is a disorder that causes episodes of acute pain and progressive organ damage. Ways to manage SCD have evolved slowly. Treatments do not always work. Researchers want to see if a drug called mitapivat can help people with SCD.
Objective:
To test the long-term tolerability and safety of mitapivat (or AG-348) in people with SCD.
Eligibility:
Adults age 18-70 with SCD who took part in and benefited from NIH study #19H0097.
Design:
Participants will be screened with a medical history and physical exam. They will give a blood sample. They will have an electrocardiogram to test heart function.
Participants will repeat some of the screening tests during the study.
Participants will complete 6-minute walk tests to measure mobility and function. They will have transthoracic echocardiograms to measure heart and lung function. They will have dual-energy X-ray absorptiometry scans to measure bone health. They will complete online questionnaires that measure their overall health and well-being.
Participants will take the study drug in the form of a tablet twice a day.
Participants will keep a study diary. They will record any symptoms they may have.
Participation will last for about 54 weeks. After 48 weeks, participants can either keep taking the study drug for 48 more weeks or be tapered off of the study drug to complete the study. Those who are on the study for 1 year will have 10 study visits. Those who are on the study for 2 years will have 14 study visits. | Study Description:
The objective of this extension study is to evaluate the safety and tolerability of mitapivat (AG-348) as long-term maintenance therapy for subjects with sickle cell disease (SCD) who have completed the Phase I dose escalation study of mitapivat (NCT04000165, protocol 19H0097). Subjects will be treated with a maintenance dose of mitapivat previously assessed for safety and tolerability in the Phase I study for an initial 48 weeks and undergo safety monitoring, evaluation of pharmacokinetics and pharmacodynamics, and assessment of secondary clinical endpoints at regular intervals over the study period. Exploratory endpoints will allow for investigation of the mechanisms by which mitapivat may modulate red cell metabolism and survival and lead to clinical benefits in SCD. Subjects benefiting from the study drug will have the option to continue therapy for an additional 5 years.
Objectives:
Primary Objective:
- To assess the long-term safety and tolerability of mitapivat in subjects with stable sickle cell disease.
Secondary Objectives:
* To evaluate the pharmacokinetic/pharmacodynamic profile of long-term dosing of mitapivat, as well as its mechanisms of action on the glycolytic pathway in SCD subjects.
* To evaluate hemoglobin (Hb) response, changes in hemolytic markers, functional status, cardiopulmonary function, and health-related quality of life in SCD subjects maintained on mitapivat long-term.
* To monitor SCD-related safety endpoints in SCD subjects maintained on mitapivat long-term.
Tertiary/Exploratory Objectives:
- To assess the feasibility and usability of digital health technology in a drug trial for patients with SCD.
Endpoints:
Primary Endpoints:
- Frequency and severity of AEs and changes in clinical and laboratory parameters over 6 years of therapy with mitapivat.
Secondary Endpoints:
* Change from baseline in pharmacokinetic and pharmacodynamic measures over time.
* Hemoglobin (Hb) response and changes in hemolytic markers at 24 and 48 weeks on mitapivat.
* Sustained Hb response from weeks 12-48.
* Change from baseline in functional and cardiopulmonary status at 24 and 48 weeks on mitapivat.
* Change from baseline in quality of life at 24 and 48 weeks on mitapivat.
* Frequency of acute vaso-occlusive clinical events at 24 and 48 weeks on mitapivat.
Tertiary/Exploratory Endpoints:
- Usability of SCD Warrior digital Microhealth application (app) by providers and participants through simple feedback tools at each protocol visit reviewing ease of use and patient satisfaction. | * INCLUSION CRITERIA:
Subjects completing Study 19H0097 will first be screened for eligibility. Eligibility criteria are identical with the exception of criteria 5.1.4, 5.2.2, and 5.2.3.p. If any of the 15 subjects completing the 19H0097 study are unable to participate in or complete the current extension study (defined as completing 24 weeks of treatment with study drug to allow for assessment of the primary endpoint), then additional new subjects naive to mitapivat treatment may be enrolled to replace them.
Subjects will enroll onto the study and undergo screening. Subjects who do not meet any of the following criteria during screening will not receive the study intervention but will be counted toward study accrual. Screen failures may be rescreened at a later time.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1.1 Have provided signed written informed consent prior to performing any study procedure, including screening procedures.
1.2 Age between 18-70 years
1.3 Unequivocal diagnosis of HbSS confirmed by hemoglobin electrophoresis performed on patients at least 90 days after a blood transfusion if previously transfused, or DNA genotyping
1.4 No transfusion in the 12 weeks prior to signing consent, or absence of Hb A on hemoglobin analysis (by high-performance liquid chromatography; HPLC)
1.5 Have adequate organ function, as defined by:
1. Serum aspartate aminotransferase (AST) \<=2.5 x Upper Limit of Normal (ULN) (unless the increased AST is assessed by the Investigator as due to hemolysis) and alanine aminotransferase (ALT) \<=2.5 x ULN.
2. Serum creatinine \<=1.25 x ULN. If serum creatinine is \>1.25 x ULN, then glomerular filtration rate (based on creatinine) must be \>=60 mL/min.
3. Absolute neutrophil count \>=1.0 x 10\^9/L.
4. Hemoglobin \>= 7 g/dL
5. Platelet count \>=100 x 10\^9/L.
6. Activated partial thromboplastin time and international normalized ratio \<=1.5 x ULN, unless the subject is receiving therapeutic anticoagulants.
1.6 For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).
1.7 For women of reproductive potential be abstinent as part of their usual lifestyle, or agree to use one highly effective form of contraception from the time of giving informed consent, during the study, and for 28 days following the last dose of study treatment. Furthermore, due to the potential for mitapivat to reduce the effectiveness of hormonal contraceptives, women using hormonal contraception as a highly effective method of contraception must also utilize an acceptable barrier method while enrolled in the study and for at least 28 days after their last dose of mitapivat. Women using nonhormonal methods of contraception as a highly effective method do not need to use an additional barrier method.
1.8 Be willing to comply with all study procedures for the duration of the study.
EXCLUSION CRITERIA:
2.1 Documented pyruvate kinase deficiency
2.2 Screening hemoglobin level of \>= 11 g/dL
2.3 Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:
1. Poorly controlled hypertension (defined as systolic blood pressure \[BP\] \>150 mmHg or diastolic BP \>90 mmHg) refractory to medical management.
2. History of recent (within 24 weeks prior to signing consent) decompensated congestive heart failure; myocardial infarction or unstable angina pectoris; hemorrhagic, embolic, or thrombotic stroke; deep venous thrombosis; or pulmonary or arterial embolism.
3. Cardiac dysrhythmias judged as clinically significant by the Investigator.
4. Heart-rate corrected QT interval-Fredericia's method (QTcF) \>480 msec with the exception of subjects with right or left bundle branch block.
5. Clinically symptomatic cholelithiasis or cholecystitis. Prior cholecystectomy is not exclusionary. Subjects with symptomatic cholelithiasis or cholecystitis may be rescreened once the disorder has been treated and clinical symptoms have resolved.
6. History of drug-induced cholestatic hepatitis.
7. Iron overload sufficiently severe to result in a clinical diagnosis by the Investigator of cardiac (e.g., clinically significant impaired left ventricular ejection fraction), hepatic (e.g., fibrosis, cirrhosis), or pancreatic (e.g., diabetes) dysfunction.
8. Have a diagnosis of any other congenital or acquired blood disorder, or any other hemolytic process as defined by a positive direct antiglobulin test (DAT), except mild allo-immunization as a consequence of transfusion therapy.
9. Positive test for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (Ab) with signs of active hepatitis B or C virus infection. If the subject is positive for HCVAb, a reverse transcriptase-polymerase chain reaction test will be conducted. Subjects with hepatitis C may be rescreened after receiving appropriate hepatitis C treatment.
10. Positive test for human immunodeficiency virus 1 or 2 Ab.
11. Active infection requiring any use of systemic antimicrobial agents (parenteral or oral) or Grade \>=3 in severity (per National Cancer Institute Common Terminology Criteria for Adverse Events) within 8 weeks prior to signing consent.
12. Diabetes mellitus judged to be under poor control by the Investigator or requiring \>3 antidiabetic agents, including insulin (all insulins are considered 1 agent); use of insulin per se is not exclusionary.
13. History of any primary malignancy, with the exception of: curatively treated nonmelanomatous skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years.
14. Current or recent history of psychiatric disorder that, in the opinion of the Investigator or Medical Monitor, could compromise the ability of the subject to cooperate with study visits and procedures.
15. Are currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo. SCD subjects on hydroxyurea or L-glutamine will also be considered, provided that they have been on an unchanged dose of hydroxyurea or LGlutamine for 12 weeks prior to signing consent. Use of the newer SCD therapies voxelotor or crizanlizumab will not be permitted on this study, and subjects who have received voxelotor or crizanlizumab in the 12 weeks prior to signing consent will be excluded.
16. Have exposure to any investigational drug (other than the current drug, mitapivat), device, or invasive procedure within 12 weeks prior to signing consent. All non-investigational invasive procedures within 12 weeks of signing consent may be considered as a potential exclusion criteria per the PI s discretion.
17. Have had a prior bone marrow or stem cell transplant.
18. Are currently pregnant or breastfeeding.
19. Are currently receiving products that are strong inhibitors of CYP3A4/5 that have not been stopped for (Bullet)5 days or a time frame equivalent to 5 half-lives (whichever is longer), or strong inducers of CYP3A4 that have not been stopped for (Bullet)28 days or a time frame equivalent to 5 half-lives (whichever is longer), prior to signing consent.
20. Are currently receiving hematopoietic stimulating agents (e.g., erythropoietins, granulocyte colony stimulating factors, thrombopoietins) that have not been stopped for a duration of at least 90 days prior to signing consent.
21. Have a history of allergy to sulfonamides if characterized by acute hemolytic anemia, drug-induced liver injury, anaphylaxis, rash of erythema multiforme type or Stevens-Johnson syndrome, cholestatic hepatitis, or other serious clinical manifestations.
22. Have a history of allergy to mitapivat or its excipients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, and mannitol). | National Institutes of Health Clinical Center (CC) | NIH | {
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"asFound": "Hemolytic Anemia",
"id": "M4073",
"name": "Anemia, Hemolytic",
"relevance": "HIGH"
},
{
"asFound": "Hemolytic",
"id": "M9547",
"name": "Hemolysis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M9490",
"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4075",
"name": "Anemia, Hemolytic, Congenital",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9539",
"name": "Hemoglobinopathies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": "Sickle Cell Disease",
"id": "T5229",
"name": "Sickle Cell Anemia",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D000755",
"term": "Anemia, Sickle Cell"
},
{
"id": "D000743",
"term": "Anemia, Hemolytic"
},
{
"id": "D006461",
"term": "Hemolysis"
}
]
} | {
"ancestors": [
{
"id": "D020536",
"term": "Enzyme Activators"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
}
],
"browseBranches": [
{
"abbrev": "Hemat",
"name": "Hematinics"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Ot",
"name": "Other Dietary Supplements"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M11110",
"name": "Liver Extracts",
"relevance": "LOW"
},
{
"asFound": "Video call",
"id": "M352324",
"name": "Mitapivat",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T424",
"name": "Pyruvate",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C000634504",
"term": "Mitapivat"
}
]
} | {
"conditions": [
{
"id": "D000755",
"term": "Anemia, Sickle Cell"
},
{
"id": "D000743",
"term": "Anemia, Hemolytic"
},
{
"id": "D006461",
"term": "Hemolysis"
}
],
"interventions": [
{
"id": "C000634504",
"term": "Mitapivat"
}
]
} |
NCT05776966 | null | Women's Opioid Treatment Follow-up Study | Increasing Women's Engagement in Medication Treatment for Opioid Use Disorder Through Digital Intervention | None | INTERVENTIONAL | RECRUITING | 2023-03-07T00:00:00 | null | null | null | [
"NA"
] | 40 | 18 | null | FEMALE | false | The goal of this study is to examine the feasibility of a gender-specific digital intervention for women with opioid use disorder. In this study, women with opioid use disorder will be randomized to receive treatment-as-usual plus a gender-specific digital intervention or treatment-as-usual only. Feasibility, satisfaction, and engagement with the intervention are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-up visits. | This study has two aims: (1) to demonstrate the feasibility of delivering a gender-specific digital intervention (GSDI) to women with opioid use disorder; (2) to collect preliminary estimates on the effect of the GSDI on engagement in medication treatment for opioid use disorder (MOUD). The investigators will conduct a pilot randomized controlled trial to achieve these aims. Women (N=40) who have recently initiated MOUD (within 30 days) will be enrolled and randomized to receive either the GSDI+TAU (gender-specific digital intervention + treatment as usual) or TAU-only. Feasibility, satisfaction, and engagement with the GSDI are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-ups. MOUD engagement will be assessed at two time-points: (1) 6-weeks and (2) 12-weeks post-enrollment to collect preliminary estimates on the effect of the GSDI on MOUD engagement. | Inclusion Criteria:
* age 18 years of age or older
* current opioid use disorder diagnosis
* have a smartphone
* initiated medication treatment for opioid use disorder in the past 30 days,
* able to provide informed consent
Exclusion Criteria:
* an acute psychiatric or medical condition, or cognitive impairment, that would impair the ability to complete study procedures
* admitted to their current treatment episode on an involuntary status | Mclean Hospital | OTHER | {
"id": "2023P000495",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-03-17T00:00:00 | {
"date": "2024-03-13",
"type": "ACTUAL"
} | {
"date": "2023-03-20",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Opioid Use Disorder"
] | null | null | [
{
"city": "Belmont",
"country": "United States",
"facility": "McLean Hospital",
"geoPoint": {
"lat": 42.39593,
"lon": -71.17867
},
"state": "Massachusetts"
}
] | [
{
"class": "NIH",
"name": "National Institute on Drug Abuse (NIDA)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Client Satisfaction Questionnaire",
"timeFrame": "Immediately after the web-based portion of the intervention, Week 12"
},
{
"description": null,
"measure": "System Usability Scale",
"timeFrame": "12 weeks"
},
{
"description": null,
"measure": "Engagement metrics",
"timeFrame": "Week 1 - Week 12"
},
{
"description": null,
"measure": "Qualitative Exit Interview",
"timeFrame": "Week 12"
}
],
"secondary": [
{
"description": null,
"measure": "Timeline Followback",
"timeFrame": "Week 2, Week 6, Week 12"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D000079524",
"term": "Narcotic-Related Disorders"
},
{
"id": "D019966",
"term": "Substance-Related Disorders"
},
{
"id": "D064419",
"term": "Chemically-Induced Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
"browseBranches": [
{
"abbrev": "BC25",
"name": "Substance Related Disorders"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"asFound": "Opioid Use Disorder",
"id": "M12244",
"name": "Opioid-Related Disorders",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M2057",
"name": "Narcotic-Related Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21837",
"name": "Substance-Related Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M30302",
"name": "Chemically-Induced Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4815",
"name": "Mental Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009293",
"term": "Opioid-Related Disorders"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M4033",
"name": "Analgesics, Opioid",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D009293",
"term": "Opioid-Related Disorders"
}
],
"interventions": []
} |
NCT01865266 | null | The Effect of Ulinastatin on Bronchoalveolar Lavage Fluid of Inflammatory Factors in Patients With Ventilator-associated Pneumonia | The Effect of Ulinastatin on Bronchoalveolar Lavage Fluid of Inflammatory Factors in Patients With Ventilator-associated Pneumonia | None | INTERVENTIONAL | UNKNOWN | 2013-05-24T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 60 | 18 | 80 | ALL | false | Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in ventilated critically ill patients specially in intensive care unit (ICU). It is associated with an increased duration of mechanical ventilation, high death rates and increased healthcare costs in the development country.
Although VAP is preventable and many practices have been demonstrated to reduce the incidence of this disease, the morbidity is still so high. VAP is hard to cure and the mortality is about to 40% which was reported in China in 2004. If the bacteria of multidrug-resistance(MDR) is isolated, the mortality can increase to 70%. So much more methods should be needed in treating VAP in addition to using antibiotics.
Ulinastatin is a serine protease inhibitor with a molecular weight of 67,000 found in healthy human urine. It is used worldwide for patients with inflammatory disorders, including disseminated intravascular coagulation(DIC),shock, and pancreatitis . Furthermore, ulinastatin administration can help reduce sepsis, prevent multiple organ dysfunction, and modulate immune functions.
Actually, three studies have showed that ulinastatin treatment is associated with reduced the levels of inflammatory factors in blood serum in patients with acute respiratory distress syndrome(ARDS).Though analyses of serum inflammatory factors such as tumor necrosis factor (TNF)-α and interleukin (IL)-6 have been used to determine the degree of systemic inflammation under various clinical conditions, they can not reflect the degrees of lung infection directly.
Basing on the results of previous studies, meta analyses and system reviews, the investigators hypothesized that the anti-inflammatory function of ulinaststin may also decrease the levels of inflammatory factors in bronchoalveolar lavage(BAL) fluid in Patients with VAP.
In addition there is no prospective study to investigate the role of ulinastatin in BAL. The investigator hopes that this study can approve the relationship between ulinastatin and inflammatory factors in BAL. And it can improve the processes,outcomes and costs of critical care as well. | This is a one-center, three-arm, randomized, single-blinded, controlled trial. When a patient was diagnosed VAP during mechanic ventilation in ICU,a sealed envelop will be opened which decide whether the patient is assigned to the normal dose ulinastatin group,the high dose ulinastatin group or the compare group.
VAP diagnosis and treatment accord with the "Comprehensive evidence-based clinical practice guidelines for ventilator-associated pneumonia:Diagnosis and treatment" which was published in 2008 by Canadian critical care trials group.
The aim of the present study is to determine the efficacy of ulinastatin for the treatment of ventilator-associated Pneumonia(VAP) and to investigate the effect to inflammatory factors in bronchoalveolar lavage fluid . | Inclusion Criteria:
* All consecutive patients with ventilator-associated pneumonia(VAP) who are admitted to the intensive care unit between 1st January 2014 at 0:00(midnight) and the finish date of 31st December 2015 at 23:59 (11:59 pm).
* Informed consent.
Exclusion Criteria:
* Patients with pneumonia when they are admitted to ICU.
* Ulinastatin was previous used before the patients were diagnosed VAP.
* Active gastropathic disorder.
* Be allergic to ulinastatin.
* Pregnancy.
* Unwilling to continue the therapy during hospitalization. | Shanghai Minhang Central Hospital | OTHER | {
"id": "VAP-YYT-003",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-05-29T00:00:00 | {
"date": "2013-05-30",
"type": "ESTIMATED"
} | {
"date": "2013-05-30",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Ventilator-associated Bacterial Pneumonia",
"Mechanical Ventilation Complication"
] | ["ventilator-associated pneumonia", "mechanical ventilation", "ulinastatin for injection", "bronchoalveolar lavage fluid", "inflammatory factors"] | null | [
{
"city": "Shanghai",
"country": "China",
"facility": "Shanghai Minhang Central Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "Ruijin Hospital"
},
{
"class": "OTHER",
"name": "RenJi Hospital"
},
{
"class": "OTHER",
"name": "Shanghai Jiao Tong University School of Medicine"
}
] | null | {
"other": [
{
"description": null,
"measure": "Adverse effects",
"timeFrame": "30 days"
}
],
"primary": [
{
"description": null,
"measure": "Levels of inflammatory factors in bronchoalveolar lavage fluid and blood serum.",
"timeFrame": "7 days"
}
],
"secondary": [
{
"description": null,
"measure": "All cause mortality.",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "Ventilation free days.",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "Antibiotic free days.",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "Percentage of MDR pathogenic bacteria.",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "Oxygenation index",
"timeFrame": "30 days"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012141",
"term": "Respiratory Tract Infections"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
},
{
"id": "D000077299",
"term": "Healthcare-Associated Pneumonia"
},
{
"id": "D003428",
"term": "Cross Infection"
},
{
"id": "D007049",
"term": "Iatrogenic Disease"
},
{
"id": "D020969",
"term": "Disease Attributes"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D001424",
"term": "Bacterial Infections"
},
{
"id": "D001423",
"term": "Bacterial Infections and Mycoses"
}
],
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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"asFound": "Pneumonia",
"id": "M13904",
"name": "Pneumonia",
"relevance": "HIGH"
},
{
"asFound": "Ventilator Associated Pneumonia",
"id": "M27445",
"name": "Pneumonia, Ventilator-Associated",
"relevance": "HIGH"
},
{
"asFound": "Bacterial Pneumonia",
"id": "M20529",
"name": "Pneumonia, Bacterial",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14978",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
"name": "Lung Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M1752",
"name": "Healthcare-Associated Pneumonia",
"relevance": "LOW"
},
{
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"id": "M6642",
"name": "Cross Infection",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10099",
"name": "Iatrogenic Disease",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22700",
"name": "Disease Attributes",
"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": "T4202",
"name": "Oculocerebral Syndrome With Hypopigmentation",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D011014",
"term": "Pneumonia"
},
{
"id": "D053717",
"term": "Pneumonia, Ventilator-Associated"
},
{
"id": "D018410",
"term": "Pneumonia, Bacterial"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
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],
"browseLeaves": [
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"asFound": null,
"id": "M240034",
"name": "Urinastatin",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7296",
"name": "Dimercaprol",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D011014",
"term": "Pneumonia"
},
{
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"term": "Pneumonia, Ventilator-Associated"
},
{
"id": "D018410",
"term": "Pneumonia, Bacterial"
}
],
"interventions": []
} |
NCT03020966 | null | IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty | IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty: a Randomized, Blinded Trial | IV Tylenol | INTERVENTIONAL | COMPLETED | 2016-12-06T00:00:00 | null | 2019-06-16T00:00:00 | 2019-06-16T00:00:00 | [
"PHASE4"
] | 154 | 18 | 90 | ALL | false | The purpose of this study is to determine how well two different methods of administrating Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR) surgery. The methods of administration are orally, via a pill that is to be swallowed, and intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol will reduce opioid consumption and opioid-related side effects after THR. | A) Opioid use after THA. Opioid use after THA can be 90 mg (+/-79) in morphine equivalents when using epidural bupivacaine / hydromorphone and multimodal analgesia. Less than 1/3 of this was via the epidural (26/90 mg). Patients reported ORSDS composite scores of 0.58
B) IV vs oral acetaminophen. The therapeutic blood concentration of acetaminophen for pain relief is 10 mcg/ml.
After an oral, single dose: In 24 fasting adult subjects, the maximal blood concentration (Cmax) of 7.7 to 17.6 mcg/mL occurred within 1 hour following a single 1000-mg dose of oral acetaminophen (liquid or caplet). Acetaminophen crosses the blood-brain barrier. Central diffusion to the brain and spinal fluid occurs within 15 to 45 minutes with maximum cerebrospinal fluid concentrations occurring at 2 to 4 hours. \[Product Information: TYLENOL(R) oral, acetaminophen oral. McNeil Consumer Healthcare, Skillman, NJ, 2010\].
In a randomized, double-blind, placebo-controlled, single-dose study, acetaminophen 1,000 mg provided significantly greater efficacy in treating postsurgical dental pain compared with acetaminophen 650 mg and placebo.
Oral, multiple-dose, immediate-release, elderly patients: In 12 very elderly patients (mean age, 89 years), the Cmax was 23.9 mcg/mL following the administration of acetaminophen 1000 mg orally 3 times daily for 5 days.
In adult subjects, the mean Cmax was 28 +/- 21 mcg/mL at the end of a 15-minute IV infusion of acetaminophen 1000 mg. \[Product Information: OFIRMEV(TM) intravenous infusion, acetaminophen intravenous infusion. Cadence Pharmaceuticals Inc., San Diego, CA, 2010\].
The oral medication has an excellent absorption and at least 85% bioavailability, but peak concentration occurs later than the IV, and the therapeutic blood concentration for pain relief (10mcg/ml) may not be achieved after one oral dose (7-17mcg/ml).A full stomach delays the absorption. With multiple doses, in elderly patients, or with renal/ liver failure, the blood concentration is higher.
Epidural bupivacaine / clonidine (Liu). Pain scores (NRS) after THA with activity on POD1 can be 3.4 mean (2.6 SD) when using epidural bupivacaine / clonidine and multimodal analgesia.
Low-opioid protocol (oxycodone may be too strong for some; cannot use Vicodin due to acetaminophen) Choice of instruments (CAM, ORSDS, Pain OUT). The ORSDS is a 4-point scale that evaluates 12 symptoms (nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating, drowsiness or difficulty staying awake, feeling lightheaded or dizzy, feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth and headache) via 3 symptom distress dimensions (frequency, severity, bothersomeness). It is validated for use after orthopaedic surgery, specifically including TKA patients receiving epidural analgesia and femoral nerve blockade.
Patients can meet criteria for delirium by CAM by having acute onset of inattention as well as either disorganized thinking or altered level of consciousness.Patients without acute onset can also meet criteria for delirium if inattention, disorganized thinking and altered level of consciousness are all present, with at least one factor judged to be fluctuating. CAM has been widely applied and has been specifically used to evaluate elderly TKA patients receiving epidural analgesia and femoral nerve blockade.
The Patient Outcome Questionnaire by the American Pain society is used for quality improvement, and measures 6 aspects of quality, including (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmacological strategies. | Inclusion criteria:
* Adult
* Scheduled for an elective primary THA with a participating surgeon,
* Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural Analgesia (PCEA)
* English-speaking
* Patients that did not receive pre-operative opioids
Exclusion criteria:
* Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney functioning tests.
* Hypersensitivity or contraindication to protocol medication
* Contraindication for CSE and PCEA
* Incapable to provide consent/answer questions in English
* Revision or urgent surgery
* Receiving Periarticular Injections
* History of opioid use
* Patients on disability or worker's compensation | Hospital for Special Surgery, New York | OTHER | {
"id": "2016-209",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-01-11T00:00:00 | {
"date": "2021-08-10",
"type": "ACTUAL"
} | {
"date": "2017-01-13",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
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"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Pain, Postoperative",
"Opioid Use"
] | null | null | [
{
"city": "New York",
"country": "United States",
"facility": "Hospital for Special Surgery",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
}
] | [
{
"class": "INDUSTRY",
"name": "Mallinckrodt"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pain With Physical Therapy on Post-operative Day 1",
"timeFrame": "24 hours after the operation (post-operative day 1)"
},
{
"description": null,
"measure": "Opioid Use",
"timeFrame": "Day of surgery to post-operative day 3"
},
{
"description": null,
"measure": "Opioid Side Effects",
"timeFrame": "24 hours after surgery (Post-operative day 1)"
}
],
"secondary": null
} | [
{
"affiliation": "Hospital for Special Surgery, New York",
"name": "Jacques Ya Deau, MD, PhD",
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NCT01819766 | null | Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease | Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease: OCEANIA Study | OCEANIA | OBSERVATIONAL | COMPLETED | 2013-03-25T00:00:00 | null | null | null | null | 440 | 18 | 84 | ALL | false | This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to participate in this study. Enrolled subjects will collect a stool sample for the Exact IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of enrollment. Tissue diagnosis of CRC will be established by histopathologic examination. | This is a prospective, cross sectional, multi-center study to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for detecting CRC alone and in combination with high grade dysplasia (HGD) and low grade dysplasia (LGD) associated with IBD and advanced adenoma in IBD patients with disease duration greater than 8 years or PSC diagnosis. Enrolled subjects will provide a single stool sample for the Exact IBD-ACRN surveillance test, no sooner than 7 days following their most recent pre-enrollment colonoscopy, within 30 days of enrollment and prior to initiating bowel prep for either the post-enrollment colonoscopy (surveillance or repeat), or surgical intervention. Stool samples will be tested using the Exact IBD-ACRN surveillance test and results compared to the colonoscopy and corresponding diagnostic histopathology results from biopsied, and any subsequently excised, lesions to establish sensitivity and specificity of the Exact IBD-ACRN surveillance test. All post-enrollment colonoscopies or surgical interventions must be performed within 60 days of enrollment.
The primary objective of this study is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test for CRC in IBD patients with disease duration of at least eight years or diagnosis of PSC. Tissue diagnosis of CRC will be established by histopathology examination. The secondary objective is to determine the sensitivity and specificity of the Exact IBD-ACRN surveillance test to detect ACRN in IBD patients with disease duration of at least eight years or diagnosis of PSC.
Enrollment will continue until at least 35 CRC; 15 HGD and 315 negative subject samples have been obtained. There is no specific recruitment goal for IBD associated LGD or LGD associated with advanced adenoma (AA). | Inclusion Criteria:
* Male or female 18-84 years of age, inclusive.
* Diagnosis of IBD or a diagnosis of PSC with IBD prior to enrollment date of this study.
* Must be a candidate for a surveillance colonoscopy, with the intention of CRC/dysplasia surveillance, or a candidate for surgical intervention based on prior histological confirmation of HGD or CRC.
* Written informed consent document signed and dated by the subject or legally acceptable representative.
Exclusion Criteria:
* Any condition that in the opinion of the investigator should preclude participation in the study.
* A history of aerodigestive tract cancer.
* Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
* IBD limited only to the rectum and without a concurrent PSC diagnosis.
* Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may be, introduced into the subject. | Exact Sciences Corporation | INDUSTRY | {
"id": "Exact Sciences 2013-01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2013-03-25T00:00:00 | {
"date": "2017-02-17",
"type": "ACTUAL"
} | {
"date": "2013-03-28",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Subjects who have diagnosed IBD and are undergoing a colorectal cancer surveillance program. Also, have either a histopathological diagnosis of high grade dysplasia or colorectal cancer resulting from colonoscopy preceding enrollment or for whom a surveillance colonscopy is indicated. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
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} | [
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"Primary Sclerosing Cholangitis (PSC)",
"Colorectal Neoplasms",
"Colorectal Cancer"
] | ["Cancer", "Colorectal Cancer", "Neoplasm", "Colorectal Neoplasm", "Intestinal Neoplasms", "Gastrointestinal Neoplasms", "Digestive System Neoplasms", "Neoplasms by Site", "Neoplasms", "Digestive System Diseases", "Gastrointestinal Diseases", "Colonic Diseases", "Intestinal Diseases", "Inflammatory Bowel Disease", "Primary Sclerosing Cholangitis"] | null | [
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"affiliation": "Icahn School of Medicine at Mount Sinai",
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NCT04609566 | null | Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors | A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects With Metastatic Solid Malignancies | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2020-10-23T00:00:00 | null | 2029-12-31T00:00:00 | 2029-12-31T00:00:00 | [
"PHASE2"
] | 141 | 18 | null | ALL | false | This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study. | null | Inclusion Criteria
* Participants must have
* Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) who either
* a) have not yet received frontline therapy for metastatic disease and without prior exposure to anti PD-1/PD-L1 or
* b) are relapsed/refractory with progression on anti PD-1/PD therapy.
* Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a PD-1 inhibitor
* Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet received frontline therapy for metastatic disease and without prior exposure to a PD-1/PD-L1 inhibitor.
* Cohorts 1-4 only: Melanoma participants must be currently on PD-1 checkpoint inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of PD-1 CPI containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 CPI therapy must be the immediate prior line of treatment.
* Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria.
* Have received at least 2 doses of an approved PD-1 inhibitor.
* Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by RECIST v1.1.
* Progressive disease has been documented within 90 days from the last dose of PD-1 inhibitor.
* Participants with melanoma will need iRECIST confirmation of progression with a second assessment at least four weeks after the initial date of progressive disease
* NSCLC participants on PD-1 inhibitor containing therapy for less than 90 days will need iRECIST confirmation of progression at least 4 weeks after the initial date of progressive disease
* Tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or less than 1
Exclusion Criteria
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Prior immunosuppressive chemotherapy, any immunotherapy other than a PD-1 inhibitor within 4 weeks of first study drug dose.
* History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. | Seagen Inc. | INDUSTRY | {
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NCT05676866 | null | Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy | Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2023-01-02T00:00:00 | null | 2025-06-01T00:00:00 | 2025-08-01T00:00:00 | [
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] | 30 | 15 | 70 | FEMALE | true | evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy | Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND).
Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection \[ALND\] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.
Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.
Breast cancer patients suitable for neoadjuvant systemic therapy \[NAST\] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker\[clip\] is inserted in the suspicious node prior to neoadjuvant therapy.
The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.
A standard surgical approach for sentinel lymph node dissection \[SLND\] is used for TAD, Patent blue dye is administered intraoperatively. dissection down to the localized node is performed. node contained the clip is subsequently sent for histology. Any residual sentinel nodes or palpable abnormal nodes are excised and examined separately. | Inclusion Criteria:
1. females with invasive breast cancer with axillary metastasis, staging of n1: n2
2. complete axillary response to neoadjuvant therapy by clinical examination and imaging
Exclusion Criteria:
* 1. breast cancer patients who are not candidate for neoadjuvant chemotherapy 2. breast cancer patients with positive axillary node post neoadjuvant chemotherapy 3. breast cancer patients with distant metastasis 4. patients with axillary lymph node metastasis from another primary tumour \[not breast cancer\] | Assiut University | OTHER | {
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NCT01501266 | null | Faslodex Specific Clinical Experience Investigation | Faslodex Specific Clinical Experience Investigation for Long-term Use | None | OBSERVATIONAL | COMPLETED | 2011-12-27T00:00:00 | null | null | null | null | 660 | null | null | FEMALE | false | The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice. | MC MD | Inclusion Criteria:
* Patients treated with Faslodex for the first time due to postmenopausal breast cancer
Exclusion Criteria:
* None | AstraZeneca | INDUSTRY | {
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"facility": "Research Site",
"geoPoint": null,
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] | null | null | {
"other": null,
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"description": null,
"measure": "Incidence of adverse drug reactions.",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Incidence of serious adverse events.",
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],
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"measure": "Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment",
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"timeFrame": "6 month"
},
{
"description": null,
"measure": "Progression-free survival",
"timeFrame": "1 year"
}
]
} | [
{
"affiliation": "AstraZeneca KK",
"name": "Shigeru Yoshida",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D009371",
"term": "Neoplasms by Site"
},
{
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"term": "Neoplasms"
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"term": "Breast Diseases"
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],
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} | {
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} |
NCT05012566 | null | Onabotulinumtoxin A and Hyaluronic Acid Fillers in the Treatment of Facial Paralysis | Clinical, Instrumental and Histological Evaluation of the Combined Use of Onabotulinumtoxin A and Hyaluronic Acid Fillers in Patients With Facial Paralysis | None | INTERVENTIONAL | UNKNOWN | 2021-06-25T00:00:00 | null | 2023-07-14T00:00:00 | 2023-07-14T00:00:00 | [
"PHASE2"
] | 70 | 18 | 65 | ALL | false | Social interaction via facial mimic expression is crucial in human relationship and communication. Neural function disorder in this mechanism therefore affects human communication and social interaction. Facial nerve palsy is the paralysis of any structure innervated by the facial nerve, thus inibiting and severely compromising facial expression. In the last decade a new algorithm of treatment of facial paralysis has been raised. It connects the expertise of Aesthetic Medicine with the expertise of Plastic and Reconstructive Surgery. It is based on the use of Botulinum Toxin (BT) and Hyaluronic Acid (HA fillers). Botulinum toxin is a paralytic toxin that determine flaccid paralysis and is nowadays used in the static correction of facial paralysis with minimal invasiveness, optimal results and no time consumption. The HA fillers has the ability to restore facial volume loss and it is used in the treatment of facial palsy to harmonize symmetry. The aim is to study the effects of the BT and HA in facial paralysis patients in order to understand the efficacy of these products that have never been injected together in this type of patients. Primary objective. To evaluate the functional improvement of facial asymmetries due to facial nerve lesion after the treatment with OnabotulinumtoxinA and hyaluronic acid fillers compared with the untreated group. The evaluation will be performed analyzing the two groups at the baseline (visit 0) and the end of the treatment period (visit 5, after 9 months). Improvement difference of at least 1 grade on the House-Brackmann scale, compared with the untreated group, will be considered clinically significant. Methods. The investigation is randomized open lab phase II single centre clinical trial. This experimental study proposes to evaluate a group of 70 patients affected by hemifacial paralysis of level 3 to 6 on the House-Brackmann scale. 35 patients will be treated (Group A) with both OnabotulinumtoxinA and hyaluronic acid fillers with a monitored follow up. A control group of 35 patients (Group B) who will not be treated, will be enrolled to compare the efficacy of the treatment. During the study all the AE/ADR will be recorded. | The patients will be evaluated with instrumental (3D pictures, neuro-physiological examination (EMG), radiological \[Magnetic Resonance Imaging (MRI)\], Cone Beam Computer Tomography (CBCT) and Ultrasound (US)) and non-instrumental analysis (clinical questionnaires and hystological analysis). The histology will be performed with both traditional and electronic approaches. The area of the biopsy will be the paralytic area in the two groups in order to study the soft tissue modulation of the injected molecules. Patient's qiality of life (QoL), through specifically test (FACE-Q), will be also evaluated. | Inclusion Criteria:
1. Aged \> 18 years and \< 65 years
2. Hemifacial paralysis from 3 to 6 on the House-Brackmann scale
3. Never treated with HA and BTX injection
4. Signed informed consent
5. Women of childbearing potential will only be included in the study if uptaking hightly effective birth control measures.
Exclusion Criteria:
1. Hypersensitivity to any component of the products used
2. Diabetes, systemic disease, coronary artery disease, acute-chronic hepatitis C, autoimmune disease and/or other disease involving poor general health clotting problem. Peripheric neuro-musculars disorders, amyotrophic lateral sclerosis.
3. Pregnant or lactating | Azienda Ospedaliera Universitaria Integrata Verona | OTHER | {
"id": "FACIAL PARALYSIS",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2021-08-12T00:00:00 | {
"date": "2022-05-16",
"type": "ACTUAL"
} | {
"date": "2021-08-19",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "monocenter, no treated controlled group, randomized clinical trial",
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Hemifacial Paralysis"
] | null | null | [
{
"city": "Verona",
"country": "Italy",
"facility": "Azienda Ospedaliera Universitaria Integrata",
"geoPoint": {
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"lon": 10.98444
},
"state": null
}
] | null | null | {
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"timeFrame": "Day 0 and day 270"
}
],
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"description": null,
"measure": "Facial Appearance",
"timeFrame": "Day 0 and day 270."
},
{
"description": null,
"measure": "Health-Related Quality of Life",
"timeFrame": "Day 0 and day 270"
},
{
"description": null,
"measure": "Adverse Effects",
"timeFrame": "Day 0 and day 270"
},
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"description": null,
"measure": "Patients experience of care",
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"measure": "Facial symmetry",
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{
"description": null,
"measure": "Facial aesthetic",
"timeFrame": "Day 0 and day 270"
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"description": null,
"measure": "Facial aesthetic - thickness of soft tissue",
"timeFrame": "Day 0 and day 270"
},
{
"description": null,
"measure": "Facial aesthetic - thickness of hard tissue",
"timeFrame": "Day 0 and day 270"
},
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"description": null,
"measure": "Facial aesthetic - tropism of muscles",
"timeFrame": "Day 0 and day 270"
},
{
"description": null,
"measure": "Facial aesthetic - patho-physiological condition",
"timeFrame": "Day 0 and day 270"
},
{
"description": null,
"measure": "Hystological analysis",
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},
{
"description": null,
"measure": "EMG",
"timeFrame": "Day 0 and day 270"
},
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"description": null,
"measure": "Adverse Events",
"timeFrame": "Day 0, day 20, day 30, day 140, day 150, day 270"
}
]
} | [
{
"affiliation": "AOUI Verona",
"name": "Dario Bertossi, Prof",
"role": "PRINCIPAL_INVESTIGATOR"
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} | {
"conditions": [
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} |
NCT01611766 | null | Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)? | Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial | None | INTERVENTIONAL | UNKNOWN | 2012-05-30T00:00:00 | null | null | null | [
"PHASE3"
] | 356 | 18 | 80 | FEMALE | false | The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer. | The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer | Inclusion Criteria:
* Age at recurrence ≥ 18 years
* Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more.
* A complete secondary cytoreduction predicting score, iMODEL \[Tian WJ, Ann Surg Oncol 2012,19(2):597-604\]\<=4.7, including FIGO stage (0 or 0.8); residual disease after primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4); Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0). If PI and CO-PI reach consensus that the recurrent tumor detected by PET/CT could be completely resected, the index of CA125 could be scored as 0. (Revised on 09/30/2013)
* Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions.
* Patients who have given their signed and written informed consent and their consent.
Exclusion Criteria:
* Patients with borderline tumors as well as non-epithelial tumors.
* Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.
* Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible.
* More than one prior chemotherapy.
* Second relapse or more
* Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
* Progression during chemotherapy or recurrence within 6 months after first-line therapy
* Any contradiction not allowing surgery and/or chemotherapy
1. Accompanied by hypoxia serious chronic obstructive pulmonary disease
2. Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
3. Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
4. Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
5. Uncontrolled diabetes
6. Uncontrolled epilepsy need long-term antiepileptic treatment.
* Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab. | Shanghai Gynecologic Oncology Group | OTHER_GOV | {
"id": "SGOG OV 2",
"link": null,
"type": null
} | Unknown | {
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} | 2012-06-04T00:00:00 | {
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"Ovarian Epithelial Cancer Recurrent",
"Fallopian Tube Carcinoma",
"Primary Peritoneal Carcinoma"
] | ["secondary cytoreductive surgery", "Ovarian Cancer", "surgery", "recurrence"] | null | [
{
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"country": "China",
"facility": "Sun Yat-sen University Cancer Center",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong"
},
{
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{
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"facility": "Zhejiang Cancer Hospital",
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},
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] | [
{
"class": "OTHER",
"name": "Fudan University"
},
{
"class": "OTHER",
"name": "Zhejiang Cancer Hospital"
},
{
"class": "OTHER",
"name": "Shanghai Zhongshan Hospital"
},
{
"class": "OTHER",
"name": "Sun Yat-sen University"
}
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{
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"timeFrame": "Up to 60 months after last patient randomized"
}
]
} | [
{
"affiliation": "Shanghai Gynecologic Oncology Group",
"name": "Rongyu Zang, MD,PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "33705695", "type": "DERIVED", "citation": "Shi T, Zhu J, Feng Y, Tu D, Zhang Y, Zhang P, Jia H, Huang X, Cai Y, Yin S, Jiang R, Tian W, Gao W, Liu J, Yang H, Cheng X, Zang R. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):439-449. doi: 10.1016/S1470-2045(21)00006-1. Epub 2021 Mar 8."}] | {"versionHolder": "2025-06-18"} | {
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NCT05643066 | null | Esketamine-propofol Versus Propofol for Flexible Bronchoscopy | Discharge Readiness After Propofol With or Without Esketamine for Outpatient Flexible Bronchoscopy: a Randomized, Controlled Study | None | INTERVENTIONAL | COMPLETED | 2022-11-14T00:00:00 | null | 2023-12-18T00:00:00 | 2023-12-21T00:00:00 | [
"PHASE4"
] | 246 | 18 | 75 | ALL | false | Bronchoscopy is a promising technology for lung and bronchus disease detection and therapy. However, this procedure is associated with a relatively high risk of hypoxemia, coughing, wheezing, and dyspnea. Despite the fact that propofol is the most commonly used agent in procedure sedation, the narrow therapeutic index remains challenging. Esketamine is the s-enantiomer of ketamine with potent analgesic and sedative properties. This study aims to test the hypothesis that adding subanesthetic esketamine to propofol is non-inferior to propofol alone for bronchoscopy on the recovery profile and discharge from the hospital. | Bronchoscopy is one of the most common procedures to detect lung and bronchus disease. The procedure is generally uncomfortable and associated with a relatively high risk of hypoxemia, coughing, wheezing, and dyspnea. Therefore, physicians are placing increasing importance on the use of procedure sedation due to the demand for comfortable medical care.
Propofol is an effective agent for sedation in bronchoscopy with rapid onset and recovery. However, the safety endpoints of propofol are not cost-effective, including injection pain, hypotension, apnea, airway compromise, and without a reversal agent. Specifically, the depressive effects on the respiratory system are more noteworthy in bronchoscopy, which may lead to hypoxia. These drawbacks may hinder functional recovery and delay the discharge time. Hence, physicians are searching for an optimal sedation regimen for bronchoscopy.
Esketamine, the s-enantiomer of ketamine, is an N-methyl-D-aspartic acid receptor antagonist with potent analgesic and sedative properties. Evidence suggested that esketamine could be used as a component of sedative regimen in many settings, such as endoscopy and endoscopic retrograde cholangiopancreatography. Nevertheless, there remains an evidence gap in the efficacy and safety of esketamine used in bronchoscopy. Therefore, we conducted this study to test the hypothesis that low-dose esketamine as an adjuvant to propofol was non-inferior to propofol alone on the recovery profile and discharge from the hospital after ambulatory bronchoscopy. | Inclusion Criteria:
1. American Society of Anesthesiologists (ASA) classification I-III;
2. Scheduled for ambulatory bronchoscopy.
Exclusion Criteria:
1. Allergic or contraindications to studying drugs
2. History of obstructive sleep apnea-hypopnea syndrome
3. History of psychiatric illness
4. History of neurological disease
5. Pre-existing memory or cognitive impairment
6. History of seizure disorders
7. Pregnancy
8. Substance abuse or intake of drugs that affect the central nervous system
9. Inability to communicate in Mandarin Chinese.
10. Illiteracy | Fujian Provincial Hospital | OTHER | {
"id": "K2021-12-067",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-12-01T00:00:00 | {
"date": "2024-01-05",
"type": "ACTUAL"
} | {
"date": "2022-12-08",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
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"CARE_PROVIDER",
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Postoperative Recovery"
] | ["bronchoscopy", "esketamine", "procedure sedation", "propofol"] | null | [
{
"city": "Fuzhou",
"country": "China",
"facility": "Fujian provincial hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Proportions of patients discharged within 30 min after bronchoscopy",
"timeFrame": "Up to 40 minutes postoperatively"
}
],
"secondary": [
{
"description": null,
"measure": "Postoperative quality of recovery",
"timeFrame": "Baseline, up to 72 hours postoperatively"
},
{
"description": null,
"measure": "Injection pain",
"timeFrame": "Immediately after administering the study drugs, on average 2 minutes"
},
{
"description": null,
"measure": "Emergency time",
"timeFrame": "Immediately after the bronchoscopy completely withdrawn, on average 8 minutes"
},
{
"description": null,
"measure": "Incidence of adverse events",
"timeFrame": "Up to 72 h postoperatively"
},
{
"description": null,
"measure": "Propofol consumption",
"timeFrame": "During the bronchoscopy procedure"
},
{
"description": null,
"measure": "Patient willingness to repeat the procedure",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "Bronchoscopist satisfaction",
"timeFrame": "At completion of bronchoscopy procedure"
},
{
"description": null,
"measure": "Patient satisfaction",
"timeFrame": "At completion of bronchoscopy procedure"
},
{
"description": null,
"measure": "Patient willingness to recommend screening",
"timeFrame": "24 hours postoperatively"
}
]
} | [
{
"affiliation": "Fujian Provincial Hospital",
"name": "Xiaochun Zheng, MD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": [
{
"id": "D006993",
"term": "Hypnotics and Sedatives"
},
{
"id": "D002492",
"term": "Central Nervous System Depressants"
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"id": "D045505",
"term": "Physiological Effects of Drugs"
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{
"id": "D018686",
"term": "Anesthetics, Intravenous"
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{
"id": "D018681",
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{
"id": "D000777",
"term": "Anesthetics"
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"id": "D000700",
"term": "Analgesics"
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{
"id": "D018689",
"term": "Sensory System Agents"
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"term": "Peripheral Nervous System Agents"
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"term": "Anesthetics, Dissociative"
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"id": "D018691",
"term": "Excitatory Amino Acid Antagonists"
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"id": "D018683",
"term": "Excitatory Amino Acid Agents"
},
{
"id": "D018377",
"term": "Neurotransmitter Agents"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
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"id": "D000928",
"term": "Antidepressive Agents"
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"id": "D011619",
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"abbrev": "Analg",
"name": "Analgesics"
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"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
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"abbrev": "All",
"name": "All Drugs and Chemicals"
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"abbrev": "PsychDr",
"name": "Psychotropic Drugs"
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"abbrev": "Ot",
"name": "Other Dietary Supplements"
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"asFound": "Undergoing",
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"id": "M18307",
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"relevance": "LOW"
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"relevance": "LOW"
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"name": "Psychotropic Drugs",
"relevance": "LOW"
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"id": "T433",
"name": "Tannic Acid",
"relevance": "LOW"
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],
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"term": "Esketamine"
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} | {
"conditions": null,
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"term": "Ketamine"
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{
"id": "D015742",
"term": "Propofol"
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{
"id": "C000629870",
"term": "Esketamine"
}
]
} |
NCT02082366 | null | Microembolic Signals During CPVI (Circumferntial Pulmonary Vein Isolation) Assessed by TCD (Trans-cranial Doppler) | Microembolic Signals During CPVI (Circumferntial Pulmonary Vein Isolation) Assessed by TCD (Trans-cranial Doppler) | None | INTERVENTIONAL | COMPLETED | 2014-03-06T00:00:00 | null | null | null | [
"NA"
] | 30 | 18 | null | ALL | false | The aim of the investigators study is to analyze the incidence of MES by TCD performed during AF ablation with the nMARQ and to compare is with the incidence of MES using a conventional irrigated ablation catheter. Objective: To investigate the incidence of MES on TCD during AF ablation with the nMARQ catheter compared to a conventional irrigated ablation catheter. Following inclusion, patients will be randomized into 2 equal different treatment groups: PVI with traditional irrigated RF catheter versus PVI using the nMARQ catheter. In all patients, anticoagulation therapy with warfarin is discontinued five-days before the procedure and low molecular weight heparin is initiated at that time. A CT-scan of the left atrium is performed and imported into the Carto 3 mapping system. The ablation procedure is conducted under general anesthesia or conscious sedation. A decapolar catheter is positioned in the coronary sinus and a quadripolar catheter is positioned at the His bundle level through the right femoral vein. Two 8F sheaths are introduced into the left atrium with double trans-septal puncture performed under fluoroscopic, trans-esophageal echocardiographic or intracardiac echocardiography guidance. Upon completion of the first trans-septal puncture, intravenous heparin is administered to maintain an activated clotting time of 350 seconds throughout the procedure. A variable Lasso circular mapping catheter is introduced through the SL1 sheath into each pulmonary vein for electrical mapping. After the second trans-septal puncture, a Navistar Thermocool 3.5mm irrigated ablation catheter or an nMARQ circular irrigated ablation catheter are introduced into the left atrium. Of note, in case of use the nMARQ catheter, the second SL-1 sheath is replaced by a steerable 8F agilis sheath after the second trans-septal puncture. Each of the 4 PVs are imaged by selective angiograms. The left atrium geometry is created using the nMARQ catheter or the Navistar catheter and then merged with the pre-acquired CT scan of the left atrium and PVs. Identification of true MESs will be possible using an event detector system, in addition to determining whether the MESs are attributed to a solid or to a gaseous embolus. Total MES counts will be collected and evaluated separately during different stages of the procedure. | Pulmonary vein isolation is increasingly been used to cure atrial fibrillation . A matter of concern comes from the evidence that AF ablation is associated by the appearance of microembolism on brain MRI scan. These microembolism are not associated with neurologic symptoms and seem to be at least partially, reversible in time. Correlation between the incidence of these cerebral lesions and the ablation technology used has been demonstrated: circular multipolar phased radiofrequency ablation using the PVAC catheter a duty-cycled non irrigated RF has been associated with the highest incidence of new lesion formation using MRI, whereas irrigated radiofrequency catheter and cryoablation seem to be the safer in this aspect. These thromboembolic events can be cumulatively assessed by the detection of microembolic signals in the cerebral arteries by transcranial Doppler performed during the ablation. Past studies have compared the incidence of MESs in TCD during PVI using different ablation techniques - Sauren et al. demonstrated that use of irrigated RF and or cryoablation produces significantly fewer cerebral MESs than the use of RF ablation with non irrigated catheters. A recent publication compared the occurrence of MESs using TCD while performing PVI by cryoablation compared with the PVAC catheter, reinforcing the MRI findings that the circumferential PVAC catheter possesses higher thromboembolic risk, possibly due to the lack of irrigation. Recently, a novel multipolar irrigated RF ablation catheter has been introduced. Ablations are performed simultaneously in a unipolar shape from 10 electrodes located at the tip of the ablation catheter. The catheter is under constant irrigation. No data exists regarding the incidence of MES in TCD during ablation with the nMARQ catheter. The aim of the investigators study is to analyze the incidence of MES by TCD performed during AF ablation with the nMARQ and to compare is with the incidence of MES using a conventional irrigated ablation catheter. Objective: To investigate the incidence of MES on TCD during AF ablation with the nMARQ catheter compared to a conventional irrigated ablation catheter. Methods: Study Population: 20 patients undergoing pulmonary vein isolation (PVI) for highly symptomatic, drug refractory paroxysmal or persistent AF. Study design: Following inclusion, patients will be randomized into 2 equal different treatment groups: PVI with traditional irrigated RF catheter versus PVI using the nMARQ catheter. In all patients, anticoagulation therapy with warfarin is discontinued five-days before the procedure and low molecular weight heparin is initiated at that time. A CT-scan of the left atrium is performed and imported into the Carto 3 mapping system. The ablation procedure is conducted under general anesthesia or conscious sedation. A decapolar catheter is positioned in the coronary sinus and a quadripolar catheter is positioned at the His bundle level through the right femoral vein. Two 8F sheaths are introduced into the left atrium with double trans-septal puncture performed under fluoroscopic, trans-esophageal echocardiographic or intracardiac echocardiography guidance. Upon completion of the first trans-septal puncture, intravenous heparin is administered to maintain an activated clotting time of 350 seconds throughout the procedure. A variable Lasso circular mapping catheter is introduced through the SL1 sheath into each pulmonary vein for electrical mapping. After the second trans-septal puncture, a Navistar Thermocool 3.5mm irrigated ablation catheter or an nMARQ circular irrigated ablation catheter are introduced into the left atrium. Of note, in case of use the nMARQ catheter, the second SL-1 sheath is replaced by a steerable 8F agilis sheath after the second trans-septal puncture. Each of the 4 PVs are imaged by selective angiograms. The left atrium geometry is created using the nMARQ catheter or the Navistar catheter and then merged with the pre-acquired CT scan of the left atrium and PVs. The PV antrum is defined with angiogram and electrograms analyses. Isolation of each PV is performed at the PV antrum by delivery of RF from multiple irrigated electrodes on the nMARQ catheter simultaneously and using the following settings: catheter irrigation flow rate of 60 mL/minute, target temperature 35 and maximal energy of 25 W for the anterior aspect of the antrum and 15W for the posterior atrial wall. RF energy is applied at each ablation site for a maximum of 45 seconds, until the local PV electrogram disappeared or its amplitude decreased by 80%. In case of RF ablation by the Navistar catheter, the ablation is performed in a "point by point" fashion at the PV antrum encircling the PV os. Ablation is performed with the following settings: catheter irrigation flow rate of 22 mL/minute, target temperature 35° and maximal energy of 35 W for the anterior aspect of the antrum and 20W for the posterior atrial wall. RF energy is applied at each ablation site for a maximum of 45 seconds, until the local PV electrogram disappeared or its amplitude decreased by 80%. Isolation of the left sided PVs is conducted during atrial pacing from the distal CS catheter whereas isolation of the right PVs is conducted during sinus rhythm. The endpoint of the procedure is the isolation of all PVs, attested by disappearance of all PV potentials in the lasso catheter within the vein and confirmed by pacing maneuvers.
TCD recording will be performed throughout the whole period of the PVI procedure from the preparation of trans-septal LA access until the termination of the procedure. The transducer is held in place by a proprietary headpiece supplied with the system. The middle cerebral arteries will be bilaterally insonated from transtemporal windows by using a multifrequency Doppler. Identification of true MESs will be possible using an event detector system, in addition to determining whether the MESs are attributed to a solid or to a gaseous embolus. Total MES counts will be collected and evaluated separately during different stages of the procedure. All statistical analysis and manuscript drafting will be performed at the Tel Aviv medical center. | Inclusion Criteria:
* 20 patients undergoing pulmonary vein isolation (PVI) for highly symptomatic, drug refractory paroxysmal or persistent AF.
* Above 18 years of age
* Following the signing of informed consent
Exclusion Criteria:
* Special populations
* Chronic Atrial fibrillation | Tel-Aviv Sourasky Medical Center | OTHER_GOV | {
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"affiliation": "Tel Aviv Medical Center",
"name": "Rephael Rosso, MD",
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NCT04084366 | null | Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors | A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors | None | INTERVENTIONAL | TERMINATED | 2019-09-05T00:00:00 | null | 2023-10-27T00:00:00 | 2023-10-27T00:00:00 | [
"PHASE1",
"PHASE2"
] | 44 | 18 | null | ALL | false | The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors. | null | Inclusion Criteria:
1. Male or female patients, 18 years of age or older at the time of consent.
2. Provide written informed consent prior to performing any study related procedure.
3. Histologically or cytologically confirmed patients with advanced solid tumors.
4. Patients must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the informed consent must state the effective therapies the patient is declining.
5. Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate organ function defined as:
a. Hepatic:
i. Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
ii. Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
iii.Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)
b. Renal:
i. Creatinine clearance \>50 mL/minute using Cockcroft Gault equation
c. Hematologic:
i. Absolute neutrophil count ≥1,500/µL
ii. Platelets ≥100,000/µL
iii. Hemoglobin ≥8 g/dL
8. Patient is willing and able to comply with all protocol required assessments, visits, and procedures, including a pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
9. Females of childbearing potential must have negative serum pregnancy test prior to starting study therapy, and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug.
Patient not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
Male patients must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug.
10. Cannot be breast feeding.
11. Patients with human immunodeficiency virus (HIV) infection are eligible if CD4+ T cell counts ≥ 350 cells/uL; patients on antiretroviral therapy (ART) should be on an established dose for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
12. Patients with serological evidence of chronic hepatitis B virus (HBV) infection are eligible if they have an HBV viral load below the limit of quantification with or without concurrent viral suppressive therapy.
13. Patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification.
14. Patients in Part B (Cohort-Expansion) must have documented Globo H H score of at least 100 from a qualified laboratory IHC assay in one of the sponsor-selected tumor types to be enrolled in the respective cohort:
* Cohort 1: Pancreatic cancer
* Cohort 2: Esophageal cancer
* Cohort 3: Gastric cancer
* Cohort 4: Colorectal cancer
* Cohort 5: Basket (any solid tumor type other than those included in Cohorts 1 through 4).
Exclusion Criteria:
1. Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of OBI 999.
2. Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of OBI 999.
3. Sensory or motor neuropathy of Grade 2 or greater.
4. Patients with a history of solid organ transplant.
5. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using NCI CTCAE version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
6. Receipt of any prior therapy targeting Globo H.
7. Known hypersensitivity to OBI 999 or its excipients.
8. Has known untreated central nervous system metastases. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) during the screening period.
9. Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina)
10. Any medical co morbidity that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance, would place the patient at an unacceptable risk and/or potential to affect interpretation of results of the study.
11. Is receiving any concurrent prohibited medication | OBI Pharma, Inc | INDUSTRY | {
"id": "OBI-999-001",
"link": null,
"type": null
} | Has not shown its expected therapeutic potential for the enrolled patients in this trial | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2019-09-09T00:00:00 | {
"date": "2025-03-26",
"type": "ACTUAL"
} | {
"date": "2019-09-10",
"type": "ACTUAL"
} | [
"ADULT",
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"Locally Advanced Solid Tumor"
] | ["antibody drug conjugate (ADC)"] | null | [
{
"city": "La Jolla",
"country": "United States",
"facility": "Scripps MD Anderson Cancer Center",
"geoPoint": {
"lat": 32.84727,
"lon": -117.2742
},
"state": "California"
},
{
"city": "New York",
"country": "United States",
"facility": "Memorial Sloan Kettering Cancer Center",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
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"state": "New York"
},
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"city": "Germantown",
"country": "United States",
"facility": "West Cancer Center",
"geoPoint": {
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"state": "Tennessee"
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"facility": "University of Texas MD Anderson Cancer Center",
"geoPoint": {
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"lon": -95.36327
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"state": "Texas"
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"timeFrame": "Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first"
}
],
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} | [
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"affiliation": "M.D. Anderson Cancer Center",
"name": "Apostolia Tsimberidou, MD, PhD",
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NCT02617966 | null | Rod and Cone Mediated Function in Retinal Disease | Rod and Cone Mediated Function in Retinal Disease | None | OBSERVATIONAL | RECRUITING | 2015-11-28T00:00:00 | null | 2029-12-30T00:00:00 | 2029-12-30T00:00:00 | null | 500 | 5 | 100 | ALL | true | Background:
Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss and night blindness. Researchers want to learn about rod and cone function in healthy people and people with retinal disease. They want to know if how well a person sees in the dark can test the severity of retinal disease.
Objectives:
To find out if how well a person sees in the dark can test the severity of retinal disease. To find out if this can help detect retinal disease and track its changes.
Eligibility:
People ages 5 and older with:
Retinal disease OR
20/20 vision or better with or without correction in at least one eye
Design:
Participants will be screened with medical and eye history and eye exam. Those with retinal disease will also have:
Eye imaging: Drops dilate the eye and pictures are taken of it.
Visual field testing: Participants look into a bowl and press a button when they see light.
Electroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the
dark with their eyes patched for 30 minutes. Then they get numbing drops and contact
lenses. Participants watch lights while retina signals are recorded.
Visit 1 will be 3-8 hours. Participants will have up to 6 more visits over 6-12 months. Visits include:
Eye exam and imaging
Time course of dark adaptation: Participants view a background light for 5 minutes then
push a button when they see colored light.
Dark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button when
they see colored light.
For participants with retinal disease, ERG and visual field testing | Objective: The objective of this protocol is to investigate local changes in rod and cone photoreceptor function across the retina in healthy volunteers and participants with retinal disease.
Study Population: Up to 250 healthy volunteers and 250 participants, age five or older, with retinal disease.
Design: This single-center, observational, case-control study will be comprised of three related Aims that assess rod and cone function with commercial perimeters and/or a commercial Cambridge Research Systems computer monitor (Display++) specialized for displaying stimuli at low light intensities. For Aim 1 the normal retinal sensitivity ranges will be established for both fundus-guided and non-guided perimeters. For Aim 2, the normal range for describing the kinetics of dark adaptation following bleaching of retinal rhodopsin will be established for the fundus-guided and non-guided perimeters. For Aim 3, local changes in rod and cone photoreceptor function across the retina in participants with retinal disease will be examined from measurement of the kinetics of dark adaptation, scotopic and photopic retinal sensitivity, and/or Radial Frequency (RF) hyperacuity on the Display++ monitor. Testing may also include patient reported outcome (PRO) questionnaires to assess vision problems under low luminance conditions.
Outcome Measures: The primary outcome for this study is to establish normal ranges for A) the kinetics of dark adaptation (time), B) retinal sensitivity (dB) for the fundus-guided and non-guided perimeters, and C) RF hyperacuity on the Display++ monitor. The secondary outcomes will be to examine changes in the kinetics of dark adaptation, scotopic and photopic retinal sensitivity, and/or RF hyperacuity in participants with retinal disease and potentially correlate these clinical measures with patients self-reported evaluation of their vision under low luminance conditions. | * INCLUSION CRITERIA:
* Participant must be five years of age or older.
* Participant (or legal guardian) must understand and sign the protocol s informed consent document.
* Participant must be able to cooperate with the testing required for this study.
For Participants with retinal disease only:
* Participant must have retinal disease, defined as evidence of loss of retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging.
* Participant must have a measurable visual acuity.
For Healthy Volunteers only:
-Participant must have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens) in at least one eye.
EXCLUSION CRITERIA:
-Participant with changes in pre-retinal media sufficient to obscure a view of the retina. | National Institutes of Health Clinical Center (CC) | NIH | {
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"CHILD",
"ADULT",
"OLDER_ADULT"
] | Up to 250 participants with retinal disease will be enrolled and up to 120 healthy volunteers will be enrolled. | NON_PROBABILITY_SAMPLE | null | {
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"Retinal Degeneration",
"Retinitis Pigmentosa",
"Stargardt's Disease"
] | ["Retina", "Retinal Degeneration", "Retinitis Pigmentosa", "Stargardt's Disease", "Dark Adaptation"] | null | [
{
"city": "Bethesda",
"country": "United States",
"facility": "National Institutes of Health Clinical Center",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
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"state": "Maryland"
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"timeFrame": "ongoing, up to 10 visits in 5 years"
}
],
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"description": null,
"measure": "Secondary outcomes will be to examine changes in the kinetics of dark adaptation and dark-adapted retinal sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease.",
"timeFrame": "ongoing, up to four visits in 5 years"
}
]
} | [
{
"affiliation": "National Eye Institute (NEI)",
"name": "Brett G Jeffrey, Ph.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "12067593", "type": "BACKGROUND", "citation": "Jackson GR, Owsley C, Curcio CA. Photoreceptor degeneration and dysfunction in aging and age-related maculopathy. Ageing Res Rev. 2002 Jun;1(3):381-96. doi: 10.1016/s1568-1637(02)00007-7."}, {"pmid": "422332", "type": "BACKGROUND", "citation": "Massof RW, Finkelstein D. Rod sensitivity relative to cone sensitivity in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 1979 Mar;18(3):263-72."}, {"pmid": "21810977", "type": "BACKGROUND", "citation": "Birch DG, Wen Y, Locke K, Hood DC. Rod sensitivity, cone sensitivity, and photoreceptor layer thickness in retinal degenerative diseases. Invest Ophthalmol Vis Sci. 2011 Sep 9;52(10):7141-7. doi: 10.1167/iovs.11-7509."}] | {"versionHolder": "2025-06-18"} | {
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NCT06131866 | null | Acceptance and Commitment Therapy Based Psychoeducation, Meaning of Life and Coping Skills in Bipolar Disorder | The Effect of Acceptance and Commitment Therapy Based Psychoeducation on Meaning and Purpose of Life and Coping Skills in Patients With Bipolar Disorder | None | INTERVENTIONAL | COMPLETED | 2023-11-03T00:00:00 | null | 2024-02-25T00:00:00 | 2024-03-20T00:00:00 | [
"NA"
] | 60 | 18 | 65 | ALL | false | This research will be conducted to determine the effect of acceptance and commitment therapy-based psychoeducation on coping skills and finding meaning in life in patients with bipolar disorder. This research is planned as a randomised controlled experimental study. The study will be conducted with euthymic stage patients diagnosed with bipolar disorder who applied to Adıyaman Besni State Hospital psychiatry outpatient clinic using randomisation method. According to the power analysis result, the study will be applied to a total of 40 individuals, 20 experimental and 20 control. "Individual Information Form" regarding socio-demographic characteristics, "Coping Attitudes Evaluation Scale COPE-R" and "Meaning and Purpose of Life Scale" will be used to collect the data. Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group. Pre-tests will be applied to the patients in the intervention and control groups just before the training, post-test will be applied to the intervention group immediately after the training sessions are completed, and follow-up test will be applied one month after the post-test, i.e. in the 12th week. After the pre-test was applied to the control group, the post-test will be applied in the 8th week and the follow-up test will be applied in the 12th week without any intervention. In the evaluation of the data; descriptive statistical methods (frequency, mean), t-test, one way Anova and correlation analyses will be used. Permission was obtained from the University Ethics Committee, the relevant institution and the individuals participating in the study. | Bipolar disorder negatively affects individuals' mental and physical health, interpersonal relationships, educational and occupational functions. Factors such as personality structure, coping with stress and social adaptation skills play an important role in the course of the disease as well as neurobiological factors. Bipolar disorder is a difficult condition for people to cope with due to its chronic nature and these individuals have problems in interpersonal relationships and coping with stress. Beyond what is perceived in relation to normal life, bipolar disorder causes individuals to experience large and complex extra dimensions in all aspects of their lives and to struggle for meaning in their lives. Three indicators of an individual's psychological well-being are the individual's goals in life, awareness of his/her existing potential and the quality of interpersonal relationships. In bipolar disorder, which also affects the psychological well-being of individuals, individuals often do not achieve complete remission despite pharmacotherapy. In addition to pharmacotherapy, various psychosocial interventions such as cognitive behavioural therapies and psychoeducation have been developed and applied to treat bipolar disorder. Acceptance and Commitment Therapy is one of the leading types of therapy methods called the third generation of cognitive behavioural therapies. Instead of teaching individuals to control their feelings, thoughts, sensations, memories and other subjective situations, acceptance and stability therapy teaches individuals to recognise and accept these experiences and, most importantly, to embrace their negative experiences. Acceptance and commitment therapy aims to change individuals' relationships with the emotions, thoughts, memories and physical sensations that they fear and avoid. It uses acceptance and awareness strategies to teach individuals to focus on the present moment and to reduce avoidance and cognitive attachment. Thus, individuals learn to clarify their goals and values and learn to adhere to behaviour change strategies. Acceptance and commitment therapy is one of the psychotherapies supported by the American Psychological Association for most psychiatric conditions, including psychosis. The transdiagnostic nature of acceptance and commitment therapy is compatible with mood disorders as well as psychotic symptoms. Acceptance and commitment therapy has been shown to be effective in many psychopathological conditions, including bipolar disorder. It is stated in the literature that an innovative group intervention combining acceptance and commitment therapy and psychoeducation approaches may be beneficial in individuals with bipolar disorder. Psychoeducational programmes are auxiliary interventions that complement pharmacological treatment in order to further reduce the burden of the disease and relapses in mental disorders. The effectiveness of psychoeducation in patients with bipolar disorder has been shown in many studies. | Inclusion Criteria:
* To be receiving outpatient treatment with the diagnosis of Bipolar Disorder according to DSM-5
* Being in euthymic mood according to the doctor's control at the time of the interview
* Having no problem in understanding and speaking Turkish
* Being literate
* Being in the 18-65 age group
* Not having undergone such training for the last 1 year
Exclusion Criteria:
* Presence of serious sensory and cognitive disabilities that would prevent answering the questionnaire
* Refusal to participate in the study after being informed
* Having another psychiatric diagnosis in addition to the diagnosis of bipolar disorder
* Having an attack period during the education process | University of Gaziantep | OTHER | {
"id": "GAÜN KThmc",
"link": null,
"type": null
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"statusForNctId": null
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"date": "2024-03-22",
"type": "ACTUAL"
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"date": "2023-11-14",
"type": "ACTUAL"
} | [
"ADULT",
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] | ["Bipolar Disorder", "Copin Skills", "Meaning and Purpose of Life", "Acceptance and Commitment Therapy", "Psychoeducation", "Randomised Controlled Trial"] | null | [
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"timeFrame": "up to 12 weeks"
}
],
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{
"description": null,
"measure": "Acceptance and commitment therapy-based psychoeducation and coping skills in patients with bipolar disorder",
"timeFrame": "up to 12 weeks"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT04631666 | null | SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion | A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals | None | INTERVENTIONAL | COMPLETED | 2020-11-05T00:00:00 | null | 2021-08-11T00:00:00 | 2021-08-11T00:00:00 | [
"PHASE1",
"PHASE2"
] | 57 | 18 | 70 | ALL | true | This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c. | The phase 1 component of this trial consists of a single intravenous infusion open-label dose-escalation phase (Groups 1A-1D and Group 2C). Subsequently, the highest tested and tolerated dose will be administered to an expansion cohort of SARS-CoV-2-infected individuals (Group 2D). In this randomized and blinded group, participants will receive DZIF-10c or placebo by intravenous infusion. | Inclusion Criteria:
Groups 1A-1D
* Age 18-65.
* SARS-CoV-2-RNA negative naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
* Non-reactivity of serum antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
Groups 2C-2D
* Age 18-70.
* SARS-CoV-2-RNA positive naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
* Onset of COVID-19 symptoms (e.g., sore throat, cough, fever, chills, fatigue, dys- or anosmia, dys- or ageusia, headache, muscle pain, gastrointestinal symptoms) within 7 days prior to study drug administration or Non-reactivity of serum or plasma antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
* Disease severity score 1-4 as defined by the WHO Clinical Progression Scale (WHO, Lancet Inf Dis 2020).
Exclusion Criteria (all groups):
* Known hypersensitivity to any constituent of the investigational medicinal product.
* Hepatitis B infection indicated by detectable HBsAg (Hepatitis B surface antigen) in blood.
* Detectable antibodies against hepatitis C virus in blood unless active hepatitis C is ruled out by negative HCV-RNA.
* HIV infection indicated by detectable HIV antigen and/or HIV antibodies in blood.
* Neutrophil count ≤1,000 cells/µl
* Hemoglobin ≤10 g/dl
* Platelet count ≤100,000 cells/µl
* ALT ≥2.0 x ULN
* AST ≥2.0 x ULN
* Total bilirubin ≥1.5 ULN
* eGFR \<60 ml/min/1.73m2
* Pregnancy or lactation.
* Any vaccination within 14 days prior to DZIF-10c administration.
* Receipt of any SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody in the past.
* Diagnosis of bronchial asthma or history of bronchial hyperresponsiveness, COPD, pulmonary fibrosis, or other chronic lung diseases.
* Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer.
* History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within ≤6 months and ≥4 weeks of enrollment is acceptable).
* Participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study.
* Dependency on the principal investigator or study staff; or site personnel directly affiliated with this trial.
* Legally incapacitated individuals
* Individuals held in an institution by legal or official order
* If engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception | University of Cologne | OTHER | {
"id": "Uni-Koeln-4288",
"link": null,
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} | Unknown | {
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} | 2020-11-14T00:00:00 | {
"date": "2024-04-08",
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} | {
"date": "2020-11-17",
"type": "ACTUAL"
} | [
"ADULT",
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] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "This study consists of an open-label dose escalation phase in healthy volunteers (Groups 1A-1C) and an additional open-label lead-in phase in SARS-CoV-2-infected individuals (Group 2C).\n\nAfter completion of the dose escalation phase, SARS-CoV-2-infected individuals will be enrolled into a randomized placebo-controlled expansion cohort (Group 2D).\n\nAn additional higher dose cohort may be included for healthy volunteers (Group 1D).",
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} | [
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"city": "Cologne",
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"facility": "University Hospital Cologne",
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"class": "OTHER",
"name": "ZKS Köln"
},
{
"class": "INDUSTRY",
"name": "Boehringer Ingelheim"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Proportion of Patients With Any AE Within 7 d of Study Drug Infusion",
"timeFrame": "7 days"
}
],
"secondary": [
{
"description": null,
"measure": "DZIF-10c Elimination Half Life",
"timeFrame": "0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose"
},
{
"description": null,
"measure": "DZIF-10c Peak Serum Concentration",
"timeFrame": "0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose"
},
{
"description": null,
"measure": "DZIF-10c Area Under the Curve",
"timeFrame": "0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose"
},
{
"description": null,
"measure": "DZIF-10c Clearance",
"timeFrame": "0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose"
},
{
"description": null,
"measure": "DZIF-10c Volume of Distribution Vz",
"timeFrame": "0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose"
},
{
"description": null,
"measure": "Anti-Drug Antibody Development",
"timeFrame": "0, 14, 28, 56, 90 days post dose"
},
{
"description": null,
"measure": "Anti-Drug Antibody Peak Titer",
"timeFrame": "0, 14, 28, 56, 90 days post dose"
},
{
"description": null,
"measure": "Time-weighted SARS-CoV-2 Viral Load Change From Baseline",
"timeFrame": "0, 1, 3, 7, 14, 28 days post dose"
},
{
"description": null,
"measure": "MMRM SARS-CoV-2 Viral Load Change From Baseline",
"timeFrame": "0, 1, 3, 7, 14, 28 days post dose"
}
]
} | [
{
"affiliation": "University of Cologne",
"name": "Gerd Fätkenheuer, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "32946786", "type": "BACKGROUND", "citation": "Kreer C, Zehner M, Weber T, Ercanoglu MS, Gieselmann L, Rohde C, Halwe S, Korenkov M, Schommers P, Vanshylla K, Di Cristanziano V, Janicki H, Brinker R, Ashurov A, Krahling V, Kupke A, Cohen-Dvashi H, Koch M, Eckert JM, Lederer S, Pfeifer N, Wolf T, Vehreschild MJGT, Wendtner C, Diskin R, Gruell H, Becker S, Klein F. Longitudinal Isolation of Potent Near-Germline SARS-CoV-2-Neutralizing Antibodies from COVID-19 Patients. Cell. 2020 Sep 17;182(6):1663-1673. doi: 10.1016/j.cell.2020.08.046. No abstract available."}, {"pmid": "34473343", "type": "DERIVED", "citation": "Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2."}] | {"versionHolder": "2025-06-18"} | {
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NCT04525066 | null | Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma | Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2020-08-11T00:00:00 | null | 2018-08-13T00:00:00 | 2018-08-13T00:00:00 | [
"PHASE2"
] | 39 | 18 | 100 | ALL | false | Objectives: Transoral Laser Microsurgery (TLM) is widely used in for treating T1/T2 glottic cancers. Hyaluronic acid (HA) is a safe and commonly-used injectable in vocal cord augmentation. We report on the results of our single-blinded, randomized-controlled trial (RCT) investigating the impact of intra-operative HA injection on voice outcomes in early glottic cancer.
Methods: Patients with T1/T2 glottic cancers were randomized to the treatment group (n=14) receiving HA injection to the unaffected cord during TLM; or the control group, receiving no injection (n=16). All patients had a Voice Handicap Index-10 (VHI-10) questionnaire and a Maximum Phonation Time (MPT) measurement preoperatively and at 3, 12 and 24 months post-operatively. Mean change in VHI-10 and MPT, between pre-operative and post-operative time points, and between the time points, were compared. Survival estimates were also calculated. | null | Inclusion Criteria:
* Males and females
* 18 years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC
* Lesion amenable to CO2 TLM resection.
Exclusion Criteria:
* Previous radiotherapy to the head and neck.
* Palpable, or radiographic, pathological lymphadenopathy.
* Allergy, or sensitivity, to HA or components of the injectable.
* Neurological disorder affecting phonation, such as multiple sclerosis or stroke. | Nova Scotia Health Authority | OTHER | {
"id": "1020322",
"link": null,
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} | Unknown | {
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"nctId": null,
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} | 2020-08-20T00:00:00 | {
"date": "2020-08-25",
"type": "ACTUAL"
} | {
"date": "2020-08-25",
"type": "ACTUAL"
} | [
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} | [
"Head and Neck Neoplasms",
"Head and Neck Squamous Cell Carcinoma",
"Voice Disorders",
"Laryngeal Cancer"
] | null | null | null | [
{
"class": "OTHER",
"name": "Nova Scotia Health Authority"
}
] | null | {
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"primary": [
{
"description": null,
"measure": "Voice Outcome",
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"description": null,
"measure": "Voice Outcome",
"timeFrame": "Changes at 12 months post-operatively compared to baseline."
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"description": null,
"measure": "Voice Outcome",
"timeFrame": "Changes at 24 months post-operatively compared to baseline."
},
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"description": null,
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},
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"description": null,
"measure": "Voice Outcome",
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}
],
"secondary": [
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"description": null,
"measure": "Overall survival",
"timeFrame": "24 months post-augmentation"
},
{
"description": null,
"measure": "Disease free survival",
"timeFrame": "24 months post-augmentation"
},
{
"description": null,
"measure": "Recurrence-free survival",
"timeFrame": "24 months post-augmentation"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"id": "M1689",
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"relevance": "HIGH"
},
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"id": "M10839",
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"relevance": "LOW"
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},
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"relevance": "LOW"
},
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"id": "T3311",
"name": "Laryngeal Cancer",
"relevance": "HIGH"
}
],
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"term": "Carcinoma"
},
{
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"term": "Squamous Cell Carcinoma of Head and Neck"
},
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"term": "Head and Neck Neoplasms"
},
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"id": "D007822",
"term": "Laryngeal Neoplasms"
},
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"id": "D014832",
"term": "Voice Disorders"
}
]
} | {
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"term": "Adjuvants, Immunologic"
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"term": "Immunologic Factors"
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"term": "Physiological Effects of Drugs"
},
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"term": "Viscosupplements"
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NCT06238466 | null | A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia | A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 Following Single and Multiple Ascending Doses in Participants With Dyslipidemia | None | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2024-01-25T00:00:00 | null | 2025-12-02T00:00:00 | 2025-12-02T00:00:00 | [
"PHASE1"
] | 96 | 18 | 65 | ALL | true | A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia. | This is a first time in human study in male and female (of non-childbearing potential) participants with dyslipidemia. The study consists of two parts:
1. Part A (single ascending dose): Part A of the study will include three parts: A1 for non-Asian participants, A2 for Japanese participants, and A3 for Chinese participants. Parts A2 and A3 are optional.
2. Part B (multiple ascending dose): Part B of the study will include three parts: B1 for non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy, B2 for Japanese participants not receiving statin therapy, and B3 for participants who may or may not be receiving moderate- or high-intensity statin therapy, with the additional diagnosis of type 2 diabetes (T2D), and with HbA1c \< 8%. Parts B2 and B3 are optional.
The study will comprise of:
* A Screening Period of maximum 60 days for both Part A and Part B.
* Part A: A single dose of AZD1705 with an in-clinic period of 3 days.
* An outpatient Follow-up Period of approximately 16 weeks.
* Part B: 2 doses of AZD1705, given 28 days apart with an in-clinic period.
* An outpatient Follow-up Period of approximately 20 weeks. | Inclusion Criteria:
* Male and female of non-childbearing potential participants with suitable veins for cannulation or repeated venipuncture.
* All females must have a negative pregnancy test.
* Participants with elevated lipids.
* BMI between 18 and 35 kg/m\^2.
Part B1 - May or may not be receiving moderate- or high-intensity statin therapy.
Part B3
* May or may not be receiving moderate- or high-intensity statin therapy.
* Diagnosed with T2D with hemoglobin A1c (HbA1c) \< 8% level.
Parts B1 and B3
- Participants on medications should be on stable medication for ≥ 3 months before Screening with no planned medication or dose change during study participation.
Parts A2 and B2:
- Participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese.
Part A3:
- Participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese.
Exclusion Criteria:
* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Any laboratory values with the following deviations at the Screening Visit or on admission to the Clinical Unit. Abnormal values may be repeated once at the discretion of the Investigator:
1. Alanine aminotransferase \> 1.5 × upper limit of normal (ULN).
2. Aspartate aminotransferase \> 1.5 × ULN.
3. Total bilirubin \> ULN (Gilbert's syndrome).
4. Estimated glomerular filtration rate \< 60 milliliter (mL)/minute/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 2021 (National Kidney Foundation).
5. Hemoglobin \< lower limit normal (LLN).
* Any clinically important abnormalities in hematology, coagulation, clinical chemistry, or urinalysis results other than those described under exclusion criterion number 4, at Screening and/or first admission to the study unit, as judged by the Investigator. Abnormal values may be repeated once at the discretion of the Investigator.
* Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab), or Human immunodeficiency virus (HIV).
* Abnormal vital signs, after 5 minutes supine rest, at Screening and/or first admission to the study unit, defined as any of the following:
1. Systolic blood pressure (BP) ≤ 90 millimeters of mercury (mmHg) or \> 140 mmHg (Part A) or \> 150 mmHg (Part B).
2. Diastolic BP \< 50 mmHg or \> 90 mmHg.
3. Heart rate \< 45 or \> 90 beats per minute (bpm). Note: Blood pressure will be measured in triplicates and the mean value will be used. Where the values are outside the required range at admission, then based on medical history, one retest may be performed at this visit.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG, at Screening and/or first admission to the study unit, as judged by the Investigator, that may interfere with the interpretation of QT interval corrected for heart rate (QTc) interval changes, including abnormal ST-T-wave morphology, particularly in the protocol-defined primary lead or left ventricular hypertrophy.
1. Prolonged ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) corrected for heart rate using Fridericia's correction (QTcF) \> 450 ms.
2. Family history of long QT syndrome.
3. Time from the onset of the P wave to the start of the QRS complex (PR) (PQ) interval shortening \< 120 milliseconds (ms) (PR \> 110 ms but \< 120 ms is acceptable if there is no evidence of ventricular pre-excitation).
4. PR (PQ) interval prolongation (\> 220 ms), persistent or intermittent second-degree atrioventricular (AV) block (participants with Wenckebach block while asleep are acceptable), third-degree AV block, or AV dissociation.
5. Persistent or intermittent complete Bundle branch block (BBB), Intermittent bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with ECG interval measured from the onset of the QRS complex to the J point (QRS) \> 110 ms.
* Participants with QRS \> 110 ms but \< 115 ms (Part A) or \< 120 ms (Part B) are acceptable if there is no evidence of ventricular hypertrophy or pre-excitation.
* Smokers who smoke \> 10 cigarettes/day and are unable to comply with the nicotine restriction during the study.
* Known or suspected history of alcohol or drug abuse or those who consume \> 3 units of alcohol per day for males or \> 2 units of alcohol per day for females (where 1 unit being equal to approximately half pint \[284 mL\] of beer, one small glass \[125 mL\] of wine, or one measure \[25 mL\] of spirits) as judged by the Investigator.
* Positive screen for drugs of abuse or alcohol at Screening or on each admission to the Clinical Unit.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to study compound.
* Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) defined as the regular consumption of more than 500 mg of caffeine per day (one cup \~100 mg caffeine; one cup of tea \~30 mg caffeine) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
* Plasma donation within one month of the Screening Visit or any blood donation/blood loss \> 500 mL during the 3 months prior to the Screening Visit.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of investigational medicinal product (IMP). The period of exclusion begins after the final dose.
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the Clinical Unit).
* Judgment by the Investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
* Participants who are vegans or have medical dietary restrictions.
* Participants who cannot communicate reliably with the Investigator.
* Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
* Clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission as per site standard practice.
* Low-density lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization.
Part A Only:
* Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose), and minerals during the 2 weeks prior to the first administration of study intervention or longer if the medication has a long half-life.
* On statin therapy.
* Urine albumin: creatinine ratio \> 30 mg/g.
Part B Only:
* Use of any herbal remedies, mega dose vitamins, and minerals during the two weeks prior to the first administration of study intervention or 5 half-lives, whichever is longer.
* Urine albumin: creatinine ratio \> 100 mg/g.
Parts B1 and B3 Only:
- Contraindication to Magnetic Resonance Imaging (MRI) such as: participants with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field; participants with a history of extreme claustrophobia; or participants who cannot fit inside the MRI scanner cavity. | AstraZeneca | INDUSTRY | {
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} | Unknown | null | 2024-01-25T00:00:00 | {
"date": "2025-05-30",
"type": "ACTUAL"
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"date": "2024-02-02",
"type": "ACTUAL"
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"other": null,
"primary": [
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"timeFrame": "Part A: From Screening (Day -60 to Day -2) until Day 113. Part B: From Screening until Day 141"
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"secondary": [
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"measure": "Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)",
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"description": null,
"measure": "Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)",
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"description": null,
"measure": "Maximum observed plasma (peak) drug concentration (Cmax)",
"timeFrame": "Part A: Day 1 to 113. Part B: Day 1 to 141"
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"measure": "Cumulative amount of drug excreted unchanged (Ae)",
"timeFrame": "Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30"
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"description": null,
"measure": "Fraction of drug excreted unchanged (fe)",
"timeFrame": "Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30"
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{
"description": null,
"measure": "Rate of renal clearance of drug (CLR)",
"timeFrame": "Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30"
},
{
"description": null,
"measure": "Change from baseline in target plasma protein",
"timeFrame": "Part A: Baseline to Day 113. Part B: Baseline to Day 141"
},
{
"description": null,
"measure": "Change from baseline in low-density lipoprotein cholesterol (LDL-C)",
"timeFrame": "Part A: Baseline to Day 113. Part B: Baseline to Day 141"
},
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"description": null,
"measure": "Change from baseline in Apolipoprotein B (ApoB)",
"timeFrame": "Part A: Baseline to Day 113. Part B: Baseline to Day 141"
},
{
"description": null,
"measure": "Change from baseline in triglycerides",
"timeFrame": "Part A: Baseline to Day 113. Part B: Baseline to Day 141"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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],
"meshes": [
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"term": "Dyslipidemias"
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]
} | {
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NCT05680766 | null | Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle. | Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle. | None | INTERVENTIONAL | RECRUITING | 2022-12-23T00:00:00 | null | 2026-01-02T00:00:00 | 2027-01-02T00:00:00 | [
"NA"
] | 30 | 18 | 60 | ALL | false | This exploratory study's primary objective is the changes of irritable bowel syndrome (IBS) symptom severity by cardiovascular endurance training (CET) in relation to the baseline sedentary or non-active lifestyle. Secondary endpoints focus on the mechanisms associated with these changes.
These mechanisms relate to dietary adaptations, changes in anxiety, depressive comorbidity, somatisation, alterations in the gut microbiome or metabolome, body composition and measures of cardiovascular fitness. Virtually all IBS guidelines mention lifestyle modifications as a management option.
Research on the role of physical activity remains underassessed as compared to the other interventions. Therefore, an exploratory proof-of-concept study will investigate the influence of regular physical exercise on symptoms in a small group of IBS patients. This study will gather data on putative underlying mechanisms related to dietary factors, faecal microbiome and metabolome, mental well-being, body composition and cardiovascular fitness. | null | Inclusion Criteria:
* Patients aged 18 - 60 years;
* Fulfilling the ROME IV criteria for Irritable bowel syndrome (IBS);
* Moderate symptom severity as defined by a IBS-Symptom Severity Scale \> 175;
* Sedentary lifestyle defined as SIT-Q-7D \> 8h/day;
* Physically inactive defined as \< 150min/week on the IPAQ score
Exclusion Criteria:
* Cardiorespiratory disorder hampering participation in a program of physical exercise as evidenced by the sport + keuringsartsen (SKA) questionnaire.
* Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded);
* Known inflammatory bowel disorder;
* Known intestinal motility disorder;
* Alcohol (defined as more than 14 U per week) or other substance abuse;
* Active psychiatric disorder;
* Known systemic or auto-immune disorder with implication for the GI system;
* Prior abdominal surgery (with the exception of appendectomy or cholecystectomy more than 6 months ago);
* Any prior diagnosis of cancer other than basocellular carcinoma;
* Current chemotherapy;
* History of gastro-enteritis in the past 8 weeks;
* Change in diet in the past 8 weeks;
* Dietary supplements unless taken at a stable dose for more than 8 weeks;
* Antibiotics, pre-, pro-, post-biotics or any combination during the past 8 weeks;
* Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed);
* Treatment with spasmolytic agents, opioids, loperamide, gelatine tannate or mucoprotect-ants during the past 8 weeks. | Universitair Ziekenhuis Brussel | OTHER | {
"id": "Face-IT",
"link": null,
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} | Unknown | {
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"nctId": null,
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"date": "2024-06-07",
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"date": "2023-01-11",
"type": "ACTUAL"
} | [
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"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "IBS subjects fulfilling the eligibility criteria will follow a structured and personalised cardiovascular endurance training (CET).",
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"primaryPurpose": "TREATMENT",
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"facility": "UZ Brussel",
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"description": null,
"measure": "Change of IBS Symptom severity",
"timeFrame": "from baseline to 6 weeks"
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} | null | null | {"versionHolder": "2025-06-18"} | {
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} |
NCT02841566 | null | Comparative Study of the Link Between the Practice of Gambling and Money and Materialism Among Problem Gamblers and Non-problem Gamblers | GAMbling and MAterialism | GAMMA | OBSERVATIONAL | COMPLETED | 2016-07-19T00:00:00 | null | null | null | null | 144 | 18 | null | ALL | true | The purpose of this study is to to explore the link between materialism and addiction to gambling and money | null | Inclusion Criteria: ( specific to problem gamblers)
* subject having at least four diagnostic criteria in "Trouble linked to gambling and money" DSM-5 (APA 2013)
* subject who had written consent for participation in the EVALADD cohort
* Subject who has started treatment for a problem with the practice of gambling and money in the addictology and psychiatric department
( specific to non-problem gamblers)
* Subject playing games of chance and money at least once a year
* Subject playing games of chance and money less than once per week OR less than € 500 per year
* Subject having a score of 0-2 at ICJE questionnaire
Exclusion Criteria:
* Subject having difficulty reading or writing of the French language
* Subject having Parkinson's Disease
* Subject under guardianship | Nantes University Hospital | OTHER | {
"id": "RC15_0372",
"link": null,
"type": null
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} | 2016-07-19T00:00:00 | {
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"type": "ESTIMATED"
} | {
"date": "2016-07-22",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | All new patients be seen by a doctor for a behavioral addiction in the addictology and psychiatric department | NON_PROBABILITY_SAMPLE | false | {
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} | [
"Gambling"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Materialism level among problem gamblers compared to non-problem gamblers",
"timeFrame": "1 year"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"term": "Disruptive, Impulse Control, and Conduct Disorders"
},
{
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"term": "Mental Disorders"
}
],
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"abbrev": "BXM",
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},
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},
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},
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"asFound": null,
"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
}
],
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{
"id": "D005715",
"term": "Gambling"
}
]
} | null | {
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{
"id": "D005715",
"term": "Gambling"
}
],
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} |
NCT02270866 | null | Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia | null | None | INTERVENTIONAL | COMPLETED | 2014-10-14T00:00:00 | null | null | null | [
"NA"
] | 9 | 18 | 75 | ALL | false | This is a single site, open label study with a single arm designed to assess the feasibility of use of caloric vestibular stimulation (CVS) in patients with post-stroke aphasia. CVS is delivered via a portable, non-invasive device. Both language and movement assessments are made. | null | Inclusion Criteria:
* \>6 months post-stroke (ischemic or hemorrhagic)
* receptive or expressive aphasia
* little or no improvement in language ability in the preceding 3 months
Exclusion Criteria:
* persons under the age of 18 or over the age of 75
* patients with pure receptive aphasia
* co-morbid CNS disease
* primary motor/oral apraxia
* pregnant or nursing women
* have a history of unstable mood disorder or unstable anxiety disorder or psychosis
* use of a hearing aid
* have a cochlear implant
* have a diagnosed vestibular dysfunction
* abuse alcohol or other drugs
* have had eye surgery within the previous three months or ear surgery within the previous six months
* have active ear infections or a perforated tympanic membrane
* have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
* Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to a CVS treatment. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness of the vestibular system to caloric stimulation. | Scion NeuroStim | INDUSTRY | {
"id": "SNS-APH-01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-10-20T00:00:00 | {
"date": "2025-03-30",
"type": "ACTUAL"
} | {
"date": "2014-10-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"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": "DEVICE_FEASIBILITY",
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} | [
"Post-stroke Aphasia"
] | ["aphasia", "stroke"] | null | [
{
"city": "Durham",
"country": "United States",
"facility": "Duke University Medical Center",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
},
"state": "North Carolina"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period",
"timeFrame": "after completing 84 days of device use"
}
],
"secondary": [
{
"description": null,
"measure": "Mood & QoL",
"timeFrame": "after completing 84 days of device use"
},
{
"description": null,
"measure": "Gait and posture",
"timeFrame": "after completing 84 days of device use"
},
{
"description": null,
"measure": "Heart rate variability (HRV)",
"timeFrame": "after completing 84 days of device use"
},
{
"description": null,
"measure": "Durability of gains",
"timeFrame": "3 months after the completion of therapy"
}
]
} | null | 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"
},
{
"id": "D013064",
"term": "Speech Disorders"
},
{
"id": "D007806",
"term": "Language Disorders"
},
{
"id": "D003147",
"term": "Communication Disorders"
},
{
"id": "D019954",
"term": "Neurobehavioral Manifestations"
},
{
"id": "D009461",
"term": "Neurologic Manifestations"
}
],
"browseBranches": [
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"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
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],
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"id": "M22306",
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},
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"asFound": "Aphasia",
"id": "M4352",
"name": "Aphasia",
"relevance": "HIGH"
},
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"name": "Cerebrovascular Disorders",
"relevance": "LOW"
},
{
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"id": "M5204",
"name": "Brain Diseases",
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"name": "Central Nervous System Diseases",
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},
{
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},
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},
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"asFound": null,
"id": "M6374",
"name": "Communication Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21826",
"name": "Neurobehavioral Manifestations",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12404",
"name": "Neurologic Manifestations",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D020521",
"term": "Stroke"
},
{
"id": "D001037",
"term": "Aphasia"
}
]
} | null | {
"conditions": [
{
"id": "D020521",
"term": "Stroke"
},
{
"id": "D001037",
"term": "Aphasia"
}
],
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} |
NCT05828966 | null | HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL | HUMAN CHORIONIC GONADOTROPIN (HcG) VS MAGNESIUM SULPHATE (MgSo4) AS A TOCOLYTIC AGENT- A RANDOMIZED CONTROLLED TRIAL | None | INTERVENTIONAL | COMPLETED | 2023-04-13T00:00:00 | null | 2023-05-15T00:00:00 | 2023-12-20T00:00:00 | [
"NA"
] | 70 | 18 | 45 | FEMALE | false | Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5) | Preterm labor is defined as regular contractions of the uterus resulting in changes in the cervix (effacement and dilatation) that start before 37 weeks of pregnancy. (1) Although preterm labor constitutes only 10% of total labors, yet 70% of infant's mortality is related to prematurity. It is therefore one of the international indices in assessment of health condition worldwide. Factors that increase the risk of preterm birth include history of previous preterm birth, short cervix, short time between pregnancies, teenage pregnancy, history of certain types of surgery on the uterus or cervix, certain pregnancy complications, such as multiple pregnancy and vaginal bleeding and lifestyle factors such as low pre-pregnancy weight, smoking during pregnancy, and substance abuse during pregnancy.
Preterm labor can be diagnosed clinically only when changes in the cervix are found after pelvic examination along with contractions also may be monitored. A transvaginal ultrasound exam may be done to measure the length of your cervix. Tocolytics are drugs used to delay delivery for a short time (up to 48 hours). They may allow time for corticosteroids or magnesium sulfate to be given or for you to be transferred to a hospital that offers specialized care for preterm infants. (1,2) Tocolytic agents are β- HCG, MgSO4, nifedipine, β-agonists(salbutamol) and atosiban. Use of salbutamol is of limited use because of many cardiovascular complications i.e., ventricular arrythmia, hypertension and hyperglycemia while atosiban is expensive and not available in Pakistan.
Human Chorionic Gonadotropin (H.C.G.) is a heterodimeric glycoprotein produced primarily in the placenta and has multiple endocrines, paracrine and immunoregulatory actions. (3) The importance of H.C.G. in maintenance of early pregnancy has been widely accepted, reports have highlighted a potential role of H.C.G. in maintaining uterine quiescence in the third trimester. H.C.G. exerts a potent concentration dependent inhibitory effect on human myometrial contractions. (4) Recent data suggests that H.C.G. might have a role as an endogenous tocolytic agent in normal pregnancy. A significant decrease in serum H.C.G. level was found 2-3 weeks before the spontaneous onset of labour. This might contribute to increasing the contractility in the uterine muscle and gradually initiating the onset of labour. (5) Following I.M. injection, peak concentration of H.C.G. occurs about 6 hrs after a dose. It is distributed primarily to gonads. Blood concentration declines in a biphasic manner, with a half-life between about 6 and 11 hrs and 23 to 38 hrs respectively. About 10 to 12% of an IM dose is excreted in urine within 24 hours. (6) | Inclusion Criteria:
1. 4 uterine contractions per 20 min or 8 contractions per hour
2. single live fetus
3. Pregnancy less than 37 weeks
4. Intact Membranes,
5. Dilatation less than 3cm and effacement less than 80%.
Exclusion Criteria:
1. Cervical Dilatation more than 4 cm
2. Abnormal vaginal bleeding
3. Premature Rupture of membranes
4. Cardiopulmonary compromised
5. Fetal and Uterine anomalies | Shaheed Zulfiqar Ali Bhutto Medical University | OTHER | {
"id": "001",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-04-13T00:00:00 | {
"date": "2024-06-07",
"type": "ACTUAL"
} | {
"date": "2023-04-25",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Preterm Labor"
] | null | null | [
{
"city": "Islamabad",
"country": "Pakistan",
"facility": "Mother and Child Care Hospital, Shaheed Zulfiqar Ali Bhutto Medical University",
"geoPoint": {
"lat": 33.72148,
"lon": 73.04329
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Tocolysis",
"timeFrame": "48 hours"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D007744",
"term": "Obstetric Labor Complications"
},
{
"id": "D011248",
"term": "Pregnancy Complications"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
}
],
"browseBranches": [
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"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"asFound": null,
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"relevance": "HIGH"
},
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"asFound": null,
"id": "M10764",
"name": "Obstetric Labor Complications",
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},
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"asFound": null,
"id": "M14127",
"name": "Pregnancy Complications",
"relevance": "LOW"
},
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"relevance": "LOW"
},
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"name": "Female Urogenital Diseases",
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},
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"id": "M8399",
"name": "Female Urogenital Diseases and Pregnancy Complications",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007752",
"term": "Obstetric Labor, Premature"
}
]
} | {
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"id": "D000700",
"term": "Analgesics"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
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"term": "Peripheral Nervous System Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
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"term": "Anesthetics"
},
{
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"term": "Central Nervous System Depressants"
},
{
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"term": "Anti-Arrhythmia Agents"
},
{
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"term": "Anticonvulsants"
},
{
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"term": "Calcium Channel Blockers"
},
{
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},
{
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"term": "Molecular Mechanisms of Pharmacological Action"
},
{
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"term": "Calcium-Regulating Hormones and Agents"
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{
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"term": "Tocolytic Agents"
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{
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],
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"name": "Analgesics"
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"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
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"name": "All Drugs and Chemicals"
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"abbrev": "BDCA",
"name": "Bone Density Conservation Agents"
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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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"term": "Magnesium Sulfate"
},
{
"id": "D006063",
"term": "Chorionic Gonadotropin"
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]
} | {
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"term": "Magnesium Sulfate"
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]
} |
NCT06891066 | null | A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060) | A Phase 2b, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Islatravir (ISL) and Ulonivirine (ULO) Once Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily | None | INTERVENTIONAL | RECRUITING | 2025-03-17T00:00:00 | null | 2027-09-24T00:00:00 | 2027-09-24T00:00:00 | [
"PHASE2"
] | 150 | 18 | null | ALL | false | Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it. | null | Inclusion:
The main inclusion criteria include but are not limited to the following:
- Has been receiving Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression \[Human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \<50 copies/mL\] for ≥6 months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen.
Exclusion:
The main exclusion criteria include but are not limited to the following:
* Has Human immunodeficiency virus type 2 (HIV-2) infection.
* Has a diagnosis of an active Acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
* Has active hepatitis C virus (HCV) coinfection.
* Has hepatitis B virus (HBV) coinfection.
* Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
* Has prior exposure to Islatravir (ISL) or Ulonivirine (ULO) for any duration any time prior to Day 1. | Merck Sharp & Dohme LLC | INDUSTRY | {
"id": "8591B-060",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-03-17T00:00:00 | {
"date": "2025-06-15",
"type": "ACTUAL"
} | {
"date": "2025-03-24",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Human Immunodeficiency Virus Type 1 (HIV-1) Infection"
] | ["HIV-1"] | null | [
{
"city": "San Francisco",
"country": "United States",
"facility": "Zuckerberg San Francisco General Hospital and Trauma Center ( Site 4107)",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California"
},
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"city": "West Hollywood",
"country": "United States",
"facility": "Mills Clinical Research ( Site 4109)",
"geoPoint": {
"lat": 34.09001,
"lon": -118.36174
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"state": "California"
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"city": "Washington",
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"facility": "Georgetown University Medical Center ( Site 4106)",
"geoPoint": {
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"state": "District of Columbia"
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"geoPoint": {
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"lon": -81.37924
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"geoPoint": {
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"lon": -80.05337
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"state": "Florida"
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"geoPoint": {
"lat": 32.08354,
"lon": -81.09983
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"state": "Georgia"
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"city": "Kansas City",
"country": "United States",
"facility": "KC CARE Health Center ( Site 4101)",
"geoPoint": {
"lat": 39.09973,
"lon": -94.57857
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"city": "Greensboro",
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"facility": "Regional Center for Infectious Diseases ( Site 4115)",
"geoPoint": {
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"geoPoint": {
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{
"city": "Dallas",
"country": "United States",
"facility": "Prism Health North Texas, Oak Cliff Health Center ( Site 4114)",
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"state": "Texas"
},
{
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"state": "Texas"
},
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"geoPoint": {
"lat": 46.01008,
"lon": 8.96004
},
"state": "Ticino"
}
] | null | null | {
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"timeFrame": "Week 24"
},
{
"description": null,
"measure": "Percentage of Participants who Experience an Adverse Event (AE)",
"timeFrame": "Up to ~ 96 weeks"
},
{
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],
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},
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"description": null,
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},
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{
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"measure": "Mean Change From Baseline in CD4+ T-cell Count at Week 24",
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"timeFrame": "Week 48"
},
{
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"measure": "Mean Change From Baseline in CD4+ T-cell Count at Week 96",
"timeFrame": "Week 96"
},
{
"description": null,
"measure": "Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 24",
"timeFrame": "Week 24"
},
{
"description": null,
"measure": "Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 48",
"timeFrame": "Week 48"
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{
"description": null,
"measure": "Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 96",
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]
} | [
{
"affiliation": "Merck Sharp & Dohme LLC",
"name": "Medical Director",
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}
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],
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{
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NCT00638066 | null | Botulinum Toxin Injection for Treatment of Vaginismus | Comparison of Efficacy of 250 Units Versus 500 Units of Botulinum Toxin in the Treatment of Refractory Vaginismus | None | INTERVENTIONAL | UNKNOWN | 2008-01-10T00:00:00 | null | null | null | [
"PHASE3"
] | 40 | 20 | 45 | FEMALE | true | According to high rate of vaginismus (about 10 percent) which leads to unconsummated marriage (about 1 percent) and low efficacy for conventional treatments such as biofeedback therapy, analgesic drugs and pain killers and surgical treatment, there's necessity to find more effective method.
In our previous study, injecting botulinum toxin in 23 patients cured 75% of them.Now we are to make comparison between different doses of toxin injection and record the patient sexual satisfaction. | Vaginismus is the recurrent or persistent involuntary contraction of the perineal muscles surrounding the outer third of the vagina when penile, finger, tampon, or speculum penetration is attempted . Vaginismus can be primary, in which the women has never been able to have intercourse, or secondary, which is often due to acquired dyspareunia. It is relatively rare, affecting about 1% of women . Treatment of vaginismus is directed toward extinguishing the conditioned involuntary vaginal spasm. This can be accomplished by teaching Kegel exercises to acquaint the patient with voluntary control of her levator muscles. Medications such as lubricants, anesthetic creams, propranolol, or alprazolam to reduce anxiety have been used effectively, but approximately 10% of patients do not respond. Botulinum toxin type A has been successfully used to treat a wide range of muscular disorders such as strabismus, blepharospasm, and cervical dystonia. It is also been used to reduce facial lines and wrinkles.The extent of paralysis depends on the amount of toxin to which there is exposure relative to muscle bulk.In our previous study, one week after injecting botulinum toxin in 23 patients (95.8%) had a vaginal exam, which showed no or little resistance; 18 (75%) achieved satisfactory intercourse after the first injection. Now we are to make comparison between different doses of toxin injection and record the patient sexual satisfaction. | Inclusion Criteria:
* Unconsummated marriage
* Difficult mating
* No response to biofeedback
Exclusion Criteria:
* Patient unlikely to have toxin injection
* Not having mutual life with partner
* Non treated pelvic and vaginal infection | Tehran University of Medical Sciences | OTHER | {
"id": "130/6/6081",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-03-17T00:00:00 | {
"date": "2008-03-18",
"type": "ESTIMATED"
} | {
"date": "2008-03-18",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | false | {
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"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Vaginismus"
] | ["vaginismus", "botulinum toxin A", "dyspareunia", "unconsummated marriage"] | null | [
{
"city": "Tehran",
"country": "Iran, Islamic Republic of",
"facility": "Tehran University of Medical Sciences, Vali e Asr Reproductive Health Research Center",
"geoPoint": {
"lat": 35.69439,
"lon": 51.42151
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "50 percent of patient satisfaction",
"timeFrame": "first two month"
}
],
"secondary": [
{
"description": null,
"measure": "total patient satisfaction",
"timeFrame": "next four month"
}
]
} | [
{
"affiliation": "Tehran University of Medical Sciences",
"name": "Abbas noroozi, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Vaginal Diseases"
},
{
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},
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},
{
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"term": "Female Urogenital Diseases and Pregnancy Complications"
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{
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},
{
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{
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},
{
"id": "D020018",
"term": "Sexual Dysfunctions, Psychological"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
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"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
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{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
"abbrev": "All",
"name": "All Conditions"
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"id": "M26960",
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"relevance": "HIGH"
},
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{
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},
{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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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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{
"id": "D052065",
"term": "Vaginismus"
}
]
} | {
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"term": "Acetylcholine Release Inhibitors"
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"term": "Membrane Transport Modulators"
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"term": "Neuromuscular Agents"
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{
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{
"id": "C542869",
"term": "abobotulinumtoxinA"
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]
} | {
"conditions": [
{
"id": "D052065",
"term": "Vaginismus"
}
],
"interventions": [
{
"id": "D001905",
"term": "Botulinum Toxins"
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{
"id": "D019274",
"term": "Botulinum Toxins, Type A"
},
{
"id": "C542869",
"term": "abobotulinumtoxinA"
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} |
NCT01934166 | null | Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects | An Interventional, Single-site, Open-label, Four-group, Single-dose Study Investigating the Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment (Mild, Moderate, or Severe) and in Healthy Subjects | None | INTERVENTIONAL | COMPLETED | 2013-08-22T00:00:00 | null | null | null | [
"PHASE1"
] | 32 | 18 | 70 | ALL | true | To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene | null | Inclusion Criteria:
* Healthy young subjects and subjects with renal impairment with a Glomerular Filtration Rate (GFR) of 50-80 ml/min/1.73m2, 30-\<50 ml/min/1.73m2, \<30 ml/min/1.73m2 will be included in the study.
* The subjects must have a BMI between 19 and 32 kg/m2.
Exclusion Criteria:
* The subject has a history of renal transplant or is undergoing dialyse treatment.
* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.
Other inclusion and exclusion criteria may apply. | H. Lundbeck A/S | INDUSTRY | {
"id": "15084A",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-08-29T00:00:00 | {
"date": "2016-11-08",
"type": "ESTIMATED"
} | {
"date": "2013-09-04",
"type": "ESTIMATED"
} | [
"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": null,
"timePerspective": null
} | [
"Renal Impairment"
] | null | null | [
{
"city": "Munich",
"country": "Germany",
"facility": "DE801",
"geoPoint": {
"lat": 48.13743,
"lon": 11.57549
},
"state": null
}
] | null | null | {
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"primary": [
{
"description": null,
"measure": "For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf)",
"timeFrame": "Up to 120 hours post-dose"
},
{
"description": null,
"measure": "For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t)",
"timeFrame": "Up to 120 hours post-dose"
},
{
"description": null,
"measure": "For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)",
"timeFrame": "Up to 120 hours post-dose"
},
{
"description": null,
"measure": "For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax)",
"timeFrame": "Up to 120 hours post-dose"
},
{
"description": null,
"measure": "For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)",
"timeFrame": "Up to 120 hours post-dose"
},
{
"description": null,
"measure": "For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)",
"timeFrame": "Up to 120 hours post-dose"
},
{
"description": null,
"measure": "For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)",
"timeFrame": "Up to 120 hours post-dose"
},
{
"description": null,
"measure": "For nalmefene: apparent volume of distribution for nalmefene (Vz /F)",
"timeFrame": "Up to 120 hours post-dose"
},
{
"description": null,
"measure": "For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent",
"timeFrame": "Up to 120 hours post-dose"
}
],
"secondary": [
{
"description": null,
"measure": "Safety and tolerability",
"timeFrame": "Up to 10 days"
}
]
} | [
{
"affiliation": "[email protected]",
"name": "Email contact via H. Lundbeck A/S",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007674",
"term": "Kidney Diseases"
},
{
"id": "D014570",
"term": "Urologic Diseases"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
{
"id": "D052801",
"term": "Male Urogenital Diseases"
}
],
"browseBranches": [
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Renal Impairment",
"id": "M26718",
"name": "Renal Insufficiency",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10698",
"name": "Kidney Diseases",
"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",
"name": "Male Urogenital Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D051437",
"term": "Renal Insufficiency"
}
]
} | {
"ancestors": [
{
"id": "D009292",
"term": "Narcotic Antagonists"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
}
],
"browseBranches": [
{
"abbrev": "NarcAntag",
"name": "Narcotic Antagonists"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Analg",
"name": "Analgesics"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
}
],
"browseLeaves": [
{
"asFound": "5-HT",
"id": "M268823",
"name": "Nalmefene",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12245",
"name": "Narcotics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12243",
"name": "Narcotic Antagonists",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C038981",
"term": "Nalmefene"
}
]
} | {
"conditions": [
{
"id": "D051437",
"term": "Renal Insufficiency"
}
],
"interventions": [
{
"id": "C038981",
"term": "Nalmefene"
}
]
} |
NCT04657926 | null | A Trial of APPA in the Treatment of Knee Osteoarthritis | A Placebo-controlled, Double-blinded, Randomized, Trial Using a Combination of Apocynin and Paeonol (APPA) for the Treatment of Knee Osteoarthritis | None | INTERVENTIONAL | COMPLETED | 2020-11-30T00:00:00 | null | 2021-09-30T00:00:00 | 2021-10-01T00:00:00 | [
"PHASE2"
] | 152 | 18 | 75 | ALL | false | A placebo controlled study of APPA in 150 participants with Osteoarthritis of the knee | This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week trial of a fixed-dose combination of apocynin and paeonol (APPA) administered orally twice daily versus placebo twice daily. Approximately 150 subjects will be randomized to one of the two treatment groups. | Inclusion Criteria:
1. Subject is able to read and understand the language and content of the study material, understand the requirements for study visits, and is willing to provide information at the scheduled evaluations and appropriate written informed consent has been obtained.
2. Femorotibial osteoarthritis of the knee, according the American College of Rheumatology (ACR) clinical and radiographic criteria (Altman et al., 1986) (Appendix A).
3. Radiological OA grade 2 or 3 of the target knee, using the Kellgren-Lawrence method (Kellgren and Lawrence, 1957) as graded by central, independent reading of X-ray obtained during screening, or on a recent (within 6 months) X-ray image which fulfills the protocol specifications for reading.
4. Age between 40 years and 85 years at the time of screening, both included; of either sex.
5. Pain score rated on an 11-point numerical rating scale of the target knee of ≥ 20 and ≤ 45 out of 50 in response to the WOMAC pain sub-score (5 questions), at the time of screening and baseline. The subject should have undergone a washout-period of at least 5 half-lives of any analgesic medication before completing the screening and baseline questionnaires.
6. Women of child-bearing potential must use a highly effective method of contraception(please see Appendix B). Postmenopausal status is defined as being amenorrheic for at least 1 year prior to screening. Sexually active men with a female partner of childbearing potential must ensure that their female partner uses a highly effective method of contraception and agree to use condom from enrolment up to at least 3 months after the study end. Furthermore, male participants must agree not to donate sperm throughout the study and at least 3 months after he study end.
7. Knee pain in the target knee for 14 days of the preceding month (periarticular knee pain due to OA and not due to non-OA conditions such as bursitis, tendonitis, etc.) based on subject report.
8. Inadequate response to or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs) as reported by the subject
Exclusion Criteria:
1. Known or suspected hypersensitivity to or previous hypersensitivity reactions to APPA, or any of the excipients in the investigational product.
2. For women of childbearing potential:
1. Pregnancy (i.e. positive pregnancy test at Screening) or breastfeeding
2. Failure to agree to practice a highly effective method of contraception (see Appendix B), from enrolment up to at least 3 months after the study end.
3. For sexually active men with a female partner of childbearing potential: Failure to agree to ensure that their female partner uses a highly effective method of contraception, to agree to use condom (see Appendix B) from enrolment up to at least 3 months after the study end, and to agree not to donate sperm throughout the study and at least 3 months after the study end.
4. Intra-articular delivery of corticosteroids within 3 months or hyaluronic acid within 6 months of screening in the target knee or into any other joint within 30 days of screening.
5. Systemic corticosteroid treatment of more than 14 days during the past 6 months prior to screening.
6. Major surgery or arthroscopy of the target knee within the previous year prior to screening.
7. Planned surgery on either knee within the next 3 months.
8. Use of a currently unapproved investigational drug, device or biologic within 3 months prior to screening.
9. Presence of inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, polymyalgia rheumatica, gout or pseudogout with history of clinical attacks.
10. Current malignancy or treatment for malignancy within the past five years, with the exception of treated non-melanoma skin cancer, unless affecting the target knee area, or carcinoma in situ events.
11. Any other abnormal laboratory results or significant medical conditions that the Investigator believes should preclude the subject's participation in the trial.
12. Prior septic arthritis of the target knee.
13. Known osteoarthritis of the hip(s) if pain in either or both hip(s) exceeds that of the target knee using the WOMAC Hip Pain sub-score for that hip at the time of screening
14. Presence of significant radicular back pain, as reported by the subject.
15. Presence of severe pain in either knee, defined as \> 45 out of 50 in response to the WOMAC pain sub-score (5 questions), at the time of screening or baseline, regardless of the eligibility of the contralateral knee.
16. Body Mass Index \> 40.0 kg/m2.
17. Estimated glomerular filtration rate \< 30 mL/min using the Modification of Diet in Renal Disease (MDRD) method.
18. Substantial use of moderate or higher strength opioid medication for the treatment of pain within 6 weeks before the screening visit, as evaluated by the investigator.
19. Use of duloxetine, pregabalin, or gabapentin within 4 weeks before the baseline visit.
20. History of alcohol or drug abuse within the past 5 years prior to randomization. | AKL Research and Development | INDUSTRY | {
"id": "APPA-P2-1",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-12-07T00:00:00 | {
"date": "2021-11-17",
"type": "ACTUAL"
} | {
"date": "2020-12-08",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_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": "TREATMENT",
"timePerspective": null
} | [
"Osteoarthritis"
] | null | null | [
{
"city": "Copenhagen",
"country": "Denmark",
"facility": "Sanos Clinic",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null
}
] | [
{
"class": "INDUSTRY",
"name": "NBCD A/S"
}
] | null | {
"other": [
{
"description": null,
"measure": "Changes in serum and urine biomarkers of joint tissue turnover",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Time to achieve a clinically relevant pain reduction defined as a decrease from baseline of at least 1 points out of 10 in the 11-point average of daily pain score",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Time to achieve \"moderate improvement\" and time to achieve \"high improvement\" in OMERACT-OARSI response",
"timeFrame": "28 days"
}
],
"primary": [
{
"description": null,
"measure": "WOMAC pain score",
"timeFrame": "28 days"
}
],
"secondary": [
{
"description": null,
"measure": "Changes from baseline in WOMAC total score and the WOMAC function and stiffness scores at week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Changes from baseline in constant, intermittent and total OA pain assessed by ICOAP scores at week 4 Changes from baseline in constant, intermittent and total OA pain assessed by ICOAP scores at week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Changes from baseline in WOMAC pain weight-bearing score (questions 1, 2, and 5) and non-weight bearing score (questions 3 and 4) at week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Changes from baseline in physical function assessed by the 20 Meter Walk Test gait speed at week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Change from baseline in the weekly mean of the average daily pain intensity at Week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Area-under-effect curves of the weekly mean of the average daily pain intensity at Week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "OMERACT-OARSI responder rate at week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Total dose of rescue medication calculated as the sum of tablets used, based on pill counts",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Time between baseline and first use of rescue medication",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Changes from baseline in the Patient Global Assessment (PGA) score at week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Changes from baseline in quality of life assessed by the EQ5D at week 4",
"timeFrame": "28 days"
},
{
"description": null,
"measure": "Safety",
"timeFrame": "28 days"
}
]
} | [
{
"affiliation": "Nordic Bioscience Clinical Development",
"name": "Asger Bihlet",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001168",
"term": "Arthritis"
},
{
"id": "D007592",
"term": "Joint Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D012216",
"term": "Rheumatic Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
}
],
"browseLeaves": [
{
"asFound": "Osteoarthritis",
"id": "M12926",
"name": "Osteoarthritis",
"relevance": "HIGH"
},
{
"asFound": "Knee Osteoarthritis",
"id": "M22168",
"name": "Osteoarthritis, Knee",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4476",
"name": "Arthritis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10621",
"name": "Joint Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15045",
"name": "Rheumatic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6323",
"name": "Collagen Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D010003",
"term": "Osteoarthritis"
},
{
"id": "D020370",
"term": "Osteoarthritis, Knee"
}
]
} | {
"ancestors": null,
"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": null,
"id": "M246498",
"name": "Acetovanillone",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D010003",
"term": "Osteoarthritis"
},
{
"id": "D020370",
"term": "Osteoarthritis, Knee"
}
],
"interventions": []
} |
NCT04789226 | null | Psychological Impact of Covid-19 Assiut University Hospital Experience | Psychological Impact of Covid-19 Assiut University Hospital Experience | None | OBSERVATIONAL | UNKNOWN | 2021-03-04T00:00:00 | null | 2022-03-01T00:00:00 | 2022-03-01T00:00:00 | null | 239 | 18 | 90 | ALL | false | Psychological impact of covid-19 in assiut university hospital | Coronavirus disease 2019 (COVID-19) is a new communicable disease caused by the new strains of severe acute respiratory syndrome coronavirus, SARS-CoV-2 . The first outbreak reported was in December2019, in Wuhan, China, as pneumonia of unknown etiology linked to a seafood market exposure COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.
The evolution of the novel Corona Virus Disease (COVID-19) and its expeditious dissemination have led the World Health Organization (WHO) to declare it a pandemic on 11 March 2020 . As of 16 May 2020, there have been 4,425,485 confirmed COVID-19 cases and 302,059 related deaths worldwide and Egypt has been among the most affected countries in the Eastern Mediterranean region with 11,228 confirmed cases and 592 deaths .
As a consequence, many countries, including Egypt, have set a state of lockdown to hinder the spread of infection among people resulting in a global atmosphere of depression and anxiety associated with social isolation, fears of getting infected, breaks in the supply chains, financial distress, disrupted travel plans, and future uncertainty . Several epidemiological studies from China detected a high prevalence of psychological disturbances among the public during the COVID-19 pandemic. For example, a large online survey of 56,679 individuals from 34 provinces in China reported numerous psychological conditions during the COVID-19 pandemic: depression (27.9%), anxiety (31.6%), stress (24.4%), and insomnia (29.2%) . Also, a study conducted on 4872 Chinese people from 31 provinces showed a high prevalence of depression (48.3%) and anxiety (22.6%) related to the COVID-19 pandemic . A similar study revealed depression (20.1%), anxiety (35.1%), and poor sleeping (18.2%) among 7236 Chinese people . Another study conducted on 7143 college students in China detected anxiety among 25% of them .
In low- and middle-income countries, such as Egypt, where infection control precautions, surveillance programs, laboratory capacity, and public health resources are limited , the response to the COVID-19 pandemic is challenging and, as a result, the psychological impacts of the pandemic on the public can be even worse. Thus, we conducted this study to evaluate several forms of psychological disturbances . | Inclusion Criteria:
* age more than 18 years old
* diagnosed as covid-19 by positive PCR
* comes to Assiut University Hospital
* both sex males and females
Exclusion Criteria:
* age less than 18 years old
* past history of psychatric disorder | Assiut University | OTHER | {
"id": "Psychology and covid 19",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-03-08T00:00:00 | {
"date": "2021-03-09",
"type": "ACTUAL"
} | {
"date": "2021-03-09",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients more than 18 years old and less than 90 years old diagnosed as covid-19 by positive PCR | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Psychological Impact of Covid-19"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Symptom Checklist 90 \"SCL 90\"",
"timeFrame": "One year"
},
{
"description": null,
"measure": "post traumatic stress disorder \"PTSD\"",
"timeFrame": "One year"
},
{
"description": null,
"measure": "Pittsburgh Sleep Quality Index \"PSQI\"",
"timeFrame": "One year"
},
{
"description": null,
"measure": "The 36- items Short Form\"SF 36\"",
"timeFrame": "one year"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D011024",
"term": "Pneumonia, Viral"
},
{
"id": "D011014",
"term": "Pneumonia"
},
{
"id": "D012141",
"term": "Respiratory Tract Infections"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D014777",
"term": "Virus Diseases"
},
{
"id": "D018352",
"term": "Coronavirus Infections"
},
{
"id": "D003333",
"term": "Coronaviridae Infections"
},
{
"id": "D030341",
"term": "Nidovirales Infections"
},
{
"id": "D012327",
"term": "RNA Virus Infections"
},
{
"id": "D008171",
"term": "Lung Diseases"
},
{
"id": "D012140",
"term": "Respiratory Tract Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "COVID-19",
"id": "M2561",
"name": "COVID-19",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M13904",
"name": "Pneumonia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13914",
"name": "Pneumonia, Viral",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14978",
"name": "Respiratory Tract Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17522",
"name": "Virus Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20490",
"name": "Coronavirus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6555",
"name": "Coronaviridae Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23685",
"name": "Nidovirales Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15149",
"name": "RNA Virus Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
"name": "Lung Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14977",
"name": "Respiratory Tract Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000086382",
"term": "COVID-19"
}
]
} | null | {
"conditions": [
{
"id": "D000086382",
"term": "COVID-19"
}
],
"interventions": null
} |
NCT06462066 | null | Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery | Effectiveness, Appropriateness and Safety of GLUTACK-Glubran® Tiss 2 Surgical Glue (NBCA: n Butyl 2 Cyanoacrylate + OCA: 2-Octyl-Cyanoacrylate) Compared to GLUTACK-Glubran® 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery (Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation). | AGluTHeMFix | INTERVENTIONAL | COMPLETED | 2024-06-12T00:00:00 | null | 2023-06-29T00:00:00 | 2023-06-29T00:00:00 | [
"NA"
] | 101 | 18 | null | ALL | false | This pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in laparoscopic and robotic hernia surgery to obtain the indication and upgrade the medical device Glubran® Tiss 2 to class IIb.Cyanoacrylate is the generic name of a group of fast-acting adhesives such as ethyl-2-cyanoacrylate, n-butyl cyanoacrylate, 2-octy1 cyanoacrylate sold under various trade names and blend. Cyanoacrylate is a liquid acrylate monomer that polymerizes exothermically in the presence of water, especially with hydroxide ions, joining the bonded surfaces in 4-5 s and reaching the final stage in 60-90 s . It bonds body tissue excellently and shows bacteriostatic effects . The film of glue is eliminated by hydrolytic breakdown, a process whose duration varies according to tissue type and quantity .
In contrast to most cyanoacrylate glues used only for external applications as skin wound closure, Glubran® 2 is a modified n-butyl-cyanoacrylate (Glubran® 2 - N-Butyl 2 Cyanoaciylate \[NBCA\]+ Methacryloxysulfolane \[MS\]), class III medical device, CE-certified for both external and internal use .
Glubran® 2 effectiveness in repairing hernias with less post-operative pain, less complications, less hernia recurrences and a greater cost-effectiveness is largely documented . Other cyanoacrylate-based glues are authorized to fix hernia meshes, i.e.: Histoacryl (pure NBCA; classified as class IIb medical device), Liquibond FIX8 (pure NBCA; classified as class III medical device) and Ifabond (n-hexyl-cyanoacrylate; classified as class III medical device). Others are authorized to be used for specific internal indication like Omnex (2-Octyl-CyanoAcrylate \[OCA\] + Butyl-Lactoyl-Cyanoacrylate), which is indicated for use in vascular reconstructions. Sometimes, abroad, also some cyanoacrylate-based glues are applied for internal uses even if not authorized .
The present prospective and randomized study was aimed at comparing the effectiveness and safety of another cyanoacrylate-based glue called Glubran® Tiss 2 (NBCA + OCA), classified as class IIa surgical medical device, CE-marked (under the European Union \[EU\] Directive 93/42 EEC), being already authorized for use as atraumatic fixation system: Glubran® 2. Both medical devices have previously demonstrated to be well-tolerated and safe.
Glubran® 2 and Glubran® Tiss 2 were to be applied by Glutack®, a CE-marked medical device system for glue application in the surgical field. Glutack® is the related Glubran® 2/ Glubran® Tiss 2 applicator device for laparoscopic mesh fixation procedures was fabricated to offer a precise and controlled delivery of Glubran® glues .
Glubran® Tiss 2 fulfils the requirements of EU Medical Device Regulation (MDR) 2017/745 (confirmation letter received by the relative Notified Body). The composition of Glubran® Tiss 2 is obtained by mixing two different monomers of cyanoacrylate (NBCA + OCA); this gives the product a better elasticity, while maintaining high levels of tensile strength. In fact, international scientific literature has shown that the common NBCA is the cyanoacrylate molecule with the greatest tensile strength (34.27 N), low elasticity, while OCA has a lower resistance (11.27 N) but has good elastic properties. Glubran® Tiss 2 glue has a tensile strength of 27.34 N and thanks to the presence of OCA, also excellent elasticity . Among its characteristics, this formulation has haemostatic, sealing, bacteriostatic and adhesive properties. Polymerization begins 1-2 seconds after application and completes within 60 seconds. The polymerization reaction generates a temperature of approximately 45°C, which is lower than that of pure cyanoacrylates .
Glubran® Tiss 2, indicated also for use in paediatrics, is a sterile, ready for use, blended cyanacrylate adhesive to be used on the skin and mucosal tissues, which is approved as class IIa medical device, effective even in patients anticoagulated and with congenital coagulopathies . | This was a pre-market, prospective, randomized, non-inferiority, clinical study aimed at evaluating the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® 2 applied for mesh fastening in laparoscopic and robotic hernia surgery to get the indication and upgrade Glubran® Tiss 2 to class IIb. The study was conducted in seven centres in Italy and was to enroll 100 patients. Patients were to be followed for 6 months. The global duration of the trial was approximately 32 months.
According to the CIP, 6 Visits were planned over the perioperative/post operative period for each patient (after 24 hours,7, 14, 90, and 180 days).
At Visit 1 (V1, day 0, Baseline visit), patients were requested to sign the written informed consent before any procedure was performed. Patients were screened for eligibility for the study ascertaining that all inclusion criteria and no exclusion criteria were met. At V1, the Investigator recorded demographic and medical history, basal clinical assessment data and performed full physical examination and evaluation of clinical signs/symptoms.
Patients were randomly assigned (1:1 allocation ratio) to one of the two treatment groups: Glutack-Glubran® system (Group 1) or Glutack-Glubran® Tiss 2 (Group 2). The application of Glutack-Glubran® system or Glutack-Glubran® Tiss 2 was performed by the investigator, after a previous appropriate training on how to assemble/use each device.
Technical success of glue fastening was evaluated intra-operatively, the investigator registered whether mesh fixation system achieved technical success or not. Technical success was to be defined as successful hernia repair as intended, but actually defined in the present analysis as a surgical procedure with no complications within the first 24 hours after surgery and a surgeon's rating for Efficacy and Control greater than or equal to 4.At specific intervals, at V2 (24 hours), V3 (7 days), V4 (14 days), V5 (90 days) and V6 (180 days), patients were requested to return to the centre for the clinical assessments of safety, quality of life and effectiveness. As regards effectiveness, at each Visit, the area of the mesh implant was evaluated for recurrence through a specific abdominal clinical examination. In case of any suspicion of recurrence, an ultrasound or MRI was to be performed according to hospital practice to distinguish true hernia recurrences from bulging. At V6 cost effectiveness was also to be evaluated.The primary objective of the study was to assess the effectiveness of Glutack-Glubran® Tiss 2 mesh fastening in comparison with mesh fixation by Glutack-Glubran® 2 evaluated in terms of hernia recurrence rate after surgery and technical success of glue fastening (evaluated intra-operatively).
The secondary objectives were aimed at investigating the following:
1. Safety in terms of side effects
2. Cost effectiveness in terms of direct costs of intervention, operating and hospitalization times, times of return to normal activity
3. The adequacy of Glutack® medical device for the application of surgical glue for fixing the prosthesis (mesh) in terms of ease of use and satisfaction of the surgeon.
This study enrolled 107 adult patients submitted to surgical treatment for laparoceles (incisional hernia) or monolateral or bilateral inguinal hernia.
6.3.1 Inclusion Criteria
Patients could be enrolled in the investigation if they met all the following inclusion criteria:
1. No significant cardiopulmonary, hepatic, or renal impairment, and no contraindications for surgery;
2. Clinical diagnosis of:
1. bilateral inguinal hernia eligible for minimally invasive repair (TAPP-TEP VLS/ROB)
2. recurrent monoliteral inguinal hernia (TAPP-TEP VLS/ROB)
3. large inguinoscrotal hernias (TAPP-TEP ROB)
4. primary ventral hernia with defects size ≤ 7cm (IPOM-TARUP-COSTA-THT-MILOS-eMILOS VLS/ROB)
5. primary abdominal border hernia (idem VLS/ROB)
6. post-incisional hernia with defect size ≤ 7cm (idem VLS)
7. post-incisional hernia and complex abdomen (RIVES-RIVES+TAR ROB)
8. Swiss-cheese defects multiple small defects if treatable with only one mesh; if the total width of the defect is ≤ 5cm will be repaired by IPOM VLSM; if it is \> 5cm will be repaired by RIVES-RIVES+TAR ROB;
3. Age \> 18 years, male and Female;
4. Obese patient (BMI\>35);
5. Patients with ASA grade from I to III;
6. Patients must sign and date the informed consent form prior to treatment. 6.3.2 Exclusion Criteria
Patients could not be enrolled in the investigation if they met any of the following exclusion criteria:
1. Incarcerated hernia;
2. Allergy to multiple classes of drugs, recent allergic disease, or use of drugs that are known harmful to vital organs during the 4 weeks before surgery;
3. Patients with ASA IV or V;
4. Participations in other clinical studies in the 3 months before surgery;
5. Atopic allergy history;
6. Mental illness history;
7. Diseases that may significantly increase Intra-Abdominal Pressure (IAP) and cannot be effectively controlled such as severe ascites, severe asthma caused by bronchitis, pulmonary emphysema, or urine retention caused by significant Benign Prostatic Hyperplasia (BPH);
8. Infection located at the surgical site or bacteraemia;
9. Patients with collagenopathies;
10. Relevant other concurrent diseases;
11. Patient with neurological disorders and/or mood disorders;
12. Hyperemotional patients;
13. Pregnant women. | Inclusion criteria:
1. No significant cardiopulmonary, hepatic, or renal impairment, and no contraindications for surgery;
2. Clinical diagnosis of:
1. bilateral inguinal hernia eligible for minimally invasive repair (TAPP-TEP VLS/ROB)
2. recurrent monoliteral inguinal hernia (TAPP-TEP VLS/ROB)
3. large inguinoscrotal hernias (TAPP-TEP ROB)
4. primary ventral hernia with defects size ≤ 7cm (IPOM-TARUP-COSTA-THT-MILOS-eMILOS VLS/ROB)
5. primary abdominal border hernia (idem VLS/ROB)
6. post-incisional hernia with defect size ≤ 7cm (idem VLS)
7. post-incisional hernia and complex abdomen (RIVES-RIVES+TAR ROB)
8. swiss-cheese defects multiple small defects if treatable with only one mesh; if the total width of the defect is ≤ 5cm will be repaired by IPOM VLSM; if it is \> 5cm will be repaired by RIVES-RIVES+TAR ROB;
3. Age \> 18 years, male and female;
4. Obese patient (BMI\>35);
5. Patients with ASA grade from I to III;
6. Patients must sign and date the informed consent form prior to treatment.
Exclusion criteria:
1. Incarcerated hernia;
2. Allergy to multiple classes of drugs, recent allergic disease, or use of drugs that are known harmful to vital organs during the 4 weeks before surgery;
3. Patients with ASA IV or V;
4. Participations in other clinical studies in the 3 months before surgery;
5. Atopic allergy history;
6. Mental illness history;
7. Diseases that may significantly increase Intra-Abdominal Pressure (IAP) and cannot be effectively controlled such as severe ascites, severe asthma caused by bronchitis, pulmonary emphysema, or urine retention caused by significant Benign Prostatic Hyperplasia (BPH);
8. Infection located at the surgical site or bacteraemia;
9. Patients with collagenopathies;
10. Relevant other concurrent diseases;
11. Patient with neurological disorders and/or mood disorders;
12. Hyperemotional patients;
13. Pregnant women. | GEM SRL | INDUSTRY | {
"id": "DGDMF/P/I.5.i.m.2/2019/1321",
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} | 2024-06-12T00:00:00 | {
"date": "2024-06-17",
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"date": "2024-06-17",
"type": "ACTUAL"
} | [
"ADULT",
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] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study plan will include a baseline visit (V1), in which eligible patients will be randomly assigned in one of the two groups: Group 1 will apply GLUTACK/Glubran® Tiss 2 whereas Group 2 GLUTACK-Glubran® 2.\n\nApplication of surgical glue will be done by the surgeons, after a previous appropriate training, carried out by principal investigator (standardization application mode). Trial parameters will be recorded by a clinical evaluator at 24 hours (V2), 7 days (V3), 14 days (V4), 90 days (V5) and 180 days (V6). The last evaluation will be performed at V6, after 6 month.",
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"Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation"
] | null | null | [
{
"city": "Grosseto",
"country": "Italy",
"facility": "Ospedale Misericordia - U.O.C Chirurgia Generale e Mini-Invasiva.",
"geoPoint": {
"lat": 42.76296,
"lon": 11.10941
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Effectiveness",
"timeFrame": "Verification of hernia recurrence at 1 day, 1 or 2 weeks, 3 months, 6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Clinical Safety:",
"timeFrame": "Verification of Clinical safety at 1 day, 1 or 2 weeks, 3 months, 6 months"
},
{
"description": null,
"measure": "Chronic pain",
"timeFrame": "Verification of chronic pain at 3 months, 6 months"
},
{
"description": null,
"measure": "Quality of the life",
"timeFrame": "Verification of QoL at 1 day, 1 or 2 weeks, 3 months, 6 months"
},
{
"description": null,
"measure": "Cost effectiveness",
"timeFrame": "Verification of cost effectiveness at 1 day, 1 or 2 weeks, 3 months, 6 months"
},
{
"description": null,
"measure": "Appropriateness",
"timeFrame": "Verification of Appropriateness at Intervention day during the procedure"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"term": "Pathological Conditions, Anatomical"
},
{
"id": "D046449",
"term": "Hernia, Abdominal"
}
],
"browseBranches": [
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"abbrev": "BC23",
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"browseLeaves": [
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"asFound": "Hernia",
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"asFound": "Ventral Hernia",
"id": "M9633",
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"relevance": "HIGH"
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"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M25675",
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}
],
"meshes": [
{
"id": "D006547",
"term": "Hernia"
},
{
"id": "D006555",
"term": "Hernia, Ventral"
}
]
} | null | {
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"term": "Hernia"
},
{
"id": "D006555",
"term": "Hernia, Ventral"
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],
"interventions": null
} |
NCT02374866 | null | Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight | Monitoring Obese Patients: Impact on the Frequency of Monitoring Weight, Quality of Life, Dietary Behavior, Physical Ability and Comorbidities | SUIVIOBESITE | INTERVENTIONAL | COMPLETED | 2015-02-18T00:00:00 | null | null | null | [
"NA"
] | 96 | 18 | 75 | ALL | false | The literature data show that long-term monitoring has an effect on weight loss, comorbidity and on improving the quality of life. However, there are still no studies on monitoring obese patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011 advocated "continuous monitoring needed to prevent weight regain, monitor the consequences of overweight and treat comorbidities. This requires a long-term support. "The frequency of follow-up consultations is not specified and "must be adapted to achieve a weight loss target and maintain." Having no specific recommendations on the frequency of monitoring, the investigators chose to experiment closer monitoring than our current monitoring to assess what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding behavior, changes in physical abilities, evolution of comorbidities associated with obesity. The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis). | 2 groups of randomized patients will be followed:
* The control group will follow the current center: every four months for a year, combined with monitoring by email or regular mail during the year.
* The experimental group will be a follow-up every two months for one year HDJ more of the same followed by email or postal mail.
Follow by email or mail is identical to the control group, as well as HDJ 12 months. | Inclusion Criteria:
* - Age ≥ 18 - ≤ 75 years
* Obesity with a BMI ≥ 35 or ≥ 30 if associated with at least one comorbidity whose support was commenced or continued during the initial hospitalization.
* Patients hospitalized for a period of at least 3 weeks in the Bernard Descottes center and were supported on dietary, psychological, psychomotor and physical education in a therapeutic approach.
* Patients who have signed consent form.
* Patients who never underwent bariatric surgery and bariatric surgery have not seen in the year following their hospitalization in Bernard Descottes Center.
* Patient accepting the constraints of the protocol in case of close monitoring.
* Patients able to travel with their own vehicle to Bernard Descottes Center.
* Affiliate or beneficiary of a social security scheme
Exclusion Criteria:
* - Patients who have hospitalized in Bernard Descottes Center.
* Failure to follow the protocol because of insufficient command of French or concomitant illness.
* Pregnant or breastfeeding.
* Patients under guardianship or under judicial protection.
* Participation to another trial which can impact on patient's experimental disease during all the study, and patients who are in an exclusion period of another trial. | University Hospital, Limoges | OTHER | {
"id": "I13031 SUIVI OBESITE",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-02-24T00:00:00 | {
"date": "2016-09-05",
"type": "ESTIMATED"
} | {
"date": "2015-03-02",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Obesity",
"Morbid Obesity",
"Quality of Life"
] | ["Obesity", "Morbid Obesity", "Therapeutic education"] | null | [
{
"city": "St Yrieix la Perche",
"country": "France",
"facility": "Centre de suivi de l'obésite Bernard Descottes",
"geoPoint": {
"lat": 45.51604,
"lon": 1.20569
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "percentage of weight loss at 12 months",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "percentage of change in BMI at 12 months",
"timeFrame": "1 year"
}
],
"secondary": [
{
"description": null,
"measure": "Change of waist at 12 months",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Changes in body composition",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Change of quality of life at 12 months",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Change of medication at 12 months",
"timeFrame": "1 year"
}
]
} | [
{
"affiliation": "Centre de l'Obesite Bernard Descottes",
"name": "Cécile de Rouvray, Md",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D050177",
"term": "Overweight"
},
{
"id": "D044343",
"term": "Overnutrition"
},
{
"id": "D009748",
"term": "Nutrition Disorders"
},
{
"id": "D001835",
"term": "Body Weight"
}
],
"browseBranches": [
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"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
}
],
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"asFound": "Obesity",
"id": "M12701",
"name": "Obesity",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M5114",
"name": "Body Weight",
"relevance": "LOW"
},
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"asFound": "Morbid Obesity",
"id": "M12702",
"name": "Obesity, Morbid",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M26186",
"name": "Overweight",
"relevance": "LOW"
},
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"asFound": null,
"id": "M25307",
"name": "Overnutrition",
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},
{
"asFound": null,
"id": "M12684",
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"relevance": "LOW"
},
{
"asFound": "Quality of Life",
"id": "T6034",
"name": "Quality of Life",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D009765",
"term": "Obesity"
},
{
"id": "D009767",
"term": "Obesity, Morbid"
}
]
} | null | {
"conditions": [
{
"id": "D009765",
"term": "Obesity"
},
{
"id": "D009767",
"term": "Obesity, Morbid"
}
],
"interventions": null
} |
NCT03195166 | null | Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years | Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years Undergoing Total Knee Arthroplasty | None | INTERVENTIONAL | COMPLETED | 2017-06-04T00:00:00 | null | 2020-06-30T00:00:00 | 2020-12-31T00:00:00 | [
"NA"
] | 20 | 65 | 85 | ALL | false | Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in elderly patients.
The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients undergoing knee arthroplasty.
Investigators use the FloTrac sensor/Vigileo haemodynamic monitoring system to assess modification blood pressure, stroke volume and cardiac output during anesthesia and specialy after every bolus of spinal anesthesia, after inflating the tourniquet and after putting it off.
they recorded number of hypotension episodes, ephedrine bolus and consumption until 2 hours after the end of surgery. | The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia (CSA) in elderly patients undergoing knee arthroplasty.
Inclusion criteria:
Adult patients, aged more than 65 years scheduled for elective total knee arthroplasty under regional anesthesia.
Study Design :
Patients had a transthoracic echocardiography one to three months before the surgical procedure, performed by a cardiologist.
An oral intake of 250 ml of water was taken 2 hours before surgery. In the operating room, patients received monitoring with electrocardiogram, pulse oximetry and had their blood pressure measured and recorded via an indwelling radial arterial catheter putting under local anesthesia.
This catheter was connected to the FloTrac sensor/Vigileo haemodynamic monitoring systeme to track continuously stroke volume and cardiac output.
All patients were given nasal oxygen during all the procedure to keep oxygen saturation \> 95 %. Fluid therapy was limited to 4 ml/kg/h until tourniquet release.
Subarachnoid puncture was performed with a 19-Gauge Tuohy needle at the L3-S1 interspace using a midline approach. Three cm of a 22-Gauge catheter was introduced through the needle. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected through the catheter. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10.
Ephedrine 6 to 9 mg was given if systolic arterial pressure \< 90 mmHg or \< 100 mmHg with clinical signs of poor tolerance (dizziness, anxiety, dyspnea, vomiting).
Sample size We included 20 patients in this observational study. | Inclusion Criteria:
* Adult patients, aged more than 65 years
* scheduled for elective total knee arthroplasty
* under regional anesthesia
Exclusion Criteria:
* contraindication to regional anesthesia
* or the patients who refused to give consent,
* patients with anemia (hemoglobin \< 13 g/dl for male and hemoglobin \< 12 g/dl for female),
* cardiac arrhythmias,
* NYHA score \> 2,
* ASA \> 2
* Cardiac ejection fraction \< 50 %,
* valvulopathy,
* pulmonary artery hypertension
* and relaxation abnormality | University Tunis El Manar | OTHER | {
"id": "101/2017",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-06-19T00:00:00 | {
"date": "2024-02-13",
"type": "ACTUAL"
} | {
"date": "2017-06-22",
"type": "ACTUAL"
} | [
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients. An oral intake of 250 ml of water was taken 2 hours before surgery.\n\nRadial arterial catheter was putted under local anesthesia and connected to the FloTrac sensor/Vigileo haemodynamic monitoring system.\n\nFluid therapy was limited to 4 ml/kg/h until tourniquet release.\n\nSubarachnoid puncture was performed at the L3-S1 interspace. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10.\n\nEphedrine 6 to 9 mg was given if systolic arterial pressure \\< 90 mmHg. Investigators measured blood pressure (systolic, diastolic and mean), stroke volume and cardiac output every 5 minutes from beginning of the operation and until 2 hours after the end.\n\nNumber of hypotension episodes and ephedrine consumption were noted.",
"maskingInfo": {
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"maskingDescription": "consecutive patient",
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},
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"primaryPurpose": "DIAGNOSTIC",
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} | [
"Hemodynamic Instability"
] | ["elderly spinal anesthesia"] | null | [
{
"city": "Tunis",
"country": "Tunisia",
"facility": "Kassab orthopedic Institute",
"geoPoint": {
"lat": 36.81897,
"lon": 10.16579
},
"state": "La Manouba"
}
] | null | null | {
"other": null,
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"description": null,
"measure": "hemodynamic profile during continuous spinal anesthesia in elderly",
"timeFrame": "Day 0"
}
],
"secondary": [
{
"description": null,
"measure": "blood pressure variation",
"timeFrame": "Day 0"
},
{
"description": null,
"measure": "ephedrine use",
"timeFrame": "Day 0"
},
{
"description": null,
"measure": "stoke volume modification",
"timeFrame": "Day 0"
}
]
} | [
{
"affiliation": "KASSAB ORTHOPEDIC INSTITUTE",
"name": "KAABACHI OLFA, PROF",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
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{
"abbrev": "VaCoAg",
"name": "Vasoconstrictor Agents"
},
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"abbrev": "Resp",
"name": "Respiratory System Agents"
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"abbrev": "CNSSti",
"name": "Central Nervous System Stimulants"
}
],
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"name": "Bupivacaine",
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},
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"name": "Anesthetics",
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"name": "Ephedrine",
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}
],
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} | {
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} |
NCT04725266 | null | A Family-based Intervention for Drug-abusing Adults in Hong Kong | A Family-based Intervention for Drug-abusing Adults in Hong Kong: a Quasi-experimental Trial | None | INTERVENTIONAL | COMPLETED | 2021-01-19T00:00:00 | null | 2022-12-31T00:00:00 | 2023-06-01T00:00:00 | [
"NA"
] | 82 | 18 | 55 | ALL | false | To develop a family-based intervention with components of engagement, family roles, affection, and competence and verify its effectiveness on drug abstinence and family functioning for drug-abusing adults in Hong Kong; To compare the difference between family-based intervention and routine care which mainly consists of individual counselling services for drug abusers. | This is a quasi-experimental trial examining the effects of a proposed family-based intervention for drug abusers on motivating them to stay drug abstinence and improve family functioning, in which 40 drug abusers with focal families (including spouses and/or children) will be recruited for intervention group receiving both family-based intervention and routine care and 40 drug abusers without involving family will be recruited for comparison group receiving routine care. In the in-take, drug-abusing subjects will be given a brief introduction and invited to provide basic background information about themselves and families. After filling the informed consent, participants will be assigned to intervention group or comparison group according to whether their family will join sessions together. After drug abusers and families fill in the online questionnaire at the baseline (T0), the intervention group will receive family-based intervention and routine care in one month, while the comparison group will receive only routine care in one month. Both groups will be assessed at two time points after intervention period (T1 = 1-month after baseline; T2 = 2-month after baseline). As hypothesized, the intervention group will show a greater reduction in the primary outcomes of drug use and greater increase in the secondary outcomes of family functioning than the comparison group. A repeated-measures analysis of covariance will be conducted to assess the effects of family-based intervention. | Inclusion criteria for intervention group:
1. Adults aged 18 to 55
2. Have used drugs in the past 90 days
3. At the time of case recruitment, the subject is engaged in an intimate relationship with a spouse/partner, or having a child/children
4. Understand oral and written Chinese
Exclusion criteria for intervention group:
1. Taking other treatments during intervention
2. The spouse or child of DA are not available to participate in the program
Inclusion criteria for comparison group:
1. Adults aged 18 to 55
2. Have used drugs in the past 90 days
3. Understand oral and written Chinese
Exclusion criteria for comparison group:
1. Taking other treatments during intervention | The University of Hong Kong | OTHER | {
"id": "200018",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-01-24T00:00:00 | {
"date": "2024-10-10",
"type": "ACTUAL"
} | {
"date": "2021-01-26",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Drug Abuse"
] | ["drug abuse"] | null | [
{
"city": "Kowloon",
"country": "Hong Kong",
"facility": "Neo-Horizon of Hong Kong Sheng Kung Hui Welfare Council Limited",
"geoPoint": {
"lat": 22.31667,
"lon": 114.18333
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "Hong Kong Sheng Kung Hui Welfare Council Limited"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Changes from baseline measurements of drug abstinenceat at 1- and 2-months",
"timeFrame": "Baseline, 1- and 2-months"
},
{
"description": null,
"measure": "Changes from baseline measurements of frequency of drug use at 1- and 2-months",
"timeFrame": "Baseline, 1-, and 2-months"
}
],
"secondary": [
{
"description": null,
"measure": "Changes from baseline measurement of marital affection at 1- and 2-months",
"timeFrame": "Baseline, 1- and 2-months"
},
{
"description": null,
"measure": "Changes from baseline measurement of family functioning at 1- and 2-months",
"timeFrame": "Baseline, 1- and 2-months"
},
{
"description": null,
"measure": "Changes from baseline measurement of family roles at 1- and 2-months",
"timeFrame": "Baseline, 1- and 2-months"
},
{
"description": null,
"measure": "Changes from baseline measurement of parenting competency at 1- and 2-months",
"timeFrame": "Baseline, 1- and 2-months"
},
{
"description": null,
"measure": "Changes from baseline measurement of mental health at 1- and 2-months",
"timeFrame": "Baseline, 1- and 2-months"
}
]
} | [
{
"affiliation": "The University of Hong Kong",
"name": "Yik Wa Law",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D064419",
"term": "Chemically-Induced Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
"browseBranches": [
{
"abbrev": "BC25",
"name": "Substance Related Disorders"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"id": "M21837",
"name": "Substance-Related Disorders",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M30302",
"name": "Chemically-Induced Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4815",
"name": "Mental Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D019966",
"term": "Substance-Related Disorders"
}
]
} | null | {
"conditions": [
{
"id": "D019966",
"term": "Substance-Related Disorders"
}
],
"interventions": null
} |
NCT05965466 | null | The Incidence of Gallstones After Gastrectomy | Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study | None | INTERVENTIONAL | COMPLETED | 2023-07-20T00:00:00 | null | 2024-11-16T00:00:00 | 2024-11-16T00:00:00 | [
"NA"
] | 531 | 18 | 75 | ALL | false | To provide preventive and therapeutic strategies for participants with gallstones after gastric cancer by comparing the risk of postoperative gallbladder stone formation with two different resection ranges using the Roux-en-Y reconstruction modality in radical gastric cancer surgery. | A large number of clinical studies have found that the incidence of gallstones in patients after radical gastric cancer surgery is higher than that in the normal population. However, the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in patients with gastric cancer remains controversial. A previous study found a statistically significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected cohort study to collect further participants with gastric cancer who underwent total gastrectomy to answer whether different surgical resection ranges during surgery increase the incidence of gallstones this question. | Inclusion Criteria:
* Patients with Gastric Cancer underwent Gastrectomy
Exclusion Criteria:
* Age less than 18 years or age greater than 75 years;
* Not Roux-en-Y reconstruction;
* R0 excision is not achieved;
* Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;
* Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic cholecystitis;
* Preoperative neoadjuvant chemotherapy or radiotherapy;
* Previous history of malignant tumours;
* Patients with mental or developmental abnormalities or women during pregnancy or breastfeeding;
* Gastric perforation or bleeding leading to emergency surgery;
* Palliative surgical treatment;
* Incomplete case information. | Hepatopancreatobiliary Surgery Institute of Gansu Province | OTHER | {
"id": "GGBS",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-07-27T00:00:00 | {
"date": "2024-11-19",
"type": "ACTUAL"
} | {
"date": "2023-07-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Distal gastrectomy and Total gastrectomy",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Gallstone",
"Gastric Cancer"
] | ["Gallstone", "Gastric Cancer", "Gastrectomy"] | null | [
{
"city": "Lanzhou",
"country": "China",
"facility": "Hepatopancreatobiliary Surgery Institute of Gansu Province",
"geoPoint": {
"lat": 36.05701,
"lon": 103.83987
},
"state": "Gansu"
},
{
"city": "Wuwei",
"country": "China",
"facility": "Wuwei Tumor Hospital",
"geoPoint": {
"lat": 37.92672,
"lon": 102.63202
},
"state": "Gansu"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of gallstone patients",
"timeFrame": "5years"
}
],
"secondary": [
{
"description": null,
"measure": "Number of patients with postoperative complications",
"timeFrame": "5years"
},
{
"description": null,
"measure": "Number of patients with bile duct stones",
"timeFrame": "5years"
}
]
} | [
{
"affiliation": "Hepatopancreatobiliary Surgery Institute of Gansu Province",
"name": "Wenbo Meng, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "27433395", "type": "RESULT", "citation": "Park DJ, Kim KH, Park YS, Ahn SH, Park do J, Kim HH. Risk Factors for Gallstone Formation after Surgery for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):98-104. doi: 10.5230/jgc.2016.16.2.98. Epub 2016 Jun 24."}, {"pmid": "33205309", "type": "RESULT", "citation": "Wu CH, Huang KH, Chen MH, Fang WL, Chao Y, Lo SS, Li AF, Wu CW, Shyr YM. Comparison of the Long-term Outcome Between Billroth-I and Roux-en-Y Reconstruction Following Distal Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2021 Aug;25(8):1955-1961. doi: 10.1007/s11605-020-04867-1. Epub 2020 Nov 17."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D005770",
"term": "Gastrointestinal Neoplasms"
},
{
"id": "D004067",
"term": "Digestive System Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D005767",
"term": "Gastrointestinal Diseases"
},
{
"id": "D013272",
"term": "Stomach Diseases"
},
{
"id": "D001660",
"term": "Biliary Tract Diseases"
},
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"term": "Gallbladder Diseases"
},
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"term": "Calculi"
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"term": "Pathological Conditions, Anatomical"
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],
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"abbrev": "BC04",
"name": "Neoplasms"
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{
"abbrev": "BC06",
"name": "Digestive System Diseases"
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{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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{
"abbrev": "Rare",
"name": "Rare Diseases"
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],
"browseLeaves": [
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"relevance": "HIGH"
},
{
"asFound": "Gallstone",
"id": "M24980",
"name": "Cholecystolithiasis",
"relevance": "HIGH"
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"id": "M6010",
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"relevance": "HIGH"
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"id": "M25095",
"name": "Gallstones",
"relevance": "HIGH"
},
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"relevance": "LOW"
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"name": "Digestive System Neoplasms",
"relevance": "LOW"
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"relevance": "LOW"
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"name": "Digestive System Diseases",
"relevance": "LOW"
},
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"name": "Stomach Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4946",
"name": "Biliary Tract Diseases",
"relevance": "LOW"
},
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"id": "M8823",
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"relevance": "LOW"
},
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"name": "Calculi",
"relevance": "LOW"
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"relevance": "LOW"
},
{
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"id": "T5486",
"name": "Stomach Cancer",
"relevance": "HIGH"
}
],
"meshes": [
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"id": "D013274",
"term": "Stomach Neoplasms"
},
{
"id": "D042882",
"term": "Gallstones"
},
{
"id": "D002769",
"term": "Cholelithiasis"
},
{
"id": "D041761",
"term": "Cholecystolithiasis"
}
]
} | null | {
"conditions": [
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},
{
"id": "D042882",
"term": "Gallstones"
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"term": "Cholelithiasis"
},
{
"id": "D041761",
"term": "Cholecystolithiasis"
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],
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} |
NCT03651466 | null | Safety and Tolerability of GX-G6 in Healthy Male Subjects | A First-in-Human, Single Ascending Dose, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Subcutaneously Administered GX-G6 in Male Healthy Volunteers. | None | INTERVENTIONAL | COMPLETED | 2018-07-05T00:00:00 | null | 2018-06-06T00:00:00 | 2018-06-28T00:00:00 | [
"PHASE1"
] | 48 | 18 | 50 | MALE | true | This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male subjects receiving ascending single s.c. doses of GX-G6 | A screening examination will be performed within 28 days prior to dosing. Eligible subjects will return to the study center in the morning of Day -1 and will remain in-patient until discharge about 98 hours after dosing (after oral glucose tolerance test in the morning of Day 5) if there are no safety issues. The s.c. injection will be administered in the morning of Day 1. Ambulatory visits will take place on Days 7, 9 and 12. A follow-up visit will take place on Day 15 and a final visit on Day 28. | Inclusion Criteria:
1. male subjects aged between 18-50 years (both inclusive)
2. healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing
3. subjects who are able and willing to give written informed consent
4. male subjects must be using 2 acceptable methods for contraception (one of these methods should be a barrier method e.g. spermicide and condom) from start of dosing and refrain from fathering a child in the 3 months following dosing.
Exclusion Criteria:
History of:
1. clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing), especially allergy to macrolide antibiotics;
2. any clinically significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system diseases or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation;
3. diabetes mellitus and thyroid dysfunction or other endocrine disorders;
4. malignancy;
5. substance abuse or addiction (alcohol, drugs) in the past 3 years.
Present Condition:
6. participation in a clinical investigation within the 30 days prior to the planned first drug administration or during this trial;
7. participation in this study at a previous dose level; | Genexine, Inc. | INDUSTRY | {
"id": "GX-G6_HV1",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-08-27T00:00:00 | {
"date": "2018-08-29",
"type": "ACTUAL"
} | {
"date": "2018-08-29",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Diabetes Mellitus"
] | null | null | [
{
"city": "Neu-Ulm",
"country": "Germany",
"facility": "NUVISAN",
"geoPoint": {
"lat": 48.39279,
"lon": 10.01112
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Incidence, nature and severity of Adverse events",
"timeFrame": "Throughout 4 weeks of study"
}
],
"secondary": [
{
"description": null,
"measure": "Pharmacodynamics(PD) variables",
"timeFrame": "Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing"
},
{
"description": null,
"measure": "Pharmacokinetics(PK) variables",
"timeFrame": "Pre-dose and 24, 48, 72, 96, 144, 192, 264 and 336 hours after dosing"
}
]
} | [
{
"affiliation": "Genexine, Inc.",
"name": "mi-sun byun, Ph. D",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"asFound": null,
"id": "M7115",
"name": "Diabetes Mellitus",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
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} |
NCT03815526 | null | The Immediate Effects of Applying Dynamic Tape, Kinesio Tape and Sport Tape With Chronic Ankle Instability | The Immediate Effects of Applying Dynamic Tape, Kinesio Tape and Sport Tape With Chronic Ankle Instability | None | INTERVENTIONAL | UNKNOWN | 2019-01-09T00:00:00 | null | 2019-12-31T00:00:00 | 2020-01-01T00:00:00 | [
"NA"
] | 90 | 18 | 65 | ALL | true | Injuries to the ankle joint account for 20% of the population that is afflicted with joint injury and the largest percentage of self-reported musculoskeletal injuries (\> 10%) are to the ankle. Ankle sprain has a large portion in ankle injuries and occurs not only in the sporting population but also in the general community. Although the acute symptom would be resolve quickly, but many people still report persisting problems, such as pain and instability. Chronic ankle instability (CAI) is one of the most common of these residual problems.
Kinesio Tape and White Duck Tape are often applied in patients with CAI, attempt to increase the ankle joint stability, and improve motor performance. However, the previous studies had controversial result to the effects of kinesio tape and white duck tape. The previous studies also showed the insufficient of supporting force and elasticity of kinesio tape and white duct tape. The Dynamic Tape was developed by Kendrick in 2009, which refined the characteristic of elasticity and supporting force.
Therefore the purpose of study is to comparison the effects of static and dynamic balance performance, weight shifting ability and functional movement between kinesio tape, white duck tape and dynamic tape when applied on patients with CAI. With the result may provide an optical method to increase the movement performance of patients with CAI.
The study suspected to recruit 90 volunteers with CAI, and randomly divided to three different groups: Kinesio tape group, White duck tape group and Dynamic tape group. We make postural stability test and limit postural stability test with Biodex Balance System (SD), Y-balance test and single leg hop test to both affected side and sound side foot before applying the tape. After applying the tape according to the divided group, we will repeat the test above again. We will compare the results of the test between groups and within groups. | null | Inclusion Criteria:
1. A history of at least one significant ankle sprain
* The initial sprain must have occurred at least 12 months prior to the study enrolment
* Was associated with inflammatory symptoms (pain, swelling, etc)
* Created at least one interrupted day of desired physical activity
2. A history of the previously injured ankle joint 'giving way' , and /or recurrent sprain and/or 'feelings of instability'.
Exclusion Criteria:
1. A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures and nerves) in either lower extremity.
2. A history of a fracture in either lower extremity requiring realignment.
3. Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 1 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity. | Taipei Medical University WanFang Hospital | OTHER | {
"id": "N201811015",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-01-21T00:00:00 | {
"date": "2019-10-29",
"type": "ACTUAL"
} | {
"date": "2019-01-24",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Taping",
"Ankle Sprains"
] | ["DynamicTape", "Sport Tape", "Kinesio Tape"] | null | [
{
"city": "Taipei",
"country": "Taiwan",
"facility": "Wanfang Hospital",
"geoPoint": {
"lat": 25.04776,
"lon": 121.53185
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Biodex Balance System",
"timeFrame": "1 day"
}
],
"secondary": [
{
"description": null,
"measure": "Y-balance test",
"timeFrame": "1 day"
},
{
"description": null,
"measure": "Single leg hop test",
"timeFrame": "1 day"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007869",
"term": "Leg Injuries"
},
{
"id": "D014947",
"term": "Wounds and Injuries"
}
],
"browseBranches": [
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"abbrev": "BC26",
"name": "Wounds and Injuries"
},
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"abbrev": "All",
"name": "All Conditions"
},
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"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M10881",
"name": "Leg Injuries",
"relevance": "LOW"
},
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"asFound": null,
"id": "M17685",
"name": "Wounds and Injuries",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D016512",
"term": "Ankle Injuries"
}
]
} | null | {
"conditions": [
{
"id": "D016512",
"term": "Ankle Injuries"
}
],
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} |
NCT01157026 | null | A Pilot Clinical Trial With Tocotrienol on Breast Cancer | Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial | BC | INTERVENTIONAL | COMPLETED | 2010-07-01T00:00:00 | null | null | null | [
"NA"
] | 240 | 40 | 60 | FEMALE | false | Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer specific survival and recurrence free survival, in women with early breast cancer and estrogen receptor positive tumors. | We conducted a, double-blinded, placebo controlled trial of TRF plus tamoxifen versus placebo plus tamoxifen in women with primary breast cancer for five years. Both the TRF and placebo drugs were prepared and supplied by Hovid Sdn Bhd, Malaysia. Hovid Sdn. Bhd. absolutely did not have any influence in the trial designing, patient recruitment, data collection, analysis and reporting. The placebo drug which contained soy oil without tocotrienols had similar appearance and taste as the TRF drug. A total of 240 women breast cancer patients were assigned to two groups by minimization method that balanced treatment groups. The intervention group was given TRF plus tamoxifen, (n = 120) while control group was given placebo plus tamoxifen, (n = 120). The primary end point was breast cancer specific survival, defined as the time from minimization to death due to breast cancer. The secondary end points included disease free survival, biochemical parameters, liver function and plasma levels of vitamin E. | Inclusion criteria:
1. women with estrogen receptor positive tumors.
2. 40-60 years of age at the start of the tamoxifen therapy.
3. histologically confirmed primary breast cancer.
4. a tumor that was positive for estrogen receptors, progesterone receptors, or both.
5. an Eastern Cooperative Oncology Group performance status of 0,1, or 2 (scored on a scale of 0 to 5, with lower scores indicating better function).
Exclusion criteria:
1. concurrent use of investigational drugs and estrogen receptor status negative or unknown. | Malaysia Palm Oil Board | OTHER_GOV | {
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{
"city": "Kajang",
"country": "Malaysia",
"facility": "Malaysian Palm Oil Board",
"geoPoint": {
"lat": 2.99424,
"lon": 101.78875
},
"state": "Selangor"
}
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"description": null,
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{
"affiliation": "Malaysia Palm Oil Board",
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}
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} |
NCT06276166 | null | Trajectory of Frailty and Cognitive Dysfunction in Older Adults | Study of the Joint Trajectory of Frailty and Cognitive Dysfunction Among Community-dwelling Older Adults | None | OBSERVATIONAL | NOT_YET_RECRUITING | 2024-02-18T00:00:00 | null | 2026-06-30T00:00:00 | 2026-12-31T00:00:00 | null | 934 | 60 | null | ALL | true | To explore the heterogeneity of the development trend of frailty and cognitive function of older adults. | According to the inclusion and exclusion criteria, the older adults will be selected from community health service centers in four districts of Beijing. Frailty and cognitive function of the older adults will be assessed for a 24-month longitudinal multi-time (baseline, 6, 12 and 24 months). The heterogeneity of the development trend of frailty and cognitive function will be explored, and the subgroups of joint development trajectory of frailty and cognitive impairment will be classified, so as to identify high-risk populations that need to be managed. | Inclusion Criteria:
* Age ≥60 years.
* Older adults with clear consciousness, ability of simple written and verbal communication.
* They volunteered to participate in this study, and signed an informed consent.
Exclusion Criteria:
* A clear diagnosis of any type of dementia.
* There are neurological diseases that clearly lead to cognitive dysfunction, such as severe cerebrovascular disease, brain trauma, intracranial tumors, etc.
* They have been clearly diagnosed with mental disorders affecting cognitive function, including schizophrenia, depression, bipolar disorder, etc. | Peking Union Medical College | OTHER | {
"id": "72374215",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-02-18T00:00:00 | {
"date": "2024-03-07",
"type": "ACTUAL"
} | {
"date": "2024-02-23",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Older adults without clear diagnosis of any type of dementia, neurological diseases, and mental disorders that affecting cognitive function. | NON_PROBABILITY_SAMPLE | null | {
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"maskingInfo": null,
"observationalModel": "COHORT",
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"timePerspective": "PROSPECTIVE"
} | [
"Frailty",
"Cognitive Dysfunction",
"Community-dwelling Older Adults"
] | null | null | null | null | null | {
"other": [
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"description": null,
"measure": "Health status and life style",
"timeFrame": "Baseline, 6 month, 12 month, and 24 month"
},
{
"description": null,
"measure": "Activities of daily life (ADLs)",
"timeFrame": "Baseline, 6 month, 12 month, and 24 month"
},
{
"description": null,
"measure": "Anxiety",
"timeFrame": "Baseline, 6 month, 12 month, and 24 month"
},
{
"description": null,
"measure": "Apathy",
"timeFrame": "Baseline, 6 month, 12 month, and 24 month"
},
{
"description": null,
"measure": "Perceived social support",
"timeFrame": "Baseline, 6 month, 12 month, and 24 month"
},
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"description": null,
"measure": "Social network",
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}
],
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"description": null,
"measure": "Frailty",
"timeFrame": "Baseline, 6 month, 12 month, and 24 month"
},
{
"description": null,
"measure": "Cognitive function",
"timeFrame": "Baseline, 6 month, 12 month, and 24 month"
}
],
"secondary": null
} | [
{
"affiliation": "Chinese Academy of Medical Sciences & Peking Union Medical College",
"name": "Zheng Li",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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]
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"term": "Frailty"
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{
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"term": "Cognitive Dysfunction"
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],
"interventions": null
} |
NCT00955266 | null | A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass | A Randomized Double-Blind Placebo-Controlled Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass | None | INTERVENTIONAL | TERMINATED | 2009-07-30T00:00:00 | null | null | null | [
"PHASE4"
] | 8 | 18 | null | ALL | false | Successful heart surgery requires the resumption of a strong beating heart prior to separation from the heart and lung machine. There are different ways to do this. At this hospital, the surgical team usually gives calcium to people when they come off of the heart and lung machine because some doctors believe that calcium can "jump start" the heart. Not every hospital does this.
Some people think that calcium may have a side effect of making the heart more stiff. Stiff hearts do not beat as well or receive as much blood to tissues as non-stiff hearts. If calcium makes the heart stiff, then doctors may have to use other medicines to support the heart in the operating room and the intensive care unit. This may ultimately lead to poorer outcomes including a longer stay in the intensive care unit and in the hospital.
This study is being performed to find out if calcium has the side effect of making the heart more stiff. This study compares calcium to placebo. The placebo looks exactly like the calcium, but it contains no calcium. During this study patients may receive placebo instead of calcium. Neither the doctor nor the study team will know which drug the subject will receive. | null | Inclusion Criteria:
* Men and women greater than 18 years of age
* Undergoing primary elective valve surgery at Brigham and Women's Hospital
* Consented for Transesophogeal Echocardiography (TEE) as part of routine intra-operative care and monitoring
Exclusion Criteria:
* Patients not consented for TEE as part of routine intra-operative care
* Any absolute contraindication to TEE
* Ionized calcium level \< 0.80 mmol/L near separation from CPB
* Myocardial infarction (MI) or acute coronary syndromes \< 3 months prior to surgery due to the presence of pre-operative diastolic dysfunction in infarcted or ischemic myocardium
* Ejection fraction (EF) \< 35%
* Atrial fibrillation / flutter the absence of an A wave on mitral inflow Doppler
* Heart rate (HR) \> 100 during 2 data point collections due to E / A wave superimposition | Brigham and Women's Hospital | OTHER | {
"id": "2009-P-000052",
"link": null,
"type": null
} | Inadequate recruitment | {
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"nctId": null,
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} | 2009-08-06T00:00:00 | {
"date": "2017-05-22",
"type": "ACTUAL"
} | {
"date": "2009-08-10",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
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},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Diastolic Dysfunction"
] | ["Separation", "Cardiopulmonary bypass", "Calcium chloride"] | null | [
{
"city": "Boston",
"country": "United States",
"facility": "Brigham and Womens Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts"
}
] | null | null | {
"other": null,
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"description": null,
"measure": "Diastolic Dysfunction",
"timeFrame": "64 enrolled patients or 9 months following start of protocol, whichever comes first"
}
],
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"description": null,
"measure": "Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability",
"timeFrame": "64 enrolled patients or 9 months following start of protocol, whichever comes first"
},
{
"description": null,
"measure": "Need for Inotropic or Vasopressor Support Upon Leaving the OR",
"timeFrame": "64 enrolled patients or 9 months following start of protocol, whichever comes first"
},
{
"description": null,
"measure": "Length of Hospital Stay (Days)",
"timeFrame": "64 enrolled patients or 9 months following start of protocol, whichever comes first"
},
{
"description": null,
"measure": "Length of ICU Stay (Days)",
"timeFrame": "64 enrolled patients or 9 months following start of protocol, whichever comes first"
}
]
} | [
{
"affiliation": "Brigham and Women's Hospital",
"name": "Michael Nurok, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
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{
"id": "D000077264",
"term": "Calcium-Regulating Hormones and Agents"
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"term": "Physiological Effects of Drugs"
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"abbrev": "All",
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"abbrev": "BDCA",
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"name": "Calcium, Dietary",
"relevance": "LOW"
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"term": "Calcium"
}
]
} | {
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"interventions": [
{
"id": "D002118",
"term": "Calcium"
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]
} |
NCT00660166 | null | Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions | HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies | None | INTERVENTIONAL | COMPLETED | 2008-04-11T00:00:00 | null | null | null | [
"PHASE1"
] | 13 | 13 | 70 | ALL | false | The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation. | Natural killer cells are blood cells that are responsible for eliminating cancer cells especially when there are only a few. It has been shown that NK cells coming from a "mismatched" person (a relative) have a better chance than the patient's own NK cells to recognize and kill cancer cells. These cells will be collected from the blood of a parent, child or sibling and after preparation in the laboratory, will be given to the patient early after an autologous stem cell transplantation like a blood or platelet transfusion. A person who has been diagnosed with a blood tumor and received an autologous stem cell transplant has the chance of his/her cancer coming back. This study uses NK cells obtained from a relative to prevent disease recurrence by potentially eliminating and eradicating any residual cancerous cells. | Inclusion Criteria:
* Patients who have undergone an autologous stem cell transplant for the following diseases:
* Acute Myeloid Leukemia
* Non-Hodgkin's Lymphoma
* Hodgkin's Disease
* Multiple Myeloma
* Age 13 - 70 years old
* Able to give informed consent
* Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal
* ECOG Performance Status less than or equal to 1 (at planned time of transplantation)
* Patients with no active infection
Exclusion Criteria:
* Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have \> grade 2 toxicity in any organ system)
* Patients who have insufficient engraftment parameters according to the following criteria: WBC \< 2,500 /mm3 and platelets \< 50,000/mm3
* Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion.
* Intrinsic impaired organ function (as stated above).
* Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance.
* Uncontrolled, life-threatening infections at the time of infusion.
* Concurrent treatment with corticosteroids and/or other immuno-suppressive drugs. | Tufts Medical Center | OTHER | {
"id": "Allogeneic NKCell post ABMT",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-04-16T00:00:00 | {
"date": "2012-06-27",
"type": "ESTIMATED"
} | {
"date": "2008-04-17",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Lymphoma",
"Myeloma",
"Leukemia"
] | ["Natural killer cells", "autologous stem cell transplant", "immunotherapy"] | null | [
{
"city": "Boston",
"country": "United States",
"facility": "Tufts Medical Center",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts"
}
] | [
{
"class": "OTHER",
"name": "University of Minnesota"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
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NCT04375826 | null | Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy | Continuous Preperitoneal Analgesia Versus Thoracic Epidural Analgesia After Open Pancreaticoduodenectomy: a Randomized Controlled Open-labeled Noninferiority Trial | Pain | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2020-04-26T00:00:00 | null | 2023-10-26T00:00:00 | 2024-12-31T00:00:00 | [
"NA"
] | 146 | 18 | null | ALL | false | This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy. | In the Enhanced recovery after surgery (ERAS) program of pancreaticoduodenectomy (PD), thoracic epidural analgesia (or epidural analgesia) was considered to be a key analgesic method because it not only effectively controls pain, but also lowers insulin resistance and helps restore bowel movement. However, epidural analgesia can cause a number of side effects despite of effective pain control. Epidural analgesia reduces peripheral vascular resistance by blocking sympathetic nerves with local anesthetics and may cause hypotension and decreasing heart rate. In addition, it can cause orthostatic hypotension, which can interfere with early ambulation after operation. In rare cases, there are potential complications of epidural abscess, meningitis, and epidural hematoma.
Continuous peritoneal analgesia using local anesthetics has recently been used as an alternative analgesic to epidural analgesia in open abdomen surgery. This is easier to perform than epidural analgesia and is known to have fewer side effects. Recently, a non-inferiority comparison study have revealed that peritoneal analgesic was not inferior to epidural analgesia in terms of pain control. However, this study included a variety of operations other than PD, and most of the incisions were substernal, not midline. In addition, the method for mounting the epidural catheter was not described. The failure rate of the epidural catheter was reported to be 15%.
The investigators will examine the effect of continuous peritoneal analgesic postoperative pain control in patients undergoing open PD to improve postoperative pain management and to create an our own ERAS program. To this end, The investigators will test non-inferiority between epidural analgesia and peritoneal analgesia. | Inclusion Criteria:
* 18 years and older
* Disease of periampullary lesions
* Elective open pancreaticoduodenectomy (PD): PD or pylorus preserving pancreaticoduodenectomy (PPPD)
* Midline incision
* Written informed consent : ability to understand and the willingness to sign a written informed consent
* Performance status (ECOG scale): 0-1 at the time of enrollment
* Physical status (ASA) : 1-2 grade
Exclusion Criteria:
* History of any abdominal surgery (except laparoscopic appendectomy, laparoscopic/robotic cholecystectomy, laparoscopic/robotic obstetrics and gynecology surgeries,Cesarean section, laparoscopic/robotic prostate surgery)
* Emergency operation
* History of chronic pain
* Chronic use of opioid, analgesics, anti-depressant, anti-epileptics (\>1year)
* Alcoholics
* Impossible to control PCA d/t delirium, cognitive impairment
* Contraindication for epidural analgesia
* Patients with coagulopathy (INR\>1.5, Prothrombin time\>1.5, platelets \<80x10\^9perL) or anti-coagulants
* Hypersensitive to fentanyl and ropivacaine
* Need other organ resection (ex. Liver, colon)
* Intubation | Seoul National University Hospital | OTHER | {
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NCT01727726 | null | A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial | A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial | None | INTERVENTIONAL | COMPLETED | 2012-10-31T00:00:00 | null | 2016-10-17T00:00:00 | 2016-11-10T00:00:00 | [
"PHASE3"
] | 2,182 | 18 | 65 | ALL | false | To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD. | This is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose) as adjunctive therapy to an assigned known anti-depressant in depressed subjects. The trial consists of a continuous 18-week double-blind treatment period with a 30-day follow-up. Subjects who complete all trial visits through the Week 18 visit may be offered entry into an optional open-label rollover trial. | Inclusion Criteria:
* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
* Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria
* Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.
Exclusion Criteria:
* Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication
* Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder
* Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.
* Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
* Subjects currently treated with insulin for diabetes.
* Subjects with uncontrolled hypertension
* Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery
* Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs
* Inability to swallow tablets or tolerate oral medication
* Abnormal laboratory test results, vital signs and ECG results
* Subjects who previously participated in any prior brexpiprazole clinical trial. | Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY | {
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] | null | null | {
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],
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},
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}
]
} | [
{
"affiliation": "Otsuka Pharmaceutical Development & Commercialization, Inc.",
"name": "Mary Hobart",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "31577867", "type": "DERIVED", "citation": "Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680."}, {"pmid": "30508090", "type": "DERIVED", "citation": "Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095."}] | {"versionHolder": "2025-06-18"} | {
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} |
NCT00247026 | null | The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes | A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes | None | INTERVENTIONAL | WITHDRAWN | 2005-10-31T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 50 | 16 | null | ALL | false | To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopenias of patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural compounds curcumin and CoQ10 in MDS because these two agents possess many of the effects that are desirable in MDS. | null | Inclusion Criteria:
* MDS patients with RA, RARS or RAEB will be eligible for treatment with CoQ10 as long as their IPSS score ≤ 1.5.
Exclusion Criteria:
* Pregnant women and nursing women will be excluded.
* History of clinically significant liver or kidney disease.
* ECOG\>2
* IPSS score \>1.5
* Poorly controlled diabetes mellitus, hypertension, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol. | Hadassah Medical Organization | OTHER | {
"id": "385-mds 1-HMO-CTIL",
"link": null,
"type": null
} | No funding | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2005-10-31T00:00:00 | {
"date": "2007-04-11",
"type": "ESTIMATED"
} | {
"date": "2005-11-01",
"type": "ESTIMATED"
} | [
"CHILD",
"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
} | [
"Myelodysplastic Syndrome"
] | ["myelodysplasia", "curcumin", "coenzyme Q10", "cytopenia"] | null | [
{
"city": "Jerusalem",
"country": "Israel",
"facility": "Hadassah Medical Organization",
"geoPoint": {
"lat": 31.76904,
"lon": 35.21633
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "major hematologic improvement in any lineage",
"timeFrame": null
}
],
"secondary": [
{
"description": null,
"measure": "Time to disease progression",
"timeFrame": null
},
{
"description": null,
"measure": "Overall and progression-free survival",
"timeFrame": null
},
{
"description": null,
"measure": "Cytogenetic response",
"timeFrame": null
}
]
} | [
{
"affiliation": "Hadassah Medical Organization",
"name": "moshe e gatt, dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D004194",
"term": "Disease"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D001855",
"term": "Bone Marrow Diseases"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D011230",
"term": "Precancerous Conditions"
},
{
"id": "D009369",
"term": "Neoplasms"
}
],
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
},
{
"abbrev": "BC04",
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},
{
"abbrev": "Rare",
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}
],
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},
{
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"id": "M12145",
"name": "Myelodysplastic Syndromes",
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},
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{
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{
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{
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]
} | {
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"id": "D011289",
"term": "Preleukemia"
},
{
"id": "D009190",
"term": "Myelodysplastic Syndromes"
},
{
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],
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"id": "C024989",
"term": "Coenzyme Q10"
},
{
"id": "D003474",
"term": "Curcumin"
}
]
} |
NCT02650726 | null | Purified Anthocyanins Supplementation and High-Density Lipoprotein (HDL) Function | Effect of Purification Anthocyanins on HDL and Endothelial Function in Subjects With Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2016-01-05T00:00:00 | null | null | null | [
"EARLY_PHASE1"
] | 80 | 40 | 60 | ALL | false | HDL function is impaired in patients with type 2 diabetes mellitus. Anthocyanin, a water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (NO) bioavailability and decreasing oxidative stress. This study was designed to evaluate whether anthocyanin supplementation might improve cardiovascular function in diabetic patients. | The study is designed as a randomized, double-blind label, interventional study on patients with T2DM. The eligible participants are randomly assigned to control and anthocyanins group. During the 24 weeks trial period, the participants are instructed to consume two anthocyanin capsules or placebo capsules twice daily (30 minutes after breakfast and supper). | Inclusion Criteria:
* Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows: (1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1
* Subject is between 40 and 60 years of age, inclusive
* Subject's BMI is \>18.5 kg/m2 and \<35 kg/m2.
Exclusion Criteria:
* Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2
* Subject that is pregnant
* Subject that has coronary artery disease, mental disorder, cancer, cirrhosis, renal disease and hepatic disease
* Subject that has had operation less than six months prior to screening visit
* Subject that uses multivitamin supplement or other polyphenol supplement | Sun Yat-sen University | OTHER | {
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NCT00523926 | null | TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis | An Open-label Study to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of TMC207 in Treatment-na�ve Subjects With Sputum Smear Positive Pulmonary Tuberculosis. | None | INTERVENTIONAL | COMPLETED | 2007-08-30T00:00:00 | null | null | null | [
"PHASE2"
] | 75 | 18 | 65 | ALL | false | The purpose of this study is to assess the effects of 3 different oral doses of TMC207 administered over a 7 day period on the organism that causes tuberculosis | This is a Phase IIa, open-label, randomized trial in treatment-naïve, sputum smear-positive, subjects with pulmonary TB to assess the extended early bactericidal activity (eEBA) of TMC207. The study population will consist of 60 treatment-naive subjects with M. tuberculosis infection.
Subjects will receive orally 25 mg TMC207 po q.d. (Treatment A), 100 mg TMC207 po q.d. (Treatment B) or 400 mg TMC207 po q.d. (Treatment C) daily for 7 days. Subjects in treatment group D will receive 600 mg rifampin po q.d. daily for 7 days and subjects in treatment group E will receive 300 mg isoniazid po q.d. daily for 7 days. After 7 days, subjects in all treatment groups will receive appropriate anti-TB therapy according to national standards of country TB guidelines and culture and sensitivity results of the sputum specimens until clinical and microbiological cures have been achieved. Three once-daily dose regimens of TMC207, for 7 days, will be studied versus 2 comparator treatments, rifampin and isoniazid in the present trial.TMC207 treatment groups: 25 mg TMC207 po q.d; 100 mg. TMC207 po q.d; 400 mg TMC207 po q.d.; TMC207 will be administered as a 10 or 40 mg/mL oral solution. Comparator groups: 600 mg rifampin po q.d. administered as capsules containing 300 mg rifampin; 300 mg isoniazid po q.d. administered as tablets containing 300 mg isoniazid. | Inclusion Criteria:
* Treatment-naive subjects with pulmonary M. tuberculosis infection, willing to start anti-TB therapy
* Positive for acid-fast bacilli on direct smear exam of sputum specimen
* Must consent to HIV testing
* Must agree to hospital admission
Exclusion Criteria:
* History or presence of hepatic or GI disease that may interfere with the absorption of TMC207, isoniazid or rifampin
* Subjects who received previous anti-mycobacterial drugs for the treatment of a mycobacteria infection and subjects who have received more than 2 weeks of treatment with a fluoroquinolone
* Subjects who have received antiretroviral therapy and/or oral or I.V. anti-fungal medication w/in the last 90 days
* Subjects with sputum cultures of M. tuberculosis resistant to rifampin
* Impaired hepatic function | Tibotec BVBA | INDUSTRY | {
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} | [
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"description": null,
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}
],
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"description": null,
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}
]
} | [
{
"affiliation": "Tibotec BVBA",
"name": "Tibotec-Virco Virology BVBA Clinical Trial",
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] | [{"pmid": "18505852", "type": "RESULT", "citation": "Rustomjee R, Diacon AH, Allen J, Venter A, Reddy C, Patientia RF, Mthiyane TC, De Marez T, van Heeswijk R, Kerstens R, Koul A, De Beule K, Donald PR, McNeeley DF. Early bactericidal activity and pharmacokinetics of the diarylquinoline TMC207 in treatment of pulmonary tuberculosis. Antimicrob Agents Chemother. 2008 Aug;52(8):2831-5. doi: 10.1128/AAC.01204-07. Epub 2008 May 27."}] | {"versionHolder": "2025-06-18"} | {
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NCT03859726 | null | Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring | Predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation | None | OBSERVATIONAL | COMPLETED | 2019-02-28T00:00:00 | null | 2019-03-31T00:00:00 | 2020-03-31T00:00:00 | null | 72 | 18 | null | ALL | false | Change and predictive Value of Sublingual Microcirculation and Peripheral Tissue Oxygen Monitoring in Sepsis Patients With Successful Fluid Resuscitation | Fluid therapy for sepsis patients has always been a research hotspot. Early studies suggest that early goal-directed therapy (EGDT) can reduce mortality in patients with sepsis and septic shock, which is included in the guidelines. However, recent studies suggest that EGDT does not reduce mortality. This may be related to the fact that EGDT only pays attention to systemic circulation and neglects microcirculation.
In the past few decades, arterial blood pressure, blood lactic acid and other circulatory indicators have been the target of septic shock treatment, but normal systemic circulation does not mean normal tissue perfusion. Obstacles to tissue perfusion, oxygenation and microcirculation may still exist. At the same time, compared with systemic hemodynamic parameters, microcirculation parameters may play a stronger role in predicting the prognosis of sepsis patients. It is believed that the ideal goal of resuscitation therapy for sepsis should be based on whether microcirculation function has been restored or not.
Objective:to observe the success rate of microcirculation imaging and oxygen saturation of peripheral tissues in sepsis patients under the guidance of current guidelines and procedures. At the same time, we compared the predictive value of microcirculation indicators to the prognosis of septic shock patients. | Inclusion Criteria:
* patients fullfilled the diagnostic criteria of Sepsis 3.0
Exclusion Criteria:
* Patients who were younger than 18 years old，
* pregnant women
* patients who had been admitted to the Intensive Care Unit(ICU for\<24 h) | Xiangya Hospital of Central South University | OTHER | {
"id": "201902035",
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} | 2019-02-28T00:00:00 | {
"date": "2020-07-27",
"type": "ACTUAL"
} | {
"date": "2019-03-01",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Results for continuous variables with normal distributions were presented as mean±standard deviations (SD)．Results for continuous variables that were not normally distributed were presented as median(Ql，Q1)． | PROBABILITY_SAMPLE | true | {
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} | [
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] | ["Sepsis, NIRS, sublingual microcirculation"] | null | [
{
"city": "Changsha",
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"facility": "Xiangya Hospital, Central South University",
"geoPoint": {
"lat": 28.19874,
"lon": 112.97087
},
"state": "Hunan"
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] | null | null | {
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"timeFrame": "72 hours"
}
],
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"measure": "28-day mortality",
"timeFrame": "28-day"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT05353426 | null | Paragastric Autonomic Blockade to Prevent Visceral Pain After Laparoscopic Sleeve Gastrectomy | Paragastric Lesser Omentum Neural Block to Prevent Visceral Pain After Laparoscopic Sleeve Gastrectomy: A Randomized Clinical Trial Protocol. | PG-ANB | INTERVENTIONAL | COMPLETED | 2022-04-16T00:00:00 | null | 2022-02-03T00:00:00 | 2022-03-21T00:00:00 | [
"NA"
] | 145 | 18 | null | ALL | false | Visceral pain (VP) following laparoscopic sleeve gastrectomy remains a substantial problem. VP is associated with autonomic symptoms, especially nausea and vomiting, and is unresponsive to traditional pain management algorithms aimed at alleviating somatic (incisional) pain. The present study was performed to evaluate the safety and effectiveness of laparoscopic paragastric autonomic neural blockade (PG-ANB) in managing the symptoms associated with VP following sleeve gastrectomy. | Introduction Although seldom discussed, visceral pain (VP) is the most significant source of pain in the first 24 hours following laparoscopic sleeve gastrectomy (LSG) and other laparoscopic procedures (1). The somatic pain induced by surgical trauma to the abdominal wall after LSG is effectively managed using conventional analgesia and transversus abdominis plane (TAP) blocks (2-4). In contrast, the visceral, colicky pain patients experience after LSG does not respond well to traditional pain management regimens. During the last 15 years at our institutions, we have used many analgesic strategies to manage these burdensome symptoms in more than 2000 LSG procedures. Despite these efforts, no analgesic strategies have been satisfactorily effective (5,8,9).
Autonomic nerve blocks have been described in the pain management literature. Specifically, celiac ganglia blocks have been reported in managing chronic pain caused by foregut malignancies or pancreatitis (11,12). In these patients, neuraxial blocks have been demonstrated to be safe and effective methods of chronic pain management. To our knowledge, however, paragastric autonomic neural blockade (PG-ANB) has not been performed as part of perioperative multimodal pain management algorithms in gastrointestinal surgery. The two proposed main mechanisms of action of this autonomic blockade are a reduction in the parasympathetic influence over the stomach, which reverses its increased muscular tone and deactivates mechanosensitive receptors in the organ wall, and blockade of the afferent sympathetic fibers that convey VP to the spinal cord (13).
In a pilot observational study involving 35 patients, we observed improvement in the severity of VP in the epigastric and retrosternal areas as well as improvement in associated autonomic symptoms following PG-ANB (14). The effect was most pronounced during the immediate postoperative period but persisted until discharge. Analgesic requirements and the presence of nausea and vomiting were also reduced. The current study was performed to further validate these preliminary findings through a randomized, double-blinded controlled trial.
Study design This prospective, double-blinded, randomized clinical trial involved patients undergoing laparoscopic sleeve gastrectomy at two high-volume institutions. The patients were randomized to laparoscopic transversus abdominis plane block with or without PG-ANB.
Sample size Previously published data have indicated that differences of 1 to 2 points on an 11-point visual analog pain scale are clinically significant (15-17). Based on these prior studies, we chose a difference of 1 point as the minimum clinically significant difference for sample size calculation and assumed a standard deviation of 2 points. With a p-value of 0.05 and a power of 0.80, we estimated that a total of 128 patients would need to be enrolled in this study. To allow for any potential loss to follow-up, we enrolled 150 patients in the study.
Randomization and blinding Randomization was performed using sealed envelopes prepared by the data manager and stratified by institution in blocks of six. The data manager stored the randomization list containing the final treatment assignments. Only the data manager had access to the randomization list throughout the study. These sealed envelopes were placed in the patients' charts and could not be opened until the patient was in the operating room under general anesthesia. At that point, the surgeon became cognizant of the procedure to perform but did not participate in assessing the patient or collecting data. Both the patient and the investigator assessing the patient were blinded to the treatment arm assignments. The investigator evaluated the patients for vital signs, pain scores, autonomic symptoms, and analgesic requirements and recorded the information.
Data collection The patients' age, sex, body mass index, current medications, and medical and surgical history were prospectively recorded at the preoperative clinic visit during study enrollment with informed consent. An analog pain scale survey was administered by an investigator blinded to the patients' groups at 1 hour postoperatively (in the recovery room), 8 hours postoperatively, and the following morning. The investigator recorded the need for analgesics; the presence of nausea, vomiting, retching, excessive salivation, hiccups; and vital signs.
Statistical analysis Continuous outcome variables were compared with two-sample t-tests. Categorical and binary outcome variables were compared using chi-squared tests. Patient-reported pain scores were further compared using linear regression with the surgeon who operated and the location of the procedure as covariates to assess the effect of the surgeon and location on the primary outcome.
Postoperative recovery protocol All patients received proton pump inhibitors, conventional antiemetics, and a scheduled baseline analgesic such as acetaminophen (1 g intravenously every 6 hours) or dipyrone (1 g intravenously every 6 hours). The first-line rescue analgesic was a nonsteroidal anti-inflammatory drug such as diclofenac (intravenously every 12 hours) together with hyoscine butylbromide (0.2 mg intravenously every 12 hours), and the second-line rescue analgesic was tramadol (1 mg per ideal body weight intravenously every 6 hours). Tramadol was the only opioid derivative used. A popsicle was offered the afternoon after surgery, and clear fluids were started the following day. Patients were discharged from the hospital at noon the day after surgery. | Inclusion Criteria:
Adult patients who were scheduled for LSG at each participating institution from 25 August 2021 to 8 February 2022 and consented to study participation.
Exclusion Criteria:
* the exclusion criteria were an age of \<18 years.
* the performance of concomitant procedures in addition to LSG.
* allergies to medications included in the postoperative management protocol.
* anesthetic complications related to the LSG that would alter the postoperative management protocol.
* surgical complications related to the LSG that would alter the postoperative management protocol. | Universidad Simón Bolívar | OTHER | {
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} | 2022-04-27T00:00:00 | {
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"date": "2022-04-29",
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] | null | null | false | {
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} | [
"Visceral Pain",
"Bariatric Surgery Candidate",
"Pain, Postoperative",
"Vomiting, Postoperative",
"Nausea, Postoperative"
] | ["Paragastric", "Autonomic Block", "Visceral pain", "Opioids", "Multimodal pain"] | null | [
{
"city": "Barranquilla",
"country": "Colombia",
"facility": "Clinica Portoazul",
"geoPoint": {
"lat": 10.96854,
"lon": -74.78132
},
"state": "Atlantico"
}
] | null | null | {
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"primary": [
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"description": null,
"measure": "The patient-reported pain scores using an 11-point visual analog scale for pain( 11 being the worse pain).",
"timeFrame": "Outcomes were assessed up to 24 hours after surgery during the period of inpatient admission following LSG."
}
],
"secondary": [
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"description": null,
"measure": "The secondary outcomes were analgesic requirements.",
"timeFrame": "The recorded administered doses of analgesics were assessed up 24 hours after surgery during the period of inpatient admission following LSG."
},
{
"description": null,
"measure": "The secondary outcome was present of nauseas",
"timeFrame": "Recorded up to 24 hours after surgery"
},
{
"description": null,
"measure": "The secondary outcome was present of vomiting",
"timeFrame": "Recorded up to 24 hours after surgery"
},
{
"description": null,
"measure": "The secondary outcome was present of retching",
"timeFrame": "Recorded up to 24 hours after surgery"
},
{
"description": null,
"measure": "The secondary outcome was present of excessive salivation",
"timeFrame": "Recorded up to 24 hours after surgery"
},
{
"description": null,
"measure": "The secondary outcome was present of hiccups",
"timeFrame": "Recorded up to 24 hours after surgery"
},
{
"description": null,
"measure": "The secondary outcomes was the mean arterial blood pressure",
"timeFrame": "Recorded at 10 minutes after blockade"
},
{
"description": null,
"measure": "The secondary outcomes was the median heart rate",
"timeFrame": "Recorded at 10 minutes after blockade."
},
{
"description": null,
"measure": "The secondary outcomes was the mean arterial blood pressure.",
"timeFrame": "Recorded up to 24 hours after surgery"
},
{
"description": null,
"measure": "The secondary outcomes was the median heart rate.",
"timeFrame": "Recorded up to 24 hours after surgery"
}
]
} | [
{
"affiliation": "Academic Director Clinica portoazul, Barranquilla, Colombia",
"name": "Jorge Daes, MD FACS",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "22915063", "type": "BACKGROUND", "citation": "Daes J, Jimenez ME, Said N, Daza JC, Dennis R. Laparoscopic sleeve gastrectomy: symptoms of gastroesophageal reflux can be reduced by changes in surgical technique. Obes Surg. 2012 Dec;22(12):1874-9. doi: 10.1007/s11695-012-0746-5."}, {"pmid": "25428846", "type": "BACKGROUND", "citation": "Browning KN, Travagli RA. Central nervous system control of gastrointestinal motility and secretion and modulation of gastrointestinal functions. Compr Physiol. 2014 Oct;4(4):1339-68. doi: 10.1002/cphy.c130055."}, {"pmid": "16129244", "type": "BACKGROUND", "citation": "Akinci D, Akhan O. Celiac ganglia block. Eur J Radiol. 2005 Sep;55(3):355-61. doi: 10.1016/j.ejrad.2005.03.008."}, {"pmid": "10201454", "type": "BACKGROUND", "citation": "Gress F, Schmitt C, Sherman S, Ikenberry S, Lehman G. A prospective randomized comparison of endoscopic ultrasound- and computed tomography-guided celiac plexus block for managing chronic pancreatitis pain. Am J Gastroenterol. 1999 Apr;94(4):900-5. doi: 10.1111/j.1572-0241.1999.01042.x."}, {"pmid": "27177956", "type": "BACKGROUND", "citation": "Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13."}, {"pmid": "31687018", "type": "BACKGROUND", "citation": "Iamaroon A, Tangwiwat S, Nivatpumin P, Lertwacha T, Rungmongkolsab P, Pangthipampai P. Risk Factors for Moderate to Severe Pain during the First 24 Hours after Laparoscopic Bariatric Surgery While Receiving Intravenous Patient-Controlled Analgesia. Anesthesiol Res Pract. 2019 Oct 3;2019:6593736. doi: 10.1155/2019/6593736. eCollection 2019."}, {"pmid": "34323436", "type": "BACKGROUND", "citation": "Tian C, Lee Y, Oparin Y, Hong D, Shanthanna H. Benefits of Transversus Abdominis Plane Block on Postoperative Analgesia after Bariatric Surgery: A Systematic Review and Meta-Analysis. Pain Physician. 2021 Aug;24(5):345-358."}, {"pmid": "7618731", "type": "BACKGROUND", "citation": "Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg. 1995 Aug;81(2):379-84. doi: 10.1097/00000539-199508000-00029."}, {"pmid": null, "type": "RESULT", "citation": "Daes J, Pantoja R, Hanssen A, et al.Paragastric, lesser omentum neural block to prevent early visceral pain after laparoscopic sleeve gastrectomy: A randomized clinical trial protocol. Revista Colombiana de Cirugia 2022;37:27-32. https://doi.org/10.30944/20117582.1017"}] | {"versionHolder": "2025-06-18"} | {
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},
{
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"term": "Postoperative Nausea and Vomiting"
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]
} | {
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"abbrev": "CNSDep",
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},
{
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},
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],
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{
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},
{
"id": "D020250",
"term": "Postoperative Nausea and Vomiting"
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],
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} |
NCT01405326 | null | REstore Working Ability in RheumatoiD Arthritis | The Effect of Six Months Adalimumab Treatment on Sick Leaves and Retirement in Patients With Rheumatoid Arthritis Who Are at a Risk of Losing Their Ability to Work | REWARD | INTERVENTIONAL | UNKNOWN | 2011-06-30T00:00:00 | null | null | null | [
"PHASE4"
] | 160 | 25 | 55 | ALL | false | The purpose of the study is to assess whether a 6-month treatment with adalimumab added on the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days on sick leave compared to placebo. In addition, the cost-effectiveness and cost-utility of the intervention compared to the conventional treatment is evaluated, and the patients who benefit most are characterized. | In spite of the improved medical treatment, rheumatoid arthritis (RA) is still causing both significant morbidity and marked loss of work productivity. Short periods of work inability, i.e., sick leaves represent a significant part of the socioeconomic burden of RA. The study is a randomized, controlled double blind multi-center study. 160 patients of 25 to 55 years of age with recent-onset (≤2 years from diagnosis) RA who have been treated with a combination of conventional antirheumatic drugs but have an inadequate response to treatment and are at the risk of losing their ability to work, are enrolled. The patients should be biologic-naïve. Their RA should be active, but not so active that the conventional criteria for biologic therapy would be fulfilled. The subjects are randomized at 1:1 ratio to receive either adalimumab (40 mg every two weeks) or placebo for 6 months added on their concurrent antirheumatic therapy. The RA-related sickness absence and clinical response will be evaluated. | Inclusion Criteria:
1. Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria
2. Time from diagnosis of RA \< 2 years
3. Age 25-55 years
4. Active RA with at least 3 active joints (tender and/or swollen joints)
5. Stable DMARD combination treatment for more than 3 months
6. At least one of the following
* Rheumatoid factor positive
* One or more erosions in x-rays of the hands and feet
* Anti-citrulline antibodies positive
7. At least other of the following
* HAQ-index 0.5 or more
* Patient or physician evaluation of RA activity \>25 mm (VAS 0-10 cm)
8. Patient has been steadily in work-life for at least one year and is currently working or on sick- leave but not applying for pension
9. Patient feels that he/she will likely have to be off-work during the following 6 months due to his/her RA
10. Patient must be willing and able to provide written informed consent for the trial
11. Each female subject must agree to use a medically accepted method of contraception while receiving study medication
Exclusion Criteria:
1. A subject must not have a history of biological drug use for RA
2. A subject must not have evidence of active or latent tuberculosis,
3. A subject must not have any history of lymphoproliferative disease or malignancy within the previous 5 years
4. A subject must not have any other condition, that according to the investigator's judgment makes him or her non-eligible for anti-TNF use
5. A subject must not have any inflammatory rheumatic disease other than RA
6. A subject must not have received any other investigational agents within 30 days prior to baseline visit, and must not receive them during the current trial
7. A female subject must not be pregnant or breast-feeding or planning pregnancy during the study
8. A subject must not have had a major surgery within one month prior to study entry and must not have a scheduled operation during the 6-month follow up
9. A subject must not have any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the optimal participation in the trial.
10. A subject must not fulfill the criteria for reimbursement for biologics for RA and he/she would not normally be prescribed a biological drug according to physicians discretion and national treatment guidelines
11. A patient must not be currently on reimbursed rehabilitation period, or such period must not be scheduled for the next six months | The Rheumatological Center of Helsinki | NETWORK | {
"id": "RE100002011",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-07-28T00:00:00 | {
"date": "2011-07-29",
"type": "ESTIMATED"
} | {
"date": "2011-07-29",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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]
},
"observationalModel": null,
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"timePerspective": null
} | [
"Rheumatoid Arthritis"
] | ["rheumatoid arthritis", "biological therapy", "adalimumab", "ability to work", "sick leaves"] | null | [
{
"city": "Helsinki",
"country": "Finland",
"facility": "Helsinki University Central Hopsital",
"geoPoint": {
"lat": 60.16952,
"lon": 24.93545
},
"state": null
},
{
"city": "Rovaniemi",
"country": "Finland",
"facility": "Lappland Central Hospital",
"geoPoint": {
"lat": 66.5,
"lon": 25.71667
},
"state": null
},
{
"city": "Tampere",
"country": "Finland",
"facility": "Tampere University hospital, Rheumatology Centre",
"geoPoint": {
"lat": 61.49911,
"lon": 23.78712
},
"state": null
},
{
"city": "Turku",
"country": "Finland",
"facility": "The Turku Universitry Central Hopsital",
"geoPoint": {
"lat": 60.45148,
"lon": 22.26869
},
"state": null
}
] | [
{
"class": "INDUSTRY",
"name": "Abbott"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of lost work days due to RA during the 6-month follow up.",
"timeFrame": "6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Change in health-related quality of life as measured by the EQ-5D index over the 6-month follow up",
"timeFrame": "baseline and 6 months"
},
{
"description": null,
"measure": "Change in functionality assessed by the HAQ over the 6-month follow up",
"timeFrame": "baseline and 6 months"
},
{
"description": null,
"measure": "Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up",
"timeFrame": "baseline and 6 months"
},
{
"description": null,
"measure": "Work Productivity and Activity Impairment Questionnaire (WPAI)",
"timeFrame": "6 months"
}
]
} | [
{
"affiliation": "The Rheumatological Center of Helsinki",
"name": "Kari K Eklund, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007592",
"term": "Joint Diseases"
},
{
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"term": "Musculoskeletal Diseases"
},
{
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"term": "Rheumatic Diseases"
},
{
"id": "D003240",
"term": "Connective Tissue Diseases"
},
{
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"term": "Autoimmune Diseases"
},
{
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"term": "Immune System Diseases"
}
],
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"abbrev": "BC05",
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},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC20",
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}
],
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},
{
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},
{
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},
{
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M6323",
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"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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}
],
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"term": "Arthritis"
},
{
"id": "D001172",
"term": "Arthritis, Rheumatoid"
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]
} | {
"ancestors": [
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},
{
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}
],
"browseBranches": [
{
"abbrev": "Infl",
"name": "Anti-Inflammatory Agents"
},
{
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"name": "Antirheumatic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
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},
{
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"relevance": "LOW"
},
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}
],
"meshes": [
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]
} | {
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"term": "Arthritis, Rheumatoid"
}
],
"interventions": [
{
"id": "D000068879",
"term": "Adalimumab"
}
]
} |
NCT05547126 | null | Comparing Different Montages of tDCS Combined With Dual-task Training on EEG Microstates | Comparing Different Montages of Transcranial Direct Current Stimulation Combined With Dual-task Training on EEG Microstates A Proof-of-concept Study | None | INTERVENTIONAL | UNKNOWN | 2022-08-18T00:00:00 | null | 2023-12-30T00:00:00 | 2023-12-30T00:00:00 | [
"NA"
] | 10 | 18 | null | ALL | false | This study investigates whether electroencephalographic (EEG) measures of functional connectivity of the target network are associated with the response to different sets of transcranial direct current stimulation combined with dual-task training in post-stroke patients. | The present study seeks to compare the effects of conventional anodic tDCS (M1) with double-site/dual-site anodic tDCS (M1 + DLPFC) and simulated tDCS on functional connectivity, as assessed by EEG, in patients after staged stroke. chronic. The study is a randomized, double-blind, placebo-controlled, crossover clinical trial. Participants will be submitted to three sessions, each session consisting of a different condition, namely: anodic tDCS - participants who will receive real current over the primary motor area; Dualsite tDCS - participants who will receive real current over the primary motor area and over the dorsolateral prefrontal area (DLPFC) and simulated tDCS - participants who will receive simulated stimulation. Participants will receive 3 tDCS sessions, lasting 20 minutes, associated with a physical therapy protocol based on dual motor and cognitive tasks, on alternate days (3 times a week). On each intervention day, pre and post-intervention assessments will be carried out, the evaluated outcomes will be: functional connectivity (EEG), functional mobility (Timed Up and Go) and executive functions (Trail-making Test A and B, the Clock Drawing Test and Phonemic Verbal Fluency Test). Statistical performance will be performed using SPSS software (Version 20.0) and MATLAB 9.20 with a significance level of p\<0.05. | Inclusion Criteria:
* Post-stroke participants for more than 6 months
* Individuals over 18 years of age;
* Both sexes;
* Patients with mild to moderate degree of injury severity (NIHHS \<17 points)
Exclusion Criteria:
* Patients with other associated pathologies that can influence motor activity (example: traumatic brain injury, brain tumor);
* Habitual use of drugs or alcohol;
* Use of drugs that modulate the activity of the Central Nervous System;
* Gestation;
* Use of metallic / electronic implants and / or cardiac pacemakers;
* Participants unable to communicate verbally; | Federal University of Paraíba | OTHER | {
"id": "tDCS+Dual-tasktraining_Stroke",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-09-15T00:00:00 | {
"date": "2023-04-25",
"type": "ACTUAL"
} | {
"date": "2022-09-21",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Stroke"
] | ["Transcranial direct current stimulation", "Stroke", "Dual-task training", "EEG"] | null | [
{
"city": "João Pessoa",
"country": "Brazil",
"facility": "Federal University of Paraíba,Department of Psychology",
"geoPoint": {
"lat": -7.115,
"lon": -34.86306
},
"state": "Paraiba"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Microstates EEG",
"timeFrame": "The evaluations will be carried out in pre-intervention"
},
{
"description": null,
"measure": "Functional connectivity",
"timeFrame": "Immediately after the intervention"
}
],
"secondary": [
{
"description": null,
"measure": "Timed up and Go test",
"timeFrame": "The evaluations will be carried out in pre-intervention"
},
{
"description": null,
"measure": "Timed up and Go test",
"timeFrame": "Immediately after the intervention"
},
{
"description": null,
"measure": "Executive Functions I",
"timeFrame": "The evaluations will be carried out in pre-intervention"
},
{
"description": null,
"measure": "Executive Functions I",
"timeFrame": "Immediately after the intervention"
},
{
"description": null,
"measure": "Executive Functions II",
"timeFrame": "The evaluations will be carried out in pre-intervention"
},
{
"description": null,
"measure": "Executive Functions II",
"timeFrame": "Immediately after the intervention"
},
{
"description": null,
"measure": "Executive Functions III",
"timeFrame": "The evaluations will be carried out in pre-intervention"
},
{
"description": null,
"measure": "Executive Functions III",
"timeFrame": "Immediately after the intervention"
}
]
} | [
{
"affiliation": "Federal University of Paraíba",
"name": "Suellen Andrade",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M22306",
"name": "Stroke",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
"interventions": null
} |
NCT02584426 | null | Subcutaneous Injection and Ultrasonic Dispersion of Cefazolin Into Chronic Pelvic-Region Pressure Ulcers in Persons With Spinal Cord Injury | null | None | INTERVENTIONAL | COMPLETED | 2015-10-15T00:00:00 | null | 2017-11-22T00:00:00 | null | [
"NA"
] | 1 | 18 | 79 | ALL | false | Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since being injured. Despite the increasing attention and emphasis on prevention, PUs still represent a major health risk for persons with SCI. PUs and other skin breakdowns are at risk for becoming infected; it is not uncommon for many different types of "bugs" to be found in the wound. It has been assumed that the presence of these organisms did not impede wound healing or skin graft survival. The current proposal will use a new type of procedure that involves the direct injection of an antibiotic (in saline) into the skin beneath the wound; it is then distributed throughout the wound using a second device that uses sound waves. The study will determine if the antibiotic treatment and the standard of care improves the rate wound closure compared to the standard of care alone in persons with SCI and a chronic pelvic-region PU. | Persons with spinal cord injury (SCI) are at increased risk of developing a Stage III or IV (full-thickness) pressure ulcer (PU). These wounds are associated with a tremendous personal and financial cost. An intervention that proves efficacious in the facilitation of healing this chronic medical condition would be of enormous medical, social, and economic benefit to persons with SCI and other cohorts with a difficult to heal PUs. From preliminary studies, it appears that hypodermoclysis (i.e., an interstitial infusion) with an antibiotic (i.e., cefazolin; a first generation cephalosporin) and subsequent dispersion with ultrasound throughout the wound recently has been shown in preliminary work to be efficacious in the treatment of infection, both recognized pathogenic organisms and those that have colonized the wound bed), which then appears to facilitate wound closure and success of standard surgical intervention. This approach to wound care represents a paradigm shift because previously it was assumed that nonpathogenic organism did not impede wound healing or skin graft survival. The investigators will test this novel approach to wound healing in persons with SCI who have a chronic PU of the pelvic region. | Inclusion Criteria:
1. Male or female, age 18 to 79;
2. Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of neurological lesion);
3. American Spinal Injury Association Impairment Scale (AIS) designation of A or B with no sensation in the pelvic region;
4. At least one Stage III or IV PU in the pelvic region (e.g., ischial or trochanteric regions) that has not shown signs of healing for a period of at least 1 month;
5. At least one Stage III or IV PU in the pelvic region greater than 100 cm2 in surface area; and,
6. Hemoglobin A1C ≤7.0%.
Exclusion Criteria:
1. Persons who are candidates for or elect to have reconstructive flap surgery of the PU;
2. Unresolved osteomyelitis diagnosed by clinical impression and supported by one or more of the following: 1) history and examination of the pressure ulcer (i.e., visible bone), 2) bone contact on sterile probe, 3) bone that has lost its normal consistency, 4) magnetic resonance imaging, or 5) open bone biopsy;
3. Hemoglobin A1C \>7.0%;
4. Psychopathology (documentation in the medical record or history of self-abusive behavior specific to PU healing which may or may not include major or minor psychiatric illness (that may conflict with the study objectives;
5. Acute illness or systemic infection;
6. Allergy to cefazolin;
7. Allergy to penicillin;
8. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association functional classification of 3;
9. Previously diagnosed active malignant disease;
10. Suspicion of skin cancer at the PU site (i.e., clinical evaluation is currently on-going);
11. Life expectancy less than 12 months;
12. Nephrosis, hemodialysis or chronic ambulatory peritoneal dialysis therapy;
13. Moderate to high dose glucocorticoid administrations (i.e., ≥ 40 mg prednisone or equivalent steroid dose) within the past 3 months;
14. Diminished mental capacity;
15. Inability or unwillingness of subject to provide informed consent; or,
16. Pregnancy or women who may become pregnant during the course of the study, or those who are nursing. | James J. Peters Veterans Affairs Medical Center | FED | {
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NCT05371626 | null | Cicatricial Upper Eyelid Entropion Management | Suture-less Procedure for Management of Cicatricial Upper Eyelid Entropion | None | INTERVENTIONAL | RECRUITING | 2022-05-05T00:00:00 | null | 2024-04-01T00:00:00 | 2024-06-01T00:00:00 | [
"NA"
] | 30 | 16 | null | ALL | false | Suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy | null | Inclusion Criteria:
* Upper eyelid cicatricial entropion with no history of previous surgery.
* Cooperative patients older then 16 years old.
Exclusion Criteria:
* Previous lid surgery.
* Senile and mechanical entropion. | Minia University | OTHER | {
"id": "Oculoplastic clinic",
"link": null,
"type": null
} | Unknown | {
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} | 2022-05-09T00:00:00 | {
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"date": "2022-05-12",
"type": "ACTUAL"
} | [
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} | [
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] | null | null | [
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"state": "Minia"
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"measure": "Eyelid margin reposition to the normal position",
"timeFrame": "1 month"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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"id": "D005141",
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NCT05252026 | null | Indicated Prevention Transdiagnostic Intervention for Adolescents At High Risk of Emotional Problems | Indicated Prevention Transdiagnostic Intervention for Adolescents At High Risk of Emotional Problems | PROCARE-I | INTERVENTIONAL | COMPLETED | 2022-02-11T00:00:00 | null | 2021-06-30T00:00:00 | 2022-06-30T00:00:00 | [
"NA"
] | 68 | 12 | 18 | ALL | true | Emotional disorders (anxiety and/or depression) are severely undiagnosed and untreated despite being among the most common mental disorders, particularly at a young age. Half of all mental disorders begin by age 14; three-quarters by age 24, which makes adolescence a particularly crucial stage. In adolescence, prodromal signs of mental disorders and even full-blown clinical conditions often remain undetected, undiagnosed and untreated. However, there is an absence of evidence-based protocols to reach at high risk youth for developing emotional disorders. There is an urgent need for a paradigm shift by developing intervention protocols to early identify and treat vulnerable adolescents, thus preventing them from developing severe mental disorders later on in life. Mental health indicated prevention is key to helping at-high risk adolescents thrive before emotional disorder evolves. To cover this gap, PROCARE-I is conceptualized as a modularized indicated preventive programme for adolescents aged 12 to 18 years, adapting UP-A protocol with author's permission and supervision. Adolescents will be allocated to a 2-arm intervention trial, delivered as a group, as telehealth format as a result of Covid19 restrictions imposed by government. The PROCARE-I protocol aims to enhance protective factors that will eventually lead to lasting positive effects for adolescents. PROCARE-I will combine quantitative analysis, with special attention to vulnerable groups in a sex/gender disaggregated way. The PROCARE-I project is expected to have a far impact ultimately contributing to preventing and reducing the prevalence of emotional disorders in the young. The outcomes of PROCARE-I will contribute to identifying and treating vulnerable adolescents at high risk for emotional mental at an early stage, before they incur personal, societal and economic cost. PROCARE-I will be culturally-adapted and implemented as a multicenter Randomized-Controlled Trial (RCT). PROCARE-I will be designed to be an acceptable, scalable, and sustainable indicated prevention program. | The general objective of PROCARE-I is to design, implement and evaluate a indicated 8-session preventive group intervention for adolescents aged 12-18 at high risk of emotional disorders like anxiety and depression. The intervention will be based on the Unified protocol for transdiagnostic treatment of emotional disorders in adolescents (UP-A), already proven as effective in the US, but adapted with indicated prevention purposes in Spain thanks support of main author of the protocol (Prf. Ehrenreich-May). It will be culturally-adapted and designed to be an acceptable, scalable, and sustainable indicated prevention program. METHODOLOGY The methodology was designed in order to achieve the project's objective of treating vulnerable adolescents at high risk of developing emotional disorders. PROCARE-I working plan will be divided into 3 interconnected stages. Firstly, in order to identify adolescents at high risk of suffering emotional disorders (anxiety and depression), the following self-reports will be administered to adolescents: Strengths and Difficulties Questionnaire (SDQ) to evaluate adolescents at-risk of emotional disorders, and the Revised Child Anxiety and Depression Scale-30 (RCADS-30) will screen for presence/absence of emotional symptomatology. Finally, ADIS5-C/P will be administered to rule-out presence of anxiety and/or mood disorders. Valuing voices from stakeholders and end-users, the investigators will focus on the study of the influence of the above described variables. Third, the investigators will test a indicated preventive intervention using multi-center randomized control trial in Spain. Special attention will be paid to particularly vulnerable young people, such as disabled, refugees, immigrants, or minorities (national, ethnic, linguistic, religious, and sexual).
IMPACT The need to include mental health among the first priorities of the public health agenda has been increasingly recognized over the past decades. The outcomes of the PROCARE-I project will have a far impact ultimately contributing to preventing and reducing the prevalence of mental disorders in the young. These problems are wide-ranging, long-lasting, and enormous and impose a range of costs on individuals, families and communities. The outcomes of the project, if successful, will have far reaching implications, contributing to identifying and treating adolescents at high risk for emotional mental disorders at an early stage, before they incur personal, societal and economic cost. | Inclusion Criteria:
* written informed consent from adolescent and legal guardian
* able to attend prevention modules on his/her own
* language competence
* Strengths and Difficulties Questionnaire ""probable diagnoses"
* score above cut-off for Revised Child Anxiety and Depression Scale-30
* absence of anxiety and/or mood disorders
Exclusion Criteria:
* in- or outpatient
* concomitant psychological/psychiatric treatment
* acute suicidality
* general medical contraindications that hamper attendance to prevention modules
* Strengths and Difficulties Questionnaire "unlikely" or "possible diagnoses"
* presence of mood and/or anxiety disorders | University of Jaén | OTHER | {
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"date": "2023-02-21",
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"date": "2022-02-23",
"type": "ACTUAL"
} | [
"CHILD",
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{
"description": null,
"measure": "Economic evaluations",
"timeFrame": "Baseline to 7 months after start of interventions"
},
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"description": null,
"measure": "Psychological flexibility",
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},
{
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]
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"affiliation": "University of Jaen",
"name": "Luis-Joaquin Garcia-Lopez, Ph.D.",
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] | [{"pmid": "32402261", "type": "RESULT", "citation": "Garcia-Escalera J, Valiente RM, Sandin B, Ehrenreich-May J, Prieto A, Chorot P. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: An Initial Cluster Randomized Wait-List-Controlled Trial. Behav Ther. 2020 May;51(3):461-473. doi: 10.1016/j.beth.2019.08.003. Epub 2019 Aug 14."}, {"pmid": "33182711", "type": "RESULT", "citation": "Sandin B, Garcia-Escalera J, Valiente RM, Espinosa V, Chorot P. Clinical Utility of an Internet-Delivered Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (iUP-A): A Pilot Open Trial. Int J Environ Res Public Health. 2020 Nov 10;17(22):8306. doi: 10.3390/ijerph17228306."}, {"pmid": "22642525", "type": "RESULT", "citation": "Levin L, Henderson HA, Ehrenreich-May J. Interpersonal predictors of early therapeutic alliance in a transdiagnostic cognitive-behavioral treatment for adolescents with anxiety and depression. Psychotherapy (Chic). 2012 Jun;49(2):218-230. doi: 10.1037/a0028265."}, {"pmid": "24960439", "type": "RESULT", "citation": "Queen AH, Barlow DH, Ehrenreich-May J. The trajectories of adolescent anxiety and depressive symptoms over the course of a transdiagnostic treatment. J Anxiety Disord. 2014 Aug;28(6):511-21. doi: 10.1016/j.janxdis.2014.05.007. Epub 2014 Jun 2."}, {"pmid": "23046789", "type": "RESULT", "citation": "Bilek EL, Ehrenreich-May J. An open trial investigation of a transdiagnostic group treatment for children with anxiety and depressive symptoms. Behav Ther. 2012 Dec;43(4):887-97. doi: 10.1016/j.beth.2012.04.007. Epub 2012 May 1."}, {"pmid": "27771133", "type": "RESULT", "citation": "Ehrenreich-May J, Rosenfield D, Queen AH, Kennedy SM, Remmes CS, Barlow DH. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents. J Anxiety Disord. 2017 Mar;46:46-55. doi: 10.1016/j.janxdis.2016.10.006. Epub 2016 Oct 17."}] | {"versionHolder": "2025-06-18"} | {
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NCT01142726 | null | Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis | A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA | None | INTERVENTIONAL | COMPLETED | 2010-06-03T00:00:00 | null | null | null | [
"PHASE3"
] | 511 | 18 | null | ALL | false | The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal. | null | Key Inclusion Criteria:
* Presence of active clinical synovitis in at least 2 joints, 1 of which must have been a small joint, for a minimum of 8 weeks prior to screening
* Onset of persistent symptoms ≤ 2 years prior to screening
* Positive test result for anticyclic citrullinated peptides 2
* Methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit
* Biologic naive, including no treatment with an investigational biologic prior to screening
* Disease Activity Score 28 based on C-reactive protein score ≥3.2 at screening
* Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization
* If receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone equivalent) for at least 4 weeks
* Able to undergo magnetic resonance imaging
Key Exclusion Criteria:
* Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus)
* Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization
* Scheduled for or anticipating joint replacement surgery
* Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
* History of malignancy in the last 5 years
* Any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection
* At risk for tuberculosis
* Evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment | Bristol-Myers Squibb | INDUSTRY | {
"id": "IM101-226",
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]
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"name": "Immune System Diseases"
}
],
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"id": "M4476",
"name": "Arthritis",
"relevance": "HIGH"
},
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"id": "M4480",
"name": "Arthritis, Rheumatoid",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10621",
"name": "Joint Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
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"relevance": "LOW"
},
{
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M6323",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M6464",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M4629",
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"relevance": "LOW"
},
{
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"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
}
],
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},
{
"id": "D001172",
"term": "Arthritis, Rheumatoid"
}
]
} | {
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"id": "D000020",
"term": "Abortifacient Agents, Nonsteroidal"
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{
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{
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{
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{
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{
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"term": "Dermatologic Agents"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D005493",
"term": "Folic Acid Antagonists"
},
{
"id": "D007166",
"term": "Immunosuppressive Agents"
},
{
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"term": "Immunologic Factors"
},
{
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"term": "Antirheumatic Agents"
},
{
"id": "D019384",
"term": "Nucleic Acid Synthesis Inhibitors"
},
{
"id": "D000082082",
"term": "Immune Checkpoint Inhibitors"
},
{
"id": "D000074322",
"term": "Antineoplastic Agents, Immunological"
}
],
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
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"abbrev": "Derm",
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{
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{
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}
],
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{
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"term": "Methotrexate"
},
{
"id": "D000069594",
"term": "Abatacept"
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]
} | {
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"term": "Arthritis, Rheumatoid"
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"id": "D008727",
"term": "Methotrexate"
},
{
"id": "D000069594",
"term": "Abatacept"
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]
} |
NCT02031926 | null | Evaluation of Correct PEP Use With the Time | Evaluation of the Reproductibility of the Pressure Generated by a Positive Expiratory Pressure Device | None | INTERVENTIONAL | COMPLETED | 2014-01-07T00:00:00 | null | null | null | [
"NA"
] | 30 | 18 | 85 | ALL | true | Healthy subjects will be trained to used correctly a positive expiratory pressure device. The aim of the study is to evaluate te reproductibility of the correct used of the device after training | null | Inclusion Criteria:
* No lung disease
* Older than 18 years
Exclusion Criteria:
* Psychological disorder | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | OTHER | {
"id": "PEP training",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-01-08T00:00:00 | {
"date": "2014-01-09",
"type": "ESTIMATED"
} | {
"date": "2014-01-09",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Healthy"
] | null | null | [
{
"city": "Brussels",
"country": "Belgium",
"facility": "Cliniques universitaires Saint-Luc",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Expiratory pressure",
"timeFrame": "within the 7 first days"
}
],
"secondary": [
{
"description": null,
"measure": "Succes rate",
"timeFrame": "Every day"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT01550926 | null | A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms | A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms | None | INTERVENTIONAL | COMPLETED | 2011-11-17T00:00:00 | null | null | null | [
"PHASE1"
] | 48 | 18 | 60 | ALL | true | The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form. | null | Inclusion Criteria:
* age: 18-60 years
* Body Mass Index: 25-33
Exclusion Criteria:
* gastrointestinal disease
* organ transplant
* HIV, hepatitis B or C
* food allergies
* alcohol or other substance abuse
* smoking | GlaxoSmithKline | INDUSTRY | {
"id": "W3680604",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-03-07T00:00:00 | {
"date": "2013-01-28",
"type": "ESTIMATED"
} | {
"date": "2012-03-12",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": null,
"timePerspective": null
} | [
"Overweight"
] | ["orlistat", "overweight", "bioequivalence"] | null | [
{
"city": "Belfast",
"country": "United Kingdom",
"facility": "MDS Pharma Services",
"geoPoint": {
"lat": 54.59682,
"lon": -5.92541
},
"state": "N. Ireland"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Fecal fat excretion",
"timeFrame": "9 days"
}
],
"secondary": null
} | [
{
"affiliation": "GlaxoSmithKline",
"name": "GSK Clinical Trials",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D044343",
"term": "Overnutrition"
},
{
"id": "D009748",
"term": "Nutrition Disorders"
},
{
"id": "D001835",
"term": "Body Weight"
}
],
"browseBranches": [
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
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],
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"id": "M26186",
"name": "Overweight",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M25307",
"name": "Overnutrition",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12684",
"name": "Nutrition Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5114",
"name": "Body Weight",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D050177",
"term": "Overweight"
}
]
} | {
"ancestors": [
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D019440",
"term": "Anti-Obesity Agents"
},
{
"id": "D057847",
"term": "Lipid Regulating Agents"
}
],
"browseBranches": [
{
"abbrev": "AnObAg",
"name": "Anti-Obesity Agents"
},
{
"abbrev": "Lipd",
"name": "Lipid Regulating Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Tenofovir Alafenamide",
"id": "M1784",
"name": "Orlistat",
"relevance": "HIGH"
},
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"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21396",
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},
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000077403",
"term": "Orlistat"
}
]
} | {
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],
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{
"id": "D000077403",
"term": "Orlistat"
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]
} |
NCT03793426 | null | Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency | Post-marketing Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency | None | OBSERVATIONAL | RECRUITING | 2018-12-19T00:00:00 | null | null | null | null | 25 | null | null | ALL | false | Open-label, Uncontrolled, Multicenter Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency | There is a need to increase the body of data on treatment effectiveness and safety in the ultra-rare setting of congenital fibrinogen deficiency. Real-world evidence (RWE) derived from non-interventional studies can describe product utilization, demonstrate value, and facilitate benefit-risk assessments; RWE can only be fully assessed once a product is launched and used in a real-life setting.
This post-marketing, observational study is designed to collect information concerning safety, efficacy, and outcomes of Fibryga administration in routine clinical use in patients of any age with congenital afibrinogenemia or hypofibrinogenemia. Documentation of the administration of Fibryga in clinical practice for the treatment of both minor and major bleeding events (BEs) will not only enhance the knowledge on the efficacy and safety profile of Fibryga, but will also gather information that cannot be obtained in the same way in controlled clinical studies. These observational data will support the safety and efficacy data generated with Fibryga in good clinical practice (GCP) clinical studies, providing benefit for both physicians and patients. | Inclusion Criteria:
* Patients of any age with a documented diagnosis of congenital afibrinogenemia or hypofibrinogenemia expected to require on-demand in-hospital treatment for BEs with Fibryga
Exclusion Criteria:
* Bleeding disorder other than congenital fibrinogen deficiency
* Patients with acquired fibrinogen deficiency or dysfibrinogenemia
* Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery, if available, of \<0.5 (mg/dL)/(mg/kg); there is currently no standard test for inhibitors
* Participation in an interventional clinical study at the time of or within 4 weeks prior to enrolment | Octapharma | INDUSTRY | {
"id": "FORMA-07",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-01-03T00:00:00 | {
"date": "2025-03-11",
"type": "ACTUAL"
} | {
"date": "2019-01-04",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Approximately 25 patients with a documented diagnosis of congenital afibrinogenemia or hypofibrinogenemia are planned to be documented in this study | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Congenital Fibrinogen Deficiency"
] | null | null | [
{
"city": "Ostrava",
"country": "Czechia",
"facility": "Fakultní nemocnice Ostrava",
"geoPoint": {
"lat": 49.83465,
"lon": 18.28204
},
"state": null
},
{
"city": "Duisburg",
"country": "Germany",
"facility": "Gerinnungszentrum rhein-ruhr",
"geoPoint": {
"lat": 51.43247,
"lon": 6.76516
},
"state": null
},
{
"city": "Frankfurt",
"country": "Germany",
"facility": "Medizinische Klinik 2 / Institut für Transfusionsmedizin Universitätsklinikum",
"geoPoint": {
"lat": 50.11552,
"lon": 8.68417
},
"state": null
},
{
"city": "Hamburg",
"country": "Germany",
"facility": "Gerinnungszentrum Hochtaunus",
"geoPoint": {
"lat": 53.57532,
"lon": 10.01534
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "The incidence of thromboembolic adverse drug reactions (ADRs)",
"timeFrame": "Day 0-28"
}
],
"secondary": [
{
"description": null,
"measure": "Hemostatic efficacy of Fibryga for all bleeding events (BEs) collected in the study will be assessed by the investigator using a 4-point hemostatic efficacy scale",
"timeFrame": "Within 2-24 hours following treatment of BEs"
},
{
"description": null,
"measure": "Dosage of Fibryga",
"timeFrame": "Within 2-24 hours following treatment of BEs"
},
{
"description": null,
"measure": "Duration of BEs",
"timeFrame": "Within 2-24 hours following treatment of BEs"
},
{
"description": null,
"measure": "Incidence of treatment-emergent adverse events (safety)",
"timeFrame": "Day 0-28"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D025861",
"term": "Blood Coagulation Disorders, Inherited"
},
{
"id": "D001778",
"term": "Blood Coagulation Disorders"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D020147",
"term": "Coagulation Protein Disorders"
},
{
"id": "D006474",
"term": "Hemorrhagic Disorders"
},
{
"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": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Fibrinogen Deficiency",
"id": "M3697",
"name": "Afibrinogenemia",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M21977",
"name": "Hemostatic Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5059",
"name": "Blood Coagulation Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23095",
"name": "Blood Coagulation Disorders, Inherited",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9490",
"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21982",
"name": "Coagulation Protein Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9560",
"name": "Hemorrhagic Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": "Congenital Fibrinogen Deficiency",
"id": "T2319",
"name": "Fibrinogen Deficiency, Congenital",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T232",
"name": "Afibrinogenemia",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000347",
"term": "Afibrinogenemia"
}
]
} | null | {
"conditions": [
{
"id": "D000347",
"term": "Afibrinogenemia"
}
],
"interventions": null
} |
NCT01181726 | null | Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions | A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg Versus Activella® (1 mg Estradiol/0.5 mg Norethindrone Acetate) Tablets in Normal, Healthy, Post-Menopausal Female Subjects. | None | INTERVENTIONAL | COMPLETED | 2010-08-11T00:00:00 | null | null | null | [
"PHASE1"
] | 40 | 18 | 65 | FEMALE | true | The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fed conditions. | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Inclusion Criteria:
* Non-smoking or smoking (up to 10 cigarettes/day), physiologically or surgically post-menopausal female within the age range of 18-65 years.
* 17β-estradiol serum levels of ≤ 92 pmol/L and follicle-stimulating hormone (FSH) of ≥ 40 IU/L.
* Body Mass Index (BMI) greater than or equal to 19.0 kg/m2 and less than or equal to 30.0 kg/m2.
* Normal findings in the physical examination, 12-lead electrocardiogram (ECG) and vital signs.
* Hemoglobin ≥ 115 g/L.
* Normal pap smear.
* Normal mammogram within 1 year for subjects who are over the age of 50 years.
* Negative for drugs of abuse and alcohol.
* Negative for hepatitis B-surface antigen, hepatitis C, and Human Immunodeficiency Virus (HIV).
* No clinical laboratory values outside the acceptable range unless the Principal Investigator or Sub-Investigator decides that they are not clinically significant (NCS).
* Negative for pregnancy.
* Subjects who are surgically post-menopausal with an intact uterus (i.e. bilateral oophorectomy) for at least 6 months, or physiologically post-menopausal (i.e. spontaneous amenorrhea) for at least 1 year, and who will adhere to contraceptive requirements from at least 10 days before Period I check-in, during the study and up until 1 month after the end of the study.
* Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed ICF.
Exclusion Criteria:
* Known history of hypersensitivity to norethindrone and estradiol combinations and/or norethindrone, and/or estradiol.
* Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, or hematological diseases, malignancies, or migraines, unless deemed not clinically significant by the Principal Investigator or Sub-Investigator.
* Known history of liver, kidney, and/or gallbladder dysfunction/disease, chronic diarrhea, or inflammatory bowel diseases.
* Known history or presence of cerebrovascular diseases or venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
* Any history of stroke.
* Presence of any significant physical or organ abnormality.
* History of osteoporosis.
* History or presence of fibrocystic breast disease.
* History or presence of breast, endometrial, cervical, and/or uterine carcinoma.
* Any illness during the 4 weeks before this study, unless deemed not clinically significant by the Principal Investigator or Sub-Investigator.
* Any history or evidence of psychiatric or psychological disease, unless deemed not clinically significant by the Principal Investigator or the Sub-Investigator.
* Any history or abnormal vaginal bleeding, unless deemed not clinically significant by the Principal Investigator or the Sub-Investigator.
* Any history of asthma (after 12 years of age).
* Evidence of pregnancy or lactation.
* Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
* Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Any history or drug abuse.
* Any recent history of alcohol abuse (less than 1 year).
* Use of any prescription medication within 30 days preceding this study.
* Use of hormone replacement therapy within 30 days before drug administration.
* Use of over-the-counter (OTC) medication or any herbal supplement within the 7 days preceding this study.
* Use of hormonal contraceptives, oral, transdermal, implant within 30 days before drug administration or a depot injection or progestogen drug within 1 year before the drug administration.
* Depot injection of any drug within 6 months.
* Blood draws within 56 days preceding this study, during the conduct of any clinical study at another facility, or within the lockout period specified by previous study.
* Blood donations within 56 days preceding this study.
* Participation as a plasma donor in a plasmapheresis program within 7 days preceding this study.
* Participation in a clinical trial with an investigational drug within 30 days preceding this study.
* Intolerance to venipuncture. | Teva Pharmaceuticals USA | INDUSTRY | {
"id": "3252",
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NCT06731426 | null | Multi-session, Personalized Cognitive Bias Modification for Thought-Action-Fusion | Effects of Multi-session, Personalized Cognitive Bias Modification for Thought-Action-Fusion Among Adults with Obsessive-Compulsive Symptoms: a Randomized Controlled Trial | None | INTERVENTIONAL | RECRUITING | 2024-11-21T00:00:00 | null | 2026-05-31T00:00:00 | 2026-05-31T00:00:00 | [
"NA"
] | 84 | 18 | null | ALL | false | Thought-Action-Fusion (TAF) is a cognitive bias that posits (1) having unwanted thoughts is morally equivalent to acting upon the thoughts (TAF-Moral; e.g., "Thinking about harming a child is as immoral as actually harming a child") and (2) having unwanted thoughts will increase the likelihood of the thoughts happening in real life (TAF-Likelihood; e.g., "My mother will get into a car accident, because I thought about it"). Given its central role in the development and maintenance of OCD, TAF has emerged as a potential treatment target for obsessive-compulsive disorder (OCD). Previous research has demonstrated that TAF is indeed a malleable construct. This study aims to examine the effects of a multi-session, personalized cognitive bias modification (CBM) for thought-action-fusion (TAF) on improving obsessive-compulsive (OC) symptoms in a college sample. | All participants will be randomized into three groups: 1) CBM-TAF, 2) CBM-SMP (stress management psychoeducation), and 3) WL (waitlist). Participants randomized into either of the training groups (CBM-TAF or CBM-SMP) will complete a total of 6 training sessions (2x/week for 3 weeks), which employ the ambiguous-sentence completion task. To strengthen the training effect, participants will watch brief animated videos about TAF (CBM-TAF) or stress management (CBM-SMP) at the beginning of each session. Participants randomized into the WL group will only complete weekly assessments without any training sessions. All participants will complete pre-, post-training and 1-month follow-up assessments. All training sessions and assessments will be housed on a mobile-based web platform. | Inclusion Criteria:
* A score of 18 or higher on the Dimensional Obsessive-Compulsive Scale (DOCS)
* Aged 18 or higher
* Access to a mobile device (i.e., smartphone)
Exclusion Criteria:
* Self-reported visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen
* Self-reported history of a bipolar disorder or psychotic disorder on a Diagnostic History Scale (DHS)
* Inability to adequately understand the study procedure as determined by the responses to comprehension questions provided at the time of the consent | University of Wisconsin, Milwaukee | OTHER | {
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] | [{"pmid": "11195984", "type": "BACKGROUND", "citation": "Mathews A, Mackintosh B. Induced emotional interpretation bias and anxiety. J Abnorm Psychol. 2000 Nov;109(4):602-15."}, {"pmid": "20230164", "type": "BACKGROUND", "citation": "Abramowitz JS, Deacon BJ, Olatunji BO, Wheaton MG, Berman NC, Losardo D, Timpano KR, McGrath PB, Riemann BC, Adams T, Bjorgvinsson T, Storch EA, Hale LR. Assessment of obsessive-compulsive symptom dimensions: development and evaluation of the Dimensional Obsessive-Compulsive Scale. Psychol Assess. 2010 Mar;22(1):180-98. doi: 10.1037/a0018260."}, {"pmid": "7726811", "type": "BACKGROUND", "citation": "Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u."}, {"pmid": null, "type": "BACKGROUND", "citation": "Shafran R, Thordarson DS, Rachman S. Thought-action fusion in obsessive compulsive disorder. Journal of Anxiety Disorders. 1996; 10(5), 379-391."}, {"pmid": null, "type": "BACKGROUND", "citation": "Siwiec S, Bodhy S, Lotfi S, Lee, HJ. Cognitive bias modification for thought-action fusion: A placebo-controlled randomized experimental trial. Journal of Obsessive-Compulsive and Related Disorders. 2023; 37, 100787."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT00581126 | null | Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B | Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b. | None | INTERVENTIONAL | COMPLETED | 2007-12-21T00:00:00 | null | null | null | [
"PHASE4"
] | 14 | 6 | null | ALL | false | To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B. | Phase IV, open-label, non comparative, multicenter, previously treated patients (PTP) clinical trial. Patients with severe or moderate hemophilia B with baseline levels of plasma factor IX \< 5% activity will participate in this study for both treatment regimens: "on demand" therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( "Short-term therapy")\*.
\* Short-Term Therapy: Prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). This short-term therapy for intermittent secondary therapy. | Inclusion Criteria:
1. Patients with moderate to severe hemophilia B ( \< 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens.
2. HIV seropositive ( asymptomatic) or seronegative subjects.
3. No history or detectable inhibitors. | Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY | {
"id": "3090A-100932",
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NCT04639726 | null | A Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response. | A Randomized, Placebo-Controlled, Single-Center, Crossover Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response in Patients with Type 2 Diabetes. | None | INTERVENTIONAL | COMPLETED | 2020-11-19T00:00:00 | null | 2020-10-26T00:00:00 | 2020-10-26T00:00:00 | [
"NA"
] | 26 | 18 | null | ALL | true | This is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes. | null | Inclusion Criteria:
* Willing and able to sign written informed consent prior to study entry.
* Male or female, \>18 years of age.
* Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a history of type 2 diabetes diagnosis).
* Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
* Patients must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
* Patients must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.
Exclusion Criteria:
* Fasting plasma glucose \>220mg/dl at screening.
* Impaired kidney function, epidermal growth factor receptor of \<60mL/min/1.73m2 at screening.
* BMI \>40kg/m2.
* Elevated liver transaminase \> 3 upper limit of normal at screening.
* Ongoing or recent (i.e. \< 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
* Ongoing or recent (i.e. \< 3month) injectable insulin therapy.
* Ongoing or recent (i.e. \< 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss \>5% within previous 6 months.
* Ongoing or recent (i.e. \< 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
* Major medical/surgical event requiring hospitalization in the last 3 months.
* Known allergy and intolerance to product components or acetaminophen.
* Alcohol intake higher than 2 servings per day. A serving is 0.4dl of strong alcohols, 1dl of red or white wine, or 3dl of beer.
* Are unable to comply with protocol procedures in the opinion of the investigator.
* Have a hierarchical link with the research team members.
* Positive pregnancy test at screening.
* Patients who have been dosed in another clinical trial with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening, or patients currently participating in any investigational trial.
* Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Patients must also agree to not donate blood within 8 weeks after their last visit. | Société des Produits Nestlé (SPN) | INDUSTRY | {
"id": "19.14.CLI",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-11-19T00:00:00 | {
"date": "2024-10-15",
"type": "ACTUAL"
} | {
"date": "2020-11-20",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Dietary Supplement"
] | null | null | [
{
"city": "Tustin",
"country": "United States",
"facility": "Orange County Research Center",
"geoPoint": {
"lat": 33.74585,
"lon": -117.82617
},
"state": "California"
}
] | null | null | {
"other": [
{
"description": null,
"measure": "Plasma glucose",
"timeFrame": "0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes"
},
{
"description": null,
"measure": "Serum insulin",
"timeFrame": "0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes"
},
{
"description": null,
"measure": "Plasma glucagon",
"timeFrame": "0, 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes)"
},
{
"description": null,
"measure": "Plasma glucose",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Serum insulin",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
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"description": null,
"measure": "Plasma glucagon",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Plasma GLP-1",
"timeFrame": "-15, 0, 30, 60, 90, 120 minutes."
},
{
"description": null,
"measure": "Plasma GIP",
"timeFrame": "-15, 0, 30, 60, 90, 120 minutes."
},
{
"description": null,
"measure": "Serum triglycerides",
"timeFrame": "-15, 0, 30, 60, 90, 120 minutes"
},
{
"description": null,
"measure": "Plasma ghrelin",
"timeFrame": "-15, 0, 30, 60, 90, 120 minutes"
},
{
"description": null,
"measure": "Plasma cholecystokinin",
"timeFrame": "-15, 0, 30, 60, 90, 120 minutes"
},
{
"description": null,
"measure": "Plasma peptide",
"timeFrame": "-15, 0, 30, 60, 90, 120 minutes."
}
],
"primary": [
{
"description": null,
"measure": "Post-prandial glycemic excursion.",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
}
],
"secondary": [
{
"description": null,
"measure": "2h post-prandial glucose",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Total glucose",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Plasma glucose",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Plasma glucose",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Plasma glucose",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Serum insulin",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Plasma glucagon",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Plasma Glucagon-like Peptide-1",
"timeFrame": "-30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes."
},
{
"description": null,
"measure": "Plasma Gastric Inhibitory Polypeptide",
"timeFrame": "-15, 0, 30, 60, 90, and 120 minutes."
},
{
"description": null,
"measure": "Plasma ghrelin",
"timeFrame": "-15, 0, 30, 60, 90, and 120 minutes."
},
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"description": null,
"measure": "Plasma cholecystokinin",
"timeFrame": "-15, 0, 30, 60, 90, and 120 minutes."
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"description": null,
"measure": "Plasma peptide",
"timeFrame": "-15, 0, 30, 60, 90, and 120 minutes."
},
{
"description": null,
"measure": "Serum triglycerides",
"timeFrame": "-15, 0, 30, 60, 90, and 120 minutes."
},
{
"description": null,
"measure": "Gastric emptying",
"timeFrame": "-15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes."
},
{
"description": null,
"measure": "Beta-cell function I",
"timeFrame": "-15, 0, 30, 60, 90, and 120 minutes."
},
{
"description": null,
"measure": "Beta-cell function II",
"timeFrame": "-15, 0, 30, 60, 90, and 120 minutes."
}
]
} | [
{
"affiliation": "Orange County Research Center",
"name": "Joel M Neutel, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M7115",
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"asFound": null,
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"relevance": "LOW"
}
],
"meshes": null
} | {
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"browseBranches": [
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"abbrev": "Ot",
"name": "Other Dietary Supplements"
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"id": "T435",
"name": "Whey Protein",
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],
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} | {
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NCT05077826 | null | Enhancing Memory in Mild Cognitive Impairment and Early Stage Alzheimer's Disease | Modern Energetic Methods of Response Improvement (MEMORI) | MEMORI | INTERVENTIONAL | COMPLETED | 2021-09-07T00:00:00 | null | 2023-04-30T00:00:00 | 2023-04-30T00:00:00 | [
"NA"
] | 98 | 50 | 90 | ALL | true | The investigators have developed a low-risk transcranial Electrical Stimulation (tES) treatment that has improved learning and performance in young adults up to nearly 4 times when compared with a sham control. This randomized pilot trial will determine if this same tES protocol improves memory in older adults (50-90 years old) who are healthy, and separately in older adults with mild cognitive impairment (MCI) or early stage Alzheimer's disease (AD). TES will be applied to the right temple and left arm for up to 40 minutes. MRI images, along with other measures, may be obtained before and after tES. If effective, this intervention may help to improve the quality of life for AD patients and their families. | null | Inclusion Criteria:
Inclusion criteria for healthy participants:
1. 50-90 years of age, as verified via photo identification with date of birth.
2. Should be right-handed and learned English by seven years old.
3. Generally healthy
Inclusion criteria for participants with MCI or AD:
1. 50-90 years of age, as verified via photo identification with date of birth.
2. Should be right-handed and learned English by seven years old.
3. Is legally able to sign the consent form on their own behalf, or has a legally authorized representative that is able to sign.
4. Has a caregiver that can assist with taking health history.
Exclusion Criteria:
Exclusion criteria for healthy participants:
1. Significant history of psychiatric disorders or current psychosis including self-report or Geriatric Depression Scale short form score-GDS \>5 if uncertain.
2. Current excessive drug, alcohol or nicotine use defined by participant self-report.
3. History of epilepsy, migraines, severe stroke, or traumatic brain injury.
4. Taking medications with significant psychotropic effects.
5. Severe sensory impairment.
6. Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
7. Severe subjective cognitive concerns.
8. Requires a helper animal.
9. Has sufficient prior experience with neurostimulation that might unblind or alter the results.
10. Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation or be an MRI contraindication, or has any other MRI contraindication.
11. Has sensitivity to components of tES electrodes being used (typically nickel or latex).
12. Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, recent or unusual (for them) loss of taste or smell, congestion or runny nose, nausea or diarrhea.
Exclusion criteria for participants with MCI or AD:
1. Significant history of psychiatric disorders or current psychosis not related to a neurodegenerative condition.
2. Current excessive drug, alcohol or nicotine use.
3. Significant history of epilepsy, stroke, or traumatic brain injury.
4. Taking medications with significant psychotropic effects, not related to neurodegenerative condition
5. Severe sensory impairment
6. Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
7. Requires a helper animal.
8. Has sufficient prior experience with neurostimulation that might unblind or alter the results.
9. Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation.
10. Has sensitivity to components of tES electrodes being used (typically nickel or latex).
11. Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, unusual loss of taste or smell, or unusual (for them) congestion or runny nose, nausea or diarrhea. | The Mind Research Network | OTHER | {
"id": "21-203",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-10-11T00:00:00 | {
"date": "2024-03-13",
"type": "ACTUAL"
} | {
"date": "2021-10-14",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Alzheimer Disease",
"Mild Cognitive Impairment"
] | ["Dementia", "Memory", "Transcranial direct current stimulation (tDCS)", "Magnetic resonance imaging (MRI)"] | null | [
{
"city": "Albuquerque",
"country": "United States",
"facility": "Mind Research Network",
"geoPoint": {
"lat": 35.08449,
"lon": -106.65114
},
"state": "New Mexico"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Learning Task Performance",
"timeFrame": "Within one hour after treatment"
}
],
"secondary": null
} | [
{
"affiliation": "University of New Mexico",
"name": "Vincent Clark, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003704",
"term": "Dementia"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D024801",
"term": "Tauopathies"
},
{
"id": "D019636",
"term": "Neurodegenerative Diseases"
},
{
"id": "D019965",
"term": "Neurocognitive Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
},
{
"id": "D003072",
"term": "Cognition Disorders"
}
],
"browseBranches": [
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"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
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"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
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"id": "M3885",
"name": "Alzheimer Disease",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M6904",
"name": "Dementia",
"relevance": "LOW"
},
{
"asFound": "Mild Cognitive Impairment",
"id": "M29705",
"name": "Cognitive Dysfunction",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M5204",
"name": "Brain Diseases",
"relevance": "LOW"
},
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"asFound": null,
"id": "M5742",
"name": "Central Nervous System Diseases",
"relevance": "LOW"
},
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"name": "Tauopathies",
"relevance": "LOW"
},
{
"asFound": null,
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"name": "Neurodegenerative Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21836",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M4815",
"name": "Mental Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6301",
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"relevance": "LOW"
},
{
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"id": "T2192",
"name": "Familial Alzheimer Disease",
"relevance": "HIGH"
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],
"meshes": [
{
"id": "D000544",
"term": "Alzheimer Disease"
},
{
"id": "D060825",
"term": "Cognitive Dysfunction"
}
]
} | null | {
"conditions": [
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"term": "Alzheimer Disease"
},
{
"id": "D060825",
"term": "Cognitive Dysfunction"
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],
"interventions": null
} |
NCT06492226 | null | Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® | A Single-center, Single-dose, Double-blind, Randomized, Three-period, Three-treatment, Six-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers | None | INTERVENTIONAL | COMPLETED | 2024-07-01T00:00:00 | null | 2024-10-23T00:00:00 | 2024-11-06T00:00:00 | [
"PHASE1"
] | 54 | 18 | 50 | MALE | true | Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® | A single-center, single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® using the euglycemic clamp technique in healthy male adult volunteers | Inclusion Criteria:
1. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the participant
2. Healthy male participants
3. Age between 18 and 50 years, both inclusive
4. Body Mass Index between 18.5 and 29.0 kg/m2, both inclusive
5. Body weight ≥ 50 kg
6. Fasting plasma glucose concentration ≤ 5.5 mmol/L at screening
7. Considered generally healthy upon completion of medical history, physical examination, vital signs, electrocardiogram (ECG), and analysis of laboratory safety variables, as judged by the Investigator
8. Willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.
9. Participants must agree to use condoms during sexual intercourse. Additionally, female partners of male participants should use highly effective contraception. All contraceptive measures apply from screening until 90 days after study
10. Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.
Exclusion Criteria:
1. Positive for human insulin antibodies at Screening
2. Are currently enrolled in or have discontinued within 3 months or 5 half-lives (whichever is longer) of any investigational drug or device or are concurrently enrolled in any other type of medical research study and judged not to be scientifically or medically compatible with this study.
3. Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin.
4. History of diabetes mellitus; episodes of hypoglycemia in the anamnesis; any history of insulin use for treatment purposes.
5. Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin.
6. Have clinically relevant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data.
7. Increased risk of thrombosis, e.g., individuals with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator.
8. Clinically significant abnormal ECG at screening.
9. Glycemia level ≥140.4 mg/dL 2 hours after the glucose load.
10. Show evidence of significant active neuropsychiatric disease.
11. Positive urine drug test at screening and/or evidence of current use of known drugs of abuse or have a history of use within the past year.
12. Show evidence of an acute infection with fever or infectious disease at the time of enrollment.
13. Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening.
14. Have positive test results for hepatitis B surface antigen (HBsAg), immunoglobulin M (IgM) antibody to hepatitis B core antigen (anti-HBc), or hepatitis C virus (HCV) antibodies at screening.
15. Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement).
16. Have donated blood or had a blood loss of 450 mL 3 months prior to study enrollment.
17. Have an average weekly alcohol intake that exceeds 21 units per week or is unwilling to stop alcohol consumption from 48 hours prior to each dosing until being discharged from the CRU. | Xentria, Inc. | INDUSTRY | {
"id": "NKF-INS(A)-101",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-07-01T00:00:00 | {
"date": "2024-12-05",
"type": "ACTUAL"
} | {
"date": "2024-07-09",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Healthy Participants"
] | null | null | [
{
"city": "Bloemfontein",
"country": "South Africa",
"facility": "Xentria Investigative Site",
"geoPoint": {
"lat": -29.12107,
"lon": 26.214
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To compare the PK of NKF-INS(A) to US-approved and EU-authorized insulin aspart to demonstrate PK similarity for insulin aspart.",
"timeFrame": "Day 1 for 12 Hours"
},
{
"description": null,
"measure": "To compare the PK of NKF-INS(A) to US-approved and EU-authorized insulin aspart to demonstrate PK similarity for insulin aspart.",
"timeFrame": "Day 1 for 12 Hours"
},
{
"description": null,
"measure": "To compare the PD of NKF-INS(A) to US-approved and EU-authorized insulin aspart injection by examining GIR profiles after a single SC dose.",
"timeFrame": "Day 1 for 12 Hours"
},
{
"description": null,
"measure": "To compare the PD of NKF-INS(A) to US-approved and EU-authorized insulin aspart injection by examining GIR profiles after a single SC dose.",
"timeFrame": "Day 1 for 12 Hours"
}
],
"secondary": [
{
"description": null,
"measure": "To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart.",
"timeFrame": "Day 1 for 12 Hours"
},
{
"description": null,
"measure": "To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart.",
"timeFrame": "Day 1 for 12 Hours"
},
{
"description": null,
"measure": "To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart.",
"timeFrame": "Day 1 for 12 Hours"
},
{
"description": null,
"measure": "To evaluate additional PK parameters of NKF-INS(A) compared to US-approved and EU-authorized insulin aspart.",
"timeFrame": "Day 1 for 12 Hours"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": [
{
"id": "D007004",
"term": "Hypoglycemic Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
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"abbrev": "Hypo",
"name": "Hypoglycemic Agents"
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],
"browseLeaves": [
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"relevance": "LOW"
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],
"meshes": [
{
"id": "D061267",
"term": "Insulin Aspart"
}
]
} | {
"conditions": null,
"interventions": [
{
"id": "D061267",
"term": "Insulin Aspart"
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]
} |
NCT01907126 | null | HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence | HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence | None | INTERVENTIONAL | COMPLETED | 2013-05-28T00:00:00 | null | null | null | [
"NA"
] | 42 | 18 | null | FEMALE | false | The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of delivering the enhanced Women's Coop and nutrition control interventions. Per recent guidance from NIMH, the investigators will also examine 95% confidence intervals around differences between the proposed intervention and a dose-matched control condition (Nutrition Program), for the following outcomes through 8 months post prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of PTSD and depression, and drug using/heavy drinking days (secondary); and increased affect management and social support (including effectiveness in obtaining substance use, mental health treatment and other resources) (tertiary). | null | Inclusion Criteria:
* Females in prison
* Experienced lifetime interpersonal violence (includes physical or sexual assault or abuse)
* At least one unprotected sexual occasion with a male partner within the 90 days prior to incarceration
* Approximately 6-10 weeks before release
* Expect to be released to locations within RI or MA
Exclusion criteria:
* Cannot complete intake interview due to problems with reality testing, brain impairment, or language barrier | Brown University | OTHER | {
"id": "R34MH094188",
"link": "https://reporter.nih.gov/quickSearch/R34MH094188",
"type": "NIH"
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-07-22T00:00:00 | {
"date": "2025-03-20",
"type": "ACTUAL"
} | {
"date": "2013-07-24",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Unsafe Sex",
"Physical Violence",
"Sexual Assault",
"Sexual Abuse"
] | ["HIV", "Sexually transmitted infections", "Sexual abuse", "Physical abuse", "Women", "Prison"] | null | [
{
"city": "Framingham",
"country": "United States",
"facility": "Massachusetts CorrectionalInstitution - Framingham",
"geoPoint": {
"lat": 42.27926,
"lon": -71.41617
},
"state": "Massachusetts"
},
{
"city": "Framingham",
"country": "United States",
"facility": "South Middlesex CorrectionalCenter",
"geoPoint": {
"lat": 42.27926,
"lon": -71.41617
},
"state": "Massachusetts"
},
{
"city": "Cranston",
"country": "United States",
"facility": "Adult Correctional Institution",
"geoPoint": {
"lat": 41.77982,
"lon": -71.43728
},
"state": "Rhode Island"
}
] | [
{
"class": "NIH",
"name": "National Institute of Mental Health (NIMH)"
}
] | null | {
"other": [
{
"description": null,
"measure": "Affect Management",
"timeFrame": "Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release"
},
{
"description": null,
"measure": "Perceived Social Support",
"timeFrame": "Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release"
},
{
"description": null,
"measure": "Effectiveness in Obtaining Resources (EOR) and Treatment Received",
"timeFrame": "Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release"
}
],
"primary": [
{
"description": null,
"measure": "Number of Unprotected Sexual Occasions (USOs; Vaginal and Anal)",
"timeFrame": "Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release"
},
{
"description": null,
"measure": "Presence of Trichomoniasis",
"timeFrame": "Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release"
},
{
"description": null,
"measure": "Treatment Acceptability",
"timeFrame": "2 months post release"
},
{
"description": null,
"measure": "Treatment Feasibility",
"timeFrame": "2 months post release"
}
],
"secondary": [
{
"description": null,
"measure": "Interpersonal violence (IPV) episodes",
"timeFrame": "Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release"
},
{
"description": null,
"measure": "PTSD Symptom Severity",
"timeFrame": "Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release"
},
{
"description": null,
"measure": "Depressive Symptom Severity",
"timeFrame": "Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release"
},
{
"description": null,
"measure": "Post Release Drug Using/Heavy Drinking Days",
"timeFrame": "Slope over time: 2 months after release, 5 months after release, 8 months after release"
}
]
} | [
{
"affiliation": "Brown University",
"name": "Jennifer E Johnson, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29954877", "type": "DERIVED", "citation": "Kuo CC, Rosen RK, Zlotnick C, Wechsberg WM, Peabody M, Johnson JE. Sexual health prevention for incarcerated women: eroticising safe sex during re-entry to the community. BMJ Sex Reprod Health. 2018 Jun 28:bmjsrh-2017-200024. doi: 10.1136/bmjsrh-2017-200024. Online ahead of print."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18250",
"name": "HIV Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15558",
"name": "Sexually Transmitted Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M3522",
"name": "Acquired Immunodeficiency Syndrome",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
"interventions": null
} |
NCT05034926 | null | A Study of Nivolumab in Participants With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology After Prior Chemotherapy Treated in Real World Settings in Greece and Cyprus | A Multinational, Non-Interventional, Prospective Study of Nivolumab (BMS-936558) in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology After Prior Chemotherapy Treated in Real World Settings in Greece and Cyprus - The 'Lucence' Study | LUCENCE | OBSERVATIONAL | ACTIVE_NOT_RECRUITING | 2021-08-16T00:00:00 | null | 2025-09-15T00:00:00 | 2025-09-15T00:00:00 | null | 350 | 18 | null | ALL | false | The purpose of this observational study is to estimate the overall survival (OS) rates in the overall study population treated with nivolumab in the second and third line setting in real world clinical practice in Greece and Cyprus. The study is descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis. | null | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Male or female adult Greek-speaking patients, of any race (residing in Greece or Cyprus), aged at least 18 years at time of initiation of nivolumab treatment.
* Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic (stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) with Squamous Cell Carcinoma (SCC) or Non-Squamous Cell Carcinoma (NSCC) histological subtype
* Initiated on second or third line treatment with nivolumab as monotherapy after prior chemotherapy as per the product's Summary of Product Characteristics (SmPC) prior to informed consent obtainment, and for whom therapy is ongoing and no more than one infusion has been administered from treatment initiation to obtaining the signed informed consent
* Decision to prescribe nivolumab treatment has been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study
* Provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study
Exclusion Criteria:
* Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
* Previously treated with nivolumab or other non-chemotherapy agents, with the exception of immune checkpoint inhibitors (anti-PD-1(Programmed cell death-1)/anti-PD-L1 (Programmed death-ligand 1) agent, other than nivolumab) administered in combination with chemotherapy
* Currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to nivolumab therapy initiation | Bristol-Myers Squibb | INDUSTRY | {
"id": "CA209-7U9",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-08-31T00:00:00 | {
"date": "2023-02-24",
"type": "ACTUAL"
} | {
"date": "2021-09-05",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | A total of 350 locally advanced/metastatic NSCLC patients who are eligible for participation in the study according to the inclusion and exclusion criteria are planned to be enrolled over a 24-month recruitment period by approximately 27 lung cancer specialists practicing in the public or private healthcare sector throughout Greece and Cyprus.
Patients treated with nivolumab in the second and third line setting in real world clinical practice and who are eligible. | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Non-Small Cell Lung Cancer"
] | ["BMS-936558", "Greece", "Cyprus", "Locally advanced", "Metastatic NSCLC", "Nivolumab", "OPDIVO\u00ae", "Prospective Study", "Stage IIIb/IV", "2nd line treatment", "3rd line treatment", "Observational study", "LUCENCE study"] | null | [
{
"city": "Athens",
"country": "Greece",
"facility": "Local Institution - 0001",
"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint of 12 months after the initiation of nivolumab treatment, in the overall study population",
"timeFrame": "Up to 12 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint of 24 months after the initiation of nivolumab treatment, in the overall study population",
"timeFrame": "Up to 24 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint of 36 months after the initiation of nivolumab treatment, in the overall study population",
"timeFrame": "Up to 36 months"
}
],
"secondary": [
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Squamous Cell Carcinoma (SCC) subpopulation",
"timeFrame": "Up to 12 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the SCC subpopulation",
"timeFrame": "Up to 24 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the SCC subpopulation",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment, among the Non-Squamous Cell Carcinoma (NSCC) subpopulation",
"timeFrame": "Up to 12 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment, among the NSCC subpopulation",
"timeFrame": "Up to 24 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment, among the NSCC subpopulation",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 12 months after the initiation of nivolumab treatment per line of nivolumab treatment",
"timeFrame": "Up to 12 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 24 months after the initiation of nivolumab treatment per line of nivolumab treatment",
"timeFrame": "Up to 24 months"
},
{
"description": null,
"measure": "Proportion of participants surviving at the landmark timepoint 36 months after the initiation of nivolumab treatment per line of nivolumab treatment",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Proportion of participants who have not progressed or died from any cause at the landmark timepoint 12 months after the initiation of nivolumab treatment",
"timeFrame": "Up to 12 months"
},
{
"description": null,
"measure": "Proportion of participants who have not progressed or died from any cause at the landmark timepoint 24 months after the initiation of nivolumab treatment",
"timeFrame": "Up to 24 months"
},
{
"description": null,
"measure": "Proportion of participants who have not progressed or died from any cause at the landmark timepoint 36 months after the initiation of nivolumab treatment",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Proportion of participants with an investigator-assessed best overall response (BOR) of either a confirmed complete response (CR) or confirmed PR (ORR rate) at the landmark timepoint of 12 months after the initiation of nivolumab treatment",
"timeFrame": "Up to 12 months"
},
{
"description": null,
"measure": "Proportion of participants with an investigator-assessed BOR of confirmed CR or PR or stable disease (SD) (DCR rate), at the landmark timepoint of 12 months after the initiation of nivolumab treatment",
"timeFrame": "Up to 12 months"
},
{
"description": null,
"measure": "Time from start of nivolumab treatment to the first documented investigator-assessed response (CR or PR) (i.e., TTR), among participants who achieved at least PR",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Time from start of nivolumab treatment to best response (e.g., if a participant had both PR and CR, time to CR), among participants who achieved at least PR",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Kaplan-Meier estimated median time from first documented response (CR or PR) to the date of first documented progression or death (due to any cause in the absence of progression), among participants who achieved at least PR (i.e., DoR)",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Kaplan-Meier estimated median time from best response (e.g., if a patient had both PR and CR, time from CR) to the date of first documented progression or death (due to any cause in the absence of progression), among patients who achieved at least PR",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Frequencies of baseline participant and disease characteristics of interest",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of associations of baseline participant and disease characteristics with survival at 36 months post-treatment initiation",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Distribution of the number of nivolumab doses administered",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of the rate of dose modifications (including dose delays/withholdings)",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of the rate of permanent treatment discontinuation",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of the frequencies of reasons for dose modifications/discontinuations",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of the types and frequencies of next treatment planned to be administered for NSCLC after nivolumab discontinuation",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Kaplan-Meier estimated time from nivolumab treatment initiation until discontinuation due to any reason",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of exposure-adjusted incidence rate (EAIR), severity (grade), and management of the specified types of treatment-related AEs in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Time to onset of high-grade (Grade 3 or higher) immune-related adverse events (irAEs) per AE category",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Time to resolution of high-grade (Grade 3 or higher) irAEs per AE category",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Incidence of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of type of adverse events leading to nivolumab treatment permanent discontinuation, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Change in the total LCSS score in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Change in the total ASBI score throughout the study observation period examined using longitudinal analysis",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Change in the total Average Symptom Burden Index (ASBI) score, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Change in the individual domain scores from baseline to each post-baseline predefined timepoint in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Symptom improvement rate, at the post-baseline predefined timepoints, using the Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI), in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Change in the EuroQol (EQ-5D) utility index score, from baseline at the post-baseline predefined timepoints, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Change in the EuroQol Visual Analogue Scale (EQ-VAS) score, from baseline at the post-baseline predefined timepoints, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Change in the proportion of participants in the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) dimension levels (no problems, with problems) from baseline at the post-baseline predefined timepoints",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of Person-time incidence rate (per 100 participant-weeks) of inpatient hospitalizations for the management of treatment-related AEs, during the entire study observation period, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of Emergency room attendances for the management of treatment-related AEs, during the entire study observation period, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of Hospital outpatient visits for the management of treatment-related AEs, during the entire study observation period, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of Visits at office-based physicians for the management of treatment-related AEs, during the entire study observation period, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of Home visits by physicians, during the entire study observation period, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of Length of hospital stay, during the entire study observation period, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of Types and frequencies of medical procedures/interventions/diagnostic testing utilization, during the entire study observation period, in the overall study population",
"timeFrame": "Up to approximately 59 months"
},
{
"description": null,
"measure": "Distribution of Prescribed medications for the management of treatment-related AEs, during the entire study observation period, in the overall study population",
"timeFrame": "Up to approximately 59 months"
}
]
} | [
{
"affiliation": "Bristol-Myers Squibb",
"name": "Bristol-Myers Squibb",
"role": "STUDY_DIRECTOR"
}
] | 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": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Lung Cancer",
"id": "M11172",
"name": "Lung Neoplasms",
"relevance": "HIGH"
},
{
"asFound": "Non-small Cell Lung Cancer",
"id": "M5546",
"name": "Carcinoma, Non-Small-Cell Lung",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5534",
"name": "Carcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14979",
"name": "Respiratory Tract Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16658",
"name": "Thoracic Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11168",
"name": "Lung Diseases",
"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": null,
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M1854",
"name": "Nivolumab",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D008175",
"term": "Lung Neoplasms"
},
{
"id": "D002289",
"term": "Carcinoma, Non-Small-Cell Lung"
}
],
"interventions": []
} |
NCT05558826 | null | Pressure Analysis of Trendelenburg Position Effect on Indices From Arterial Pressure | Analysis of Intra-abdominal Pressure and Trendelenburg Position Effect on Dynamic Indices of Arterial Pressure Waveform | None | OBSERVATIONAL | UNKNOWN | 2022-09-25T00:00:00 | null | 2023-10-01T00:00:00 | 2024-10-01T00:00:00 | null | 100 | 20 | 80 | ALL | null | Intraoperative fluid management is key component of care for patients undergoing surgery. Hypovolemia and hypervolemia both associate with increased morbidity, length of stay in the intensive care unit and mortality. Thus, maintaining adequate intravascular volume yet avoiding fluid overload is crucial to achieve optimal outcomes. Goal-directed fluid therapy based on arterial pressure waveform analysis is widely used for intraoperative fluid management and have been shown to improve surgical outcomes compared with conventional clinical assessment in several studies. However, dynamic indices of arterial pressure waveform analysis such as pulse pressure variation (PPV) and stroke volume variation (SVV) are altered by certain situations including elevated intra-abdominal pressure and Trendelenburg position. Intravascular fluid status might thus be misinterpreted. Carbon dioxide pneumoperitoneum with increased intra-abdominal pressure and Trendelenburg position are commonly seen in laparoscopic surgeries including colorectal, gynecological, and genitourinary procedures. Understanding how dynamic indices change in these clinical situations are essential for achieving appropriate intraoperative fluid management. This study focus on identifying the effects of different levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform. | In this prospective observational study, the investigators will enroll 100 patients undergoing laparoscopic surgery for medical reason. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from standard monitoring instruments, including electrocardiography, photo-plethysmography , blood pressure, neurological system information (Bispectral index and Density spectral array ), the respiratory gas monitoring (gas analyzer and respiratory waveform) and dynamic indices of arterial pressure waveform analysis (cardiac index, stroke volume variation, pulse pressure variation, hypotension prediction index... etc.) from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences) every 20 seconds.
After anesthesia induction as routine clinical practice, slow IV fluid infusion will be maintained. The patient will be placed in Trendelnburg position with different angles ranging from 0-25 degree. CO2 pneumoperitoneum will be created by surgeons for laparoscopic surgery. Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded. The recording is ended after emergence when surgery ends. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform. Methods including signal processing, modeling, classification will be used. | Inclusion Criteria:
* Patients aged between 20 and 80
* Scheduled for laparoscopic surgery
* American Society of Anesthesiologists (ASA) physical status I to III.
Exclusion Criteria:
* Neurologic or behavioral disorders
* American Society of Anesthesiologists (ASA) physical status ≥ IV
* History of arrhythmia
* Drug abuse or alcoholism
* Resting room air SpO2 \< 90%. | Taipei Veterans General Hospital, Taiwan | OTHER_GOV | {
"id": "2022-04-002AC",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-09-25T00:00:00 | {
"date": "2022-09-28",
"type": "ACTUAL"
} | {
"date": "2022-09-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | The investigators plan to enroll patients who will laparoscopic surgery under general anesthesia. These patients will be screened for eligibility. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Anesthesia",
"Fluid and Electrolyte Imbalance",
"Hemodynamic Instability"
] | ["Goal directed fluid therapy", "Arterial waveform analysis", "Pneumoperitoneum", "Trendelenburg position"] | null | [
{
"city": "Taipei",
"country": "Taiwan",
"facility": "Taipei Veterans General Hospital",
"geoPoint": {
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"lon": 121.53185
},
"state": null
}
] | null | null | {
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{
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"measure": "Stroke volume variation (SVV)",
"timeFrame": "Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends"
},
{
"description": null,
"measure": "Pulse pressure variation (PPV)",
"timeFrame": "Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends"
},
{
"description": null,
"measure": "Hypotension Prediction Index (HPI)",
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},
{
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"measure": "Dynamic arterial elastance (Eadyn)",
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},
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"measure": "dP/dt",
"timeFrame": "Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends"
}
],
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"measure": "Bispectral index (BIS) value",
"timeFrame": "BIS monitor are recorded starting from anesthesia induction, and stopped after emergence when surgery ends"
}
]
} | [
{
"affiliation": "Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan",
"name": "Chien-Kun Ting, MD.PhD",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "34916049", "type": "BACKGROUND", "citation": "Jessen MK, Vallentin MF, Holmberg MJ, Bolther M, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Lind PC, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Hoybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Paelestik K, Granfeldt A, Andersen LW. Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Mar;128(3):416-433. doi: 10.1016/j.bja.2021.10.046. Epub 2021 Dec 13."}, {"pmid": "32960954", "type": "BACKGROUND", "citation": "Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557."}, {"pmid": "25558337", "type": "BACKGROUND", "citation": "Min JH, Lee SE, Lee HS, Chae YK, Lee YK, Kang Y, Je UJ. The correlation between the Trendelenburg position and the stroke volume variation. Korean J Anesthesiol. 2014 Dec;67(6):378-83. doi: 10.4097/kjae.2014.67.6.378. Epub 2014 Dec 29."}, {"pmid": "30896602", "type": "BACKGROUND", "citation": "Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121."}, {"pmid": "21457517", "type": "BACKGROUND", "citation": "Tavernier B, Robin E. Assessment of fluid responsiveness during increased intra-abdominal pressure: keep the indices, but change the thresholds. Crit Care. 2011;15(2):134. doi: 10.1186/cc10074. Epub 2011 Mar 18."}] | {"versionHolder": "2025-06-18"} | {
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NCT00276926 | null | Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias | Open Label Pilot Phase II Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias | None | INTERVENTIONAL | UNKNOWN | 2006-01-12T00:00:00 | null | null | null | [
"PHASE2"
] | null | 18 | null | ALL | false | The purpose of this study is to assess the clinical anti-proliferative activity of STI571 (Glivec®, Novartis, Pharma) in patients with HES defined as:
1. Idiopathic Hypereosinophilic Syndrome (secondary HES), defined as a peripheral blood eosinophilia greater than 1,500 cells/µL for longer than 6 months, absence of other apparent aetiologies for eosinophilia and with or without signs and symptoms of organ involvement, irrespective to expression of any of imatinib targets (c-Kit receptor, PDGFR, bcr-abl receptor) on bone marrow cells.
2. Familiar hypereosinophilia defined as a peripheral blood eosinophilia greater than 1,500 cells/µL for longer than 6 months, absence of other apparent aetiologies for eosinophilia and signs and symptoms of organ involvement, irrespective to expression of any of imatinib targets (c-Kit receptor, PDGFR, bcr-abl receptor) on bone marrow cells, and with a recognized or reported cases of hypereosinophilia in the patient's family.
3. Chronic myeloproliferative disorder, defined as chronic eosinophilic leukemia (CEL) with the presence of blasts (\>10%) in the bone marrow (BM), or the presence of immature eosinophils in different tissues, or an aggressive clinical course or the presence of clonal cytogenetic anomalies.
4. Myeloproliferative disorder (MPD) with eosinophilia, eosinophilic leukemia or chronic myelomonocytic leukemia \[myeloproliferative disorders/myelodysplastic syndromes (MPD/MDS)\] with evidence of:
* t(5;12)(q33;p13) by cytogenetic or fluorescent in situ hybridization (FISH) analysis, or
* ETV6/TEL-PDGFRB fusion transcript by reverse transcription polymerase chain reaction (RT-PCR), or
* PDGFRB disruption, assessed or suspected, by other translocations with additional partner genes (H4, HIP1, CEV14 and Rab5) 5, or
* MPD/MDS who have constitutive activation of the gene for platelet-derived growth factor receptor beta (PDGFRB) 6 by point mutations | null | Inclusion Criteria:
1. Presence of primary or secondary HES
2. Not a candidate for allogeneic bone marrow transplantation.
3. ECOG performance score of 0, 1, 2 or 3 (Karnofsky performance score \> 40%).
4. Life expectancy \> 4 weeks.
5. Adequate hepatic and renal function, as defined by serum transaminases \< 2.5x upper limits of normal (ULN), bilirubin \< 1.5x ULN, and creatinine \< 1.5x ULN.
6. Age 18 years or greater.
7. Post-menopausal, surgically sterile, or taking effective contraception in female patients.
8. Documentation of written informed consent to participate in the trial.
9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment:
1. Patients with clear evidence of secondary hypereosinophilia.
2. Acute myeloblastic leukemia with inv(16) positive blast or
3. CBFb-MYH11 transcripts positive leukemia
4. Lack of recovery from the acute toxic effects of previous chemotherapy \[to common toxicity criteria (CTC) grade \> 1\] with the exception of chemotherapy-induced alopecia.
5. Treatment with any investigational agent within 4 weeks prior to study therapy.
6. Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
7. Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to
8. Presence of central nervous system (CNS) illness and involvement of disease.
9. Active uncontrolled bacterial infection.
10. Known human immunodeficiency virus (HIV) infection.
11. Grade 3 or 4 bleeding.
12. Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months. Due to the low cardiac toxicity profile of Glivec, it is not considered an exclusion criterion if the presence of severe complications to the viscera, among which cardiopathies, and in particular endomyocardial fibrosis, is due or considered to be due to HES.
13. Increased blood eosinophil counts due to the presence of physician-diagnosed asthma. However, due to low pulmonary toxicity profile of Glivec, it is not considered an exclusion criterion, if HES is associated with asthma, and the presence of severe complications damaging the lungs, are considered due to HES.
14. Pregnancy or breast-feeding.
15. Malabsorption syndromes | University of Bologna | OTHER | {
"id": "HES0203",
"link": null,
"type": null
} | Unknown | {
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} | 2006-01-12T00:00:00 | {
"date": "2009-09-15",
"type": "ESTIMATED"
} | {
"date": "2006-01-13",
"type": "ESTIMATED"
} | [
"ADULT",
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} | [
"Hypereosinophilic Syndrome",
"Chronic Eosinophilic Leukemia (CEL)",
"Myeloproliferative Disorders"
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] | [
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NCT04503226 | null | Deep Learning Applied to Plain Abdominal Radiographic Surveillance After Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA) | Deep Learning Applied to Plain Abdominal Radiographic Surveillance After Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA) | DeepLearn | OBSERVATIONAL | UNKNOWN | 2020-08-04T00:00:00 | null | 2020-10-15T00:00:00 | 2020-12-31T00:00:00 | null | 800 | null | null | ALL | false | Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA). | Abdominal aortic aneurysm (AAA) is a condition in which the abdominal aorta, a large artery, dilates gradually, secondary to a degenerative process within its wall. This can lead to rupture of the weakened wall with subsequent exsanguination into the abdomen. This scenario is usually fatal. The diameter of the aneurysm positively correlates with the risk of rupture. Aneurysm size is therefore the primary determinant when considering whether or not to electively repair AAAs.
Endovascular aneurysm repair (EVAR) has become the standard treatment for AAAs in the vast majority of patients. It is a minimally invasive technique that aims to exclude the aneurysm from the circulation by placement of a synthetic "stent-graft" within the aortic lumen. Metallic barbs as well as radial force maintain stent-graft position in non-aneurysmal aorta above the aneurysm as well as in the iliac arteries below the aneurysm.
Level 1 evidence has consistently demonstrated improved perioperative survival with EVAR as compared to traditional open surgery. However, there are concerns regarding the long-term durability of EVAR stent-grafts, with 1 in 5 patients requiring further surgery to the aneurysm in the 5 years after the operation. This is often due to failure of the position and integrity of the stent-graft. Therefore, standard international practice is to keep patients are life-long surveillance after EVAR. This is usually in the form of plain radiographs in combination with either computerised tomography (CT) or duplex ultrasound scans, all performed on an annual basis.
Stent-grafts are visible on plain radiographs of the abdomen and by comparing series of images taken over time, it is possible to diagnose a myriad of stent-graft problems including migration, disintegration and distortion. But these changes can be subtle on plain radiographs and difficult to spot, even to the most trained human eye. As a result, patients undergo more detailed scans that unfortunately carry a risk of nephrotoxicity and radiation-induced malignancy.
The aim of our research is to improve the diagnostic potential of plain radiographs by applying modern deep learning computer algorithms for interpretation.
Artificial intelligence (AI) in the form of deep learning has shown great success in recent years on numerous challenging problems. The success of deep learning is largely underpinned by advances in powerful graphics processing units (GPUs). GPUs enable us to speed up training algorithms by orders of magnitude, bringing run-times of weeks down to days.
Our study will explore the use of artificial intelligence in interpreting series of anonymised plain radiographs to identify features of a failing stent-graft.
A deep-learning algorithm will be applied to post-EVAR plain radiographs that have already been performed at our institution in England over the last 10 years. We will then compare the effectiveness of the machine in identifying stent-graft related problems to the known outcomes identified by human interpretation previously.
This project will rely on recent advances in deep learning techniques. It is expected that deep learning will bring good performance for EVAR surveillance in line with its successful application in domains such as the recognition of digits, Chinese characters, and traffic signs where computers have produced better accuracy than humans. | Inclusion Criteria:
* Patients who have undergone EVAR at the Royal Liverpool University Hospital between 2005 and 2013.
* Patients who were treated for standard infra-renal AAAs.
* Patients who are on our post-operative surveillance programme and have had 5 plain abdominal radiographs to date.
Exclusion Criteria:
* None | Liverpool University Hospitals NHS Foundation Trust | OTHER_GOV | {
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NCT05352126 | null | Effects of Puressentiel Purifying Spray on Asthma Control in Patients With Mild to Moderate Allergy-induced Asthma. | Effects of Repeated Sprays of an Air Purifying Spray Containing Essential Oils in an Indoor Environment on Asthma Control in Patients With Mild to Moderate Allergy-induced Asthma. | PSIndAC | INTERVENTIONAL | UNKNOWN | 2022-04-22T00:00:00 | null | null | null | [
"NA"
] | 80 | 18 | 80 | ALL | false | The main objective of this study is to evaluate, in real life, the efficacy of prolonged use (6 months) of Puressentiel Air Purifying Spray with 41 essential oils on the control of allergy-induced asthma in the homes of patients with mild to moderate asthma. This will be performed by evaluating the efficacy of prolonged use (6 months) in the indoor environment on the exacerbation and the symptoms of asthma in patients with mild to moderate asthma. The tolerance of the study patients to spraying in an indoor environment will also be analysed. | At the inclusion visit (V1), the number of exacerbations requiring oral corticosteroids, and asthma treatments (base and rescue medication) during the previous 12 months are collected.
An Asthma Control Test (ACT) for self-assessment is given to the patient. This questionnaire (Appendix 1) contains 5 questions related to asthma symptoms and their frequency as well as the rescue medication used in the previous 4 weeks. The ACT score ranges from 5 (most badly controlled) to 25 (fully controlled asthma). The threshold for controlled asthma is 20, with a lower score indicating uncontrolled asthma. (14).
Vials of Puressentiel Air Purifying Spray with 41 essential oils or weighed identical placebo bottles are given to the patient according to the randomisation period that he/she has been assigned to. The patient is asked to spray in 2 corners of the bedroom (at bedtime (2/D) for 6 months). A telephone visit will be carried out by the CRA of the study at 3 months (see telephone visit). At the end of the 6 months, the subject is reviewed (V2) and will bring back the used spray bottles which will be weighed to assess compliance. In a second Asthma Control Test (ACT), the number of exacerbations, during the 6 months of use of Puressentiel Air Purifying Spray with 41 essential oils or the placebo is collected. Bottles of placebo air spray or Puressentiel Air Purifying Spray with 41 essential oils are given to the patient according to the randomisation period that he/she has been assigned to during the first visit (V1).
The patient is seen again 6 months later (V3), during which time he/she will use the placebo spray or Puressentiel Air Purifier Spray with 41 essential oils, one spray in 2 corners of the bedroom (i.e. 2 sprays in total) in the evening (2/D). A second Asthma Control Test (ACT) is performed and the number of exacerbations over the 6 months is collected. A telephone visit will be carried out by the CRA of the study at 9 months (see telephone visit).
If the patient has been randomised to receive the placebo spray during the first six-month period, he/she will use Puressentiel Air Purifying Spray with 41 essential oils during the second six-month period. | Inclusion Criteria:
* • Mild to moderate asthma patients with or without rhinitis who were diagnosed with asthma at least one year beforehand. At least partially controlled (16≥ACT≥23)
* Patients who are allergic to one allergen per year and/or season (proof of prick tests or specific IgE).
* Patients who are over 18 years old.
* Patients who have read and signed the informed consent form
* Patients who are affiliated to the social security regime
Exclusion Criteria:
* • Patients who have had a viral infection in the month prior to inclusion
* Patients with uncontrolled asthma.
* Pregnant or breastfeeding women.
* People with a history of seizure disorders, or epilepsy
* People with allergies to any of the components of the product
* Patients with comprehension difficulties
* Patients who cannot be monitored throughout the entire period | Puressentiel | INDUSTRY | {
"id": "Prof. Pascal Demoly",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
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} | 2022-04-22T00:00:00 | {
"date": "2022-04-28",
"type": "ACTUAL"
} | {
"date": "2022-04-28",
"type": "ACTUAL"
} | [
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] | null | null | false | {
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"timeFrame": "6 months"
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],
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"description": null,
"measure": "Exacerbation of asthma",
"timeFrame": "6 months"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"term": "Bronchial Diseases"
},
{
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"term": "Lung Diseases, Obstructive"
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"term": "Lung Diseases"
},
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"term": "Respiratory Hypersensitivity"
},
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"term": "Hypersensitivity, Immediate"
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"term": "Hypersensitivity"
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],
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"relevance": "LOW"
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{
"id": "D001249",
"term": "Asthma"
}
]
} | {
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"term": "Anti-Infective Agents"
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"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
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NCT00647426 | null | Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC | A Phase II Study of Sorafenib in Combination With Carboplatin and Docetaxel in the First Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer | None | INTERVENTIONAL | COMPLETED | 2008-03-25T00:00:00 | null | null | null | [
"PHASE2"
] | 7 | 18 | null | ALL | false | This is an open-label, single institution, phase II study of Sorafenib in combination with docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib twice a day on the 1st day of treatment and continue to take the medication every day until progression of disease, prohibitive toxicity, or patient withdrawal from the study. Chemotherapy courses will repeat every 21 days in the absence of disease progression or unacceptable toxicity for a total of four cycles. | Patients will be monitored after every two cycles (6 weeks) for tumor response, stability, or progression by radiographic imaging studies. The primary goal of this study is to determine the clinical response rate of this regimen in patients with advanced lung cancer. Secondary endpoints include time to progression, overall survival, and toxicity. Blood levels of ERK-phosphorylation, activated caspase 3, cyclin D1, anti -cIAP2, p-Akt, and Mcl1 activity will be measured at the beginning, middle and end of therapy to help identify predictors of drug response and toxicity during the first cycle of treatment. | Inclusion Criteria:
* Histologically or cytologically confirmed NSCLC with clinical or radiological evidence of advanced disease (Stage IIIB/IV)
* Uni-dimensionally measurable disease
* Age =\> 18 years
* ECOG performance status of 0-1
* Life expectancy \> 3 months
Exclusion Criteria:
* Small-cell or mixed histologies including a small cell component
* Prior chemotherapy, biotherapy, radiotherapy to an area of measurable disease
* Patients with peripheral neuropathy grade =\> 2 | Abramson Cancer Center at Penn Medicine | OTHER | {
"id": "UPCC 12506",
"link": null,
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"nctId": null,
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"date": "2019-10-22",
"type": "ACTUAL"
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"type": "ESTIMATED"
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} | [
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"facility": "Abramson Cancer Center of University of Pennsylvania",
"geoPoint": {
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"lon": -75.16379
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"state": "Pennsylvania"
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"measure": "The Number of Patients With Stage IIIB/IV NSCLC Response Rate to the Combination Therapy of Sorafenib and Docetaxel/Carboplatin",
"timeFrame": "30 months"
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],
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"description": null,
"measure": "Number of Participants the Progression-free Survival (PFS) .",
"timeFrame": "30 months"
},
{
"description": null,
"measure": "Number of Participants With Serious Adverse Events",
"timeFrame": "30 months"
},
{
"description": null,
"measure": "The Number of Participants With Biomarkers of Sorafenib Activity and Toxicity",
"timeFrame": "30 months"
}
]
} | [
{
"affiliation": "University of Pennsylvania",
"name": "Tracey Evans, MD",
"role": "PRINCIPAL_INVESTIGATOR"
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] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Respiratory Tract Neoplasms"
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"term": "Neoplasms by Site"
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},
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NCT00747526 | null | A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive | A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects With GERD 1 to 11 Months Old, Inclusive | None | INTERVENTIONAL | COMPLETED | 2008-09-04T00:00:00 | null | null | null | [
"PHASE1"
] | 51 | 1 | 11 | ALL | false | The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time), pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after single and multiple daily administration in infants between the ages of 1 and 11 months, inclusive, with Gastroesophageal Reflux Disease (GERD). | This is an open-label (both physician and patient know the name of the study medication), multicenter, Phase I study, consisting of 2 parts. The first part of the study will be nonrandomized (study drug is intentionally assigned), and all patients will receive the same dose. In the second part of the study, patients will be randomized (study medication assigned by chance) into 2 dose groups. The purpose of the study is to evaluate the pharmacokinetics (PK), pharmacodynamics (intraesophageal/intragastric pH, clinical global impression, formulation palatability and Gastroesophageal Reflux Disease (GERD) daily symptom diary) and safety of rabeprazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 and 11 months, inclusive (up to 11 months 29 days), with GERD. As this study is an exploratory assessment of the PK, pharmacodynamics and safety of rabeprazole in children, no formal hypothesis testing is applied. Safety and tolerability, including monitoring of adverse events, clinical laboratory results, physical examination, vital signs and electrocardiogram measurements (the measuring of the electrical currents in the heart), will be evaluated throughout the study. Patients will receive rabeprazole sodium as single daily oral doses for 5 successive days (Option 1), or up to 14 successive days (10 days minimum) (Option 2) as a bead formulation. In Part 1, patients will receive single and multiple daily (every 24 hours) doses of 0.5 mg/kg, using increments of 1 mg dose. Safety and PK data from Part 1 of the study will determine the 2 dosages to be studied in Part 2 of the study. In Part 2, patients may receive rabeprazole sodium as single daily oral doses for up to a maximum of 28 consecutive days as a bead formulation. Patients will be randomized into either the 5 mg dose or 10 mg dose group. | Inclusion Criteria:
* Minimum weight of 5 kg (treatment Option 1) or 3 kg (treatment Option 2) with a diagnosis of GERD
* Informed consent signed by at least one parent
* Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2 blockers, or antacids are eligible (as long as they can go off antacids for 24 hours, and PPIs and H2 blockers for three days prior to dosing, except for cimetidine, which must be discontinued for at least seven days prior to dosing) and remain off these medications for the treatment period
Exclusion Criteria:
* Patients who have history of or current clinically significant medical illness (excluding GERD) including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results
* Primary pulmonary or ears, nose, and throat (ENT) symptoms
* History of or current presence of peptic ulcers
* Presence of "warning signals", suggesting cause of vomiting/regurgitation other than GERD
* Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study | Janssen Research & Development, LLC | INDUSTRY | {
"id": "CR013948",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-09-04T00:00:00 | {
"date": "2013-07-08",
"type": "ESTIMATED"
} | {
"date": "2008-09-05",
"type": "ESTIMATED"
} | [
"CHILD"
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"maskingInfo": {
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"primaryPurpose": "TREATMENT",
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} | [
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] | ["Gastroesophageal Reflux Disease (GERD)", "Pediatrics", "Pharmacokinetics", "Pharmacodynamics", "Rabeprazole", "GERD", "Aciphex"] | null | [
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NCT06259526 | null | A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression | None | INTERVENTIONAL | COMPLETED | 2024-02-06T00:00:00 | null | 2024-10-23T00:00:00 | 2024-10-23T00:00:00 | [
"PHASE2"
] | 267 | 18 | 65 | ALL | false | The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression | null | Inclusion Criteria:
* All of the following standards must be met:
1. Age range from 18 to 65 years old (including boundary values), both male and female;
2. Single or recurrent episodes (296.2/296.3) that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
3. During the screening and baseline periods, the total score of the Montgomery Asperger Depression Rating Scale (MADRS) was ≥ 26 points;
4. Screening and baseline periods, with a Clinical Global Impression Scale Disease Severity (CGI-S) score of ≥ 4 points;
5. Voluntary participation in clinical trials, able to sign informed consent forms, and able to understand and comply with research procedures.
Exclusion Criteria:
* Those who meet any of the following criteria cannot be included in this experiment:
1. Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) or Duloxetine;
2. Those who have used at least two antidepressants in sufficient dosage and duration (treated according to the maximum dosage in the instructions for at least 4 weeks) in a single or current episode in the past but still have no effect;
3. Those who have been ineffective in using Duloxetine in sufficient amounts during the previous treatment course;
4. The patients of depression secondary to other mental or physical illnesses;
5. Patients of depression with accompanying psychiatric symptoms;
6. Significant suicidal attempt or behavior within the past year, with a score of ≥ 3 on the 10th item (suicidal ideation) of the MADRS scale;
7. During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period;
8. Individuals with a history of epileptic seizures (excluding convulsions caused by febrile seizures in children);
9. Individuals who have received depression related systemic physical therapy within 3 months prior to their first administration: modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), phototherapy, or systemic psychotherapy;
10. Systematically receiving antidepressant treatment within the first 2 weeks of randomization, or discontinuing antidepressant medication for less than 5 half-lives before randomization;
11. Individuals with severe unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, and other physical diseases or medical history;
12. Accompanied by a history of malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
13. Screening or baseline electrocardiogram abnormalities that have clinical significance and are deemed unsuitable for inclusion by investigators, such as male QTcF ≥ 450 ms, female QTcF ≥ 470 ms, or having a history of long QT syndrome;
14. A history of symptomatic orthostatic hypotension (i.e. orthostatic syncope) with clinical significance;
15. During the screening or baseline period, TBIL is above 2 times the upper limit of normal value, and ALT or AST is above 2 times the upper limit of normal value; Cr is higher than 1.2 times the upper limit of normal value;
16. Thyroid dysfunction (TSH above 1.2 times the upper limit of normal value or below 0.8 times the lower limit of normal value) or the presence of hyperthyroidism or hypothyroidism determined by the investigators;
17. Individuals with a history of elevated intraocular pressure or narrow angle glaucoma;
18. Screening period, drug abuse screening positive individuals;
19. A history of alcohol dependence within one year prior to screening;
20. Pregnant and lactating women, male or female subjects who have a family planning or are unable to take effective contraceptive measures within 30 days after signing the informed consent form and ending the trial;
21. Screening for individuals who have participated in clinical trials and taken investigational drugs within the first 30 days;
22. The investigators believe that the subjects have poor compliance or there are other clinical, social, or family factors that are not suitable for enrollment. | Tasly Pharmaceutical Group Co., Ltd | INDUSTRY | {
"id": "TSL-CM-JS1-1-01-Ⅱ",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
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} | 2024-02-06T00:00:00 | {
"date": "2025-06-03",
"type": "ACTUAL"
} | {
"date": "2024-02-14",
"type": "ACTUAL"
} | [
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] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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"maskingDescription": null,
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Depression"
] | null | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Capital Medical University Affiliated Anding Hospital",
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"lat": 39.9075,
"lon": 116.39723
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"state": "Beijing"
},
{
"city": "Peking",
"country": "China",
"facility": "Peking University Sixth Hospital",
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"state": "Beijing"
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"facility": "Chongqing 11th People's Hospital",
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"facility": "The Affiliated Brain Hospital of Guangzhou Medical University",
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},
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"city": "Baoding",
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"facility": "Hebei Provincial Mental Health Center",
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"lon": 115.49028
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"facility": "The First Hospital of Hebei Medical University",
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"lon": 114.47861
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"facility": "Daqing Third Hospital",
"geoPoint": {
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"lon": 125
},
"state": "Heilongjiang"
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"city": "Wuxi",
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"facility": "Wuxi Mental Health Center",
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"lon": 120.28857
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"state": "Jiangsu"
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"city": "Zhenjiang",
"country": "China",
"facility": "Zhenjiang Mental Health Center",
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"lon": 119.45508
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"state": "Jiangsu"
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"city": "Nanchang",
"country": "China",
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"state": "Jiangxi"
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"city": "Siping",
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"facility": "Jilin Provincial Neuropsychiatric Hospital",
"geoPoint": {
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"lon": 124.37785
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"state": "Jilin"
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"country": "China",
"facility": "Shandong Provincial Mental Health Center",
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"state": "Shandong"
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"country": "China",
"facility": "Tianjin Anding Hospital",
"geoPoint": {
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"facility": "Ürümqi Fourth People's Hospital",
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"facility": "The First Affiliated Hospital of Kunming Medical University",
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"timeFrame": "8 weeks"
}
],
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"measure": "The change in HAMD-17 total score from baseline",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The effective rate of MADRS",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The effective rate of HAMD-17",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The response rate of MADRS",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The response rate of HAMD-17",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The change in CGI-I and CGI-S total score from baseline",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The change in HAMA total score from baseline",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The change in MADRS Single item score from baseline",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The change in HAMD-17 factor score from baseline",
"timeFrame": "8 weeks"
},
{
"description": null,
"measure": "The change in SHAPS total score from baseline",
"timeFrame": "8 weeks"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT05348226 | null | The ENVI Study: Effect of Entresto on Left Ventricular Remodelling on Cardiac MRI | Effect of Sacubitril/Valsartan (ENtresto) on Left Ventricular Reverse Remodelling as Demonstrated by Cardiac Magnetic Resonance (CMR) Imaging | ENVI | OBSERVATIONAL | COMPLETED | 2022-04-05T00:00:00 | null | 2023-03-23T00:00:00 | 2023-03-23T00:00:00 | null | 50 | null | null | ALL | false | A prospective, single centre, observational cohort study at University Hospital Southampton NHS Foundation Trust of 50 consecutive patients with Heart Failure with reduced Ejection Fraction and Ejection Fraction ≤35% who are eligible for sacubitril/valsartan (Entresto) initiation as per European Society of Cardiology guidelines.
Participants will have baseline and repeat cardiac magnetic resonance imaging (CMR) scans after 4-6 months of Entresto therapy. The CMR scans will be compared.
Clinical outcomes at 6 months including combined outcome of death and/or heart failure hospitalisation, KCCQ-12 questionnaire, 6-minute walk test, routine blood tests and NTproBNP will also be described.
This study will be the first to examine the effects of sacubitril/valsartan (Entresto) therapy on left ventricular reverse remodelling in patients with symptomatic HFrEF as demonstrated by Cardiac Magnetic Resonance Imaging. | The landmark trial PARADIGM-HF (2014) showed that a new drug sacubitril/valsartan (Entresto) was superior to a well-established drug (ACE-Inhibitors) for patients with severe heart failure. Entresto resulted in a 20% reduction in risk of death and hospitalisations, as well as improving quality of life and symptoms. This represented a major breakthrough in heart failure treatment and guidelines changed to recommend Entresto for patients in whom heart function had not improved on conventional heart failure drug treatments.
At the same point as recommending Entresto, international heart failure guidelines also recommend an Implantable Cardioverter-Defibrillator (ICD). An ICD is a device which can detect and treat potentially life-threatening heart rhythm abnormalities, which may occur in patients with persistently severe heart failure. The risk of complications associated with ICD implantation is not insignificant, up to 15%. Currently, there is a lack of consensus between clinicians regarding when best to offer ICD implantation in relation to Entresto treatment.
The exact mechanism of how Entresto achieves its beneficial effect is not fully understood. There are studies describing an improvement in heart function on Echocardiography (ultrasound). Some studies suggest a reduction in abnormal heart rhythms. There are however, no studies describing the effects of Entresto on heart tissue or function described on Cardiac Magnetic Resonance (CMR) Imaging. CMR is a specialised non-invasive scan which is excellent at looking at characteristics of heart tissue and is the gold standard for calculating heart function.
The study will enrol 50 patients who have been referred for Entresto treatment. Participants will undergo a baseline CMR to evaluate heart characteristics and function before being started on Entresto. After 6 months, participants will receive another CMR and the two scans will be compared for differences in heart size, function and tissue characteristics.
The Investigators hypothesize that there will be an improvement in a variety of CMR parameters and the findings will help better understand the mechanisms by which this is achieved e.g. reduction in fibrosis (subtle scarring) of heart tissue. The Investigators also believe a proportion of patients will avoid the need for an ICD, due to improvement in heart function. | Inclusion Criteria:
* ≥18 years
* HFrEF EF ≤35% despite optimisation of ACE-Inhibitor, Beta Blocker \& Mineralocorticoid Receptor Antagonist and referred for Entresto initiation
* Symptomatic NYHA II-III
* Able and willing to provide informed consent
* Able to undergo Cardiac Magnetic Resonance Imaging (CMR) scan
Exclusion Criteria:
* Pre-existing cardiac device (i.e. pacemaker/defibrillator)
* Symptomatic hypotension (BP \<95mmHg) - \[PARADIGM exclusion\]
* Severe renal failure (GFR \<30)
* Hyperkalaemia (K \>5.4mmol/L)
* History of angioedema
* Diagnosis of amyloidosis, sarcoidosis or HCM
* Myocardial infarction or revascularisation within the last 40 days
* Valve disease expected to require surgery
* Life expectancy \<2 years secondary to any other cause (i.e. malignancy)
* Pregnancy | University Hospital Southampton NHS Foundation Trust | OTHER | {
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"date": "2023-04-21",
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"date": "2022-04-27",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
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"Heart Failure With Reduced Ejection Fraction"
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"city": "Southampton",
"country": "United Kingdom",
"facility": "University Hospital Southampton NHS Foundation Trust",
"geoPoint": {
"lat": 50.90395,
"lon": -1.40428
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"state": "Hampshire"
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] | null | null | {
"other": [
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"description": null,
"measure": "Combined outcome of death and/or heart failure hospitalisation",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Quality of Life assessment: KCCQ-12 questionnaire",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Quality of Life assessment: 6 Minute Walk Test",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "N-terminal pro B type natriuretic peptide (NTproBNP)",
"timeFrame": "6 months"
}
],
"primary": [
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"description": null,
"measure": "Left Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging",
"timeFrame": "6 months"
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"description": null,
"measure": "Indexed Left Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging",
"timeFrame": "6 months"
}
],
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"description": null,
"measure": "Cardiac Fibrosis quantification as measured by T1 mapping on Cardiac Magnetic Resonance Imaging",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Strain Analysis as measured by feature tracking on Cardiac Magnetic Resonance Imaging",
"timeFrame": "6 months"
}
]
} | [
{
"affiliation": "University Hospital Southampton NHS Foundation Trust",
"name": "Andrew S Flett, MBBS BSc MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
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],
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
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"name": "All Conditions"
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}
],
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"id": "D006333",
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]
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} | {
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],
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NCT04730726 | null | In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules | In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules | THYNODE | INTERVENTIONAL | UNKNOWN | 2021-01-26T00:00:00 | null | 2021-12-01T00:00:00 | 2022-04-01T00:00:00 | [
"NA"
] | 50 | 18 | null | ALL | false | Thyroid nodules are common in clinical practice. Head and neck ultrasound is recommended as a routine examination for all patients with thyroid lesions. The Thyroid Imaging Reporting And Documentation System (TIRADS) criteria helps to estimate the risk of malignancy based on ultrasound patterns and nodule sizes guiding the performance of fine-needle-aspiration (FNA). Approximately 20% of FNA results cannot be specified whether being benign or malig-nant tissue. A definitive diagnosis can only be made from histopathology after diagnostic (hemi)thyroidectomy. However, (hemi)thyroidectomy has disadvantages as it leads to over-treatment and has a risk of postoperative morbidity (e.g. hypothyroidism and laryngeal nerve injury). Furthermore, (hemi)thyroidectomy is known to be associated with poor quality of life. Clearly, there is an unmet need for additional diagnostic tools in order to identify malignant thyroid nodules and thereby support the decision making for treatment of the thyroid.
Multispectral optoacoustic tomography (MSOT) is an innovative, non-invasive imaging method currently available in the UMCG that enables visualization of endogenous chromophores and exogenous contrast agents using the generation of ultrasound waves due to light absorption by using high frequency pulsed laser light. Recently, this system has been used by other groups for non-invasive determination of thyroid nodules. Results show that multispectral optoacoustic imaging of thyroid nodules may distinguish benign from malignant nodules. However, most certainly, a larger cohort is necessary to confirm this finding. | null | Inclusion Criteria:
1. Patients with thyroid nodules who underwent or will undergo an ultrasonography (with TIRADS score) with FNA if indicated and will be scheduled for a (hemi)thyroidectomy if indicated;
2. Age ≥ 18 years;
3. Written informed consent.
Exclusion Criteria:
1. Medical or psychiatric conditions that compromise the patients' ability to give informed consent;
2. Previous surgery in head and neck area
3. Previous radiotherapy in head and neck area
4. Pregnancy | University Medical Center Groningen | OTHER | {
"id": "201900301",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-01-26T00:00:00 | {
"date": "2021-01-29",
"type": "ACTUAL"
} | {
"date": "2021-01-29",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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},
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"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Thyroid Nodule"
] | null | null | [
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"city": "Groningen",
"country": "Netherlands",
"facility": "University Medical Center Groningen",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "MSOT signals of endogenous biomarkers",
"timeFrame": "2 years"
}
],
"secondary": [
{
"description": null,
"measure": "Potential correlation FNA",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "Potential correlation ultrasound",
"timeFrame": "2 years"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"id": "D004700",
"term": "Endocrine System Diseases"
},
{
"id": "D013964",
"term": "Thyroid Neoplasms"
},
{
"id": "D004701",
"term": "Endocrine Gland Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D006258",
"term": "Head and Neck Neoplasms"
}
],
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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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"abbrev": "BC04",
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],
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"id": "M18986",
"name": "Thyroid Nodule",
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"asFound": null,
"id": "M9348",
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}
],
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"term": "Thyroid Nodule"
},
{
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"term": "Thyroid Diseases"
}
]
} | null | {
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"term": "Thyroid Nodule"
},
{
"id": "D013959",
"term": "Thyroid Diseases"
}
],
"interventions": null
} |
NCT03887026 | null | Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis | Efficacy and Safety of Single Doses of Norketotifen in Adult Subjects With Allergen-Induced Allergic Rhinitis in an Allergen Challenge Chamber | None | INTERVENTIONAL | COMPLETED | 2019-03-21T00:00:00 | null | 2019-05-18T00:00:00 | 2019-05-29T00:00:00 | [
"PHASE2"
] | 36 | 18 | 45 | ALL | false | This is a Phase 2a study to evaluate the efficacy and safety of Norketotifen (NKT) in subjects with allergic rhinitis. | This is a single-center, double-blind, randomized, placebo-controlled, 3-way crossover study evaluating the efficacy and safety of NKT in adult subjects with allergen-induced allergic rhinitis in an allergen challenge chamber. | Inclusion Criteria:
* Ability and willingness to provide informed consent and comply with the protocol procedures
* Males and females, age 18 to 45 years, inclusive
* Other than seasonal allergic rhinitis, participant is healthy as determined by pre-study medical history, physical examination and vital signs. Any chronic conditions that may interfere with the study outcomes or the subject's safety will be considered clinically significant and a reason for exclusion.
* History of seasonal allergic rhinitis to mountain cedar pollen for at least the past 2 consecutive seasons
* Positive mountain cedar pollen skin prick test at Screening or within 12 months prior to Screening (wheal diameter ≥5 mm larger than the negative control)
* For females, negative serum pregnancy test. Females of childbearing potential and males must agree to use required contraception as outlined in the protocol
Exclusion Criteria:
* Female subjects who are pregnant or lactating
* Any history of epilepsy, diabetes mellitus, blood pressure abnormalities or cardiac arrhythmias
* Presence of any uncontrolled medical or psychiatric illness
* Treatment for controlled concurrent medical conditions has not been stable in terms of either doses or medications for at least 30 days prior to the baseline visit or is anticipated to change during the study
* Current use of or expected use of any of the prohibited medications within the indicated withholding timeframes as outlined in the protocol
* History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study
* Any history of malignancy within the past 5 years, with the exception of non-melanoma skin cancer
* History of pulmonary disease and/or active asthma requiring daily drug therapy. Mild, intermittent asthma is permitted (managed with short acting beta-agonist less than 3 times per week). Isolated exercise-induced bronchospasm is also permitted
* Any infection or inflammatory condition within the 2 weeks prior to screening
* Positive human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) antibody screen
* Any clinically significant abnormal laboratory or ECG test. Presence of thrombocytopenia at screening is exclusionary
* Evidence of illicit drug use or positive urine Class A drug, alcohol, or cotinine screen
* Regular use of tobacco or nicotine containing products, including vaping, within 1 year prior to Screening
* Received any investigational drug within 30 days prior to Screening
* Any prior exposure to norketotifen
* History of allergic reaction to ketotifen
* In the opinion of the investigator, subject would be unlikely to comply with required study visits, self-assessments, and interventions | Emergo Therapeutics, Inc. | INDUSTRY | {
"id": "NKT-201",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2019-03-21T00:00:00 | {
"date": "2020-08-21",
"type": "ACTUAL"
} | {
"date": "2019-03-22",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
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"timePerspective": null
} | [
"Allergic Rhinitis",
"Allergic Rhinoconjunctivitis"
] | null | null | [
{
"city": "San Antonio",
"country": "United States",
"facility": "Biogenics Research Chamber",
"geoPoint": {
"lat": 29.42412,
"lon": -98.49363
},
"state": "Texas"
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Change in Total Nasal Symptom Score (TNSS) from pre-dose to 6 hours post-dose",
"timeFrame": "6 hours"
}
],
"secondary": [
{
"description": null,
"measure": "Change in Total Ocular Symptom Score (TOSS) from pre-dose to 6 hours post-dose",
"timeFrame": "6 hours"
},
{
"description": null,
"measure": "Change in Total Symptom Score (TSS) from pre-dose to 6 hours post-dose",
"timeFrame": "6 hours"
},
{
"description": null,
"measure": "Area under the curve (AUC) of TNSS over 6 hours post-dose",
"timeFrame": "6 hours"
},
{
"description": null,
"measure": "AUC of TOSS over 6 hours post-dose",
"timeFrame": "6 hours"
},
{
"description": null,
"measure": "AUC of TSS over 6 hours post-dose",
"timeFrame": "6 hours"
},
{
"description": null,
"measure": "Change in individual nasal symptoms from pre-dose to 6 hours post-dose",
"timeFrame": "6 hours"
},
{
"description": null,
"measure": "Change in individual ocular symptoms from pre-dose to 6 hours post-dose",
"timeFrame": "6 hours"
}
]
} | [
{
"affiliation": "Emergo Therapeutics, Inc.",
"name": "Hazar Awad Granko, RPh, PhD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Otorhinolaryngologic Diseases"
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],
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NCT01106326 | null | A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents | A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents | None | INTERVENTIONAL | COMPLETED | 2010-04-16T00:00:00 | null | null | null | [
"NA"
] | 30 | 12 | 15 | ALL | false | The goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational interviewing intervention to help the teen transition to independence with their medical treatment plan. We hypothesize that this community-based pilot intervention will; 1) be feasible and acceptable among this population and among school personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). We anticipate that enhancing preventive healthcare for urban teens with asthma through partnerships with schools will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs. This new method of preventive care delivery could be sustained within the school nursing system, and could be implemented in schools nationwide. Further, it could be applied to other chronic illnesses affecting disadvantaged populations. | null | Inclusion Criteria:
* Physician-diagnosed asthma
* Persistent asthma (criteria based on NHLBI guidelines).
* Age \>12 and \<15 years.
* Attending school in the Rochester City School District.
* Signed physician permission to enroll the child.
* Current prescription of a daily preventive asthma medication
* Parent or caregiver and the adolescent must consent to the intervention.
Exclusion Criteria:
* Inability to speak and understand English.
* No access to a working phone for follow-up surveys
* The family planning to leave the school district within fewer than 6 months.
* The teen having other significant medical conditions
* The teen having a diagnosed developmental condition per parent report.
* Adolescents in foster care or other situations in which consent cannot be obtained from a guardian.
* Adolescents that were previously enrolled in our School-Based Asthma Study | University of Rochester | OTHER | {
"id": "28198",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-04-16T00:00:00 | {
"date": "2014-08-01",
"type": "ESTIMATED"
} | {
"date": "2010-04-19",
"type": "ESTIMATED"
} | [
"CHILD"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
} | [
"Asthma"
] | ["Asthma"] | null | [
{
"city": "Rochester",
"country": "United States",
"facility": "University of Rochester",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York"
}
] | [
{
"class": "NIH",
"name": "National Institutes of Health (NIH)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of Symptom-free Days Over Two Weeks",
"timeFrame": "2 and 4 month follow-up assessments"
}
],
"secondary": [
{
"description": null,
"measure": "Additional Asthma Morbidity Measures",
"timeFrame": "2 month, 4 month, final follow-up assessments"
}
]
} | [
{
"affiliation": "University of Rochester",
"name": "Jill S. Halterman, MD, MPH",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "24494626", "type": "BACKGROUND", "citation": "Blaakman SW, Cohen A, Fagnano M, Halterman JS. Asthma medication adherence among urban teens: a qualitative analysis of barriers, facilitators and experiences with school-based care. J Asthma. 2014 Jun;51(5):522-9. doi: 10.3109/02770903.2014.885041. Epub 2014 Feb 7."}, {"pmid": "21599562", "type": "RESULT", "citation": "Halterman JS, Riekert K, Bayer A, Fagnano M, Tremblay P, Blaakman S, Borrelli B. A pilot study to enhance preventive asthma care among urban adolescents with asthma. J Asthma. 2011 Jun;48(5):523-30. doi: 10.3109/02770903.2011.576741."}] | {"versionHolder": "2025-06-18"} | {
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NCT06596226 | null | Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism | Evaluating The Efficacy of Pathways Parent-Mediated Intervention's Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism: A Randomized Control Trial | None | INTERVENTIONAL | RECRUITING | 2024-08-21T00:00:00 | null | 2026-06-01T00:00:00 | 2026-06-01T00:00:00 | [
"NA"
] | 80 | 16 | 30 | ALL | false | Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds.
What Will Happen: Researchers will compare two versions of the Pathways Intervention:
* Version 1: Includes mutual gaze strategies.
* Version 2: Does not include mutual gaze strategies.
What to Expect: Participants will:
* Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations).
* Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways. | Purpose of the Study: The primary goal of this clinical trial is to evaluate whether a parent-mediated treatment can improve social communication, language, and adaptive functioning in 16-30-month-old children from diverse cultural and language backgrounds who are at high risk for autism (referred to as children with social challenges).
Study Design:
* Study Phase: N/A
* Intervention Model: Participants are assigned to one of two groups in parallel.
Study Description:
* Participants: 80 children aged 16-30 months who show social communication challenges and are at high risk for autism will be randomly assigned to one of two groups:
1. Group 1: Pathways Intervention with mutual gaze strategies.
2. Group 2: Pathways Intervention without mutual gaze strategies.
* Intervention Sessions: Participants will attend 12 sessions, each lasting 1.5 hours, over approximately 15 weeks (allowing for possible cancellations) of parent-mediated intervention in their homes or another convenient location.
Assessments: To track progress and evaluate long-term effects, participants will undergo several culturally and linguistically appropriate assessments at three time points:
1. Baseline: Within two weeks before starting the intervention.
2. Post-Intervention: Within two weeks after completing the intervention.
3. Three-Month Follow-Up: 12-15 weeks after completing the intervention.
Each evaluation will take around two hours and will include:
* Child Assessments:
* Mullen Scale of Early Learning (MSEL): Assesses general developmental age (administered only at baseline).
* Communication and Symbolic Behavior Scales-Developmental Profile (CSBS-DP): Evaluates social communication.
* EarliPointTM: Measures social, verbal, and nonverbal cognition.
* Caregiver Questionnaires:
* Vineland Adaptive Behavior Scales, Third Edition (VABS-III): Assesses adaptive functioning.
* PhenX Toolkit Core Measures: Collects family and child demographic information, including parents' and grandparents' place of birth (administered only at baseline).
The CSBS-DP and VABS-III have been validated as appropriate measures for determining meaningful changes in children with or at high risk for autism, based on previous research | Inclusion Criteria:
* Children must be between 16-30 months old at the start of the study;
* Children must receive social disability index of 7 or lower on the EarliPointTM assessment with a researcher (i.e., human) confirming social challenges are present;
* Parents must report no other known neurological or genetic concerns or disorders
* Parents must be fluent in English
* Parents must live within a 30-mile radius of the Callier Center Dallas.
Exclusion Criteria:
* Children younger than 16 months or older than 30 months at the start of the study
* Children who are not at high risk for autism based on an EarliPointTM assessment (with researcher confirmation of social challenges)
* Children whose parents report they have any other known neurological or genetic concerns or disorders;
* Children whose parents are not fluent in English. | The University of Texas at Dallas | OTHER | {
"id": "UTD IRB 24-804",
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"description": null,
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"description": null,
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} | [
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"affiliation": "University of Texas at Dallas",
"name": "Pamela Rollins, EdD",
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] | [{"pmid": "25096930", "type": "BACKGROUND", "citation": "Anagnostou E, Jones N, Huerta M, Halladay AK, Wang P, Scahill L, Horrigan JP, Kasari C, Lord C, Choi D, Sullivan K, Dawson G. Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder. Autism. 2015 Jul;19(5):622-36. doi: 10.1177/1362361314542955. Epub 2014 Aug 5."}, {"pmid": null, "type": "BACKGROUND", "citation": "(Anagnostou et al., 2015; Chatham et al., 2018; McCracken et al., 2021)."}, {"pmid": "28941213", "type": "BACKGROUND", "citation": "Chatham CH, Taylor KI, Charman T, Liogier D'ardhuy X, Eule E, Fedele A, Hardan AY, Loth E, Murtagh L, Del Valle Rubido M, San Jose Caceres A, Sevigny J, Sikich L, Snyder L, Tillmann JE, Ventola PE, Walton-Bowen KL, Wang PP, Willgoss T, Bolognani F. Adaptive behavior in autism: Minimal clinically important differences on the Vineland-II. Autism Res. 2018 Feb;11(2):270-283. doi: 10.1002/aur.1874. Epub 2017 Sep 21."}, {"pmid": "34158222", "type": "BACKGROUND", "citation": "McCracken JT, Anagnostou E, Arango C, Dawson G, Farchione T, Mantua V, McPartland J, Murphy D, Pandina G, Veenstra-VanderWeele J; ISCTM/ECNP ASD Working Group. Drug development for Autism Spectrum Disorder (ASD): Progress, challenges, and future directions. Eur Neuropsychopharmacol. 2021 Jul;48:3-31. doi: 10.1016/j.euroneuro.2021.05.010. Epub 2021 Jun 19."}, {"pmid": null, "type": "BACKGROUND", "citation": "Mullen, E. M. (1995). Mullen Scales of Early Learning. American Guidance Service, Guilford Press."}, {"pmid": null, "type": "BACKGROUND", "citation": "Wetherby, A., & Prizant, B. (2002). Communication and Symbolic Behavior Scales- Developmental Profile (1st normed ed.). Paul H. Brookes."}, {"pmid": null, "type": "BACKGROUND", "citation": "Sparrow, S. S., Cicchetti, D. V., & Saulnier, C. A. (2016). Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). Pearson."}] | {"versionHolder": "2025-06-18"} | {
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NCT01033526 | null | Symptomatic Treatment of Common Cold Symptoms | A Two-arm, Multicenter, Randomized, Double-blind, Single Dose Placebo-controlled Parallel Groups Study Evaluating Efficacy and Tolerability of 800 mg Acetylsalicylic Acid (Aspirina® C) in Adult Patients With a Common Cold During a Two Hour in Patient Phase; and a Follow-up Period of Five Days of Home Treatment as Required | None | INTERVENTIONAL | COMPLETED | 2009-12-15T00:00:00 | null | null | null | [
"PHASE4"
] | 388 | 18 | 65 | ALL | false | A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required. | null | Inclusion Criteria:
* Age between 18 and 65 years
* Onset of cold symptoms within 48 hours before screening
* Objective symptoms of common cold
* Subjective symptoms of common cold
Exclusion Criteria:
* Pregnancy or lactation period
* Active peptic ulcer
* Hemorrhagic diathesis
* History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding
* Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens | Bayer | INDUSTRY | {
"id": "11756",
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"term": "Fibrinolytic Agents"
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"id": "D050299",
"term": "Fibrin Modulating Agents"
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{
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"term": "Molecular Mechanisms of Pharmacological Action"
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{
"id": "D010975",
"term": "Platelet Aggregation Inhibitors"
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{
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"term": "Cyclooxygenase Inhibitors"
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"id": "D004791",
"term": "Enzyme Inhibitors"
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"term": "Antipyretics"
}
],
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"abbrev": "Antipy",
"name": "Antipyretics"
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"abbrev": "Infl",
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"name": "Antirheumatic Agents"
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{
"abbrev": "FiAg",
"name": "Fibrinolytic Agents"
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"name": "Analgesics"
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"name": "Platelet Aggregation Inhibitors"
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"name": "All Drugs and Chemicals"
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"abbrev": "Micro",
"name": "Micronutrients"
},
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"name": "Vitamins"
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],
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"name": "Ascorbic Acid",
"relevance": "LOW"
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"relevance": "LOW"
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"relevance": "LOW"
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"name": "Cyclooxygenase Inhibitors",
"relevance": "LOW"
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"name": "Enzyme Inhibitors",
"relevance": "LOW"
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"name": "Antipyretics",
"relevance": "LOW"
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"name": "Vitamin C",
"relevance": "LOW"
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}
],
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{
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"term": "Aspirin"
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]
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"id": "D003139",
"term": "Common Cold"
}
],
"interventions": [
{
"id": "D001241",
"term": "Aspirin"
}
]
} |
NCT06316726 | null | The Effectiveness of Two Nursing Programs on the Surgery-related Pressure Injury | The Effectiveness of Two Nursing Programs on the Surgery-Related Pressure Injury in Surgery Patients | None | INTERVENTIONAL | COMPLETED | 2024-02-29T00:00:00 | null | 2023-08-31T00:00:00 | 2023-08-31T00:00:00 | [
"NA"
] | 461 | 20 | null | ALL | true | Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions.
Methods: This study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). Measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries. | null | Inclusion Criteria:
* 20 and more years old
* Over 4 hours lying flat on the operating table (eg., orthognathic surgery, microtia reconstruction surgery, etc.)
* Those who are conscious clearly and can communicate in Mandarin and Taiwanese
* Those with agree to participate in this study
Exclusion Criteria:
* Those whose skin is red, swollen, hot, painful, redness, rash, purple spots, bruising, scaly skin, damaged, etc.
* Refuse to participate in the study | Chang Gung Memorial Hospital | OTHER | {
"id": "202100409A3",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-03-15T00:00:00 | {
"date": "2024-03-18",
"type": "ACTUAL"
} | {
"date": "2024-03-18",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care).",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Pressure Injury",
"Surgery"
] | ["surgery-related pressure injury", "incidence", "grade", "sites", "time"] | null | [
{
"city": "Taoyuan",
"country": "Taiwan",
"facility": "Taoyuan Chang Gung Memorial Hospital",
"geoPoint": {
"lat": 24.95233,
"lon": 121.20193
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "the occurrence of surgery-related pressure injuries",
"timeFrame": "baseline, pre-surgery; every two hours during the surgery till ten hours; and post-surgery to the 2nd day after surgeryl"
}
],
"secondary": null
} | [
{
"affiliation": "Nursing Department of Taoyuan Chang Gung Memorial Hospital",
"name": "Mei-Chu Tsai, MN",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "9801935", "type": "RESULT", "citation": "Nixon J, McElvenny D, Mason S, Brown J, Bond S. A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores. Int J Nurs Stud. 1998 Aug;35(4):193-203. doi: 10.1016/s0020-7489(98)00023-6."}, {"pmid": "16422733", "type": "RESULT", "citation": "Feuchtinger J, de Bie R, Dassen T, Halfens R. A 4-cm thermoactive viscoelastic foam pad on the operating room table to prevent pressure ulcer during cardiac surgery. J Clin Nurs. 2006 Feb;15(2):162-7. doi: 10.1111/j.1365-2702.2006.01293.x."}, {"pmid": "16881492", "type": "RESULT", "citation": "Sewchuk D, Padula C, Osborne E. Prevention and early detection of pressure ulcers in patients undergoing cardiac surgery. AORN J. 2006 Jul;84(1):75-96. doi: 10.1016/s0001-2092(06)60100-2."}, {"pmid": "21841719", "type": "RESULT", "citation": "Donnelly J, Winder J, Kernohan WG, Stevenson M. An RCT to determine the effect of a heel elevation device in pressure ulcer prevention post-hip fracture. J Wound Care. 2011 Jul;20(7):309-12, 314-8. doi: 10.12968/jowc.2011.20.7.309."}, {"pmid": "30517574", "type": "RESULT", "citation": "Oliveira KF, Pires PDS, De-Mattia AL, Barichello E, Galvao CM, Araujo CA, Barbosa MH. Influence of support surfaces on the distribution of body interface pressure in surgical positioning. Rev Lat Am Enfermagem. 2018 Nov 29;26:e3083. doi: 10.1590/1518-8345.2692.3083."}, {"pmid": "30601427", "type": "RESULT", "citation": "Joseph J, McLaughlin D, Darian V, Hayes L, Siddiqui A. Alternating Pressure Overlay for Prevention of Intraoperative Pressure Injury. J Wound Ostomy Continence Nurs. 2019 Jan/Feb;46(1):13-17. doi: 10.1097/WON.0000000000000497."}, {"pmid": "33612359", "type": "RESULT", "citation": "Neo TG, Koo SH, Chew STH, Png GK, Lacuesta MJ, Wu MYL, Tay RYC, Singh PA, Chandran R. A randomized controlled trial to compare the interface pressures of alternating pressure overlay with gel pad versus gel pad alone during prolonged surgery. J Tissue Viability. 2021 May;30(2):222-230. doi: 10.1016/j.jtv.2021.02.003. Epub 2021 Feb 6."}, {"pmid": "36782315", "type": "RESULT", "citation": "Ahmad B, Rubio-Sefati M, Yacob MM. Incidence and risk factors for pressure injuries in patients who have undergone vascular operations: a scoping review. Eur J Med Res. 2023 Feb 13;28(1):77. doi: 10.1186/s40001-023-01036-3."}, {"pmid": "25874704", "type": "RESULT", "citation": "Chen HL, Chen XY, Wu J. The incidence of pressure ulcers in surgical patients of the last 5 years: a systematic review. Wounds. 2012 Sep;24(9):234-41."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012883",
"term": "Skin Ulcer"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
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{
"abbrev": "BC26",
"name": "Wounds and Injuries"
},
{
"abbrev": "All",
"name": "All Conditions"
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{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
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],
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"id": "M6870",
"name": "Pressure Ulcer",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17206",
"name": "Ulcer",
"relevance": "LOW"
},
{
"asFound": "Injury",
"id": "M17685",
"name": "Wounds and Injuries",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M15686",
"name": "Skin Ulcer",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M15674",
"name": "Skin Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003668",
"term": "Pressure Ulcer"
},
{
"id": "D014947",
"term": "Wounds and Injuries"
},
{
"id": "D000071576",
"term": "Crush Injuries"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Derm",
"name": "Dermatologic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M146105",
"name": "Pyrithione zinc",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D003668",
"term": "Pressure Ulcer"
},
{
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"term": "Wounds and Injuries"
},
{
"id": "D000071576",
"term": "Crush Injuries"
}
],
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} |
NCT04165226 | null | LLLT and Fractional CO2 Laser in the Treatment of Stria Alba | Low Level Light Therapy and Fractional Carbon Dioxide Laser in the Treatment of Stria Alba: A Randomised Controlled Study | None | INTERVENTIONAL | COMPLETED | 2018-12-20T00:00:00 | null | 2019-09-17T00:00:00 | 2019-09-17T00:00:00 | [
"NA"
] | 30 | 18 | null | ALL | false | Stria alba (aka white or atrophic stretch marks) is a very common dermatologic condition that causes major psychological distress to those afflicted. We study the effect of low level light therapy using infra red diode 808/915 nm laser in comparison to fractional CO2 alone and combined both therapies. | All patients will be subjected to the following:
* Written informed consent.
* Detailed history and clinical evaluation.
The treated areas will be photographed (in standardized settings of light and position) and measured in order to allow comparison and assessment of striae improvement following treatment.
Patients will be allocated according to randomization into one of 3 arms:
Arm A will be treated by fractional CO2 laser. Arm B will be treated by low level light therapy (LLLT). Arm C will be treated with a combination of fractional CO2 laser and LLLT.
Digital photographs will be taken for each patient, at the baseline and 1 and 3 months after last session and the width of the widest striae in each patient will be measured at the same time. Patients will be assessed before and after treatment by one unblinded and 2 blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (\<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (\>76%).
In addition, a patient satisfaction score will be rated using the following scale; 0=not satisfied, 1=slightly satisfied, 2= satisfied, 3=very satisfied, 4=extremely satisfied as well as patients' satisfaction questionnaire (Yang and Lee; 2011). | Inclusion Criteria:
* Subjects, above the age of 18 years old, with stria alba.
* Both genders.
Exclusion Criteria:
* Pregnant or lactating females.
* Subjects who were treated with any interventional procedure (lasers, radiofrequency, dermabrasion, microdermabrasion, or chemical peeling) within 6 months prior to the study.
* Subjects who applied topical corticosteroids, retinoid, vitamin C, or vitamin E within 3 months prior to the study.
* Subjects who orally took retinoids or corticosteroids within 3 months.
* Subjects who had a history of hypertrophic scar, keloid or immunosuppression or cancer. | Kasr El Aini Hospital | OTHER | {
"id": "MMikhail",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-11-13T00:00:00 | {
"date": "2020-06-17",
"type": "ACTUAL"
} | {
"date": "2019-11-15",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
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]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Striae; Albicantes"
] | ["Stria alba", "Fractional CO2", "Fractional carbon dioxide laser 00", "Low level light therapy", "Striae atrophicae", "Infra red diode laser", "808 nm", "915 nm", "10600 nm"] | null | [
{
"city": "Cairo",
"country": "Egypt",
"facility": "Kasr El Ainy hospital",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study)",
"timeFrame": "3 months"
}
],
"secondary": [
{
"description": null,
"measure": "Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1",
"timeFrame": "1 month"
},
{
"description": null,
"measure": "Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1",
"timeFrame": "1 month"
},
{
"description": null,
"measure": "Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1",
"timeFrame": "1 month"
},
{
"description": null,
"measure": "Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Comparative tolerability of the fractional CO2 versus combined fractional and LLLT as regards duration of side effects in days after each laser session (edema, pain, erythema, itching, peeling)",
"timeFrame": "3 months"
}
]
} | [
{
"affiliation": "Cairo University",
"name": "Doaa Mahgoub, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Cairo University",
"name": "Vanessa Hafez, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "22148016", "type": "BACKGROUND", "citation": "Yang YJ, Lee GY. Treatment of Striae Distensae with Nonablative Fractional Laser versus Ablative CO(2) Fractional Laser: A Randomized Controlled Trial. Ann Dermatol. 2011 Nov;23(4):481-9. doi: 10.5021/ad.2011.23.4.481. Epub 2011 Nov 3."}, {"pmid": "16176771", "type": "BACKGROUND", "citation": "Weiss RA, McDaniel DH, Geronemus RG, Weiss MA, Beasley KL, Munavalli GM, Bellew SG. Clinical experience with light-emitting diode (LED) photomodulation. Dermatol Surg. 2005 Sep;31(9 Pt 2):1199-205. doi: 10.1111/j.1524-4725.2005.31926."}, {"pmid": "28748217", "type": "BACKGROUND", "citation": "Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19."}, {"pmid": "25653800", "type": "BACKGROUND", "citation": "Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62."}, {"pmid": "16987267", "type": "BACKGROUND", "citation": "Cho S, Park ES, Lee DH, Li K, Chung JH. Clinical features and risk factors for striae distensae in Korean adolescents. J Eur Acad Dermatol Venereol. 2006 Oct;20(9):1108-13. doi: 10.1111/j.1468-3083.2006.01747.x."}, {"pmid": null, "type": "BACKGROUND", "citation": "K. Sawhney, Mossum & Hamblin, Michael. (2014). Low-level light therapy (LLLT) for cosmetics and dermatology. Progress in Biomedical Optics and Imaging - Proceedings of SPIE. 8932. 10.1117/12.2041330."}, {"pmid": "26923916", "type": "BACKGROUND", "citation": "Aldahan AS, Shah VV, Mlacker S, Samarkandy S, Alsaidan M, Nouri K. Laser and Light Treatments for Striae Distensae: A Comprehensive Review of the Literature. Am J Clin Dermatol. 2016 Jun;17(3):239-56. doi: 10.1007/s40257-016-0182-8."}, {"pmid": "28375972", "type": "BACKGROUND", "citation": "Ross NA, Ho D, Fisher J, Mamalis A, Heilman E, Saedi N, Jagdeo J. Striae Distensae: Preventative and Therapeutic Modalities to Improve Aesthetic Appearance. Dermatol Surg. 2017 May;43(5):635-648. doi: 10.1097/DSS.0000000000001079."}, {"pmid": "26580868", "type": "BACKGROUND", "citation": "Mishra V, Miller L, Alsaad SM, Ross EV. The Use of a Fractional Ablative Micro-Plasma Radiofrequency Device in Treatment of Striae. J Drugs Dermatol. 2015 Nov;14(11):1205-8."}, {"pmid": "26147455", "type": "BACKGROUND", "citation": "Ibrahim ZA, El-Tatawy RA, El-Samongy MA, Ali DA. Comparison between the efficacy and safety of platelet-rich plasma vs. microdermabrasion in the treatment of striae distensae: clinical and histopathological study. J Cosmet Dermatol. 2015 Dec;14(4):336-46. doi: 10.1111/jocd.12160. Epub 2015 Jul 6."}, {"pmid": "22374035", "type": "BACKGROUND", "citation": "Mazzarello V, Farace F, Ena P, Fenu G, Mulas P, Piu L, Rubino C. A superficial texture analysis of 70% glycolic acid topical therapy and striae distensae. Plast Reconstr Surg. 2012 Mar;129(3):589e-590e. doi: 10.1097/PRS.0b013e3182419c40. No abstract available."}, {"pmid": "23579949", "type": "BACKGROUND", "citation": "Ud-Din S, McAnelly SL, Bowring A, Whiteside S, Morris J, Chaudhry I, Bayat A. A double-blind controlled clinical trial assessing the effect of topical gels on striae distensae (stretch marks): a non-invasive imaging, morphological and immunohistochemical study. Arch Dermatol Res. 2013 Sep;305(7):603-17. doi: 10.1007/s00403-013-1336-7. Epub 2013 Apr 12."}, {"pmid": null, "type": "BACKGROUND", "citation": "Elson, M. (1994). Topical tretinoin in the treatment of striae distensae and in the promotion of wound healing: A review. Journal of Dermatological Treatment, 5(3), 163-165. doi:10.3109/09546639409084563"}, {"pmid": "9747352", "type": "BACKGROUND", "citation": "Watson RE, Parry EJ, Humphries JD, Jones CJ, Polson DW, Kielty CM, Griffiths CE. Fibrillin microfibrils are reduced in skin exhibiting striae distensae. Br J Dermatol. 1998 Jun;138(6):931-7. doi: 10.1046/j.1365-2133.1998.02257.x."}, {"pmid": "7955466", "type": "BACKGROUND", "citation": "Lee KS, Rho YJ, Jang SI, Suh MH, Song JY. Decreased expression of collagen and fibronectin genes in striae distensae tissue. Clin Exp Dermatol. 1994 Jul;19(4):285-8. doi: 10.1111/j.1365-2230.1994.tb01196.x."}, {"pmid": "1774350", "type": "BACKGROUND", "citation": "Sheu HM, Yu HS, Chang CH. Mast cell degranulation and elastolysis in the early stage of striae distensae. J Cutan Pathol. 1991 Dec;18(6):410-6. doi: 10.1111/j.1600-0560.1991.tb01376.x."}, {"pmid": "22796062", "type": "BACKGROUND", "citation": "Gilmore SJ, Vaughan BL Jr, Madzvamuse A, Maini PK. A mechanochemical model of striae distensae. Math Biosci. 2012 Dec;240(2):141-7. doi: 10.1016/j.mbs.2012.06.007. Epub 2012 Jul 14."}, {"pmid": "28551068", "type": "BACKGROUND", "citation": "Hague A, Bayat A. Therapeutic targets in the management of striae distensae: A systematic review. J Am Acad Dermatol. 2017 Sep;77(3):559-568.e18. doi: 10.1016/j.jaad.2017.02.048. Epub 2017 May 24."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"term": "Skin Manifestations"
}
],
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"abbrev": "BC23",
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"abbrev": "All",
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"browseLeaves": [
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"asFound": "Striae",
"id": "M28905",
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"relevance": "HIGH"
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{
"asFound": null,
"id": "M15680",
"name": "Skin Manifestations",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D057896",
"term": "Striae Distensae"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
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"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
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"asFound": null,
"id": "M4107",
"name": "Anesthetics",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D057896",
"term": "Striae Distensae"
}
],
"interventions": []
} |
NCT03487926 | null | Microglial Activation in Inflammatory Bowel Disease | Naturalistic Monitoring of Microglial Activation in Inflammatory Bowel Disease | None | OBSERVATIONAL | COMPLETED | 2018-01-18T00:00:00 | null | 2024-11-19T00:00:00 | 2024-11-19T00:00:00 | null | 40 | 19 | 65 | ALL | true | The purpose of this study is to monitor microglial activation in participants with inflammatory bowel disease (IBD) and investigate the relationship that exists between these patients and their risk of acquiring major depressive episodes (MDE). Patients with both IBD and MDE will be subsequently approached to participate in the study. | Detailed Description:
Participants may undergo up to 3 PET Scans : \[18F\]FEPPA PET (for TSPO) before and 3 to 6 months later and \[11C\]SL25.1188 PET (for MAO-B) as well as 1 MRI scan.
The primary hypothesis is that :
1. The neuroinflammation (TSPO VT) will be increased in PFC, ACC, and insula regions in those with inflammatory bowel disease (IBD) patients compared to healthy people.
2. The neuroinflammation (TSPO VT) in PFC, ACC, and insula regions will be reduced after treatment for IBD.
The Secondary Hypothesis:
1. Elevations in neuroinflammation (TSPO VT) will be similar in those with ulcerative colitis and Crohn's disease.
2. Neuroinflammation (TSPO VT) will be greater in IBD with depression than in depression without IBD.
3. Biologics (TNFalpha antibody treatments), and fecal transplantation will be associated with greater reduction in neuroinflammation in brain than Sulfasalazine/5-Aminosalicylates.
4. MAO-B VT will be elevated in in the PFC, ACC, and insula in IBD compared to healthy controls.
There will be no alterations to standard care of patients due to participation in the study. | Inclusion Criteria:
* Age 18 to 65
* aside from IBD groups and common comorbidities of IBD, otherwise good physical health with no current active medical conditions.
* a lifetime diagnosis of IBD verified by medical record, which can include prescription for IBD treatment
Exclusion Criteria:
* no history of neurological illness, excluding migraine
* no use of glucocorticoid antagonists or lithium or medications that bind with affinity higher than 500nM to peripheral benzodiazepine receptors (or TSPO) in the previous two months
* no use of herbal remedies in the previous month that would be expected to influence neuroinflammation
* non-cigarette smoking
* no history of abuse of substances that affect mood and negative urine drug screens for substances of abuse including cotinine (urine drug screen is done at screening and on each PET scan day)
* no history of psychotic symptoms
* not pregnant based on a negative pregnancy test (for women)
* not breastfeeding (for women)
* no recent treatment with electroconvulsive therapy or magnetic seizure therapy in the previous 6 months
* no coagulation disorders, or anticoagulant medication use
* no presence of metal objects or implanted electrical devices in the body that would preclude MRI scanning
* no claustrophobia
* no self-reported history of fainting from blood withdrawals
* size and weight does not exceed capacity of scanner, for which size may vary and weight is 350 lbs
* no history of undergoing a number of PET scans that, including the number of PET scans under this protocol, will bring the total to more than 8 PET scans/lifetime, exceeding permissible limit for subjects participating in research set by our centre's guidelines | Centre for Addiction and Mental Health | OTHER | {
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"date": "2025-04-22",
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"date": "2018-04-04",
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"ADULT",
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"Major Depressive Episode",
"Inflammatory Bowel Diseases"
] | null | null | [
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"class": "OTHER",
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"other": null,
"primary": [
{
"description": null,
"measure": "TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula",
"timeFrame": "within 3 to 4 weeks after initiation of screening"
},
{
"description": null,
"measure": "change in TSPO VT in prefrontal cortex, anterior cingulate cortex, and insula before and after 3 to 6 months",
"timeFrame": "3 to 6 months"
},
{
"description": null,
"measure": "MAO-B VT in prefrontal cortex, anterior cingulate cortex, insula in IBD compared to controls",
"timeFrame": "within 3 to 4 weeks after initiation of screening"
}
],
"secondary": [
{
"description": null,
"measure": "TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between Crohns disease and ulcerative colitis",
"timeFrame": "within 3 to 4 weeks of initiating screening of subjects"
},
{
"description": null,
"measure": "TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between IBD with MDE compared to MDE controls",
"timeFrame": "within 3 to 4 weeks after initiation of screening"
},
{
"description": null,
"measure": "change in TSPO VT in prefrontal cortex, anterior cingulate cortex, insula compared between naturalistic treatment with sulfasalazine/5-aminosalicylates versus other interventions like biologics or fecal transplantation",
"timeFrame": "3 to 6 months"
}
]
} | [
{
"affiliation": "Research Imaging Centre, Centre for Addiction and Mental Health",
"name": "Jeffrey H Meyer, M.D.,PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "25629589", "type": "BACKGROUND", "citation": "Setiawan E, Wilson AA, Mizrahi R, Rusjan PM, Miler L, Rajkowska G, Suridjan I, Kennedy JL, Rekkas PV, Houle S, Meyer JH. Role of translocator protein density, a marker of neuroinflammation, in the brain during major depressive episodes. JAMA Psychiatry. 2015 Mar;72(3):268-75. doi: 10.1001/jamapsychiatry.2014.2427."}, {"pmid": "28636705", "type": "BACKGROUND", "citation": "Attwells S, Setiawan E, Wilson AA, Rusjan PM, Mizrahi R, Miler L, Xu C, Richter MA, Kahn A, Kish SJ, Houle S, Ravindran L, Meyer JH. Inflammation in the Neurocircuitry of Obsessive-Compulsive Disorder. JAMA Psychiatry. 2017 Aug 1;74(8):833-840. doi: 10.1001/jamapsychiatry.2017.1567."}, {"pmid": "28939116", "type": "BACKGROUND", "citation": "Holmes SE, Hinz R, Conen S, Gregory CJ, Matthews JC, Anton-Rodriguez JM, Gerhard A, Talbot PS. Elevated Translocator Protein in Anterior Cingulate in Major Depression and a Role for Inflammation in Suicidal Thinking: A Positron Emission Tomography Study. Biol Psychiatry. 2018 Jan 1;83(1):61-69. doi: 10.1016/j.biopsych.2017.08.005. Epub 2017 Aug 12."}, {"pmid": "29269262", "type": "BACKGROUND", "citation": "Li H, Sagar AP, Keri S. Translocator protein (18kDa TSPO) binding, a marker of microglia, is reduced in major depression during cognitive-behavioral therapy. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Apr 20;83:1-7. doi: 10.1016/j.pnpbp.2017.12.011. Epub 2017 Dec 19."}] | {"versionHolder": "2025-06-18"} | {
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NCT06714526 | null | Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy in Symptomatic ICAD | Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy in Symptomatic Intracranial Atherosclerotic Disease: A Pilot Prospective, Randomized, Open-label, Blinded-endpoint (PROBE) Multi- Centre Study | NUANCE-ICAD | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-11-25T00:00:00 | null | null | null | [
"NA"
] | 100 | 40 | null | ALL | false | Stroke is an important cause of death, disability, and memory problems in adults. The build-up of plaque in arteries inside the brain is known as "intracranial atherosclerotic disease" or "ICAD" for short, and can reduce blood flow in the brain. Clopidogrel is a medicine used to prevent strokes because it stops blood from clotting. However, there are some people who do not get as much benefit from Clopidogrel because of differences in their genes; they have a variation in a certain gene and their body is not able to properly process Clopidogrel. Another medication called Ticagrelor can benefit people who have this genetic variation. The study investigators will randomize patients who have had a stroke due to ICAD to receive genetic testing, or standard of care. The standard-of-care group will take Clopidogrel for 90 days. The genetic testing group will complete a genetic test to see if they can properly process Clopidogrel. Depending on the results of the genetic test, patients will either take Clopidogrel or Ticagrelor for 90 days. All patients will have a brain scan at baseline and 90 days to see if they had any new strokes. Patients will also complete tests and questionnaires about function and memory at baseline and 90 days. This study will be one of the first to see if it is feasible and safe to use genetic testing to help choose medications for patients who have had a stroke. This will help the study investigators design a larger study that can test if genetic testing in stroke patients reduces future stroke risk and improves health outcomes. | null | Inclusion Criteria:
* Age ≥ 40 years old, male and female.
* TIA or ischemic stroke secondary to symptomatic atherosclerotic stenosis of 30- 99% involving the intracranial ICA or MCA or posterior circulation arteries as evidenced by CT or MR angiography.
* Index TIA or ischemic stroke event occurred within past 30 days.
* Clinical indication for DAPT for at least 3 months.
Exclusion Criteria:
* Any contraindication to DAPT.
* Any contraindication to use of clopidogrel (Plavix) or ticagrelor (Brilinta), such as pregnancy. A pregnancy test will be performed on all women of child-bearing age prior to enrollment in the study.
* Indication for chronic anticoagulation based on guideline recommendations or investigator's judgment (e.g., atrial fibrillation, mechanical heart valve, intracardiac clot, dilated cardiomyopathy, ejection fraction \<30%, etc.).
* Intracranial arterial occlusion (i.e. 100% stenosis) responsible for the acute brain ischemia.
* Intracranial arterial stenosis secondary to causes other than atherosclerosis.
* Extracranial carotid disease with a plan for carotid revascularization.
* Intraluminal thrombus.
* Unstable subdural hematoma within 12 months of randomization not amenable to embolization.
* Previous spontaneous hemorrhagic stroke.
* Traumatic brain hemorrhage within 1 month of randomization.
* Living in a nursing home or requiring daily nursing care or assistance with activities of daily living.
* Intracranial tumor (except meningioma) or any intracranial vascular malformation.
* Life expectancy less than 6 months.
* Enrolment in another study that would conflict with the current study. | Sunnybrook Health Sciences Centre | OTHER | {
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} | Unknown | {
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} | 2024-11-28T00:00:00 | {
"date": "2025-05-18",
"type": "ACTUAL"
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"date": "2024-12-03",
"type": "ACTUAL"
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"city": "Calgary",
"country": "Canada",
"facility": "University of Calgary",
"geoPoint": {
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"lon": -114.08529
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"country": "Canada",
"facility": "Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario"
}
] | null | null | {
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"description": null,
"measure": "Rate of recruitment",
"timeFrame": "Through study completion, an average of 90 days"
},
{
"description": null,
"measure": "Rate of study completion",
"timeFrame": "Through study completion, an average of 90 days"
},
{
"description": null,
"measure": "Rate of protocol deviations",
"timeFrame": "Through study completion, an average of 90 days"
},
{
"description": null,
"measure": "Proportion of patients with Symptomatic intracerebral hemorrhage (ICH)",
"timeFrame": "Through study completion, an average of 90 days"
},
{
"description": null,
"measure": "Proportion of patients with major extracranial bleeding",
"timeFrame": "Through study completion, an average of 90 days"
},
{
"description": null,
"measure": "Proportion of patients with non-bleeding adverse events",
"timeFrame": "Through study completion, an average of 90 days"
}
],
"secondary": [
{
"description": null,
"measure": "Proportion of patients who have Microembolic Signals on Transcranial Doppler Ultrasound",
"timeFrame": "Day 5 ± 2"
},
{
"description": null,
"measure": "Change in volume of ischemic strokes and white matter hyperintensities (optional)",
"timeFrame": "Day 0 + 14 and Day 90 ± 14"
},
{
"description": null,
"measure": "Change in number of ischemic strokes and white matter hyperintensities",
"timeFrame": "Day 0 + 3 and Day 90 ± 14"
},
{
"description": null,
"measure": "Number of patients with ischemic stroke, myocardial infarction, or death",
"timeFrame": "Day 90 ± 14"
},
{
"description": null,
"measure": "Change in Montreal Cognitive Assessment (MoCA) score from baseline to follow-up",
"timeFrame": "Day 0 and Day 90 ± 14"
},
{
"description": null,
"measure": "Change in NIH Stroke Scale (NIHSS) score from baseline to follow-up",
"timeFrame": "Day 0 and Day 90 ± 14"
},
{
"description": null,
"measure": "Change or shift in modified Rankin Scale (mRS) score from baseline to follow-up",
"timeFrame": "Day 0 and Day 90 ± 14"
},
{
"description": null,
"measure": "Self-reported Quality of Life as assessed by the EQ-5D-5L",
"timeFrame": "Day 90 ± 14"
},
{
"description": null,
"measure": "Self-reported Dementia Screening assessed by the AD8 Dementia Screening Interview",
"timeFrame": "Day 90 ± 14"
},
{
"description": null,
"measure": "Self-reported functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale",
"timeFrame": "Day 90 ± 14"
}
]
} | [
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"affiliation": "Sunnybrook Health Sciences Centre",
"name": "Mark I Boulos, MD",
"role": "PRINCIPAL_INVESTIGATOR"
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] | null | {"versionHolder": "2025-06-18"} | {
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} |
NCT04089826 | null | Long Term Oxygen Therapy in Patients With Interstitial Lung Disease | Role of LTOT in Pateints With ILD | None | OBSERVATIONAL | UNKNOWN | 2019-09-10T00:00:00 | null | null | null | null | 10 | 18 | 70 | ALL | null | Study the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia | long term oxygen can be used in patients with interstitial lung disease with hypoxia and the aim of this study is to k ow whether this will improve life style , exercise tolerance in those patients | Inclusion Criteria :
* patients with ILD and hypoxia with SO2\<88 at room air and PO2 \< or equal 7.3k.pa or \< or equal 8 k.pa in presence of lower limb edema , pulmonary hypertension or polycythemia
* age group 18 : 70
Exclusion Criteria :
* Causes of chronic respiratory failure other than ILD. | Assiut University | OTHER | {
"id": "Role of LTOT in Pateints e ILD",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-09-12T00:00:00 | {
"date": "2019-09-16",
"type": "ACTUAL"
} | {
"date": "2019-09-13",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | patients with ILDs who are prescribed for LTOT between eighteen and seventy years old | NON_PROBABILITY_SAMPLE | null | {
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} | [
"Long Term Oxygen Therapy",
"Interstitial Lung Disease"
] | null | null | null | null | null | {
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"description": null,
"measure": "Dyspnea score improvement",
"timeFrame": "Baseline"
},
{
"description": null,
"measure": "Quality of life improvement",
"timeFrame": "Baseline"
}
],
"secondary": null
} | null | [{"pmid": "30392161", "type": "BACKGROUND", "citation": "Cobo-Ibanez T, Lopez-Longo FJ, Joven B, Carreira PE, Munoz-Fernandez S, Maldonado-Romero V, Larena-Grijalba C, Cubas IL, Muriel ET, Mateos CB, de la Pena Lefebvre PG, Gomez-Gomez A, Nogal LB, Perez A, Almodovar R, Lojo L, Ruiz-Gutierrez L, Lopez-Robledillo JC, Garcia de Yebenes MJ, Nuno-Nuno L. Long-term pulmonary outcomes and mortality in idiopathic inflammatory myopathies associated with interstitial lung disease. Clin Rheumatol. 2019 Mar;38(3):803-815. doi: 10.1007/s10067-018-4353-2. Epub 2018 Nov 3."}] | {"versionHolder": "2025-06-18"} | {
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],
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{
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} | null | {
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NCT01160926 | null | Dual REctcal Angiogenesis or MEK Inhibition radioTHERAPY Trial | Dual Phase I Studies to Determine the Dose of Cediranib (AZD2171) or AZD6244 to Use With Conventional Rectal Chemoradiotherapy | DREAMtherapy | INTERVENTIONAL | TERMINATED | 2010-07-07T00:00:00 | null | null | 2016-11-04T00:00:00 | [
"PHASE1"
] | 31 | 18 | null | ALL | false | To determine the maximum tolerated dose (MTD) of AZD6244 or AZD2171 when combined with pre-operative capecitabine and radiotherapy in patients with locally advanced rectal cancer. | The best curative resection rates reported for patients with operable rectal cancer treated with standard chemoradiotherapy are approximately 50-60%.The pathological complete response rates are only 10-20%. Therefore, there is a need for more effective treatment. In this trial we will evaluate the combination of chemoradiotherapy with either a VEGFR (vascular endothelial growth factor receptor) or MEK (MAP Kinase)inhibitor.
Aims
1. Define the tolerability, MTD (maximum tolerated dose) and DLT (dose limiting toxicities) of chemoradiotherapy in combination with
* cediranib, a VEGF receptor tyrosine kinase inhibitor that inhibits angiogenesis or
* AZD6244, a potent MEK inhibitor that inhibits cell proliferation
2. Define a dose suitable for phase II evaluation
3. Test the impact of the combination on soluble and imaging (FLT-PET and DCEMRI/DWI) biomarkers to guide their use in phase II testing Summary Patients will receive standard chemoradiotherapy plus ascending doses of AZD6244 or cediranib from day -10 (relative to start of chemoradiotherapy) to day 35. If feasible, patients' tumours will be resected 10-12 weeks after treatment. Translational studies on available tissue and blood will be performed and DCE-MRI/DWI and FLT-PET will be carried out on 5 patients in the expanded cohort for AZD6244 (FLT-PET and DCE-MRI) and 5 patients in the expanded cohort for cediranib (DCE-MRI).
Cohorts Cediranib - 15mg od, 20mg od and 30mg od AZD6244 - 50mg bd and 75mg bd | Inc Criteria:
* Histologically confirmed rectal adenocarcinoma
* MRI (magnetic resonance imaging) and triphasic CT (computerised tomography) defined locally advanced rectal cancer:
* Mesorectal fascia involved or
* Mesorectal fascia threatened or
* Any T3 tumours \< 5cm from the anal verge
* Primary resection unlikely to achieve clear margins
* No previous chemotherapy or radiotherapy for rectal cancer
* Bone marrow function: absolute neutrophil count ≥1.5 x109/l and platelet count \>100 x109/l
* Hepatobiliary function: serum bilirubin \<1.5 x upper limit of normal (ULN); serum ALP \<5 x ULN; serum transaminase (AST or ALT) \<2.5 x ULN
* Renal function: Serum creatinine clearance \>50mL/min by either Cockcroft-Gault formula or EDTA (ethylenediaminetetraacetic acid) clearance
* ECOG PS(Eastern Cooperative Oncology Group Performance Status) 0-1
* Disease can be encompassed within a radical radiotherapy treatment volume
* No pre-existing condition which would deter radiotherapy, e.g. fistulas, severe ulcerative colitis, Crohn's disease, prior adhesions
* For women of child-bearing potential a negative pregnancy test is required and adequate contraceptive precautions such as a condom for their partner must be used. For men - adequate contraception must be used.
* Fit to receive all study treatments
* Able to comply with oral medication and protocol
* Signed, written and dated informed consent.
* Life expectancy ≥ 3 months.
Exc Criteria:
* Concurrent uncontrolled medical illness, or other previous/current malignant disease likely to interfere with protocol treatments
* Age\<18
* Any pregnant, lactating women or potentially childbearing patients not using adequate contraception
* Previous chemotherapy or radiotherapy for rectal cancer
* Metastatic disease
* ECOG PS\>1
* Patients who have very significant small bowel delineated within the radiation fields.
* Current or impending rectal obstruction (unless defunctioning stoma present), metallic colonic rectal stent in situ
* Pelvic sepsis.
* Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude trial therapy or informed consent.
* Cardiac conditions as follows:
* Uncontrolled hypertension (resting BP ≥150/95mmHg despite optimal therapy)
* Heart failure NYHA Class II or above
* Prior or current cardiomyopathy
* Atrial fibrillation with heart rate \>100 bpm
* Unstable ischaemic heart disease
* Refractory nausea and vomiting, chronic gastrointestinal diseases, or significant bowel resection that would preclude adequate absorption of trial drug
* Patients who are deemed unsuitable for surgery because of co-morbidity or coagulation problems.
* Recent (\<14 days) major thoracic or abdominal surgery prior to entry into the study or a surgical incision that is not fully healed which would prevent administration of study treatment
* Known DPD (dihydropyrimidine dehydrogenase)deficiency
* Patients suffering from any condition that may affect the absorption of capecitabine or IMP (investigational medical product)
* Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have Hep B, Hep C or HIV
* Mean QTc with Bazetts correction \>470msec in screening ECG or history of familial long QT syndrome
EXC CRITERIA (AZD6244 cohorts)
* KRAS (Kirsten ras sarcoma viral oncogene) wild-type
* Prior treatment with a MEK inhibitor
* Baseline LVEF (left ventricular ejection fraction) ≤50%
EXC CRITERIA (Cediranib cohorts)
* Known hypersensitivity to Cediranib or any of its excipients
* Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein \< 1.5g in a 24 hr period or protein/creatinine ratio \< 1.5.
* Significant haemorrhage (\>30mL bleeding/episode in previous 3 months) or haemoptysis (\>5mL fresh blood in previous 4 weeks)
* APTT ratio \> 1.5 x ULN
* Arterial thromboembolic event (including ischemic attack) in the previous 12 months | The Christie NHS Foundation Trust | OTHER | {
"id": "09_DOG03_184",
"link": null,
"type": null
} | 2 DLTs had been reported from first 4 patients on lowest possible dose cohort. | {
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} | 2010-07-12T00:00:00 | {
"date": "2023-04-24",
"type": "ACTUAL"
} | {
"date": "2010-07-13",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
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} | [
"Rectal Cancer"
] | ["rectal cancer", "capecitabine", "radiotherapy", "AZD6244", "MEK inhibitor", "AZD2171", "Cediranib", "VEGFR inhibitor", "FLT-PET (fluoro-l-pyrimidine positron emission tomography)", "DCE-MRI (dynamic contrast enhanced magnetic resonance imaging)"] | null | [
{
"city": "Manchester",
"country": "United Kingdom",
"facility": "The Christie NHS Foundation Trust",
"geoPoint": {
"lat": 53.48095,
"lon": -2.23743
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "Cancer Research UK"
},
{
"class": "INDUSTRY",
"name": "AstraZeneca"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To determine the MTD (maximum tolerated dose) of AZD6244 or AZD2171 when combined with pre-operative capecitabine and radiotherapy in patients with locally advanced rectal cancer.",
"timeFrame": "At point of surgery (10-12 weeks post treatment)"
}
],
"secondary": [
{
"description": null,
"measure": "Grade 3 or 4 toxicity",
"timeFrame": "Up to point of surgery and long-term effects monitored for 3 years post treatment"
},
{
"description": null,
"measure": "Radiotherapy compliance",
"timeFrame": "for the 5 weeks of chemoradiotherapy"
},
{
"description": null,
"measure": "MRI (Magnetic Resonance Imaging)Response Rate",
"timeFrame": "8 weeks post chemoradiation - at point of MRI scan"
},
{
"description": null,
"measure": "Histologically confirmed R0 resection rate",
"timeFrame": "10-12 weeks post chemoradiation - at time of surgery"
},
{
"description": null,
"measure": "Pathological Complete Response (pCR)",
"timeFrame": "10-12 weeks post chemoradiation - at point of surgery"
},
{
"description": null,
"measure": "Morbidity - post operative and long term",
"timeFrame": "3 years post chemoradiation"
},
{
"description": null,
"measure": "To explore biological and radiological markers of response or toxicity",
"timeFrame": "Various timepoints up to point of surgery"
}
]
} | [
{
"affiliation": "The Christie NHS Foundation Trust",
"name": "Mark P Saunders, MBBS",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D015179",
"term": "Colorectal Neoplasms"
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{
"id": "D007414",
"term": "Intestinal Neoplasms"
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{
"id": "D005770",
"term": "Gastrointestinal Neoplasms"
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{
"id": "D004067",
"term": "Digestive System Neoplasms"
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],
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"relevance": "LOW"
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"relevance": "LOW"
}
],
"meshes": [
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"term": "Rectal Neoplasms"
}
]
} | {
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"term": "Antineoplastic Agents"
},
{
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{
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"term": "Enzyme Inhibitors"
},
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"relevance": "HIGH"
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"relevance": "LOW"
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"id": "C500926",
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NCT02432326 | null | A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors | A Phase Ib Clinical Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors | None | INTERVENTIONAL | COMPLETED | 2015-04-28T00:00:00 | null | null | null | [
"PHASE1"
] | 147 | 18 | null | ALL | false | This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally in combination to patients with advanced solid tumors. The primary goal is to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen. | null | Inclusion Criteria
1. Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
2. A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard therapies do not exist or are no longer effective
a. Patients must not be considered eligible for a potentially curative resection
3. ≥ 18 years of age
4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last dose
7. Females of childbearing potential must have a negative serum pregnancy test
8. Aspartate transaminase (AST) \< 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ≤ 2.5 × ULN.
1. Patients who do not have hepatocellular carcinoma but who have liver lesions or liver metastases may be eligible if they have AST \< 3.5 x ULN and AST \< 3.5 x ULN if agreed upon by the investigator and medical monitor for the sponsor.
2. Patients with hepatocellular carcinoma may be eligible provided they have AST and ALT that are ≤ 5.0 x ULN.
9. Hemoglobin (Hgb) ≥ 9 g/dL
10. Total bilirubin ≤ 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin ≤ 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor.
1. Patients with hepatocellular carcinoma may be eligible provided they have total bilirubin ≤ 3.0 x ULN and are considered Child-Pugh Class A or Child-Pugh Class B7 (Child-Pugh Class B with a total Child-Pugh score not to exceed 7).
2. Patients with Gilbert's syndrome uncomplicated by other liver disease may be eligible if agreed upon by the investigator and medical monitor for the sponsor.
11. Creatinine ≤ 1.5 × ULN or, for patients with creatinine levels above institutional upper limit of normal, creatinine clearance must be \> 60 mL/min/1.73 m\^2.
12. Absolute neutrophil count ≥ 1.5 x 10\^9/L
13. Platelets ≥ 100 x 10\^9/L; patients with hepatocellular carcinoma may enroll provided they have a platelet count ≥ 75 x 10\^9/L.
14. Life expectancy ≥ 3 months
Exclusion Criteria
1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI608 and BBI503. Patients may begin BBI608 and BBI503 on a date determined by the investigator and medical monitor for the sponsor after a minimum of 7 days since last receiving anti-cancer treatment, provided that all treatment-related adverse effects have resolved or have been deemed irreversible
2. Surgery within 4 weeks prior to first dose
3. Any known untreated brain metastases. Treated subjects must be stable 4 weeks after completion of treatment for brain metastases and image documented stability is required. Patients must have no clinical symptoms from brain metastases and must be either off of steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated
4. Pregnant or breastfeeding
5. Significant gastrointestinal disorder(s) (e.g., active Crohn's disease or ulcerative colitis, or a history of extensive gastric resection and/or small intestinal resection) such that absorption of oral medications is impaired.
6. Unable or unwilling to swallow BBI608 and/or BBI503 capsules daily
7. Prior treatment with either BBI608 or BBI503
8. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or on mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
9. Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; and c) other primary solid tumors (with no known active disease present) that, in the opinion of the investigator, will not affect patient outcome in the setting of the current diagnosis
1. Patients with adenocarcinoma of unknown primary are excluded
2. Patients with a diagnosis of two co-existing primary cancers are excluded
10. Abnormal ECGs that are clinically significant such as QT prolongation (QTc \> 480 msec), clinically significant cardiac enlargement or hypertrophy, new bundle branch block or existing left bundle branch block, or signs of new, active ischemia a. Patients with evidence of prior infarction who are New York Heart Association (NYHA) functional class II, III, or IV are excluded, as are patients with marked arrhythmia such as Wolff Parkinson White pattern or complete atrioventricular (AV) dissociation | Sumitomo Pharma America, Inc. | INDUSTRY | {
"id": "BBI401-101",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-05-01T00:00:00 | {
"date": "2023-11-08",
"type": "ACTUAL"
} | {
"date": "2015-05-04",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
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"maskingDescription": null,
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Cancer",
"Advanced Solid Tumors"
] | ["Neoplasms"] | null | [
{
"city": "Chicago",
"country": "United States",
"facility": "University of Chicago Medicine Comprehensive Cancer Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
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"state": "Illinois"
},
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"country": "United States",
"facility": "Indiana University Simon Cancer Center",
"geoPoint": {
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"state": "Indiana"
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"country": "United States",
"facility": "Texas Oncology - Fort Worth 12th Ave",
"geoPoint": {
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"lon": -97.32085
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"state": "Texas"
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"country": "United States",
"facility": "Texas Oncology, P.A.",
"geoPoint": {
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"lon": -98.49363
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"state": "Texas"
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"country": "United States",
"facility": "Texas Oncology, P.A.",
"geoPoint": {
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"state": "Texas"
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"country": "United States",
"facility": "Texas Oncology - Tyler",
"geoPoint": {
"lat": 32.35126,
"lon": -95.30106
},
"state": "Texas"
},
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"city": "Fairfax",
"country": "United States",
"facility": "Virginia Cancer Specialists, PC",
"geoPoint": {
"lat": 38.84622,
"lon": -77.30637
},
"state": "Virginia"
},
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"city": "Vancouver",
"country": "United States",
"facility": "Northwest Cancer Specialists, PC",
"geoPoint": {
"lat": 45.63873,
"lon": -122.66149
},
"state": "Washington"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Determination of the safety and tolerability of BBI608 and BBI503 when administered in combination by assessing dose-limiting toxicities (DLTs)",
"timeFrame": "4 weeks"
},
{
"description": null,
"measure": "Determination of the Recommended Phase 2 Dose of BBI608 and BBI503 when administered in combination based on DLT criteria, pharmacokinetic/pharmacodynamic observations and tolerability overall",
"timeFrame": "20 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Pharmacokinetic profile of BBI608 and BBI503 when administered in combination as assessed by maximum plasma concentration and area under the curve.",
"timeFrame": "-5min, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hours on day 1, cycles 1 and 2"
},
{
"description": null,
"measure": "Pharmacodynamic activity assessed by tumor biopsy",
"timeFrame": "4 weeks"
},
{
"description": null,
"measure": "Assessment of the preliminary anti-tumor activity by performing tumor assessments",
"timeFrame": "16 weeks"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": null,
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"meshes": [
{
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"term": "Neoplasms"
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NCT03997526 | null | 3C Patch® Medicare Claims Study | Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study | None | OBSERVATIONAL | TERMINATED | 2019-06-21T00:00:00 | null | 2022-02-21T00:00:00 | 2022-02-21T00:00:00 | null | 22 | null | null | ALL | false | This prospective study will compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care, tested against a historical control group of similar patients that received usual care during a randomized controlled trial. | This is a prospective, observational, longitudinal, claims-based study with a historical control group. Data will be collected via claim forms and will be extracted directly from the Centers for Medicare \& Medicaid Services (CMS) Medicare Research Identifiable Files (RIFs), which contain all medical claims for 100% of Medicare beneficiaries enrolled in the Medicare fee-for-service program. The study will be conducted in accordance with relevant guidelines of a central institutional review board (IRB), relevant informed consent regulations, and all other applicable regulatory requirements. | Inclusion Criteria:
* Medicare beneficiaries diagnosed with diabetic foot ulcer and receiving at least one treatment with the 3C Patch® System.
* Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four week period prior to the first application of the 3C Patch® (percentage change in cross-sectional area determined clinically by the treating physician by estimation at examination).
* Eligible ulcer's cross-sectional area will increase by less than 25% during a 4-week period prior to the first application of the 3C Patch® (percentage change determined clinically by treating physician by estimation at examination)
* The cross-sectional area of the index ulcer will be ≥50 and ≤1000 mm2 at the end of the 4 week period prior to the first application of the 3C Patch® (size determined clinically by the treating physician by estimation at examination).
* Participants will have the capacity to understand study procedures, and will be able to provide written informed consent.
Exclusion Criteria:
* Presence of sickle-cell anemia, hemophilia, thrombocytopenia (\<100x109/L) or other clinically significant blood dyscrasia
* Known potential infectivity of blood products, including known HIV and hepatitis
* Patient in dialysis
* Clinical signs of infection of the index ulcer or reason to suspect that infection is present
* Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to the first application of the 3C Patch®
* Current treatment with cytotoxic drugs or with systemically administered glucocorticoids or other immunosuppressants
* Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the 8 weeks prior to the first application of the 3C Patch®
* The need for continued use of negative pressure wound therapy
* Likely inability to comply with the need for follow up visits because of planned activity
* Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to the first application of the 3C Patch®
* Prior enrollment in this study
* Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent | Reapplix | OTHER | {
"id": "REAPCEDUS01",
"link": null,
"type": null
} | CMS status changed - 3C Patch is now fully covered (NCD) - Medicare will no longer be collecting claims under CED | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-06-22T00:00:00 | {
"date": "2022-03-09",
"type": "ACTUAL"
} | {
"date": "2019-06-25",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Medicare beneficiaries diagnosed with diabetic foot ulcer | PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Diabetic Foot Ulcer"
] | ["3C Patch", "Reapplix", "LeucoPatch"] | null | [
{
"city": "Phoenix",
"country": "United States",
"facility": "Mayo Clinic",
"geoPoint": {
"lat": 33.44838,
"lon": -112.07404
},
"state": "Arizona"
},
{
"city": "Natchitoches",
"country": "United States",
"facility": "Natchitoches Regional Medical Center",
"geoPoint": {
"lat": 31.76072,
"lon": -93.08627
},
"state": "Louisiana"
},
{
"city": "Opelousas",
"country": "United States",
"facility": "Opelousas General Hospital Wound Center",
"geoPoint": {
"lat": 30.53353,
"lon": -92.08151
},
"state": "Louisiana"
},
{
"city": "Cape Girardeau",
"country": "United States",
"facility": "Southeast Wound Care and Hyperbaric Medical Center",
"geoPoint": {
"lat": 37.30588,
"lon": -89.51815
},
"state": "Missouri"
},
{
"city": "Poplar Bluff",
"country": "United States",
"facility": "Regional One Physician Specialists",
"geoPoint": {
"lat": 36.757,
"lon": -90.39289
},
"state": "Missouri"
},
{
"city": "Chapel Hill",
"country": "United States",
"facility": "UNC Chapel Hill",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Complete healing",
"timeFrame": "within 20 weeks of the first application of the 3C Patch."
}
],
"secondary": [
{
"description": null,
"measure": "Number of 3C Patch® treatments administered",
"timeFrame": "20 weeks"
},
{
"description": null,
"measure": "Major amputation - target limb",
"timeFrame": "24 weeks"
},
{
"description": null,
"measure": "Major amputation - contralateral limb",
"timeFrame": "24 weeks"
},
{
"description": null,
"measure": "Minor amputation - target limb",
"timeFrame": "24 weeks"
},
{
"description": null,
"measure": "Minor amputation - contralateral limb",
"timeFrame": "24 weeks"
}
]
} | null | [{"pmid": "30243803", "type": "BACKGROUND", "citation": "Game F, Jeffcoate W, Tarnow L, Jacobsen JL, Whitham DJ, Harrison EF, Ellender SJ, Fitzsimmons D, Londahl M; LeucoPatch II trial team. LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):870-878. doi: 10.1016/S2213-8587(18)30240-7. Epub 2018 Sep 19."}, {"pmid": "25853474", "type": "BACKGROUND", "citation": "Londahl M, Tarnow L, Karlsmark T, Lundquist R, Nielsen AM, Michelsen M, Nilsson A, Zakrzewski M, Jorgensen B. Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study. J Wound Care. 2015 Apr;24(4):172-4, 176-8. doi: 10.12968/jowc.2015.24.4.172."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003925",
"term": "Diabetic Angiopathies"
},
{
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"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D007871",
"term": "Leg Ulcer"
},
{
"id": "D012883",
"term": "Skin Ulcer"
},
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},
{
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},
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},
{
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"term": "Endocrine System Diseases"
},
{
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"term": "Diabetic Neuropathies"
},
{
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"term": "Foot Diseases"
}
],
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
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"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
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"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
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"name": "Nervous System Diseases"
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],
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"relevance": "LOW"
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},
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],
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"term": "Diabetic Foot"
},
{
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"term": "Foot Ulcer"
}
]
} | null | {
"conditions": [
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"term": "Diabetic Foot"
},
{
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}
],
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} |
NCT06630026 | null | Examining the Validity and Reliability of the Dresden Falls Questionnaire in Patients with Parkinson's Diagnosis Living in Turkey | Examining the Validity and Reliability of the Dresden Falls Questionnaire in Patients with Parkinson's Diagnosis Living in Turkey | DREFAQ | OBSERVATIONAL | NOT_YET_RECRUITING | 2024-10-04T00:00:00 | null | 2024-12-15T00:00:00 | 2024-12-30T00:00:00 | null | 50 | 18 | 80 | ALL | false | The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ) to Turkish society and to make its validity and reliability in Turkish. The DREFAQ) scale developed by Frank, Anika, et al assesses falls in patients with Parkinson. It has 5 questions. This study will be conducted with Parkinson patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 50 participants will be included in the study. In order to evaluate the validity of the DREFAQ, the Modified Falls Efficacy Scale (MFES), which can evaluate the efficacy of falls and has been validated in Turkish, and the Parkinson's Disease Quality of Life (PDQOL) questionnaire, which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability. | The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.
The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, Frank, Anika, et al approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of DREFAQ will be able to be modified. The data of DREFAQ are collecting through face-to-face when the patients came to the rehabilitation center. 50 participants will be included in the study.
In order to evaluate the validity of the DREFAQ, the Modified Falls Efficacy Scale (MFES), which can evaluate the efficacy of falls and has been validated in Turkish, and the Parkinson's Disease Quality of Life (PDQOL) questionnaire, which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability. | Inclusion Criteria:
* Individuals with a Hoehn \& Yahr score between 1-4,
* Individuals who can ambulate with or without assistive equipment,
* Individuals with a Mini Mental State Examination score of \>24,
* Individuals with a history of falling at least once in the last year,
Exclusion Criteria:
* communication or cognitive problems,
* aphasia and speech disorders
* unstable medical conditions | Istanbul Medeniyet University | OTHER | {
"id": "2024/115 DREFAQ",
"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"
] | Parkinson patients who are aged 18-80 years with Hoehn \& Yahr score between 1-4 and able to speak and read Turkish. | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Parkinson Disease",
"Falls",
"Scale Reliability Validity"
] | ["Parkinson disease", "Falls", "Scale reliability validity"] | null | [
{
"city": "İstanbul",
"country": "Turkey",
"facility": "İstanbul Medeniyet University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Falls",
"timeFrame": "Baseline"
},
{
"description": null,
"measure": "Falls Efficacy",
"timeFrame": "Baseline"
}
],
"secondary": [
{
"description": null,
"measure": "Quality of Life",
"timeFrame": "Baseline"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D020734",
"term": "Parkinsonian Disorders"
},
{
"id": "D001480",
"term": "Basal Ganglia Diseases"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D009069",
"term": "Movement Disorders"
},
{
"id": "D000080874",
"term": "Synucleinopathies"
},
{
"id": "D019636",
"term": "Neurodegenerative Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
}
],
"browseLeaves": [
{
"asFound": "Parkinson's",
"id": "M13213",
"name": "Parkinson Disease",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M22494",
"name": "Parkinsonian Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M25603",
"name": "Ganglion Cysts",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16358",
"name": "Synovial Cyst",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4774",
"name": "Basal Ganglia Diseases",
"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": "M12029",
"name": "Movement Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2217",
"name": "Synucleinopathies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21558",
"name": "Neurodegenerative Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D010300",
"term": "Parkinson Disease"
}
]
} | null | {
"conditions": [
{
"id": "D010300",
"term": "Parkinson Disease"
}
],
"interventions": null
} |
NCT05089526 | null | Opioid-free Anesthesia in Laparoscopic Cholecystectomies | Opioid-free Anesthesia With a Mixture of Dexmedetomidine-lidocaine-ketamine in Laparoscopic Cholecystectomies | None | INTERVENTIONAL | UNKNOWN | 2021-10-10T00:00:00 | null | 2023-06-30T00:00:00 | 2023-06-30T00:00:00 | [
"NA"
] | 70 | 25 | 75 | ALL | false | The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic cholecystectomies | Inadequately treated postoperative pain after laparoscopic cholecystectomy may untowardly affect early recovery and also lead to the development of chronic pain. Laparoscopic surgery is associated with diminished postoperative pain but this does not mean that patients subjected to laparoscopic operations are not in need for analgesia intra- and postoperatively. Pneumoperitoneum can lead to postoperative discomfort and occasionally intense postoperative shoulder pain. Opioid-based analgesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia.
Therefore, in recent years research has focused on the quest for non-opioid-based regimens for perioperative analgesia in the context of multimodal analgesic techniques. These techniques have been shown to possess significant advantages, such as allowing earlier mobilization after surgery, early resumption of enteral feeding and reduced hospital length of stay. In this context, the intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control, reduce opioid consumption and improve the quality of postoperative functional recovery after general anesthesia. Intraoperative infusions of ketamine (an N-methyl-D-aspartate receptor inhibitor) have also been correlated with reduced pain scores and a decrease in analgesic requirements postoperatively. Lastly, dexmedetomidine is a highly selective alfa-2 adreno-ceptor agonist that provides sedation, analgesia, and sympatholysis. Its perioperative intravenous administration has been associated with a reduction in postoperative pain intensity, analgesic consumption and nausea. There is insufficient data in literature investigating the effect of combinations of these agents intraoperatively. It would be of interest to demonstrate whether the administration of combinations can be used towards the achievement of a completely opioid-free anesthetic regimen. Additionally, it can be hypothesized that the combination of non-opioid drugs with different targets can lead to enhanced postoperative recovery, an improved opioid-sparing effect and a decrease in the development of chronic pain as compared to the administration of opioids. Therefore, the aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine-ketamine-dexmedetomidine versus fentanyl on recovery profile and postoperative pain after elective laparoscopic cholecystectomy. | Inclusion Criteria:
* adult patients
* American Society of Anesthesiologists (ASA) classification I-II
* elective laparoscopic cholecystectomy
Exclusion Criteria:
* body mass index (BMI) \>35 kg/m2
* contraindications to local anesthetic administration or non-steroidal agents administration
* systematic use of analgesic agents preoperatively
* chronic pain syndromes preoperatively
* neurological or psychiatric disease on treatment
* pregnancy
* severe hepatic or renal disease
* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
* bradycardia(\<55 beats/minute)
* drug or alcohol abuse
* language or communication barriers lack of informed consent | Aretaieion University Hospital | OTHER | {
"id": "lap-chol-opioid free",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-10-10T00:00:00 | {
"date": "2023-02-24",
"type": "ACTUAL"
} | {
"date": "2021-10-22",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Pain, Postoperative",
"Pain, Acute",
"Pain, Chronic",
"Cholecystectomy",
"Ketamine",
"Dexmedetomidine",
"Lidocaine",
"Central Nervous System Depressants",
"Analgesia",
"Analgesics",
"Analgesic Non-narcotic"
] | null | null | [
{
"city": "Athens",
"country": "Greece",
"facility": "Evangelismos General Hospital",
"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
},
"state": null
}
] | null | null | {
"other": [
{
"description": null,
"measure": "time to emergence",
"timeFrame": "up to 2-3 hours after start of surgery"
},
{
"description": null,
"measure": "time to extubation",
"timeFrame": "up to 2-3 hours after start of surgery"
}
],
"primary": [
{
"description": null,
"measure": "pain score on arrival to Post-Anesthesia Care Unit (PACU)",
"timeFrame": "immediately postoperatively"
},
{
"description": null,
"measure": "pain score at discharge from Post-Anesthesia Care Unit (PACU)",
"timeFrame": "at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively"
},
{
"description": null,
"measure": "pain score 3 hours postoperatively",
"timeFrame": "3 hours postoperatively"
},
{
"description": null,
"measure": "pain score 6 hours postoperatively",
"timeFrame": "6 hours postoperatively"
},
{
"description": null,
"measure": "pain score 24 hours postoperatively",
"timeFrame": "24 hours postoperatively"
}
],
"secondary": [
{
"description": null,
"measure": "Post Anesthesia Care Unit (PACU) duration of stay",
"timeFrame": "immediately postoperatively"
},
{
"description": null,
"measure": "sedation on arrival to Post-Anesthesia Care Unit",
"timeFrame": "immediately postoperatively"
},
{
"description": null,
"measure": "sedation at discharge from Post-Anesthesia Care (PACU) Unit",
"timeFrame": "at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively"
},
{
"description": null,
"measure": "sevoflurane consumption during general anesthesia",
"timeFrame": "change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours"
},
{
"description": null,
"measure": "time to first request for analgesia",
"timeFrame": "during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively"
},
{
"description": null,
"measure": "morphine consumption in Post-Anesthesia Care Unit (PACU)",
"timeFrame": "immediately postoperatively"
},
{
"description": null,
"measure": "tramadol consumption in the first 24 hours",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "sleep quality",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "first mobilization after surgery",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "gastrointestinal recovery after surgery",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "satisfaction from postoperative analgesia",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "first fluid intake",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "first solid intake",
"timeFrame": "24 hours postoperatively"
},
{
"description": null,
"measure": "hospitalization time",
"timeFrame": "96 hours postoperatively"
},
{
"description": null,
"measure": "fentanyl requirement during surgery",
"timeFrame": "intraoperatively"
},
{
"description": null,
"measure": "side effects intraoperatively",
"timeFrame": "intraoperatively"
},
{
"description": null,
"measure": "side effects postoperatively",
"timeFrame": "48 hours postoperatively"
},
{
"description": null,
"measure": "incidence of chronic pain 1 month after surgery",
"timeFrame": "1 month after surgery"
},
{
"description": null,
"measure": "incidence of chronic pain 3 months after surgery",
"timeFrame": "3 months after surgery"
}
]
} | [
{
"affiliation": "Aretaieion University Hospital",
"name": "Kassiani Theodoraki",
"role": "PRINCIPAL_INVESTIGATOR"
}
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NCT02112526 | null | Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma | An Open-label, Phase 1b Study of ACP 196 in Subjects With Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma | None | INTERVENTIONAL | COMPLETED | 2014-04-10T00:00:00 | null | 2020-06-30T00:00:00 | 2024-10-04T00:00:00 | [
"PHASE1"
] | 21 | 18 | null | ALL | false | To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL). | null | Inclusion Criteria:
* Men and women ≥ 18 years of age.
* Pathologically confirmed de novo ABC DLBCL
* Relapsed or refractory disease
* Subjects must have ≥ 1 measurable disease sites
Exclusion Criteria:
* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF \< 50%
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Breast feeding or pregnant | Acerta Pharma BV | INDUSTRY | {
"id": "ACE-LY-002",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-04-11T00:00:00 | {
"date": "2024-12-20",
"type": "ACTUAL"
} | {
"date": "2014-04-14",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)"
] | ["de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma", "Diffuse Large B-Cell Lymphoma", "de Novo Activated B-cell (ABC)", "de Novo Activated B-cell", "ABC DLBCL", "DLBCL", "Lymphoma", "B-Cell", "Immunoproliferative Disorders", "Immune System Diseases", "Bruton's tyrosine kinase"] | null | [
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"country": "United States",
"facility": "Research Site",
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"lat": 34.05223,
"lon": -118.24368
},
"state": "California"
},
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"city": "Atlanta",
"country": "United States",
"facility": "Research Site",
"geoPoint": {
"lat": 33.749,
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"facility": "Research Site",
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] | null | null | {
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"description": null,
"measure": "Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.",
"timeFrame": "SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose."
}
],
"secondary": [
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"description": null,
"measure": "Area Under the Plasma Concentration (AUC)",
"timeFrame": "1 Cycle (28 days)"
},
{
"description": null,
"measure": "Maximum Observed Plasma Concentration (Cmax)",
"timeFrame": "1 Cycle (28 days)"
},
{
"description": null,
"measure": "Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)",
"timeFrame": "2 Cycles (1 cycle = 28 days) and at end of treatment"
},
{
"description": null,
"measure": "Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)",
"timeFrame": "From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)"
}
]
} | [
{
"affiliation": "1-877-240-9479; [email protected]",
"name": "AstraZeneca Clinical Trials",
"role": "STUDY_DIRECTOR"
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] | null | {"versionHolder": "2025-06-18"} | {
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} | {
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NCT01758926 | null | Association Between Inflammatory Activities and Gap Density | Association Between Inflammatory Activities and Epithelial Gap Density in Inflammatory Bowel Disease | None | OBSERVATIONAL | UNKNOWN | 2012-12-27T00:00:00 | null | null | null | null | 50 | 18 | 80 | ALL | true | The study aims to:
1. To determine the relationship between inflammatory activities and epithelial gaps in IBD by CLE and evaluate epithelial gaps healing via dexamethasone treatment.
2. To demonstrated the alteration of local barrier function in IBD using CLE. | The primary end-point of this study was the cohort comparison of epithelial gap density and local barrier function as determined by CLE of subjects with IBD versus controls. Despite discontinuities in the cellular layer, the intestinal barrier function is maintained during this high cell turnover rate at the apical pole of the epithelial layer. Gaps first identified in vivo through acriflavine have pivotal definitions (lacked nuclei or cytosol, appeared to be filled with an impermeable substance). However, Current endoscopic technology does not identify whether there is material present in human gaps, so investigators could not formally resolve whether human epithelial gaps compromise or defend the epithelial barrier. | Inclusion Criteria:
* Male or Female aged 18-80
* IBD： Patients previously diagnosed as having IBD
* Health control: Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
* Subjects who experienced successful intubation of the terminal ileum.
Exclusion Criteria:
* Subjects age \< 18 or \>80 years
* Subjects under conditions unsuitable for performing CLE including coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 s), cirrhosis, renal dysfunction (creatinine level \>1.2 mg/dL), pregnancy or breastfeeding, acute gastrointestinal bleeding, jaundice and known allergy to fluorescein sodium. | Shandong University | OTHER | {
"id": "2012SDU-QILU-G03",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-12-27T00:00:00 | {
"date": "2013-01-01",
"type": "ESTIMATED"
} | {
"date": "2013-01-01",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department. | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Inflammatory Bowel Disease"
] | ["Inflammatory Bowel Disease", "Confocal Laser Endomicroscopy"] | null | [
{
"city": "Jinan",
"country": "China",
"facility": "Department of Gastroenterology, Qilu Hospital, Shandong University",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "gap density",
"timeFrame": "6 months"
}
],
"secondary": [
{
"description": null,
"measure": "local barrier function",
"timeFrame": "6 months"
}
]
} | [
{
"affiliation": "Department of Gastroenterology, Qilu Hospital",
"name": "Yanqing Li, MD, PhD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D005767",
"term": "Gastrointestinal Diseases"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D005759",
"term": "Gastroenteritis"
}
],
"browseBranches": [
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Bowel Disease",
"id": "M10444",
"name": "Intestinal Diseases",
"relevance": "HIGH"
},
{
"asFound": "Inflammatory Bowel Disease",
"id": "M17917",
"name": "Inflammatory Bowel Diseases",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8875",
"name": "Gastroenteritis",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D015212",
"term": "Inflammatory Bowel Diseases"
}
]
} | null | {
"conditions": [
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D015212",
"term": "Inflammatory Bowel Diseases"
}
],
"interventions": null
} |
NCT04066426 | null | Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain | Analgesic Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain: A Randomized Double-blind Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2019-08-17T00:00:00 | null | 2019-04-01T00:00:00 | 2019-07-15T00:00:00 | [
"PHASE4"
] | 200 | 18 | 69 | ALL | false | Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen in the dental clinics. Many factors work together to initiate or aggravate the condition, so it is a multifactorial disorder. The etiology of TMDs may be a result of parafunctional habits such as clenching and bruxism, acute trauma to the jaw, trauma from hyperextension e.g. after a long dental treatment, joint laxity, psychological distress, occlusal disharmony like presence of high crown or free-end saddle leading to joint instability or systemic diseases such as Rheumatoid arthritis or Osteoarthritis. The aim of this study was to evaluate the effects of naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, and naproxen sodium on pain in patients complaining from temporomandibular pain. | null | Inclusion Criteria:
* Without a systemic disease,
* Not used any medication in the last week
* Have a habit of clenching and / or grinding teeth, individuals with normal preoperative results, suffering with pain and / or limitation of the mouth opening in the temporomandibular region
Exclusion Criteria:
Individuals who smoke
* Have a parafunctional habits (except for squeezing and grinding teeth)
* Pregnant and breastfeeding individuals
* Allergies to study medicines
* Do not use their medications / use different drugs and non-follow-up | Yuzuncu Yıl University | OTHER | {
"id": "16.02.2018/12",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-08-22T00:00:00 | {
"date": "2021-02-15",
"type": "ACTUAL"
} | {
"date": "2019-08-26",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Temporomandibular Disorder"
] | ["naproxen sodium", "codeine phosphate", "dexamethasone", "pain", "temporomandibular joint"] | null | [
{
"city": "Van",
"country": "Turkey",
"facility": "Van Yuzuncu Yil University, Faculty of Dentistry",
"geoPoint": {
"lat": 38.49457,
"lon": 43.38323
},
"state": "Tuşba"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pain Evaluation",
"timeFrame": "Pre-treatment (baseline)"
},
{
"description": null,
"measure": "Pain Evaluation",
"timeFrame": "At the first week"
},
{
"description": null,
"measure": "Pain Evaluation",
"timeFrame": "At the second week"
},
{
"description": null,
"measure": "Pain Evaluation",
"timeFrame": "At the first month"
}
],
"secondary": null
} | [
{
"affiliation": "Cairo University",
"name": "Volkan KAPLAN, PhD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D017271",
"term": "Craniomandibular Disorders"
},
{
"id": "D008336",
"term": "Mandibular Diseases"
},
{
"id": "D007571",
"term": "Jaw Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D007592",
"term": "Joint Diseases"
},
{
"id": "D009135",
"term": "Muscular Diseases"
},
{
"id": "D009057",
"term": "Stomatognathic Diseases"
},
{
"id": "D009209",
"term": "Myofascial Pain Syndromes"
}
],
"browseBranches": [
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
},
{
"abbrev": "BC07",
"name": "Mouth and Tooth Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
}
],
"browseLeaves": [
{
"asFound": "Temporomandibular Disorders",
"id": "M16477",
"name": "Temporomandibular Joint Disorders",
"relevance": "HIGH"
},
{
"asFound": "Temporomandibular Disorders",
"id": "M16478",
"name": "Temporomandibular Joint Dysfunction Syndrome",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10621",
"name": "Joint Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16355",
"name": "Syndrome",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19566",
"name": "Craniomandibular Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11327",
"name": "Mandibular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10601",
"name": "Jaw Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12092",
"name": "Muscular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12017",
"name": "Stomatognathic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8486",
"name": "Fibromyalgia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12161",
"name": "Myofascial Pain Syndromes",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D013705",
"term": "Temporomandibular Joint Disorders"
},
{
"id": "D013706",
"term": "Temporomandibular Joint Dysfunction Syndrome"
}
]
} | {
"ancestors": [
{
"id": "D000893",
"term": "Anti-Inflammatory Agents"
},
{
"id": "D000932",
"term": "Antiemetics"
},
{
"id": "D001337",
"term": "Autonomic Agents"
},
{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D005765",
"term": "Gastrointestinal Agents"
},
{
"id": "D005938",
"term": "Glucocorticoids"
},
{
"id": "D006728",
"term": "Hormones"
},
{
"id": "D006730",
"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
},
{
"id": "D018931",
"term": "Antineoplastic Agents, Hormonal"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D018712",
"term": "Analgesics, Non-Narcotic"
},
{
"id": "D000700",
"term": "Analgesics"
},
{
"id": "D018689",
"term": "Sensory System Agents"
},
{
"id": "D058633",
"term": "Antipyretics"
},
{
"id": "D000894",
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{
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},
{
"id": "D006074",
"term": "Gout Suppressants"
},
{
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"term": "Cyclooxygenase Inhibitors"
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{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D000701",
"term": "Analgesics, Opioid"
},
{
"id": "D009294",
"term": "Narcotics"
},
{
"id": "D002492",
"term": "Central Nervous System Depressants"
},
{
"id": "D000996",
"term": "Antitussive Agents"
},
{
"id": "D019141",
"term": "Respiratory System Agents"
}
],
"browseBranches": [
{
"abbrev": "Infl",
"name": "Anti-Inflammatory Agents"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
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{
"abbrev": "AnEm",
"name": "Antiemetics"
},
{
"abbrev": "Gast",
"name": "Gastrointestinal Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
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{
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"name": "Analgesics"
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{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
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{
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"name": "Antitussive Agents"
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{
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"name": "Respiratory System Agents"
},
{
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"name": "Antipyretics"
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{
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"name": "Anti-Obesity Agents"
},
{
"abbrev": "VaCoAg",
"name": "Vasoconstrictor Agents"
}
],
"browseLeaves": [
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"asFound": "Adults",
"id": "M7102",
"name": "Dexamethasone",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M235549",
"name": "Dexamethasone acetate",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M199152",
"name": "BB 1101",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4032",
"name": "Analgesics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10043",
"name": "Hypnotics and Sedatives",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11982",
"name": "Morphine",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4217",
"name": "Anti-Inflammatory Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4033",
"name": "Analgesics, Opioid",
"relevance": "LOW"
},
{
"asFound": "NCT",
"id": "M12239",
"name": "Naproxen",
"relevance": "HIGH"
},
{
"asFound": "Best Practice",
"id": "M6290",
"name": "Codeine",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M29176",
"name": "Antipyretics",
"relevance": "LOW"
},
{
"asFound": "Emergency",
"id": "M2340",
"name": "Acetaminophen",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4251",
"name": "Antiemetics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8881",
"name": "Gastrointestinal Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9047",
"name": "Glucocorticoids",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9788",
"name": "Hormone Antagonists",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20966",
"name": "Antineoplastic Agents, Hormonal",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20786",
"name": "Analgesics, Non-Narcotic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4218",
"name": "Anti-Inflammatory Agents, Non-Steroidal",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20604",
"name": "Antirheumatic Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19209",
"name": "Cyclooxygenase Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12245",
"name": "Narcotics",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13570",
"name": "Phenylpropanolamine",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9238",
"name": "Guaifenesin",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M186319",
"name": "Chlorpheniramine, phenylpropanolamine drug combination",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4312",
"name": "Antitussive Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21137",
"name": "Respiratory System Agents",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000082",
"term": "Acetaminophen"
},
{
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"term": "Dexamethasone"
},
{
"id": "D009288",
"term": "Naproxen"
},
{
"id": "D003061",
"term": "Codeine"
}
]
} | {
"conditions": [
{
"id": "D013705",
"term": "Temporomandibular Joint Disorders"
},
{
"id": "D013706",
"term": "Temporomandibular Joint Dysfunction Syndrome"
}
],
"interventions": [
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"id": "D000082",
"term": "Acetaminophen"
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{
"id": "D003907",
"term": "Dexamethasone"
},
{
"id": "D009288",
"term": "Naproxen"
},
{
"id": "D003061",
"term": "Codeine"
}
]
} |
NCT05053126 | null | Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users | A Phase 4 Randomized Double-Blind Double-Dummy Placebo & Active-Controlled Single-Dose Six-Way Crossover Study Evaluating the Abuse Potential of Lyrica® Taken Orally With Oxycodone HCL in Healthy Non-Drug Dependent Recreational Opioid Users | None | INTERVENTIONAL | COMPLETED | 2021-09-13T00:00:00 | null | 2022-04-01T00:00:00 | 2022-04-01T00:00:00 | [
"PHASE4"
] | 60 | 18 | 55 | ALL | true | This is a Phase 4 clinical study in healthy non-drug dependent recreational opioid users to assess the abuse potential of Lyrica when taken alone or in combination with oxycodone. | This is a randomized, double-blind, double-dummy, placebo- and active-controlled, 6-treatment, 6-period crossover, single-dose study in healthy male and/or female adult, non drug-dependent recreational opioid users. The study includes Screening, a Qualification Phase, a Treatment Phase and Follow-up. This study will randomize approximately 60 adult male and female (at least 20% female) participants (10 participants in each sequence) in the Treatment Phase to ensure at least 48 participants complete the Treatment Phase of the study. There will be 8 visits to the clinic in total and a follow-up telephone call at the end of the study. The duration of participation will be approximately 16 weeks and 7 of the visits will involve clinic stays of 4 days/3 nights. | Inclusion Criteria:
1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of screening. There must be no less than 20% female participants in the Treatment Phase.
2. Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.
3. Participants must have drug abuse experience with opioids; ie, must have used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions within the last year and at least once in the 8 weeks before the Screening Visit (Visit 1).
4. Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination.
5. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
6. Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight
≥50 kg (110 lb).
7. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD).
Exclusion Criteria:
1. Current or past diagnosis of any type of drug dependence within the past year. Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine) will be assessed by the Investigator using the Diagnostic and Statistical Manual-4 (DSM-4) criteria performed at Screening. Current drug use will be allowed if the candidate can produce a negative urine sample and are free of any signs/symptoms of withdrawal. The candidate will be informed if they have a positive breathalyzer test.
2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
3. Any condition possibly affecting drug absorption (eg, gastrectomy) excluding cholecystectomy within 1 year prior to study.
4. Abnormal baseline EtCO2 \<35mm Hg or \>45 mm Hg.
5. Clinical or laboratory evidence of active hepatitis A infection or a history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C and/or positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb).
6. Participants with active suicidal ideation or suicidal behavior within 5 year prior to Screening as determined through the use of the Columbia-Suicide Severity Rating Scale (C-SSRS) or active ideation identified at Screening or on Day 0.
7. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
8. Patients with: sleep apnea, myasthenia gravis and glaucoma.
9. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
10. Herbal supplements and herbal medications must be discontinued at least 28 days prior to the first dose of study medication.
11. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of investigational product used in this study.
12. Positive urine drug screen (UDS) for substances of abuse at each admission in the Qualification and Treatment Phase, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at his/her discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participant is permitted to participate in any phase of the study.
13. Unable to abstain from using THC during the Qualification and Treatment Phase of the study.
14. Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
15. Has a positive alcohol breathalyzer or urine test at each admission to the study center during qualification and treatment phase. Positive results may be repeated and/or participants re-scheduled at the Investigator's discretions.
16. Participants are heavy smokers or users of other types of nicotine products (\>20 cigarettes equivalents per day).
17. Participants are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.
18. Screening sitting blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes rest. If BP is ≥140 mm Hg (systolic) or
≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. Repeated BP tests should be spaced at least 5 minutes apart.
19. Baseline (screening) 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval as determined by the Fridericia method (QTcF) \>450 msec, complete left bundle branch block \[LBBB\], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular \[AV\] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is \>450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
20. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level 1.5 × upper limit of normal (ULN); Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
21. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
22. History of sensitivity to heparin or heparin-induced thrombocytopenia.
23. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
24. History of hypersensitivity to pregabalin or oxycodone or any of the components in the formulation of the study products.
25. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Sponsor employees, including their family members, directly involved in the conduct of the study. | Viatris Inc. | INDUSTRY | {
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"affiliation": "Mylan Pharmaceutials",
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"id": "D018689",
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"term": "Central Nervous System Depressants"
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"abbrev": "ChanBlk",
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NCT04817826 | null | TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC. | TremelImumab aNd Durvalumab Combination For the Non-operatIve Management (NOM) of Microsatellite InstabiliTY (MSI)-High Resectable Gastric or Gastroesophageal Junction Cancer: The Multicentre, Single-arm, Multi-cohort, Phase II INFINITY Study. | INFINITY | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2021-03-11T00:00:00 | null | 2025-04-30T00:00:00 | 2026-04-30T00:00:00 | [
"PHASE2"
] | 31 | 18 | null | ALL | false | INFINITY is a Phase II, multicentre, single-arm, multi-cohort trial aimed at evaluating the activity and safety of the combination of tremelimumab and durvalumab as neoadjuvant (Cohort 1) and definitive (Cohort 2) treatment for MSI-high gastric/gastroesophageal juction cancer patients eligible for radical surgery. | This study will pre-screen approximately 310 patients, in order to enrol a total number of 31 patients, 18 in Cohort 1 and 13 in Cohort 2, across 25 Italian Centres.
After central confirmation of MSI-high, dMMR and EBV-negative status, patients with resectable gastric or gastroesophageal junction cancer (Siewert II/III), categorized as cT≥2, any cN, M0 or any cT, cN1-3, M0 according to TNM classification 8th edition, will be enrolled and they will receive a pre-operative treatment with tremelimumab 300 mg single administration (day 1) and durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57).
All patients will undergo a complete disease restaging with chest-abdomen-pelvis CT scan, 18-FDG PET/CT, EUS with biopsies and liquid biopsy.
In Cohort 1, patients will undergo standard gastrectomy with D2 lymphadenectomy between weeks 15 and 18 from enrolment (at least six weeks after the last treatment administration), followed by an active follow-up every 12 weeks for two years and then a standard follow-up every six months until the end of the fifth year from surgery. In Cohort 2, patients with no evidence of complete clinical response (defined as absence of disease persistence at radiological imaging, liquid biopsy and EUS) will be treated as in Cohort 1. Patients with complete clinical response will undergo a non-operative management (NOM) and will start an active follow-up phase every 12 weeks for two years with chest-abdomen-pelvis CT with contrast, 18-FDG PET/TC, if clinically indicated by the Investigator, EUS with multiple random biopsies of the tumor site and FNA of clinically suspicious regional nodes and liquid biopsy, followed by standard follow-up every six months until the end of the fifth year. At any time during follow-up, in case of clinical suspicion or confirmation of residual gastric cancer, either at imaging, pathologically at tissue biopsies/cytological specimens or at ctDNA in liquid biopsy, the patients will undergo standard surgery according to the clinical practice at their Centre (subtotal/total gastrectomy with D2 lymphadenectomy).
Enrolment in Cohort 2 will start only after the completion of enrolment in Cohort 1 and after the extensive evaluation of the final results of Cohort 1 regarding to all endpoints (including exploratory endpoints) and after potential amendment(s) on study design, eligibility criteria and study procedures requested by the Sponsor's Steering Committee and an Independent Data Monitoring Committee made of foreign experts, and after the approval of the Ethics Committee and the Italian Medicines Agency. | Inclusion Criteria:
1. Written informed consent and any locally required authorization (such as the European Union \[EU\] Data Privacy Directive) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
2. Age ≥ 18 years old.
3. ECOG Performance Status 0-1.
4. Body weight \>30 kg.
5. Diagnosis of resectable gastric or gastroesophageal junction (Siewert II-III) cancer, categorized according to TNM classification 8th edition:
* cT ≥ 2, any cN, M0
* Any cT, cN1-3, M0
6. Absence of distant metastases as defined by negativity of computed tomography (CT) and 18-fluorodeoxyglucose positron-emission tomography (18-FDG PET).
7. Life expectancy of at least 12 weeks
8. MSI-high status confirmed by IHC and multiplex PCR, and EBV-negative status by ISH, as determined centrally at the Co-ordinating Centre. Lack of heterogeneity of dMMR status as showed by lack of tumor cells showing concomitant expression of all 4 protein markers.
9. Adequate bone marrow and organ function, as defined by laboratory tests:
1. Neutrophil count ≥ 1.5 x 10\^3/μL
2. Platelet count ≥ 100 x 10\^6/μL
3. Haemoglobin ≥ 9 g/dL
4. Total bilirubin lower than 1.5 time the upper-normal limits (ULN) of the Institutional normal values
5. AST (SGOT) and/or ALT (SGPT) \< 2.5 x ULN
6. Creatinine clearance (calculated according to Cockroft and Gault) \> 40 mL/min or serum creatinine \< 1.5 x ULN.
10. Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating Centre.
Exclusion Criteria:
1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
2. Previous enrolment in the present study
3. Participation in another clinical study with an investigational product during the last 12 months
4. Signs of distant metastases.
5. Prior medical treatments or irradiation for gastric cancer.
6. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
7. Previous treatments with immune checkpoint inhibitors targeting CTLA4, including tremelimumab, PD-1 or PD-L1, including durvalumab.
8. History of allergy or severe hypersensitivity reaction to monoclonal antibodies.
9. History of autoimmune diseases or history of organ transplantation that require immunosuppressive therapy. The following are exceptions to this criterion:
* Patients with vitiligo or alopecia
* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
* Any chronic skin condition that does not require systemic therapy
* Patients with celiac disease controlled by diet alone
10. History of active primary immunodeficiency. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
11. Any condition requiring systemic treatment with corticosteroids at doses equal or superior to 10 mg daily of prednisone or equivalents, or other immunosuppressive drugs within 14 days from the inclusion in the study. The following medications are exceptions to this criterion:
* Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
12. Administration of live vaccines within 4 weeks from the inclusion in the study. Note: Patients, if enrolled, should not receive live vaccine while receiving study drug(s) and up to 30 days after the last dose of study drug(s).
13. History of allogenic organ transplantation
14. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
15. Women in pregnancy or lactation condition. Women with child-bearing potential or sexually-active men not willing to use adequate contraception during the whole study period.
16. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. | Gruppo Oncologico del Nord-Ovest | OTHER | {
"id": "2020-003440-92",
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"date": "2025-06-10",
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"date": "2021-03-26",
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"interventionModelDescription": "Phase II, multicentre, single-arm, multi-cohort trial.",
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"Microsatellite Instability"
] | ["Durvalumab", "Tremelimumab", "Non-operative management", "Surgery", "Gastric cancer", "Microsatellite Instability"] | null | [
{
"city": "Milan",
"country": "Italy",
"facility": "Fondazione IRCCS Istituto Nazionale dei Tumori di Milano",
"geoPoint": {
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"lon": 9.18951
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"other": null,
"primary": [
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"description": null,
"measure": "Primary outcome of Cohort 1: Pathological complete response (ypT0N0) and negative ctDNA status",
"timeFrame": "From the enrollment of the first patient in Cohort 1 up to 4 months from the enrollment of the last patient in Cohort 1"
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"description": null,
"measure": "Primary outcome of Cohort 2: 2-year complete response rate",
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"secondary": [
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"description": null,
"measure": "Patients' quality of life",
"timeFrame": "For each Cohort, from the enrollment of the first patient up to 4 months from the last patient starting the pre-operative treatment phase"
},
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"description": null,
"measure": "Patients' quality of life",
"timeFrame": "For each Cohort, from the enrollment of the first patient up to 4 months from the last patient starting the pre-operative treatment phase"
},
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"description": null,
"measure": "3-year disease-free survival",
"timeFrame": "For each Cohort, from the enrollment of the first patient up to 3 years from the enrollment of the last patient"
},
{
"description": null,
"measure": "5-year overall survival",
"timeFrame": "For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient"
},
{
"description": null,
"measure": "Metastases-free survival",
"timeFrame": "For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient"
},
{
"description": null,
"measure": "Gastrectomy-free survival (Cohort 2 only)",
"timeFrame": "From the enrollment of the first patient up to 5 years from the enrollment of the last patient"
},
{
"description": null,
"measure": "Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]",
"timeFrame": "For each Cohort, from the enrollment of the first patient up to 5 years from the enrollment of the last patient"
},
{
"description": null,
"measure": "Post gastrectomy complications",
"timeFrame": "For each Cohort, from the enrollment of the first patient up to 1 year from the enrollment of the last patient"
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} | [
{
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"name": "Filippo Pietrantonio, MD",
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] | [{"pmid": "32251400", "type": "BACKGROUND", "citation": "Chalabi M, Fanchi LF, Dijkstra KK, Van den Berg JG, Aalbers AG, Sikorska K, Lopez-Yurda M, Grootscholten C, Beets GL, Snaebjornsson P, Maas M, Mertz M, Veninga V, Bounova G, Broeks A, Beets-Tan RG, de Wijkerslooth TR, van Lent AU, Marsman HA, Nuijten E, Kok NF, Kuiper M, Verbeek WH, Kok M, Van Leerdam ME, Schumacher TN, Voest EE, Haanen JB. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med. 2020 Apr;26(4):566-576. doi: 10.1038/s41591-020-0805-8. Epub 2020 Apr 6."}] | {"versionHolder": "2025-06-18"} | {
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NCT01917526 | null | The Performance of Two Oxygen Delivery Devices Used After General Anesthesia. | The Performance Comparison of Two Oxygen Delivery Devices [Nasal Cannula and Mask] Used After General Anesthesia. | None | INTERVENTIONAL | COMPLETED | 2013-08-05T00:00:00 | null | null | null | [
"NA"
] | 500 | 18 | 70 | ALL | false | After general anesthesia, there are the risks for airway obstruction, hypoventilation, atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement in PACU seems necessary.
This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2 methods can equally provide effective oxygen supplement to prevent anesthesia-related hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more comfortable to patient. | The incidence and causes of hypoxemia in PACU will be identified, if necessary, a higher flow or changing oxygen delivery system can be used to prevent and treat hypoxemia. If any patients fail from oxygen weaning protocol in PACU and need longer oxygen therapy at ward, the duration of oxygen therapy will be recorded and also the compliance with oxygen delivery devices. | Inclusion Criteria:
* General anesthesia
* Age 18-70 years
* American Society of Anesthesiology (ASA)physical status 1-3
* Elective case
Exclusion Criteria:
* ASA physical status class 4 or more
* Unstable pulmonary diseases
* BMI \> 35 kg/m2
* oxygen saturation \< 94% when breathing in room air
* Respiratory muscle weakness eg.myasthenia gravis
* Central nervous system abnormalities eg.drowsiness, hypoventilation
* Patients who have been intubated or needed ventilatory support before operation
* Plan to remain intubated after the operation
* Intracranial, intrathoracic and upper abdomen surgery
* Patients who nasogastric tube is inserted
* Airway problems eg. sinusitis
* Nasal cavity related surgery or nasal packing eg. endoscopic sinus surgery
* Patient refusal | Mahidol University | OTHER | {
"id": "066/2556 (EC3)",
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} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2013-08-05T00:00:00 | {
"date": "2017-01-04",
"type": "ESTIMATED"
} | {
"date": "2013-08-06",
"type": "ESTIMATED"
} | [
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} | [
"Hypoxemia"
] | ["Oxygen", "PACU", "Hypoxemia"] | null | [
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"country": "Thailand",
"facility": "Siriraj hospital",
"geoPoint": {
"lat": 13.76266,
"lon": 100.47798
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"state": "Bangkok"
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"description": null,
"measure": "Number of Participants With Hypoxemia in Both Groups",
"timeFrame": "In PACU (1 hr after anesthesia)"
}
],
"secondary": [
{
"description": null,
"measure": "The Causes of Hypoxemia",
"timeFrame": "In PACU (1 hr after anesthesia)"
}
]
} | [
{
"affiliation": "Mahidol University",
"name": "Manee Raksakietisak, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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NCT04448626 | null | Micro-environment Involvement in Muscle Alteration Induced | Micro-environment Involvement in Muscle Alteration Induced by Copd Exacerbation | MicAMI-BPCO | OBSERVATIONAL | COMPLETED | 2020-06-15T00:00:00 | null | 2020-05-01T00:00:00 | 2020-05-30T00:00:00 | null | 27 | 40 | 85 | ALL | true | Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of strengh and muscle mass) is one of comorbidities affecting 30% to 60% of patients and playing a key role in their prognosis. During exacerbation, some studies have suggested an association between muscle dysfunction and modifications of inflammatory circulating factors such as CRP, TNF-alpha, IL- 6, IL8, but no exhaustive study has identified precisely one (or more) biomarker(s) that can induce this muscle wasting during the exacerbation of COPD. Our hypothesis is that the serum of exacerbated COPD patients represents a deleterious microenvironment for the muscle cells which would amplify the mechanisms of atrophy linked to hospitalization. Our team has already developed a cell culture model to study the effects of the plasma microenvironment on atrophy of cultured myotubes. The investigators have shown that the serum of COPD patients can induce muscle atrophy.
The objectives of this study are : 1/ to evaluate the effects of circulating pro-inflammatory factors on atrophy and the myogenic capacities of muscle cells; and 2/ to identify one (or more) circulating biomarker (s) that may be responsible for the muscle damage induced by the microenvironment of hospitalized patients for exacerbation of COPD. First, myotubes and myoblasts of healthy subjects will be cultivated with 9 exacerbation copd patient serum or 9 copd patient serum or 9 healthy subject serum. Myotube diameters, atrophy, inflammatory and oxidative stress markers and alteration of the myogenic capacity of satellite cells will be compared between three groups. Second, the differential expression of circulating proinflammatory molecules will be compared in the serum of the three groups. Identifying circulating factors associated with muscle weakness is a necessary step to better understand the mechanisms and consider a personalized therapeutic approach that can improve the functional and clinical prognosis of disease.
. | null | Inclusion criteria 1/ for COPD patients hospitalized for exacerbation:
* Hospitalization for COPD exacerbation 2/ for COPD patients
* COPD patients GOLD II à IV
* Not having followed respiratory réhabilitation stay for at least one year 3/ for Healthy subjects
* healthy and sedentary (Voorips score \<9)
Exclusion criteria:
1. for COPD patients hospitalized for exacerbation:
* concomitant acute cardiac évent
* trachéal intubation with mechanical ventilation
* chronic respiratory disease other than COPD
* locomotor, neurologic or psychiatric comorbidities
2. for COPD patients
* Exacerbation with récent hospitalization (\<4 weeks)
* Neurologic comorbidity
3. for Healthy subjects - long term drug treatment with proven central effects | University Hospital, Montpellier | OTHER | {
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"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | COPD patients hospitalized for exacerbation in Montpellier university hospital, France.
COPD patients recruited in Clinique du Souffle, La Vallonie, Lodève, France. Healthy volunteer subject recruited in Clinique du Souffle, La Vallonie, Lodève, France. | NON_PROBABILITY_SAMPLE | false | {
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"Chronic Obstructive Pulmonary Disease",
"Exacerbations",
"Skeletal Muscle Atrophy"
] | ["COPD Exacerbation", "Muscle atrophy", "Inflammation", "Oxidative stress", "Biomarkers"] | null | [
{
"city": "Montpellier",
"country": "France",
"facility": "Uhmontpellier",
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{
"class": "OTHER",
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"primary": [
{
"description": null,
"measure": "Effects evaluation of circulating pro-inflammatory factors on atrophy",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Effects evaluation of circulating pro-inflammatory factors on the myogenic capacities of muscle cells",
"timeFrame": "6 months"
}
],
"secondary": [
{
"description": null,
"measure": "Identification of one (or more) circulating biomarker (s)",
"timeFrame": "3 months"
}
]
} | [
{
"affiliation": "University Hospital, Montpellier",
"name": "Maurice HAYOT, MD, PhD",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "12947130", "type": "BACKGROUND", "citation": "Spruit MA, Gosselink R, Troosters T, Kasran A, Gayan-Ramirez G, Bogaerts P, Bouillon R, Decramer M. Muscle force during an acute exacerbation in hospitalised patients with COPD and its relationship with CXCL8 and IGF-I. Thorax. 2003 Sep;58(9):752-6. doi: 10.1136/thorax.58.9.752."}, {"pmid": "20332630", "type": "BACKGROUND", "citation": "Crul T, Testelmans D, Spruit MA, Troosters T, Gosselink R, Geeraerts I, Decramer M, Gayan-Ramirez G. Gene expression profiling in vastus lateralis muscle during an acute exacerbation of COPD. Cell Physiol Biochem. 2010;25(4-5):491-500. doi: 10.1159/000303054. Epub 2010 Mar 23."}, {"pmid": "17883420", "type": "BACKGROUND", "citation": "Crul T, Spruit MA, Gayan-Ramirez G, Quarck R, Gosselink R, Troosters T, Pitta F, Decramer M. Markers of inflammation and disuse in vastus lateralis of chronic obstructive pulmonary disease patients. Eur J Clin Invest. 2007 Nov;37(11):897-904. doi: 10.1111/j.1365-2362.2007.01867.x. Epub 2007 Sep 20."}, {"pmid": "32173533", "type": "BACKGROUND", "citation": "Catteau M, Gouzi F, Blervaque L, Passerieux E, Blaquiere M, Ayoub B, Bughin F, Mercier J, Hayot M, Pomies P. Effects of a human microenvironment on the differentiation of human myoblasts. Biochem Biophys Res Commun. 2020 May 14;525(4):968-973. doi: 10.1016/j.bbrc.2020.03.020. Epub 2020 Mar 12."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Chronic Disease"
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{
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NCT06753526 | null | L-Arginine Role for Stone Lower Ureter : A Randomized Control Study | L-Arginine Role for Stone Lower Ureter : A Randomized Control Study | None | INTERVENTIONAL | COMPLETED | 2024-12-18T00:00:00 | null | 2024-04-30T00:00:00 | 2024-06-30T00:00:00 | [
"PHASE4"
] | 153 | 18 | null | ALL | false | To evaluate the effects of L-Arginine 1000mg once daily as a medical expulsive therapy (MET) for lower ureter stones. | Urolithiasis is a common disease worldwide and its incidence is growing \[1\]. Urinary stones are frequently located in the ureter and most ureteral stones are reported to be located distally \[2\]. Stones \< 3 mm in diameter have a better chance to pass spontaneously in the majority of cases, whereas stones \> 6 mm in the ureter are unlikely to pass in most situations \[3\].
Therefore, active watchful waiting forms one of the treatment options in some clinical scenarios.
Minimal invasive treatment strategies such as extracorporeal shockwave lithotripsy and ureteroscopy are frequently applied procedures in ureteral stone disease. However, indications for watchful waiting might be extended by the addition of so-called 'expulsive medical therapy'.
Nitric Oxide (NO) L -Arginine-derived NO is the major inhibitory NANC neurotransmitter in the lower urinary tract \[4\]. Neuronal NO synthase (NOS)-positive neuronal axons and nerve-ending-like structures have been detected in muscular layers of the human ureter suggesting that ureteral relaxation may involve the NO pathway \[5\]. NOS-reactive nerves have also been demonstrated immunohistochemically in the human intravesical ureter.
A recent study suggested that the L-arginine/NO/cyclic GMP pathway may play a role in the regulation of the valve function of the ureterovesical junction \[6\].
NO has been shown to have a smooth muscle-relaxing effect in various animal species and humans. Mastrangelo et al. \[7\] showed that urothelium-produced NO inhibits contractile responses in the proximal ureter in rats. NOS was also demonstrated in the nerve fibers of the porcine intravesical ureter and was suggested to mediate the inhibitory neurotransmission \[8\].
Neuronal NOS-positive nerves have been shown in the human ureter, particularly in the distal part which seems to have an important function regarding peristalsis and ureterovesical junction motility \[9\]. Therefore, this pathway may also be a new target for new drugs producing relaxation of the human ureter.
In renal colic The severe pain of renal colic (RC) caused by urinary stone disease has an occurrence rate of 1-10% for each person per their lives and accounts for 2% of all admittances to the emergency department \[10-12\]. The stone passing into the ureter produces high intraluminal pressure, which may cause contractions of the smooth muscles of the ureter and induce irritation and obstruction, which hereby produces spasms that lead to unbearable pain \[13,14\].
Nitric oxide (NO), which is synthesized from L-arginine, has a role in the physiopathology of RC. Because axons and neuronal endings that are positive for neuronal nitric oxide synthase (nNOS) reside in the human ureter, NOS, which participates in the synthesis of NO may be related to The hypothetical relationship between NO and RC is expressed in the hypothesis that NO can cause the progression of a stone to be easier and stiffer with a dilatation effect on the ureter where the smooth muscle is located. The possible relationship between RC and endothelial NOS (eNOS), which is a different isoenzyme that is involved in the synthesis of NO that functions in smooth muscle organs such as the ureter, has been left mostly unexplored to this day. Endothelial NOS, which is coded for by a gene that is located on the long arm of the 7th chromosome, has a role in the synthesis of NO, which relaxes the smooth muscles of the gastrointestinal and cardiovascular systems and acts in other pathophysiological processes \[16,17\].
Objectives To evaluate the effects of L-Arginine once daily as a medical expulsive therapy for stone lower ureter by conducting a randomized study Study Design The design of the research will be a prospective randomized controlled study. Study Setting/Location The study will be conducted in a single tertiary center at the Urology department in Sohag University, Egypt.
Local ethics committee approval was obtained for this trial. all participants will be discussed to participate in this study.
Patients and Methods Inclusion criteria All the participants, older than 18 years old ureter stones in size between 4 and 10 mm single stone Exclusion criteria Acute azotemia, stones larger than 8mm, solitary kidney, drainage due to urinary tract infection, symptomatic urinary system infection, impacted status, concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics; severe hydronephrosis, multiple stones, pregnancy, previous ureter and bladder operations, anatomic urinary system abnormalities, benign prostate hyperplasia, uncontrolled hypertension (systolic blood pressure≥180 mmHg, diastolic blood pressure≥110 mmHg), bilateral ureter stone, stones bigger than 10 mm, residual stone after any procedure (shock wave lithotripsy, ureterolithotripsy, ureterolithotomy, etc.), Study procedure Evaluations included
1. Detailed history
2. Physical examination
3. Urinalysis \& urine culture
4. Renal function tests
5. Ultrasonography
6. PUT
7. Computed tomography of the urinary tract. Intramural ureteral stones were diagnosed using kidney-ureter-bladder radiography and urinary system ultrasonography A computed tomography (CT) scan was performed on suspected patients
Recorded details included:
Baseline characteristics of patients.
* Number of patients
* age
* gender
* stone's laterality,
* stone's location
* stone's surface area (Stone size)
* degree of hydronephrosis medical history, family history, complaints secondary to pain and the presence of fever, blood pressure, cardiac pulse, and respiratory rate abnormalities of the RC. Follow up Patients will followed weekly for 4 weeks by ultrasonography and/or KUB Follow up details
* Spontaneous stone expulsion rates (SER),
* stone expulsion time,
* the number of daily colic episodes
* total required analgesic dosage of the patients
Study Procedures
Patients meeting the inclusion criteria will be randomly allocated to 3 groups:
1. 1st group will be control
2. 2nd group will take L-Arginine 500 mg.
3. 3rd group will undergo Tamsulosin 0.4 mg. I. Randomisation Randomization will be performed using computer generated random tables using stratified blocked randomization in 1:1:1 ratio.
Eligible patient will be informed on details of the study at our outpatient clinic. They also received written information.
Statistical Considerations And Data Analysis Sample size and statistical power The trial size was calculated concerning the primary endpoints by power calculations based on data from previous local comparative studies.
with an 80% power "beta", a 0.05 level of significance is considered "alpha" and with an expected 10% dropout rate. | Inclusion criteria:
Patients older than 18 years old, ureter stones in size between 4 and 10 mm, single stone
Exclusion criteria:
Acute azotemia, stones larger than 10 mm, solitary kidney, symptomatic urinary system infection, impacted status, severe hydronephrosis, multiple or bilateral stones, pregnancy, anatomic urinary system abnormalities, benign prostate hyperplasia. | Sohag University | OTHER | {
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] | ["stone", "medical expulsive therapy"] | null | [
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"measure": "Stone expulsion time",
"timeFrame": "From 1st renal colic till the time of stone pass or for four weeks"
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"measure": "Total required analgesic dosage",
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NCT00605826 | null | A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence | A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence | None | INTERVENTIONAL | COMPLETED | 2008-01-09T00:00:00 | null | 2009-11-23T00:00:00 | 2009-11-23T00:00:00 | [
"NA"
] | 206 | 18 | 75 | ALL | false | The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase. | Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx.
Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study. | Inclusion Criteria:
* 18-75 years of age, male or female.
* Screening fecal incontinence severity score (CCFIS).
* Fecal incontinence episodes over a 14-day period.
* Failed conservative treatment for fecal incontinence.
Exclusion Criteria:
* Complete external sphincter disruption.
* Significant anorectal disease.
* Anorectal surgery within the last 12 months prior to the study.
* Active Inflammatory Bowel Disease (IBD).
* Immunodeficiency or receiving immunosuppressive therapy.
* Malignancies in remission for less than 2 years prior to the study.
* Bleeding disorders or receiving anticoagulant therapy.
* Chemotherapy within the last 12 months prior to the study.
* Prior Pelvic radiotherapy.
* Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
* Women within one year post partum.
* Participation in any other clinical study within 3 month prior to the study.
* Hypersensitivity to hyaluronic acid containing products.
* Other severe conditions or in other ways unsuitable to participate according to investigator judgement. | Bausch Health Americas, Inc. | INDUSTRY | {
"id": "33DA0404",
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} | Unknown | {
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} | 2008-01-30T00:00:00 | {
"date": "2020-08-18",
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"date": "2008-01-31",
"type": "ESTIMATED"
} | [
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} | [
"Fecal Incontinence"
] | null | null | [
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"lon": -122.41942
},
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{
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},
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{
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},
"state": "Massachusetts"
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{
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},
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{
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{
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},
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{
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] | [
{
"class": "INDUSTRY",
"name": "Oceana Therapeutics, Inc."
},
{
"class": "INDUSTRY",
"name": "Galderma R&D"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Percentage of Participants Who Are Responder50.",
"timeFrame": "6 months after last blinded treatment"
},
{
"description": null,
"measure": "Percentage of Participants Who Are Responder25.",
"timeFrame": "12 months after last treatment"
}
],
"secondary": [
{
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"timeFrame": "up to 6 months after last treatment"
},
{
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"measure": "Number of Incontinence Free Days",
"timeFrame": "up to 6 months after last treatment"
},
{
"description": null,
"measure": "Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).",
"timeFrame": "up to 6 months after last treatment"
},
{
"description": null,
"measure": "Cleveland Clinic Florida Incontinence Score (CCFIS).",
"timeFrame": "up to 6 months after last treatment"
}
]
} | null | [{"pmid": "21420555", "type": "DERIVED", "citation": "Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011 Mar 19;377(9770):997-1003. doi: 10.1016/S0140-6736(10)62297-0."}] | {"versionHolder": "2025-06-18"} | {
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{
"id": "D012002",
"term": "Rectal Diseases"
},
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D005767",
"term": "Gastrointestinal Diseases"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Fecal Incontinence",
"id": "M8381",
"name": "Fecal Incontinence",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M14844",
"name": "Rectal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10444",
"name": "Intestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
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},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D005242",
"term": "Fecal Incontinence"
}
]
} | null | {
"conditions": [
{
"id": "D005242",
"term": "Fecal Incontinence"
}
],
"interventions": null
} |
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