nct_id
string | updated_at
timestamp[us] | brief_title
string | official_title
string | acronym
string | study_type
string | overall_status
string | study_first_submit_date
timestamp[ms] | start_date
timestamp[ms] | primary_completion_date
timestamp[ms] | completion_date
timestamp[ms] | phases
sequence | enrollment_count
float64 | minimum_age
float64 | maximum_age
float64 | sex
string | healthy_volunteers
bool | brief_summary
string | detailed_description
string | eligibility_criteria
string | lead_sponsor_name
string | lead_sponsor_class
string | org_study_id_info
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bool | design_info
dict | conditions
sequence | keywords
string | interventions
null | locations
list | collaborators
list | arm_groups
null | outcomes
dict | overall_officials
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string | misc_info_module
string | condition_browse_module
dict | intervention_browse_module
dict | mesh_terms
dict |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT01273766 | null | Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies | Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload | None | INTERVENTIONAL | COMPLETED | 2011-01-07T00:00:00 | null | null | null | [
"PHASE2"
] | 16 | 18 | null | ALL | false | RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions.
PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies. | PRIMARY OBJECTIVES: I. To determine the effects of the iron-chelating agent deferasirox on changes in: neutrophil function; macrophage function; lymphocyte function.
SECONDARY OBJECTIVES: I. To determine the effect of chelation on the incidence of bacterial, viral and fungal infections documented by clinical, microbiologically-proven versus radiologically-proven criteria. II. To determine the effect of iron chelation on mortality and morbidity with incidence of the following parameters: Need for hospitalization; Duration of hospitalization; Need for ventilatory support; Need for exchange transfusion/apheresis; Need for treatment with antifungals or antibiotics for documented infections.
OUTLINE: Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity. | Inclusion Criteria:
* Patients must have a pathology confirmed diagnosis of one of the following: myelodysplastic syndrome (MDS); acute leukemia; multiple myeloma; myelofibrosis; lymphoma; chronic anemia; sickle cell anemia
* Iron score \>= 2
* Absolute Neutrophil Count (ANC) \>= 1,000
* Platelets \>= 50,000
* Albumin \>= 2 g/dL
* Alkaline phosphatase =\< 5X Upper Limit of Normal (ULN)
* Total bilirubin =\< 1.5
* Creatinine =\< 2X age-appropriate Upper Limit of Normal (ULN) OR creatinine clearance \>= 40 ml/min
* Serum Glutamic Oxaloacetic Transaminase (SGOT) \[AST\] and Serum Glutamic Pyruvic Transaminase (SGPT) \[ALT\] =\< 5X Upper Limit of Normal (ULN)
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with active disease undergoing chemotherapy treatment
* Patient who have been treated with rituximab or immunomodulating drugs =\< 1 month prior to enrollment
* HIV-positive patients
* Hepatitis-C positive patients
* Women who are pregnant or breastfeeding
* Patients on hemodialysis/patients with renal failure
* Patients with sepsis or acute illness
* Known hypersensitivity to deferasirox
* Patients with moderate or severe hearing loss as defined by audiogram | Wake Forest University Health Sciences | OTHER | {
"id": "IRB00015287",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-01-07T00:00:00 | {
"date": "2018-09-07",
"type": "ACTUAL"
} | {
"date": "2011-01-10",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
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"Adult Acute Lymphoblastic Leukemia in Remission",
"Adult Acute Myeloid Leukemia in Remission",
"Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities",
"Adult Acute Myeloid Leukemia With Del(5q)",
"Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)",
"Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)",
"Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)",
"Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)",
"Adult Grade III Lymphomatoid Granulomatosis",
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"Stage IV Mantle Cell Lymphoma",
"Stage IV Marginal Zone Lymphoma",
"Stage IV Mycosis Fungoides/Sezary Syndrome",
"Stage IV Small Lymphocytic Lymphoma",
"Testicular Lymphoma",
"Untreated Adult Acute Lymphoblastic Leukemia",
"Untreated Adult Acute Myeloid Leukemia",
"Waldenstrom Macroglobulinemia"
] | null | null | [
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"city": "Winston-Salem",
"country": "United States",
"facility": "Comprehensive Cancer Center of Wake Forest University",
"geoPoint": {
"lat": 36.09986,
"lon": -80.24422
},
"state": "North Carolina"
}
] | [
{
"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
] | null | {
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"description": null,
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}
],
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"description": null,
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},
{
"description": null,
"measure": "Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections",
"timeFrame": "Baseline, up to 6 months"
}
]
} | [
{
"affiliation": "Wake Forest University Health Sciences",
"name": "Mary Ann Knovich, MD",
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},
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{
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{
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NCT00787566 | null | Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting | A Randomized, Single Administration, Double-blind, Parallel-group Phase 2 Dose Finding Study to Assess the Efficacy, Tolerability, and Safety of TRG (Intranasal Granisetron) in Patients With Chemotherapy-induced Nausea and Vomiting (CINV) Associated With the Administration of Highly Emetogenic Chemotherapy | None | INTERVENTIONAL | COMPLETED | 2008-11-05T00:00:00 | null | null | null | [
"PHASE2"
] | 68 | 18 | null | ALL | false | Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2 dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly emetogenic chemotherapy.
Primary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and tolerability of 3 doses of TRG in patients with CINV associated with the administration of highly emetogenic chemotherapy. | null | Inclusion Criteria:
* Patients with histologically and/or cytologically confirmed cancer
* ECOG performance status of 0, 1, or 2
* Patients with life expectancy of at least 3 months
* Patients who are chemotherapy naïve
* Patients who will be receiving the first cycle of a highly emetogenic regimen according to the MASCC criteria or the Hesketh criteria
* Patients with adequate metabolic or hematologic values for chemotherapy
* Patients with intact nasal mucosa
* Non child-bearing potential patients
* Patients able to read and write at a competent level, and capable of giving legal consent
* Patients who have provided written informed consent
Exclusion Criteria:
* Patients who do not receive a chemotherapy regimen which is a highly emetogenic chemotherapy regimen according to the MASCC or the Hesketh criteria
* Patients with nasal cancers, pharyngeal cancers, maxillary sinus cancers, or ethmoid sinus cancers
* Patients with nasal ulcers, septal perforation, or other nasal conditions that may interfere with IN administration
* Patients with any episode of retching, vomiting, or uncontrolled nausea within 48 hours before dosing with TRG and/or administration of chemotherapy
* Patients who have received radiation therapy in the 14 days before dosing with TRG, or for whom radiation therapy is scheduled during the 7 days after a TRG dose
* Patients who have received any investigational product within 30 days prior to study entry
* Patients who have received any drug or who were scheduled to receive any drug with antiemetic efficacy within 24 hours of the start of treatment
* Patients who have an allergy or hypersensitivity to granisetron or other selective 5hydroxytryptamine3(5-HT3) receptor antagonists
* Patients with ECOG performance status of 3 or 4
* Patients who have or have a history of brain tumors, head cancers, or neck cancers
* Patients who have a psychological problem that, in the Investigator's opinion, is severe enough to interfere with study eligibility or with interpretation of study results
* Patients who are pregnant (urine test) or breastfeeding
* Patients who have received prior cytotoxic chemotherapy given for the treatment of cancer
* Patients scheduled to receive multiple day chemotherapy
* Patients with clinically relevant abnormal laboratory values at the discretion of the Investigator
* Patients with clinically relevant hepatic, renal, infectious, neurological, or psychiatric disorders, or any other major systemic illness at the discretion of the Investigator
* Patients with any prevalence or cause of nausea and vomiting other than chemotherapy
* Patients using systemic steroids for any indication, or patients using steroids other than dexamethasone for prevention of chemotherapy-induced nausea and vomiting, or patients using dexamethasone for chemotherapy-induced nausea and vomiting at doses other than recommended in the MASCC antiemetic guidelines
* Patients with a QT interval greater than 500 ms or with acute ischemic changes or cardiac abnormality predisposing to arrhythmia on screening electrocardiogram (ECG) or by history
* Patients with a history of drug and/or alcohol abuse. | Shin Nippon Biomedical Laboratories, Ltd. | INDUSTRY | {
"id": "TRG-002",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-11-06T00:00:00 | {
"date": "2011-07-12",
"type": "ESTIMATED"
} | {
"date": "2008-11-07",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Chemotherapy-Induced Nausea and Vomiting"
] | ["Highly emetogenic chemotherapy induced nausea and vomiting"] | null | [
{
"city": "The study is managed by Kendle International, in Wilmington",
"country": "United States",
"facility": "The study is conducted at 14 Centers, in 14 cities accross the United States",
"geoPoint": null,
"state": "North Carolina"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Percentage of Patients With Complete Control",
"timeFrame": "24 hours"
}
],
"secondary": [
{
"description": null,
"measure": "Percentage of Patients With Complete Response",
"timeFrame": "24 hours"
},
{
"description": null,
"measure": "Percentage of Patients With Total Response",
"timeFrame": "24 hours"
},
{
"description": null,
"measure": "Percentage of Patients With Major Control of Emesis",
"timeFrame": "24 hrs"
},
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NCT00497666 | null | Association Between Rosiglitazone Use and Clinical Course of Diabetic Nephropathy: Population-Based Study | Retrospective Study Evaluating the Association Between Rosiglitazone Use and Clinical Course of Diabetic Nephropathy: Population-Based Study | None | OBSERVATIONAL | UNKNOWN | 2007-07-06T00:00:00 | null | null | null | null | null | 18 | 90 | ALL | null | Recent data show that Rosiglitazone treatment can reduce proteinuria in diabetic patients. However, currently there are no trials that examine the effects of Rosiglitazone on kidney disease progression, that is, doubling of serum creatinine or time to onset of end-stage renal disease, in patients with diabetic nephropathy.
We decided to study retrospectively the possible association between rosiglitazone use and clinical course of diabetic nephropathy, including rate of deterioration of renal function, appearance and progression of microalbuminuria/proteinuria, survival and acceptance to renal replacement therapy. | Background Type 2 diabetes mellitus is a public health concern, and projections of its future effect are alarming. According to the World Health Organization, diabetes affects more than 170 million people worldwide, and this number will rise to 370 million by 2030 \[1\]. About one third of those affected will eventually have progressive deterioration of renal function \[2, 3\]. The first clinical sign of renal dysfunction in patients with diabetes is generally microalbuminuria (a sign of endothelial dysfunction that is not necessarily confined to the kidney)\[4\], which develops in 2 to 5 percent of patients per year \[5,6\]. In type 2 diabetes, unlike type 1 diabetes \[7\], microalbuminuria is seldom reversible \[8\], but, instead, progresses to overt proteinuria in 20 to 40 percent of patients.\[9,10\]. In 10 to 50 percent of patients with proteinuria, chronic kidney disease develops that ultimately requires dialysis or transplantation \[11,12,13\]. Forty to 50 percent of patients with type 2 diabetes who have microalbuminuria eventually die of cardiovascular disease \[14,15\]; this is three times as high a rate of death from cardiac causes as among patients who have diabetes but have no evidence of renal disease \[6\].
In patients with diabetes and renal disease, lowering blood pressure and the levels of urinary albumin is effective in reducing the risk of end-stage renal disease as well as that of myocardial infarction, heart failure, and stroke \[16\]. Angiotensin-converting-enzyme (ACE) inhibitors or angiotensin II antagonists appear to be the most effective renoprotective and antihypertensive agents \[11, 12, 17-21\] . Treatment with the ACE inhibitor enalapril over a period of six years decreased the incidence of microalbuminuria in patients with type 2 diabetes who were normotensive and not obese \[22\].
Preventing (or delaying) the development of microalbuminuria is a key treatment goal for renoprotection \[23\] and, possibly, for cardioprotection \[4\]. Recent clinical trials suggested that inhibition of the renin-angiotensin system may actually prevent nephropathy. The post hoc analyses of the reduction in hypertension in the Heart Outcomes Prevention Evaluation study \[18\] and in the Losartan Intervention for Endpoint study \[24\] found a lower incidence of overt nephropathy in subjects with type 2 diabetes who received therapy that inhibited the renin-angiotensin system than in controls.
Recent BENEDICT study indicates that treatment with trandolapril with or without verapamil significantly reduces the incidence of microalbuminuria in patients with type 2 diabetes and normal urinary albumin excretion, as compared with placebo \[25\]. Trandolapril alone also appeared to decrease the incidence of microalbuminuria, whereas verapamil had no effect. Thiseffect of trandolapril plus verapamil and trandolapril alone in preventing microalbuminuria exceeded expectations based on changes in blood pressure alone.
Unfortunately, even with the appropriate use of available therapy, diabetic nephropathy still remains the leading cause of ESRD \[2\]. More effective strategies are needed in order to retard the progression of diabetic nephropathy and to reduce cardiovascular mortality in diabetic population.
Thiazolidinediones (TZDs) represent a class of compounds currently used for the treatment of type 2 DM that exert their hypoglycemic properties through reduction of IR \[26\]. These agents act by stimulating a certain type of nuclear receptor, called peroxisome proliferator-activated receptor gamma (PPAR ). Such receptors are abundant in adipose tissue cells, but they are also present in various other cell types, such as vascular smooth muscle cells, macrophages, vascular endothelial cells, colon epithelial cells, as well as renal glomerular and tubular cells. Through transcriptional regulation of various genes, PPAR receptors play an important role in adipocyte differentiation and lipid and carbohydrate metabolism \[26\]. Apart from improving glycemic control in patients with type 2 DM, several lines of evidence support the notion that TZDs have beneficial effects on other components of the metabolic syndrome, such as blood pressure (BP) lowering, triglyceride reduction, high-density lipoprotein-cholesterol elevation, redistribution of body fat away from the central compartment, decrease of C-reactive protein and plasminogen activator inhibitor -1 (PAI-1) levels, and others \[26\].
Additionally, several animal studies demonstrate that TZDs also reduce urine albumin or protein excretion and protect against injury to the kidney \[27\]. Moreover, experimental studies exposed numerous actions of TZDs in the kidney that could explain a possible renoprotective effect \[27-30\]. Our recent study on diabetic rats showed that rosiglitazone exerts its anti-inflammatory renoprotective effect by inhibition of mesangial cells proliferation, downregulation of apoptosis and blunting responsiveness to angiotensin-2 \[31\].
Human study also report significant reductions in UAE among patients with type 2 diabetes by rosiglitazone \[32\].
Another human study was part of a cardiac safety study where rosiglitazone 4 mg b.i.d. was compared to glyburide in 121 patients for 52 weeks \[32\]. After 28 weeks of treatment, both groups had significant reductions in ACR of about 30%, but after 52 weeks only rosiglitazone group continued to demonstrate a significant ACR reduction. This finding suggests that duration of follow-up is an important variable in assessing the effect of TZDs \[32\].
Overall, the above data clearly show that TZD treatment can reduce UAE. However, it should be emphasized that currently there are no trials that examine the effects of TZDs on kidney disease progression, that is, doubling of serum creatinine or time to onset of end-stage renal disease, in patients with diabetic nephropathy \[33\]. Such studies are needed in order to provide the best evidence for a renoprotective effect of TZDs.
Based on this data, we decided to study the possible association between rosiglitazone use and clinical course of diabetic nephropathy, including rate of deterioration of renal function, appearance and progression of microalbuminuria/proteinuria, survival and acceptance to renal replacement therapy.
Methods. Study population. The study is planned as retrospective cohort study using automated clinical data of Central Region Clalit Health Survices from 1999 until 2007.
Inclusion criteria: 1. Diagnosis of Diabetes Mellitus Type II; 2. Treatment With Oral hypoglycemics; 3. Availability of Baseline and follow up clinical data Exclusion criteria: 1. Insulin Therapy at baseline; 2. Malignancy Patients will be divided into 2 groups: rosiglitazone-treated group and non-treated with rosiglitazone ( control) group.
Baseline Data ( separately for two groups). Number of patients. Gender Race/etnicity Age Weight, BMI Duration of DM Diabetic microangiopathy: retinopathy, neuropathy, nephropathy Medications for DM Creatinine Microalbumin Proteinuria HbA1c% Hb Ca, P, PTH Albumin Hypertension: BP Cholesterol, LDL, TG Smoking: current, previous Alcohol consumption Comorbidites: HTN, CAD, CHF, PVD, Hypercholesterolemia, CVA/TIA Drugs: ACEi, ARBs, CCB, beta-blockers, statines, antiplatlate Use of nephrotoxic medications: NSAIDs
Follow up data Duration of rosiglitasone therapy/follow up Use of contrast media during study
Every year data:
Creatinine eGFR Microalbumin Proteinuria HbA1C% Start of insulin therapy
Events:
Hospitalisation (cause) Death (cause) ESRD/Dialysis Reported CHF MI CVA Angiography PVD Amputation References
1. World Health Organization. The Diabetes Program 2004. (at http://www.who.int/diabetes/en/.)
2. Remuzzi G, Schieppati A, Ruggenenti P. Nephropathy in patients with type 2 diabetes. N Engl J Med 2002;346:1145-1151.
3. Ruggenenti P, Remuzzi G. The diagnosis of renal involvement in non-insulin-dependent diabetes mellitus. Curr Opin Nephrol Hypertens 1997;6:141-145.
4. Ritz E. Albuminuria and vascular damage -- the vicious twins. N Engl J Med 2003;348:2349-2352.
5. Gall MA, Hougaard P, Borch-Johnsen K, Parving HH. Risk factors for development of incipient and overt diabetic nephropathy in patients with non-insulin dependent diabetes mellitus: prospective, observational study. BMJ 1997;314:783-788.
6. Adler AI, Stevens RJ, Manley SE, Bilous RW, Cull CA, Holman RR. Development and progression of nephropathy in type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS 64). Kidney Int 2003;63:225-232.
7. Perkins BA, Ficociello LH, Silva KH, Finkelstein DM, Warram JH, Krolewski AS. Regression of microalbuminuria in type 1 diabetes. N Engl J Med 2003;348:2285-2293
8. Parving HH, Lehnert H, Brochner-Mortensen J, Gomis R, Andersen S, Arner P. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med 2001;345:870-878
9. Mogensen CE. Microalbuminuria predicts clinical proteinuria and early mortality in maturity-onset diabetes. N Engl J Med 1984;310:356-360
10. Nelson RG, Knowler WC, Pettitt DJ, Saad MF, Charles MA, Bennett PH. Assessing risk of overt nephropathy in diabetic patients from albumin excretion in untimed urine specimens. Arch Intern Med 1991;151:1761-1765.
11. Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001;345:861-869.
12. Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001;345:851-860.
13. Nelson RG, Newman JM, Knowler WC, et al. Incidence of end-stage renal disease in type 2 (non-insulin-dependent) diabetes mellitus in Pima Indians. Diabetologia 1988;31:730-736
14. Eurich DT, Majumdar SR, Tsuyuki RT, Johnson JA. Reduced mortality associated with the use of ACE inhibitors in patients with type 2 diabetes. Diabetes Care 2004;27:1330-1334.
15. Parving HH, Mauer M, Ritz E. Diabetic nephropathy. In: Brenner BM, ed. Brenner \& Rector's The kidney. 7th ed. Vol. 2. Philadelphia: Saunders, 2004:1777-818.
16. Dinneen SF, Gerstein HC. The association of microalbuminuria and mortality in non-insulin-dependent diabetes mellitus: a systematic overview of the literature. Arch Intern Med 1997;157:1413-1418
17. Parving HH, Jacobsen P, Rossing K, Smidt UM, Hommel E, Rossing P. Benefits of long-term antihypertensive treatment on prognosis in diabetic nephropathy. Kidney Int 1996;49:1778-1782
18. Heart Outcomes Prevention Evaluation (HOPE) Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes melllitus: results of the HOPE study and MICRO-HOPE substudy. Lancet 2000;355:253-259. \[Erratum, Lancet 2000;356:860.\]
19. Viberti G, Mogensen CE, Groop LC, Pauls JF. Effect of captopril on progression to clinical proteinuria in patients with insulin-dependent diabetes mellitus and microalbuminuria. JAMA 1994;271:275-279.
20. Ravid M, Lang R, Rachmani R, Lishner M. Long-term renoprotective effect of angiotensin-converting enzyme inhibition in non-insulin-dependent diabetes mellitus: a 7-year follow-up study. Arch Intern Med 1996;156:286-289
21. Lewis EJ, Hunsicker LG, Bain RF, Rohde RD. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med 1993;329:1456-1462. \[Erratum, N Engl J Med 1993;330:152.
22. Ravid M, Brosh D, Levi Z, Bar-Dayan Y, Ravid D, Rachmani R. Use of enalapril to attenuate decline in renal function in normotensive, normoalbuminuric patients with type 2 diabetes mellitus: a randomized, controlled trial. Ann Intern Med 1998;128:982-988
23. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-853. \[Erratum, Lancet 1999;354:602.\]
24. Lindholm LH, Ibsen H, Dahlof B, et al. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomized trial against atenolol. Lancet 2002;359:1004-1010.
25. Ruggenenti P, Fassi A, Ilieva A, et al. Preventing Microalbuminuria in Type 2 Diabetes. N Engl J Med 2004; 351: 1941-51.
26. Lebovitz HE, Banerji MA. Insulin resistance and its treatment by thiazolidinediones. Recent Prog Horm Res 2001; 56: 265-294.
27. Haneda M, Koya D, Kikkawa R. Cellular mechanisms in the development and progression of diabetic nephropathy: activation of the DAG-PKC-ERK pathway. Am J Kidney Dis 2001; 38: S178-S181
28. Asano T, Wakisaka M, Yoshinari M et al. Peroxisome proliferator-activated receptor gamma1 (PPARgamma1) expresses in rat mesangial cells and PPARgamma agonists modulate its differentiation. Biochim Biophys Acta 2000; 1497: 148-154
29. Xiong Z, Huang H, Li J et al. Anti-inflammatory effect of PPARgamma in cultured human mesangial cells. Renal Failure 2004; 26: 497-505.
30. Gumieniczek A. Effect of the new thiazolidinedione-pioglitazone on the development of oxidative stress in liver and kidney of diabetic rabbits. Life Sci 2003; 74: 553-562
31. Weissgarten J, Berman S, Efrati S, et al. Apoptosis and proliferation of cultured mesangial cell isolated from kidneys of rosiglitasone-treated pregnant diabetic rats. Nephrol Dial Transplant 2006; 21: 1198-204
32. Bakris G, Viberti G, Weston WM et al. Rosiglitazone reduces urinary albumin excretion in type 2 diabetes. J Hum Hypertens 2003; 17: 7-12.
33. Sarafidis P, Bakris G. Protection of the kidney by thiazolidinediones: An assessment from bench to bedside. Kidney Int 2006; 70: 1223-1233. | Inclusion Criteria:
1. Diagnosis of Diabetes Mellitus Type II
2. Treatment With Oral hypoglycemics
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Exclusion Criteria:
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NCT01978366 | null | Open Label Extension Study of HT-100 in Patients With DMD | An Open Label Extension Study of HT-100 in Patients With Duchenne Muscular Dystrophy Who Have Completed Protocol HALO-DMD-01 | None | INTERVENTIONAL | TERMINATED | 2013-10-31T00:00:00 | null | 2016-04-30T00:00:00 | 2016-04-30T00:00:00 | [
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* Completed both the single ascending dose (SAD) and multiple ascending dose (MAD) phases of predecessor study HALO-DMD-01
* Maintained the same corticosteroid therapy from the predecessor study HALO-DMD-01
* Ability to provide written informed consent
* Ambulatory or non-ambulatory
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* Recent, substantial change in use of cardiac medications or medications affecting muscle function
* Clinically significant major disease, not related to DMD
* Significantly compromised cardio-respiratory function
* History of severe allergic or anaphylactic reactions
* Prior treatment with another investigational product in past 6 months
* Inability to undergo magnetic resonance imaging (MRI)
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"state": "Maryland"
},
{
"city": "Saint Louis",
"country": "United States",
"facility": "Washington University School of Medicine",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri"
},
{
"city": "Cincinnati",
"country": "United States",
"facility": "Cincinnati Children's Hospital Medical Center",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio"
},
{
"city": "Columbus",
"country": "United States",
"facility": "Nationwide Children's Hospital",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Safety and tolerability of administration of 6 months of chronic, oral, multiple doses of HT-100 to boys with DMD.",
"timeFrame": "Months 2, 4, 6, 7"
}
],
"secondary": [
{
"description": null,
"measure": "Pharmacodynamic signals of HT-100 following chronic oral administration of multiple doses to boys with DMD.",
"timeFrame": "Months 4, 6, 7"
},
{
"description": null,
"measure": "Pharmacokinetic plasma profile of HT-100 following chronic oral administration of multiple doses to boys with DMD.",
"timeFrame": "Months 4, 6"
}
]
} | [
{
"affiliation": "AkashiTherapeutics",
"name": "Diana M Escolar, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D020966",
"term": "Muscular Disorders, Atrophic"
},
{
"id": "D009135",
"term": "Muscular Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
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"term": "Neuromuscular Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
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"term": "Genetic Diseases, Inborn"
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{
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}
],
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{
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],
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"id": "M22185",
"name": "Muscular Dystrophy, Duchenne",
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},
{
"asFound": null,
"id": "M4589",
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{
"asFound": null,
"id": "M12092",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M22697",
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},
{
"asFound": null,
"id": "M12097",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M12411",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
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},
{
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"id": "M24877",
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"relevance": "LOW"
},
{
"asFound": "Muscular Dystrophy",
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"name": "Muscular Dystrophy",
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},
{
"asFound": "Duchenne Muscular Dystrophy",
"id": "T698",
"name": "Becker Muscular Dystrophy",
"relevance": "HIGH"
},
{
"asFound": "Duchenne Muscular Dystrophy",
"id": "T1945",
"name": "Duchenne Muscular Dystrophy",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D009136",
"term": "Muscular Dystrophies"
},
{
"id": "D020388",
"term": "Muscular Dystrophy, Duchenne"
}
]
} | {
"ancestors": [
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D003049",
"term": "Coccidiostats"
},
{
"id": "D000981",
"term": "Antiprotozoal Agents"
},
{
"id": "D000977",
"term": "Antiparasitic Agents"
},
{
"id": "D000890",
"term": "Anti-Infective Agents"
},
{
"id": "D011500",
"term": "Protein Synthesis Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D020533",
"term": "Angiogenesis Inhibitors"
},
{
"id": "D043924",
"term": "Angiogenesis Modulating Agents"
},
{
"id": "D006133",
"term": "Growth Substances"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D006131",
"term": "Growth Inhibitors"
}
],
"browseBranches": [
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"abbrev": "Infl",
"name": "Anti-Inflammatory Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M4217",
"name": "Anti-Inflammatory Agents",
"relevance": "LOW"
},
{
"asFound": "Transplantation, Allogeneic",
"id": "M341691",
"name": "Halofuginone",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4298",
"name": "Antiprotozoal Agents",
"relevance": "LOW"
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{
"asFound": null,
"id": "M4294",
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"relevance": "LOW"
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{
"asFound": null,
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"id": "M7951",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M22318",
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},
{
"asFound": null,
"id": "M9231",
"name": "Growth Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C010176",
"term": "Halofuginone"
}
]
} | {
"conditions": [
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"id": "D009136",
"term": "Muscular Dystrophies"
},
{
"id": "D020388",
"term": "Muscular Dystrophy, Duchenne"
}
],
"interventions": [
{
"id": "C010176",
"term": "Halofuginone"
}
]
} |
NCT01971866 | null | Camera Based System to Monitor Patient Movement During Radiation Treatment | Improving Safety and Accuracy of Proton Therapy by Use of Camera-Based Patient Localization System | DS02 | OBSERVATIONAL | TERMINATED | 2013-10-17T00:00:00 | null | null | null | null | 1 | 18 | null | ALL | false | This study aims to investigate the advantages of using AlignRT, a commercially available, FDA approved camera-based imaging system for proton therapy patients prior to and during their radiation treatment delivery. | null | Inclusion Criteria:
Patients with tumors of the brain, head and neck, thorax, upper abdomen, posterior spine/sacrum and extremities | University of Florida | OTHER | {
"id": "UFPTI 1215-DS02",
"link": null,
"type": null
} | Slow enrollment, feasibility issues | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-10-23T00:00:00 | {
"date": "2016-01-27",
"type": "ESTIMATED"
} | {
"date": "2013-10-29",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients who are undergoing proton radiation therapy at UFPTI | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Set up and Monitoring of Patients Receiving Proton Radiation"
] | ["Proton radiation", "AlignRT"] | null | [
{
"city": "Jacksonville",
"country": "United States",
"facility": "University of Florida Proton Therapy Institute",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Paired difference between image accuracy plan data from the AlignRT system compared to the current x-ray based imaging system.",
"timeFrame": "3 months"
}
],
"secondary": null
} | [
{
"affiliation": "University of Florida Proton Therapy Institute",
"name": "Maria Mamalui-Hunter, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT04912466 | null | IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors. | A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors. | None | INTERVENTIONAL | COMPLETED | 2021-05-28T00:00:00 | null | 2022-12-03T00:00:00 | 2023-08-25T00:00:00 | [
"PHASE1"
] | 61 | 18 | 75 | ALL | false | The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia. | null | Inclusion Criteria:
1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
2. Per RECIST1, at least one evaluable or measurable lesion.
3. Male or female subject above 18 years old, no more than 75 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
5. Must have adequate organ function
Exclusion Criteria:
1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
2. Direct coombs test was positive or have history of hemolytic anemia.
3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
4. Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
5. Subjects who have a history of blood transfusion within 2 weeks prior to the study. | Innovent Biologics (Suzhou) Co. Ltd. | INDUSTRY | {
"id": "CIBI322A105",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-05-28T00:00:00 | {
"date": "2023-09-06",
"type": "ACTUAL"
} | {
"date": "2021-06-03",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Advanced Solid Tumor"
] | null | null | [
{
"city": "Jinan",
"country": "China",
"facility": "Shandong Province Cancer Hospital",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of DLT",
"timeFrame": "21 Days"
},
{
"description": null,
"measure": "Number of treatment related AEs",
"timeFrame": "up to 90 days post last dose"
},
{
"description": null,
"measure": "Number of patients with response",
"timeFrame": "Last patient enrolled+24 months"
}
],
"secondary": [
{
"description": null,
"measure": "Biomarker evaluation",
"timeFrame": "from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months."
},
{
"description": null,
"measure": "positive rate of ADA&NAB",
"timeFrame": "from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months."
},
{
"description": null,
"measure": "Area under the plsma concentration versus time curve(AUC)",
"timeFrame": "Up to 90 days post last dose"
},
{
"description": null,
"measure": "Peak Plasma concentration(Cmax)",
"timeFrame": "Up to 90 days post last dose"
},
{
"description": null,
"measure": "Clearance rate(CL)",
"timeFrame": "Up to 90 days post last dose"
},
{
"description": null,
"measure": "the distribution volumn (Vd)",
"timeFrame": "Up to 90 days post last dose"
},
{
"description": null,
"measure": "half-life period(t1/2)",
"timeFrame": "Up to 90 days post last dose"
},
{
"description": null,
"measure": "Percentage of receptor occupancy",
"timeFrame": "Up to 90 days post last dose"
},
{
"description": null,
"measure": "Hemoglobin level",
"timeFrame": "Up to 90 days post last dose"
},
{
"description": null,
"measure": "Reticulocyte count (RET)",
"timeFrame": "Up to 90 days post last dose"
},
{
"description": null,
"measure": "platelet count (PLT)",
"timeFrame": "Up to 90 days post last dose"
}
]
} | [
{
"affiliation": "No.440, Jiyan Road, Jinang City, Shandong Province, China",
"name": "Jinming Yu, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": null,
"browseLeaves": null,
"meshes": [
{
"id": "D009369",
"term": "Neoplasms"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M10184",
"name": "Immunoglobulins",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4225",
"name": "Antibodies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20194",
"name": "Antibodies, Bispecific",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D009369",
"term": "Neoplasms"
}
],
"interventions": []
} |
NCT03409666 | null | Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty. | Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty. | None | INTERVENTIONAL | COMPLETED | 2018-01-08T00:00:00 | null | 2020-11-06T00:00:00 | 2020-11-06T00:00:00 | [
"NA"
] | 50 | 18 | 70 | ALL | false | This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem. | A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.
All potential study subjects will be required to participate in the Informed Consent process. | Inclusion Criteria:
* Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
* Correction of functional deformity.
* Male or female
-≥ 18 and ≤ 70 years of age
* Subjects willing to return for follow-up evaluations.
* Subjects able to read and understand Dutch language.
Exclusion Criteria:
* active Infection (or within 6 weeks after infection)
* Sepsis
* Osteomyelitis
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* diagnosed Osteoporosis or Osteomalacia
* Metabolic disorders which may impair bone formation
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease. | Zimmer Biomet | INDUSTRY | {
"id": "ORTHO.CR.GH60",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-01-17T00:00:00 | {
"date": "2022-07-14",
"type": "ACTUAL"
} | {
"date": "2018-01-24",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "1:1 assignment of treatment",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Hip Osteoarthritis",
"Noninflammatory Degenerative Joint Disease",
"Avascular Necrosis",
"Correction of Functional Deformity",
"Rheumatoid Arthritis"
] | ["Total Hip Arthroplasty", "Medical Device", "Performance", "Safety", "Hip prosthesis", "Roentgen Stereophotogrammetric Analysis"] | null | [
{
"city": "Roosendaal",
"country": "Netherlands",
"facility": "Bravis",
"geoPoint": {
"lat": 51.53083,
"lon": 4.46528
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)",
"timeFrame": "2 years postoperatively"
}
],
"secondary": [
{
"description": null,
"measure": "Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty",
"timeFrame": "2 years postoperatively"
},
{
"description": null,
"measure": "Early Survival Assessed by Counting the Number of Implant Revisions",
"timeFrame": "Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively"
},
{
"description": null,
"measure": "Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)",
"timeFrame": "pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively"
},
{
"description": null,
"measure": "Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation",
"timeFrame": "6 weeks, 1 year and 2 years postoperatively"
},
{
"description": null,
"measure": "Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)",
"timeFrame": "2 years postoperatively"
},
{
"description": null,
"measure": "Clinical Performance Measured by Patient Based Outcome EQ5D",
"timeFrame": "2 years postoperatively"
},
{
"description": null,
"measure": "Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)",
"timeFrame": "pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively"
},
{
"description": null,
"measure": "Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)",
"timeFrame": "6 weeks, 1 year and 2 years postoperatively"
}
]
} | [
{
"affiliation": "Zimmer Biomet",
"name": "Paola Vivoda, BSc",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D001168",
"term": "Arthritis"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
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"id": "D012216",
"term": "Rheumatic Diseases"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
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"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
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{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
}
],
"browseLeaves": [
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"asFound": "Joint Disease",
"id": "M10621",
"name": "Joint Diseases",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12",
"name": "Congenital Abnormalities",
"relevance": "LOW"
},
{
"asFound": "Necrosis",
"id": "M12284",
"name": "Necrosis",
"relevance": "HIGH"
},
{
"asFound": "Degenerative Joint Disease",
"id": "M12926",
"name": "Osteoarthritis",
"relevance": "HIGH"
},
{
"asFound": "Hip Osteoarthritis",
"id": "M17912",
"name": "Osteoarthritis, Hip",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4476",
"name": "Arthritis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4480",
"name": "Arthritis, Rheumatoid",
"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": "D007592",
"term": "Joint Diseases"
},
{
"id": "D015207",
"term": "Osteoarthritis, Hip"
},
{
"id": "D009336",
"term": "Necrosis"
}
]
} | null | {
"conditions": [
{
"id": "D010003",
"term": "Osteoarthritis"
},
{
"id": "D007592",
"term": "Joint Diseases"
},
{
"id": "D015207",
"term": "Osteoarthritis, Hip"
},
{
"id": "D009336",
"term": "Necrosis"
}
],
"interventions": null
} |
NCT00622466 | null | Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer | Phase II Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer | None | INTERVENTIONAL | TERMINATED | 2008-02-22T00:00:00 | null | null | null | [
"PHASE2"
] | 20 | 18 | null | ALL | false | RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer. | OBJECTIVES:
Primary
* To evaluate the efficacy of sorafenib tosylate and paclitaxel by measuring tumor response, as defined by RECIST criteria, in patients with metastatic, HER2-negative breast cancer.
Secondary
* To evaluate time to disease progression in patients treated with this regimen.
* To evaluate six-month progression-free survival of patients treated with this regimen.
* To evaluate time to treatment failure in patients treated with this regimen.
* To evaluate clinical benefit rate (tumor response and stable disease) at 24 weeks in patients treated with this regimen.
* To evaluate duration of response in patients treated with this regimen.
* To evaluate the tolerability of this regimen in these patients.
* To examine the relationship of gene expression and tissue/serum protein markers, where available, related to response to therapy focusing on growth factor receptor pathways.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks. | DISEASE CHARACTERISTICS:
Inclusion criteria:
* Histologically\* confirmed breast cancer
* Stage IV (metastatic) disease
* Radiographic evidence of metastases NOTE: \*Histological confirmation of the actual metastasis is not required.
* Measurable disease by RECIST criteria defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (i.e., physical examination, CT scan, MRI, or x-ray) or ≥ 10 mm by spiral CT scan
* No prior radiotherapy unless growth has been documented following radiotherapy
* Primary tumor or metastatic tumor HER2-negative, defined as the following:
* Immunohistochemistry of 0 or 1+ OR the equivalent, if an automated quantitative assay is used
* HER2 fluorescent in situ hybridization (FISH) assay negative as defined by a HER2:chromosome 17 centromeric probe ratio \< 1.8 (or \< 2.2 if immunohistochemistry is less than 3+ or equivalent) OR equivalent values for negative FISH assays that do not normalize to chromosome 17
* Hormone-receptor positive (estrogen receptor-\[ER\] or progesterone receptor \[PgR\]-positive) disease or hormone receptor-negative (ER- or PgR-negative) disease
* Tumor block from initial breast cancer primary or a biopsy of a metastatic site must be available for correlative studies
* Brain metastases allowed provided the patient is stable after completion of treatment (i.e., surgery and/or radiotherapy), asymptomatic, and off steroids with 2 consecutive stable brain scans at least 4 weeks after radiotherapy
Exclusion criteria:
* Bone-only or other nonmeasurable-only disease
* Newly diagnosed brain metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-1
* Life expectancy \> 6 months
* Menopausal status not specified
* WBC ≥ 3,000/mcL
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Total bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT transaminases ≤ 2.5 times ULN (\< 5 times ULN if liver involvement)
* Creatinine \< 1.5 times ULN OR creatinine clearance \> 60 mL/min
* INR \< 1.5 OR PT/PTT normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception prior to and during (women and men) and for at least 3 months after (men) study therapy
* Able to swallow and absorb oral medications
Exclusion criteria:
* Active or uncontrolled medical illness (e.g., active infection \> CTCAE grade 2), including any of the following:
* HIV or chronic hepatitis B or C
* Uncontrolled diabetes
* NYHA class II-IV uncompensated congestive heart failure
* Unstable angina (anginal symptoms at rest)
* New onset angina (i.e., began within the past 3 months)
* Coronary artery disease
* Myocardial infarction within the past 6 months
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis or coagulopathy
* Pulmonary hemorrhage/bleeding event \> CTCAE grade 2 within 4 weeks of first dose of study drug
* Any other hemorrhage/bleeding event \> CTCAE grade 3 within 4 weeks of first study drug
* Thrombotic or embolic events (i.e., cerebrovascular accident), including transient ischemic attacks within the past 6 months
* Hypertension that cannot be controlled with medication to ≤ 150/90 mm Hg
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib tosylate
* Prior invasive cancer other than breast cancer except nonmelanoma skin cancer
* Chronic nonhealing wound or ulcer
PRIOR CONCURRENT THERAPY:
* No more than 1 prior chemotherapy regimen for metastatic breast cancer (MBC)
* At least 3 weeks since prior hormonal therapy for MBC or adjuvant or neoadjuvant chemotherapy
* More than 1 year since adjuvant paclitaxel
* At least 4 weeks since major thoracic, abdominal, or pelvic surgery and recovered
* At least 3 weeks since prior and no concurrent investigational drugs
* Concurrent bisphosphonates allowed
* Concurrent anticoagulation agents (i.e., warfarin or heparin) allowed
* No anticipated need for or concurrent radiotherapy
* No concurrent Hypericum perforatum (St. John wort) or rifampin (rifampicin)
* No other concurrent anti-neoplastic drugs | University of Texas Southwestern Medical Center | OTHER | {
"id": "STU 082010-161",
"link": null,
"type": null
} | Study sponsor requested that the study be permanently closed by letter. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-02-22T00:00:00 | {
"date": "2020-10-19",
"type": "ACTUAL"
} | {
"date": "2008-02-25",
"type": "ESTIMATED"
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"ADULT",
"OLDER_ADULT"
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"allocation": "NA",
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"primaryPurpose": "TREATMENT",
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} | [
"Breast Cancer"
] | ["stage IV breast cancer", "male breast cancer", "recurrent breast cancer", "HER2-negative breast cancer"] | null | [
{
"city": "Dallas",
"country": "United States",
"facility": "University of Texas Southwestern Medical Center",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Time to Tumor Progression",
"timeFrame": "Time from first treatment to disease progression or death (up to 36 months)"
}
],
"secondary": [
{
"description": null,
"measure": "Tumor Response Rate",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Six-month Progression-free Survival",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Time to Treatment Failure",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Clinical Benefit Rate (Tumor Response and Stable Disease) at 24 Weeks",
"timeFrame": "24 weeks"
},
{
"description": null,
"measure": "Duration of Response",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Tolerability of Sorafenib/Paclitaxel Regimen",
"timeFrame": "Up to 36 months"
},
{
"description": null,
"measure": "Determine the Relationship of Gene Expression and Tissue/Serum Protein Markers, Where Available, Related to Response to Therapy Focusing on Growth Factor Receptor Pathways.",
"timeFrame": "Up to 36 months"
}
]
} | [
{
"affiliation": "Simmons Cancer Center",
"name": "Barbara B. Haley, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
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"term": "Neoplasms by Site"
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} | {
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"term": "Antineoplastic Agents, Phytogenic"
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"term": "Antineoplastic Agents"
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NCT03807466 | null | Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care | Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term | FIRST AID-LTC | INTERVENTIONAL | COMPLETED | 2019-01-15T00:00:00 | null | 2020-04-30T00:00:00 | 2021-03-31T00:00:00 | [
"NA"
] | 356 | null | null | ALL | false | There is a high rate of inappropriate antibiotic use in long-term care (LTC) facilities, with both unnecessary initiation and prolongation of treatments. Although there are challenges to rational antibiotic use in LTC, the variability in antibiotic initiation and use of prolonged treatment durations is driven by prescriber tendencies rather than resident characteristics. Audit-and-feedback is a well-established intervention to improve professional practices, and is ideally suited for use to improve antibiotic prescribing tendencies in LTC. The literature is saturated with trials indicating benefit of audit-and-feedback, but is in dire need of studies to identify methods to improve the impact of this technique. Health Quality Ontario (HQO), a key partner in the FIRST AID-LTC research program, is already providing audit-and-feedback for other inappropriate prescribing practices in LTC, and has identified antibiotic prescribing as a priority focus. | Overarching Goals
The overarching goals of FIRST AID - LTC are two-fold:
1. Improve rational antibiotic prescribing by physicians to minimize harms among LTC residents.
2. Advance the science of audit-and-feedback to improve physician prescribing practices.
Specific Aims
To improve rational antibiotic prescribing in LTC:
1. by decreasing unnecessary initiation of antibiotic treatments among Ontario LTC residents, as well as the variability in initiation rates across LTC prescribers.
2. by decreasing unnecessary prolonged duration of antibiotic treatments among Ontario LTC residents, as well as the variability in prolonged duration treatment use across LTC prescribers.
To advance audit-and-feedback implementation science:
1. by evaluating whether a dynamic audit-and-feedback report highlighting antibiotic prescribing can lead to greater reductions in antibiotic use, than a static paginated report
Anticipated Contributions to Health-Related Knowledge
Although the literature is inundated with trials examining the impact of audit-and-feedback compared to usual care, there is a need for studies to improve audit-and-feedback delivery. FIRST AID-LTC will test optimal delivery and peer comparison techniques for audit-and-feedback. The knowledge learned can be extrapolated to antibiotic interventions in LTC in other provinces across Canada, as well more broadly to inappropriate medication prescribing practices in LTC.
Anticipated Contributions to Health Care, Health Systems and Health Outcomes
FIRST AID-LTC will lead to immediate reductions in excess antibiotic use in Ontario LTC facilities, which in turn should result in substantial reductions in direct drug costs, as well as downstream complications of allergy, organ toxicity, C. difficile infections and antimicrobial resistance. With easy transferability to other Canadian provinces, the improvements in cost-savings and patient outcomes could be massive in scope. | To Identify an LTC Resident
Inclusion Criteria:
An individual having a minimum of 2 records on separate days within the quarter meeting any combination of the following criteria:
* a record for a non-emergency long-term care inpatient services OR
* an Ontario Drug Benefits record administered in long-term care
Index date = The analysis will be anchored on the most recent of either of the records above within a given quarter or their date of death (whichever date is earliest)
Exclusion Criteria:
* Non-Ontario resident at index date
* Invalid age (age\<19 or age\>115) at index date
* Missing or invalid sex or date of birth at index date
* Death date is \>7 days before index date
* If the individual does not live in a nursing home or home for the aged
* Cannot be linked to a Most Responsible Physician (MRP) (see methodology below)
To Identify the Most Responsible Physician (MRP) Using Virtual Rostering
For each patient in the above resident cohort, the study team will retrieve all records from health care providers in the 6 month period preceding the index date (180 days), keeping only records from physicians who have a specialty of 1) general practice, 2) community medicine or 3) geriatrics.
Steps for MRP assignment:
Step 1) The study team will first select physicians with the highest count of records for the monthly management of a nursing home or home for the aged. This is completed for as many residents as possible.
Step 2) If there were no monthly management fee records as described above then the physician with highest count of non-emergency long-term care inpatient services records for each patient will be selected. This step is only applied to residents who could not be matched to a physician by Step 1. \*\*Physician must have seen the patient one or more times in 90 days prior to and including index date to be considered MRP. This criteria is applied to ensure the physician has seen the resident within the reporting quarter.
Step 3) Some patients will virtually roster to physicians in Enrollment groups, some will virtually roster to physicians that are not in a group. For these, the study team will recode enrollment program type to 'NOR' (not otherwise rostered) - these are likely fee for service physicians. | Institute for Clinical Evaluative Sciences | OTHER | {
"id": "441-2017",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-01-15T00:00:00 | {
"date": "2021-08-25",
"type": "ACTUAL"
} | {
"date": "2019-01-17",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Assess two interventional parallel study models consisting of two intervention arms each",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "The team at Health Quality Ontario will be aware of the physicians' assignment to dynamic versus paginated reports so that they can send the correct audit-and-feedback document. However, the analytic team at ICES will be masked, and outcome data will be extracted by the analysis team from routinely collected administrative databases (Ontario drug benefits database).",
"whoMasked": [
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"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Antibiotic Initiation",
"Antibiotic Duration"
] | null | null | [
{
"city": "Toronto",
"country": "Canada",
"facility": "ICES",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario"
}
] | [
{
"class": "OTHER_GOV",
"name": "Canadian Institutes of Health Research (CIHR)"
},
{
"class": "OTHER_GOV",
"name": "Ontario Agency for Health Protection and Promotion"
},
{
"class": "OTHER",
"name": "Health Quality Ontario"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Antibiotic initiation",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Antibiotic duration",
"timeFrame": "3 months"
}
],
"secondary": [
{
"description": null,
"measure": "ER visit or hospitalization for infection",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "ER visit or hospitalization for antibiotic harms",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Net Clinical impact",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Anti-psychotic use",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Benzodiazepine use",
"timeFrame": "3 months"
}
]
} | [
{
"affiliation": "ICES",
"name": "Nick Daneman, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "33754632", "type": "DERIVED", "citation": "Daneman N, Lee SM, Bai H, Bell CM, Bronskill SE, Campitelli MA, Dobell G, Fu L, Garber G, Ivers N, Lam JMC, Langford BJ, Laur C, Morris A, Mulhall C, Pinto R, Saxena FE, Schwartz KL, Brown KA. Population-Wide Peer Comparison Audit and Feedback to Reduce Antibiotic Initiation and Duration in Long-Term Care Facilities with Embedded Randomized Controlled Trial. Clin Infect Dis. 2021 Sep 15;73(6):e1296-e1304. doi: 10.1093/cid/ciab256."}, {"pmid": "33547157", "type": "DERIVED", "citation": "Laur C, Sribaskaran T, Simeoni M, Desveaux L, Daneman N, Mulhall C, Lam J, Ivers NM. Improving antibiotic initiation and duration prescribing among nursing home physicians using an audit and feedback intervention: a theory-informed qualitative analysis. BMJ Open Qual. 2021 Feb;10(1):e001088. doi: 10.1136/bmjoq-2020-001088."}] | {"versionHolder": "2025-06-18"} | null | {
"ancestors": null,
"browseBranches": [
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"abbrev": "Infe",
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"name": "All Drugs and Chemicals"
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"name": "Antibiotics, Antitubercular",
"relevance": "LOW"
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],
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NCT04868266 | null | End Tidal Carbon Dioxide in Minimal Sedation | A Randomized Controlled Trial of the Effect of Capnography for Preventing Hypoxia in Minimally Sedated Pediatric Patients | ETCO2 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2021-04-25T00:00:00 | null | 2024-04-30T00:00:00 | 2024-12-30T00:00:00 | [
"NA"
] | 214 | null | 18 | ALL | false | This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation. | null | Inclusion Criteria:
* pediatric patients undergoing minimal sedation for procedure.
Exclusion Criteria:
* none | Seoul National University Hospital | OTHER | {
"id": "D-2103-187-1208",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-04-27T00:00:00 | {
"date": "2024-05-31",
"type": "ACTUAL"
} | {
"date": "2021-04-30",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Complication of Anesthesia"
] | null | null | [
{
"city": "Seoul",
"country": "Korea, Republic of",
"facility": "Jin-Tae Kim",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Incidence of oxygen desaturation",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
}
],
"secondary": [
{
"description": null,
"measure": "number of Staff intervetions",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "Severe oxygen desaturation",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "Lowest oxygen saturation",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "Episode of apnea",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "sedation level",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "inappropriate monitoring",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "Airway obstruction",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "Integrated pulmonary index",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "success of procedure",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "Hemodynamic instability",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
},
{
"description": null,
"measure": "Medication",
"timeFrame": "from immediately after sedation to end of procedure, up to 2 hours"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"name": "Hypoxia",
"relevance": "LOW"
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} |
NCT06147466 | null | Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy | Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY) | Timely | OBSERVATIONAL | RECRUITING | 2023-04-03T00:00:00 | null | 2026-03-01T00:00:00 | 2026-06-01T00:00:00 | null | 50 | 18 | null | FEMALE | true | Prospective cohort study to determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis | null | Inclusion Criteria:
1. Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a HbA1c of \>6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above.
2. ≤14 weeks gestation,
3. age ≥18 years
4. Willingness to use the study devices a minimum of 10 days per trimester
5. Able to provide informed consent
6. Have access to email
Exclusion Criteria:
1. Non-type 2 diabetes
2. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
3. Known or suspected allergy against insulin
4. Women with nephropathy (eGFR\<30), severe autonomic neuropathy, uncontrolled gastroparesis that, as judged by the investigator, is likely to interfere with the normal conduct of the study and interpretation of study results
5. Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
6. Unable to communicate effectively in English as judged by the investigator
7. Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results | Mount Sinai Hospital, Canada | OTHER | {
"id": "21-0065-E",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-11-21T00:00:00 | {
"date": "2024-03-20",
"type": "ACTUAL"
} | {
"date": "2023-11-27",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Pregnant Women with Type 2 diabetes with either a HbA1c of \>6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
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"timePerspective": "PROSPECTIVE"
} | [
"Diabete Type 2",
"Pregnancy in Diabetic"
] | ["glucose range", "neonatal outcomes", "glycemic control", "hypoglycemia", "insulin resistance", "preganant", "pregnancy", "CGM", "Continuous Glucose Monitoring", "Dexcom", "maternal outcomes", "Pregnancy in Diabetes"] | null | [
{
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"country": "Canada",
"facility": "Mount Sinai Hospital",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario"
}
] | [
{
"class": "OTHER",
"name": "University of Manitoba"
},
{
"class": "OTHER",
"name": "Women's College Hospital"
}
] | null | {
"other": null,
"primary": [
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"description": null,
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"timeFrame": "7-9 months"
}
],
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"description": null,
"measure": "Delivery outcome",
"timeFrame": "7-9 months"
},
{
"description": null,
"measure": "Maternal outcome",
"timeFrame": "7-9 months"
},
{
"description": null,
"measure": "Maternal outcome (HTN)",
"timeFrame": "7-9 months"
},
{
"description": null,
"measure": "Neonatal weight at birth",
"timeFrame": "7-9 months (Delivery of neonate)"
},
{
"description": null,
"measure": "Neonatal outcomes (hypoglycemia)",
"timeFrame": "7-9 months (Delivery of neonate)"
},
{
"description": null,
"measure": "Neonatal outcomes (chromosomal abnormality)",
"timeFrame": "7-9 months (Delivery of neonate)"
},
{
"description": null,
"measure": "Neonatal outcomes (congenital anomaly)",
"timeFrame": "7-9 months (Delivery of neonate)"
},
{
"description": null,
"measure": "Neonatal outcomes (birth injury)",
"timeFrame": "7-9 months (Delivery of neonate)"
},
{
"description": null,
"measure": "Neonatal outcomes (hyperbilirubinemia)",
"timeFrame": "7-9 months (Delivery of neonate)"
},
{
"description": null,
"measure": "Neonatal outcomes (neonatal intensive care admission)",
"timeFrame": "Delivery of neonate to 6 weeks postpartum"
},
{
"description": null,
"measure": "Covariates (maternal obesity)",
"timeFrame": "16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum"
},
{
"description": null,
"measure": "Covariates (maternal ethnicity)",
"timeFrame": "Enrollment (16-24 weeks gestation)"
},
{
"description": null,
"measure": "Covariates (Mother's total household income)",
"timeFrame": "enrollment 16-24 weeks gestation"
},
{
"description": null,
"measure": "Adverse events",
"timeFrame": "7-9 months"
},
{
"description": null,
"measure": "Blood Insulin",
"timeFrame": "at 16-24 weeks gestation"
},
{
"description": null,
"measure": "Measures of insulin resistance (HOMA-IR )",
"timeFrame": "at 16-24 weeks gestation"
},
{
"description": null,
"measure": "Mean blood glucose measurement",
"timeFrame": "at 16-24 weeks gestation"
},
{
"description": null,
"measure": "Diabetes distress",
"timeFrame": "at 16-24 weeks gestation and at 34 weeks gestation"
},
{
"description": null,
"measure": "Sleep quality",
"timeFrame": "at 16-24 weeks gestation and at 34 weeks gestation"
},
{
"description": null,
"measure": "Sleep apnea",
"timeFrame": "at 16-24 weeks gestation and at 34 weeks gestation"
},
{
"description": null,
"measure": "Perceived social support",
"timeFrame": "16-24 weeks gestation"
}
]
} | [
{
"affiliation": "Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital",
"name": "Denice Feig",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D003920",
"term": "Diabetes Mellitus"
},
{
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{
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},
{
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{
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"term": "Pregnancy Complications"
},
{
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},
{
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"term": "Urogenital Diseases"
}
],
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}
],
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},
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},
{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
}
]
} | {
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"abbrev": "Hypo",
"name": "Hypoglycemic Agents"
},
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"name": "All Drugs and Chemicals"
}
],
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"id": "M173166",
"name": "Insulin, Globin Zinc",
"relevance": "LOW"
}
],
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} | {
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"term": "Pregnancy in Diabetics"
},
{
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"term": "Diabetes, Gestational"
},
{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
}
],
"interventions": []
} |
NCT05279066 | null | Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband | A Clinical Validation Study for Measuring Cardiac Output and Ejection Fraction Using a Wrist-worn Device. | None | OBSERVATIONAL | UNKNOWN | 2022-01-27T00:00:00 | null | 2022-07-15T00:00:00 | 2022-07-15T00:00:00 | null | 100 | 18 | null | ALL | true | In this study, the investigators will compare the accuracy of the Biostrap wristband, a wearable device with a clinical-grade Photoplethysmography (PPG) sensor, to measure ejection fraction and cardiac output in patients undergoing a cardiac ultrasound and pulmonary arterial catheterization, respectively. | This in an introductory clinical study with both cardiac patients undergoing elective cardiac ultrasound and cardiac ICU patients with pulmonary arterial catheters featuring Biostrap wristband. This is a single site, non-blinded, non-randomized study. The wristband is a wearable device that contains a clinical-grade Photoplethysmography (PPG) sensor which will measure parameters quasi-continuously and non-invasively. The device, Biostrap wristband, will measure cardiac ejection fraction (EF) and cardiac output (CO). We will enroll a total of 100 patients: 2 groups of 50. 50 patients undergoing an elective cardiac ultrasound as part of their routine medical care will wear the device for 1-2 hours as an outpatient depending on the duration of the test. 50 hospitalized patients with a scheduled or completed pulmonary arterial catheter inserted as part of their standard medical care will wear the device for 7 days.
The investigators will perform a retrospective analysis comparing the accuracy of EF and CO measured by the device in comparison to those from a 'reference device', which is the cardiac ultrasound for ejection fraction and the pulmonary arterial catheter for cardiac output values. Cardiac Ultrasound and pulmonary arterial catheters are standard of care procedures. | Inclusion Criteria:
1. ≥ 18 years of age.
2. Subjects who are undergoing elective cardiac ultrasound as an outpatient for group 1 or are scheduled for/completed a pilmonary arterial catheterization for group 2.
3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
1. Subject is unable or unwilling to wear the wristband for the required duration. | University of California, Los Angeles | OTHER | {
"id": "21-001030",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-03-03T00:00:00 | {
"date": "2022-03-15",
"type": "ACTUAL"
} | {
"date": "2022-03-15",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Men and woman over the age of 18 years old. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Heart Failure"
] | ["ejection fraction", "cardiac output"] | null | [
{
"city": "Los Angeles",
"country": "United States",
"facility": "Ronald Reagan UCLA Medical Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Association between obtained PPG waveforms and recorded ejection (EF) fractions",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Association between obtained PPG waveforms and recorded cardiac outputs (CO)",
"timeFrame": "6 months"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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{
"asFound": "Heart Failure",
"id": "M9421",
"name": "Heart Failure",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006333",
"term": "Heart Failure"
}
]
} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
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"asFound": null,
"id": "M11767",
"name": "Metronidazole",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D006333",
"term": "Heart Failure"
}
],
"interventions": []
} |
NCT06874166 | null | Social Cognition in Dystrophinopathies and Neurodevelopmental Disorders | Social Cognition in Dystrophinopathies and Neurodevelopmental Disorders. Behavioural and Psychophisiological Measures | None | OBSERVATIONAL | NOT_YET_RECRUITING | 2025-02-17T00:00:00 | null | null | null | null | 45 | 4 | null | MALE | true | The primary aim of this observational study is to investigate specific aspects of social cognition in dystrophinopathies. Body awareness, interpersonal distance and emotional processing will be measured in a sample of patients affected by Becker (BMD) and Duchenne (DMD) muscular dystrophy, compared with a sample of patients affected by osteogenesis imperfecta (OI), and both compared with a control sample with typical development.
The secondary aim is to study cortical activity at rest, by means of electroencephalography (EEG), to explore frequencies and time course of EEG responses. Moreover, the relationship between EEG activity and neuropsychological, dispositional and subjective measures will be explored through correlational analyses. | Study procedure includes: 1. Eligibility assessment according to inclusion and exclusion criteria. 2. Administration of questionnaires and scales for the characterization of cognitive and psychological features related with BMD/DMD and OI : Wechsler Intelligence Scale for Children 4th Edition (WISC-IV), Raven's Progressive Matrices; NEPSY-II; The Child Behavior Checklist (CBCL); PedsQL; Toronto Alexithymia Scale (TAS-20); Emotion Regulation Questionnaire (ERQ); Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA); Multidimensional Assessment of Interoceptive Awareness (MAIA); Body Shape Questionnaire (BSQ-14); and the Autism Spectrum Quotient (AQ, adult or child version) 3. Administration of experimental tasks. The Comfort-Distance Task (CDT) to measure the interpersonal comfort distance, the task will be implemented in immersive virtual reality by means of head-mounted displays (OCULUS ©2024 Meta). Interoceptive accuracy will be measured through a modified version of the heartbeat counting task. An emotional priming task will be administered in order to measure emotion processing, participants will be asked to detect trial by trial the target emotion which could be preceded by a congruent or incongruent visual priming.
All the tasks will be performed in a counterbalanced order, for an overall duration of about 40 minutes.
4. Recording of resting state EEG will be collected. | Inclusion Criteria:
* Patients diagnosed with Duchenne and Becker muscular dystrophy (genetic and histological diagnosis and clinical diagnosis) (ambulant and non-ambulant).
* Patients diagnosed with osteogenesis imperfecta.
* Control group: participants without any neurological or psychiatric disorder
Exclusion Criteria:
* presence of comorbid diagnoses,
* sensory deficit
* specific condition that could prevent the application of the tests and tasks under study, such as: a) the need for PEG; b) the need for tracheostomy; c) the need for assisted ventilation.
* cognitive level lower than 60. | IRCCS Eugenio Medea | OTHER | {
"id": "L2-227",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2025-03-11T00:00:00 | {
"date": "2025-03-13",
"type": "ACTUAL"
} | {
"date": "2025-03-13",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | For the statistical power analysis the size of the effect reported in Candini et al., 2017 (η2p = 0.28) has been considered, about the effect of diagnostic features on the peripersonal space, and the effect reported by Garcia et al., 2023 (η2p = 0.20) about the differences between DMD/BMD patients and neurotypicals in social cognition. The calculation, performed separately for the two different effects, returns a sample size between 17 and 23 minimum patients per group. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Duchenne / Becker Muscular Dystrophy",
"Osteogenesis Imperfecta (OI)",
"Social Cognition"
] | ["Social Cognition", "Duchenne / Becker muscular dystrophy", "Osteogenesis Imperfecta (OI)", "EEG", "Interpersonal distance", "Interoception"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Interoception",
"timeFrame": "Day 1"
},
{
"description": null,
"measure": "Interpersonal distance",
"timeFrame": "Day 1"
},
{
"description": null,
"measure": "Emotional processing",
"timeFrame": "Day 1"
},
{
"description": null,
"measure": "EEG power",
"timeFrame": "once"
},
{
"description": null,
"measure": "EEG power",
"timeFrame": "Day 1"
},
{
"description": null,
"measure": "EEG power",
"timeFrame": "Day 1"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D020966",
"term": "Muscular Disorders, Atrophic"
},
{
"id": "D009135",
"term": "Muscular Diseases"
},
{
"id": "D009140",
"term": "Musculoskeletal Diseases"
},
{
"id": "D009468",
"term": "Neuromuscular Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
},
{
"id": "D040181",
"term": "Genetic Diseases, X-Linked"
},
{
"id": "D001523",
"term": "Mental Disorders"
},
{
"id": "D010009",
"term": "Osteochondrodysplasias"
},
{
"id": "D001848",
"term": "Bone Diseases, Developmental"
},
{
"id": "D001847",
"term": "Bone Diseases"
},
{
"id": "D003095",
"term": "Collagen Diseases"
},
{
"id": "D003240",
"term": "Connective Tissue Diseases"
}
],
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"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
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"name": "All Conditions"
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"name": "Musculoskeletal Diseases"
},
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"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
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"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
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"name": "Rare Diseases"
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],
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"relevance": "HIGH"
},
{
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"id": "M22185",
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"relevance": "HIGH"
},
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{
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"relevance": "LOW"
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"relevance": "LOW"
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},
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},
{
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"name": "Neuromuscular Diseases",
"relevance": "LOW"
},
{
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"id": "M23686",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M24877",
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"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
{
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"relevance": "LOW"
},
{
"asFound": null,
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"name": "Mucopolysaccharidosis IV",
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},
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"asFound": null,
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"relevance": "LOW"
},
{
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M15045",
"name": "Rheumatic Diseases",
"relevance": "LOW"
},
{
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"relevance": "LOW"
},
{
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"relevance": "LOW"
},
{
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},
{
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"id": "T698",
"name": "Becker Muscular Dystrophy",
"relevance": "HIGH"
},
{
"asFound": "Becker Muscular Dystrophy",
"id": "T1945",
"name": "Duchenne Muscular Dystrophy",
"relevance": "HIGH"
},
{
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"id": "T4306",
"name": "Osteogenesis Imperfecta",
"relevance": "HIGH"
},
{
"asFound": "Dystrophinopathy",
"id": "T1992",
"name": "Dystrophinopathy",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T3909",
"name": "Mucopolysaccharidosis Type IV",
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}
],
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"id": "D009136",
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},
{
"id": "D020388",
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},
{
"id": "D010013",
"term": "Osteogenesis Imperfecta"
},
{
"id": "D065886",
"term": "Neurodevelopmental Disorders"
}
]
} | null | {
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},
{
"id": "D020388",
"term": "Muscular Dystrophy, Duchenne"
},
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"term": "Osteogenesis Imperfecta"
},
{
"id": "D065886",
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}
],
"interventions": null
} |
NCT06580366 | null | Comparing Sennosid A+B and Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation | Sennosid A+B Versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation; A Prospective Randomized Observer-Blinded Study | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-08-27T00:00:00 | null | 2024-12-22T00:00:00 | 2025-03-22T00:00:00 | [
"PHASE4"
] | 600 | 18 | 80 | ALL | false | Colonoscopy Preparation: Comparing Sennoside A+B and PM/Ca
Colonoscopy is a test used to examine the inside of the bowel. Proper bowel preparation is crucial because it helps doctors get a clear view during the procedure.
What is Sennoside A+B? Sennoside A+B is a type of laxative made from the senna plant. It works by stimulating the bowel to move and reducing the absorption of water, making it easier to pass stools. Research has shown that high doses of sennoside A+B can be effective for bowel preparation.
Sennoside A+B vs. PEG:
Some studies have found that sennoside A+B is more effective than PEG, another laxative, but can cause more abdominal pain. Other studies have found no significant difference in effectiveness between the two.
What is Picosulfate/Magnesium Oxide/Citric Acid (PM/Ca)? PM/Ca is a combination of sodium picosulfate, magnesium oxide, and citric acid. Sodium picosulfate stimulates bowel movements, while magnesium oxide and citric acid help increase water in the bowel, making it easier to pass stools.
PM/Ca vs. PEG:
Research has shown that PM/Ca is as effective as PEG for bowel preparation. Patients using PM/Ca generally tolerate the preparation process better than those using PEG.
Conclusion:
While PEG is the preferred option according to guidelines, its high cost can make it less accessible in some places. In this study, we aim to compare the effectiveness and patient tolerance of Sennoside A+B and PM/Ca since no direct comparison between these two preparations has been made before. | Colonoscopy is an endoscopic imaging method used to examine the lumen and mucosa of the bowel. It is the gold standard method used for colorectal cancer screening and the detection of most colorectal pathologies. Successful bowel preparation is one of the key factors for a successful colonoscopic examination.
Sennoside A+B is a stimulant laxative derived from the senna plant (Cassia senna). Studies have shown that after senna is ingested, it is activated by the gut flora, directly interacts with the intestinal mucosa, stimulates bowel movements, and inhibits the absorption of electrolytes and water. High doses of senna have been shown to be beneficial as a bowel preparation agent.
There are many studies in the literature comparing senna compounds with polyethylene glycol (PEG) solutions. In a randomized controlled study conducted by Coskun et al. on 474 patients, it was found that bowel cleansing was better with sennoside A+B compared to PEG, but abdominal pain was more common in the senna group. Another randomized controlled study conducted by Shavakhi et al. on 322 patients found no difference in effectiveness between the two agents.
Drugs containing sodium picosulfate-magnesium oxide-citric acid (PM/Ca) are laxative agents recommended for colonoscopy preparation in ESGE and ASGE guidelines. While sodium picosulfate acts as a stimulant laxative, magnesium oxide and citric acid act as osmotic laxatives.
In the SEE CLEAR II randomized controlled trial comparing PM/Ca with PEG, PM/Ca was found to be as effective as PEG. No significant difference was found between the two groups in terms of side effects, but participants using PM/Ca tolerated the bowel preparation procedure much better.
The ASGE and ESGE guidelines primarily recommend PEG solutions for colon preparation. However, due to the lack of reimbursement by the Social Security Institution (SGK) in our country and the resulting cost, access to PEG treatment is difficult for patients. For these reasons, other treatments recommended in the available guidelines are used more frequently in our country.
Although there are many studies in the literature comparing PM/Ca and sennoside A+B preparations with PEG and other preparations in terms of efficacy for bowel preparation, no study has directly compared PM/Ca with sennoside A+B to date. We aimed to compare the efficacy and patient tolerance of these two commonly used preparations in our country. | Inclusion Criteria:
* Adults aged 18-80 years scheduled for elective outpatient colonoscopy.
* Ability to provide informed consent.
Exclusion Criteria:
* History of intra-abdominal surgery.
* Chronic kidney failure.
* Congestive heart failure.
* Chronic liver failure.
* Inflammatory bowel disease.
* Electrolyte imbalance.
* Hospitalized patients.
* Patients unable to use the bowel preparation treatment
* Known allergy or hypersensitivity to Sennoside A+B or PM/Ca components
* Known gastrointestinal motility disorders. | Hitit University | OTHER | {
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} | Unknown | {
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{
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"lon": 34.95333
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],
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"affiliation": "Hitit University",
"name": "İbrahim Durak",
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}
] | [{"pmid": "24659864", "type": "BACKGROUND", "citation": "Park S, Lim YJ. Adjuncts to colonic cleansing before colonoscopy. World J Gastroenterol. 2014 Mar 21;20(11):2735-40. doi: 10.3748/wjg.v20.i11.2735."}, {"pmid": "32424868", "type": "BACKGROUND", "citation": "Coskun Y, Yuksel I. Polyethylene glycol versus split high-dose senna for bowel preparation: A comparative prospective randomized study. J Gastroenterol Hepatol. 2020 Nov;35(11):1923-1929. doi: 10.1111/jgh.15101. Epub 2020 Jun 8."}, {"pmid": "22091224", "type": "BACKGROUND", "citation": "Shavakhi A, Kianinia M, Torabi G, Nemati A, Saeidian B, Hoseinzadeh M, Madjlesi F, Navaei P, Rashidinejad F, Minakari M. High dose Senna or Poly Ethylene Glycol (PEG) for elective colonoscopy preparation: a prospective randomized investigator-blinded clinical trial. J Res Med Sci. 2011 Feb;16(2):149-55."}, {"pmid": "23318484", "type": "BACKGROUND", "citation": "Katz PO, Rex DK, Epstein M, Grandhi NK, Vanner S, Hookey LC, Alderfer V, Joseph RE. A dual-action, low-volume bowel cleanser administered the day before colonoscopy: results from the SEE CLEAR II study. Am J Gastroenterol. 2013 Mar;108(3):401-9. doi: 10.1038/ajg.2012.441. Epub 2013 Jan 15."}, {"pmid": "31295746", "type": "BACKGROUND", "citation": "Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11."}] | {"versionHolder": "2025-06-18"} | null | {
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NCT05371366 | null | The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial) | A Multicenter, Randomized, Parallel-controlled Clinical Trial to Evaluate the Efficacy and Safety of a New Atrial Septal Defect Occluder, ReAces®, and Delivery System for the Treatment of Atrial Septal Defect Occlusion | None | INTERVENTIONAL | UNKNOWN | 2022-05-04T00:00:00 | null | 2023-04-22T00:00:00 | 2023-04-22T00:00:00 | [
"NA"
] | 128 | 18 | 70 | ALL | false | A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion. Compared with the traditional atrial septal occluder, this new atrial septal occluder supports re-puncture after occluder implantation. Thus those patients who have undergone atrial septal defect closure with the novel device may be eligible for future radiofrequency ablation of atrial fibrillation or mitral valve intervention.
The trial is expected to enroll 128 patients who will be randomly assigned to the test group or control group in a 1:1 ratio. Patients in test group will received ReAces occluder，and the others the regular occluder.The experiment is scheduled to enroll 128 patients who will be randomly allocated to one of two groups: test or control. Patients in the test group will receive a ReAces occluder, while those in the control group will receive a standard occluder.The safety and efficacy of the two groups at 1 year after surgery will be compared. | null | Inclusion Criteria:
1. aged 18-70 years;
2. with congenital secundum atrial septal defect;
3. the maximal ASD diameter was ≤38 mm;
4. with atrial-level left-to-right shunt, with Qp/Qs shunt ratio ≥1.5:1, or TTE or clinical manifestations indicated the existence of defect that inducing overfilling of right atrium;
5. the distance from the margin of defect to coronary sinus, atrioventricular (AV) valve, and right superior pulmonary vein (RSPV) was ≥5 mm, according to the echocardiography measurements;
6. volunteered to participate in this study, and signed informed consents.
Exclusion Criteria:
1. ostium primordium ASD and sinus venosus ASD.
2. infective endocarditis and hemorrhagic disorders.
3. active thrombosis.
4. patients with severe pulmonary hypertension (mean pulmonary artery pressure measured by catheter \> 30 mmHg) who are not taking targeted drugs
5. patients with a porous atrial septal defect that cannot be completely occluded by a single occluder.
6. with severe myocardial disorders or valvular disease not associated with ASD
7. infectious disease within the last 1 month, or uncontrolled infectious disease
8. bleeding disorders, untreated gastric or duodenal ulcers
9. thrombosis in left atrium
10. partial or total pulmonary vein ectopic drainage
11. left atrial septum, left atrial or left ventricular dysplasia
12. Patients whose size (too small for TEE probe, catheter size, etc.) or physical condition (active infection, etc.) makes them unsuitable for cardiac catheterization
13. Patients who are allergic to nickel
14. Patients with any contraindication to aspirin therapy (except for those able to take other antiplatelet agents for 6 consecutive months).
15. Pregnant or lactating women and those who plan to become pregnant during the trial
16. Patients with a life expectancy of \<12 months or those who are unable to complete the study's prescribed follow-up schedule
17. Participation in another clinical trial of a drug or medical device within 30 days prior to screening.
18. Patients who have previously undergone surgical atrial septal defect repair or percutaneous interventional atrial septal defect closure.
19. Patients who, in the opinion of the investigator, are not suitable for participation in this study. | Shanghai Zhongshan Hospital | OTHER | {
"id": "HYYL2022-06ZC-01",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
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} | 2022-05-07T00:00:00 | {
"date": "2022-05-24",
"type": "ACTUAL"
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"date": "2022-05-12",
"type": "ACTUAL"
} | [
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} | [
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"facility": "180 Fenglin Road",
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"lon": 121.45806
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"state": "Shanghai"
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] | null | null | {
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],
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"description": null,
"measure": "Adverse events",
"timeFrame": "0-360 days"
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]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT00992966 | null | Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms | Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms. | None | OBSERVATIONAL | SUSPENDED | 2009-10-08T00:00:00 | null | null | null | null | 80 | 3 | 18 | ALL | false | The VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed. | This study is a prospective, single center study to determine the value of VRI images as an aid in determining whether a chest x ray is necessary to evaluate children presenting with acute respiratory complaints.
Study participants will be children, selected from the Emergency Department (ED), who were designated to undergo a PA and Left Lateral CXR because of acute respiratory complaints such as a new respiratory condition, acute cough, onset of shortness of breath, or fever.
Patients who meet the study inclusion and exclusion criteria will be enrolled and will be recorded by the VRI device.
A technician will perform a CXR on the enrolled patients. The CXR and the VRI will be performed on the same day within 6 hours of each other.
VRI readers, who are blinded to the patient's CXR, history, and physical exam, will evaluate the VRI recording. The VRI reader will review the VRI images and, using the lexicon of images supplied by Deep Breeze, determine whether the VRI is normal or abnormal.
Certified radiologists will review the patient's CXR and will determine whether the CXR is normal or abnormal based solely on the CXR.
The VRI readers determination of normal or abnormal for each subject will be compared to the radiologists determination of normal or abnormal CXR for each subject. | Inclusion Criteria:
1. Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
2. Boy or girl in the age range of 3-18 years.
3. Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever.
4. Patient referred by ED physician and presented for CXR.
Exclusion Criteria:
1. Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
2. Potentially contagious skin lesion on the back;
3. Subject has had lung surgery;
4. Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms. | Deep Breeze | INDUSTRY | {
"id": "DB048",
"link": null,
"type": null
} | Study initiation has been delayed due to Sponsor decision | {
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"type": "ESTIMATED"
} | {
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"ADULT"
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} | [
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] | ["to acquire database of pneumonia cases in children"] | null | null | null | null | null | [
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},
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"role": "PRINCIPAL_INVESTIGATOR"
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NCT03829566 | null | Autologous Transplant To End NMO Spectrum Disorder | Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) | ATTEND | INTERVENTIONAL | WITHDRAWN | 2019-02-01T00:00:00 | null | null | 2025-11-28T00:00:00 | [
"PHASE2",
"PHASE3"
] | 0 | 18 | 65 | ALL | false | This study is designed to treat your disease with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy to reset your immune system and to determine if your disease will go into long-term remission. | The autologous stem cell transplant used in this research study is an investigational procedure that uses cyclophosphamide (chemotherapy), rabbit antithymocyte globulin (rATG) (a protein that kills the immune cells that are thought to be causing your disease), rituximab (a biologic drug that targets B cells of your immune system), and intravenous immunoglobulin (IVIg) (pooled IgG antibodies from plasma donors with immunomodulatory and anti-inflammatory effects), followed by return of your own previously collected blood stem cells (autologous stem cell transplant). One day of plasmapheresis will also be performed the day prior to admission for stem cell transplant to remove disease-causing antibodies. The ability of this experimental treatment to stop relapses and progression (worsening) of your NMOSD will be assessed. | Inclusion Criteria:
1. Age 18 - 65 years old at the time of pre-transplant evaluation
2. An established diagnosis of NMOSD (with or without aquaporin 4 (AQP4)-IgG antibody)
Exclusion Criteria:
1. Under age of 18 or over age of 65
2. Prisoners
3. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible, or any adult who is unable to consent (for adults cognitively impaired due to disease, consent may be obtained from the closest living relative).
4. Paraplegia or quadriplegia (must be able to use a walker if even for only a few feet)
5. Extensive subcortical white matter lesions
6. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment
7. Myocardial infarction within the last 12 months. If longer than 12 months, must pass a dobutamine stress test and be cleared by cardiology.
8. Active systemic lupus erythematous, Sjogren's, myasthenia gravis, or another autoimmune disease
9. Sickle cell disease, sickle cell disease, or coagulopathy
10. Prior history of malignancy that required any radiotherapy, chemotherapy, or biological therapy
11. Positive pregnancy test, inability or unable to pursue effective means of birth control, or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy
12. Women who are breastfeeding
13. Untreated life-threatening cardiac arrhythmia on electrocardiogram (EKG) or 24-hour holter
14. Left ventricular ejection fraction (LVEF) \<50%
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18. Major hematological abnormalities such as platelet count \< 100,000/μl or absolute neutrophil count (ANC) \< 1000/μl
19. Active infection except asymptomatic bacteriuria
20. Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have magnetic resonance imaging (MRI) exams
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22. Human immunodeficiency virus (HIV) positive
23. Hepatitis B or C positive
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NCT05046366 | null | Development of an Artificial Intelligence System for Intelligent Pathological Diagnosis and Therapeutic Effect Prediction Based on Multimodal Data Fusion of Common Tumors and Major Infectious Diseases in the Respiratory System Using Deep Learning Technology. | Research and Development of an Artificial Intelligence Technology System for Digital Pathological Diagnosis and Therapeutic Effect Prediction Based on Multimodal Data Fusion of Common Tumors and Major Infectious Diseases in the Respiratory System Using Deep Learning Technology. | None | OBSERVATIONAL | UNKNOWN | 2021-06-27T00:00:00 | null | null | null | null | 1,000 | 18 | 90 | ALL | true | To improve accurate diagnosis and treatment of common malignant tumors and major infectious diseases in the respiratory system, we aim to establish a large medical database that includes standardized and structured clinical diagnosis and treatment information such as electronic medical records, image features, pathological features, and multi-omics information, and to develop a multi-modal data fusion-based technology system for individualized intelligent pathological diagnosis and therapeutic effect prediction using artificial intelligence technology. | The main aims are as follows:
1. To establish a medical big data platform for multi-modal information fusion of common tumors and major infectious diseases (lung cancer/pulmonary nodules, tuberculosis, and COVID-19) based on the existing pathological image features and clinical multi-omics information database: The medical big data platform supports the acquisition of the patient's clinical electronic medical records (including routine clinical detection), full view digital section of pathological image data, medical imaging (CT, MRI, ultrasound, nuclear medicine, etc.), multiple omics data (genome, transcriptome, and metabolome, proteomics) omics data, etiology, pathology, and associated graphic data reports and multimodal medical treatment data. We aim to realize the storage, sharing, fusion computing, privacy protection, and security supervision of multi-modal and cross-scale biomedical big data. Our work will open up key business processes and links across regions, across hospitals, between different terminals, between hospitals and doctors, and between departments, so as to promote continuous data accumulation and knowledge precipitation in hospitals and promote medical collaboration.
2. To create a multimodal information fusion database with pathologic features, imaging features, multi-omics (pathologic, genomic, transcriptome, metabolome, proteomics, etc.), and clinical information of patients at different stages of lung cancer/pulmonary nodules, tuberculosis, and COVID-19. The database scale includes multimodal data of at least 600 lung cancer/pulmonary nodules, 200 tuberculosis, and 200 COVID-19 patients. Moreover, there will be more than 10 biomarkers significantly related to the diagnosis and treatment of patients with lung cancer/pulmonary nodules, tuberculosis and COVID-19 were excavated through association analysis, providing parameters for artificial intelligence model construction.
3. We will make use of artificial intelligence technology to create the multi-modal medical big data cross-analysis technology and the above disease individualized accurate diagnosis and curative effect prediction models. In order to solve the three key problems of multi-modal data fusion mining, such as unbalanced, small sample size, and poor interpretability, we will establish an ARTIFICIAL intelligence recognition algorithm for image images and pathological images, and use image processing and deep learning technologies to mine multi-level depth visual features of image data and pathological data. In addition, we will use bioinformatics analysis algorithms to conduct molecular network mining and functional analysis of molecular markers at the level of multiple omics technologies (pathologic, genomic, transcriptome, metabolome, proteome, etc.). | Inclusion Criteria:
1. Participants with the clinical diagnosis of lung cancer, pulmonary tuberculosis, and COVID-19.
2. Participants that have signed informed consent.
3. Participants \>= 18 years old and \< 90 years old.
4. Participants with detailed electronic medical records, image records, pathological records, multi-omics information, and other important clinical diagnostic information.
5. Healthy participants with no clinical diagnosis of lung cancer, pulmonary tuberculosis, and COVID-19.
Exclusion Criteria:
1. Participants \< 18 years old.
2. Participants with primary clinical and pathological data missing.
3. Participants lost to follow-up.
4. Participants with too poor medical image quality to perform segment and mark ROI accurately. | Wuhan Union Hospital, China | OTHER | {
"id": "[2021]IEC(491)",
"link": null,
"type": null
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"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-09-15T00:00:00 | {
"date": "2021-11-16",
"type": "ACTUAL"
} | {
"date": "2021-09-16",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
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"allocation": null,
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"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Artificial Intelligence",
"Deep Learning",
"Pathology, Molecular",
"Medical Informatics",
"Database",
"Lung Cancer",
"Pulmonary Tuberculosis",
"Covid19"
] | null | null | [
{
"city": "Wuhan",
"country": "China",
"facility": "Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",
"geoPoint": {
"lat": 30.58333,
"lon": 114.26667
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"state": "Hubei"
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] | null | null | {
"other": null,
"primary": [
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"measure": "The outcome of clinical diagnosis of suspected patients with lung cancer/pulmonary nodular (Benign/Malignant nodule).",
"timeFrame": "2021-2024"
},
{
"description": null,
"measure": "The outcome of clinical diagnosis of suspected patients with pulmonary tuberculosis (Positive/Negative).",
"timeFrame": "2021-2024"
},
{
"description": null,
"measure": "The outcome of clinical diagnosis of suspected patients with COVID-19 (Positive/Negative).",
"timeFrame": "2021-2024"
},
{
"description": null,
"measure": "Treatment response of anti-cancer therapy at first evaluation in patients with lung cancer/pulmonary nodules (CR, PR, PD, SD).",
"timeFrame": "2021-2024"
},
{
"description": null,
"measure": "Treatment response of anti-inflammation and antiviral therapy at first evaluation in patients with COVID-19 (effective/ineffective treatment).",
"timeFrame": "2021-2024"
},
{
"description": null,
"measure": "Treatment response of antituberculous bacilli and anti-inflammation therapy at first evaluation in patients with pulmonary tuberculosis.",
"timeFrame": "2021-2024"
},
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"description": null,
"measure": "Progression free survival",
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"measure": "Overall survival",
"timeFrame": "2021-2024"
},
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"description": null,
"measure": "Whole genome sequencing of blood samples",
"timeFrame": "2021-2024"
},
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"description": null,
"measure": "Whole-genome sequencing of tissue samples",
"timeFrame": "2021-2024"
},
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"description": null,
"measure": "Whole genome sequencing of exhaled air condensate samples",
"timeFrame": "2021-2024"
},
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"description": null,
"measure": "Whole genome sequencing of urine samples",
"timeFrame": "2021-2024"
},
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"description": null,
"measure": "Transcriptome sequencing of blood samples",
"timeFrame": "2021-2024"
},
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"description": null,
"measure": "Transcriptome sequencing of tissue samples",
"timeFrame": "2021-2024"
},
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NCT00003666 | null | Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer | Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer | None | INTERVENTIONAL | COMPLETED | 1999-11-01T00:00:00 | null | null | null | [
"PHASE2"
] | 36 | 18 | 120 | ALL | false | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer. | OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II. Determine the duration of response to this regimen in this patient population. III. Determine the effect of prior response to chemotherapy on the response to HMAF in these patients. IV. Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients.
OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease progression. Patients are followed at least every 3 months for 1 year, then every 6 months until death.
PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this study within 12-18 months. | DISEASE CHARACTERISTICS: Histologically or cytologically proven recurrent or refractory non-small cell lung cancer Squamous cell Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic (giant and clear cell carcinomas) Measurable disease (not bone disease only, pleural or pericardial effusions, or irradiated lesions, unless progression is documented after radiotherapy) No CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater 1.5 mg/dL SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than ULN Cardiovascular: No active cardiac disease No unstable angina No myocardial infarction within 6 months No congestive heart failure No inability to tolerate hypotension Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No uncontrolled diabetes mellitus No psychiatric disorders No concurrent secondary malignancies except nonmelanomatous skin cancer or patients with less than a 30% risk of relapse
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin) At least 1 prior chemotherapy agent or combination, including adjuvant or neoadjuvant therapy for non-small cell lung cancer No more than 1 prior chemotherapy agent or combination for metastatic or recurrent disease No prior HMAF No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except for nondisease related conditions Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: Not specified | Alliance for Clinical Trials in Oncology | OTHER | {
"id": "CALGB-39805",
"link": null,
"type": null
} | Unknown | {
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} | 2004-09-10T00:00:00 | {
"date": "2016-07-20",
"type": "ESTIMATED"
} | {
"date": "2004-09-13",
"type": "ESTIMATED"
} | [
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"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
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"primaryPurpose": "TREATMENT",
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} | [
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{
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{
"class": "NIH",
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"affiliation": "Medical University of South Carolina",
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] | [{"pmid": "15301880", "type": "RESULT", "citation": "Sherman CA, Herndon JE 2nd, Watson DM, Green MR; Cancer and Leukemia Group B. A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with relapsed or refractory non-small cell lung cancer. Lung Cancer. 2004 Sep;45(3):387-92. doi: 10.1016/j.lungcan.2004.02.017."}, {"pmid": null, "type": "RESULT", "citation": "Sherman CA, Herndon JE, Green MR, et al.: CALGB 39805: phase II trial of 6-hydroxymethylacylfulvene (HMAF; MGI-114) in patients with relapsed or refractory non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2163, 2000."}] | {"versionHolder": "2025-06-18"} | {
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} |
NCT05698966 | null | Low Dose Antenatal Corticosteroids for Late Preterm Delivery | Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study) | LoDAC | INTERVENTIONAL | RECRUITING | 2022-12-31T00:00:00 | null | 2027-01-01T00:00:00 | 2028-01-01T00:00:00 | [
"NA"
] | 1,510 | 18 | 45 | ALL | false | This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants. | Antenatal corticosteroids (ACS) are a type of steroid medication that is administered to pregnant women at risk of preterm birth in order to reduce the risk of respiratory distress syndrome (RDS) and other complications in the newborn. ACS were first demonstrated to be effective in a controlled trial conducted in the 1970s by Liggins and Howie, who used a combination of betamethasone at a dose of 12 mg given in two doses 24 hours apart. Since then, numerous randomized controlled trials and meta-analyses have shown that ACS can significantly reduce neonatal death, RDS, intraventricular hemorrhage, necrotizing enterocolitis, and the need for respiratory support and neonatal intensive care unit admission in preterm infants. ACS are now recommended for use in virtually all pregnancies at risk of preterm delivery between 24 and 34 weeks of gestation. The use of ACS in late preterm pregnancies (between 34 and 37 weeks) has also been studied, with mixed results. The largest study to date, the ALPS trial, found that ACS reduced composite adverse outcomes and respiratory morbidity in late preterm infants, but did not significantly reduce the risk of RDS or mortality. The American Congress of Obstetricians and Gynecologists has recommended the use of ACS in late preterm pregnancies, but with caution due to the potential for adverse effects such as hypoglycemia. Long-term follow-up studies are needed to evaluate the potential long-term effects of ACS in late preterm infants. In this the participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants. | Inclusion Criteria:- - Singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation at risk for / high probability of delivery in the late preterm period (34+0-36+5 weeks of gestation).
Criteria for determination of late preterm delivery risk:
1. Preterm uterine contractions with intact membranes, and at least 3 cm dilation or 75% cervical effacement
2. Spontaneous rupture of the membranes
3. Expected preterm delivery for any other indication via induction or cesarean between 24 hours to 7 days after the planned randomization, as determined by the obstetric provider.
-
Exclusion Criteria: They had already received a full course of betamethasone.
* Expected delivery in less than 12 hours, irrespective of cause including: 1)ruptured membranes in the presence of more than 6 contractions per hour or cervical dilation of 3 centimeters or more unless oxytocin was withheld for at least 12 hours (although other induction agents were allowed), 2) chorioamnionitis, 3) cervical dilation of 8 cm or more, and 4) evidence of non-reassuring fetal status requiring immediate delivery.
* Prior ACS treatment
* Current known or suspected infection ( viral, bacterial or other)
* Pre-gestational diabetes mellitus.
* Any infection that required antibiotics or hospitalization in the month prior to study allocation - Poor understanding of the inform consent language | Rambam Health Care Campus | OTHER | {
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] | null | null | {
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"measure": "other neonatal morbidities other neonatal morbidities",
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]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT02861066 | null | Abbreviating Mindfulness-Based Therapy for Depressive and Anxious Symptoms | Reducing Barriers to Mental Health Care: Abbreviating Mindfulness-Based Therapy for Depressive and Anxious Symptoms in a Heterogeneous Clinical Outpatient Group | None | INTERVENTIONAL | COMPLETED | 2016-08-05T00:00:00 | null | null | null | [
"NA"
] | 54 | 18 | null | ALL | false | Symptoms of depression and anxiety are extremely prevalent in the population. Unfortunately, patients often face barriers to accessing mental health care, particularly psychotherapeutic interventions, including long wait-times and demanding therapeutic protocols. For instance, Mindfulness-Based Therapy (MBT) has demonstrated effectiveness at decreasing symptoms of depression and anxiety, and improving wellbeing; however, 'traditional' MBT can demand over 30 hours of clinical time, and 50-60 hours of homework, all of which can be barriers to care. The goal of this project is to test the effectiveness of an Abbreviated MBT (\<10 hours of clinical time and \<10 hours of homework) in reducing symptoms of depression/anxiety and improving wellbeing. If effective, this Abbreviated MBT could reduce barriers to accessing mental health care. | BACKGROUND: ABBREVIATED-MINDFULNESS BASED INTERVENTION (A-MBI)
By the age of 40, 1 in 2 Canadians have been or are presently experiencing mental health issues. In particular, anxiety and mood disorders are the most prevalent lifetime mental health illnesses, affecting 11.6% of the population. Mindfulness based treatments (MBTs) have strong evidence for improving patient wellness through reduction of anxiety and mood symptoms in clinical populations. Although efficacious, 'traditional' MBTs are very demanding in terms of time and homework a relevant factor when considering the recent calls for wait time reductions in psychotherapeutic mental health services. These programs take 30+ hours (including 2-3 hr. weekly sessions across 8 weeks, plus a 1-day retreat) and expect 45-60 min./day of meditation homework. The goal of this project is to test the effectiveness of an abbreviated MBI in reducing anxiety and/or mood disturbances and improving patient well-being.
MBTs use a non-stigmatizing approach, combining secularized eastern meditative practices with western psychological advances to improve stress-management and self-care. Participants learn to generate less distress, engage more positively and fully in their lives and experiences, and respond more adaptively to challenges instead of reacting in automatic and unhelpful ways. Participants in MBI often describe the intervention as transformative. Professional experience and new insights into MBTs suggest that these 'tradition' treatment programs can be further abbreviated to develop a effective and accessible clinical intervention. This abbreviated MBT has been developed, which if effective will curtail wait-times and increase patient treatment annually.
RATIONAL \& HYPOTHESIS/RESEARCH QUESTION
Rational
Patients face barriers to accessing psychotherapy, including long wait-times and/or protocols that are too demanding for many patients. Traditional Mindfulness-Based Therapies (MBTs) are highly studied and well-recognized treatment options to reduce anxiety and mood symptoms - demonstrating repeated efficacy in clinical populations. However, the high demands of clinical time and homework are a barrier to many patients. Further, longer clinical interventions mean fewer patients being treated per hour of clinician's time, and therefore longer wait-times. Clinical experience and new insights into MBTs suggest that these 'tradition' treatment programs can be further abbreviated to develop an effective and more accessible therapy. If this Abbreviated MBT is demonstrated to be clinically effective, it can reduce barriers to mental health care by reaching more patients in a more timely fashion.
The specific objective of this study will be to evaluate a novel and potentially highly effective strategy to reduce symptoms of depression, anxiety and improve quality of life among outpatients in the chosen pilot site, the Odette Cancer Centre.
Hypothesis/Research Question
The overall study hypothesis is that patients participating in an Abbreviated MBT will show improvement in self-reported measures of clinical primary (Depression, Anxiety) and secondary (well-being) outcomes. Improvement will be determined by effect size (magnitude of change ≥0.2) based on the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BDI).
Study Significance
The current pilot study will explore the effects of an Abbreviated-MBT on symptoms of depression and anxiety in an outpatient clinical sample; if effective: a) this would be the first known pilot study to consider and demonstrate efficacy of an Abbreviated-MBT in a clinical outpatient population; b) this treatment could increase the volume of patients treated by up to 3x, reduce wait-times by 2-3 fold, and reach a broader group of patients, including those for whom the investment of time of traditional MBT is too prohibitive. | Inclusion Criteria:
* Consenting mood and anxiety outpatients referred to Dr. Selchen in the Sunnybrook Mindfulness-Based Therapy Clinic
* Due to the nature of the assessment procedures, which include English-language self-report questionnaires and scales, ability to communicate in written and spoken English is an inclusion criterion
Exclusion Criteria:
* Patients who have active or recent (within 3 months) substance abuse/dependence, a history of dementia, untreated posttraumatic stress symptoms, active psychotic or manic symptoms, recent suicide attempt/active suicidality, or current self-injurious behaviour
* Previously completed a course (≥ 8 weeks) of a Mindfulness-Based Therapy within the last 3 years | Sunnybrook Health Sciences Centre | OTHER | {
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} | 2016-08-05T00:00:00 | {
"date": "2018-09-20",
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} | [
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} | [
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}
],
"meshes": [
{
"id": "D003863",
"term": "Depression"
}
]
} | null | {
"conditions": [
{
"id": "D003863",
"term": "Depression"
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],
"interventions": null
} |
NCT04059666 | null | Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas | Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas | None | INTERVENTIONAL | TERMINATED | 2019-05-08T00:00:00 | null | 2022-02-02T00:00:00 | 2022-02-02T00:00:00 | [
"NA"
] | 57 | 7 | 18 | ALL | true | This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period. | null | Inclusion Criteria:
* 7-18 days of age at Visit 1
* Singleton birth
* Gestational age of 37-42 weeks
* Birth weight of 2500 g (5 lbs 8 oz) or more
* Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
* Signed informed consent and use of PHI for infant and birth mother
* Receipt of three protocol-compliant Baseline stool samples
Infants receiving formula:
* Exclusively receiving infant formula for at least 24 hours prior to randomization
* Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
Infants receiving human milk:
* Mother has intention to exclusively provide mother's-own breast milk for the duration of the study
Exclusion Criteria:
* Caesarean delivery
* Infant consumption of donor milk prior to randomization/registration
* Maternal antibiotic use within 48 hours prior to or at time of delivery
* Maternal antibiotic use while providing mother's-own breast milk to infant
* Infant use of systemic antibiotics prior to randomization/registration
* Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration
* Weight at Visit 1 is \<95% of birth weight
* Infant use of probiotics
* Evidence of significant feeding difficulties
* Infant was born large for gestational age
* History of underlying metabolic or chronic disease or congenital malformation
* Infant is immunocompromised
Infants receiving human milk:
* Consumption of infant formula from 1 day of age | Mead Johnson Nutrition | INDUSTRY | {
"id": "3390-1",
"link": null,
"type": null
} | Slow enrolment | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-08-14T00:00:00 | {
"date": "2022-08-25",
"type": "ACTUAL"
} | {
"date": "2019-08-16",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | false | {
"allocation": "RANDOMIZED",
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"timePerspective": null
} | [
"Gastrointestinal Microbiome"
] | null | null | [
{
"city": "Birmingham",
"country": "United States",
"facility": "Birmingham Pediatric Associates",
"geoPoint": {
"lat": 33.52066,
"lon": -86.80249
},
"state": "Alabama"
},
{
"city": "Altamonte Springs",
"country": "United States",
"facility": "Children's Research, LLC",
"geoPoint": {
"lat": 28.66111,
"lon": -81.36562
},
"state": "Florida"
},
{
"city": "Owensboro",
"country": "United States",
"facility": "Owensboro Pediatrics",
"geoPoint": {
"lat": 37.77422,
"lon": -87.11333
},
"state": "Kentucky"
},
{
"city": "Kingsport",
"country": "United States",
"facility": "Holston Medical Group",
"geoPoint": {
"lat": 36.54843,
"lon": -82.56182
},
"state": "Tennessee"
},
{
"city": "Memphis",
"country": "United States",
"facility": "Memphis & Shelby County Pediatric",
"geoPoint": {
"lat": 35.14953,
"lon": -90.04898
},
"state": "Tennessee"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Comparison of stool microbiome between breast fed and formula fed babies",
"timeFrame": "Over 60 days"
}
],
"secondary": [
{
"description": null,
"measure": "Oral microbiome at each visit",
"timeFrame": "Over 60 days"
},
{
"description": null,
"measure": "Stool molecules at each visit",
"timeFrame": "Over 60 days"
},
{
"description": null,
"measure": "24 hour recall of formula intake",
"timeFrame": "2 times over 60 days"
},
{
"description": null,
"measure": "Stool color and consistency",
"timeFrame": "3 times over 60 days"
},
{
"description": null,
"measure": "Medically confirmed adverse events",
"timeFrame": "60 days"
},
{
"description": null,
"measure": "Stool pH",
"timeFrame": "Over 60 days"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Ot",
"name": "Other Dietary Supplements"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
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"asFound": null,
"id": "T435",
"name": "Whey Protein",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": null,
"interventions": []
} |
NCT03539666 | null | Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing | The Effect of Pork and Chicken Diets on Gut Microbiota Composition and Metabolites Related to Cardiometabolic Wellbeing | None | INTERVENTIONAL | COMPLETED | 2018-05-16T00:00:00 | null | 2019-03-14T00:00:00 | 2019-04-16T00:00:00 | [
"NA"
] | 38 | 50 | null | ALL | true | The project will characterize human gut microbiome response to two different diets and the possible physiological and biochemical implications of such response on cardiometabolic risk factors. The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns. | The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns. | Inclusion Criteria:
* generally good health status based on one routine physical in the past 15 months, current health status
* normal HbA1C, weigh 110 lb or more
* Age 50 years or more, generally healthy, all races and both sexes
* generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and
* willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
Exclusion Criteria:
* medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
* Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
* impaired kidney functions
* Active history of cancer, diabetes, heart, liver, and kidney diseases
* major gastrointestinal disorders in the past 3 months
* history of heart attacks or stroke
* Unable to meet in-person visit requirements for dining, picking up meals, and tests
* Any mental health condition that would affect the ability to provide written informed consent.
* If they had not had a routine health checkup during the 12 months prior to recruitment.
* If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period. | South Dakota State University | OTHER | {
"id": "IRB-1804010-EXP",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-05-16T00:00:00 | {
"date": "2021-11-10",
"type": "ACTUAL"
} | {
"date": "2018-05-29",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
} | [
"Healthy"
] | null | null | [
{
"city": "Brookings",
"country": "United States",
"facility": "South Dakota State University, Wagner Hall 416",
"geoPoint": {
"lat": 44.31136,
"lon": -96.79839
},
"state": "South Dakota"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Microbiota-dependent TMAO-response, measured as serum concentration",
"timeFrame": "10 days per diet arm"
},
{
"description": null,
"measure": "Serum concentration of biogenic amine metabolites",
"timeFrame": "10 days per diet arm"
}
],
"secondary": null
} | [
{
"affiliation": "South Dakota State University",
"name": "Moul Dey, Ph.D",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT04328766 | null | Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers | An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers | None | INTERVENTIONAL | COMPLETED | 2020-03-24T00:00:00 | null | 2020-11-21T00:00:00 | 2020-11-21T00:00:00 | [
"PHASE1"
] | 36 | 19 | 50 | ALL | true | An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers | null | Inclusion Criteria:
* Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
* Capable of understanding provided information and complying with protocol requirements
* Provide written informed consent to participate in the study | Daewoong Pharmaceutical Co. LTD. | INDUSTRY | {
"id": "DW_DWP14012106",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-03-30T00:00:00 | {
"date": "2021-08-16",
"type": "ACTUAL"
} | {
"date": "2020-03-31",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | null | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Drug-drug Interaction"
] | null | null | [
{
"city": "Queensland",
"country": "Australia",
"facility": "Nucleus Network (QPharm)",
"geoPoint": null,
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Area under the plasma drug concentration-time curve",
"timeFrame": "upto 48 hours postdose"
},
{
"description": null,
"measure": "Peak Plasma Concentration (Cmax)",
"timeFrame": "upto 48 hours postdose"
},
{
"description": null,
"measure": "Incidence of Treatment-Emergent Adverse Events",
"timeFrame": "up to 19 days"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | null | {
"ancestors": [
{
"id": "D005765",
"term": "Gastrointestinal Agents"
}
],
"browseBranches": [
{
"abbrev": "Gast",
"name": "Gastrointestinal Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Endoscopic Submucosal Dissection",
"id": "M350719",
"name": "Fexuprazan",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M8881",
"name": "Gastrointestinal Agents",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C000634065",
"term": "Fexuprazan"
}
]
} | {
"conditions": null,
"interventions": [
{
"id": "C000634065",
"term": "Fexuprazan"
}
]
} |
NCT04791566 | null | Preoperative High-dose Dexamethasone and Emergency Laparotomy | The Effects of Preoperative High-dose Dexamethasone on Inflammatory Response and Recovery After Emergency Laparotomy, a Randomized, Double-blind, Placebo-controlled Clinical Trial - AHA STEROID TRIAL | None | INTERVENTIONAL | COMPLETED | 2021-03-03T00:00:00 | null | 2022-10-09T00:00:00 | 2022-12-09T00:00:00 | [
"PHASE4"
] | 120 | 18 | null | ALL | false | The aim of this trial is to evaluate the effect of high-dose glucocorticoid on inflammatory response and recovery after emergency laparotomy in participants with intestinal obstruction and perforated viscus.
Primary outcome is the reduction of C-reactive protein on postoperative day 1. Secondary outcomes are organ specific complications in the post anaesthesia phase, endothel and inflammatory markers, fluid status, preload dependency, pain, lung function, nausea and mobilization during the first 5 days after surgery, .
The investigators hypothesize, that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy. | Surgical trauma and accompanying inflammation results in increased capillary permeability leading to tissue edema. Since the vascular endothelium contributes to homeostasis, endothelial damage may increase the risk of cardiovascular and hemodynamic complications.
Pre-operative high-dose glucocorticoids provide reduction in the inflammatory response after surgery, effective pain relief in several major surgical procedures, as well as reducing fatigue, impairing endothelial dysfunction, potentially amend fluid extravasation, edema and dyscoagulation and vasodilation.
However, glucocorticoids have not been assessed in patients with peritonitis or intestinal obstruction, specifically, the impact on pain, fluid dynamics, respiratory as well as endothelial function and mobilization in both obstruction and perforation.
In this study, patients will be randomized to either high dose dexamethason (1 mg /kg) or placebo (0,9% NaCl), administered as a single dose preoperatively. The investigatoris hypothesize that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy. | Inclusion Criteria:
1. Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology:
1. Primary perforated viscus (perforated ulcer, small intestine or colon)
2. Primary intestinal obstruction ( small intestine or colon)
2. Provided verbal and written informed consent
3. Must speak and understand the Danish language
Exclusion Criteria:
1. Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases.
2. Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage
3. Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute surgery is defined as surgery planned within 48 hours.
4. Intestinal Ischemia
5. intraabdominal bleeding
6. Traumas, gynecological, urogenital and other vascular pathology, pregnant participants.
7. Dementia and/or cognitive dysfunction (diagnosed).
8. Participants not oriented in time, place and person
9. Insuline treatment for diabetes mellitus type I and II
10. Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids)
11. Allergies to trial medicine
- | Copenhagen University Hospital, Hvidovre | OTHER | {
"id": "H-20038432",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-03-08T00:00:00 | {
"date": "2022-12-14",
"type": "ACTUAL"
} | {
"date": "2021-03-10",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Intestinal Obstruction and Ileus",
"Perforated Viscus",
"Sepsis",
"Pathophysiology",
"Inflammatory Response"
] | null | null | [
{
"city": "Hvidovre",
"country": "Denmark",
"facility": "Mirjana Cihoric",
"geoPoint": {
"lat": 55.65719,
"lon": 12.47364
},
"state": null
}
] | null | null | {
"other": [
{
"description": null,
"measure": "changes in postoperative inflammatory responses (IL-6, TNF alfa)",
"timeFrame": "Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Change in plasma Syndecain-1sE-Selectin (CD62E)",
"timeFrame": "Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Change in plasma soluble thrombomodulin (sTM)(CD141)",
"timeFrame": "Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Change in plasma sE-Selectin (CD62E)",
"timeFrame": "Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Change in vascular endothelial growth factor (VEGF)",
"timeFrame": "Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "quick Sequential Organ Failure Assessment score, qSOFA",
"timeFrame": "Assessed once preoperatively and 4 times daily during the first 5 postoperative days"
},
{
"description": null,
"measure": "Preload dependency via stroke volume(SV) guided resuscitation",
"timeFrame": "Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Fluid distribution, full body water via bioelectrical impedance vector analysis",
"timeFrame": "Preoperatively, 6 hours postoperatively, as well as postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Peak flow measurements",
"timeFrame": "Once a day on postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Postoperative need for antiemetic and analgesic beyond standard course",
"timeFrame": "Once a day during the the first 5 postoperative days"
},
{
"description": null,
"measure": "Mobilization, The Cumulated Ambulation Score (CAS)",
"timeFrame": "Once a day on postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Postoperative delirium via Confusion Assessment method scale",
"timeFrame": "Once a day during the the first 5 postoperative days"
},
{
"description": null,
"measure": "Postoperative resting pain measured according to Numeric Rating Scale (NRS)",
"timeFrame": "6 hours after surgery as well as once a day one postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "Postoperative pain during mobilization, measured according to Numeric Rating Scale (NRS)",
"timeFrame": "6 hours after surgery as well as once one postoperative day 1,3 and 5"
},
{
"description": null,
"measure": "30-day postoperative mortality",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "90-day postoperative mortality",
"timeFrame": "90 days"
},
{
"description": null,
"measure": "30-day postoperative complications",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "Length of ICU stay",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "Overall hospital stay",
"timeFrame": "30 days"
},
{
"description": null,
"measure": "Plasma NO-bioavailability (L-arginine, asymmetric dimethylarginine)",
"timeFrame": "preoperatively, 6 hours after surgery as well as once one postoperative day 1,3 and 5"
}
],
"primary": [
{
"description": null,
"measure": "plasma C-reactive protein",
"timeFrame": "24* hours (*+/- 6 hours) after surgery."
}
],
"secondary": [
{
"description": null,
"measure": "changes in plasma C-reactive protein",
"timeFrame": "Preoperatively, 6 hours postoperatively, as well as postoperative day 3 and 5"
}
]
} | [
{
"affiliation": "Dept. of Anaesthesiology and Intensive Care",
"name": "Nicolai Bang Foss, Professor",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D005767",
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},
{
"id": "D004066",
"term": "Digestive System Diseases"
}
],
"browseBranches": [
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]
} | {
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{
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{
"id": "D018373",
"term": "Peripheral Nervous System Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
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"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",
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],
"browseBranches": [
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"name": "Anti-Inflammatory Agents"
},
{
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"name": "Antineoplastic Agents"
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},
{
"abbrev": "Gast",
"name": "Gastrointestinal Agents"
},
{
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"name": "All Drugs and Chemicals"
},
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
}
],
"browseLeaves": [
{
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"id": "M7102",
"name": "Dexamethasone",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M235549",
"name": "Dexamethasone acetate",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4107",
"name": "Anesthetics",
"relevance": "LOW"
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{
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{
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"relevance": "LOW"
},
{
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"id": "M20966",
"name": "Antineoplastic Agents, Hormonal",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003907",
"term": "Dexamethasone"
}
]
} | {
"conditions": [
{
"id": "D007415",
"term": "Intestinal Obstruction"
}
],
"interventions": [
{
"id": "D003907",
"term": "Dexamethasone"
}
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NCT00251966 | null | ASTERIX: Low Dose ASA and Nexium | A Randomized Double-Blind Placebo-Controlled Study to Assess the Prevention of Low-Dose Acetylsalicylic Acid (ASA) Associated Gastroduodenal Lesions and Upper Gastrointestinal Symptoms in Patients Taking Esomeprazole 20 mg Once Daily for 26 Weeks. | None | INTERVENTIONAL | COMPLETED | 2005-11-09T00:00:00 | null | null | null | [
"PHASE3"
] | 960 | 60 | null | ALL | false | The purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA. | null | Inclusion Criteria:
* A clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose ASA, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week).
* Age \>= 60 years.
* No gastric and/or duodenal ulcer at the baseline endoscopy.
* H. pylori negative by serology test at screening.
Exclusion Criteria:
* Upper GI symptoms
* Erosive oesophagitis
* Malignancy | AstraZeneca | INDUSTRY | {
"id": "D9617C00011",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2005-11-09T00:00:00 | {
"date": "2009-03-12",
"type": "ESTIMATED"
} | {
"date": "2005-11-11",
"type": "ESTIMATED"
} | [
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"OLDER_ADULT"
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"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
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{
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NCT02736266 | null | Neoadjuvant Pembrolizumab for Muscle-invasive Urothelial Bladder Carcinoma | An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab (MK-3475) Before Cystectomy for Patients With Muscle-invasive Urothelial Bladder Cancer. | PURE-01 | INTERVENTIONAL | COMPLETED | 2016-04-09T00:00:00 | null | 2018-10-20T00:00:00 | 2022-09-23T00:00:00 | [
"PHASE2"
] | 174 | 18 | null | ALL | false | Patients with T2-T4a N0 urothelial bladder carcinoma (UBC) with residual disease after transurethral resection of the bladder (TURB, surgical opinion, cystoscopy or radiological presence) will receive 3 cycles of pembrolizumab (MK-3475) at the dose of 200mg 3 weekly prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 3 weeks of the last dose (accounting for a total of 9 weeks).
Computed tomography (CT) scan and fluorodeoxyglucose positron emission tomography (FDG-PET)/CT scan will be done during screening and before surgery. After cystectomy, patients with the evidence of pathologic stage T3-4 (pT3-4) and/or pathologically node-positive disease will be managed according to local guidelines. Further anti programmed-death (PD)-1 or anti PD-ligand 1 (PD-L1) therapy will not be given post-operatively.
PD-L1 status will be centralized and assessed on TURB specimen using an anti-PD-L1 antibody (Ab) and a prototype immunohistochemical (IHC) assay. PD-L1 positivity will be defined as any staining in the stroma or in ≥1% of tumor cells.
Pathologic complete response (pCR) is the primary endpoint. All patients enrolled who receive at least 1 cycle of study drug will be includes in the intention-to-treat (ITT) analysis.
The alternative hypothesis (H1) is pCR ≥20% and null hypothesis (H0) pCR≤10%. A 2-stage design will be used to estimate the number of pts required. Out of 90 pts overall, with the first stage of 49 pts, ≥6 pCR will be required in the first stage, and ≥13 pCR in the whole study population (80% power and a 2-sided test of significance at the 10% level).
Correlative research on tissue/blood samples will include immune-cell profiling in tumor and blood during Pembrolizumab, cytokine assessment, and molecular profiling of tumor samples. | Patients with T2-T4a N0 urothelial bladder carcinoma (UBC) with residual disease after transurethral resection of the bladder (TURB, surgical opinion, cystoscopy or radiological presence) will receive 3 cycles of pembrolizumab (MK-3475) at the dose of 200mg 3 weekly prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 3 weeks of the last dose (accounting for a total of 9 weeks). | Inclusion Criteria:
1. Willing and able to provide written informed consent.
2. Ability to comply with the protocol.
3. Age ≥ 18 years.
4. Histopathologically confirmed transitional cell carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
5. Fit and planned for cystectomy (according to local guidelines).
6. Clinical stage T2-T4a N0 M0 disease by CT (or MRI) + PET/CT (within 4 weeks of randomization by RECIST v1.1).
7. Residual disease after TURB (surgical opinion, cystoscopy or radiological presence).
8. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for testing at the study sponsor site and determined to be evaluable for tumor PD-L1 expression prior to study enrolment; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Merck representatives.
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
10. Adequate hematologic and end-organ function tests.
Exclusion Criteria:
* Patients taking regular oral steroids, above the allowed limit of 10mg/day methylprednisolone or analogues, for any reason. Patients must not have had steroids for 28 days prior to study entry.
* Previously intravenous chemotherapy bladder cancer. Patients who have previously had radiotherapy or concurrent chemo-radiation would be eligible.
* Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score ≤ 3 + 4 and PSA \< 10 ng/mL undergoing active surveillance and treatment naive).
* Evidence of measurable nodal or metastatic disease.
* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome).
* Pregnant female patients. All female patients of childbearing potential with a positive pregnancy test within 2 weeks prior to the first dose of study treatment will be excluded from the study.
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias, or unstable angina.
* Severe infections within 4 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
* Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the pembrolizumab formulation
* History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
* Patients with a history of autoimmune-related hypothyroidism, unless on a stable dose of thyroid-replacement hormone.
* Patients with uncontrolled Type 1 diabetes mellitus
* Uncontrolled hypercalcemia
* Patients with prior allogeneic stem cell or solid organ transplantation.
* History of idiopathic pulmonary fibrosis
* Positive test for HIV.
* Patients with active hepatitis infection
* Patients with active tuberculosis.
* Prior treatment with anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
* Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrolment
* History of severe immune-related adverse effects from anti-CTLA-4 (CTCAE Grade 3 and 4).
* Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment. | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | OTHER | {
"id": "INT 101/16",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-04-09T00:00:00 | {
"date": "2023-07-18",
"type": "ACTUAL"
} | {
"date": "2016-04-13",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Urothelial Bladder Carcinoma"
] | ["Muscle-invasive", "Urothelial bladder carcinoma", "Neoadjuvant therapy", "Radical cystectomy"] | null | [
{
"city": "Milano",
"country": "Italy",
"facility": "Fondazione IRCCS Istituto Nazionale dei Tumori",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
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"state": "Mi"
}
] | [
{
"class": "INDUSTRY",
"name": "Merck Sharp & Dohme LLC"
}
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"other": null,
"primary": [
{
"description": null,
"measure": "Pathologic complete response",
"timeFrame": "At the time of radical cystectomy (within 9 weeks of the first dose of pembrolizumab)"
}
],
"secondary": [
{
"description": null,
"measure": "Adverse events",
"timeFrame": "Up to 2 years"
},
{
"description": null,
"measure": "Percentage of treatment-related delay in surgery",
"timeFrame": "Starting at week 9"
},
{
"description": null,
"measure": "Frequency of treatment-related adverse events",
"timeFrame": "Up to 1 year"
}
]
} | [
{
"affiliation": "Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",
"name": "Filippo G. de Braud, MD",
"role": "PRINCIPAL_INVESTIGATOR"
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Epub 2021 Jun 17."}, {"pmid": "33720424", "type": "DERIVED", "citation": "Trevisani F, Di Marco F, Raggi D, Bettiga A, Vago R, Larcher A, Cinque A, Salonia A, Briganti A, Capitanio U, Necchi A, Montorsi F. Renal function outcomes in patients with muscle-invasive bladder cancer treated with neoadjuvant pembrolizumab and radical cystectomy in the PURE-01 study. Int J Cancer. 2021 Jul 1;149(1):186-190. doi: 10.1002/ijc.33554. Epub 2021 Mar 26."}, {"pmid": "33172772", "type": "DERIVED", "citation": "Marandino L, Capozza A, Bandini M, Raggi D, Fare E, Pederzoli F, Gallina A, Capitanio U, Bianchi M, Gandaglia G, Fossati N, Colecchia M, Giannatempo P, Serafini G, Padovano B, Salonia A, Briganti A, Montorsi F, Alessi A, Necchi A. Incidence and Clinical Impact of Inflammatory Fluorodeoxyglucose Positron Emission Tomography Uptake After Neoadjuvant Pembrolizumab in Patients with Organ-confined Bladder Cancer Undergoing Radical Cystectomy. Eur Urol Focus. 2021 Sep;7(5):1092-1099. doi: 10.1016/j.euf.2020.10.003. Epub 2020 Nov 7."}, {"pmid": "33071107", "type": "DERIVED", "citation": "Marandino L, Capozza A, Bandini M, Raggi D, Fare E, Pederzoli F, Gallina A, Capitanio U, Bianchi M, Gandaglia G, Fossati N, Colecchia M, Giannatempo P, Serafini G, Padovano B, Salonia A, Briganti A, Montorsi F, Alessi A, Necchi A. [18F]Fluoro-Deoxy-Glucose positron emission tomography to evaluate lymph node involvement in patients with muscle-invasive bladder cancer receiving neoadjuvant pembrolizumab. Urol Oncol. 2021 Apr;39(4):235.e15-235.e21. doi: 10.1016/j.urolonc.2020.09.035. Epub 2020 Oct 16."}, {"pmid": "32979511", "type": "DERIVED", "citation": "Bandini M, Gibb EA, Gallina A, Raggi D, Marandino L, Bianchi M, Ross JS, Colecchia M, Gandaglia G, Fossati N, Pederzoli F, Luciano R, Colombo R, Salonia A, Briganti A, Montorsi F, Necchi A. Does the administration of preoperative pembrolizumab lead to sustained remission post-cystectomy? First survival outcomes from the PURE-01 study\u2606. Ann Oncol. 2020 Dec;31(12):1755-1763. doi: 10.1016/j.annonc.2020.09.011. Epub 2020 Sep 23."}, {"pmid": "32847746", "type": "DERIVED", "citation": "Pederzoli F, Bandini M, Marandino L, Raggi D, Giannatempo P, Salonia A, Gallina A, Briganti A, Montorsi F, Necchi A. Neoadjuvant Chemotherapy or Immunotherapy for Clinical T2N0 Muscle-invasive Bladder Cancer: Time to Change the Paradigm? Eur Urol Oncol. 2021 Dec;4(6):1006-1010. doi: 10.1016/j.euo.2020.07.006. Epub 2020 Aug 23."}, {"pmid": "32605888", "type": "DERIVED", "citation": "Bandini M, Calareso G, Raggi D, Marandino L, Colecchia M, Gallina A, Giannatempo P, Pederzoli F, Gandaglia G, Fossati N, Capitanio U, Colombo R, Salonia A, Briganti A, Montorsi F, De Cobelli F, Messina A, Necchi A. The Value of Multiparametric Magnetic Resonance Imaging Sequences to Assist in the Decision Making of Muscle-invasive Bladder Cancer. Eur Urol Oncol. 2021 Oct;4(5):829-833. doi: 10.1016/j.euo.2020.06.004. Epub 2020 Jun 27."}, {"pmid": "32516377", "type": "DERIVED", "citation": "Bandini M, Ross JS, Raggi D, Gallina A, Colecchia M, Luciano R, Giannatempo P, Fare E, Pederzoli F, Bianchi M, Colombo R, Gandaglia G, Fossati N, Marandino L, Capitanio U, Deho' F, Ali SM, Madison R, Chung JH, Salonia A, Briganti A, Montorsi F, Necchi A. Predicting the Pathologic Complete Response After Neoadjuvant Pembrolizumab in Muscle-Invasive Bladder Cancer. J Natl Cancer Inst. 2021 Jan 4;113(1):48-53. doi: 10.1093/jnci/djaa076."}, {"pmid": "32417369", "type": "DERIVED", "citation": "Necchi A, Raggi D, Giannatempo P, Marandino L, Fare E, Gallina A, Colecchia M, Luciano R, Salonia A, Gandaglia G, Fossati N, Bandini M, Pederzoli F, Dittamore R, Liu Y, Davicioni E, Ross JS, de Jong JJ, Briganti A, Montorsi F, Gibb EA. Can Patients with Muscle-invasive Bladder Cancer and Fibroblast Growth Factor Receptor-3 Alterations Still Be Considered for Neoadjuvant Pembrolizumab? A Comprehensive Assessment from the Updated Results of the PURE-01 Study. Eur Urol Oncol. 2021 Dec;4(6):1001-1005. doi: 10.1016/j.euo.2020.04.005. Epub 2020 May 14."}, {"pmid": "32165065", "type": "DERIVED", "citation": "Necchi A, Raggi D, Gallina A, Ross JS, Fare E, Giannatempo P, Marandino L, Colecchia M, Luciano R, Bianchi M, Colombo R, Salonia A, Gandaglia G, Fossati N, Bandini M, Pederzoli F, Capitanio U, Montorsi F, de Jong JJ, Dittamore R, Liu Y, Davicioni E, Boormans JL, Briganti A, Black PC, Gibb EA. Impact of Molecular Subtyping and Immune Infiltration on Pathological Response and Outcome Following Neoadjuvant Pembrolizumab in Muscle-invasive Bladder Cancer. Eur Urol. 2020 Jun;77(6):701-710. doi: 10.1016/j.eururo.2020.02.028. Epub 2020 Mar 9."}, {"pmid": "31882281", "type": "DERIVED", "citation": "Necchi A, Bandini M, Calareso G, Raggi D, Pederzoli F, Fare E, Colecchia M, Marandino L, Bianchi M, Gallina A, Colombo R, Fossati N, Gandaglia G, Capitanio U, Deho F, Giannatempo P, Luciano R, Salonia A, Madison R, Ali SM, Chung JH, Ross JS, Briganti A, Montorsi F, De Cobelli F, Messina A. Multiparametric Magnetic Resonance Imaging as a Noninvasive Assessment of Tumor Response to Neoadjuvant Pembrolizumab in Muscle-invasive Bladder Cancer: Preliminary Findings from the PURE-01 Study. Eur Urol. 2020 May;77(5):636-643. doi: 10.1016/j.eururo.2019.12.016. Epub 2019 Dec 25."}, {"pmid": "31708296", "type": "DERIVED", "citation": "Necchi A, Raggi D, Gallina A, Madison R, Colecchia M, Luciano R, Montironi R, Giannatempo P, Fare E, Pederzoli F, Bandini M, Bianchi M, Colombo R, Gandaglia G, Fossati N, Marandino L, Capitanio U, Deho F, Ali SM, Chung JH, Ross JS, Salonia A, Briganti A, Montorsi F. Updated Results of PURE-01 with Preliminary Activity of Neoadjuvant Pembrolizumab in Patients with Muscle-invasive Bladder Carcinoma with Variant Histologies. Eur Urol. 2020 Apr;77(4):439-446. doi: 10.1016/j.eururo.2019.10.026. Epub 2019 Nov 8."}, {"pmid": "30811283", "type": "DERIVED", "citation": "Necchi A, Montorsi F. Reply to S. Zhang. J Clin Oncol. 2019 Apr 10;37(11):940-941. doi: 10.1200/JCO.18.02448. Epub 2019 Feb 27. No abstract available."}, {"pmid": "30343614", "type": "DERIVED", "citation": "Necchi A, Anichini A, Raggi D, Briganti A, Massa S, Luciano R, Colecchia M, Giannatempo P, Mortarini R, Bianchi M, Fare E, Monopoli F, Colombo R, Gallina A, Salonia A, Messina A, Ali SM, Madison R, Ross JS, Chung JH, Salvioni R, Mariani L, Montorsi F. Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Urothelial Bladder Carcinoma (PURE-01): An Open-Label, Single-Arm, Phase II Study. 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NCT01857466 | null | Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix | Additional Benefit of Hemostatic Sealant in Preserving Ovarian Reserve During Laparoscopic Ovarian Cystectomy: a Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2013-05-16T00:00:00 | null | null | null | [
"PHASE3"
] | 100 | 18 | 45 | FEMALE | false | Laparoscopy has become the gold standard for the surgical treatment of benign ovarian cysts and is usually performed by stripping the ovarian cyst wall, followed by bleeding control of the ovarian wound ground using bipolar coagulation. However, the hemostasis with bipolar coagulation could result in the damage of ovarian reserve and decrease the response of the ovaries to hormonal stimulation for assisted reproductive technologies. The possible mechanism may contribute to thermal destruction of ovarian follicles by excessive use of bipolar coagulation for hemostasis purposes.
To avoid additional ovarian tissue damage by conventional bipolar coagulation being potentially important ovarian reproductive function, hemostasis using various topical hemostatic agents has introduced to control post-cystectomy ovarian wound bleeding. Among them, FloSeal (Baxter Healthcare Corporation, Deerfield, IL, USA) is a hemostatic matrix sealant composed of a gelatin-based matrix and thrombin solution. On coming into contact with blood after application at a bleeding site, the gelatin particles swell and tamponade bleeding. The bulk of the gelatin matrix-thrombin composite has the effect of slowing blood flow and providing exposure to a high thrombin concentration, thus hastening clot formation. Therefore, it may more suitable for use in post-cystectomy ovarian wound bleeding, where there is superficially pervasive focus of bleeding.
Ovarian reserve is defined as the functional potential of the ovary, which reflects the number and quality of antral follicles left in the ovary, and is correlated with the response to ovarian stimulation using exogenous gonadotropin. Serum anti-Müllerian hormone (AMH) has been accepted as the most reliable and easily measurable marker for postoperative assessment of ovarian reserve.
The investigators conducted a multicenter, large-scale, randomized controlled trial to investigate whether hemostasis by Floseal was superior to that by bipolar coagulation in preserving ovarian reserve by assessing serial AMH levels in patients undergoing laparoscopic ovarian cystectomy for benign ovarian cysts. | null | Inclusion Criteria:
* age between 18 and 45 years
* maximum diameter of the cyst between 3 and 10 cm
* regular menstrual bleeding (defined as cycle length less than 21 or more than 45 days)
* appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).
Exclusion Criteria:
* any suspicious finding of malignant ovarian diseases
* postmenopausal status
* baseline serum AMH \< 0.50 ng/mL
* pregnancy
* lactation
* any other endocrine diseases (such as thyroid dysfunction, hyperprolactinemia, or Cushing's syndrome)
* use of hormonal treatments in the 3 months before enrollment | CHA University | OTHER | {
"id": "KNC13-017",
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"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2013-05-17T00:00:00 | {
"date": "2014-06-25",
"type": "ESTIMATED"
} | {
"date": "2013-05-20",
"type": "ESTIMATED"
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} | [
"Ovarian Cysts"
] | null | null | [
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"city": "Goyang",
"country": "Korea, Republic of",
"facility": "National Health Insurance Service Ilsan Hospital",
"geoPoint": {
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"city": "Seoul",
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"facility": "Kangbuk Samsung Hospital, Sungkyunkwan University",
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},
"state": null
}
] | null | null | {
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"description": null,
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}
],
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} | [
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"affiliation": "CHA Gangnam Medical Center, Seoul, Republic of Korea",
"name": "Taejong Song, M.D",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "24903197", "type": "DERIVED", "citation": "Song T, Lee SH, Kim WY. Additional benefit of hemostatic sealant in preservation of ovarian reserve during laparoscopic ovarian cystectomy: a multi-center, randomized controlled trial. Hum Reprod. 2014 Aug;29(8):1659-65. doi: 10.1093/humrep/deu125. Epub 2014 Jun 4."}] | {"versionHolder": "2025-06-18"} | {
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},
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{
"id": "D000291",
"term": "Adnexal Diseases"
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{
"id": "D005831",
"term": "Genital Diseases, Female"
},
{
"id": "D052776",
"term": "Female Urogenital Diseases"
},
{
"id": "D005261",
"term": "Female Urogenital Diseases and Pregnancy Complications"
},
{
"id": "D000091642",
"term": "Urogenital Diseases"
},
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"term": "Genital Diseases"
},
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"id": "D006058",
"term": "Gonadal Disorders"
},
{
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"term": "Endocrine System Diseases"
}
],
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"abbrev": "BC04",
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "All",
"name": "All Conditions"
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"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
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],
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"id": "M12971",
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"relevance": "HIGH"
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},
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{
"asFound": null,
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},
{
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"id": "M7862",
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}
],
"meshes": [
{
"id": "D010048",
"term": "Ovarian Cysts"
}
]
} | {
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"abbrev": "Coag",
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],
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} | {
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],
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NCT03221166 | null | Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors | Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network | None | INTERVENTIONAL | TERMINATED | 2017-07-05T00:00:00 | null | 2020-07-31T00:00:00 | 2020-07-31T00:00:00 | [
"PHASE3"
] | 9 | 6 | 17 | ALL | false | Crohn's disease (CD) is a life-long inflammatory bowel disease disease with an unknown pathogenesis. The ultimate goal of therapy is to modify the natural history of CD thus reducing complications. Thalidomide is a small molecule with immunomodulatory and anti-angiogenetic properties. It is currently approved for the treatment of erythema nodosum leprosum, an immunological complication of leprosy and multiple myeloma. It has also been used in several other inflammatory diseases of the skin and of the mucosal membranes, such as Behcet disease, oropharyngeal ulcers in AIDS, cutaneous lupus, and graft versus host disease. Many case series and one pediatric randomized controlled trial proved the efficacy of thalidomide in the treatment of children with CD refractory to standard treatments. In these patients, clinical remission was achieved in about 50% of the cases and was maintained for a mean time superior of 3 years. Mucosal healing after 52 weeks of treatment was observed in 40% of the patients in clinical remission. Moreover, thalidomide was found to have a steroid-sparing effect and to decrease the need for surgical interventions. The clinical and endoscopic efficacy of thalidomide was also observed in children with failure to respond or intolerance to anti-TNF biological drugs.
The aim of this multicentric prospective randomized controlled is to evaluate the efficacy and safety of thalidomide vs infliximab in changing the natural history of CD in patients with poor prognostic outcome. Moreover, the study will evaluate the immunological and genetical mechanisms of CD, the mechanisms of action thalidomide in CD and will the pharmacokinetics, metabolomics and pharmacogenomics of thalidomide, and their impact on thalidomide safety and effectiveness. | null | Inclusion Criteria:
* Age at diagnosis \<18 years and \>=6 years
* New diagnosis of CD based on Porto criteria
* CD with inflammatory phenotype (non-penetrating, non-fistulizing) and with no need for surgery except for perinal fistulas
* Presence of at least one of the following risk factors for poor prognosis:
* fistulizing perianal disease
* pan-enteric disease
* disease extension \> 60 cm
* severe growth delay (height z-score \< -2 DS)
* severe osteoporosis (z score \< -2 DS)
* hypoalbuminemia (\< 3g/dL) or high C-reactive protein (2 times higher the normal range)
* Acceptance of the Risk Evaluation and Mitigation Strategy (REMS) program for reducing the teratogenic risk.
Exclusion Criteria:
* ongoing pregnancy
* presence of peripheral neuropathy
* HIV
* patients with transplanted organs
* ongoing major infections or other severe diseases
* participation to other experimental studies. | IRCCS Burlo Garofolo | OTHER | {
"id": "NET-2013-02355002",
"link": null,
"type": null
} | Difficulty in recruiting subjects who meet the inclusion/exclusion criteria | {
"hasExpandedAccess": false,
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"statusForNctId": null
} | 2017-07-14T00:00:00 | {
"date": "2020-09-04",
"type": "ACTUAL"
} | {
"date": "2017-07-18",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | false | {
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"maskingDescription": null,
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Crohn Disease"
] | ["Children", "Crohn disease", "Thalidomide", "Mucosal healing"] | null | [
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"city": "Napoli",
"country": "Italy",
"facility": "Dipartimento di Pediatria dell'Università di Napoli \"Federico II\"",
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"lat": 40.85216,
"lon": 14.26811
},
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"facility": "IRCCS Burlo Garofolo",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": "Friuli Venezia Giulia"
},
{
"city": "Genoa",
"country": "Italy",
"facility": "Pediatria III Gastroenterologia ed Endoscopia Digestiva, Istituto Giannina Gaslini",
"geoPoint": {
"lat": 44.40478,
"lon": 8.94438
},
"state": "Liguria"
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"country": "Italy",
"facility": "Fondazione MBBM , Azienda Ospedaliera San Gerardo - Università Milano Bicocca",
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"lat": 45.58005,
"lon": 9.27246
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"state": "Lombardia"
},
{
"city": "Messina",
"country": "Italy",
"facility": "Unità di Gastroenterologia Pediatrica e Fibrosi Cistica, Dipartimento di Scienze Pediatriche Mediche e Chirurgiche, Policlinico Universitario",
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"lon": 15.55256
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"state": "Sicilia"
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"city": "Firenze",
"country": "Italy",
"facility": "Gastroenterologia e Nutrizione Pediatrica, Azienda Ospedaliero Universitaria Meyer",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
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"class": "OTHER",
"name": "Centro di Riferimento Oncologico - Aviano"
},
{
"class": "OTHER",
"name": "Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Efficacy in inducing mucosal healing",
"timeFrame": "52 weeks"
}
],
"secondary": [
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"description": null,
"measure": "Efficacy in inducing clinical response",
"timeFrame": "12 weeks"
},
{
"description": null,
"measure": "Efficacy in inducing clinical response",
"timeFrame": "52 weeks"
},
{
"description": null,
"measure": "Efficacy in inducing clinical remission",
"timeFrame": "12 weeks"
},
{
"description": null,
"measure": "Efficacy in inducing clinical remission",
"timeFrame": "52 weeks"
},
{
"description": null,
"measure": "Efficacy in reducing the need to change therapy",
"timeFrame": "12 weeks"
},
{
"description": null,
"measure": "Efficacy in reducing the need to change therapy",
"timeFrame": "52 weeks"
},
{
"description": null,
"measure": "Efficacy in reducing hospitalizations",
"timeFrame": "52 weeks"
},
{
"description": null,
"measure": "Efficacy in reducing the need for surgery",
"timeFrame": "52 weeks"
},
{
"description": null,
"measure": "Efficacy in reducing erythrocyte sedimentation rate",
"timeFrame": "Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)"
},
{
"description": null,
"measure": "Efficacy in reducing C-reactive protein",
"timeFrame": "Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)"
},
{
"description": null,
"measure": "Efficacy in reducing faecal calprotectin",
"timeFrame": "Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)"
},
{
"description": null,
"measure": "Efficacy in modifying body mass index",
"timeFrame": "Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)"
},
{
"description": null,
"measure": "Efficacy in modifying height-for-age z score",
"timeFrame": "Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)"
},
{
"description": null,
"measure": "Efficacy in modifying weight-for-age z score",
"timeFrame": "Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)"
},
{
"description": null,
"measure": "Evaluation of the Treatment-Emergent Adverse Events",
"timeFrame": "Between enrolment and 52 weeks"
},
{
"description": null,
"measure": "Direct and indirect costs",
"timeFrame": "52 weeks"
}
]
} | [
{
"affiliation": "IRCCS Burlo Garofolo",
"name": "Alessandro Ventura, MD PhD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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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": "Immunologic Factors"
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"term": "Physiological Effects of Drugs"
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"term": "Leprostatic Agents"
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"term": "Angiogenesis Modulating Agents"
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],
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"relevance": "LOW"
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M10201",
"name": "Immunologic Factors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4222",
"name": "Anti-Bacterial Agents",
"relevance": "LOW"
},
{
"asFound": null,
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{
"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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}
],
"meshes": [
{
"id": "D013792",
"term": "Thalidomide"
},
{
"id": "D000069285",
"term": "Infliximab"
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]
} | {
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"term": "Thalidomide"
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{
"id": "D000069285",
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]
} |
NCT00895466 | null | Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients | A Phase I-II Open Label Clinical Trial, Evaluating the Efficacy and Safety of Administration of the Therapeutic Vaccine PEP-223/CoVaccine HT, to Hormone Treatment naïve, Immunocompetent Subjects With T1-3, N0-1/x, M0 Prostate Cancer, Eligible for Hormone Therapy. | None | INTERVENTIONAL | UNKNOWN | 2009-05-06T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 12 | null | null | MALE | false | The purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones. | Prostate cancer growth is influenced by the male hormone testosterone. Treatment with drugs that stop the production of testosterone often results in a decrease of the tumor or inhibition of its growth. This is particularly important prior to radiotherapy, since radiation can better be focused on the prostate with as a result less frequent or less severe side effects of the radiation.
Most of the drugs used to date to stop the production of testosterone have the disadvantage that initially they may cause a rise of testosterone levels before the production is effectively blocked. The new drug that will be investigated in this trial is a vaccine. The vaccine offers a different treatment modality since it interferes at a different level of the hormonal axis that drives the testosterone production; it will not cause an initial surge.
In this trial the vaccine will be administered three times, testosterone levels will be monitored for a total period of three months. | Inclusion Criteria:
* pathological confirmed prostatic adenocarcinoma, clinical stage (c) cT1-3, cN0-1/x, cM0
* baseline testosterone levels of \> 4 nmol/l
* baseline PSA level of \> 10 microg/l
* eligible for hormone therapy
* willingness to comply with the protocol conditions and procedures
* willing and able to give informed consent
Exclusion Criteria:
* clinical evidence of distant metastases
* previous hormonal therapy administered specifically for prostatic carcinoma
* development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
* primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
* concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
* concomitant radiotherapy for prostate cancer
* presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion
* simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
* BMI \> 30 kg/square meter
* previous serious reaction to a vaccine such as angioedema or anaphylaxis | Pepscan Therapeutics | INDUSTRY | {
"id": "PEP223-NL-0701",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-05-07T00:00:00 | {
"date": "2009-05-08",
"type": "ESTIMATED"
} | {
"date": "2009-05-08",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | null | [
"Prostate Cancer"
] | ["prostatic diseases", "neoplasms", "prostatic neoplasms", "hormones", "androgen antagonists", "vaccines", "peptide vaccines", "adjuvants, immunological"] | null | [
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"state": null
},
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"facility": "UMC Nijmegen",
"geoPoint": {
"lat": 51.8425,
"lon": 5.85278
},
"state": null
}
] | [
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"class": "INDUSTRY",
"name": "TFS Trial Form Support"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Testosterone suppression",
"timeFrame": "after 12 weeks treatment as compared to baseline"
}
],
"secondary": [
{
"description": null,
"measure": "The time course of testosterone suppression",
"timeFrame": "after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline"
},
{
"description": null,
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NCT03958266 | null | MyIBD Care - Feasibility Study | A Feasibility Study of a Novel Mobile Phone Application in the Long Term Management of Patients With Inflammatory Bowel Diseases | None | OBSERVATIONAL | WITHDRAWN | 2019-05-15T00:00:00 | null | null | null | null | 0 | 16 | 80 | ALL | false | The aim of this study is appraise the safety and feasibility of utilising a novel mobile phone application and linked clinical platform to replace and enhance traditional outpatient appointments for patients with Inflammatory Bowel Diseases. The goal of this study is to demonstrate whether the platform can reduce the costs of managing patients on complex immunomodulators and biologic therapies whilst maintaining safety monitoring such as clinical patient reported outcome measures (PROMs), haematological and biochemical tests. | 15 million people in the England suffer from long term conditions (LTCs). Furthermore, the number of people with three or more LTC's has risen from 1.9 million people in 2008 to 2.9 million in 2018. And with the growing number of people suffering from these conditions, the pressure grows for health care providers to provide long term solutions to meet this increase in demand.
Inflammatory Bowel Disease (IBD) is an exemplar for LTCs, requiring frequent routine appointments, an ongoing testing regimen and costly pharmacological intervention. Moreover, people living with Crohn's disease (CD) or Ulcerative Colitis (UC) are often young and report that their condition leads to a significant reduction in quality of life (QOL) even when symptoms are relatively well-controlled. Patients present with diarrhoea, abdominal pain, weight loss and other symptoms that have a significant impact on quality of life (taking into account social functioning, employment status, psychological distress). The condition has an estimated prevalence of 0.3% in North America, Northern Europe and Oceania (1) with a substantial direct and indirect costs. The majority of patients require lifelong medication and are followed up in secondary care. Like many immune mediated inflammatory conditions, it is a disease of relapse and remission. At times of relapse patients require rapid access to specialist advice, managing flares early leads to better outcomes such as returning to work or daily activities and avoids costly admission to hospital.
Up to 76% of patients with CD and 51% with UC, will need immunomodulators (thiopurines or methotrexate) which require regular blood monitoring at minimum 4 times per year to screen for side effects of myeloid and hepatotoxicity (2). Patients on sub-cutaneous biologic medications such as adalimumab, golimumab and Ustekinumab also require regular blood monitoring which often necessitates clinic visits. In a recent nationwide survey of 2400 consecutive outpatient appointments in a wide variety of hospitals throughout England and Scotland up to 75% of patients were deemed to be in a quiescent or mildly active phase of disease (2). The majority of those patients are being seen in outpatients based on an antiquated model of routine follow up appointments, with dates of 2, 3, 4, 6 and 12-month intervals chosen either to have safety-based blood tests or a date arbitrarily chosen by clinician or patient. Appointments such as these rarely reflect a clinical need and lead to an inflexible system in which patients Clinicians at King's College Hospital wanted to explore whether digital self-management could be an effective way of reducing the burden the condition places on the patient and on the health system. Using the My IBD Care app, they provided patients with a convenient digital touchpoint for their treatment, facilitating easy access to information, including their care plan, health record and self-management content; and digital contact with hospital staff via an app.
From a hospital perspective, self-managing patients cost less to treat and place less of a burden on hospital appointments, thereby contributing to shorter waiting times. Moreover, My IBD Care allows patients to submit PROMs to their clinical teams remotely and in real time, allowing clinical staff to monitor their status and intervene as required.
Scientifically validated digital therapeutics exist for diabetes, cardiovascular disease and sleeping disorders, however there are none addressing the complex, costly challenges of inflammatory conditions.
In the context of these conditions - which include Crohn's, ulcerative colitis, inflammatory arthritis and psoriasis (UK TAM c3.5m people) - a digital therapeutic is digitally-supported behaviour change, tailored to the alleviation of symptoms such as pain, fatigue and anxiety. Importantly, for a therapeutic to be accepted as such, an evidence-based approach is required. | Inclusion Criteria:
* • Any patient 16-80 years of age at inclusion
* Established diagnosis of IBD (including UC, CD, inflammatory bowel disease of uncertain aetiology (IBD-U) and inflammation of an ileo-anal pouch (pouchitis))
* for more than 6 months prior to enrolment
* Has a smart phone device with access to the Apple AppStore or Google Play Store
* On stable medication by which we mean
* No change in oral 5-ASA dose in the last 1 month. Note, addition of 'as required' topical 5-ASA therapy is permitted
* Any revent oral corticosteroids must have been finished within 4 weeks. Note
* No change in immunomodulator dose for 3 months
* No change in biologic (Adalimumab, Infliximab, Ustekinumab and Vedolizumab) regime for 8 weeks
* Must be able to comply with all study requirements for the duration of the study as outlined in the protocol.
* Must be able to understand and be willing to provide written informed consent
Exclusion Criteria:
* • Currently taking part in a clinical trial of an Investigation Medical Procedure
* Significant psychiatric morbidity
* Patients likely to change IBD team within the next 12 months
* Patients taking Cyclosporine or Tacrolimus | Barts & The London NHS Trust | OTHER | {
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} | COVID pandemic | {
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} | 2019-05-17T00:00:00 | {
"date": "2023-02-10",
"type": "ACTUAL"
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"date": "2019-05-22",
"type": "ACTUAL"
} | [
"CHILD",
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] | Stable patients with Inflammatory Bowel disease as stipulated above recruited in out-patients and infusion clinics | NON_PROBABILITY_SAMPLE | false | {
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"name": "King's College Hospital NHS Trust"
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"primary": [
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"measure": "Adverse events",
"timeFrame": "1 year"
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],
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"description": null,
"measure": "Health economic assessment",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Patient Activation Measure",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "IBD Related Knowledge (CCKNOW)",
"timeFrame": "1 year"
}
]
} | [
{
"affiliation": "King's College Hospital NHS Trust",
"name": "Bu Hayee, PhD, FRCP",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "29050646", "type": "BACKGROUND", "citation": "Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16."}, {"pmid": "28949018", "type": "BACKGROUND", "citation": "Selinger CP, Parkes GC, Bassi A, Fogden E, Hayee B, Limdi JK, Ludlow H, McLaughlin S, Patel P, Smith M, Raine T. A multi-centre audit of excess steroid use in 1176 patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2017 Nov;46(10):964-973. doi: 10.1111/apt.14334. Epub 2017 Sep 26."}] | {"versionHolder": "2025-06-18"} | {
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NCT06385366 | null | Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test | Developing and Evaluating Models for Early Prediction of Obstetrical Diseases: Preeclampsia, Spontaneous Preterm Birth, and Gestational Diabetes in The Pregnant Women Performed Non-invasive Prenatal Screening (NIPT) | None | OBSERVATIONAL | NOT_YET_RECRUITING | 2024-04-22T00:00:00 | null | 2025-05-06T00:00:00 | 2025-06-06T00:00:00 | null | 1,105 | 18 | 80 | FEMALE | null | This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam. | This study is estimated to enroll 663 pregnant women with adverse pregnancy complications, including 221 cases of PE/eclampsia, 221 cases of SPB due to Preterm premature rupture of membranes (PPROM) or preterm labor, and 221 cases of GDM. Furthermore, the control group will enroll 442 participants, who are healthy pregnancies, ≥ 37 weeks of gestation. Study subjects who participate should meet the study inclusion and exclusion criteria:
As part of the protocol, demographic data, medical and family history, outcomes at delivery, and any relevant prior concomitant medication data will be recorded during follow-up visits. All participants are to be followed until birth delivery.
SAMPLE COLLECTION
* At recruitment, 10 mL of peripheral blood is collected for cffDNA and cfRNA analyses.
* An available NIPT sample at 1st trimester is processed for cffDNA and cfRNA analyses.
* A case report forms (CRF-1 and CRF-2) are used to collect demographic data, medical and family history, any relevant prior concomitant medication data, and outcomes at delivery.
The study end date of a participant is estimated within 7 months since her enrollment date. | Inclusion Criteria:
1. At recruitment, women with singleton pregnancies must fulfill the conditions:
Cases: diagnosis of Preeclampsia/eclampsia, Preterm premature rupture of membranes (PPROM)/preterm labor leading to SPB, and/or gestational diabetes mellitus.
Controls: healthy pregnancy at ≥ 37 weeks of gestation
2. History of undergoing non-invasive prenatal testing (NIPT) at 9-13 weeks 6 days of gestation at Gene Solutions Lab. NIPT report was at low-risk. No abnormal fetal and maternal conditions were confirmed at NIPT time.
3. NIPT blood sample is available according to post-test sample storage procedures at Gene Solutions Lab.
4. Consent to voluntarily participate in the study
Exclusion Criteria:
1. Multiple pregnancies
2. Pregnancy with any genetic abnormality
3. Pregnancy with any fetal structural abnormality
4. Pregnancy with indications for termination, miscarriage, or stillbirth due to other complications
5. Maternal medical history of diabetes mellitus type 1/ type 2, chronic hypertension, and chronic kidney disease. Maternal abnormal uterus anatomy and history of cervical cone biopsy sample or loop electrocautery excision procedures (LEEP). | Gene Solutions | INDUSTRY | {
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} | Unknown | {
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"type": "ACTUAL"
} | {
"date": "2024-04-26",
"type": "ACTUAL"
} | [
"ADULT",
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] | ["cffDNA", "cfRNA", "Vietnam"] | null | null | [
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"class": "UNKNOWN",
"name": "Medical Genetics Institute (MGI)"
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] | null | {
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"timeFrame": "12 months"
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"timeFrame": "12 months"
},
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"description": null,
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"timeFrame": "12 months"
},
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"description": null,
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"timeFrame": "12 months"
},
{
"description": null,
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"timeFrame": "12 months"
}
],
"secondary": null
} | [
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] | [{"pmid": "21094932", "type": "BACKGROUND", "citation": "Brosens I, Pijnenborg R, Vercruysse L, Romero R. The \"Great Obstetrical Syndromes\" are associated with disorders of deep placentation. Am J Obstet Gynecol. 2011 Mar;204(3):193-201. doi: 10.1016/j.ajog.2010.08.009. Epub 2010 Nov 20."}, {"pmid": "25225057", "type": "BACKGROUND", "citation": "Gabbay-Benziv R, Baschat AA. Gestational diabetes as one of the \"great obstetrical syndromes\"--the maternal, placental, and fetal dialog. Best Pract Res Clin Obstet Gynaecol. 2015 Feb;29(2):150-5. doi: 10.1016/j.bpobgyn.2014.04.025. Epub 2014 Aug 20."}, {"pmid": "32682859", "type": "BACKGROUND", "citation": "Chaemsaithong P, Sahota DS, Poon LC. First trimester preeclampsia screening and prediction. Am J Obstet Gynecol. 2022 Feb;226(2S):S1071-S1097.e2. doi: 10.1016/j.ajog.2020.07.020. Epub 2020 Jul 16."}, {"pmid": "27190902", "type": "BACKGROUND", "citation": "Rani PR, Begum J. Screening and Diagnosis of Gestational Diabetes Mellitus, Where Do We Stand. J Clin Diagn Res. 2016 Apr;10(4):QE01-4. doi: 10.7860/JCDR/2016/17588.7689. Epub 2016 Apr 1."}, {"pmid": "33562187", "type": "BACKGROUND", "citation": "Reicher L, Fouks Y, Yogev Y. Cervical Assessment for Predicting Preterm Birth-Cervical Length and Beyond. J Clin Med. 2021 Feb 7;10(4):627. doi: 10.3390/jcm10040627."}, {"pmid": "25225060", "type": "BACKGROUND", "citation": "Hod M, Lieberman N. Maternal-fetal medicine--how can we practically connect the \"M\" to the \"F\"? Best Pract Res Clin Obstet Gynaecol. 2015 Feb;29(2):270-83. doi: 10.1016/j.bpobgyn.2014.06.008. Epub 2014 Aug 21."}, {"pmid": "27640943", "type": "BACKGROUND", "citation": "Roberge S, Nicolaides K, Demers S, Hyett J, Chaillet N, Bujold E. The role of aspirin dose on the prevention of preeclampsia and fetal growth restriction: systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Feb;216(2):110-120.e6. doi: 10.1016/j.ajog.2016.09.076. Epub 2016 Sep 15."}, {"pmid": "17671254", "type": "BACKGROUND", "citation": "Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815."}, {"pmid": "38097030", "type": "BACKGROUND", "citation": "Becking EC, Scheffer PG, Henrichs J, Bax CJ, Crombag NMTH, Weiss MM, Macville MVE, Van Opstal D, Boon EMJ, Sistermans EA, Henneman L, Schuit E, Bekker MN. Fetal fraction of cell-free DNA in noninvasive prenatal testing and adverse pregnancy outcomes: a nationwide retrospective cohort study of 56,110 pregnant women. Am J Obstet Gynecol. 2024 Aug;231(2):244.e1-244.e18. doi: 10.1016/j.ajog.2023.12.008. Epub 2023 Dec 12."}, {"pmid": "33475978", "type": "BACKGROUND", "citation": "Karapetian capital A, Cyrilliccapital O, Cyrillic, Baev capital O, CyrillicR, Sadekova capital A, Cyrilliccapital A, Cyrillic, Krasnyi capital A, Cyrilliccapital EM, Cyrillic, Sukhikh GT. Cell-Free Foetal DNA as a Useful Marker for Preeclampsia Prediction. Reprod Sci. 2021 May;28(5):1563-1569. doi: 10.1007/s43032-021-00466-w. Epub 2021 Jan 21."}, {"pmid": "32611681", "type": "BACKGROUND", "citation": "Munchel S, Rohrback S, Randise-Hinchliff C, Kinnings S, Deshmukh S, Alla N, Tan C, Kia A, Greene G, Leety L, Rhoa M, Yeats S, Saul M, Chou J, Bianco K, O'Shea K, Bujold E, Norwitz E, Wapner R, Saade G, Kaper F. Circulating transcripts in maternal blood reflect a molecular signature of early-onset preeclampsia. Sci Transl Med. 2020 Jul 1;12(550):eaaz0131. doi: 10.1126/scitranslmed.aaz0131."}, {"pmid": "37211139", "type": "BACKGROUND", "citation": "Zhou S, Li J, Yang W, Xue P, Yin Y, Wang Y, Tian P, Peng H, Jiang H, Xu W, Huang S, Zhang R, Wei F, Sun HX, Zhang J, Zhao L. Noninvasive preeclampsia prediction using plasma cell-free RNA signatures. Am J Obstet Gynecol. 2023 Nov;229(5):553.e1-553.e16. doi: 10.1016/j.ajog.2023.05.015. Epub 2023 May 19."}, {"pmid": "26875947", "type": "BACKGROUND", "citation": "Dugoff L, Barberio A, Whittaker PG, Schwartz N, Sehdev H, Bastek JA. Cell-free DNA fetal fraction and preterm birth. Am J Obstet Gynecol. 2016 Aug;215(2):231.e1-7. doi: 10.1016/j.ajog.2016.02.009. Epub 2016 Feb 11."}, {"pmid": "31334093", "type": "BACKGROUND", "citation": "Darghahi R, Mobaraki-Asl N, Ghavami Z, Pourfarzi F, Hosseini-Asl S, Jalilvand F. Effect of cell-free fetal DNA on spontaneous preterm labor. J Adv Pharm Technol Res. 2019 Jul-Sep;10(3):117-120. doi: 10.4103/japtr.JAPTR_371_18."}, {"pmid": "35398029", "type": "BACKGROUND", "citation": "Camunas-Soler J, Gee EPS, Reddy M, Mi JD, Thao M, Brundage T, Siddiqui F, Hezelgrave NL, Shennan AH, Namsaraev E, Haverty C, Jain M, Elovitz MA, Rasmussen M, Tribe RM. Predictive RNA profiles for early and very early spontaneous preterm birth. Am J Obstet Gynecol. 2022 Jul;227(1):72.e1-72.e16. doi: 10.1016/j.ajog.2022.04.002. Epub 2022 Apr 6."}, {"pmid": "35741140", "type": "BACKGROUND", "citation": "Weiner CP, Cuckle H, Weiss ML, Buhimschi IA, Dong Y, Zhou H, Ramsey R, Egerman R, Buhimschi CS. Evaluation of a Maternal Plasma RNA Panel Predicting Spontaneous Preterm Birth and Its Expansion to the Prediction of Preeclampsia. Diagnostics (Basel). 2022 May 27;12(6):1327. doi: 10.3390/diagnostics12061327."}, {"pmid": "32274292", "type": "BACKGROUND", "citation": "Guo Z, Yang F, Zhang J, Zhang Z, Li K, Tian Q, Hou H, Xu C, Lu Q, Ren Z, Yang X, Lv Z, Wang K, Yang X, Wu Y, Yang X. Whole-Genome Promoter Profiling of Plasma DNA Exhibits Diagnostic Value for Placenta-Origin Pregnancy Complications. Adv Sci (Weinh). 2020 Feb 18;7(7):1901819. doi: 10.1002/advs.201901819. eCollection 2020 Apr."}, {"pmid": "33045922", "type": "BACKGROUND", "citation": "Del Vecchio G, Li Q, Li W, Thamotharan S, Tosevska A, Morselli M, Sung K, Janzen C, Zhou X, Pellegrini M, Devaskar SU. Cell-free DNA Methylation and Transcriptomic Signature Prediction of Pregnancies with Adverse Outcomes. Epigenetics. 2021 Jun;16(6):642-661. doi: 10.1080/15592294.2020.1816774. Epub 2020 Oct 13."}, {"pmid": "24582925", "type": "BACKGROUND", "citation": "Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. 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},
{
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},
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"relevance": "HIGH"
},
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},
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"name": "Obstetric Labor, Premature",
"relevance": "LOW"
},
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"relevance": "LOW"
},
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"name": "Urogenital Diseases",
"relevance": "LOW"
},
{
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"name": "Female Urogenital Diseases",
"relevance": "LOW"
},
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},
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},
{
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"relevance": "LOW"
},
{
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"id": "M7862",
"name": "Endocrine System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10024",
"name": "Hypertension",
"relevance": "LOW"
},
{
"asFound": null,
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"relevance": "LOW"
},
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"relevance": "LOW"
}
],
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"term": "Premature Birth"
},
{
"id": "D016640",
"term": "Diabetes, Gestational"
},
{
"id": "D011225",
"term": "Pre-Eclampsia"
},
{
"id": "D011248",
"term": "Pregnancy Complications"
}
]
} | null | {
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"term": "Premature Birth"
},
{
"id": "D016640",
"term": "Diabetes, Gestational"
},
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"term": "Pre-Eclampsia"
},
{
"id": "D011248",
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],
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} |
NCT02350166 | null | Short-term Effects of LASI Surgery Versus Conventional Laparotomy for Colorectal Liver Metastasis | Short-term Effects of Laparoscopic-assisted Small-incision Surgery Versus Conventional Laparotomy in Treatment of Resectable Colorectal Liver Metastasis | None | INTERVENTIONAL | UNKNOWN | 2015-01-19T00:00:00 | null | null | null | [
"PHASE3"
] | 40 | 18 | 80 | ALL | false | Surgical resection is still recommended as the optional treatment for colorectal liver metastasis (CLM) patients. There are two main concerns for resectable colorectal liver metastasis which remain controversial: surgical time and surgical type. As for the former, synchronous resection of primary colorectal tumor and liver metastasis, with the reason of fare overall survival rate and absence of a second surgery, has gained wide population from gastrointestinal surgeons who believe it will bring benefits to CLM patients. With regard to surgical type, Open liver resection is the optimum choice for CLM patients no matter what the metastasis profile is. And for management of primary tumor, laparoscopic procedure is mature in surgical skill and has been evidenced equivalent overall survival rate compared with open resection. So, primary colorectal tumor resection could be either open or laparoscopic procedure. Therefore, the investigators team conducted the controlled trial to compare two surgical procedures in treatment of resectable colorectal liver metastasis. Patients will be randomly assigned into conventional laparotomy group for simultaneously resection of both primary colorectal tumor and liver metastasis, or laparoscopic-assisted small-incision group for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis. The aim of this trial is to observing short-term operative effects after surgeries. | Nowadays, colorectal liver metastasis (CLM) is gaining wide population from multi-disciplinary doctors including gastroenterologists, oncologists, and hepatic doctors for its increasing incidence and poor prognosis. Nearly, 15%-25% of colorectal cancer patients present with simultaneous liver metastasis at the time of diagnosis and 20%-35% patients are evaluated with primary tumor and liver metastasis resectable synchronously. Although the use of chemotherapy regimen has been certified favorable outcomes, surgical resection is still recommended as the optional treatment for CLM patients. However, there are two main concerns for resectable colorectal liver metastasis which remain controversial: surgical time and surgical type. As for the former, a latest evidence shows synchronous resection of primary colorectal tumor and liver metastasis, with the reason of fare overall survival rate and absence of a second surgery. Moreover, an increasing number of surgeons favor synchronous resection from their initial experience and they believe it will bring benefits to CLM patients.
With regard to surgical type, although laparoscopic liver resection has been proven feasible, safe and efficient in management of liver metastasis, this procedure is limited in selected patients such as tumor size less than 10 centimeters or located in left liver. In addition, laparoscopic liver resection is technically difficult which is applied in most medical centers. So open liver resection may be the optimum choice for CLM patients no matter what the metastasis profile is. In the management of primary tumor, laparoscopic procedure is mature in surgical skill and has been evidenced equivalent overall survival rate compared with open resection. A research conducted by Arezzo also confirms lower 30-day morbidity of laparoscopic colorectal cancer resection. Unlike liver metastasis resection, primary colorectal tumor resection could be either open or laparoscopic procedure.
Therefore, the investigators team conducted the controlled trial to compare two surgical procedures in treatment of resectable colorectal liver metastasis. Patients will be randomly assigned into conventional laparotomy group for simultaneously resection of both primary colorectal tumor and liver metastasis, or laparoscopic-assisted small-incision group for resection of laparoscopic colorectal tumor combined with synchronously small-incision open resection of liver metastasis. The aim of this trial is to observing short-term operative effects after surgeries. | Inclusion Criteria:
1. Pathologically confirmed resectable upper rectal cancer, sigmoid cancer, and left colon cancer
2. MRI/CT confirmed resectable liver metastasis after muti-disciplinary team assessment
3. No evidence of other metastasis
4. Organs function well to tolerance simultaneous surgery, especially liver function
5. No special treatment before surgery
6. Informed consent was written
Exclusion Criteria:
1. Right colon cancer and transverse colon cancer
2. Pregnant or lactating women
3. A history of malignant tumor within 5 years
4. There was contraindication for operation
5. Discovery of metastasis in other organs in the operation
6. With mental disorder | West China Hospital | OTHER | {
"id": "sLRC-201312",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-01-24T00:00:00 | {
"date": "2015-11-17",
"type": "ESTIMATED"
} | {
"date": "2015-01-29",
"type": "ESTIMATED"
} | [
"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
} | [
"Colorectal Cancer"
] | ["colorectal cancer", "hepatectomy", "laparoscopic surgery", "laparotomy", "complications"] | null | [
{
"city": "Chengdu",
"country": "China",
"facility": "West China hospital, Sichuan University",
"geoPoint": {
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"lon": 104.06667
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"facility": "West China Hospital",
"geoPoint": {
"lat": 30.66667,
"lon": 104.06667
},
"state": "Sichuan"
}
] | null | null | {
"other": null,
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"description": null,
"measure": "30-day complications",
"timeFrame": "Postoperative 30 days"
}
],
"secondary": [
{
"description": null,
"measure": "Pain score",
"timeFrame": "Postoperative 7 days"
},
{
"description": null,
"measure": "Hospital time",
"timeFrame": "an expected average of 7 days"
},
{
"description": null,
"measure": "C-reactive protein",
"timeFrame": "Postoperative 5 days"
}
]
} | [
{
"affiliation": "West China Hospital",
"name": "Ziqiang Wang, MD,PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "21296855", "type": "BACKGROUND", "citation": "Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4."}, {"pmid": "21685461", "type": "BACKGROUND", "citation": "Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin. 2011 Jul-Aug;61(4):212-36. doi: 10.3322/caac.20121. Epub 2011 Jun 17."}, {"pmid": "16904315", "type": "BACKGROUND", "citation": "Van Cutsem E, Nordlinger B, Adam R, Kohne CH, Pozzo C, Poston G, Ychou M, Rougier P; European Colorectal Metastases Treatment Group. Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer. 2006 Sep;42(14):2212-21. doi: 10.1016/j.ejca.2006.04.012. Epub 2006 Aug 10."}, {"pmid": "10615075", "type": "BACKGROUND", "citation": "Kemeny N, Huang Y, Cohen AM, Shi W, Conti JA, Brennan MF, Bertino JR, Turnbull AD, Sullivan D, Stockman J, Blumgart LH, Fong Y. Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. N Engl J Med. 1999 Dec 30;341(27):2039-48. doi: 10.1056/NEJM199912303412702."}, {"pmid": "17925551", "type": "BACKGROUND", "citation": "Tomlinson JS, Jarnagin WR, DeMatteo RP, Fong Y, Kornprat P, Gonen M, Kemeny N, Brennan MF, Blumgart LH, D'Angelica M. Actual 10-year survival after resection of colorectal liver metastases defines cure. J Clin Oncol. 2007 Oct 10;25(29):4575-80. doi: 10.1200/JCO.2007.11.0833."}, {"pmid": "22971038", "type": "BACKGROUND", "citation": "Li ZQ, Liu K, Duan JC, Li Z, Su CQ, Yang JH. Meta-analysis of simultaneous versus staged resection for synchronous colorectal liver metastases. Hepatol Res. 2013 Jan;43(1):72-83. doi: 10.1111/j.1872-034X.2012.01050.x. Epub 2012 Sep 13."}, {"pmid": "24489916", "type": "BACKGROUND", "citation": "Wei M, He Y, Wang J, Chen N, Zhou Z, Wang Z. Laparoscopic versus open hepatectomy with or without synchronous colectomy for colorectal liver metastasis: a meta-analysis. PLoS One. 2014 Jan 29;9(1):e87461. doi: 10.1371/journal.pone.0087461. eCollection 2014."}, {"pmid": "23183871", "type": "BACKGROUND", "citation": "Arezzo A, Passera R, Scozzari G, Verra M, Morino M. Laparoscopy for rectal cancer reduces short-term mortality and morbidity: results of a systematic review and meta-analysis. Surg Endosc. 2013 May;27(5):1485-502. doi: 10.1007/s00464-012-2649-x. Epub 2012 Nov 25."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Intestinal Neoplasms"
},
{
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{
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"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": "D003108",
"term": "Colonic Diseases"
},
{
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"term": "Intestinal Diseases"
},
{
"id": "D012002",
"term": "Rectal Diseases"
}
],
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"abbrev": "BC04",
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"name": "All Conditions"
},
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"name": "Wounds and Injuries"
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{
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],
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},
{
"asFound": null,
"id": "M1112",
"name": "Surgical Wound",
"relevance": "LOW"
},
{
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},
{
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},
{
"asFound": null,
"id": "M8883",
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
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"relevance": "LOW"
},
{
"asFound": null,
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"name": "Colonic Diseases",
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},
{
"asFound": null,
"id": "M10444",
"name": "Intestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14844",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D015179",
"term": "Colorectal Neoplasms"
}
]
} | {
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"browseBranches": [
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"abbrev": "Hemat",
"name": "Hematinics"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
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],
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],
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} | {
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{
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],
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} |
NCT05789966 | null | Fullscale_Intervention Study: Genetic Risk Communication in Coronary Heart Disease and Wearables | The Effect of Communicating Genetic Risk of Coronary Heart Disease and Wearable Technologies On Wearable-Device-Measured Behavioral Outcomes in East Asians: Protocol of a Randomized Controlled Trial | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2023-03-16T00:00:00 | null | 2026-01-01T00:00:00 | 2026-06-01T00:00:00 | [
"NA"
] | 414 | 60 | null | ALL | true | Background: This study aims to determine the effects of communicating genetic risk for Coronary Heart Disease (CHD) alone or in combination with goal setting and prompts from a wearable device on objectively measured sedentary time (ST) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively ST, and that such changes will be more likely to be sustained over 6-month follow-up.
Methods: In a parallel group, randomized controlled trial, a total 414 individuals of East Asians aged over 60years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of CHD genetic and analysis of metabolic risk markers. Genetic risk for CHD will be estimated based on recently identified 79 SNPs (associated with CHD for East Asians) using an established methodology. Questionnaires and physical measurement will be administered at Before and after the 12-month intervention and at 6-month follow-up. Each group will receive a Fitbit device. Both intervention groups will be given CHD genetic risk estimates along with lifestyle advice but one of them will additionally use Fitbit's step-goal setting and prompt functions. The primary outcome is objectively measured sedentary time. Secondary outcomes include objectively measured MVPA, calories burned, and five intermediate metabolic risk markers (total cholesterol/HDL-C/LDL-C/triglycerides). | null | Inclusion Criteria:
* East Asian ancestry
* Do not meet the WHO-recommended levels of PA (i.e., ≥150 minutes/week of moderate-intensity PA, ≥75 minutes/week of vigorous-intensity PA, or an equivalent combination of the two; determined through the IPAQ-Short Form).
Exclusion Criteria:
* Previously diagnosed with CHD, and/or participation in another exercise-intervention study. | The University of Hong Kong | OTHER | {
"id": "Fullscale_CHD_RCT",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-03-16T00:00:00 | {
"date": "2023-03-29",
"type": "ACTUAL"
} | {
"date": "2023-03-29",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "parallel-group, open randomized controlled trial",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Staff without knowledge of participant information will create a computer-generated list that consists of blocks of six that contain two of each of the three groups per block in a random order. The randomisation list will be incorporated into a computer program that our staff will use for enrolment and automated random assignment of participants. Group allocation will be concealed from study staff until the 7-day pre-intervention period begins (to allow preparation of genetic risk estimates and/or calculate Fitbit step goals from baseline data) and concealed from participants until the intervention begins. Given the nature of the interventions, it is impossible for participants to be blinded to their group allocation; however, research staff analysing participants' deidentified data will remain blinded to participant group assignments.",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Fitness Trackers",
"Sedentary Time",
"Genetic Predisposition to Disease",
"Coronary Heart Disease"
] | ["Coronary Heart Disease", "Genetic risk", "Sedentary Time", "Wearable Technology", "Randomized Controlled Trial"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Changes in ST (average, in minutes/day) between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up",
"timeFrame": "Baseline, 12-month post-intervention, 6-month follow-up"
}
],
"secondary": [
{
"description": null,
"measure": "Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)",
"timeFrame": "Baseline, 12-month post-intervention, 6-month follow-up"
},
{
"description": null,
"measure": "Changes in four CHD markers (total cholesterol/HDL-C/LDL-C/triglycerides) between baseline and 6-month follow-up",
"timeFrame": "Baseline and 6-month follow-up"
},
{
"description": null,
"measure": "Changes in hand grip strength between baseline and 6-month follow-up",
"timeFrame": "Baseline and 6-month follow-up"
},
{
"description": null,
"measure": "Changes in systolic/diastolic blood pressure between baseline and 6-month follow-up",
"timeFrame": "Baseline and 6-month follow-up"
},
{
"description": null,
"measure": "Changes in Self-reported Physical Activity between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up",
"timeFrame": "Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up"
},
{
"description": null,
"measure": "Changes in Self-reported Fruit and Vegetable Consumption between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up",
"timeFrame": "Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up"
},
{
"description": null,
"measure": "Changes in Self-reported Smoking Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up",
"timeFrame": "Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up"
},
{
"description": null,
"measure": "Changes in Self-reported Psychological Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up",
"timeFrame": "Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up"
}
]
} | [
{
"affiliation": "The University of Hong Kong",
"name": "Youngwon Kim, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D001161",
"term": "Arteriosclerosis"
},
{
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"term": "Arterial Occlusive Diseases"
},
{
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"term": "Disease Susceptibility"
},
{
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"term": "Disease Attributes"
},
{
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],
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"name": "All Conditions"
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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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"relevance": "LOW"
},
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"relevance": "LOW"
},
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],
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{
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"term": "Myocardial Ischemia"
},
{
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]
} | null | {
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{
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"term": "Myocardial Ischemia"
},
{
"id": "D020022",
"term": "Genetic Predisposition to Disease"
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],
"interventions": null
} |
NCT01629966 | null | Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder | A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder. | VLZ-MD-05 | INTERVENTIONAL | COMPLETED | 2012-06-26T00:00:00 | null | 2014-02-28T00:00:00 | 2014-03-31T00:00:00 | [
"PHASE3"
] | 680 | 18 | 70 | ALL | false | The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD) | null | Inclusion Criteria:
* Male and female, 18 - 70 years of age
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)
* Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)
Exclusion Criteria:
* Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control
* History of meeting DSM-IV-TR criteria for any of the following:
* Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
* Any depressive episode with psychotic or catatonic features
* Panic disorder with or without agoraphobia
* Obsessive-compulsive disorder
* Schizophrenia, schizoaffective, or other psychotic disorder
* Bulimia or anorexia nervosa
* Presence of borderline personality disorder or antisocial personality disorder
* Mental retardation, dementia, amnesia, or other significant cognitive disorders
* Patients who are considered a suicide risk | Forest Laboratories | INDUSTRY | {
"id": "VLZ-MD-05",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-06-27T00:00:00 | {
"date": "2019-12-18",
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NCT03303066 | null | Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS) | A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome | None | INTERVENTIONAL | COMPLETED | 2017-10-02T00:00:00 | null | 2023-01-11T00:00:00 | 2023-02-08T00:00:00 | [
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* Diagnosis of primary MDS classified as very low, low or intermediate risk with \<5% blasts (documented within 12 weeks prior to Day 1)
* Screening Hb \<10 g/dL and ≥6g/dL
* Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1
* Erythropoiesis-stimulating agent (ESA)-naïve (not within 30 days of Day 1)
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Key Exclusion Criteria:
* Diagnosis of secondary MDS
* Significant myelofibrosis (\>2+fibrosis)
* Prior therapy with azacitidine, decitabine, antithymocyte globulin, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to Day 1
* Baseline erythropoietin level of \>400 units (U)/liter (L)
* Clinically significant anemia due to non-MDS etiologies
Note: Other inclusion and exclusion criteria may apply. | FibroGen | INDUSTRY | {
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"type": null
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"country": "China",
"facility": "West China Hospital, Sichuan University",
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"lon": 104.06667
},
"state": "Sichuan"
},
{
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"country": "China",
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"lon": 117.17667
},
"state": "Tianjin"
},
{
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"country": "China",
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},
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},
{
"city": "Tianjin",
"country": "China",
"facility": "Tianjin Medical University General Hospital",
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"lon": 117.17667
},
"state": "Tianjin"
},
{
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"lat": 25.03889,
"lon": 102.71833
},
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},
{
"city": "Hangzhou",
"country": "China",
"facility": "The First Affiliated Hospital, Zhejiang University Medical College",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang"
}
] | [
{
"class": "INDUSTRY",
"name": "AstraZeneca"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Percentage of Participants With a Hemoglobin (Hb) Response to FG-4592 Without Transfusion",
"timeFrame": "26 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Number of Participants With Hb Increase ≥1.0 g/dL From Baseline",
"timeFrame": "26 weeks"
},
{
"description": null,
"measure": "Time to First Hb Response",
"timeFrame": "26 weeks"
},
{
"description": null,
"measure": "Change From Baseline in Mean Hb in Weeks 25 to 27",
"timeFrame": "Baseline, Weeks 25 to 27"
},
{
"description": null,
"measure": "Percentage of Participants With Mean Hb ≥10.0 g/dL Within Any 8-week Period During the Study Without Transfusion",
"timeFrame": "26 weeks"
},
{
"description": null,
"measure": "Number of Participants that Require Transfusions or Hb <6 g/dL up to Week 27",
"timeFrame": "Up to Week 27"
},
{
"description": null,
"measure": "Mean Change From Baseline in Functional Assessment of Cancer Therapy - Anemia (FACT-An) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores at Week 27",
"timeFrame": "30 weeks"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"id": "D004194",
"term": "Disease"
},
{
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"term": "Pathologic Processes"
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{
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"term": "Hematologic Diseases"
},
{
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"term": "Bone Marrow Diseases"
},
{
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"term": "Precancerous Conditions"
},
{
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"term": "Neoplasms"
}
],
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"name": "Symptoms and General Pathology"
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"name": "All Conditions"
},
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"name": "Blood and Lymph Conditions"
},
{
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"name": "Neoplasms"
},
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}
],
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},
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},
{
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"name": "Anemia",
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},
{
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"name": "Preleukemia",
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},
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"name": "Hematologic Diseases",
"relevance": "LOW"
},
{
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"name": "Bone Marrow Diseases",
"relevance": "LOW"
},
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"id": "M14111",
"name": "Precancerous Conditions",
"relevance": "LOW"
},
{
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"id": "T3993",
"name": "Myelodysplastic Syndromes",
"relevance": "HIGH"
}
],
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{
"id": "D011289",
"term": "Preleukemia"
},
{
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"term": "Anemia"
},
{
"id": "D009190",
"term": "Myelodysplastic Syndromes"
},
{
"id": "D013577",
"term": "Syndrome"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Infl",
"name": "Anti-Inflammatory Agents"
},
{
"abbrev": "ARhu",
"name": "Antirheumatic Agents"
},
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"abbrev": "Analg",
"name": "Analgesics"
},
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"name": "Chrysarobin",
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}
],
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},
{
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}
],
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} |
NCT02289066 | null | Impact of Periodontal Disease on Outcomes in Diabetes | Impact of Periodontal Disease on Outcomes in Diabetes | None | OBSERVATIONAL | COMPLETED | 2014-10-23T00:00:00 | null | null | null | null | 250 | 18 | null | ALL | true | This study examines how periodontal disease affects the complications of diabetes and how treatment for periodontal disease affects biomarkers associated with the complications of diabetes. | The goal is to look for predictive factors of poor oral health and the impact of poor oral health on the complications of diabetes. The prevalence of periodontal disease among patients with diabetes is higher than in the general population. Periodontal disease is associated with dental loss and increased systemic inflammation which is associated with cardiovascular and bone disease. However, current evidence that treatment of POD will result in improvement of outcomes in patients with diabetes is mixed. Identifying patterns of disease and following biomarkers in patients with diabetes and periodontal disease will answer some of the questions and result in more appropriate recommendations and interventions with reduction in morbidity, mortality and healthcare cost.
This study will be conducted using a cross-sectional design. Investigators will survey 200 consecutive patients with diabetes during routine clinic visits using a questionnaire. Investigators will collect data on demographic information, socio-economic status, oral health status/care, diabetes history (duration, control and complications) and bone health. A subgroup of 24 participants with survey responses suggestive of periodontal disease will be selected to receive treatment for periodontal disease. We will measure their hemoglobin A1c and biomarkers before and after treatment and will compare their levels for changes with treatment. Investigators will analyze collected data using test of proportions, Student's t-test and multivariate regression analyses. | Inclusion Criteria:
All patients 18 years or older with diabetes for more than 2 years who present for their regular clinic visit will be eligible for inclusion in the survey part of the study. Further criteria for enrollment into the subgroup (n = 24) will include; Inclusion criteria
* Answers on the questionnaire suggesting POD or gingivitis.
* At least 16 teeth in place
* On a stable treatment for their diabetes
* Hemoglobin A1c between 6 and 10
Exclusion Criteria:
* Treatment with anti-inflammatory medications
* Cigarette smoking
* Treatment with thiazolidinediones
* Previous diagnosis of osteoporosis or treatment for osteoporosis with FDA approved agents. | University of Nevada, Reno | OTHER | {
"id": "1U54GM104944",
"link": "https://reporter.nih.gov/quickSearch/1U54GM104944",
"type": "NIH"
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-11-07T00:00:00 | {
"date": "2015-12-02",
"type": "ESTIMATED"
} | {
"date": "2014-11-13",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | University of Nevada School of Medicine (Las Vegas) Internal medicine and endocrinology clinics | NON_PROBABILITY_SAMPLE | true | {
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Periodontal Disease",
"Diabetes Mellitus"
] | null | null | [
{
"city": "Las Vegas",
"country": "United States",
"facility": "University of Nevada School of Medicine",
"geoPoint": {
"lat": 36.17497,
"lon": -115.13722
},
"state": "Nevada"
}
] | [
{
"class": "NIH",
"name": "National Institute of General Medical Sciences (NIGMS)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Changes in hemoglobin A1c",
"timeFrame": "At enrollment, 3 months after enrollment and 6 months after enrollment."
},
{
"description": null,
"measure": "biomarkers of inflammation (high sensitivity C - reactive protein and tumor necrosis factor - alpha)",
"timeFrame": "At enrollment, 3 months after enrollment and 6 months after enrollment."
},
{
"description": null,
"measure": "markers of bone turnover (bone specific alkaline phosphatase and C terminal",
"timeFrame": "At enrollment, 3 months after enrollment and 6 months after enrollment."
}
],
"secondary": [
{
"description": null,
"measure": "Evaluation of the relationship between periodontal disease and diabetes control and complications",
"timeFrame": "At enrollment only"
}
]
} | [
{
"affiliation": "University of Nevada, Reno",
"name": "Kenneth E Izuora, MD, MBA",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": null, "type": "BACKGROUND", "citation": "1. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011."}, {"pmid": "20969750", "type": "BACKGROUND", "citation": "Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010 Oct 22;8:29. doi: 10.1186/1478-7954-8-29."}] | {"versionHolder": "2025-06-18"} | {
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{
"id": "D044882",
"term": "Glucose Metabolism Disorders"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
},
{
"id": "D004700",
"term": "Endocrine System Diseases"
},
{
"id": "D009059",
"term": "Mouth Diseases"
},
{
"id": "D009057",
"term": "Stomatognathic Diseases"
}
],
"browseBranches": [
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"abbrev": "BC07",
"name": "Mouth and Tooth Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
},
{
"abbrev": "BC19",
"name": "Gland and Hormone Related Diseases"
}
],
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},
{
"asFound": "Diabetes",
"id": "M7115",
"name": "Diabetes Mellitus",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M11639",
"name": "Metabolic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M25403",
"name": "Glucose Metabolism Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7862",
"name": "Endocrine System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12019",
"name": "Mouth Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12017",
"name": "Stomatognathic Diseases",
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}
],
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{
"id": "D010510",
"term": "Periodontal Diseases"
},
{
"id": "D003920",
"term": "Diabetes Mellitus"
}
]
} | null | {
"conditions": [
{
"id": "D010510",
"term": "Periodontal Diseases"
},
{
"id": "D003920",
"term": "Diabetes Mellitus"
}
],
"interventions": null
} |
NCT05523466 | null | Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis | Effect of Acupuncture on Heart Rate Variability in Individuals With Multiple Sclerosis | None | INTERVENTIONAL | UNKNOWN | 2022-07-25T00:00:00 | null | null | null | [
"NA"
] | 40 | 18 | 50 | ALL | false | The Objective of this study is to evaluate the heart rate variability in individuals with multiple sclerosis during the applicability of Acupuncture, to analyze the behavior of the autonomic nervous system before, during, and after therapy and the changes of the condition. | A double-blinded randomized sham-controlled crossover trial with a 1:1 allocation ratio will be conducted, 40 individuals without previous illness will be evaluated, who will constitute the control group and 40 individuals with MS will constitute the experimental group, paired by age and gender. All participants will undertake active or sham acupuncture sessions. Active-Sham group will start with 5 sessions (1 per week) of active acupuncture combined with HRV evaluation for 20 min. After a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with HRV evaluation. Meanwhile, Sham-Active group will carry out the opposite protocol, participants will start an allocated 5 sessions (1 per week) of sham acupuncture combined with HRV evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with HRV evaluation. | Inclusion Criteria:
* Individuals diagnosed with Multiple Sclerosis
* Aged over 18 years
* Motor and intellectual capacity to understand the evaluations
* Light and moderate functional classification levels (EDSS scale)
* Who accept to participate in the study through agreement with informed consent form
Exclusion Criteria:
* Do not understand the evaluations
* Cardiac diseases that impede the assessment of HRV
* Have a cardiac pacemaker. | University of Sao Paulo | OTHER | {
"id": "1239/2018",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-08-29T00:00:00 | {
"date": "2022-08-31",
"type": "ACTUAL"
} | {
"date": "2022-08-31",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | null | {
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"interventionModel": "CROSSOVER",
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"maskingInfo": {
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"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Multiple Sclerosis"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Changes in the Heart Rate Variability after intervention",
"timeFrame": "84 days"
}
],
"secondary": null
} | [
{
"affiliation": "Federal University of São Paulo",
"name": "Celso Ferreira, Dr",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D020278",
"term": "Demyelinating Autoimmune Diseases, CNS"
},
{
"id": "D020274",
"term": "Autoimmune Diseases of the Nervous System"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D003711",
"term": "Demyelinating Diseases"
},
{
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"term": "Autoimmune Diseases"
},
{
"id": "D007154",
"term": "Immune System Diseases"
}
],
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"abbrev": "BC10",
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},
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"id": "M15415",
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},
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"id": "M4629",
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},
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"asFound": null,
"id": "M10200",
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}
],
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{
"id": "D009103",
"term": "Multiple Sclerosis"
},
{
"id": "D012598",
"term": "Sclerosis"
}
]
} | null | {
"conditions": [
{
"id": "D009103",
"term": "Multiple Sclerosis"
},
{
"id": "D012598",
"term": "Sclerosis"
}
],
"interventions": null
} |
NCT00882466 | null | The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction | Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction | None | INTERVENTIONAL | COMPLETED | 2009-04-15T00:00:00 | null | null | null | [
"PHASE4"
] | 58 | 18 | null | ALL | false | The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction. | null | Inclusion Criteria:
* Acute myocardial infarction \<12hr
* Age \>18yrs
* First myocardial infarction
* culprit lesion : proximal to mid left anterior descending artery
* Baseline coronary flow : TIMI Grade 0\~1
Exclusion Criteria:
* Patients with previous myocardial infarction
* History of thrombotic complication
* History of cerebral infarction
* Uncontrolled hypertension
* Increased hemoglobin level \>17g/dL
* Patients with mechanical valve
* Cardiogenic shock | Seoul National University Bundang Hospital | OTHER | {
"id": "EPO in AMI",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-04-15T00:00:00 | {
"date": "2009-04-17",
"type": "ESTIMATED"
} | {
"date": "2009-04-16",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Acute Myocardial Infarction"
] | ["erythropoietin"] | null | [
{
"city": "Seongnam",
"country": "Korea, Republic of",
"facility": "Seoul National University Bundang Hospital",
"geoPoint": {
"lat": 37.43861,
"lon": 127.13778
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Creatinine kinase (CK), creatinine kinase-MB (CK-MB)",
"timeFrame": "4hr, 8hr, 12hr, 24hr, 48hr, 72hr"
}
],
"secondary": [
{
"description": null,
"measure": "Infarct size assessed by cardiac MRI",
"timeFrame": "day 4"
}
]
} | [
{
"affiliation": "Seoul National University Bundang Hospital",
"name": "Dong-Ju Choi, MD,PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "20199815", "type": "DERIVED", "citation": "Suh JW, Chung WY, Kim YS, Kim KI, Jeon EJ, Cho YS, Youn TJ, Chae IH, Kim CH, Choi DJ. The effect of intravenous administration of erythropoietin on the infarct size in primary percutaneous coronary intervention. Int J Cardiol. 2011 Jun 2;149(2):216-220. doi: 10.1016/j.ijcard.2010.02.002. Epub 2010 Mar 2."}] | {"versionHolder": "2025-06-18"} | {
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},
{
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{
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"term": "Necrosis"
},
{
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"term": "Myocardial Ischemia"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
}
],
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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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},
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"id": "M10282",
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},
{
"asFound": null,
"id": "M10543",
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},
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"id": "T170",
"name": "Acute Graft Versus Host Disease",
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}
],
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"term": "Myocardial Infarction"
},
{
"id": "D007238",
"term": "Infarction"
}
]
} | {
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"term": "Hematinics"
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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": "Infarction"
}
],
"interventions": [
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"id": "D000068817",
"term": "Epoetin Alfa"
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]
} |
NCT02523066 | null | Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients | Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients | None | OBSERVATIONAL | TERMINATED | 2015-08-06T00:00:00 | null | 2017-04-29T00:00:00 | 2025-05-07T00:00:00 | null | 215 | null | null | ALL | false | Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients. | null | Inclusion Criteria:
* The patients who implanted with Magna Ease Heart Valve (Type:7300TFX and 3300TFX) in Fuwai Hospital in China.
* The patients agree to sign the inform consent form (ICF).
Exclusion Criteria:
* No specific exclusion criteria. | Edwards Lifesciences | INDUSTRY | {
"id": "Magna Ease CN001",
"link": null,
"type": null
} | Sponsor decision | {
"hasExpandedAccess": false,
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} | 2015-08-13T00:00:00 | {
"date": "2025-05-18",
"type": "ACTUAL"
} | {
"date": "2015-08-14",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | The patients who had the heart valves (Type: 7300TFX and 3300TFX), and are willing to participate in the study. | NON_PROBABILITY_SAMPLE | true | {
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} | [
"Mitral Valve or Aortic Valve Replacement"
] | null | null | [
{
"city": "Beijing",
"country": "China",
"facility": "The Chinese academy of medical sciences fuwai hospital cardiovascular disease",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | null | null | {
"other": null,
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"description": null,
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}
],
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} | null | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT00588666 | null | Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma | Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma | None | INTERVENTIONAL | COMPLETED | 2007-12-26T00:00:00 | null | null | null | [
"PHASE2"
] | 51 | 18 | null | ALL | false | Gemcitabine and carboplatin are two standard chemotherapy drugs used to treat tumors of the urothelial tract. These drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer.
New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. One new class of drugs are called 'angiogenesis-inhibitors'. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Bevacizumab is an anti-angiogenic drug.
In some other cancers such as colon cancer and lung cancer, combining bevacizumab with standard chemotherapy shrinks tumors in a greater proportion of patients and makes patients live longer than using standard chemotherapy alone. This has never been tested in urothelial cancer and we do not know if bevacizumab will have the same effects in this disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, carboplatin, and bevacizumab has on you and your cancer. | This is a phase II trial of gemcitabine, carboplatin, and bevacizumab in chemotherapy naïve patients with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract. | Inclusion Criteria:
* Histologic documentation: diagnosis of transitional cell carcinoma of the bladder,urethra, ureter, or renal pelvis.
* Unresectable or metastatic disease
* Ineligible for cisplatin (or incurable with cisplatin)
* ≥ 4 weeks since prior RT
* Karnofsky Performance Status ≥ 60%
* Age ≥ 18 years of age
* Required Initial Laboratory Values: Absolute neutrophil count ≥ 1.2 x 109/L; Platelets ≥ 100 x 109/L; Bilirubin ≤ 1.5 times the upper limit of normal (x ULN) for the institution; Aspartate transaminase (AST) and alanine transaminase(ALT) ≤ 3.0 x ULN;Serum creatinine \< 2.0 or calculated creatinine clearance (CrCl) ≥ 30 mL/min
Exclusion Criteria:
* Prior treatment with systemic chemotherapy (prior intravesical therapy is permitted)
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
* Blood pressure of \>150/100 mmHg
* Unstable angina
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction within 6 months
* History of stroke within 6 months
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Presence of central nervous system or brain metastases
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0
* Anticipation of need for major surgical procedure during the course of the study
* Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
* Pregnant (positive pregnancy test) or lactating
* Albuminuria as demonstrated by a urinary albumin of greater or = to 1.0 g/24 hr at screening
* History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 6 months prior to Day 0
* Serious, non-healing wound, ulcer, or bone fracture
* Inability to comply with study and/or follow-up procedures
* History of persistent gross hematuria | Memorial Sloan Kettering Cancer Center | OTHER | {
"id": "06-006",
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"type": null
} | Unknown | {
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"date": "2016-01-22",
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"date": "2008-01-08",
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} | [
"ADULT",
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} | [
"Myeloproliferative Disorder",
"Urothelial Carcinoma",
"Cancer"
] | ["Myeloproliferative Disorder", "urinary bladder", "Cancer", "ureter", "renal pelvis", "chemotherapy"] | null | [
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"city": "Basking Ridge",
"country": "United States",
"facility": "Memorial Sloan-Kettering at Basking Ridge",
"geoPoint": {
"lat": 40.70621,
"lon": -74.54932
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"state": "New Jersey"
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"geoPoint": {
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"lon": -73.85847
},
"state": "New York"
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] | null | null | {
"other": null,
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"description": null,
"measure": "Evaluate the Time to Disease Progression",
"timeFrame": "3 years"
}
],
"secondary": [
{
"description": null,
"measure": "The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.",
"timeFrame": "3 years"
}
]
} | [
{
"affiliation": "Memorial Sloan Kettering Cancer Center",
"name": "Dean Bajorin, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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]
} | {
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},
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},
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"term": "Angiogenesis Inhibitors"
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{
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} |
NCT00927966 | null | RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms | Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms | None | INTERVENTIONAL | COMPLETED | 2009-06-24T00:00:00 | null | null | null | [
"PHASE1"
] | 21 | 18 | null | ALL | false | The purpose of this research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally. This drug has been extensively studied in many cancers. In particular, it has shown to be effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered drug that may stop tumor growth. It is currently being studied in a wide variety of cancers, and information from those other research studies suggests that these two drugs in combination may help to stop cancer growth. | * In this research study, each "cycle" of study drug dosing lasts 21 days. In the first cycle, participants will come to the clinic on Days 1, 8, and 15. During cycles 2 through 4, participants will come to the clinic on Days 1 and 8. The rest of the clinic visits will occur on Day 1 of every cycle thereafter.
* During each cycle, participants will take RAD001 orally, once a day in the morning. In addition, participants will receive CP-751,871 intravenously once every cycle on the first day of each cycle.
* Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study drug. The dose will depend on the number of participants enrolled in the study and how well they tolerated their doses.
* Participants may remain on this research study as long as they do not have serious side effects or their diseae does not get worse. | Inclusion Criteria:
* Histologically confirmed advanced sarcoma or other advanced malignant solid tumor for which no known curative therapy exists. Patients must have had prior progression on, intolerance or refused approved standard therapies proven to prolong life.
* Measurable disease per RECIST. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment
* 18 years of age or older
* ECOG Performance Status 0-1
* Participants must have normal organ and marrow function as outlined in the protocol
* Fully recovered from the acute effects of prior cancer therapy before initiation of study drug
* Negative urine or serum pregnancy test within 7 days prior to initiation of study drug for women of child-bearing potential
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for up to 6 months after the last dose of study drug
Exclusion Criteria:
* Participants with gastrointestinal tumors (GIST) on approved tyrosine kinase inhibitors within 2 weeks prior to study entry
* All other participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin C) prior to study entry
* Participants who have had radiotherapy and/or major surgery within 2 weeks prior to study entry
* Concurrent use of any other anti-cancer therapies, study agents, growth hormones, growth hormone inhibitors or aminoglycoside antibiotics
* Participants who have had chronic high dose immunosuppressive steroid therapy within 2 weeks prior to enrollment. Previous high dose steroid treatment \> 2 weeks prior to study entry, topical and inhaled corticosteroids are allowed
* Presence of symptomatic or uncontrolled brain or central nervous system metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001 and/or CP-751,871
* Participants receiving any medications or substances that are inhibitors or inducers of CYP3A
* Uncontrolled diabetes
* Bleeding diathesis or requirement for therapeutic anticoagulation
* Uncontrolled intercurrent illness
* Pregnant or nursing women
* HIV positive individuals on combination anti-retroviral therapy | Dana-Farber Cancer Institute | OTHER | {
"id": "09-091",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-06-24T00:00:00 | {
"date": "2013-11-14",
"type": "ESTIMATED"
} | {
"date": "2009-06-25",
"type": "ESTIMATED"
} | [
"ADULT",
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] | null | null | true | {
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},
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} | [
"Sarcoma",
"Solid Tumor"
] | ["RAD001", "CP-751,871", "advanced sarcoma", "advanced malignant solid tumor"] | null | [
{
"city": "Boston",
"country": "United States",
"facility": "Dana-Farber Cancer Institute",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
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"state": "Massachusetts"
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] | [
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{
"class": "INDUSTRY",
"name": "Novartis"
},
{
"class": "INDUSTRY",
"name": "Pfizer"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "To assess the safety and tolerability of daily oral RAD001, administered in combination with CP-751,871 given as an intravenous infusion in patients with advanced sarcomas and other advanced solid tumors that are incurable with any current modality.",
"timeFrame": "3 years"
}
],
"secondary": [
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"description": null,
"measure": "To assess the pharmacokinetics of this combination regimen.",
"timeFrame": "3 years"
},
{
"description": null,
"measure": "To allow a preliminary assessment of the anti-tumor effects of this novel drug combination.",
"timeFrame": "3 years"
}
]
} | [
{
"affiliation": "Dana-Farber Cancer Institute",
"name": "Suzanne George, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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}
],
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"term": "Everolimus"
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]
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],
"interventions": [
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"id": "D000068338",
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]
} |
NCT05064566 | null | Evaluation of Caries Detection Methods | Clinical Performance of Diagnostic Methods in Early Occlusal Caries | None | OBSERVATIONAL | UNKNOWN | 2021-05-28T00:00:00 | null | 2022-10-20T00:00:00 | 2022-12-20T00:00:00 | null | 101 | 18 | null | ALL | true | The investigators aim will be to compare the diagnostic performance of clinical visual examination (ICDAS II), intraoral/bite wing radiography (BW), near infrared light transillumination (NIR-LT), and laser fluorescence (LF), in comparison to microcomputed tomography (micro-CT) for the detection of non-cavitated occlusal enamel and dentin caries in third molar teeth. Potential participants will be consecutively recruited. | Studies regarding comparison of diagnostic techniques for caries detection are generally conducted under in vitro conditions due to ethical concerns. Considering the many recently published in vitro studies which attempted to assess the diagnostic ability of different caries diagnosis systems, it is not possible to know at what rate in vitro findings are applicable to the clinical situation.The investigators would like to assess initial occlusal caries lesions by using different diagnostic methods under in vivo conditions. In the present study, the investigators will assess diagnostic accuracy of clinical visual examination (ICDAS II), digital intraoral radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), by examining third molar teeth in comparison to gold standard micro-CT images. The null hypothesis of the study is that no significant difference exists for the clinical performance of the evaluated methods in detecting non-cavitated occlusal caries in either the enamel or the dentin. This prospective study will include 101 third molars of 101 patients with non-cavitated occlusal caries requiring extraction. ICDAS II, BW, NIR-LT and LF examinations will be carried out by two examiners. Gold standard will be determined by micro-CT imaging after extraction. Intraclass correlation coefficient (ICC) value will be calculated for examiner agreement. Accuracy rate, sensitivity, specificity, predictive values and areas under receiver operating characteristic curves (Az) will be calculated. Clinical application time and patient comfort/pain analysis will be compared. Nonparametric variables will be assessed by Kruskal Wallis Test. Significance level will be set at p\<0.05. | Inclusion Criteria:
* According to the American Society of Anesthesiologists (ASA) only status 1/ healthy patients
* Completely erupted permanent dentition,
* No fixed orthodontic apparatus, prosthetic restoration and filling material,
* A minimum age of 18 years,
* At least one third erupted molar teeth (third mandibular or third maxillary molar from each patient was included),
* Non cavitated occlusal caries,
* Teeth with no hypoplasia or hypomineralization,
* Third molar teeth that require extraction for surgery, orthodontics and prosthetic reasons,
* If clinical indicators suggest a current caries risk or activity that required additional diagnosis, the patients will be asked to participate in this additional examination.
Exclusion Criteria:
* Patients younger than 18
* Patients that can not be recruited according to the inclusion criteria. | Mersin University | OTHER | {
"id": "2017-1-AP1-2000",
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NCT02165566 | null | Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit | null | None | INTERVENTIONAL | COMPLETED | 2014-05-07T00:00:00 | null | null | null | [
"PHASE4"
] | 28 | 18 | 80 | ALL | false | Insulin preparation -random assignment to regular insulin lin or lispro insulin as first treatment- was administered at constant infusion rate (0.04 units/Kg/h) in patients presenting blood glucose concentration ≥180 mg/dl and was discontinued when blood glucose concentration ≤140 mg/dl (therapeutic blood glucose concentration drop). Further reduction in blood glucose concentration after discontinuation of insulin infusion was recorded (post-infusional blood glucose concentration drop). During the study period blood glucose concentration, in whole blood, was measured every 30 minutes. At least 6 hours interval was allowed between the 2 treatments. | Inclusion criteria: Patients older than 18 years of age receiving full nutritional calories supply who presented blood glucose concentration ≥180 mg/dl. Exclusion criteria: moribund patients and patients enrolled on other studies were excluded. Patients with type 1 diabetes, patients with insulin-dependent diabetes are excluded and patients with glycated hemoglobin (glycosilated hemoglobin) \>5.6% are also excluded because of the potential of underlying insulin resistance.
A randomized crossover design is used. Patients receiving insulin infusion therapy are prospectively enrolled and randomly assigned to start the treatment either with lispro insulin or regular insulin at a dose of 0.04 units/Kg/h. After full enteral or parenteral nutrition is established, the insulin infusion therapy is started if blood glucose concentration ≥180 mg/dl (upper blood glucose concentration threshold) and is kept constant until blood glucose concentration is ≤140 mg/dl (lower blood glucose concentration threshold). Insulin infusion is discontinued after the blood glucose concentration reached ≤140 mg/dl. Because of the crossover design of the study, the same patient is treated with both lispro insulin or regular insulin infusion allowing an interval of at least 6 hours between the 2 treatments. During the study period -IIT and after insulin infusion is discontinued- the blood glucose concentration is measured every 30 minutes in whole blood (with blood gas analysis) until blood glucose concentration values return within the target threshold (140-180 mg/dl). The primary outcome measure was the extent of "residual effect" after that insulin (Hlog or Hlin) infusion has been discontinued. This variable is expressed as the ratio between blood glucose concentration reduction during insulin infusion (from the beginning of insulin infusion for blood glucose concentration values \>180 mg/dl, to the first measurement ≤140 mg/dl) and blood glucose concentration reduction after insulin infusion is discontinued (from the first blood glucose concentration value ≤140 mg/dl to the lowest blood glucose concentration value recorded). Secondary end point measures are: rate of blood glucose concentration reduction during insulin infusion (mg/dl/h-1), duration of the "residual effect" (time elapsed between insulin infusion discontinuation and the lowestblood glucose concentration value), and the rate of blood glucose concentration increase from lowest blood glucose concentration value to the first blood glucose concentration value ≥140 mg/dl. | Inclusion Criteria:
* critical care patients with blood glucose concentration \>180mg/dl
Exclusion Criteria:
* insulin dependent diabetes | University of Roma La Sapienza | OTHER | {
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NCT01437566 | null | Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy | A Phase II, Double-Blind, Placebo Controlled, Randomized Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy | None | INTERVENTIONAL | COMPLETED | 2011-09-08T00:00:00 | null | null | null | [
"PHASE2"
] | 318 | 18 | null | FEMALE | false | This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation. | null | Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* As per national or local treatment guidelines, endocrine therapy (i.e., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not necessary for participants, at time of entry into the study.
* Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during treatment with (or within 6 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting.
* Part II: Postmenopausal women with locally ABC or MBC whose disease has progressed during or after treatment with an AI. Participants who discontinued the AI for toxicity rather than completion of regimen or for disease progression are not eligible
* Estrogen receptor (ER)-positive disease and human epidermal receptor 2 (HER2)-negative disease
* Participants must have measurable disease by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 or bone-only disease with radiologic scans
* Adequate hematologic and end-organ function
Exclusion Criteria:
* Prior treatment with fulvestrant, phosphoinositide 3-kinase (PI3K) inhibitor, or mechanistic target of rapamycin (mTOR) inhibitor for ABC or MBC
* Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
* Prior treatment with greater than (\>) one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on \> two endocrine therapies for MBC
* Participants requiring anti-hyperglycemic therapy
* Clinically significant cardiac or pulmonary dysfunction
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease
* Active uncontrolled autoimmune disease or active inflammatory disease
* Immunocompromised status
* Need for current chronic corticosteroid therapy
* Pregnancy, lactation, or breastfeeding
* Current severe, uncontrolled systemic disease
* Symptomatic hypercalcemia
* Known untreated or active central nervous system (CNS) metastases
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or patients who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence | Genentech, Inc. | INDUSTRY | {
"id": "GDC4950g",
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} | [
{
"affiliation": "Genentech, Inc.",
"name": "Gallia Levy, M.D., Ph.D.",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "27155741", "type": "DERIVED", "citation": "Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Jun;17(6):811-821. doi: 10.1016/S1470-2045(16)00106-6. Epub 2016 May 4."}] | {"versionHolder": "2025-06-18"} | {
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NCT05264766 | null | The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery | The Use of Cooling Helmet for Neuroprotection Management in Patient Undergoing Open Heart Surgery: an Evaluation of Postoperative Neuron-specific Enolase (NSE) and Delirium | None | INTERVENTIONAL | COMPLETED | 2022-02-18T00:00:00 | null | 2021-12-31T00:00:00 | 2021-12-31T00:00:00 | [
"NA"
] | 26 | 18 | null | ALL | false | To know the relationship between the use of cooling helmet with the changes of NSE level and postoperative delirium event in open heart surgery | Subjects were assigned into two groups after giving consent to participate in the study using random allocation, 13 subjects per group. Blood sample from CVC were obtained to assess NSE preoperative. After induction, cooling helmet with circulating cold water were placed on patients group A and without circulating cold water on group B. Blood samples were obtain again 6 hours after cardiopulmonary bypass off to assess NSE postoperative. Delirium was assessed using Confusion Assessment Method - Intensive Care Unit (CAM-ICU) | Inclusion Criteria:
* Patient undergoing their first open heart surgery using cardiopulmonary bypass
* Age ≥18 year-old
* Patient with American Society of Anesthesiologists (ASA) III
* Patient with Glasgow Coma Scale (GCS) 15, fully aware and oriented
* Patient fluent in Indonesia
Exclusion Criteria:
* Patients did not give consent to participate in the study
* Patients with central nervous system disease (stroke, intracranial tumor)
* Patients with psychiatric problem (schizophrenia, depression)
* Patients with cognitive problem
* Blind and deaf patient
* Patient on psychotrophic or narcotics medication
Drop out criteria
* Surgery without cardiopulmonary bypass
* Patient demise after surgery
* Patients decided to refrain from the study | Indonesia University | OTHER | {
"id": "IndonesiaUAnes333",
"link": null,
"type": null
} | Unknown | {
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"date": "2022-03-03",
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"date": "2022-03-03",
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"Heart; Surgery, Heart, Functional Disturbance as Result"
] | ["cooling helmet", "neuron specific enolase", "delirium", "open heart surgery"] | null | [
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"country": "Indonesia",
"facility": "Cipto Mangunkusumo Central National Hospital",
"geoPoint": {
"lat": -6.1818,
"lon": 106.8223
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"description": null,
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"timeFrame": "6 hours post cardiopulmonary bypass off"
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"timeFrame": "Changes of CAM-ICU from 12 hours to 24 hours postoperative"
}
],
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NCT00003766 | null | O6-benzylguanine Followed by Surgery in Treating Patients With Solid Tumors That Can Be Removed During Surgery | Determination of Optimal O6-Benzylguanine Dose to Achieve O6-Alkylguanine-DNA Alkyltransferase Depletion in Patients With Surgically Resectable Solid Tumors | None | INTERVENTIONAL | COMPLETED | 1999-11-01T00:00:00 | null | null | null | [
"PHASE1"
] | 25 | null | null | ALL | false | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of O6-benzylguanine followed by surgery in treating patients who have solid tumors that can be removed during surgery. | OBJECTIVES: I. Determine the minimal O6-benzylguanine (O6-BG) dose required to deplete tumor activity to less than 10 fmol/mg protein at a specified time after administration in patients with surgically resectable solid tumors. II. Correlate tumor tissue AGT depletion with AGT depletion in peripheral blood mononuclear cells (PBMC) obtained at a specified time after O6-BG administration in these patients.
OUTLINE: This is a dose escalation study. Patients receive a single dose of O6-benzylguanine (O6-BG) IV over 1 hour at one of two dose levels. Patients undergo surgery 16-20 hours after administration of O6-BG. Up to 13 patients receive the lower dose level of O6-BG. If more than 3 patients have detectable AGT levels, additional patients receive the higher dose. The optimal biologic dose (OBD) is defined as the lowest dose level at which at least 11 of 13 patients have AGT activity less than 10 fmol/mg protein after O6-BG dosing. Patients are followed at 1 and 3 weeks post surgery.
PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study over approximately 10 months. | DISEASE CHARACTERISTICS: Histologically or cytologically confirmed surgically resectable solid tumor
PATIENT CHARACTERISTICS: Age: Not specified Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Medically cleared for surgery No active medical or psychiatric disease that would prevent compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified | University of Chicago | OTHER | {
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} | 2004-02-19T00:00:00 | {
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"type": "ESTIMATED"
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} | [
"Unspecified Adult Solid Tumor, Protocol Specific"
] | ["unspecified adult solid tumor, protocol specific"] | null | [
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"city": "Chicago",
"country": "United States",
"facility": "University of Chicago Cancer Research Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
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"state": "Illinois"
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"class": "NIH",
"name": "National Cancer Institute (NCI)"
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"primary": [
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"description": null,
"measure": "Determine minimal dose",
"timeFrame": "2 years"
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} | [
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"affiliation": "University of Chicago",
"name": "Mark J. Ratain, MD",
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"term": "Antineoplastic Agents"
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"term": "Enzyme Inhibitors"
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"term": "Molecular Mechanisms of Pharmacological Action"
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NCT03828266 | null | Prediction of Abdominal Complications After GastroEnterological Surgery | Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry | PACAGE | OBSERVATIONAL | UNKNOWN | 2019-01-30T00:00:00 | null | 2019-12-31T00:00:00 | 2020-12-31T00:00:00 | null | 4,000 | 18 | null | ALL | false | The aim of this multi-centered study is to understand the epidemiology of infectious complications after gastrointestinal surgery in China. In total, 17 centers from China will prospectively register their patients undergo gastric or colorectal surgeries. Patient demographic data, operation information, and postoperative data including the infectious complications and the outcomes will be registered. We expect to include 2000 gastric and 2000 colorectal patients within one year and the study is expected to be finished in 2020. | All participating hospital will log in on a website based e-CRF system. Researchers need to register the patient information that three time-points: admission, after surgery, after discharge.
The detailed registered information includes:
I. Basic and surgical information:
Age, height, weight, history of abdominal surgery, ASA score, surgical procedure, extent of lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it is emergency surgery, whether it is combined with organ resection, whether it is palliative resection, whether combined with preoperative treatment, whether combined with preoperative infection and intraoperative complications.
II. Postoperative information:
Primary lesion histological type, margin, pathological stage (pTNM); other complications, postoperative death and discharge time, CRP, PCT, WBC levels.
III. Abdominal Infection information:
Abdominal infection (Y/N), anastomotic leakage (Y/N), intervention, outcome. | Inclusion Criteria:
* Planned gastrointestinal surgery.
* Inform consent received.
Exclusion Criteria:
* Endoscopic surgery.
* Inform consent denied. | Peking University | OTHER | {
"id": "2018YJZ56",
"link": null,
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} | 2019-01-31T00:00:00 | {
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} | {
"date": "2019-02-04",
"type": "ACTUAL"
} | [
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} | [
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] | null | null | [
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"country": "China",
"facility": "Peking University Cancer Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
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"state": "Beijing"
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"facility": "Fujian Medical University Union Hospital",
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"lon": 119.30611
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"state": "Fujian"
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"facility": "Xiamen University First Hospital",
"geoPoint": {
"lat": 24.47979,
"lon": 118.08187
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"state": "Fujian"
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"facility": "Guangdong People's Hospital",
"geoPoint": {
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"country": "China",
"facility": "South Hospital",
"geoPoint": null,
"state": "Guangdong"
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"facility": "Nanchang University First Hospital",
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"lon": 115.85306
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"country": "China",
"facility": "Jilin University Second Hospital",
"geoPoint": {
"lat": 43.88,
"lon": 125.32278
},
"state": "Jilin"
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"country": "China",
"facility": "Dalian Medical University First Hospital",
"geoPoint": {
"lat": 38.91222,
"lon": 121.60222
},
"state": "Liaoning"
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"city": "Xining",
"country": "China",
"facility": "Qinghai University Affiliated Hospital",
"geoPoint": {
"lat": 36.62554,
"lon": 101.75739
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"state": "Qinghai"
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"country": "China",
"facility": "Shandong Provincial Hospital",
"geoPoint": {
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"lon": 116.99722
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"state": "Shandong"
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"geoPoint": {
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"lon": 120.38042
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"state": "Shandong"
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"city": "Shanghai",
"country": "China",
"facility": "Fudan University Cancer Hospital",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
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"state": "Shanghai"
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"country": "China",
"facility": "Huashan Hospital",
"geoPoint": {
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"lon": 121.45806
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"state": "Shanghai"
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"city": "Shanghai",
"country": "China",
"facility": "Ruijin Hospital",
"geoPoint": {
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"state": "Shanghai"
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"country": "China",
"facility": "Zhongshan Hospital",
"geoPoint": {
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"state": "Shanghai"
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"facility": "Xi'an Jiao Tong University First Hospital",
"geoPoint": {
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"lon": 108.92861
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"state": "Shanxi"
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"facility": "Hangzhou First Hospital",
"geoPoint": {
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"lon": 120.16142
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"facility": "Run Run Shaw Hospital",
"geoPoint": {
"lat": 30.29365,
"lon": 120.16142
},
"state": "Zhejiang"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Abdominal Infection rate after gastrectomy.",
"timeFrame": "From surgery until discharge, up to 90 days."
},
{
"description": null,
"measure": "Abdominal Infection rate after colorectal surgery.",
"timeFrame": "From surgery until discharge, up to 90 days."
}
],
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"description": null,
"measure": "Classification of Abdominal Infection after Surgery",
"timeFrame": "From surgery until discharge, up to 90 days."
},
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"description": null,
"measure": "Diagnosis time of Abdominal Complication",
"timeFrame": "From surgery until discharge, up to 90 days."
},
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"description": null,
"measure": "Outcome of Abdominal Infection Treatment",
"timeFrame": "From surgery until discharge, up to 90 days."
}
]
} | [
{
"affiliation": "Peking University Cancer Hospital & Institute",
"name": "Ziyu Li, MD PhD",
"role": "PRINCIPAL_INVESTIGATOR"
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NCT02777866 | null | LAW Trial -The Impact of Local Anesthetics Infiltration in Surgical Wound of Gastrointestinal Procedures | LAW Trial -The Impact of Local Anesthetics Infiltration in Surgical Wound of Gastrointestinal Procedures: A Blind Prospective Randomized Trial | LAW | INTERVENTIONAL | UNKNOWN | 2016-05-16T00:00:00 | null | null | null | [
"NA"
] | 570 | 18 | null | ALL | false | The purpose of this study is to determine if the infiltration of 0.5% Bupivacaine in the surgical wound is effective to diminish the pain and the risk of surgical site infections in patients who go to a open gastrointestinal procedure. | This is an experimental, randomized, prospective, double blind study, in which will compare two groups. First group of participants who will be non urgent operated of an open gastrointestinal surgery, where an opening of the gastrointestinal lumen occurs (bile duct, stomach, small bowel or colon), who will be infiltrated in the total thickness of the abdominal wall (Peritoneum-muscle fascia- Subcutaneous tissue) with 0.5% Bupivacaine, every 1 cm, on each side of the surgical wound; Second group of participants who will be non urgent operated of an open gastrointestinal surgery, where an opening of the gastrointestinal lumen occurs, who will be infiltrated in the total thickness of the abdominal wall with 0.9% Saline Solution, every 1 cm, on each side of the surgical wound.
In all participants undergoing to the protocol will make basic maneuvers to decreasing surgical site infection, which has already been standardized in the Institute. These maneuvers consist of administering prophylactic antibiotic 30 minutes before the incision, shaving of the abdominal wall with clipper in the OR, preoperative skin preparation with chlorhexidine gluconate 4%. All participants will get glucose control (\<200 mg / dL), maintenance of the normothermia by putting hot air in the areas not exposed to the surgery field, heating fluids and getting intraoperative hyperoxia. Blood and components will be avoided as possible.
At the moment of closing of the abdominal wall, all the surgical personal will change the surgical gloves, also all the material that will be used should be sterile. The surgical nurse will pass the solution that will be injected, the investigator will not know the contents. 1 ml of the solution will be applied for each centimeter of the wound, covering the total thickness of the wall, on each side of the wound. After the closure of the fascia, the subcutaneous tissue will be washed with 1 liter of 0.9% saline solution. The skin will be closed with metal skin staples. The total administered dose of Bupivacaine should not be greater than stated as toxic (3mg/kg).
In all participants a 0.9% saline with 200 mg of Tramadol will be indicated for 24 hours. Participants may also receive IV Tramadol bolus of 25 mg, with a maximum of 4 in a day (top dose of 300 mg/day); in those participants in whom analgesia fails to control, the investigator may use other drugs like morphine of NSAIDs. No epidural or subarachnoid analgesia will be used.
All participants will be assessed 2 times per day for the presence of pain, this will be done with a numerical verbal scale from 0 to 10, when 0 is none pain, and 10 is the greatest pain that can reaches. The investigator will review the surgical wound once daily. The participant will be assessed every 7 days once discharged from hospital, in the outpatient clinic, until 30 days after the surgical procedure.
The sample size was calculated based on the incidence of surgical site infections in the Institute, which is 5%. The sample side required to demonstrate an expected reduction of 5% to 1%, with a power of 80% and a type 1 error of 5%, is 285 participants per group.
Randomization will be done electronically, which will be assigned 285 participants in each group.The investigators will annotate the number that will be given by the program in the participant expedient. The list of the numbers will be blind for investigators, and only the attending anesthesiologists will have it. The attending or resident anesthesiologist will give the syringe with the contents, being a blind study for the investigator and participant.
Statistical analysis will be performed using SPSS version 20.0 IBM, Microsoft Excel and numbers of iWorks for Macintosh. Statistical analysis according to the type of scaling of the variables analyzed will be performed. For comparison of dimensional variables will make a Student t test and ANOVA. For categorical variables a test of Kendall tau and chi square will be performed. Investigators will consider statistically significant any value equal or less than 0.05 or 5% for a hypothesis test two-tailed. | Inclusion Criteria:
* Patients who are planned to a elective gastrointestinal surgery.
* Biliary-pancreatic open procedures: biliodigestive Derivation, Pancreatoduodenectomy, Pancreato-jejunostomy (Puestow procedure, Frey).
* Open upper gastrointestinal procedures: total gastrectomy, subtotal gastrectomy (distal gastrectomy with Billroth I reconstruction or Billroth II or Roux-Y), Gastro-jejunum anastomosis, Open gastro-jejunal Roux Y bypass, intestinal resection, intestinal reconnection, intestinal Fistulectomy.
* Open colorectal procedures: Right or Left Hemicolectomy, total colectomy, low anterior resection, abdominal-perineal resection.
* Patients who decide signing the informed consent after explained the study.
* Patients with postoperative follow-up of at least 30 days, in whom the wound and / or local complications will be evaluated.
Exclusion Criteria:
* Patients operated laparoscopically.
* Patients operated at another hospital.
* Patients with clean surgical wounds.
* Patients in whom an epidural or subarachnoid block is used.
* Patients who are unable to sign the informed consent.
* Patients with less than 50 kg.
* Patients wiht history of: Malignant hyperthermia, cardiac disease (Heart failure, history of myocardial infarction, arrhythmias), Epilepsy, Allergic to amides.
* Patients with incomplete follow-up (less than 30 days).
* Pregnant patients. | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | OTHER | {
"id": "CIBH-1566",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-05-18T00:00:00 | {
"date": "2016-05-19",
"type": "ESTIMATED"
} | {
"date": "2016-05-19",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
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"primaryPurpose": "PREVENTION",
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} | [
"Surgical Site Infection",
"Wound Infection",
"Postoperative Pain",
"Local Anesthetics"
] | null | null | [
{
"city": "Tlalpan, Mexico City",
"country": "Mexico",
"facility": "Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran",
"geoPoint": null,
"state": "Mexico City"
}
] | null | null | {
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"primary": [
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"description": null,
"measure": "Postoperative Surgical Site Infection (SSI) defined by the Centre for Disease Control (CDC) criteria",
"timeFrame": "30 days following operation"
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"description": null,
"measure": "Efficacy of 0.5% Bupivacaine Infiltration for Post-op Pain measured using a Numeric Scale; 0-10",
"timeFrame": "Baseline to 48 hours postoperative"
}
],
"secondary": null
} | [
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"name": "Noel Salgado-Nesme",
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}
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"abbrev": "BC26",
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NCT05204966 | null | Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development | Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development | None | INTERVENTIONAL | UNKNOWN | 2022-01-03T00:00:00 | null | 2024-12-31T00:00:00 | 2024-12-31T00:00:00 | [
"NA"
] | 50 | null | 6 | ALL | false | The purpose of this study is to develop an evaluation of dysphagia through deep learning-based video analysis in newborns and infants, and to report the correlation with future development. | Although the exact frequency of dysphagia in newborns is not known, according to a paper published by Motion et al. in 2001, the prevalence of eating problems in premature infants under 37 weeks of age was 10.5%, and in 2001, Mercado-Deane et al. reported that about 26% had dysphagia. In 1996, Reilly et al. reported that more than 90% of children with polio had oral movement disorders and 38% had dysphagia. It is known that the frequency of dysphagia in newborns and infants is not low. The risk factors that cause these dysphagia are very diverse, and dysphagia in children can be induced by causes that can affect the whole process of swallowing.
The evaluation of dysphagia can be divided into an evaluation method that does not use an instrument such as SOMA, SDS, and quality of life measurement, and an evaluation method that uses an instrument such as VFSS and FEES. However, it is difficult to conduct tests such as VFSS in newborns and infants due to poor coordination, and there is also a risk of radiation exposure. In addition, there are practical difficulties in applying the evaluation in all medical institutions because special facilities are required to implement VFSS and specialized clinical personnel are required.
The Neonatal Oral-Motor Assessment Scale (NOMAS), developed by Marjorie Meyer Palmer in 1983, is an evaluation method for dysphagia applicable to infants under 48 weeks of PMA that evaluates whether there are abnormal findings by observing sucking for 5 minutes. However, NOMAS has the disadvantage that a person has to directly observe the sucking and may show differences in results between raters.
Therefore, in this study, inspired by the evaluation method of NOMAS, investigators try to develop an evaluation method to evaluate swallowing disorders by videotaping bottle feeding in newborns and infants, then calculating and analyzing the features of the baby's face related to swallowing with artificial intelligence. investigators would like to analyze the relationship between this evaluation result and future development. | Inclusion Criteria:
* Newborns and infants under 6 months of correctional age
* Clinically suspected to have dysphagia
* In case parental consent is obtained
Exclusion Criteria:
* In case of cardiopulmonary instability (ECMO, Ventilator, etc. are being applied)
* When it is not possible to secure sufficient fields for artificial intelligence analysis of images due to factors such as anatomical abnormalities of the head and neck | Asan Medical Center | OTHER | {
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NCT00899366 | null | DNA Analysis of Tissue From Patients With T-Cell Acute Lymphoblastic Leukemia | Molecular Mechanisms of NOTCH Induced Transformation in T-ALL | None | OBSERVATIONAL | COMPLETED | 2009-05-09T00:00:00 | null | 2009-07-30T00:00:00 | 2009-07-30T00:00:00 | null | 49 | 18 | 120 | ALL | false | RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at tissue samples from patients with T-cell acute lymphoblastic leukemia. | OBJECTIVES:
* Identify the transcriptional signatures associated with the presence of NOTCH1 mutations in primary T-cell acute lymphoblastic leukemia (T-ALL) cells using oligonucleotide microarrays.
* Characterize the global changes on gene expression resulting from the inactivation of NOTCH signaling in human T-ALL lymphoblasts.
OUTLINE: This is a multicenter study.
Frozen lymphoblast samples from patients with T-cell acute lymphoblastic leukemia (NOTCH1-mutated and wild type) are assessed for genetic expression profiles and mutations by microarray analysis and activated NOTCH1 protein by western blot analysis.
PROJECTED ACCRUAL: A total of 48 samples from patients will be accrued for this study. | DISEASE CHARACTERISTICS:
* Confirmed diagnosis of T-cell acute lymphoblastic leukemia
* Frozen lymphoblast samples available
* NOTCH1-mutated or wild type sample available
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
Exclusion Criteria:
* Not applicable | Eastern Cooperative Oncology Group | NETWORK | {
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NCT05748366 | null | Ultrasound Guided Serratus Anterior Plane Block for Rib Fractures | Ultrasound Guided Serratus Anterior Plane Block Versus Standard Therapy for Analgesic Relief of Rib Fractures in the Emergency Department | None | INTERVENTIONAL | RECRUITING | 2023-02-14T00:00:00 | null | 2025-03-31T00:00:00 | 2025-06-30T00:00:00 | [
"NA"
] | 60 | 18 | null | ALL | false | This study is a single center, randomized controlled trial examining the effect of serratus anterior plane block (SAPB) on pain, PIC scores and other clinical outcomes in emergency department patients with multiple rib fractures in comparison to the use of analgesic medication alone.
Objectives
1. Compare SAPB performed in the ED setting to analgesic medication alone with regard to pain, respiratory status and PIC score of patients with multiple rib fractures.
2. Assess the safety and feasibility of performing ultrasound-guided SAPB in the ED.
3. Evaluate outcomes of patients receiving the SAPB in the ED including amount of analgesic medications used, level of care required, need for upgrading level of care, and length of stay. | Background Rib fractures are a common injury encountered in the emergency department (ED) affecting an estimated 10% of all trauma patients. They are associated with significant morbidity and mortality, especially in elderly patients. Rib fractures are the leading indication for intensive care unit (ICU) admission in patients with traumatic injuries to the thorax, accounting for approximately 42% of patients who require critical care in trauma. Secondary complications from rib fractures include atelectasis, pneumonia, and acute respiratory distress syndrome. These complications are often attributed to a relative respiratory functional deficit secondary to pain which limits adequate inspiratory capacity and coughing; therefore, the management of acute rib fractures has largely been focused on controlling pain. The most common method of pain control employed in the ED has historically been the use of a multimodal analgesic approach which includes opioids, acetaminophen, and NSAIDS. Opioids confer additional risks which include respiratory depression, suppressed cough reflex, delirium, nausea, constipation, and the potential for addiction.
Ultrasound-guided serratus anterior plane block (SAPB) is an alternative method of pain control that utilizes targeted delivery of a local anesthetic agent in the serratus anterior fascial plane. This method was first described in 2013 and has been well described for the treatment of pain associated with thoracic surgical procedures, including those of the breast and chest wall. The SAPB has also been demonstrated to provide analgesic relief of pain associated with rib fractures and other blunt chest-wall traumatic injuries.
Over recent years, the SAPB technique has been gaining popularity due to its efficacy, relative ease of performance, and favorable side effect profile. This ultrasound guided technique uses a high frequency linear ultrasound transducer to identify the serratus anterior fascial planes, latissimus dorsi muscle, ribs, and pleural space. The intended target is the superficial serratus anterior fascial plane, which is bordered by the latissimus dorsi muscle posteriorly and the pectoralis muscles anteriorly. This fascial plane houses the lateral cutaneous branches of the intercostal nerves and a plane block of the superior facial plane has also been postulated to provide analgesia in the distribution of the long thoracic and thoracodorsal nerves. The block primarily works at the level of T2-T9, and previous literature has suggested that the SAPB works best for anterolateral rib fractures. The SAPB has a relatively safe side effect profile. Major complications include pneumothorax and local anesthetic systemic toxicity (LAST); however, the incidence of adverse events following SAPB performed in the ED has been low in previous studies.
Point of care ultrasound (POCUS) for procedural guidance is commonly employed by emergency physicians in daily clinical practice. Several retrospective and case-series studies have demonstrated the efficacy, feasibility, and safety of SAPB in the ED when performed by trained ED physicians. Studies like those performed by Diwan et al. and Kring et al. have demonstrated improved pain scores and decreased opioid consumption following SAPB. Despite this, to date, there has only been one published randomized controlled trial comparing the analgesic effects of SAPB versus opioid pain medication. More data is needed to further evaluate the analgesic effect of ED performed SAPB and the outcome of patients who present with acute rib fractures.
The Pain, Inspiratory capacity, and Cough (PIC) score is a tool currently utilized in blunt chest trauma cases at WellSpan York Hospital to guide inpatient management and predict the need for escalating care. This ten-point scoring tool accounts for the patient's pain level (mild/moderate/severe), inspiratory capacity (percent predicted value), and cough effort, with a goal score of \>8. Inspiratory capacity and cough effort are often directly related to the level of pain a patient is experiencing, therefore, improving rib fracture pain through SAPB may improve PIC scores and help reduce the need for intensive care unit (ICU) level care. Additionally, analgesic relief with SAPB should decrease opioid consumption and its associated risks in the immediate period following rib fractures.
The goal of this study is to examine the effect of ED-performed SAPB on pain, PIC scores and other clinical outcomes in patients with multiple rib fractures in comparison to the use of analgesic medication alone.
Objectives
1. Compare SAPB performed in the ED setting to analgesic medication alone with regard to pain, respiratory status and PIC score of patients with multiple rib fractures.
2. Assess the safety and feasibility of performing ultrasound-guided SAPB in the ED.
3. Evaluate outcomes of patients receiving the SAPB in the ED including amount of analgesic medications used, level of care required, need for upgrading level of care, and length of stay.
Outcomes: See subsequent entries.
Research methods
Study design This will be a randomized, controlled, superiority trial consisting of adult patients presenting to the WellSpan York Hospital ED with \>1 unilateral rib fracture on either x-ray or CT imaging. Screening for potential subjects will be conducted by ED staff working clinically, as well as ultrasound/procedure emergency medicine residents and US fellows/faculty on "scanning shifts." Informed consent will be obtained by a member of the study team prior to data collection or study procedures. Patients enrolled in the study will be randomized to one of two groups. Group 1 (control) will receive standard multimodal pain control as deemed appropriate by the treating physician. Group 2 (intervention) will receive the SAPB according to the attached protocol, as well as standard multimodal analgesia per standard of care. It should be emphasized that patients in group 2 will still receive standard multimodal pain medication at the discretion of the treating physician if the SAPB is not providing adequate analgesic relief. Both SAPB and analgesic medications fall within the current standard of care for pain management in rib fractures.
A point-of-care (POC) ultrasound will be performed by an ED attending, fellow or resident under the supervision of an emergency physician accredited in ultrasound-guided SAPB. Clinical and demographic data, including the number and location of rib fractures, procedural details, and initial pain/PIC scores will be documented at the bedside. Ultrasound images will be recorded via the usual ultrasound archival software and undergo the standard QA process used for all POC US studies performed in the ED. ED residents/fellows/attendings participating in this study will be trained on study protocols by accredited staff prior to participation in consent, ultrasonography and data collection.
Additional follow up data will be collected via a phone call at 1 week and a review of the electronic medical record at 30 days. All research data will be documented on standardized data collection forms.
Study population and recruitment Study population will include ED patients over the age of 18 identified with rib fractures on x-ray or CT imaging. Patients will be seen initially by the treating physician and receive the usual standard of care. If rib fractures are identified, the treating physician will contact a member of the study team to assess eligibility, discuss the study with the patient and/or the legally authorized representative (LAR) and obtain consent. The POC ultrasound procedure may be performed by a physician member of the study team or another credentialed emergency physician.
Inclusion/exclusion criteria: See subsequent entries.
Role of subjects Study participants will receive standard treatment at the discretion of the treating physician or advanced practice provider. The patient's decision to participate in this study will not directly affect their care in the ED. The treating provider will not necessarily be blinded to the treatment provided as they will need to perform the SAPB if the patient is randomized to the interventional group 2.
Research procedures Screening for inclusion in this study will occur in the ED as outlined above. Informed consent will be given to eligible patients/LARs for review. Written informed consent will be obtained prior to randomization to treatment vs control group. If randomized to the control group, patients will sign a separate procedure consent form for SAPB.
Each patient will be assigned a study ID number at the time of enrollment and a linking document will be maintained. Once data collection is complete, forms will be de-identified by the removal of the patient's name/MRN/FIN/identifying information.
Randomization will be determined by pre-filled, numbered study folders available in the ED at the start of the study. Each enrolled subject will be randomized based on the contents of the study folder labeled with their corresponding study ID number.
Of note, subjects initially assigned to group 1 (control) are eligible to crossover and undergo SABP if their pain is inadequately controlled 2 hours post-randomization or later. This option will be left up to shared decision-making between the treating physicians and patient.
All patients undergoing SABP will be additionally consented specifically for the medical procedure per usual ED standard of care.
Ultrasound/Procedural technique: Please see later fields.
Data analysis and sample size calculations Descriptive statistics will be reported as means/medians with standard deviation/interquartile range for continuous variables and proportions with percentages for categorical variables. Differences in continuous outcome variables between study groups will be compared via Student T-test for parametric data and Mann-Whitney U test for non-parametric data with associated 95% confidence intervals. Differences in dichotomous variables between groups will be compared via chi-squared or Fisher's exact tests, as appropriate. Primary analysis will be conducted on an intention to treat basis; however, given the potential for cross-over, per protocol sensitivity analysis is also planned. Interrater reliability for follow up data collection from the medical record will be assessed via Cohen's kappa. p\<0.05 will be considered statistically significant. Statistical analysis will be performed using SPSS software (IBM, Armonk, NY).
Power calculations are based on prior published literature and local data on patients admitted to WellSpan York Hospital with rib fractures over the past year. We assume a baseline pain VAS mean=7.7/SD=2.2, an expected mean 2-hour pain VAS change difference between study groups of 2.5 and a margin of superiority of 1.0. Allowing for 5-10% attrition, we plan to enroll a total of 60 subjects (30 per arm, randomized 1:1) to achieve 80% power at alpha=0.05. | Inclusion Criteria:
* Age \>18 years
* \>1 Unilateral, acute rib fractures diagnosed on x-ray or CT imaging
* Patient presenting to the WellSpan York Hospital ED
* Patient requiring IV analgesia or oral opioid to control pain related to rib fractures
Exclusion Criteria:
* Age \<18 years
* Inability to provide informed consent
* Allergy to local anesthesia
* Subsequent visit for rib fractures
* Patients taken emergently to the OR or discharged from the ED
* Significant distracting injuries/polytrauma that would not be expected to be responsive to analgesia from SAPB and confound pain scores, i.e. long bone fractures, intraabdominal injuries, etc. | WellSpan Health | OTHER | {
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"other": [
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"measure": "Safety Outcomes",
"timeFrame": "30 days"
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"primary": [
{
"description": null,
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"timeFrame": "2 hours"
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"description": null,
"measure": "Pain Score",
"timeFrame": "4 hours, 6 hours, 8 hours, and 12 hours following randomization"
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"measure": "Pain/Inspiratory Effort/Cough (PIC) Score",
"timeFrame": "4 hours, 6 hours, 8 hours, and 12 hours following randomization"
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"description": null,
"measure": "Morphine Milligrams Equivalent (MME)",
"timeFrame": "2 hours, 4 hours, 6 hours, 8 hours and 12 hours following randomization"
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"timeFrame": "During index hospitalization following randomization"
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"timeFrame": "From date of randomization until the date of discharge from the hospital or death from any cause, whichever came first, assessed up to 100 months"
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"timeFrame": "From date/time of randomization until the date/time of departure from the ED or death from any cause, whichever came first, assessed up to 24 hours"
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] | [{"pmid": "30860711", "type": "BACKGROUND", "citation": "Southgate SJ, River GF, Herbst MK. Ultrasound-Guided Serratus Anterior Blocks. 2024 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538476/"}, {"pmid": "34766933", "type": "BACKGROUND", "citation": "Terry SM, Shoff KA, Sharrah ML. Improving Blunt Chest Wall Injury Outcomes: Introducing the PIC Score. J Trauma Nurs. 2021 Nov-Dec 01;28(6):386-394. doi: 10.1097/JTN.0000000000000618."}, {"pmid": "35533604", "type": "BACKGROUND", "citation": "Bass GA, Stephen C, Forssten MP, Bailey JA, Mohseni S, Cao Y, Chreiman K, Duffy C, Seamon MJ, Cannon JW, Martin ND. Admission Triage With Pain, Inspiratory Effort, Cough Score can Predict Critical Care Utilization and Length of Stay in Isolated Chest Wall Injury. J Surg Res. 2022 Sep;277:310-318. doi: 10.1016/j.jss.2022.04.001. Epub 2022 May 6."}, {"pmid": "29766081", "type": "BACKGROUND", "citation": "Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017."}, {"pmid": "33511786", "type": "BACKGROUND", "citation": "Schnekenburger M, Mathew J, Fitzgerald M, Hendel S, Sekandarzad MW, Mitra B. Regional anaesthesia for rib fractures: A pilot study of serratus anterior plane block. Emerg Med Australas. 2021 Oct;33(5):788-793. doi: 10.1111/1742-6723.13724. Epub 2021 Jan 29."}, {"pmid": "23923989", "type": "BACKGROUND", "citation": "Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7."}, {"pmid": "35186581", "type": "BACKGROUND", "citation": "Nair A, Diwan S. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Managing Pain Due to Multiple Rib Fractures: A Scoping Review. Cureus. 2022 Jan 17;14(1):e21322. doi: 10.7759/cureus.21322. eCollection 2022 Jan."}, {"pmid": "33745771", "type": "BACKGROUND", "citation": "Davis K, Connor X. Single injection serratus anterior plane blocks for traumatic rib fractures. A good start but a missed opportunity. Am J Emerg Med. 2021 Dec;50:810. doi: 10.1016/j.ajem.2021.03.045. Epub 2021 Mar 14. No abstract available."}, {"pmid": "34759553", "type": "BACKGROUND", "citation": "Diwan S, Nair A. A retrospective study comparing analgesic efficacy of ultrasound-guided serratus anterior plane block versus intravenous fentanyl infusion in patients with multiple rib fractures. J Anaesthesiol Clin Pharmacol. 2021 Jul-Sep;37(3):411-415. doi: 10.4103/joacp.JOACP_349_19. Epub 2021 Oct 12."}, {"pmid": "35106815", "type": "BACKGROUND", "citation": "Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2."}, {"pmid": "32064417", "type": "BACKGROUND", "citation": "Lin J, Hoffman T, Badashova K, Motov S, Haines L. Serratus Anterior Plane Block in the Emergency Department: A Case Series. Clin Pract Cases Emerg Med. 2020 Jan 21;4(1):21-25. doi: 10.5811/cpcem.2019.11.44946. eCollection 2020 Feb."}, {"pmid": "33304071", "type": "BACKGROUND", "citation": "Paul S, Bhoi SK, Sinha TP, Kumar G. Ultrasound-Guided Serratus Anterior Plane Block for Rib Fracture-Associated Pain Management in Emergency Department. J Emerg Trauma Shock. 2020 Jul-Sep;13(3):208-212. doi: 10.4103/JETS.JETS_155_19. Epub 2020 Sep 18."}, {"pmid": "33383266", "type": "BACKGROUND", "citation": "Teksen S, Oksuz G, Oksuz H, Sayan M, Arslan M, Urfalioglu A, Gisi G, Bilal B. Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. Am J Emerg Med. 2021 Mar;41:16-20. doi: 10.1016/j.ajem.2020.12.041. Epub 2020 Dec 23."}, {"pmid": "11354213", "type": "BACKGROUND", "citation": "Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205."}, {"pmid": "9835471", "type": "BACKGROUND", "citation": "Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x."}] | {"versionHolder": "2025-06-18"} | {
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NCT01792466 | null | RCT of the Double Wire Technique for Sphincterotomy | A Randomized Controlled Trial of the Double Wire Technique With or Without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation | None | INTERVENTIONAL | TERMINATED | 2013-02-11T00:00:00 | null | null | null | [
"NA"
] | 16 | 18 | 100 | ALL | false | Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening.
Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct. The more attempt to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and decrease the number of attempts at entering the bile duct then it might be a better way to approach the patient whom we had difficulty in entering the bile duct. | This will be a prospective, non blinded randomized controlled trial. We will screen and offer enrollment to all patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla and an indication for cholangiography and sphincterotomy. Informed consent will be obtained in the preoperative area after obtaining consent for the ERCP. We will randomize all patients in whom we fail to deeply cannulate the CBD using a sphincterotome (Autotome, Boston Scientific) and 0.035" guidewire (0.035" Jagwire or Dreamwire, Boston Scientific) in over 5 minutes or with more than 5 attempts and in whom the wire can be passed in a stable configuration in the Pancreatic duct (PD). We will exclude patients who have any contraindication to undergoing an ERCP, contraindications to sphincterotomy (e,g,, abnormal anatomy, uncorrectable coagulopathy) and those who have pancreas divisum. Patients will be randomized 1:1 using opaque envelopes in blocks of 4 stratified for gender. (Gender stratification is necessary as the risks of ERCP vis pancreatitis are different for males and females). In those randomized to the DWT group, the PD wire will be left in place, the catheter removed and then reinserted next to the PD wire with a second wire to attempt CBD cannluation as previously described (1). In those randomized to TPS, a pancreatic sphincterotomy will be performed with the sphincterotome. The catheter will be removed with the PD wire left in place. The catheter and a second wire will be inserted and CBD cannluation attempted as for the DWT group. All patients will receive a 5Fr pancreatic stent and indomethacin 100 mg rectally to reduce the risk of pancreatitis as per our standard of care (patients with contraindications to NSAIDs (e.g., sensitivity to Indomethacin, aspirin or class, active peptic ulcer disease) will not receive Indomethacin. Patients who fail DWT (at least 10 minutes or 10 further attempts) may be crossed over to TPS at the endoscopist's discretion. Further care the patients receive will be standard of care. We will contact the patients around a months later by telephone to ask about any procedure related complications that were not reported to us.
outcome measures will be assessed on day 1 at the end of the procedure and on day 30. | Inclusion criteria
1. All patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla
2. Failure to deeply cannulate the CBD in over 5 minutes and with more than 5 attempts
3. Stable wire placement into the Pancreatic duct (PD) exclusion criteria
1. Any contraindication to undergoing an ERCP. 2. Contraindications to sphincterotomy. 3. Pancreas divisum. | Mayo Clinic | OTHER | {
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"date": "2013-02-15",
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"Cholangiopancreatography, Endoscopic Retrograde",
"Sphincterotomy, Endoscopic",
"VATER'S AMPULLA"
] | ["difficult biliary cannulation"] | null | [
{
"city": "Scottsdale",
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],
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"affiliation": "Mayo Clinic",
"name": "Douglas Faigel, MD",
"role": "PRINCIPAL_INVESTIGATOR"
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] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT05617066 | null | Stress, Scleroderma and Quality of Life | Psychological Stress and Systemic Sclerosis | None | INTERVENTIONAL | COMPLETED | 2022-11-09T00:00:00 | null | 2023-03-31T00:00:00 | 2023-09-01T00:00:00 | [
"NA"
] | 150 | 18 | null | ALL | false | 150 patients of legal age will participate in this project, diagnosed with systemic sclerosis.
Patients will be randomly assigned, as will be detailed later, to one of the following three groups:
Therapy Group (GT): This group will be made up of 50 patients who will receive cognitive behavioral therapy of coping with stress (online modality) in groups of 10-12 people during twelve sessions Consecutive weekly courses of 1.5 to 2 hours duration taught by psychology professionals. of this mode 4 subgroups will be made. Psychological Support Group (AP): This group will be made up of 50 patients who will receive psychoeducation about stress and its consequences and the specific stress suffered by people with a autoimmune disease such as scleroderma. It will have a duration of twelve weekly sessions.
Consecutive sessions of 1.5 to 2 hours in length taught by professional psychologists. In this way they will 4 subgroups. Usual Care Group (CG): This group will be made up of 50 patients who will follow their usual care. Later, once the study is over, they will be offered to participate in coping with stress to the person who is interested. | 150 elderly patients diagnosed with systemic sclerosis in any of its variants, both diffuse, limited or sine scleroderma.
The inclusion criteria are: diagnosis made by a medical specialist, good command of the Spanish language (oral and written comprehension) and have an internet connection. As exclusion criteria they must not suffer no psychiatric illness. Patients will be randomly assigned into each of the three groups.
Informed consent. Patients must be informed in writing of the objectives of the project and of the work protocol in which they are going to be included. Once read and understood, They will sign the consent. The research staff is obliged to save said consents.
Confidentiality and data protection commitment. Ethical principles will be followed and deontological related to psychological research collected in the main codes currently nationally or internationally: The Code of the Official College of Psychologists (1987), the Meta- Code of the European Federation of Psychological Associations (1995), and The Ethical Principles and Code of Conduct of Psychologists of the American Psychological Association (2002).
Instruments:
All the evaluation as well as the therapies will be carried out online through Google Form and GoogleMeet, where questions regarding sociodemographic variables and information will be asked related to variables about your disease: disease variant (ESd, ESl or ESss), profile of autoantibodies, age at diagnosis, evolution time, presence of Raynaud's, current digital ulcers, pulmonary hypertension, interstitial lung disease, esophageal involvement, intestinal involvement, renal or cardiac involvement; as well as current treatment. Information will also be collected on possible comorbidities: high blood pressure, diabetes, hypercholesterolemia or hypertriglyceridemia, and toxic habits such as tobacco and/or alcohol use.
For the psychological evaluation, the following instruments will be completed:Perceived Stress Scale (EEP-14). It's about a instrument that evaluates the perception of stress in different life situations. It is composed of fourteen items on a five-point Likert-type scale. It has adequate reliability (consistency internal=.81 and test-retest= 0.73). Stress Vulnerability Inventory (IVE). This questionnaire assesses the individual's predisposition to be influenced by perceived stress. This composed of twenty-two dichotomous items and the maximum value that can be obtained is twenty-two points. The Cronbach's alpha reliability coefficient is 0.87.
Connor and Davidson Resilience. Assesses resilience being understood as the individual's ability to coping and adapting to circumstances, is made up of twenty-five Likert-type scale items of five points; higher scores reflect greater resilience. It has good reliability with an alpha of Cronbach of 0.89. Revised Symptom Inventory (SCL-90-R). It is an instrument with ninety items on a five-point Likert-type scale, zero being nothing and four much, which evaluates nine dimensions: somatization, obsession-compulsion, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. The scale also consists of seven extra items distributed into three global distress indices: the GSI, which measures global psychological distress, the PSDI, which is used to measure the intensity of symptoms and the Total Symptom Index which is used to measure the number of symptoms that the person reports. The scores are transformed into percentiles (0-100), in this line the percentiles ≥75 represent clinical symptoms in any of the subscales of this instrument. The nine dimensions show acceptable reliability, with Cronbach's alpha for internal consistency of 0.81.
EUROQOL-5Q health questionnaire. Measure quality of life related to health (HRQoL) both in the general population and in groups of patients with different pathologies. The individual himself assesses his state of health, first in levels of severity by dimensions and then on a more general assessment visual analog scale. A third element is the index of values that is obtained for each state of health generated by the instrument. The descriptive system contains five dimensions of health (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression) and each of them has three levels of severity (no problems, some problems or moderate problems and serious problems). In this part of the questionnaire the individual must mark the level gravity corresponding to his state of health in each of the dimensions, referring to the same day to complete the questionnaire. In each dimension, severity levels are coded 1 if the response option is "no (I have) problems"; with a 2 if the answer option is "some or moderate problems"; and with a 3 if the answer option is "many problems".
DIENER life satisfaction scale.It consists of five items that assess satisfaction with life through the global judgment that people make about this from the degree of agreement (from 1: STRONGLY DISAGREE to 5: STRONGLY AGREE) on five aspects: if the type of life is similar to what has always been dreamed of having, if the conditions of life are excellent, if I am satisfied with my life, if important things have been obtained and finally if I could live again I would like everything to be the same.
Short Survey on Health SF-36.Short survey on health of 36 items (SF-36) of. The 36 items measure eight dimensions: Physical function (limitations in physical activities due to health problems), Social function (limitations in social activities due to physical or emotional problems), Physical role (limitations in activities of roles due to physical health problems), Body pain, General mental health (discomfort and well-being), Social Role (limitations in usual role activities due to problems emotional), Vitality (energy and fatigue), Perception of general health.
Evaluation of cortisol concentrations in hair: Strands of hair with a diameter of Approximately 3 mm, near the scalp, in the middle posterior region of the head, where the has indicated less variability in cortisol levels. They will be cut with scissors clean as close to the scalp as possible, not including the hair follicle itself, not recommended for analysis. Each hair sample will be kept in aluminum foil and inside an airtight bag, so that neither light nor moisture penetrates the sample. For this, each participant will be sent both a tutorial as an envelope with the entire kit for collecting and storing the sample (except the scissors), for once collected, they are sent to the laboratory of the Faculty of Pharmacy of the University of Granada, where the levels of cortisol in hair will be analyzed and obtained. This whole process will be totally free for the patients. | Inclusion Criteria:
* Diagnosis made by a specialist doctor, good command of the Spanish language (oral and written comprehension) and have an internet connection.
Exclusion Criteria:
* No psychiatric illness. | Asociación Española de Esclerodermia | OTHER | {
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NCT02415166 | null | Influenza Challenge in Mood Disorders | Influenza Challenge in Mood Disorders | None | INTERVENTIONAL | TERMINATED | 2015-04-08T00:00:00 | null | null | null | [
"NA"
] | 6 | 18 | 55 | FEMALE | true | The aim of this project is to evaluate the efficacy of the influenza vaccine in individuals with major depressive disorder (MDD) as well as to elucidate the nature of the immunological abnormalities in MDD using a quasi-experimental design. Specifically, the investigators plan to induce transient, mild inflammation in medically-healthy study participants using the influenza vaccine. Initially the investigators will conduct a pilot project with up to 20 individuals in order to evaluate the time-point at which the peak inflammatory response to the vaccine occurs. Subjects will receive the seasonal influenza vaccine and provide blood samples 4 hours, 2 days, and 30 days post vaccination. Subsequent to the pilot study, both depressed and psychiatrically-healthy participants will be randomized in a parallel group, double-blind design so that they receive either influenza vaccine (seasonal vaccine) or saline (i.m). At baseline, subjects will provide a blood sample, complete a number of rating scales to measure mood and fatigue, and may complete approximately one hour of MRI scanning with or without simultaneous EEG recording. Two-days post vaccination, they will provide a second blood sample, complete more clinical ratings and may complete another identical MRI session with or without simultaneous EEG. Four weeks later, participants will be asked to return to provide a third blood sample and complete additional clinical ratings. The blood samples will be used to measure both innate and adaptive immune function and may be used to correlate the vaccine-induced immunological changes to neurophysiological changes in the brain measured by MRI and/or EEG. | Psychological stress has been shown to impair the efficacy of the influenza vaccine, particularly in older individuals (\> 60 years). However, the effect of depression (as opposed to stress per se) on vaccine response has not been measured, especially in younger people. One possible cause of this putative impaired vaccine response is suppression of the immune system in a subgroup of individuals with depression. Major depressive disorder (MDD) has been associated with a decline in total numbers of circulating B-cells, T-cells, and natural killer cells (NKC), a reduction in the proliferative responses of NKC and T-cells in vitro that is ameliorated by administration of selective serotonin reuptake inhibitors (SSRIs), increased susceptibility to various viral infections, and a decline in the efficacy of the herpes zoster vaccine in the elderly (1, 2). On the other hand, MDD appears also to be characterized by immunological abnormalities that manifest both as low-grade inflammation, including over-activity of the innate immune system (3). Whether inflammation and immune suppression are two different manifestations of the same underlying abnormality (unitary model) or whether inflammation and immune suppression are distinct phenomena occurring in different MDD subtypes (independent model) is not known.
MDD is also characterized by neurophysiological abnormalities of striatal, cortical midline, and limbic brain structures that regulate hormonal, autonomic, and emotional responses to reward and stress (4-6). Yet, it remains unclear how immune function relates to these depression-associated functional neuroimaging abnormalities. Studies of healthy volunteers (HCs) administered endotoxin or the typhoid vaccine have reported inflammation-associated increases in negative affect along with neurophysiological changes in brain regions comprising the affective and reward circuitry (7-8). However, because these studies were limited to HCs, it is possible that the observed inflammation-induced neurophysiological changes were adaptive and therefore not applicable to MDD populations. That is, it remains unclear whether any experimentally-induced immune abnormalities in MDD are correlated and therefore potentially causally-related to the neuroimaging abnormalities observed in MDD.
In order to address these questions, we use a parallel group, placebo-controlled influenza vaccine challenge to induce transient inflammation that peaks 2-days post vaccination in MDD subjects and HCs. Subjects may complete a pre-and-post vaccination MRI scan, the latter during the peak inflammatory response.
Aim 1: To examine whether influenza vaccine effectiveness is compromised in a young-to-middle-aged sample (18-55 years of age) of individuals with MDD.
Hypothesis 1.1. Compared with HCs (n=40), individuals with MDD (n=40) will display reduced vaccine titers and reduced influenza virus-induced CD4+ memory T-cell proliferation four weeks post vaccination (T2).
Hypothesis 1.2. A greater number of MDD subjects than HCs will fail to show a four-fold increase in antibody titer, the conventional standard for determining a clinically significant response to a viral vaccine.
Aim 2: To test the competing models of immune dysfunction in MDD.
Hypothesis 2.1. At T0 and T1, stimulated and unstimulated monocytes from MDD subjects will show increased interleukin 6 (IL-6) and tumor necrosis factor (TNF) production compared with HCs. The effect will be most salient at T1 in individuals receiving vaccine.
Hypothesis 2.2. Consistent with the unitary model, monocyte IL-6 and/or TNF production at T0 and T1 will be inversely correlated with antibody titers at T2 in the MDD group.
Aim 3: To test for neurophysiological differences between MDD patients and HCs in resting state cerebral blood flow (with arterial spin labeling), resting EEG activity, and BOLD response to monetary rewards and interoceptive stimuli (with fMRI) at T0 and T1, and to correlate depression-associated perfusion, EEG activity, reward response, and interoceptive function with immune function at T0 and T1.
Hypothesis 3.1: Compared with HCs, the MDD subjects will display reduced perfusion of the subgenual anterior cingulate cortex (sgACC) and/or pregenual ACC (pgACC), hemispheric asymmetry in the alpha (8-13 Hz) power band (left prefrontal cortex hypoactivation), as well as reduced hemodynamic response to anticipatory reward in the ventral striatum. These differences will be most salient at T1 in the MDD group receiving vaccine versus the HCs receiving vaccine.
Hypothesis 3.2: The functional imaging abnormalities in the MDD group at T0 and/or T1 will be correlated with the abnormalities in monocyte activation in the MDD group at T0 and/or T1. | Inclusion Criteria:
Major Depressive Disorder Patient Group - Currently Depressed: Subjects will have met Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-V) criteria for primary MDD in a current major depressive episode and current Hamilton Depression Rating Scale (HAM-D) or Montgomery Asberg Depression Rating Scale (MADRS) score in the mild-to-severely depressed range and will have been deemed to be medically stable by a physician listed on this protocol. Subjects who do not wish to receive treatment with psychotropic medication in the future and have not taken psychotropic medication for at least 3 weeks will be included in the study.
Healthy Comparison Group: Subjects will be selected who have not met criteria for any Axis I psychiatric disorder, have no known first-degree relatives with mood or anxiety disorders, and have a current score on the HAM-D or MADRS in the non-depressed range.
Exclusion Criteria:
Inability to provide informed consent, pregnant or nursing women, known hypersensitivity to vaccines, age of onset of MDD \> 40 years, metal implants or other factors that would preclude MRI scanning, serious risk of suicide, delusions or hallucinations, medical or neurological illnesses (such as diabetes, autoimmune disorders or inflammatory bowel disease) that affect brain structure, function or immune measurements, previous head injury with loss of consciousness, abuse of drugs or alcohol within the previous year or a lifetime history of substance dependence, treatment with medications that impact immune function (e.g. prednisone), HIV or other chronic infection, a recent acute illness (e.g. influenza), receipt of a vaccine within 3 months of commencing the study. Subjects whose first major depressive episodes arose temporally after other major medical or psychiatric conditions will also be excluded, since their functional imaging results generally differ from those reported in primary MDD.
Subjects will be asked not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48 hr. before each study day. The use of oral contraceptives and menstrual phase or status are not exclusion criteria but this information will be recorded. The same exclusion criteria apply to healthy controls with the added criterion that first-degree relatives should be free of major psychiatric illness as assessed with the Family Interview for Genetic Studies (FIGS). | Laureate Institute for Brain Research, Inc. | OTHER | {
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},
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{
"affiliation": "Laureate Institute for Brain Research",
"name": "Jonathan B Savitz, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "17360153", "type": "BACKGROUND", "citation": "Irwin MR, Miller AH. Depressive disorders and immunity: 20 years of progress and discovery. Brain Behav Immun. 2007 May;21(4):374-83. doi: 10.1016/j.bbi.2007.01.010. Epub 2007 Mar 13."}, {"pmid": "20955778", "type": "BACKGROUND", "citation": "Blume J, Douglas SD, Evans DL. Immune suppression and immune activation in depression. Brain Behav Immun. 2011 Feb;25(2):221-9. doi: 10.1016/j.bbi.2010.10.008. Epub 2010 Oct 16."}, {"pmid": "18073775", "type": "BACKGROUND", "citation": "Dantzer R, O'Connor JC, Freund GG, Johnson RW, Kelley KW. From inflammation to sickness and depression: when the immune system subjugates the brain. Nat Rev Neurosci. 2008 Jan;9(1):46-56. doi: 10.1038/nrn2297."}, {"pmid": "19693001", "type": "BACKGROUND", "citation": "Price JL, Drevets WC. Neurocircuitry of mood disorders. Neuropsychopharmacology. 2010 Jan;35(1):192-216. doi: 10.1038/npp.2009.104."}, {"pmid": "22420038", "type": "BACKGROUND", "citation": "Robinson OJ, Cools R, Carlisi CO, Sahakian BJ, Drevets WC. Ventral striatum response during reward and punishment reversal learning in unmedicated major depressive disorder. Am J Psychiatry. 2012 Feb;169(2):152-9. doi: 10.1176/appi.ajp.2011.11010137."}, {"pmid": "19428491", "type": "BACKGROUND", "citation": "Savitz J, Drevets WC. Bipolar and major depressive disorder: neuroimaging the developmental-degenerative divide. Neurosci Biobehav Rev. 2009 May;33(5):699-771. doi: 10.1016/j.neubiorev.2009.01.004. Epub 2009 Jan 21."}, {"pmid": "20719303", "type": "BACKGROUND", "citation": "Eisenberger NI, Berkman ET, Inagaki TK, Rameson LT, Mashal NM, Irwin MR. Inflammation-induced anhedonia: endotoxin reduces ventral striatum responses to reward. Biol Psychiatry. 2010 Oct 15;68(8):748-54. doi: 10.1016/j.biopsych.2010.06.010. Epub 2010 Aug 16."}, {"pmid": "19423079", "type": "BACKGROUND", "citation": "Harrison NA, Brydon L, Walker C, Gray MA, Steptoe A, Critchley HD. Inflammation causes mood changes through alterations in subgenual cingulate activity and mesolimbic connectivity. Biol Psychiatry. 2009 Sep 1;66(5):407-14. doi: 10.1016/j.biopsych.2009.03.015. Epub 2009 May 7."}] | {"versionHolder": "2025-06-18"} | {
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NCT03340766 | null | Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) | A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | HARBOUR | INTERVENTIONAL | COMPLETED | 2017-10-23T00:00:00 | null | 2020-11-06T00:00:00 | 2023-08-14T00:00:00 | [
"PHASE1"
] | 31 | 18 | 100 | ALL | false | The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL. | The study was planned as 2 parts:
* Part 1 will test the safety of up to 3 different blinatumomab target dose levels in combination with pembrolizumab in a rolling 6 design. A Dose Level Review Team (DLRT) will review the safety data to evaluate possible drug effects and dose-limiting toxicities (DLTs).
* Part 2 will consist of an expansion cohort to assess pharmacokinetics (PK), safety, and preliminary efficacy data at the chosen target dose. The part 2 dose will be determined by the totality of the clinical data from part 1 as determined by the DLRT.
Based on the results from Part 1, a decision was made not to proceed with Part 2 of this study.
Secondary objectives of the study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of blinatumomab in combination with pembrolizumab. Tumor response will be evaluated according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al, 2007). With implementation of Protocol Amendment 5, response will also be assessed according to the Lugano Classification (Cheson et al, 2014). Only participants enrolled after implementation of Protocol Amendment 5 (03 December 2019) will have tumor assessments using the Lugano criteria. | Inclusion Criteria:
* Have histologically confirmed diffuse large B-cell lymphoma that is either:
* Refractory after at least one regimen of systemic chemotherapy and/or targeted therapy, or
* In first or later relapse if have received at least 2 systemic regimens since time of diagnosis, or
* Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT) with adequate organ function after proximity to transplantation time exclusions
* Have measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Life expectancy of ≥ 12 weeks in the opinion of the Investigator
* Biopsy proven DLBCL (biopsy proven at least at primary diagnosis of DLBCL)
Other Inclusion Criteria May Apply
Exclusion Criteria:
* Richter's transformation (DLBCL arising in the setting of prior chronic lymphocytic leukemia) or primary mediastinal B cell lymphoma (PMBCL)
* History or presence of clinically relevant central nervous system pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
* Has a diagnosis of immunodeficiency or has received systemic steroid therapy (in excess of 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol specified therapy.
* Has undergone prior allogeneic HSCT:
* within the last 5 years OR
* greater than 5 years ago but has active graft versus host disease (GvHD) requiring systemic treatment.
* Has received autologous HSCT within 6 weeks prior to start of treatment.
Other Exclusion Criteria May Apply. | Amgen | INDUSTRY | {
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"description": null,
"measure": "Complete Response Rate During the Treatment Period Using the Revised Response Cheson Criteria",
"timeFrame": "From Day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days."
},
{
"description": null,
"measure": "Cohort IIIa Only: Complete Response Rate During the Treatment Period Using the Lugano Classification",
"timeFrame": "From Day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days."
},
{
"description": null,
"measure": "Progression Free Survival by the Revised Response Cheson Criteria",
"timeFrame": "From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0)."
},
{
"description": null,
"measure": "Cohort IIIa Only: Progression Free Survival Using the Lugano Classification",
"timeFrame": "From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0)."
},
{
"description": null,
"measure": "Overall Survival",
"timeFrame": "From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0)."
},
{
"description": null,
"measure": "Duration of Response for Participants Who Achieved CR/PR Using the Revised Response Cheson Criteria",
"timeFrame": "From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0)."
},
{
"description": null,
"measure": "Cohort IIIa Only: Duration of Response for Participants Who Achieved CMR/PMR Using the Lugano Classification",
"timeFrame": "From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0)."
},
{
"description": null,
"measure": "Blinatumomab Steady State Concentration (Css)",
"timeFrame": "Day 2 for 9 µg/day Css (all cohorts), days 10, 15, 22, 29, and 43 for 28 µg/day Css (Cohort Ia), day 10 for 28 µg/day Css (Cohorts IIa and IIIa), and days 19, 26, and 40 for 56 µg/day and 112 µg/day Css (Cohorts IIa and IIIa respectively)."
},
{
"description": null,
"measure": "Blinatumomab Clearance",
"timeFrame": "Day 2 for 9 µg/day Css (all cohorts), days 10, 15, 22, 29, and 43 for 28 µg/day Css (Cohort Ia), day 10 for 28 µg/day Css (Cohorts IIa and IIIa), and days 19, 26, and 40 for 56 µg/day and 112 µg/day Css (Cohorts IIa and IIIa respectively)."
},
{
"description": null,
"measure": "Pembrolizumab Peak Serum Concentration",
"timeFrame": "Within approximately 30 minutes after the end of the infusion in cycle 1 (study day 15 for Cohort Ia, study day 19 for Cohorts IIa and IIIa) and cycle 8 (study day 162 for Cohort Ia and day 166 for Cohorts IIa and IIIa)."
},
{
"description": null,
"measure": "Pembrolizumab Minimum Serum Concentration",
"timeFrame": "Pre-dose on pembrolizumab cycles 2, 4, 6, 8, and 12 (Study days 36, 78, 120, 162, and 246, respectively)."
},
{
"description": null,
"measure": "Number of Participants With Treatment-emergent Adverse Events (TEAEs)",
"timeFrame": "From first dose of blinatumomab to minimum of 30 days after last dose of blinatumomab or pembrolizumab (whichever was later) or end of study: median (min, max) duration was 22.7 (1.0, 85.8) days."
}
]
} | [
{
"affiliation": "Amgen",
"name": "MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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{
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{
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"term": "Lymphoma"
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"term": "Lymphoma, B-Cell"
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"term": "Lymphoma, Large B-Cell, Diffuse"
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]
} | {
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NCT01232166 | null | Which is the Best Bedside Test to Detect Endobronchial Intubation? | Endotracheal Tube Insertion Depth Better Detects Endobronchial Intubation Than Bilateral Auscultation or Observation of Chest Movements - a Prospective Randomised Trial | None | INTERVENTIONAL | COMPLETED | 2010-10-29T00:00:00 | null | null | null | [
"NA"
] | 160 | 19 | 75 | ALL | false | Background: Endotracheal intubation has become a well established standard in protecting the airway during surgical procedures, and in emergency situations. Serious complications can occur from the incorrect placement of an endotracheal tube in a mainstem bronchus. If unrecognized it can lead to hypoxemia secondary to atelectasis of the unventilated lung and hyperinflation of the intubated lung, which can result in barotrauma. As bedside method the golden standard to verify the correct endotracheal tube placement is bilateral ausculation of the chest. However this is not always satisfactory, as breath sounds can be transmitted to the opposite side of the chest in spite of endobronchial intubation. Therefore other clinical tests to verify the correct endotracheal tube placement have become part of daily clinical practice, like observation of symmetric chest movements, and use of the cm markings printed on the endotracheal tube. However so far no study investigated which of these bedside clinical methods works best in detecting an inadvertently placed endobronchial tube in adults. We therefore designed a study to compare three different bedside methods to verify endotracheal or endobronchial tube placement.
Objective: To determine which of four commonly used bedside methods of detecting inadvertent endobronchial intubation in adults has the highest sensitivity and specificity.
Design: Prospective randomized, blinded study. Setting: Tertiary, academic hospital, department of anaesthesia. Participants: 160 consecutive ASA I or II patients, aged 19-75 years, scheduled for elective gynaecological or urological surgery.
Interventions: Patients were randomly assigned to eight study groups. In four groups, an endotracheal tube (ETT) was fiberoptically positioned 2.5-4.0 cm above the carina, whereas in the other four groups the tube was positioned in the right mainstem bronchus. The four groups differed in the bedside test used to verify the position of the endotracheal tube. First-year residents and experienced anaesthesiologists independently performed one of the following randomly assigned bedside tests in each patient in an effort to determine whether the tube was properly positioned in the trachea: 1) bilateral auscultation of the chest (Auscultation); 2) observation and palpation of symmetric chest movements (Observation); 3) estimating the position of the ETT by the insertion depth (Tube Depth); and, 4) a combination of all three mentioned tests (All Three).
Main outcome measures: Correct and incorrect judgements of endotracheal tube (ETT) position as independently assessed by first-year anaesthesia residents and experienced anaesthesiologists with each of the four bedside tests. | null | Inclusion Criteria:
ASA I or II patients, aged 19-75 years, scheduled for elective gynaecological or urological surgery that needs endotracheal intubation.
Exclusion Criteria:
* Pre-existing lung disease, pleural effusion, anticipated difficult airway, known endobronchial or tracheal lesions, or patients at risk for aspiration of gastric contents. | Medical University of Vienna | OTHER | {
"id": "MUW464/2003",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-11-01T00:00:00 | {
"date": "2010-11-02",
"type": "ESTIMATED"
} | {
"date": "2010-11-02",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
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"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Endobronchial Intubation"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Sensitivity/Specificity to detect endobronchial intubation",
"timeFrame": "1-5 minutes after intubation"
}
],
"secondary": null
} | null | [{"pmid": "21062875", "type": "DERIVED", "citation": "Sitzwohl C, Langheinrich A, Schober A, Krafft P, Sessler DI, Herkner H, Gonano C, Weinstabl C, Kettner SC. Endobronchial intubation detected by insertion depth of endotracheal tube, bilateral auscultation, or observation of chest movements: randomised trial. BMJ. 2010 Nov 9;341:c5943. doi: 10.1136/bmj.c5943."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT05875766 | null | Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee (DIDT OSTEO) | Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee | DIDT OSTEO | INTERVENTIONAL | UNKNOWN | 2023-05-16T00:00:00 | null | 2024-04-07T00:00:00 | 2024-12-07T00:00:00 | [
"NA"
] | 94 | 18 | 35 | ALL | false | The antero-external cruciate ligament (ACL) is the ligament located inside the knee, which allows the rotation of the knee by stabilizing the femur and the tibia. Rupture of the ACL is common during the practice of certain so-called "pivot" sports, whether contact or not. It is manifested by acute pain or instability of the knee, following a crack during a twist and/or a blockage of the joint. The diagnosis will be confirmed by a clinical examination and X-rays to eliminate any fracture or tearing and by MRI to visualize the ligament rupture and the associated lesions, in particular a lesion of the meniscus.
Treatment is required because the ruptured ligament does not heal on its own and the rupture of the ligament may eventually promote the appearance of osteoarthritis. Two types of treatment can be considered, rehabilitation or surgery, depending on the patient's age and motivation to resume sports. There are several surgical techniques, the most common is to reconstruct the ruptured ligament by arthroscopy using a graft taken from the tendons of the Internal Rectus and Demi muscles tendinous (DIDT). Rehabilitation by physiotherapy is often started preoperatively and immediately after the operation, as soon as you wake up, to find a functional and painless knee. Functional recovery often depends on patient motivation.
The main objective is to show that osteopathic care in addition to physiotherapy rehabilitation improves knee functionality in patients 6 months after reconstruction of the ACL by DIDT. | null | Inclusion Criteria:
* Patient, male or female, aged 18 to 35 inclusive
* Patient with a BMI between 18.5 and 30 kg/m² (limits included).
* Patient presenting with a total rupture of the unilateral anterior cruciate ligament (ACL).
* Candidate patient for reconstruction of the ACL with the DIDT method.
* Affiliated patient or beneficiary of a social security scheme.
* Patient having been informed and having given their free consent, enlightened and written.
Exclusion Criteria:
* Patient with damage to another structure of the knee, other than meniscal lesions.
* Patient with a contraindication to osteopathic intervention.
* Patient for whom a method other than DIDT has been proposed.
* Patient with iterative rupture of the ACL.
* Patient having undergone ligamentoplasty of the contralateral knee
* Patient participating in another research.
* Patient in period of exclusion from another research still in progress at the time of inclusion.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, breastfeeding or parturient women.
* Patient hospitalized without consent. | Ramsay Générale de Santé | OTHER | {
"id": "2022-A00450-43",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-05-16T00:00:00 | {
"date": "2023-05-25",
"type": "ACTUAL"
} | {
"date": "2023-05-25",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | null | {
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},
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} | [
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"Knee Ligament Injury",
"Osteopathia"
] | null | null | [
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"city": "Lyon",
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"facility": "Hopital privé Jean Mermoz",
"geoPoint": {
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"lon": 4.84669
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}
] | null | null | {
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"measure": "assess the functionality of the knee",
"timeFrame": "6 months"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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"abbrev": "BC26",
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NCT00556166 | null | Enterra Therapy Gastric Stimulation System | Enterra Therapy Gastric Stimulation System | Enterra | INTERVENTIONAL | TERMINATED | 2007-11-08T00:00:00 | null | null | null | [
"PHASE4"
] | 4 | 18 | 99 | ALL | false | Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin.
In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the helpfulness of this therapy has not been proven. Physicians at Columbia University Medical Center hope to prove the helpfulness of this device. | Gastroparesis is a debilitating disease in which patients suffer from a number of upper gastrointestinal (GI) symptoms including nausea, vomiting, early satiety, bloating, postprandial fullness, epigastric pain and burning, and cardiac pain and burning. Severe symptoms, particularly vomiting and nausea, can significantly impair a patients daily activities and quality of life.
Current medical practice for the treatment and/or management of gastroparesis consists of dietary modifications, drug therapies, enteral feeding, parenteral feeding and surgery. These treatments are successful for some patients, but have significant drawbacks. Patients may initially be treated with various dietary modifications including frequent low fat meals. However, if dietary modifications alone are unsuccessful, antiemetic and prokinetic drugs, or combinations thereof, are generally tried. If symptoms cannot be controlled with medication, supplemental nutrition via enteral or parenteral feeding may be required to maintain hydration and nutritional status. Prokinetic drugs are intended to promote gastric motility, i.e., to return abnormally slow gastric emptying states to normal. Antiemetic drugs are intended to alleviate symptoms of nausea and vomiting, but have no effect on motility. None of the prokinetic drugs are labeled for improved gastric emptying in gastroparesis. Metoclopramide is the only antiemetic or prokinetic drug indicated for use in the treatment of symptoms of diabetic gastroparesis.
Surgical procedures are occasionally employed to manage symptoms of gastroparesis while maintaining the ability for enteral feeding. Surgical procedures, including gastrectomy, pyloroplasty, and gastrojejunostomy, have had limited success in managing symptoms of gastroparesis. When drug therapies or surgery are ineffective, supplemental enteral feeding via gastric or jejunal feeding tubes or total parenteral nutrition (TPN) may be required to meet the patient's nutritional needs.
For those patients who cannot be adequately treated or managed by current medical practice, the GES has no satisfactory alternative. It is this group of patients for which the GES System is indicated. | Inclusion Criteria:
* Chronic(long term, lasting greater than 3 months)
* Intractable (drug refractory, failed medical management with prokinetic and antiemetic drugs
* Failed dietary modifications, and/or requiring enteral feeding) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology
Exclusion Criteria:
* Only patients whom the physician determines are not a candidate for surgical procedures and/or anesthesia due to physical or mental conditions will be excluded. This includes pregnant women, anyone unable to tolerate general anesthesia, and uncorrectable coagulopathy. | Columbia University | OTHER | {
"id": "AAAA5072",
"link": null,
"type": null
} | Principal investigator left institution. | {
"hasExpandedAccess": false,
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} | 2007-11-08T00:00:00 | {
"date": "2016-08-02",
"type": "ESTIMATED"
} | {
"date": "2007-11-09",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
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},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Gastroparesis"
] | ["Enterra therapy", "Gastric Simulation System"] | null | [
{
"city": "New York",
"country": "United States",
"facility": "Columbia University College of Physicians and Surgeons",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of Episodes of Nausea and Vomiting",
"timeFrame": "1 year"
}
],
"secondary": [
{
"description": null,
"measure": "Number of Episodes of Abdominal Pain, Bloating, and Early Satiety",
"timeFrame": "1 year"
}
]
} | [
{
"affiliation": "Columbia University",
"name": "Dennis L. Fowler, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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"term": "Paralysis"
},
{
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],
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"abbrev": "BC06",
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"abbrev": "BC23",
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"name": "All Conditions"
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},
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}
],
"meshes": [
{
"id": "D018589",
"term": "Gastroparesis"
}
]
} | null | {
"conditions": [
{
"id": "D018589",
"term": "Gastroparesis"
}
],
"interventions": null
} |
NCT01472666 | null | Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth" | Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth" | None | INTERVENTIONAL | COMPLETED | 2011-11-01T00:00:00 | null | null | null | [
"NA"
] | 63 | 18 | null | ALL | false | Dairy food contains a large amount of long-chain saturated fat, which traditionally has been linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and in particular whey proteins have been shown to have a beneficial effect on glucose disposal as well as anti-inflammatory properties. Therefore dairy products have a potential role in the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human data from intervention studies are lacking.
Aims of this project is to explore and understand the influence on human health of both medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well as their interaction and potential positive synergy on the MeS.
The investigators hypothesize that whey protein and medium-chain saturated fatty acids improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory stress in humans and that they possess preventive effects on the risk of developing CVD and type 2 diabetes mellitus (T2DM).
A total of 64 people with MeS or abdominal obesity will be included. The design is a randomized double-blinded, controlled parallel diet-intervention trial.
Subjects are assigned one of four experimental diets for 12 weeks. The diets consist of either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA + whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to integrate the test foods in their habitual diet, which also continues unchanged. The subjects' energy intake is matched so they are kept weight stable throughout the study. | See above. | Inclusion Criteria:
Metabolic syndrome
* Central obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)
* with two or more of the following
* Fasting triglyceride \> 1.7 mmol/l
* HDL-cholesterol; male \< 1.03 mmol/l, female \< 1.29 mmol/l
* BP ≥ 130/85
* Fasting plasma glucose ≥ 5,6 mmol/l (but not diabetes)
Or abdominal obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)
Exclusion Criteria:
* Significant cardiovascular, renal or endocrine disease
* Psychiatric history
* Treatment with steroids
* Alcohol- or drug-addiction
* Pregnancy or lactation | University of Aarhus | OTHER | {
"id": "CERN-DairyHealth",
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"date": "2011-11-16",
"type": "ESTIMATED"
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"Metabolic Syndrome",
"Type 2 Diabetes",
"Cardiovascular Disease",
"Abdominal Obesity"
] | ["Medium chain fatty acids", "Saturated fatty acids", "Whey protein", "Casein protein", "Metabolic syndrome", "Type 2 diabetes", "Cardiovascular disease", "Dairy products", "Dietary intervention"] | null | [
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"name": "Wageningen University"
},
{
"class": "OTHER",
"name": "University of Dublin, Trinity College"
}
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"measure": "Postprandial triglyceride response",
"timeFrame": "Change from week 0 to week 12"
}
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"description": null,
"measure": "24 hour blood pressure (BP)",
"timeFrame": "Change from week 0 to week 12"
},
{
"description": null,
"measure": "Indirect calorimetry",
"timeFrame": "Change from week 0 to week 12"
},
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"description": null,
"measure": "Dexa-scan (body composition)",
"timeFrame": "Change from week 0 to week 12"
},
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"measure": "Weight",
"timeFrame": "Change from week 0 to week 12"
},
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"description": null,
"measure": "Biomarkers in blood samples",
"timeFrame": "Change from week 0 to week 12"
},
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"description": null,
"measure": "Waist and hip circumference",
"timeFrame": "Change from week 0 to week 12"
},
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"description": null,
"measure": "Fat tissue biopsy",
"timeFrame": "Change from week 0 to week 12"
},
{
"description": null,
"measure": "Biomarkers in urine",
"timeFrame": "Change from week 0 to week 12"
},
{
"description": null,
"measure": "Glucose tolerance",
"timeFrame": "Change from week 0 to week 12"
},
{
"description": null,
"measure": "Dietary compliance",
"timeFrame": "Change from week 0 to week 12"
},
{
"description": null,
"measure": "Postprandial apolipoprotein-48 (apoB-48), 6 hour",
"timeFrame": "Change from week 0 to week 12"
}
]
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{
"affiliation": "Aarhus University Hospital",
"name": "Kjeld Hermansen, Professor",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Department of Food Science, University of Aarhus",
"name": "Hanne C Bertram, Scientist",
"role": "STUDY_CHAIR"
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{
"affiliation": "School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin, Ireland",
"name": "Lorraine O'Driscoll, Professor",
"role": "STUDY_CHAIR"
},
{
"affiliation": "Division of Human Nutrition, Wageningen University, The Netherlands",
"name": "Michael Müller, Professor",
"role": "STUDY_CHAIR"
}
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NCT02315066 | null | Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566 | A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS | None | INTERVENTIONAL | COMPLETED | 2014-12-04T00:00:00 | null | 2020-11-12T00:00:00 | 2020-11-12T00:00:00 | [
"PHASE1"
] | 174 | 18 | null | ALL | false | To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose. | null | Inclusion Criteria:
* Part A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.
* Part A2 only: Patients with histological or cytological diagnosis of advanced/metastatic HCC who are treatment naïve and have declined standard of care, or have had at least 1 prior line of systemic therapy. Prior anti PD L1/PD 1 therapy is allowed.
* Part B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC, melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.
* Part B2
Arm 1 only:
1. Ocular melanoma patients with advanced/metastatic disease, or
2. Cutaneous/acral melanoma patients with advanced/metastatic disease who have received checkpoint inhibitor (anti PD L1, anti PD 1, or anti CTLA4) based treatment on which disease progressed. \[Note: Checkpoint inhibitor may have been part of a combination therapy, as long as the combination did not contain OX40 or 4 1BB agonist.\] Any questions on prior treatment may be discussed with the Sponsor.
Arm 2 only:
* Histological or cytological diagnosis of NSCLC with advanced/metastatic disease. Patients must have previously received prior anti PD L1 or anti PD 1 mAb on which disease progressed. \[Note: Previous anti PD L1 or anti PD 1 mAb may have been part of a combination therapy, eg, in combination with chemotherapy, as long as the combination did not contain OX40 or 4 1BB agonist.\]
* Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function
Exclusion Criteria:
* Brain metastases requiring steroids
* Major surgery, Radiation therapy within 4 weeks of starting study treatment (except: palliative radiotherapy to a limited field is allowed after consultation with sponsor's medical monitor at any time during study participation, including during screening), or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
* Active and clinically significant bacterial, fungal, or viral infection
* History of active autoimmune disorders
* History of immune-mediated adverse events requiring immunosuppressive therapy or were grade 3 or higher related to prior immune-modulatory therapy
* Prior treatment with an OX40 agonist and 4-1BB agonist (for Part B1/B2)
* Prior anthracycline treatment and at risk of cardiac failure (New York Heart Association Class 2) | Pfizer | INDUSTRY | {
"id": "B0601002",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-12-09T00:00:00 | {
"date": "2022-04-21",
"type": "ACTUAL"
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"date": "2014-12-11",
"type": "ESTIMATED"
} | [
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"Neoplasms"
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"timeFrame": "The first 2 cycles of treatment (Day 1 up to Day 28)"
},
{
"description": null,
"measure": "Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A",
"timeFrame": "AEs: The informed consent date up to the last dosing date + 28 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period."
},
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"timeFrame": "The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)"
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"timeFrame": "The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)"
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],
"secondary": [
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"description": null,
"measure": "Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A",
"timeFrame": "Baseline up to 24 months post first dose"
},
{
"description": null,
"measure": "Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A",
"timeFrame": "Baseline up to 24 months post first dose"
},
{
"description": null,
"measure": "Number of Participants Having Stable Disease (SD) in Part A",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Overall Survival Rates at Months 6, 12, and 24 in Part A",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A.",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A.",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A",
"timeFrame": "For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A",
"timeFrame": "Baseline up to end of treatment (maximum of 14 weeks)."
},
{
"description": null,
"measure": "Mean Unbound Cell Surface OX40 in Part A1",
"timeFrame": "Pre-dose, 4 and 24 hours post dose on Cycle 1 Day 1, and Day 8 on Cycles 1 to 3, then pre-dose on Cycles 4 and 7 and end of treatment in Part A1"
},
{
"description": null,
"measure": "ORR Assessed by RECIST Version 1.1 and irRECIST in Part B",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Kaplan-Meier Estimate of Median PFS in Part B",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Kaplan-Meier Estimate of Median TTP in Part B",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Number of Participants Having SD in Part B",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Kaplan-Meier Estimate of Median DoR in Part B",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Kaplan-Meier Estimate of Median OS in Part B",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Overall Survival Rates at Months 6, 12, and 24 in Part B",
"timeFrame": "Baseline up to 24 months post first dose."
},
{
"description": null,
"measure": "Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "CL of PF-04518600 Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Cav of Utomilumab Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "CL of Utomilumab Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Vss of Utomilumab Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Rac of Utomilumab Following Multiple Doses on C3D1 in Part B",
"timeFrame": "For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3."
},
{
"description": null,
"measure": "Number of Participants With ADA and NAb Against PF-04518600 in Part B",
"timeFrame": "Baseline up to end of treatment (maximum of 14 weeks)."
},
{
"description": null,
"measure": "Number of Participants With ADA and NAb Against Utomilumab in Part B",
"timeFrame": "Baseline up to end of treatment (maximum of 14 weeks)."
}
]
} | [
{
"affiliation": "Pfizer",
"name": "Pfizer CT.gov Call Center",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "36302562", "type": "DERIVED", "citation": "Hamid O, Chiappori AA, Thompson JA, Doi T, Hu-Lieskovan S, Eskens FALM, Ros W, Diab A, Spano JP, Rizvi NA, Wasser JS, Angevin E, Ott PA, Forgie A, Yang W, Guo C, Chou J, El-Khoueiry AB. First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e005471. doi: 10.1136/jitc-2022-005471."}, {"pmid": "34615725", "type": "DERIVED", "citation": "Diab A, Hamid O, Thompson JA, Ros W, Eskens FALM, Doi T, Hu-Lieskovan S, Klempner SJ, Ganguly B, Fleener C, Wang X, Joh T, Liao K, Salek-Ardakani S, Taylor CT, Chou J, El-Khoueiry AB. A Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers. Clin Cancer Res. 2022 Jan 1;28(1):71-83. doi: 10.1158/1078-0432.CCR-21-0845. Epub 2021 Oct 6."}] | {"versionHolder": "2025-06-18"} | {
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"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BXS",
"name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M12307",
"name": "Neoplasm Metastasis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11113",
"name": "Liver Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11172",
"name": "Lung Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5546",
"name": "Carcinoma, Non-Small-Cell Lung",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11528",
"name": "Melanoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5534",
"name": "Carcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9613",
"name": "Carcinoma, Hepatocellular",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9348",
"name": "Head and Neck Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5030",
"name": "Urinary Bladder Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16064",
"name": "Stomach Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5548",
"name": "Carcinoma, Renal Cell",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5830",
"name": "Uterine Cervical Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5550",
"name": "Carcinoma, Squamous Cell",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10703",
"name": "Kidney Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T5486",
"name": "Stomach Cancer",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T4906",
"name": "Renal Cell Carcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T1341",
"name": "Clear Cell Renal Cell Carcinoma",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T4192",
"name": "Ocular Melanoma",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009369",
"term": "Neoplasms"
}
]
} | {
"ancestors": [
{
"id": "D007155",
"term": "Immunologic Factors"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Hemat",
"name": "Hematinics"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M2853",
"name": "Immunomodulating Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11110",
"name": "Liver Extracts",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10184",
"name": "Immunoglobulins",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4225",
"name": "Antibodies",
"relevance": "LOW"
},
{
"asFound": "Connective Tissue Diseases",
"id": "M4230",
"name": "Antibodies, Monoclonal",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M19117",
"name": "Immunoglobulins, Intravenous",
"relevance": "LOW"
},
{
"asFound": "Connective Tissue Diseases",
"id": "M10122",
"name": "Immunoglobulin G",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M10201",
"name": "Immunologic Factors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000911",
"term": "Antibodies, Monoclonal"
},
{
"id": "D007074",
"term": "Immunoglobulin G"
}
]
} | {
"conditions": [
{
"id": "D009369",
"term": "Neoplasms"
}
],
"interventions": [
{
"id": "D000911",
"term": "Antibodies, Monoclonal"
},
{
"id": "D007074",
"term": "Immunoglobulin G"
}
]
} |
NCT01459666 | null | Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer | A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of AbobotulinumtoxinA (BTX-A) in Improving Forehead Wounds After Mohs Micrographic Surgery and Reconstruction for Skin Cancer | None | INTERVENTIONAL | TERMINATED | 2011-10-18T00:00:00 | null | null | null | [
"PHASE4"
] | 9 | 18 | null | ALL | false | This study will test if the use of DysportTM (abobotulinumtoxinA) improves wound healing and scarring after Mohs surgery. Research in the laboratory as well as previous studies in humans have shown improved wound healing and scarring with the use of a similar medication called Botox.
Dysport may improve wound healing and scarring by relaxing facial muscles and therefore minimizes the muscle tension and possibly the inflammation around the wound. | Primary Objective:
-To evaluate the efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS) at 6 weeks post surgery.
Secondary Objectives:
* To evaluate efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Patient and Observer Assessment Scale (POSAS) at week 1, 6, and 24.
* To evaluate the efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS) at week 1 and 24 post surgery.
* To evaluate patient satisfaction
* To evaluate safety (adverse events)
This is a 6 month, prospective, multicenter, double-blinded, randomized, placebo-controlled study. A total of 40 male or female healthy volunteers, 20 in each arm, will be enrolled. Up to 10 more patients can be enrolled to account for patient drop-out. Subjects will all undergo Mohs micrographic surgical removal of a skin cancer lesion on the forehead followed by reconstruction. Subjects will be randomized to receive either aboBTX-A injection or placebo injection in the frontalis, procerus, and corrugator muscles prior to reconstruction. Photographs, POSAS, and clinical assessments will be taken immediately after initial wound closure, at 1 week follow-up, at 6 weeks follow-up, and at 6 months follow-up. Adverse events will also be reviewed at each study visit. After the completion of the study, the photographs will be assessed (blinded as to the patient identifiers) using a 10 cm visual analog scale (VAS). The first few photographs will be evaluated by the surgeons together to calibrate the VAS and ensure inter-reliability. | Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for enrollment:
* Ability to understand the risks, benefits, and alternative to participation and give informed consent
* Have biopsy proven skin cancer on the medial forehead that is amenable to Mohs surgery. Medial forehead is defined as the area superiorly from the hairline, inferiorly at the eyebrow, and laterally to the tip of the lateral brow (see diagram).
* Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to Mohs surgery with defect size measuring 1.0 cm or greater
* If female, not currently pregnant, no potential for pregnancy, or if of child-bearing age, must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for 30 days after the last dose of study drug. A negative urine pregnancy test is required at study entry for female subjects of childbearing potential: a woman is considered to be of child bearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal (without a menstrual period for at least one year)
* Agrees to not use disallowed concomitant medications (retinoids)
Exclusion Criteria:
The presence of any of the following will exclude a patient from study enrollment.
* Pregnant women, women who are breastfeeding, or women of child bearing age who are unwilling to use adequate contraception (described above) during the study period
* Current or past history of a neuromuscular disease (such as myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)
* Currently taking aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents)
* History of radiation therapy or chemotherapy
* History of keloid or other hypertrophic scar formation
* Current or past history of scleroderma
* Has used botulinum toxin in the forehead area within one year.
* Has significant resting eyebrow ptosis
* Has used any topical retinoids to the forehead area within the past 4 weeks
* Undergo any scar revision procedure for the duration of the study including intralesional kenalog, laser treatment, and/or scar revision surgeries
* Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or any previous hypersensitivity to any botulinum toxin A or related product.
* Non-English speaking: These patients are excluded since translation of the informed consent into other languages is time-consuming and expensive as it requires a bona fide translator for the particular language of interest and this type of person may be difficult to locate.
* House staff and students, medical students on a clerkship, and employees related to study personnel or who work for any study personnel, and members of the study team are not eligible to participate in this study as a subject.
* The investigator feels that for any reason the subject is not eligible to participate in the study | University Hospitals Cleveland Medical Center | OTHER | {
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"facility": "University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center",
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"state": "Ohio"
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"facility": "UH Cleveland Medical Center-Westlake",
"geoPoint": {
"lat": 41.45532,
"lon": -81.91792
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"state": "Ohio"
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] | null | null | {
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"description": null,
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{
"affiliation": "University Hospitals Cleveland Medical Center",
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] | null | {"versionHolder": "2025-06-18"} | {
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],
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"abbrev": "BC26",
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"term": "Skin Neoplasms"
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NCT03140566 | null | Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF | Ultrasound Evaluation of the Inferior Vena Cava in Addition to Clinical Assessment to Guide Decongestion in Acute Decompensated Heart Failure: a Pilot Study | CAVA-ADHF | INTERVENTIONAL | COMPLETED | 2017-04-25T00:00:00 | null | 2019-09-24T00:00:00 | 2019-09-24T00:00:00 | [
"NA"
] | 388 | 18 | null | ALL | false | CAVA-ADHF is designed as a prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial. The objective is to test whether evaluation of the inferior vena cava diameter in addition to clinical assessment is superior compared to clinical assessment alone with respect to the surrogate endpoint of change in NT-proBNP from baseline to discharge. The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK). | Only limited evidence is available on the best method to monitor and guide decongestion in acute decompensated heart failure. Therefore, no specific guideline recommendations are made in this regard. It is unknown whether an objective congestion marker can be used to guide decongestion or such marker is only of prognostic value by identifying high-risk patients with an advanced disease state.
CAVA-ADHF is designed as prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial and aims to demonstrate effectiveness of inferior vena cava (IVC)-guided decongestion, its feasibility, and to estimate effect size and variability of clinical endpoints following the intention-to-treat principle.
After inclusion and exclusion criteria have been checked patients will be randomized:
Experimental intervention: Decongesting treatment guided by clinical assessment and ultrasound evaluation of the IVC diameter. Decongestion should lead to a maximal IVC diameter ≤2.1 cm and IVC collapsibility index \>50% in addition to relief of symptoms and signs of congestion before discharge.
Control intervention: Decongesting treatment guided by clinical assessment alone. The IVC ultrasound evaluation is performed, but results are not reported to treating physicians.
Trial intervention will end with discharge from the index hospitalization. Patients will be followed-up for 180 to 210 days after randomization.
The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK). | Inclusion Criteria:
* Hospitalization for ADHF with dyspnea ≥NYHA III, peripheral edema, and pulmonary congestion (rales on auscultation or pulmonary vascular congestion on chest radiograph)
* Age ≥18 years
* NT-proBNP \>300 ng/l within 24 h after admission
* Sufficient ultrasound visualization to evaluate IVC
* IVCmax \>2.1 cm and IVCCI ≤50 % in the baseline assessment within 24 h after admission
* Capability to sign informed consent personally
Exclusion Criteria:
* Cardiogenic shock with systolic blood pressure \<90 mmHg plus end-organ hypoperfusion
* ADHF due to significant arrhythmias
* Severe pulmonary disease as primary cause of dyspnea
* Simplified Modification of Diet in Renal Disease estimated glomerular filtration rate \<30 ml/min/1.73 m²
* Need for non-invasive or invasive ventilation support at baseline
* Pregnancy
* Participation in another interventional trial regarding heart failure treatment | University of Luebeck | OTHER | {
"id": "CAVA-ADHF-DZHK10",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-05-02T00:00:00 | {
"date": "2019-09-25",
"type": "ACTUAL"
} | {
"date": "2017-05-04",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
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"maskingInfo": {
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]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Heart Failure"
] | ["heart failure", "acute decompensated heart failure", "congestion", "inferior vena cava"] | null | [
{
"city": "Lübeck",
"country": "Germany",
"facility": "Universitäres Herzzentrum Lübeck",
"geoPoint": {
"lat": 53.86893,
"lon": 10.68729
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in NT-proBNP from baseline to discharge",
"timeFrame": "Measured at baseline (within 24 hours of admission to index hospitalization) and on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)"
}
],
"secondary": [
{
"description": null,
"measure": "Proportion of patients with IVC ultrasound on two thirds of days in hospital and at discharge among all randomized patients",
"timeFrame": "Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)"
},
{
"description": null,
"measure": "All-cause mortality",
"timeFrame": "180 days after randomization"
},
{
"description": null,
"measure": "Cardiovascular mortality",
"timeFrame": "180 days after randomization"
},
{
"description": null,
"measure": "Unscheduled readmission for any cause",
"timeFrame": "180 days after randomization"
},
{
"description": null,
"measure": "Readmission for heart failure",
"timeFrame": "180 days after randomization"
},
{
"description": null,
"measure": "Hemoconcentration",
"timeFrame": "Measured at baseline (within 24 hours of admission to index hospitalization) and on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)"
},
{
"description": null,
"measure": "Freedom from signs of congestion at discharge",
"timeFrame": "Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)"
},
{
"description": null,
"measure": "Cumulative loop diuretic dose during index hospitalization",
"timeFrame": "Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)"
},
{
"description": null,
"measure": "Length of index hospitalization",
"timeFrame": "Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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"abbrev": "BC14",
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"name": "All Conditions"
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],
"meshes": [
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} | {
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NCT05545566 | null | Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery | Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery | EchTHor | INTERVENTIONAL | COMPLETED | 2022-09-10T00:00:00 | null | 2023-02-28T00:00:00 | 2023-02-28T00:00:00 | [
"NA"
] | 60 | 18 | null | ALL | false | The investigator would like to conduct a study in patients undergoing thoracic surgery to evaluate the effectiveness of thoracic ultrasound in the decision to discharge the patient after pleural drain removal. | Thoracic drainage is a common and almost systematic practice after thoracic surgery requiring daily management and monitoring until and after its removal.
It allows, after opening the pleura, the evacuation of liquid and/or air retained in the pleural cavity.
The overall monitoring of the patient after thoracic surgery is based on clinical vigilance combined with thoracic imaging, in particular the chest X-ray which remains the Gold Standard (reference examination).
The removal of the drain is decided according to the quantity and appearance of the evacuated fluid, the persistence of air leaks, etc... A few hours after the removal of the drain, it is routine to perform a chest X-ray before authorizing a possible discharge from the department.
This practice does not correspond to an established scientific protocol but is systematically performed in our department before discharge.
Several studies have defended the place of ultrasound in thoracic imaging and its contribution to the detection of postoperative and intensive care complications.
Unlike radiography, this technique is non-irradiating, less expensive and more readily available. It allows the detection of pneumothorax, pleural effusions and other complications detectable on X-ray.
To our knowledge, the contribution of thoracic ultrasound has not been studied in the decision to authorize the discharge of the patient after removal of the thoracic drain. | Inclusion Criteria:
Patients undergoing thoracic surgery (lung resection, pleural symphysis, biopsy or resection of a mediastinal tumor or ganglion, pleural decortication/decalcification) admitted immediately after surgery in the thoracic surgery department (standard care or continuous care) of the University Hospital of Limoges.
Exclusion Criteria:
* Admission to the intensive care unit after thoracic surgery.
* Pneumonectomy
* Chest wall surgery
* Patients \<18 years old
* Not affiliated to social security
* Under guardianship or curatorship
* Pregnant women
* Not knowing the French language | University Hospital, Limoges | OTHER | {
"id": "87RI22_0022 (EchTHor)",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2022-09-14T00:00:00 | {
"date": "2023-03-16",
"type": "ACTUAL"
} | {
"date": "2022-09-19",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
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"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
} | [
"Thoracic Ultrasound",
"Pleural Drain Removal"
] | ["postoperative thoracic surgery", "discharge decision", "thoracic ultrasound", "pleural drain removal", "chest X-ray", "thoracic surgery monitoring"] | null | [
{
"city": "Limoges",
"country": "France",
"facility": "Limoges Univesity Hospital",
"geoPoint": {
"lat": 45.83153,
"lon": 1.25781
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Theoretical patient discharge",
"timeFrame": "At the study completion, an average of 10 days"
}
],
"secondary": [
{
"description": null,
"measure": "Pain du to examination",
"timeFrame": "Day 0, Day 1 and At the study completion, an average of 10 days"
},
{
"description": null,
"measure": "Subcutaneous emphysema",
"timeFrame": "Day 0, Day 1 and At the study completion, an average of 10 days"
},
{
"description": null,
"measure": "Pneumothorax",
"timeFrame": "Day 0, Day 1 and At the study completion, an average of 10 days"
},
{
"description": null,
"measure": "Pleural effusion",
"timeFrame": "Day 0, Day 1 and At the study completion, an average of 10 days"
},
{
"description": null,
"measure": "Pulmonary Condensation",
"timeFrame": "Day 0, Day 1 and At the study completion, an average of 10 days"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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}
],
"meshes": [
{
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"term": "Aortic Dissection"
}
]
} | null | {
"conditions": [
{
"id": "D000784",
"term": "Aortic Dissection"
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],
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NCT03232866 | null | Effects of Load Monitoring on Pilates Training | Effects of Load Monitoring on Pilates Training: a Randomized Clinical Trial | None | INTERVENTIONAL | COMPLETED | 2017-07-25T00:00:00 | null | 2019-05-01T00:00:00 | 2019-12-01T00:00:00 | [
"NA"
] | 47 | 18 | 36 | MALE | true | There has been an increasing awareness about the need to practice some physical activity, including several objectives, mainly as a preventive character. From this perspective, notice the use of the Pilates method as an instrument of therapeutic exercise for the protection and promotion of health. However, despite being popularly performed, there is still no scientific evidence on the standardization of the use of the method and its progression to an adequate prescription of physical training. The objective is monitoring the progression of loads of a 12-week training among the basic, intermediate and advanced levels of the Pilates method through heart rate (HR), subjective exertion perception (PSE) and heart rate variability (HRV). In addition, analyzing the effect of the method on cardiorespiratory and autonomic parameters. 40 healthy men aged 18-36 will receive Pilates training for 12 weeks. After the initial assessment and familiarization with the method, the training period will begin totalizing 36 sessions for three months, where each class lasts approximately 1 hour. During the three months, the participants must pass through the three levels of training: Basic, Intermediate and Advanced. During each session, the investigators will initially collect: psychological questionnaire, visual analogue pain scale (VAS), and cardiorespiratory parameters (systolic and diastolic blood pressure, HR, respiratory rate and partial oxygen saturation). Throughout the session a heart rate meter will be positioned on the chest of the participant to capture HR, which will occur every five minutes together with the PSE illustrated in the model proposed by Borg. At the end of each session, the cardiorespiratory parameters will be collected again. In addition, cardiorespiratory parameters and HRV will be analyzed at baseline and after three months of training. In the case of HRV analysis, linear methods in the time and frequency domain will be verified. For the statistical analysis of the cardiorespiratory and autonomic parameters in the pre and post training moments will be used paired t test for normal data or Wilcoxon test for non normal data. For the analysis of the training load will be used the correlation of Pearson or Sperman according to normality. The definition of cutoff points for the HRV and PSE indices will be obtained by the ROC curve. | null | Inclusion Criteria:
* male sex
* healthy
* aged between 18 and 36 years
Exclusion Criteria:
* smokers
* alcoholics
* use drugs that influenced cardiac autonomic activity
* cardiovascular, metabolic or endocrine diseases. | Paulista University | OTHER | {
"id": "69459517.8.0000.5402",
"link": null,
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} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2017-07-25T00:00:00 | {
"date": "2020-03-03",
"type": "ACTUAL"
} | {
"date": "2017-07-28",
"type": "ACTUAL"
} | [
"ADULT"
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} | [
"Pilates Method",
"Exercise"
] | ["Exercise Movement Techniques", "Exercise", "Monitoring, Physiologic", "Heart Rate", "Autonomic Nervous System", "Heart rate variability"] | null | [
{
"city": "Presidente Prudente",
"country": "Brazil",
"facility": "Franciele Marques Vanderlei",
"geoPoint": {
"lat": -22.12556,
"lon": -51.38889
},
"state": "São Paulo"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change from baseline in the indices of heart rate variability in different levels of pilates (basic, intermediate and advanced)",
"timeFrame": "Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)"
}
],
"secondary": [
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"timeFrame": "Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)"
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"timeFrame": "Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)"
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} | null | [{"pmid": "34672201", "type": "DERIVED", "citation": "Cavina AP, Silva NM, Biral TM, Lemos LK, Junior EP, Pastre CM, Vanderlei LC, Vanderlei FM. Effects of 12-week Pilates training program on cardiac autonomic modulation: a randomized controlled clinical trial. J Comp Eff Res. 2021 Dec;10(18):1363-1372. doi: 10.2217/cer-2021-0195. Epub 2021 Oct 21."}, {"pmid": "31623638", "type": "DERIVED", "citation": "de Souza Cavina AP, Pizzo Junior E, Machado AF, Biral TM, Pastre CM, Vanderlei FM. Load monitoring on Pilates training: a study protocol for a randomized clinical trial. Trials. 2019 Oct 17;20(1):597. doi: 10.1186/s13063-019-3684-x."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT01342666 | null | Tomato Consumption and High Density Lipoprotein-cholesterol | Effect of Tomato Consumption on Serum High Density Lipoprotein-cholesterol Levels. A Randomized, Open-label, Single Blind, Clinical Trial | None | INTERVENTIONAL | COMPLETED | 2011-04-26T00:00:00 | null | null | null | [
"NA"
] | 50 | 18 | 65 | ALL | false | * This is a randomized, open-label, single blind, clinical trial
* The study evaluated the effect of tomato consumption in serum HDL-cholesterol levels.
* The hypothesis was that two daily tomatoes during one month will increase the HDL-c levels.
* Since a placebo of tomatoes cannot be done, the control group will receive same proportion of cucumber because 1) it was not possible to have a tomato placebo; 2) cucumber does not have any lycopene; 3) both can be prepared similarly; and 4) the required quantity can be measured in the same way.
* The intervention was during 1 month and was assigned by randomization.
* Personnel who did the clinical and biochemical evaluation were blinded for the intervention.
* Lipid profile was measured before and after the intervention.
* Confounding factors such as daily physical activity, diet, consumption of fish or alcoholic beverages, smoking status were considered during statistical analyses. | Cardiovascular disease (CVD) is a main cause of death worldwide (1) and there are well recognized risk factors associated with its development. Low high density lipoprotein-cholesterol (HDL-c) rank among the most common lipid abnormalities associated with CVD (2). Low HDL-c is currently defined as an HDL-c value below 40 mg/dL for men and below 50 mg/dL for women (3). Factors related with low HDL-c are cigarette smoking (4), high triglycerides (5), sedentary lifestyle (6), and insulin resistance (7). Non-pharmacologic strategies to increase HDL-c concentration are increasing alcohol (8) and fish consumption (9), weight reduction (3), increment in physical activity (10), and smoking cessation (8). Some of these strategies are not applicable or hard to implement in individuals affected with low HDL-c. Moreover, in low-income countries, these interventions could be costly for the general population. Vegetables consumption could be a more affordable and accessible option to treat low HDL-c. Epidemiologic evidence indicates that high consumption of vegetables reduces the risk of cardiovascular disease (11) and particular attention has received tomato-based products. Growing evidence from several epidemiological studies has indicated that lycopene, the major carotenoid in tomato (12), might be more important than other carotenoids in preventing atherosclerosis and CVD (13, 14). The consumption of more than 7 servings per week of tomato-based products has been associated with a 30% reduction in the relative risk of CVD (15). Such potential benefits to vascular health from a tomato-rich diet could be related to low arterial intimal wall thickness (13, 16), reduction of LDL cholesterol levels (17), and inverse correlation with markers of inflammation and vascular endothelial dysfunction (18). However, HDL-c levels could also be positively influenced by tomato consumption. In a pilot study we found that tomato juice consumption did not increase HDL-c after one month (unpublished data), this finding also was recently reported by another group (19). In contrast, other study showed that daily consumption of 300g of uncooked tomatoes, during one month significantly increased HDL-c levels by 15.2% (20). However, this study was not controlled, not blinded, and neither randomized. Roma tomatoes consumption could be an accessible intervention to improve HDL-c levels; however, a longitudinal clinical trial is necessary to evaluate this association. Therefore, we performed a randomized, open-label, single blind, clinical trial to specifically evaluate if consumption of two uncooked tomatoes per day (14 servings/week) during one month could produce a favorable effect on HDL-c. | Inclusion Criteria:
* Males with HDL-c less than 40 mg/dl
* Females with HDL-c less than 50 mg/dl
* Age between 18 to 65 years old
* Acceptance for participation with signed informed consent
Exclusion Criteria:
Previous diagnosis of:
* Diabetes,
* Hypertension,
* Kidney, liver or heart insufficiency,
* Hyperuricemia,
* Hyperandrogenic anovulation,
* Thyroid dysfunction (hypo or hyperthyroidism),
* Any difficulty to swallow appropriately, or
* Hospitalization in the previous six months.
Additionally, those subjects under current treatment with fibrates, statins, nicotinic acid, steroids, allopurinol, hormone replacement therapy (testosterone, estrogens or progesterone), metformin, other oral hypoglycemic agents, insulin, sibutramine, or orlistat treatment and those with daily consumption of any non-steroidal anti-inflammatory drug were also excluded. | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | OTHER | {
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] | [{"pmid": "19148834", "type": "BACKGROUND", "citation": "Ali MM, Agha FG. Amelioration of streptozotocin-induced diabetes mellitus, oxidative stress and dyslipidemia in rats by tomato extract lycopene. Scand J Clin Lab Invest. 2009;69(3):371-9. doi: 10.1080/00365510802658473."}, {"pmid": "9832077", "type": "BACKGROUND", "citation": "Agarwal S, Rao AV. Tomato lycopene and low density lipoprotein oxidation: a human dietary intervention study. Lipids. 1998 Oct;33(10):981-4. doi: 10.1007/s11745-998-0295-6."}, {"pmid": "10837319", "type": "BACKGROUND", "citation": "Arab L, Steck S. Lycopene and cardiovascular disease. Am J Clin Nutr. 2000 Jun;71(6 Suppl):1691S-5S; discussion 1696S-7S. doi: 10.1093/ajcn/71.6.1691S."}, {"pmid": "17144439", "type": "BACKGROUND", "citation": "Blum A, Merei M, Karem A, Blum N, Ben-Arzi S, Wirsansky I, Khazim K. Effects of tomatoes on the lipid profile. Clin Invest Med. 2006 Oct;29(5):298-300."}, {"pmid": "18629373", "type": "BACKGROUND", "citation": "Denniss SG, Haffner TD, Kroetsch JT, Davidson SR, Rush JW, Hughson RL. Effect of short-term lycopene supplementation and postprandial dyslipidemia on plasma antioxidants and biomarkers of endothelial health in young, healthy individuals. Vasc Health Risk Manag. 2008;4(1):213-22. doi: 10.2147/vhrm.2008.04.01.213."}, {"pmid": "16177251", "type": "BACKGROUND", "citation": "Ashen MD, Blumenthal RS. Clinical practice. Low HDL cholesterol levels. N Engl J Med. 2005 Sep 22;353(12):1252-60. doi: 10.1056/NEJMcp044370. No abstract available."}, {"pmid": "9168909", "type": "BACKGROUND", "citation": "Fuhrman B, Elis A, Aviram M. Hypocholesterolemic effect of lycopene and beta-carotene is related to suppression of cholesterol synthesis and augmentation of LDL receptor activity in macrophages. Biochem Biophys Res Commun. 1997 Apr 28;233(3):658-62. doi: 10.1006/bbrc.1997.6520."}, {"pmid": "11868053", "type": "BACKGROUND", "citation": "Gianetti J, Pedrinelli R, Petrucci R, Lazzerini G, De Caterina M, Bellomo G, De Caterina R. Inverse association between carotid intima-media thickness and the antioxidant lycopene in atherosclerosis. Am Heart J. 2002 Mar;143(3):467-74. doi: 10.1067/mhj.2002.120776."}, {"pmid": "9345115", "type": "BACKGROUND", "citation": "Kohlmeier L, Kark JD, Gomez-Gracia E, Martin BC, Steck SE, Kardinaal AF, Ringstad J, Thamm M, Masaev V, Riemersma R, Martin-Moreno JM, Huttunen JK, Kok FJ. Lycopene and myocardial infarction risk in the EURAMIC Study. Am J Epidemiol. 1997 Oct 15;146(8):618-26. doi: 10.1093/oxfordjournals.aje.a009327."}, {"pmid": "14647219", "type": "BACKGROUND", "citation": "Re R, Mishra GD, Thane CW, Bates CJ. Tomato consumption and plasma lycopene concentration in people aged 65 y and over in a British national survey. Eur J Clin Nutr. 2003 Dec;57(12):1545-54. doi: 10.1038/sj.ejcn.1601723."}] | {"versionHolder": "2025-06-18"} | {
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NCT00859066 | null | Evaluation of Radiology Resident Anxiety When Beginning Emergency Room (ER) Call | Evaluation of Radiology Resident Anxiety When Beginning ER Call | None | OBSERVATIONAL | TERMINATED | 2009-03-09T00:00:00 | null | null | null | null | 19 | null | null | ALL | true | The purpose of this study is to quantify levels of resident anxiety under the current system (take call alone) and compare results to a modified system. | The study purpose is to quantify resident perceptions and feelings under the current 1700 call system (take call alone) and compare those with resident perceptions and feelings under a modified system where two partial shifts are taken with an experienced resident ("buddy call") prior to taking call alone. | Inclusion Criteria:
* first year radiology residents | University of Michigan | OTHER | {
"id": "HUM00026874",
"link": null,
"type": null
} | Original Principal Investigator (Andrew Trout M.D.) left the University. | {
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} | 2009-03-09T00:00:00 | {
"date": "2012-04-30",
"type": "ESTIMATED"
} | {
"date": "2009-03-10",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | First year radiology residents | NON_PROBABILITY_SAMPLE | true | {
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} | [
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] | null | null | [
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"facility": "University of Michigan Hospital",
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"state": "Michigan"
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] | null | null | {
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],
"secondary": null
} | [
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"affiliation": "University of Michigan Hospital",
"name": "Richard Cohan, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
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NCT01291966 | null | Efficacy of a Intervention to Reduce Medication Errors and Improve Adherence | Efficacy of a Intervention to Reduce Medication Errors and Therapeutic Failure in Patients Over 65 Years Polypharmacy | ATEM-AP | INTERVENTIONAL | COMPLETED | 2011-01-26T00:00:00 | null | null | null | [
"NA"
] | 154 | 65 | null | ALL | true | The purpose of this study is to demonstrate that an intervention based on the motivational interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to reduce the errors of Medication in major measure that the habitual intervention. | null | Inclusion Criteria:
* Patients with polypharmacy (5 or more medicines)
* That detects to them a problem of Therapeutic Adherence
* That agree to take part in the study
Exclusion Criteria:
* Immobilized patients or with an index of Barthel lower than 60 points
* Incapable to fulfill ABVD
* Patients with cognitive deterioration
* Patients with diagnosis of ictus in the last 6 months
* That has been admitted to hospital 2 or more times in the last year Institutionalized patients | Hospital Universitario Reina Sofia de Cordoba | OTHER_GOV | {
"id": "PI-0101/2008",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
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} | 2011-02-08T00:00:00 | {
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"type": "ESTIMATED"
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"date": "2011-02-09",
"type": "ESTIMATED"
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],
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NCT07009366 | null | Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial | Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2025-05-29T00:00:00 | null | 2024-12-31T00:00:00 | 2024-12-31T00:00:00 | [
"NA"
] | 75 | 1 | 24 | ALL | false | This study aimed to determine the efficacy of different NCPAP weaning strategies in pre-term infants presenting with respiratory distress, and ultimately establishing the best method to withdraw from NCPAP. | Pakistan, as well as other developing countries, lacks data regarding the weaning protocol of NCPAP. Ascertaining the best weaning method that could facilitate a shorter duration on nasal CPAP and the least length of hospital stay is very much needed. Findings of this study would help clinicians to achieve better outcomes for the patients receiving nasal CPAP. | Inclusion Criteria:
* Preterm infants
* Any gender
* Low birth weight
* Gestational ages between 28 to below 37 weeks
* Presented with respiratory distress
* Neonates with radiological findings suggestive of respiratory distress, congenital pneumonia/sepsis, or transient tachypnea of the newborn (TTN)
Exclusion Criteria:
* Complex congenital abnormalities like diaphragmatic hernia, CNS malformations, intrapartum-related hypoxia, or congenital heart disease.
* Intraventricular hemorrhage grade III or IV or low APGAR scores (\<4 or 5 at 5 minutes) | RESnTEC, Institute of Research | OTHER | {
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"facility": "Ziauddin University",
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{
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"term": "Respiratory Distress Syndrome, Newborn"
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]
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NCT02367066 | null | A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM) | A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX After Administration of Repeated Doses for 3 Days in Subjects With Type 2 Diabetes Mellitus | None | INTERVENTIONAL | COMPLETED | 2015-02-13T00:00:00 | null | null | null | [
"PHASE1"
] | 30 | 18 | 130 | ALL | false | A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus | A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus | Inclusion Criteria
* Provision of informed consent
* Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
* Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)
* ody mass index \>19 to \<38 kg/m2
* he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL, nclusive) on the morning of Visit 1.
* Clinical diagnosis of type 2 diabetes mellitus
* Metformin as only anti-diabetic treatment, at least for the last 3 months
Exclusion Criteria:
* History or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results \>3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
* Patients treated with single Insulin therapy within the last 3 months | AstraZeneca | INDUSTRY | {
"id": "D6420C00001",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
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} | 2015-02-19T00:00:00 | {
"date": "2016-06-23",
"type": "ESTIMATED"
} | {
"date": "2015-02-20",
"type": "ESTIMATED"
} | [
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"OLDER_ADULT"
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} | [
"Type 2 Diabetes Mellitus"
] | ["patients", "glycaemic control on metformin"] | null | [
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"country": "United States",
"facility": "Research Site",
"geoPoint": {
"lat": 32.64005,
"lon": -117.0842
},
"state": "California"
}
] | null | null | {
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"primary": [
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"description": null,
"measure": "Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint MMTT C_max for Plasma Glucose",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
}
],
"secondary": [
{
"description": null,
"measure": "Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint Fasting Beta-cell Responsiveness",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Fasting Insulin at Endpoint",
"timeFrame": "Day 3 and Day 9"
},
{
"description": null,
"measure": "Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Time of Maximum Plasma AZD1081 Concentration, t_ss,Max",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Plasma AZD1981 AUC(0-1h)",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Plasma AZD1981 AUC(0-2h)",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Plasma AZD1981 AUC(1-2h)",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Plasma Paracetamol Maximum Concentration, C_max",
"timeFrame": "Days 3,9"
},
{
"description": null,
"measure": "Time of Maximum Plasma Paracetamol Concentration, t_max",
"timeFrame": "Days 3,9"
},
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"description": null,
"measure": "Plasma Paracetamol AUC(0-t)",
"timeFrame": "Days 3,9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose",
"timeFrame": "Day -1 to Day 3 and Day 6 to Day 9"
},
{
"description": null,
"measure": "Plasma AZD1981 AUC(0-4h)",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Plasma AZD1981 AUC(0-12h)",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Plasma AZD1981 AUC(0-24h)",
"timeFrame": "Days 2,3,8,9"
},
{
"description": null,
"measure": "Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F",
"timeFrame": "Days 2,3,8,9"
}
]
} | [
{
"affiliation": "Profil Institute for Clinical Research, Inc.",
"name": "Liliana Uribe-Bruce, MD, MCI",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "AstraZeneca R&D Mölndal",
"name": "Stanko Skrtic, MD, PhD",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "30557325", "type": "DERIVED", "citation": "Skrtic S, Tyrberg B, Broberg M, Ericsson H, Schnecke V, Kjaer M, Hompesch M, Andersson EM, Ryberg E, Aivazidis A, Wennberg Huldt C, Lofgren L, Morrow L, Parkinson J, Ryden-Bergsten T, Watkins E, Sorhede Winzell M. Exploring the insulin secretory properties of the PGD2-GPR44/DP2 axis in vitro and in a randomized phase-1 trial of type 2 diabetes patients. PLoS One. 2018 Dec 17;13(12):e0208998. doi: 10.1371/journal.pone.0208998. eCollection 2018."}] | {"versionHolder": "2025-06-18"} | {
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],
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NCT06137066 | null | The Effect of Green Coffee Extract on Blood Glucose Homeostasis in Healthy Adults | The Effect of Green Coffee Extract With Alpha-lipoic Acid or Dihydroberberine on Blood Glucose Homeostasis in Healthy Adults | None | INTERVENTIONAL | COMPLETED | 2023-11-13T00:00:00 | null | 2024-05-08T00:00:00 | 2024-05-08T00:00:00 | [
"NA"
] | 20 | 18 | 45 | ALL | true | Green coffee extract (GCE) supplementation has been shown to induce favourable health benefits on glucose metabolism and weight management. Previous literature suggests that the benefits of GCE are due to the high bioavailability of chlorogenic acid (CGA) which is known for its antioxidant and anti-inflammatory properties but is destroyed during the bean roasting process used to make coffee in Western societies. While some studies examining chronic and high-dose GCE supplementation (4-12 weeks) report beneficial effects on glucose handling and reductions in body mass following supplementation, comparably less is known about the effect of acute (single dose) GCE supplementation. The purpose of the current study is to determine the impact of acute supplementation of GCE on blood sugar levels following consumption of a carbohydrate drink in healthy adults. A secondary objective is to evaluate the effect of GCE on insulin levels, other measures of glucose metabolism, and appetite perceptions. | Green coffee extract (GCE) supplementation has been shown to induce favourable benefits on glucose metabolism and weight management. These effects are attributed to its high chlorogenic acid (CGA) content, recognized for its anti-inflammatory properties. Chronic CGA supplementation (4-12 weeks) has been linked to reduced body mass, waist circumference, fasting glucose, and insulin resistance in both healthy adults and those with metabolic disease. Yet, comparably fewer studies have examined the effects of acute GCE supplementation and yielded inconsistent results, likely owing to variations in study design and participant selection, which limit our understanding of its acute effects.
Alpha-lipoic acid (ALA) is a cofactor of mitochondrial dehydrogenase complexes and a potent antioxidant that has been implicated in glucose metabolism. ALA increases the translocation of glucose transporter type 4 to cell membranes and improves insulin sensitivity through adenosine monophosphate-activated protein kinase (AMPK) activation, both of which facilitate glucose uptake. Furthermore, 300mg of ALA has been shown to improve endothelial function and reduce fasted blood glucose concentrations in clinical populations. Therefore, investigating the effects of a lower ALA dosage, specifically 200mg, compared to 400mg in the acute fed state, as well as whether ALA and GCE can act synergistically to elicit favourable effects on postprandial glucose control requires further investigation in healthy adults.
Berberine, a known AMPK activator, is a natural alkaloid present in various parts (root, stem, fruit, bark) of multiple plants including, in particular, species found in the Coptis, Hydrastis, and Berberis genus. Chronic berberine supplementation (lasting 1 month) resulted in reduced fasting blood glucose, 2-hour postprandial blood glucose levels, and insulin resistance index scores, outperforming standard care alone in individuals with metabolic syndrome, suggesting that berberine may assist with blood glucose regulation in this population. Berberine has low bioavailability (\<1%) reported in both animal and human models largely due to poor intestinal absorption and high levels of first-pass removal in the intestines and liver. To overcome this limitation, higher doses of berberine (500-1500mg) are commonly administered, which may lead to gastrointestinal adverse events. Dihydroberberine (DHB), a highly bioavailable form of berberine, has been shown to achieve greater area under the curve as well as peak berberine concentrations when compared to oral ingestion of 500 mg berberine or placebo in humans. However, whether acute DHB supplementation in combination with green coffee extract elicits beneficial effects on postprandial glucose handling in healthy adults has yet to be elucidated.
The purpose of the current study is to determine the impact of acute supplementation of GCE on postprandial glycemia in healthy adults. A secondary objective is to evaluate the effect of GCE on postprandial insulinemia, insulin sensitivity, glucose oxidation and appetite perceptions. The investigators hypothesize that compared to placebo, a 200mg dose of GCE combined with 400 mg alpha-lipoic acid consumed 30 min prior to a 75g oral glucose challenge will 1) lower 2-hour glucose incremental area under the curve (AUC; primary outcome); 2) lower 2-hour insulin incremental AUC and insulin resistance (Matsuda Index); 3) increase rates of glucose oxidation; and 4) lower appetite perceptions. The investigators also hypothesize that the 200 mg dose of GCE combined with 400 mg alpha-lipoic acid will exert effects like, or greater than, the 200 mg dose of GCE with 200 mg of DHB. | Inclusion Criteria:
* Males and females 18-45 years
* BMI between 18.5-30 kg/m2
* No history of smoking or cardiovascular and metabolic diseases (stroke, hypertension, type II diabetes) or other diseases that could impact the study outcomes
* Weight stable (within ±2kg for 6 months)
* Generally healthy as assessed by medical and physical activity questionnaires
* No oral contraceptive use except for triphasic contraceptives
Exclusion Criteria:
* Any concurrent medical, psychiatric, or orthopedic condition that, subject to investigators' discernment, would negatively affect the subject's ability to comply with the study requirements
* Any history of cardiovascular, neurological, respiratory, skeletal muscle or metabolic disease
* Using medication to manage blood glucose or lipid metabolism
* Bleeding disorders or antiplatelet/ anticoagulation therapy
* Currently using (or use within the last 3 months) monophasic or biphasic oral contraceptives
* Currently supplementing with GCE, ALA, or dihydroberberine
* Any known allergies to green coffee extract, alpha-lipoic acid, dihydroberberine or berberine, or supplementing within the last 3 months
* Currently pregnant or lactating
* Have irregular menstrual cycles (\<21 days or \>35 days)
* Any form of cancer currently or in the last 5 years
* Are recreational smokers of any form (tobacco or cannabis)
* Use of corticosteroids, testosterone replacement therapy, or any anabolic steroid
* Not willing to consume the 24-hour control diet prior to metabolic trials
* Any current Illness which could interfere with the study (e.g., prolonged diarrhea, regurgitation, etc.) | Queen's University | OTHER | {
"id": "6039146",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-11-13T00:00:00 | {
"date": "2024-05-10",
"type": "ACTUAL"
} | {
"date": "2023-11-18",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Four-arm study. All participants receive all acute nutritional interventions: placebo (microcrystalline cellulose with 5mg magnesium stearate and 5mg silicon dioxide), 200mg GCE +200mg ALA, 200mg GCE + 400mg ALA, 200mg GCE + 200mg dihydroberberine.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Supplements will be coded as either 'A', 'B', 'C', or 'D'. A third-party researcher not involved in data collection will store the code key and only reveal the information after the data has been analyzed to maintain the double-blinded nature of the trial.",
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},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Healthy"
] | ["Green Coffee Extract", "Chlorogenic Acid", "Alpha-Lipoic Acid", "Dihydroberberine"] | null | [
{
"city": "Kingston",
"country": "Canada",
"facility": "Queen's University",
"geoPoint": {
"lat": 44.22976,
"lon": -76.48101
},
"state": "Ontario"
}
] | [
{
"class": "INDUSTRY",
"name": "Iovate Health Sciences International Inc"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "2-hour plasma glucose incremental area under the curve",
"timeFrame": "2 hours"
}
],
"secondary": [
{
"description": null,
"measure": "2- hour plasma insulin incremental area under the curve",
"timeFrame": "Aggregate 2 hours during the oral glucose tolerance test"
},
{
"description": null,
"measure": "Postprandial glucose oxidation",
"timeFrame": "Aggregate 2 hours during the oral glucose tolerance test"
},
{
"description": null,
"measure": "Appetite perceptions",
"timeFrame": "-30 minutes, 0 minutes, 60 minutes, 120 minutes, during the oral glucose tolerance test."
},
{
"description": null,
"measure": "Mean glucose concentration",
"timeFrame": "2 hours"
},
{
"description": null,
"measure": "Mean insulin concentration",
"timeFrame": "2 hours"
},
{
"description": null,
"measure": "Peak glucose concentration",
"timeFrame": "2 hours"
},
{
"description": null,
"measure": "Peak insulin concentration",
"timeFrame": "2 hours"
},
{
"description": null,
"measure": "Insulin sensitivity",
"timeFrame": "2 hours"
}
]
} | [
{
"affiliation": "Queen's University",
"name": "Chris McGlory",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | {
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"abbrev": "Ot",
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],
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} | {
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NCT01130766 | null | Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC) | Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC) | None | INTERVENTIONAL | UNKNOWN | 2010-05-25T00:00:00 | null | null | null | [
"PHASE3"
] | 176 | 18 | null | ALL | false | The prognosis of NSCLC patients with asymptomatic brain metastasis, who are not treated with SRS or WBRT has not been fully investigated yet. This randomized phase III trial is conducted to determine the exact role of SRS in NSCLC patients with asymptomatic oligo brain metastases whether early treatment with SRS would improve survival even in patients with asymptomatic brain metastasis. | null | Inclusion Criteria:
* Histologically confirmed non-small cell lung cancer with synchronous brain metastases (diagnosis of brain lesion before or within 2 months from diagnosis of the primary site tumor)
* One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
1. Well circumscribed tumor(s) with brain edema Grade 0-1
2. Maximum diameter ≤ 3.0 cm
* No prior complete resection of all known brain metastases or RT ④ No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
* Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0) ⑥ Age, 18 and over ⑦ ECOG performance status 0-1 ⑧ Written informed consent
Exclusion Criteria:
* severe co-morbid illness and/or active infections ② pregnant or lactating women
* RTOG neurologic function status of 1\~4 ④ Uncontrollable extracranial metastases | Samsung Medical Center | OTHER | {
"id": "2009-01-059",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-05-25T00:00:00 | {
"date": "2010-05-26",
"type": "ESTIMATED"
} | {
"date": "2010-05-26",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Non-small Cell Lung Cancer"
] | ["Non-small Cell Lung Cancer", "Asymptomatic brain metastasis", "Stereotactic radiosurgery (SRS)"] | null | [
{
"city": "Seoul,",
"country": "Korea, Republic of",
"facility": "Samsung Medical Center",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
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"state": null
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] | null | null | {
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"description": null,
"measure": "Overall survival",
"timeFrame": "36 months"
}
],
"secondary": [
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"description": null,
"measure": "time to CNS progression",
"timeFrame": "36 months"
},
{
"description": null,
"measure": "time to symptomatic brain metastasis",
"timeFrame": "36 months"
},
{
"description": null,
"measure": "quality of life",
"timeFrame": "36 months"
},
{
"description": null,
"measure": "cause of death (neurologic vs. others)",
"timeFrame": "36 months"
},
{
"description": null,
"measure": "neurocognitive function",
"timeFrame": "36 months"
}
]
} | [
{
"affiliation": "Samsung Medical Center",
"name": "Myungju Ahn, M.D., Ph.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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{
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},
{
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NCT07006766 | null | Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education | Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education | None | OBSERVATIONAL | COMPLETED | 2025-05-27T00:00:00 | null | 2025-02-15T00:00:00 | 2025-02-15T00:00:00 | null | 10 | 18 | null | ALL | true | The aim of this study is to assess the strengths and weaknesses of training models that are accessible, reproducible, and geared toward new learners. Specifically, the investigators aim to compare the four following models: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel, and the "blue-blood" chicken thigh model. This information will be valuable in assessing the utility of implementing a Japanese shirataki konjac noodle model in beginner microsurgical courses for both local and global education and outreach. | The significant benefit Japanese shirataki konjac noodle as a model for microsurgical simulation training is that they are very cost effective and allow for acquisition of microsurgical skills in a low stake environment. This is particularly useful for the microsurgery novice to become familiar with the tools and basics of placing microsuture.
In this study, the evaluator will complete a "pre-exercise" survey online using a laptop in the microsurgical work space. The evaluator will be oriented to the work space and then attempt to perform an end-to-end anastomoses on each of the four models.
The following three measurements will be taken: time to perform anastomosis, number of stitches, and patency (Yes/No).
Following these trials, the evaluator will take a "post-exercise" survey. This survey will obtain the evaluator's assessment of the models including most and least valuable aspects of each model, ease \& comfort of placing a suture, and microsuture/microsurgical tool handling. Only one evaluator will be in the microsurgical lab space at one time. All study tasks will take approximately 1-2 hours. The individuals with no formal surgery/microsurgery education will be guided by an expert microsurgeon throughout the anastomoses. No varying instructional techniques will be assessed; all participants without formal training will receive identical guidance from the expert microsurgeon. The surgical residents will not need supervision or guidance. The training surgeries will not be offered if people are unable to take the research surveys. | Inclusion Criteria:
* Participant is able to commit 1-2 hours to the study.
* Participants must either be a surgical resident or an individual with no formal surgery/microsurgery education. Five participants will be placed into each of these two categories.
Exclusion Criteria:
* Participant is unable to commit 1-2 hours to the study. | University of Wisconsin, Madison | OTHER | {
"id": "2023-1534",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
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"statusForNctId": null
} | 2025-05-27T00:00:00 | {
"date": "2025-06-05",
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"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Surgical residents or individual with no formal microsurgical education. | NON_PROBABILITY_SAMPLE | null | {
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"Surgical Procedure, Unspecified"
] | ["microsuture", "microsurgery", "surgical training", "microsurgical education", "global", "accessibility", "noodle", "synthetic", "vessel", "anastomosis", "patency", "education", "outreach", "low-cost", "microsurgical simulation", "simulation", "vessel simulator"] | null | [
{
"city": "Madison",
"country": "United States",
"facility": "UW School of Medicine and Public Health",
"geoPoint": {
"lat": 43.07305,
"lon": -89.40123
},
"state": "Wisconsin"
}
] | null | null | {
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"description": null,
"measure": "Time to Perform Anastomosis",
"timeFrame": "up to 30 min"
},
{
"description": null,
"measure": "Number of Stitches",
"timeFrame": "up to 30 min"
},
{
"description": null,
"measure": "Patency (either Yes or No)",
"timeFrame": "up to 30 min"
}
],
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} | [
{
"affiliation": "UW School of Medicine and Public Health",
"name": "Samuel Poore, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
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] | [{"pmid": "24603055", "type": "BACKGROUND", "citation": "Prunieres GJ, Taleb C, Hendriks S, Miyamoto H, Kuroshima N, Liverneaux PA, Facca S. Use of the Konnyaku Shirataki noodle as a low fidelity simulation training model for microvascular surgery in the operating theatre. Chir Main. 2014 Apr;33(2):106-11. doi: 10.1016/j.main.2013.12.003. Epub 2014 Feb 4."}, {"pmid": "34291182", "type": "BACKGROUND", "citation": "Mohammad S, Hanstein R, Lo Y, Levy IM. Validating a Low-Fidelity Model for Microsurgical Anastomosis Training. JB JS Open Access. 2021 Jul 16;6(3):e20.00148. doi: 10.2106/JBJS.OA.20.00148. eCollection 2021 Jul-Sep."}, {"pmid": "34915484", "type": "BACKGROUND", "citation": "Ng ZY, Honeyman C, Lellouch AG, Pandya A, Papavasiliou T. Smartphone-Based DIY Home Microsurgical Training with 3D Printed Microvascular Clamps and Japanese Noodles. Eur Surg Res. 2023;64(2):301-303. doi: 10.1159/000521439. Epub 2021 Dec 15."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT06905366 | null | Cognitive Function and Postoperative Quality of Recovery | Association Between Cognitive Function and Postoperative Quality of Recovery - a Prospective Cohort Study | KoSQoR | OBSERVATIONAL | NOT_YET_RECRUITING | 2025-03-25T00:00:00 | null | null | null | null | 140 | 65 | null | ALL | false | This study aims to assess the association between perioperative cognitive function and postoperative quality of recovery. | null | Inclusion Criteria:
* elective non-cardiac surgery
* age ≥65 years
* duration of surgery ≥60 years
Exclusion Criteria:
* inability to give informed consent | Universitätsklinikum Hamburg-Eppendorf | OTHER | {
"id": "2025-101433-BO-ff",
"link": null,
"type": null
} | Unknown | {
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} | 2025-03-25T00:00:00 | {
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"type": "ACTUAL"
} | {
"date": "2025-04-01",
"type": "ACTUAL"
} | [
"OLDER_ADULT"
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"Postoperative Quality of Recovery"
] | ["cognitive function"] | null | null | null | null | {
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"primary": [
{
"description": null,
"measure": "QoR-15GE",
"timeFrame": "first postoperative day"
}
],
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} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT04034966 | null | Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis | Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis | None | INTERVENTIONAL | UNKNOWN | 2018-10-31T00:00:00 | null | null | null | [
"NA"
] | 750 | 18 | 80 | ALL | false | Peritoneal dialysis (PD) technology is available but has not been tested in the real world. Therefore, the aim of this study is to test the utility of telemedicine in reducing mortality, hospitalizations, unscheduled visits, and cost derived from preventable complications. Incident patients to PD treatment will be followed from various hospitals in Mexico City and Guadalajara. Direct medical costs will be evaluated, along with unplanned hospital visits and complications over 2 years using the Claria telemedicine apparatus from Baxter Laboratories. | Study Background \& Rationale: (background information including previous studies as applicable )
Chronic kidney disease (CKD) is a growing problem world-wide which increases in parallel with some risk factors such as chronic diseases, mainly diabetes mellitus and hypertension. CKD imposes elevated costs both from the standpoint of human resources and hospital infrastructure, and above all in the economic aspect. In the United States, the cost of CKD equals more than 30 billion USD a year to care for a population of 450,000 patients, which means an elevated cost per patient per year. Mexico does not have precise statistics but it is estimated that the burden of the disease is higher than that faced by other health institutions in any of the therapeutic modalities. For IMSS, chronic kidney disease is found among the six diseases that cause the greatest expenses, datum that is magnified when considering that the current population in any dialysis program consists of only 60,000 patients. On the other hand, the number of nephrologists is insufficient to care for the patients, considering that the proportion recommended is 100 patients per nephrologist in dialysis programs. In IMSS, these proportions are greatly surpassed, and the need to increase human resources or use alternative technologies to ease the task is evident.
Since its introduction at the end of the 70's, peritoneal dialysis (PD) has been consolidated in many countries as a viable, long-term substitutive therapy for renal function. Frequency of use of PD in patients with end-stage renal disease (ESRD) has broad variations, from zero in some regions of France and Japan to 40% in the United Kingdom, 60% in Mexico, and 80% in Hong Kong.
In terms of outcomes, PD and hemodialysis (HD) are comparable. Mortality in PD is similar and even less than in HD, and the greatest advantage of PD over HD is its home application and simplified technique, since it gives the patient total autonomy for daily life. This advantage is even greater with nocturnal automated systems, or automated PD (APD).
In recent years, the concept of "telemedicine" has been developed, term that is used to name all electronic transfers of data, audio and video between the health team and patients, with the purpose of consultation, examination or performing long-distance medical procedures.
The facility of electronic communication has empowered the advantages of PD; with the use of telemedicine systems the rate of hospitalization has been reduced from 5.7 to 2.2, resulting in lower costs. One worry behind these efforts is knowing if the patients are prepared to join these systems. Luckily, the results of some surveys indicate that the degree of acceptance is high.
Telemedicine systems applied to PD include telephone devices with connection to land phones, tablets or teleconferences via the network. In Japan, telemedicine is used to monitor blood pressure, heart frequency, urinary volume or serum glucose, and in Spain it has been used for teleconferences, for clinical visits and audiovisual presentations to re-train patients. In Canada, contact through tablets favored communication between patients and health staff and, through the introduction of alerts in structured interviews; a significant number of hospital visits were avoided. In addition, they obtained a high level of patient satisfaction with the system.
Even when APD is an effective, safe procedure for treating patients with ESRD, the nephrologist depends on an important number of data that the patient should offer in order to write a prescription adjusted to the clinical conditions of each case. Some very illustrative aspects are, for example:
1. Ultrafiltration and total liquid removal (dialysis + urine) are crucial data to prescribe osmolarity and glucose content in dialysate. According to the clinical practice guides, there should be a minimum volume of 1.0 L/day, without forgetting that each mL of ultrafiltration is associated with the absorption of an important amount of glucose, with the consequent metabolic cost.
2. The volume of infused liquid should be adjusted to the body surface area of the patient, and should take into account that the total volume in the peritoneum has an additional increase from the ultrafiltration obtained. This should be achieved without exceeding the patient's tolerance and without forcing the generation of inflammatory stimuli.
3. In general, treatment adherence is estimated by the monthly consumption of dialysis solutions and patient self-reporting. However, the two procedures contain a large amount of subjectivity.
4. Adjustment or prescription of automated peritoneal dialysis (APD) requires calculation of the effective time of presence of the solutions in the cavity; that is, from the start of infusion to the end of drainage, discounting transit time.
All these data are impossible to obtain in a nocturnal treatment without the support of telemedicine. One aspect of great importance comes from the lack of achieving prescription goals, which negatively impacts clinical outcomes and incurs additional costs for unscheduled doctor visits and treatment of complications that are preventable through closer follow-up, such as the case of fluid overload through lack of ultrafiltration and symptoms of uremic syndrome from insufficient dialysis.
Potentially preventable hospitalization is understood as hospitalizations caused by ambulatory handling. It is about clinical conditions that can be prevented with good handling externally and that are recognized as indicators of efficiency in ambulatory handling. For the case of this project, in which telemedicine is expected to help make dialysis and ultrafiltration more efficient, potentially preventable hospitalizations will be considered in manifestations of uremic syndrome, hyperkalemia, and those derived from liquid overload, such as: edema, hypertension and heart failure.
Before the impossibility of obtaining complete, objective information necessary for the prescription of APD and adequate management of the patient, APD machines have incorporated a telemedicine module that recovers information on movement and volume of dialysis solution, glucose concentration, and in addition to objectively measuring treatment adherence. This new technology is already available, but its use in the "real world" has not been evaluated. Having this information in the investigator's medium is necessary, given that PD treatment predominates, especially in IMSS, which is the institution on which the weight of ESRD in the country rests. | Inclusion Criteria: Hospitals will be randomly assigned to control (without telemedicine device) or intervention groups (with telemedicine device). Hospitals will be selected and matched according their basic infrastructure (Outpatient dialysis clinic, Emergency Room, Laboratory and Radiology Departments, Hospitalization Facility, accessibility to the internet and direct telephone communication with the patient and/or contact or person in charge of the patient), as well as Human Resources (Nephrologist, Internist, specialists to attend to the most frequent complications of PD, Nurses trained in PD, and Social Workers), and availability of a structured PD Program (Manuals, Supervised training programs for patients and caregivers, Registers for peritonitis, technique failure, and mortality rates).
Inclusion criteria
* Over 18 years of age
* Diagnosed with chronic kidney disease
* Incident to automated peritoneal dialysis
* Agree to sign informed consent
Exclusion Criteria:
* seropositive for HIV, hepatitis B or C, with cancer
* in treatment with immunosuppressors or with acute complications in the 30 days previous to recruitment.
* patients who voluntarily withdraw from the study, who change residence or who lose social security coverage. | Coordinación de Investigación en Salud, Mexico | OTHER_GOV | {
"id": "R-2018-785-035",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-07-24T00:00:00 | {
"date": "2019-07-29",
"type": "ACTUAL"
} | {
"date": "2019-07-29",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The Project will consist in the conventional clinical treatment of the APD patient cared for in IMSS regarding the kind of dialysis solution, handling of laboratory and office procedures, as well as the handling of complications. One arm will utilize the Claria device, and the other will utilize normal treatment procedures.\n\nThe APD device in the control group will be called Claria® (Baxter, S.A. de C.V.) without the telemedicine device, and in the intervention group it will be the same device with the telemedicine module. Handling will be done according to the basic operating instructions established by the manufacturer.\n\nAccording to the preliminary analysis of the flow of patients in PD indicated in the above paragraphs, recruitment of the sample size will not represent a problem. Infrastructure available in both technical and experienced human resources makes the study feasible.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "750 Patients will be cluster randomized.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Chronic Kidney Disease Stage 5",
"Peritoneal Dialysis Complication"
] | ["peritoneal dialysis", "Claria", "telemedicine"] | null | [
{
"city": "Mexico City",
"country": "Mexico",
"facility": "Unidad de Investigacion Medica en Enfermedades Nefrologicas, Hospital de Especialidades Centro Medico Nacional Siglo XXI",
"geoPoint": {
"lat": 19.42847,
"lon": -99.12766
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "MORTALITY RATE",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "DAYS OF HOSPITALIZATION",
"timeFrame": "2 years"
},
{
"description": null,
"measure": "DAYS OF PREVENTABLE HOSPITALIZATION",
"timeFrame": "2 years"
}
],
"secondary": [
{
"description": null,
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}
]
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{
"affiliation": "Instituto Mexicano del Seguro Social",
"name": "Fabio Salamanca, PhD",
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] | [{"pmid": "17568785", "type": "BACKGROUND", "citation": "Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13."}, {"pmid": "16014087", "type": "BACKGROUND", "citation": "Amato D, Alvarez-Aguilar C, Castaneda-Limones R, Rodriguez E, Avila-Diaz M, Arreola F, Gomez A, Ballesteros H, Becerril R, Paniagua R. Prevalence of chronic kidney disease in an urban Mexican population. Kidney Int Suppl. 2005 Aug;(97):S11-7. doi: 10.1111/j.1523-1755.2005.09702.x."}, {"pmid": null, "type": "BACKGROUND", "citation": "USRDS Annual Report 2015. Chapter 11: Medicare Expenditures for Persons with ESRD"}, {"pmid": "24211750", "type": "BACKGROUND", "citation": "Cortes-Sanabria L, Paredes-Cesena CA, Herrera-Llamas RM, Cruz-Bueno Y, Soto-Molina H, Pazarin L, Cortes M, Martinez-Ramirez HR. Comparison of cost-utility between automated peritoneal dialysis and continuous ambulatory peritoneal dialysis. Arch Med Res. 2013 Nov;44(8):655-61. doi: 10.1016/j.arcmed.2013.10.017. Epub 2013 Nov 8."}, {"pmid": null, "type": "BACKGROUND", "citation": "Informe al Ejecutivo Federal y al Congreso de la Uni\u00f3n 2015-2016V.6.1. An\u00e1lisis del gasto en enfermedades cr\u00f3nico-degenerativas de alto impacto financiero para el IMSS. El Consejo T\u00e9cnico del Instituto Mexicano del Seguro Social. Ciudad de M\u00e9xico, junio de 2016"}, {"pmid": "23929773", "type": "BACKGROUND", "citation": "Harley KT, Streja E, Rhee CM, Molnar MZ, Kovesdy CP, Amin AN, Kalantar-Zadeh K. Nephrologist caseload and hemodialysis patient survival in an urban cohort. J Am Soc Nephrol. 2013 Oct;24(10):1678-87. doi: 10.1681/ASN.2013020123. Epub 2013 Aug 8."}, {"pmid": "18472681", "type": "BACKGROUND", "citation": "Thomas-Hawkins C, Flynn L, Clarke SP. Relationships between registered nurse staffing, processes of nursing care, and nurse-reported patient outcomes in chronic hemodialysis units. Nephrol Nurs J. 2008 Mar-Apr;35(2):123-30, 145; quiz 131."}, {"pmid": "10406512", "type": "BACKGROUND", "citation": "Balaskas EV, Ikonomopoulos D, Sioulis A, Dombros N, Kassimatis E, Bamichas G, Katsara I, Tourkantonis A. Survival and complications of 225 catheters used in continuous ambulatory peritoneal dialysis: one-center experience in Northern Greece. Perit Dial Int. 1999;19 Suppl 2:S167-71."}, {"pmid": null, "type": "BACKGROUND", "citation": "USRDS Annual Report 2015. Chapter 13: International Comparisons."}, {"pmid": "19270223", "type": "BACKGROUND", "citation": "Pecoits-Filho R, Campos C, Cerdas-Calderon M, Fortes P, Jarpa C, Just P, Luconi P, Lugon JR, Pacheco A, Paniagua R, Rodriguez K, Sanabria M, Sciaraffia V, Velasco C, De Arteaga J. Policies and health care financing issues for dialysis in Latin America: extracts from the roundtable discussion on the economics of dialysis and chronic kidney disease. Perit Dial Int. 2009 Feb;29 Suppl 2:S222-6."}, {"pmid": "20639759", "type": "BACKGROUND", "citation": "Jiwakanon S, Chiu YW, Kalantar-Zadeh K, Mehrotra R. Peritoneal dialysis: an underutilized modality. Curr Opin Nephrol Hypertens. 2010 Nov;19(6):573-7. doi: 10.1097/MNH.0b013e32833d67a3."}, {"pmid": "21997506", "type": "BACKGROUND", "citation": "Mehrotra R. Choice of dialysis modality. Kidney Int. 2011 Nov;80(9):909-911. doi: 10.1038/ki.2011.262."}, {"pmid": "23307879", "type": "BACKGROUND", "citation": "Lukowsky LR, Mehrotra R, Kheifets L, Arah OA, Nissenson AR, Kalantar-Zadeh K. Comparing mortality of peritoneal and hemodialysis patients in the first 2 years of dialysis therapy: a marginal structural model analysis. Clin J Am Soc Nephrol. 2013 Apr;8(4):619-28. doi: 10.2215/CJN.04810512. Epub 2013 Jan 10."}, {"pmid": "17785025", "type": "BACKGROUND", "citation": "Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906."}, {"pmid": "15384807", "type": "BACKGROUND", "citation": "Nakamoto H, Nishida E, Ryuzaki M, Sone M, Yoshimoto M, Itagaki K. Blood pressure monitoring by cellular telephone in patients on continuous ambulatory peritoneal dialysis. Adv Perit Dial. 2004;20:105-10."}, {"pmid": "12720083", "type": "BACKGROUND", "citation": "Edefonti A, Boccola S, Picca M, Paglialonga F, Ardissino G, Marra G, Ghio L, Parisotto MT. Treatment data during pediatric home peritoneal teledialysis. Pediatr Nephrol. 2003 Jun;18(6):560-4. doi: 10.1007/s00467-003-1147-8. Epub 2003 Apr 29."}, {"pmid": "12691517", "type": "BACKGROUND", "citation": "Cargill A, Watson AR. Telecare support for patients undergoing chronic peritoneal dialysis. Perit Dial Int. 2003 Jan-Feb;23(1):91-4. No abstract available."}, {"pmid": "12626104", "type": "BACKGROUND", "citation": "Ghio L, Boccola S, Andronio L, Adami D, Paglialonga F, Ardissino G, Edefonti A. A case study: telemedicine technology and peritoneal dialysis in children. Telemed J E Health. 2002 Winter;8(4):355-9. doi: 10.1089/15305620260507486."}, {"pmid": "24335134", "type": "BACKGROUND", "citation": "Lew SQ, Sikka N. Are patients prepared to use telemedicine in home peritoneal dialysis programs? Perit Dial Int. 2013 Nov-Dec;33(6):714-5. doi: 10.3747/pdi.2012.00203. No abstract available."}, {"pmid": "17556306", "type": "BACKGROUND", "citation": "Nakamoto H. Telemedicine system for patients on continuous ambulatory peritoneal dialysis. Perit Dial Int. 2007 Jun;27 Suppl 2:S21-6."}, {"pmid": "16892826", "type": "BACKGROUND", "citation": "Gallar P, Gutierrez M, Ortega O, Rodriguez I, Oliet A, Herrero JC, Mon C, Ortiz M, Molina A, Vigil A. [Telemedicine and follow up of peritoneal dialysis patients]. Nefrologia. 2006;26(3):365-71. Spanish."}, {"pmid": "27757228", "type": "BACKGROUND", "citation": "Dey V, Jones A, Spalding EM. Telehealth: Acceptability, clinical interventions and quality of life in peritoneal dialysis. SAGE Open Med. 2016 Oct 4;4:2050312116670188. doi: 10.1177/2050312116670188. eCollection 2016."}, {"pmid": "16973513", "type": "BACKGROUND", "citation": "Avila-Diaz M, Ventura MD, Valle D, Vicente-Martinez M, Garcia-Gonzalez Z, Cisneros A, Furlong MD, Gomez AM, Prado-Uribe MD, Amato D, Paniagua R. Inflammation and extracellular volume expansion are related to sodium and water removal in patients on peritoneal dialysis. Perit Dial Int. 2006 Sep-Oct;26(5):574-80."}, {"pmid": "19679559", "type": "BACKGROUND", "citation": "Paniagua R, Ventura MD, Avila-Diaz M, Hinojosa-Heredia H, Mendez-Duran A, Cueto-Manzano A, Cisneros A, Ramos A, Madonia-Juseino C, Belio-Caro F, Garcia-Contreras F, Trinidad-Ramos P, Vazquez R, Ilabaca B, Alcantara G, Amato D. NT-proBNP, fluid volume overload and dialysis modality are independent predictors of mortality in ESRD patients. Nephrol Dial Transplant. 2010 Feb;25(2):551-7. doi: 10.1093/ndt/gfp395. Epub 2009 Aug 12."}, {"pmid": "15119636", "type": "BACKGROUND", "citation": "Paniagua R, Ventura Mde J, Rodriguez E, Sil J, Galindo T, Hurtado ME, Alcantara G, Chimalpopoca A, Gonzalez I, Sanjurjo A, Barron L, Amato D, Mujais S. Impact of fill volume on peritoneal clearances and cytokine appearance in peritoneal dialysis. Perit Dial Int. 2004 Mar-Apr;24(2):156-62."}, {"pmid": "21454393", "type": "BACKGROUND", "citation": "Fischbach M, Issad B, Dubois V, Taamma R. The beneficial influence on the effectiveness of automated peritoneal dialysis of varying the dwell time (short/long) and fill volume (small/large): a randomized controlled trial. Perit Dial Int. 2011 Jul-Aug;31(4):450-8. doi: 10.3747/pdi.2010.00146. Epub 2011 Mar 31."}, {"pmid": "27821636", "type": "BACKGROUND", "citation": "Ronksley PE, Hemmelgarn BR, Manns BJ, Wick J, James MT, Ravani P, Quinn RR, Scott-Douglas N, Lewanczuk R, Tonelli M. Potentially Preventable Hospitalization among Patients with CKD and High Inpatient Use. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):2022-2031. doi: 10.2215/CJN.04690416. Epub 2016 Oct 6."}, {"pmid": "17602147", "type": "BACKGROUND", "citation": "Paniagua R, Ramos A, Fabian R, Lagunas J, Amato D. Chronic kidney disease and dialysis in Mexico. Perit Dial Int. 2007 Jul-Aug;27(4):405-9."}] | {"versionHolder": "2025-06-18"} | {
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NCT01436266 | null | Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion | Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester | PreopMiso | INTERVENTIONAL | TERMINATED | 2011-09-15T00:00:00 | null | null | null | [
"PHASE3"
] | 3 | 18 | 50 | FEMALE | false | Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to aid in softening the cervix as well as decreasing blood loss after abortion or vaginal delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester surgical abortion decreases blood loss from the procedure. The investigators will also assess whether misoprostol improves cervical dilation, changes the length of the procedure, changes the need for additional mechanical dilation, changes the subjective ease of the procedure, and changes a woman's pain. | This project is a placebo-controlled, double-blinded randomized controlled trial comparing the effect of misoprostol 400mcg buccally to placebo on blood loss in second trimester surgical abortion between 16-21 weeks gestation. The probability of group assignment is 50% with half of the women randomized to misoprostol and half to placebo (folic acid 1 mg).
Folic acid was chosen at the placebo as it looks similar to misoprostol, and when it is held in the cheek it has very little taste, similar to misoprostol. A compounded placebo that was tasteless had a very different appearance and was not suitable as a control.
Consent will be obtained after consent for the abortion has been completed and counseling and explanation of the abortion has been completed. Consent may be obtained before the abortion procedures have begun of the day prior to abortion (osmotic dilator placement and induction of fetal demise if appropriate), or after these procedures have been completed. No study procedures take place on the day prior to abortion.
On the day of the abortion, 1 hour prior to the procedure, the following study procedures will be conducted. Women will be given the study medication, which consists of two tablets of either misoprostol 200 mcg (400 mcg total) or placebo (folic acid 2 mg). The medication will be dispensed from opaque sequentially numbered vials so that double-blinding is maintained. The subject will be asked questions about symptoms prior to administration of the study medication. She will then hold the medication buccally (in her cheek) for 20 minutes and then swallow any remaining tablet. Immediately prior to the abortion, the subject will be asked about her symptoms again.
The abortion will commence 1 hour after administration of the study medication. The following study procedure will be done at the start of the abortion. The amount of cervical dilation will be measured by cervical dilators, starting with the largest dilator and progressively using smaller dilators until the largest one that will pass is determined. This generally takes less than 30 seconds.
The abortion will then be done with a combination of suction and extraction, which is part of standard clinical care at BMC. The following research procedures will be conducted: the length of the procedure will be recorded, and the woman will be asked afterward about her pain level during the abortion. This concludes the study procedures for the woman. Her time in the study is one day.
After the abortion, the fetus and placenta will be removed from the collected specimen and weighed and sent to pathology as per usual clinical procedure. The following study procedure will be done. The collected fluid from the suction machine, consisting of blood and amniotic fluid, will be measured. If the drapes or towels have been soiled with blood or fluid, they will be weighed and the amount added to the total measured from the suction machine. The amount of blood will be calculated by comparison with the expected amount of amniotic fluid as published by Hern (attached in Section S). Note that the amount of fetal blood is very small, less than 20 ml at the highest gestational age in this study, and will not appreciably change the total. If all of the blood and fluid has been collected into the suction jar (and none of the towels are soiled), then 5 ml of the mixed fluid will be sent for a hemoglobin level, and the percentage of blood calculated from that, as pure amniotic fluid will have a hemoglobin level of zero. This results will be used for confirmation when available, but will not be used as the primary outcome. Measurements on the fluid will be completed on the day of abortion. The fluid is normally discarded and will be discarded after measures are complete. | Inclusion Criteria:
* English or Spanish speaking
* Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound dating on the day of enrollment
* Ultrasound used for dating purposes must be within the last two weeks.
* Women 18-50 years of age undergoing surgical termination of pregnancy
Exclusion Criteria:
* Spontaneous fetal demise
* Ruptured membranes or intrauterine infection
* Fibroids that significantly distort the uterine shape
* Uterine abnormality such as unicornuate uterus
* Prior transmural myomectomy
* Severe oligohydramnios
* Morbid obesity with BMI\>45
* Inability to place osmotic dilators | Boston University | OTHER | {
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"date": "2017-05-30",
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"date": "2011-09-19",
"type": "ESTIMATED"
} | [
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NCT05555966 | null | CardioInsight 1 RBBB | Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy | CardioInsight1 | INTERVENTIONAL | UNKNOWN | 2022-09-15T00:00:00 | null | 2024-08-31T00:00:00 | 2024-12-31T00:00:00 | [
"NA"
] | 93 | 18 | null | ALL | false | Cardiac resynchronization therapy (CRT) is an established therapy for symptomatic heart failure patients. However, there are still 30 to 40% of studied patients being nonresponder to CRT. The plausible reasons of lack of effect of CRT in these patients include relative less baseline electrical dyssynchrony. The aim of our study is to investigate whether there is an optimal configuration of CRT delivery that varies between patients with different pattern of activation delay. | null | Inclusion Criteria:
* Adult (aged 18 or above) of both sexes
* Ischemic or non-ischemic cause of heart failure
* QRS duration \> 120 ms, non-left bundle branch block (LBBB) type of conduction disturbance
* NYHA class III or above
* Informed consent by the patient
* Already received stable dose of guideline directed medical therapy for at least 3 months
Exclusion Criteria:
* LBBB patients
* Pregnant women
* Participation in another study
* Patient with contraindication to left ventricle catheterization by a retrograde aortic approach | Chinese University of Hong Kong | OTHER | {
"id": "2017.316",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2022-09-22T00:00:00 | {
"date": "2022-09-27",
"type": "ACTUAL"
} | {
"date": "2022-09-27",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
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},
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"primaryPurpose": "TREATMENT",
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} | [
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] | null | null | [
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"country": "Hong Kong",
"facility": "The Chinese University of Hong Kong",
"geoPoint": {
"lat": 22.38333,
"lon": 114.18333
},
"state": null
}
] | null | null | {
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"primary": [
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"description": null,
"measure": "Left Ventricle (LV) end systolic volume reduction",
"timeFrame": "6 months"
}
],
"secondary": [
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"description": null,
"measure": "Electrical dyssynchrony index",
"timeFrame": "During procedure"
},
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"description": null,
"measure": "Hemodynamic response monitoring",
"timeFrame": "During procedure"
},
{
"description": null,
"measure": "Procedure outcome with optimal CRT delivery",
"timeFrame": "During procedure"
},
{
"description": null,
"measure": "Cine images and chest X ray",
"timeFrame": "6 months"
},
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"description": null,
"measure": "Echocardiogram parameter: left ventricular systolic and diastolic volume",
"timeFrame": "6 months"
},
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"description": null,
"measure": "Multi-dimensional Quality of life changes",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Device set-up parameter :defibrillation threshold",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Post-operation Complication rate",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Device set-up parameter :defibrillation sensitivity",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Device set-up parameter: lead impedance of pacing leads",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Change in 6 minute hall walk test",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Change in HF Patient Global Assessment Questionnaire",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Change in quality of life",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Implantation success rate with optimal CRT delivery",
"timeFrame": "During procedure"
},
{
"description": null,
"measure": "Echocardiogram parameter: left ventricular ejection fraction",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Echocardiogram parameter: degree of mitral regurgitation",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Echocardiogram parameter: strain imaging",
"timeFrame": "6 months"
}
]
} | [
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"affiliation": "Chinese University of Hong Kong",
"name": "Bryan Yan",
"role": "PRINCIPAL_INVESTIGATOR"
}
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NCT01411566 | null | Clinical Intervention Psychosis and Addiction | Evaluation of an Integrative Therapeutic Concept for Schizophrenic Patients With Comorbid Substance Use Disorder | KLIPS | INTERVENTIONAL | UNKNOWN | 2011-03-02T00:00:00 | null | null | null | [
"EARLY_PHASE1"
] | 122 | 18 | 60 | ALL | false | The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic patients with comorbid substance use disorder. | null | Inclusion Criteria:
* Schizophrenia
* Addiction
* Written statement of agreement
* Majority
Exclusion Criteria:
* Acute psychosis
* Further neuropsychiatric disorder | University of Cologne | OTHER | {
"id": "Koeln-Fortune 104/2010",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-08-05T00:00:00 | {
"date": "2011-08-08",
"type": "ESTIMATED"
} | {
"date": "2011-08-08",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
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} | [
"Psychosis",
"Substance Abuse"
] | ["KLIPS"] | null | [
{
"city": "Cologne",
"country": "Germany",
"facility": "LVR Clinic Cologne - Academic Clinic of the University of Cologne",
"geoPoint": {
"lat": 50.93333,
"lon": 6.95
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Substance use",
"timeFrame": "one year"
},
{
"description": null,
"measure": "Substance use",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Substance use",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Change in drug use motivation",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Change in drug use motivation",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Change in drug use motivation",
"timeFrame": "1 year"
}
],
"secondary": null
} | [
{
"affiliation": "University of Cologne",
"name": "Joerg Daumann, PhD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D019967",
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],
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"abbrev": "BXM",
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],
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],
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"term": "Psychotic Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
]
} | null | {
"conditions": [
{
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"term": "Substance-Related Disorders"
},
{
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"term": "Psychotic Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
"interventions": null
} |
NCT02909166 | null | Role of ALiskiren, a Direct Renin Inhibitor, in Preventing Atrial Fibrillation in Patients With a Pacemaker; RALF. | Role of ALiskiren, a Direct Renin Inhibitor, in Preventing Atrial Fibrillation in Patients With a Pacemaker; RALF. A Double-blind, Randomized, Parallel-group, Single Centre Study | RALF | INTERVENTIONAL | UNKNOWN | 2016-09-16T00:00:00 | null | null | null | [
"PHASE3"
] | 70 | 18 | 85 | ALL | false | The aim of the study is to find out whether aliskiren reduces atrial fibrillation burden measured with a pacemaker device | The aim of the study is to find out the effect of a direct renin inhibitor, aliskiren, in reduction of AF with patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation.
Hypothesis is that there is a possibility to reduce atrial remodeling due to AF and also to enhance atrial reverse remodeling with aliskiren. The effect of aliskiren to total AF burden will be evaluated from the pacemaker's memory storage.
The main purpose of the study is to find new and safe drug treatments targeting to reduce AF recurrences and related complications in pacemaker patients. Also the aim is to evaluate the feasibility of a modern and highly sophisticated pacemaker system in the evaluation of drug treatment with AF reduction. | Inclusion Criteria:
* age between 18 and 85 years
* sinus node disease and paroxysmal AF
* provided signed informed consent according to the Declaration of Helsinki for study participation
* a previously implanted St. Jude Medical Identity / Victory / Zephyr ADX or any newer model of SJM DDDR pacemaker with ability to record high atrial rates
Exclusion Criteria:
* contraindication for the use of aliskiren
* severe impairment of renal function (serum creatinine \> 160 µmol/L) or patient with solitary kidney or renal transplant or renal artery stenosis
* significant known aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy
* hypersensitivity to aliskiren or to any of the excipients
* concomitant treatment with cyclosporine
* patients with uncontrolled hypertension requiring treatment for hypertension
* systolic blood pressure measured in two separate occasions ≥ 160 mmHg
* diastolic blood pressure in two separate occasions ≥ 100 mmHg
* absolute indication for the use of an RAAS blocker
* chronic, persisting AF (persisting AF at screening with ≥ 4 cardioversions performed beforehand)
* sitting systolic arterial blood pressure of less than 100 mm Hg at the time of randomisation
* need for ventricular pacing more than 30% at the enrolment
* pregnancy and/or lactation
* women of childbearing potential (only postmenopausal women or women after tubal ligation will be allowed)
* other serious disease expected to cause substantial deterioration of patient's health during the next two years
* past or present alcohol or drug abuse
* participation in other clinical trials during the last three months
* suspicion of poor study compliance | Helsinki University Central Hospital | OTHER | {
"id": "RALF",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-09-20T00:00:00 | {
"date": "2016-09-21",
"type": "ESTIMATED"
} | {
"date": "2016-09-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Atrial Fibrillation"
] | null | null | [
{
"city": "Helsinki",
"country": "Finland",
"facility": "Helsinki University Central Hospital",
"geoPoint": {
"lat": 60.16952,
"lon": 24.93545
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "burden of atrial fibrillation",
"timeFrame": "From the start of the study to the end of the study; 0 - 12 months"
}
],
"secondary": [
{
"description": null,
"measure": "number of AF episodes",
"timeFrame": "From the start of the study to the end of the study; 0 - 12 months"
},
{
"description": null,
"measure": "number of persistent AF episodes lasting more than 48 hours",
"timeFrame": "From the start of the study to the end of the study; 0 - 12 months"
},
{
"description": null,
"measure": "the length of the paced P-wave measured by high resolution ECG (SAECG)",
"timeFrame": "after each 6-month period"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001145",
"term": "Arrhythmias, Cardiac"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "All",
"name": "All Conditions"
}
],
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"id": "M4586",
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"relevance": "HIGH"
},
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"asFound": null,
"id": "M4453",
"name": "Arrhythmias, Cardiac",
"relevance": "LOW"
},
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"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001281",
"term": "Atrial Fibrillation"
}
]
} | {
"ancestors": [
{
"id": "D000092502",
"term": "Renin Inhibitors"
},
{
"id": "D011480",
"term": "Protease Inhibitors"
},
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"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
}
],
"browseBranches": [
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"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
}
],
"browseLeaves": [
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"asFound": "Oxycodone",
"id": "M352589",
"name": "Aliskiren",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M2932",
"name": "Renin Inhibitors",
"relevance": "LOW"
},
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"asFound": null,
"id": "M19609",
"name": "HIV Protease Inhibitors",
"relevance": "LOW"
},
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"asFound": null,
"id": "M14343",
"name": "Protease Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C446481",
"term": "Aliskiren"
}
]
} | {
"conditions": [
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"id": "D001281",
"term": "Atrial Fibrillation"
}
],
"interventions": [
{
"id": "C446481",
"term": "Aliskiren"
}
]
} |
NCT05501366 | null | Strategies to Augment Ketosis: Optimization of Ketone Delivery Strategies | Strategies to Augment Ketosis: Optimization of Ketone Delivery Strategies | STAK: OK'd | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2022-08-01T00:00:00 | null | null | null | [
"NA"
] | 14 | 20 | 30 | MALE | true | One important difference between KE compounds is the ketone-promoting components, which determines the circulating ratio of blood ketone bodies, BHB and AcAc, and may in turn lead to important metabolic and signaling differences. Whereas some actions of the ketone bodies BHB and AcAc are shared, R-BHB has a broad range of signaling functions that are distinct from AcAc, some of which are shared by the non-circulating, non-oxidizable enantiomer, S-BHB. AcAc also has metabolic and signaling actions that are independent of BHB and is selectively oxidized in some cells that cannot oxidize BHB. Furthermore, responses to different ketone bodies vary between tissue types. A second difference between KE arises from the balance between direct delivery of ketones compared to indirectly elevating ketone concentration via metabolism of non-classical or classical ketogenic precursors. Classical ketogenesis itself may drive adaptation and some of the functional benefits associated with ketosis. BDO is included in all of the KE compounds, but it is currently unknown how consumption of BDO alone, and its metabolism via non-classical ketogenesis acutely affects metabolism. Additionally, ketogenesis is now understood to occur in certain cells outside the liver with important local biological effects, for example ketogenesis driven by medium chain fatty acids has been reported in astrocytes in vitro. Provision of systemic BHB by a KE may elicit different biological effects in some tissues such as the brain versus promoting in situ ketogenesis in that tissue. Overall, not only are functional effects of KE incompletely defined, but also it is unknown which effects are common to all KE versus which are specific to an individual KE compound (i.e., BHB Monoester vs AcAc Diester) or which may be attributable to the BDO precursor common to all of the KE. This study will be the first comparative full crossover study of all available KE and the precursor BDO at two serving sizes. Outcomes will focus on established effects of the BHB Monoester (including the effects on ketones, glucose and acid-base balance) and compare these with the effects of the AcAc Diester, C8 Ketonef Diester and BDO. | BHB Monoester, C8 Diester, and (R) 1,3 Butanediol are commercially available in the products 'deltaG' (TdeltaS Global, FL, USA), 'Cognitive Switch' (Juvenescence Ltd, NJ, USA) and 'Avela' (Genomatica, CA, USA), respectively. The AcAc Diester is commercially available and is currently being used in clinical studies of Angelman's Disease. Therefore, we will standardize KE dosing to LBM (assessed using DXA) for all trials at 180 and 360 mg/kg LBM, which for a participant with 70 kg of lean mass corresponds to \~12.5 and 25 g, respectively. These doses are representative of typical commercial serving sizes and are expected to elevate blood BHB in the range of 1.5 - 2 mM39,61. All KEs will be consumed in their finished commercial form. As the KEs have different delivery matrices and flavorings (water-based beverage, emulsion beverage, gel capsules), we will not blind participants to each condition as this will not alter the metabolic outcomes of interest. Screening Visit: Participants that meet the initial qualifying criteria will visit the study center for a screening meeting in a private office to discuss the informed consent form with research team. The informed consent form will be provided to the participant for their review, the study will be described in full detail and any questions the interested participant has will be encouraged and responded to. The participant will be informed that even if they have signed the consent form, their participation in the study is dependent on anthropometric measures and diet and medical questionnaire answers to determine if they meet the study criteria. If the participant provides consent, they will be provided with questionnaires including Automated Self-administered 24-hour Dietary Assessment Tool (ASA24®),and medical history. All collected samples and data will be coded to maintain participant anonymity. We will give the participants a small volume of Study Product to screen for tolerance of the bitter tasting Study Products. We will also measure height, weight, BMI and body composition using a DXA scanner. If the participant is eligible for the study and is still interested in participating then they will be randomized to a study product order and scheduled to return to the study center for the first testing visit. Eligible participants will report to the study center in compliance with pre-test instructions (fasted \> 10h, no alcohol \>24h, no exercise \>24h, consumed pre-test food). Upon testing day, participants will complete a baseline Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale. Participants will be asked to completely void their bladder and a sample will be analyzed for hydration status. Bluetooth heart rate monitor chest strap will be administered. A study team member will assist the participant with application of a continuous ketone meter into the back of the arm, this will be removed and replaced with a fresh sensor at Test Days at \~2-week intervals; the sensor will be removed 24 hours after the cessation of the last in lab testing bout. Participants will be given written instructions on how to remove and dispose of monitor. A trained member of the study team will insert an IV cannula into a vein in the antecubital fossa to allow for repeated blood sampling. The cannula will be flushed with a small volume of saline after each sample withdrawal to maintain patency. We will collect 56mL of blood (7 x 8mL tubes) per testing day, which will be about 504mL of blood for the entire study. This is about 2.1 cups of blood. We will also collect capillary blood samples from a finger for real-time analysis of blood BHB and glucose concentration, using lancing device, commercially available test strips and a handheld monitor (KetoMojo, CA, USA). Participants will wear a fitted facemask connected to a metabolic cart for 10 minutes to collect measures of respiratory gas exchange. Participants will exhale once into a commercially available handheld breath acetone analyzer (Readout, MI, USA). Baseline blood sample, baseline respiratory gas measures and baseline breath acetone will be collected. Participants will then consume the Study Product that they were randomly allocated for that Test Day (details of Study Products attached in other files). Time of ingestion should be +/- 60 minutes from the time established at Test Day 1; they will be given 5 minutes to consume the Product. After Study Product consumption, they will remain at the study center for \~4 hours, repeating the aforementioned tests at 30min, 60 min, 90min, 180min \& 240min. Participants will be asked to minimize ambulatory movement during the Test Day. Non caloric beverages (i.e.,water) will be permitted ad libitum and intake volumes will be recorded. At the end of each Test Day, the heart rate monitor and IV cannula will be removed and a dressing will be applied to the cannula site. Participants will be given a snack to consume before leaving the site. | Inclusion Criteria:
* Male
* BMI between 18 and 29 kg/m2
* Aged 20 - 30 years
* Participant is willing and able to comply with all study procedures including the following prior to Test Days: fasting (\>10 h; water only), no alcohol (\>24 h), no exercise (\>24 h), no acute illness and controlled feeding before each Test Day, maintain diet, exercise, medication, and supplement habits throughout the study.
* Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history.
* Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.
Exclusion Criteria:
* Participant follows a low-carbohydrate diet (\<30% energy from carbohydrate) or have used exogenous ketone supplements within 4-months of study participation.
* Participant has a Primary Care Physician diagnosed history or presence of uncontrolled and/or clinically important hypertension (blood pressure \>150/95 mmHg), pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders.
* Participant has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages, including soy and milk protein, wheat, shellfish, fin fish, eggs, tree nuts or peanuts (production facility handles nuts).
* Participant has unstable use of a medication or supplement that the Investigator considers may affect the outcomes of the trial.
* Consumption of alcohol more than 3 drinks per day or more than 18 drinks per week.
* Consumption of tobacco.
* Consumption of cannabis.
* Participant is currently in another research study or has been in the 14 days before screening.
* Participant has had a blood draw or donation in the last 8 weeks.
* Participant has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study beverage \[e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the Investigator), history of frequent diarrhea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the Investigator, medication managed reflux and/or clinically important lactose intolerance\].
* Participant has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk. | Ohio State University | OTHER | {
"id": "2022H0160",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-08-11T00:00:00 | {
"date": "2025-05-29",
"type": "ACTUAL"
} | {
"date": "2022-08-15",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"Ketosis"
] | null | null | [
{
"city": "Columbus",
"country": "United States",
"facility": "The Ohio State University",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Total Plasma Ketone AUC",
"timeFrame": "Up to ~ 4 weeks"
}
],
"secondary": [
{
"description": null,
"measure": "Capillary d-BHB concentrations",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "AcAc, R-BHB and S-BHB changes across trials",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Continuous Ketone and Glucose Monitoring",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Ketone Excretion",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Ketone in breathe expiration",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Alanine Change",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Lactate Change",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Free Fatty Acid Change",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Heart Rate Variability",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Satiety Visual Analogue Scale",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Beverage tolerability questionnaire (BTQ)",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Insulin",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Ghrelin",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Acid-Base Balance",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Respiratory Gas Exchange",
"timeFrame": "Up to ~ 4 weeks"
},
{
"description": null,
"measure": "Whole blood clinical chemistry",
"timeFrame": "Up to ~ 4 weeks"
}
]
} | [
{
"affiliation": "Ohio State University",
"name": "Jeff S Volek, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D000138",
"term": "Acidosis"
},
{
"id": "D000137",
"term": "Acid-Base Imbalance"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
}
],
"browseBranches": [
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"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
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"abbrev": "All",
"name": "All Conditions"
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"name": "Acidosis",
"relevance": "LOW"
},
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"asFound": null,
"id": "M3498",
"name": "Acid-Base Imbalance",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11639",
"name": "Metabolic Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007662",
"term": "Ketosis"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "CNSDep",
"name": "Central Nervous System Depressants"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Ot",
"name": "Other Dietary Supplements"
}
],
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"relevance": "LOW"
},
{
"asFound": null,
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"name": "Tannic Acid",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T371",
"name": "Caproate",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D007662",
"term": "Ketosis"
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],
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} |
NCT06419166 | null | An Exploratory Clinical Study of GC012F Injection for Refractory gMG | An Exploratory Clinical Study of GC012F Injection for the Treatment of Refractory Generalized Myasthenia Gravis | gMG | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-04-25T00:00:00 | null | 2027-06-01T00:00:00 | 2027-10-01T00:00:00 | [
"EARLY_PHASE1"
] | 18 | 18 | 75 | ALL | false | This study is a single-arm, open-label early exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of GC012F injection in subjects with refractory GMG. Additionally, the study aims to assess the pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and immunogenicity of GC012F injection in subjects. | This study is a single-arm, open-label early exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of GC012F injection in subjects with refractory GMG. Additionally, the study aims to assess the pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and immunogenicity of GC012F injection in subjects.
The trial consists of several phases: screening period, apheresis day, baseline period, lymphodepletion period, pre-infusion assessment period, GC012F infusion period, safety and efficacy follow-up period, long-term follow-up period, and study discontinuation visit (if applicable).
Qualified subjects will undergo apheresis and receive the infusion after the production of CAR-T products. Subjects will undergo lymphodepletion before CAR-T cell infusion and assessment before infusion. Subjects meeting the cell infusion criteria will receive CAR-T cell infusion according to the dose specified in the protocol. Dose adjustments may occur based on safety and clinical efficacy for subjects in the same group or subsequent trial groups. | Inclusion Criteria:
1. Subjects or his/her legal proxy/guardian voluntary signing the ICF, and willing and able to follow the procedure in this study.
2. Aged ≥18 years old, no gender limitation;
3. Patients with confirmed refractory GMG, and the clinical classification is IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa and IVb) in screening;
4. Patients whose MG-ADL score is 5 or more, and the proportion of ocular symptoms is less than 50% in the total score;
5. Patients with poor efficacy of conventional treatment and/or no effective treatment means relapse or exacerbation despite conventional hormone, immunosuppressant (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporin A, cyclophosphamide, etc.), or rituximab treatment;
6. Patients who are on corticosteroids, the dose of prednisone should not exceed 20 mg/d (or no more than an equivalent dose of another corticosteroid) during the 3 weeks prior to apheresis, and the dose isn't escalated during 3weeksk prior to apheresis, the dose isn't changed within 4 weeks prior to infusion;
7. Patients with positive MG-specific autoantibodies in the screening period: acetylcholine receptor autoantibody (anti-AChR) titer or muscle-specific tyrosine kinase autoantibody (anti-MuSK) or low-density lipoprotein receptor-associated protein 4 autoantibody (anti-LRP4) or anti-acetylcholine receptor cluster antibody must be higher than the upper limit of the laboratory reference normal value;
8. Life expectancy ≥3 months;
9. The results of laboratory test during screening period shall meet all following criteria:
1. Neu ≥1.0 × 109/L; Hb ≥8.0 g/dL; PLT ≥50 × 109/L;
2. ALT ≤3 × ULN; AST ≤3 × ULN; TBIL \<2 × ULN (DBIL ≤1.5 × ULN for subjects with Gilbert's syndrome)
3. Creatinine clearance (19.3 Appendix 3) ≥30 mL/min;
4. APTT ≤1.5 × ULN, PT ≤1.5 × ULN;
5. LVEF ≥50% based on echocardiography, no findings of pericardial effusion.
10. Women of child-bearing age should:
1. Have a negative serum β human chorionic gonadotropin (β-hCG) pregnancy test confirmed by investigators during the screening period;
2. Agree to avoid breastfeeding during the study period until at least 1 year after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later).
11. Any male subjects who have sexual partners and female subjects with childbearing potential shall agree to take effective contraceptive methods (e.g. oral contraceptive pills, intrauterine device or condoms) from the screening starting until at least 1 year post GC012F Injection infusion or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later. Male subjects must agree to use condoms during sexual contact with pregnant females or females with fertility for at least 1 year after the infusion of GC012F Injection, even if a successful vasectomy has been performed;
12. Venous access available for blood collection, and no contraindications for leukapheresis.
exclusion criteria:
1. Subjects have a history of severe hypersensitivity or allergy;
2. Any contraindication for fludarabine, cyclophosphamide and any component of the investigational product;
3. Subjects with any of the following heart diseases:
1. Congestive heart failure (New York Heart Association (NYHA) Class III or IV);
2. Experienced myocardial infarction or underwent coronary artery bypass grafting (CABG) within 6 months prior to screening period;
3. Clinically significant ventricular arrhythmias or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval \>480 ms during screening;
4. History of severe non-ischemic cardiomyopathy.
4. Accompanied by other uncontrolled malignancies. Subjects with the following conditions should be excluded: early-stage tumors that have received radical treatment (carcinoma in situ or grade 1 tumors, or non-ulcerated primary melanoma with a depth \<1 mm and no involvement of lymph nodes), basal cell skin cancer, skin squamous cell carcinoma, cervical carcinoma in situ, or breast cancer in situ that has received potential radical treatment;
5. Severe underlying medical conditions, such as:
1. Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require general intravenous administration;
2. Significant clinical evidence of dementia or mental status changes;
3. History of any central nervous system (CNS) or neurodegenerative diseases, (e.g., epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychiatric disorders).
6. Positive results in any of the following tests:
1. HIV antibody positive;
2. HBsAg positive; or HBcAb positive and HBV-DNA above the lower limit of detection of the analytical method;
3. HCV antibody positive with HCV RNA above the lower limit of detection of the analysis method; or known history of hepatitis C without completion of antiviral therapy for ≥24 weeks;
4. Syphilis antibody positive.
7. Received therapy of non-hormonal immunosuppressants within 3 weeks prior to apheresis;
8. Major surgery within 2 weeks prior to leukapheresis or surgery plan during the study (except for local anesthesia surgery, but not performed within 2 weeks after infusion);
9. Receipt of a live-attenuated vaccine within 4 weeks prior to leukapheresis;
10. Intravenous injection of immunoglobulins or therapy of plasma exchange (PE);
11. Receipt of other biologics for MG within 3 weeks prior to apheresis or within 8 weeks prior to infusion;
12. Participation in any other clinical trial within 4 weeks prior to signing ICF, or the date of signing the ICF still within 5 half-lives of the drug from the last dose in the last clinical trial (whichever is longer);
13. Thymectomy within 12 months prior to ICF signing;
14. Pregnant women or lactating women who do not agree to abstain from breastfeeding, men and women who have a fertility plan during participation in this study or within 1 year after receiving study treatment;
15. Any situation that may hinder subjects' participation in the entire trial or confuse the results, or any situation in which investigators believe that participation in this study is not in the subject's best interests. | Zhejiang University | OTHER | {
"id": "TXB2024002",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-05-13T00:00:00 | {
"date": "2024-07-29",
"type": "ACTUAL"
} | {
"date": "2024-05-17",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Refractory Generalized Myasthenia Gravis"
] | null | null | [
{
"city": "Hanzhou",
"country": "China",
"facility": "The First Affiliated Hospital,College of Medicine, Zhejiang University",
"geoPoint": {
"lat": 26.4965,
"lon": 99.437
},
"state": "Zhejiang"
}
] | [
{
"class": "INDUSTRY",
"name": "Gracell Biotechnologies (Shanghai) Co., Ltd."
}
] | null | {
"other": [
{
"description": null,
"measure": "• Detection rate of CAR-T cell antibodies in peripheral blood within 24 weeks post-GC012F infusion;",
"timeFrame": "within 24 weeks post-GC012F infusion;"
},
{
"description": null,
"measure": "• Changes in serum immunoglobulin levels (including IgG, IgM, IgA, and IgE) in patients within 24 weeks post-GC012F infusion;",
"timeFrame": "within 24 weeks post-GC012F infusion"
},
{
"description": null,
"measure": "• Detection rate of replication-competent lentivirus (RCL).",
"timeFrame": "Within 15 years after GC012F injection infusion"
}
],
"primary": [
{
"description": null,
"measure": "Incidence of DLT",
"timeFrame": "Within 28 days after GC012F injection infusion"
},
{
"description": null,
"measure": "Frequency and severity of abnormal findings in electrocardiograms",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Frequency and severity of abnormal findings of adverse events.",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Frequency and severity of abnormal findings in physical examinations",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Frequency and severity of abnormal findings in laboratory tests",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Frequency and severity of abnormal findings in vital signs",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "RP1D",
"timeFrame": "2 years after GC012F injection infusion"
},
{
"description": null,
"measure": "MTD",
"timeFrame": "2 years after GC012F injection infusion"
}
],
"secondary": [
{
"description": null,
"measure": "PK parameters of CAR-T cells in peripheral blood after GC012F infusion (Cmax);",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "PK parameters of CAR-T cells in peripheral blood after GC012F infusion (Tmax);",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "PK parameters of CAR-T cells in peripheral blood after GC012F infusion ( AUC);",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Levels of cytokines [IL-6、IL-10、IFN-γ、TNF-α、MCP-1(as applicable)], lymphocyte subsets, and soluble BCMA in peripheral blood after GC012F infusion;",
"timeFrame": "Within 28 days after GC012F injection infusion"
},
{
"description": null,
"measure": "Disease activity indices:MG-ADL",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Disease activity indices:MGC",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Disease activity indices:QMG",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Disease activity indices: MG-QoL 15r",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
},
{
"description": null,
"measure": "Disease activity indices: post-intervention status according to the Myasthenia Gravis Foundation of America (MGFA) classification",
"timeFrame": "Within 96 weeks after GC012F injection infusion"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D020361",
"term": "Paraneoplastic Syndromes, Nervous System"
},
{
"id": "D009423",
"term": "Nervous System Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D010257",
"term": "Paraneoplastic Syndromes"
},
{
"id": "D020274",
"term": "Autoimmune Diseases of the Nervous System"
},
{
"id": "D019636",
"term": "Neurodegenerative Diseases"
},
{
"id": "D020511",
"term": "Neuromuscular Junction Diseases"
},
{
"id": "D009468",
"term": "Neuromuscular Diseases"
},
{
"id": "D001327",
"term": "Autoimmune Diseases"
},
{
"id": "D007154",
"term": "Immune System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
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"name": "Rare Diseases"
}
],
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"id": "M12112",
"name": "Myasthenia Gravis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M16355",
"name": "Syndrome",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M13170",
"name": "Paraneoplastic Syndromes",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22160",
"name": "Paraneoplastic Syndromes, Nervous System",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12367",
"name": "Nervous System Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4629",
"name": "Autoimmune Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22094",
"name": "Autoimmune Diseases of the Nervous System",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21558",
"name": "Neurodegenerative Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22297",
"name": "Neuromuscular Junction Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12411",
"name": "Neuromuscular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10200",
"name": "Immune System Diseases",
"relevance": "LOW"
},
{
"asFound": "Myasthenia Gravis",
"id": "T3973",
"name": "Myasthenia Gravis",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D009157",
"term": "Myasthenia Gravis"
}
]
} | null | {
"conditions": [
{
"id": "D009157",
"term": "Myasthenia Gravis"
}
],
"interventions": null
} |
NCT00990366 | null | Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve | Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve | None | INTERVENTIONAL | TERMINATED | 2009-10-05T00:00:00 | null | null | null | [
"NA"
] | 15 | 18 | 89 | ALL | false | Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve. | null | Inclusion Criteria:
* age 18-89
* biliary obstruction in the lower two thirds of the choledochus
Exclusion Criteria:
* allergy to contrast media
* future pancreaticoduodenectomy
* refusal from the study
* previous stent | Turku University Hospital | OTHER_GOV | {
"id": "58/180/2009",
"link": null,
"type": null
} | Interim analysis results, study terminated 5/2010 | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-10-05T00:00:00 | {
"date": "2011-10-12",
"type": "ESTIMATED"
} | {
"date": "2009-10-06",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Biliary Obstruction",
"Cholangitis"
] | ["antireflux valve", "biliary obstruction", "cholangitis", "biliary stent"] | null | [
{
"city": "Turku",
"country": "Finland",
"facility": "Turku University Hospital",
"geoPoint": {
"lat": 60.45148,
"lon": 22.26869
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "patency of a biliary stent",
"timeFrame": "one year"
}
],
"secondary": [
{
"description": null,
"measure": "Cholangitis",
"timeFrame": "one year"
}
]
} | [
{
"affiliation": "Turku University Hospital",
"name": "Paulina Salminen, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001649",
"term": "Bile Duct Diseases"
},
{
"id": "D001660",
"term": "Biliary Tract Diseases"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Cholangitis",
"id": "M6002",
"name": "Cholangitis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4935",
"name": "Bile Duct Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4946",
"name": "Biliary Tract Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D002761",
"term": "Cholangitis"
}
]
} | null | {
"conditions": [
{
"id": "D002761",
"term": "Cholangitis"
}
],
"interventions": null
} |
NCT05462366 | null | Omics Sequencing of Specimen Derived From Mother-Infant-Pairs | Omics Sequencing of Specimen Derived From Mother-Infant-Pairs | None | OBSERVATIONAL | RECRUITING | 2022-07-06T00:00:00 | null | 2024-12-30T00:00:00 | 2026-12-30T00:00:00 | null | 100 | null | 40 | ALL | true | The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens. | null | Inclusion Criteria:
* healthy pregnant women aged between 20y and 40y.
* Vaginal birth
* BMI\<23.5 before pregnancy
* Infants' birth weight, between 2500g and 4000g.
Exclusion Criteria:
* gestational diabetes
* diagnosis of depressive disorder during pregnancy
* gestational hypertension
* diagnosis of other diseases during pregnancy
* Under probiotics or antibiotic treatment from 3 months prior to pregnancy till 3 months after delivery
* histrory of smoking and drinking alcohol
* history of diarrhea from 3 months prior to pregnancy till 3 months after delivery | Zhujiang Hospital | OTHER | {
"id": "ZhujiangHFCYXZX",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-07-13T00:00:00 | {
"date": "2023-07-25",
"type": "ACTUAL"
} | {
"date": "2022-07-18",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | This study intends to screen pregnant women in the Obstetrics and Gynecology Center of Zhujiang Hospital, Southern Medical University, and preliminarily recruit subjects that meet the inclusion criteria according to clinical diagnosis and auxiliary examination results. According to the specific conditions of vaginal delivery and post-birth newborns, the final inclusion of healthy pregnant women and newborns will be determined, and a total of 40-50 mother-infant-pairs will be recruited | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "FAMILY_BASED",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Healthy",
"Breast-milk Collection",
"Feces"
] | null | null | [
{
"city": "Guangzhou",
"country": "China",
"facility": "Zhujiang Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Compare the omics differences of the specimens between the experimental and control groups",
"timeFrame": "2021.7.1-2026.12.30"
},
{
"description": null,
"measure": "Compare the microbial feature differences of the specimens between the experimental and control groups",
"timeFrame": "2021.7.1-2026.12.30"
}
],
"secondary": [
{
"description": null,
"measure": "Compare the health status differences between the experimental and control groups",
"timeFrame": "2021.7.1-2026.12.30"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT04778566 | null | Evaluating the Cologuard Test for Use in Lynch Syndrome | Evaluating the Cologuard Test for Use in Lynch Syndrome | None | OBSERVATIONAL | WITHDRAWN | 2021-02-26T00:00:00 | null | null | null | null | 0 | 18 | 89 | ALL | false | This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit. | The primary aim is to perform a pilot study to gain information toward the implementation of a larger prospective study that will compare the performance of Cologuard with the gold-standard colonoscopy in identifying advanced adenomas and colorectal cancers in LS. Data regarding rate of consent, and adherence to the protocol will be recorded. Since patients with known genetic predisposition to cancers tend to view screening tests more positively than the general population, a second aim of the study is to evaluate patient satisfaction with bowel preparation, colonoscopies, and Cologuard testing. Up to 90 individuals with genetically confirmed LS will be recruited via Geisinger's HRC to complete a goal of 90 Cologuard studies. Upon enrollment, Cologuard will be ordered by the study team at no cost to the subject and will be completed according to the standard instructions for use. Results will be securely obtained and blinded until the time of data analysis. Subjects will undergo colonoscopy as part of their routine HRC visit. Results from the colonoscopy (and biopsy as indicated) will be retrieved from the Electronic Health Record (EHR) and documented in a research-associated spreadsheet. If repeat colonoscopy is clinically indicated, repeat Cologuard may be completed if the subject meets inclusion criteria. | Inclusion Criteria:
* Patients age 18-89
* Diagnosis of genetically confirmed LS
* Scheduled for standard of care colonoscopy within 60 days of enrollment
Exclusion Criteria:
* Diagnosis of other inherited genetic disorders that increase risk for Colorectal Cancer (CRC) (Familial Adenomatous Polyposis (FAP), Cowden's syndrome, Turcot syndrome, Gardner syndrome, and Peutz-Jeghers syndrome)
* Diagnosis of other inherited Inflammatory bowel disease (i.e. Crohn disease, ulcerative colitis)
* Others with elevated risk of CRC outside of the inclusion criteria (i.e. ≥2 first-degree relatives who have been diagnosed with CRC without a defined inherited genetic disorder, Hereditary Non-Polyposis Colon Cancer (HNPCC) without genetic confirmation of LS)
* Participation in any interventional clinical study within the previous 30 days
* Personal history of CRC not in full remission (5 consecutive cancer-free years)
* Current active treatment with chemotherapy
* Treatment with chemotherapy within 12 months prior to consent date | Geisinger Clinic | OTHER | {
"id": "2020-0239",
"link": null,
"type": null
} | Recent discovery of a novel assay that is more likely to be beneficial for patients with Lynch Syndrome. Investing into current version of Cologuard test would provide little clinical benefit. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-02-26T00:00:00 | {
"date": "2021-11-17",
"type": "ACTUAL"
} | {
"date": "2021-03-03",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Adult patients being followed in the HRC with a diagnosis of LS | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Lynch Syndrome",
"Colorectal Cancer",
"Colonic Adenoma",
"Colonic Polyp"
] | ["Lynch Syndrome", "Colorectal Cancer", "Hereditary non-polyposis colon cancer", "High-Risk Colon Cancer", "Health-Related Quality of Life", "Bowel Prep Tolerability", "Colonoscopy", "Procedural anxiety"] | null | [
{
"city": "Danville",
"country": "United States",
"facility": "Geisinger Health",
"geoPoint": {
"lat": 40.96342,
"lon": -76.61273
},
"state": "Pennsylvania"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Evaluate the feasibility of the Cologuard test for Lynch Syndrome",
"timeFrame": "3 months"
}
],
"secondary": [
{
"description": null,
"measure": "Evaluate patient satisfaction with Cologuard",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Evaluate health-related quality of life in Lynch Syndrome",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Evaluate depressive symptoms",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Evaluate anxiety symptoms surrounding routine colonoscopy",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Evaluate bowel preparation tolerability",
"timeFrame": "3 months"
}
]
} | [
{
"affiliation": "Geisinger Clinic",
"name": "Rajiv Panikkar, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D004194",
"term": "Disease"
},
{
"id": "D010335",
"term": "Pathologic Processes"
},
{
"id": "D007414",
"term": "Intestinal Neoplasms"
},
{
"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"
},
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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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},
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},
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}
],
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{
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},
{
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"id": "T6034",
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}
],
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},
{
"id": "D003111",
"term": "Colonic Polyps"
}
]
} | {
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"abbrev": "HB",
"name": "Herbal and Botanical"
},
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}
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"term": "Syndrome"
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{
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],
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} |
NCT01645566 | null | Task Focusing Strategy During a Simulated Cardiopulmonary Resuscitation | Impact of a Task Focusing Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation: A Randomized Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2012-07-15T00:00:00 | null | null | null | [
"NA"
] | 124 | 18 | null | ALL | true | This is a prospective randomized controlled study. The aim of this study is to
1. describe the stress patterns experienced during a CPR situation;
2. investigate whether the perceived stress was associated with CPR performance in terms of hands-on time and time to start CPR;
3. to investigate whether this task focusing strategy reduces perceived stress levels, and
4. whether this translates into better CPR performance. Based on findings that clear, directive leadership can enhance performance in cardiac resuscitation, we further 5) investigate if stress was associated with fewer leadership statements. | null | Inclusion Criteria:
* 4th year medical students
Exclusion Criteria:
* No informed consent | University Hospital, Basel, Switzerland | OTHER | {
"id": "BS1330978",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-07-19T00:00:00 | {
"date": "2012-07-20",
"type": "ESTIMATED"
} | {
"date": "2012-07-20",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
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"timePerspective": null
} | [
"Mental Stress"
] | ["cardiopulmonary resuscitation", "stress", "intervention"] | null | [
{
"city": "Basel",
"country": "Switzerland",
"facility": "University Hospital Basel",
"geoPoint": {
"lat": 47.55839,
"lon": 7.57327
},
"state": "BS"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "perceived levels of stress and feeling overwhelmed (stress/overload)",
"timeFrame": "time from start of CPR until scenario is finished (usually 5-10min)"
}
],
"secondary": [
{
"description": null,
"measure": "hands-on time",
"timeFrame": "time from start of CPR until scenario is finished (usually 5-10min)"
},
{
"description": null,
"measure": "time to start CPR",
"timeFrame": "time from start of CPR until scenario is finished (usually 5-10min)"
},
{
"description": null,
"measure": "Number of leadership statements",
"timeFrame": "time from start of CPR until scenario is finished (usually 5-10min)"
}
]
} | [
{
"affiliation": "University Hospital Basel, Medical Intensive Care Unit",
"name": "Sabina Hunziker, MD, MPH",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "22115935", "type": "BACKGROUND", "citation": "Hunziker S, Semmer NK, Tschan F, Schuetz P, Mueller B, Marsch S. Dynamics and association of different acute stress markers with performance during a simulated resuscitation. Resuscitation. 2012 May;83(5):572-8. doi: 10.1016/j.resuscitation.2011.11.013. Epub 2011 Nov 22."}, {"pmid": "21695475", "type": "BACKGROUND", "citation": "Hunziker S, Laschinger L, Portmann-Schwarz S, Semmer NK, Tschan F, Marsch S. Perceived stress and team performance during a simulated resuscitation. Intensive Care Med. 2011 Sep;37(9):1473-9. doi: 10.1007/s00134-011-2277-2. Epub 2011 Jun 22."}, {"pmid": "21658557", "type": "BACKGROUND", "citation": "Hunziker S, Johansson AC, Tschan F, Semmer NK, Rock L, Howell MD, Marsch S. Teamwork and leadership in cardiopulmonary resuscitation. J Am Coll Cardiol. 2011 Jun 14;57(24):2381-8. doi: 10.1016/j.jacc.2011.03.017."}, {"pmid": "23607331", "type": "DERIVED", "citation": "Hunziker S, Pagani S, Fasler K, Tschan F, Semmer NK, Marsch S. Impact of a stress coping strategy on perceived stress levels and performance during a simulated cardiopulmonary resuscitation: a randomized controlled trial. BMC Emerg Med. 2013 Apr 22;13:8. doi: 10.1186/1471-227X-13-8."}] | {"versionHolder": "2025-06-18"} | {
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],
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}
],
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{
"id": "D013315",
"term": "Stress, Psychological"
}
]
} | null | {
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}
],
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} |
NCT04720066 | null | Hip POCUS for the Diagnosis of Pediatric Hip Effusion. | Accuracy of Point of Care Ultrasound (POCUS) for the Diagnosis of Hip Effusion Among Children in the Pediatric Emergency Department | None | OBSERVATIONAL | UNKNOWN | 2021-01-19T00:00:00 | null | null | null | null | 100 | 0 | 18 | ALL | false | Limping is a common complaint among children presenting in the Pediatric ED the evaluation of a limp among infants and toddlers is challenging doe to the lack of specific history and the difficulty in locating the pain - therefore hip sonography is frequently used in the clinical evaluation of these children.
Sonographic examination for the diagnosis of hip effusion is routinely performed by the radiologist, however, since the integration of Point of care Ultrasound (POCUS) as part of the clinical evaluation of children in the ED in many application - Hip pocus is frequently performed by pediatric Emergency Medicine physicians.
The existing data on hip POCUS is scarce and comprised of small uncontrolled studies.
We aimed to examine the specificity and sensitivity of hip Pocus performed by pediatric emergency physicians by comparing it to the scan performed by the radiologist.
the primary outcome measurement is the ability of the POCUS exam to identify or rule out the existence of hip effusion as demonstrated in the formal radiological Ultrasound scan. | Children (0-18 years) presenting to the PED in Meir medical center with limp pain (not due to trauma) or a limp are recruited After consenting to participate in the study and completing the registration process the primary physician who is an approved researcher by the institutes IRB will perform hip POCUS as part of the clinical evaluation and will record his interpretation in the medical file. A formal ultrasound scan will be perfumed additionally by the radiologist. Both examination will be reviewed by POCUS lead physician and the Pediatric radiologist.
The patient's clinical and epidemiological data will be extracted from the electronic chart. | Inclusion Criteria: pediatric patients presenting to the PED with the complaint of a limp or a lower limb pain
-
Exclusion Criteria:
* trauma patients
* patients with an obvious diagnosis other than pain resulting from the hip joint on their physical examination. | Meir Medical Center | OTHER | {
"id": "0119-20-MMC",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-01-21T00:00:00 | {
"date": "2021-10-26",
"type": "ACTUAL"
} | {
"date": "2021-01-22",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | * pediatric patients (age 0-18 years) presenting to the PED with the complaint of a limp or a lower limb pain | NON_PROBABILITY_SAMPLE | null | {
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"maskingInfo": null,
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"timePerspective": "PROSPECTIVE"
} | [
"Hip Effusion"
] | ["Hip Effusion, point of care sonography, pediatric,"] | null | [
{
"city": "Kfar Saba",
"country": "Israel",
"facility": "Ayelet Shles",
"geoPoint": {
"lat": 32.175,
"lon": 34.90694
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "accuracy of POCUS examination for the detection of hip effusion among limping children",
"timeFrame": "both examination are performed during the same 1 day ED visit."
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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"name": "Symptoms and General Pathology"
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],
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} |
NCT04820166 | null | The Effect of Monitoring PVP on Clinical Outcomes in Patients With PH | The Effect of Monitoring Portal Venous Pressure on Clinical Outcomes in Patients With Portal Hypertension: a Prospective, Single-center, Observational Study | None | OBSERVATIONAL | RECRUITING | 2021-03-18T00:00:00 | null | 2025-12-31T00:00:00 | 2025-12-31T00:00:00 | null | 200 | 18 | 80 | ALL | null | The complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. HVPG (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of NSBBS. However, monitoring HVPG has many limitations，and the clinical application is also limited to a certain extent. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. At the same time, to explore the correlation between HVPG and PPG in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension. | null | Inclusion Criteria:
* With chronic liver disease
* Age 18-80 years
* Patients who require a portal pressure measurement at the discretion of the treating physician
* Voluntarily signed informed consent
Exclusion Criteria:
* With serious cardiopulmonary disease or other diseases affect survival
* With severe renal dysfunction
* Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis
* Women who are planning to become pregnant or who are pregnant or breastfeeding
* The researcher judged that it was not suitable to participate in this study | Nanfang Hospital, Southern Medical University | OTHER | {
"id": "NFEC-2021-062",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-03-26T00:00:00 | {
"date": "2021-03-29",
"type": "ACTUAL"
} | {
"date": "2021-03-29",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | patients with portal hypertension | PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Portal Hypertension"
] | null | null | [
{
"city": "Guangzhou",
"country": "China",
"facility": "Nanfang Hospital",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Gastroesophageal varices bleeding",
"timeFrame": "three years"
},
{
"description": null,
"measure": "Ascites",
"timeFrame": "three years"
},
{
"description": null,
"measure": "Hepatic encephalopathy",
"timeFrame": "three years"
}
],
"secondary": [
{
"description": null,
"measure": "Death or final follow-up time (3 years)",
"timeFrame": "three years"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D008107",
"term": "Liver Diseases"
},
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"id": "D004066",
"term": "Digestive System Diseases"
}
],
"browseBranches": [
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
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"abbrev": "All",
"name": "All Conditions"
},
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"abbrev": "BC06",
"name": "Digestive System Diseases"
}
],
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"id": "M10024",
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},
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"id": "M10026",
"name": "Hypertension, Portal",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11107",
"name": "Liver Diseases",
"relevance": "LOW"
},
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"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
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"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D006975",
"term": "Hypertension, Portal"
},
{
"id": "D006973",
"term": "Hypertension"
}
]
} | null | {
"conditions": [
{
"id": "D006975",
"term": "Hypertension, Portal"
},
{
"id": "D006973",
"term": "Hypertension"
}
],
"interventions": null
} |
NCT01876966 | null | Interaction Between Etravirine or Darunavir/Ritonavir and Artemether / Lumefantrine | A Phase I, Partially Randomized, Open Label, Two-way, Two Period Cross-over Study to Investigate the Pharmacokinetic Interaction Between Etravirine or Darunavir/Rtv and Artemether/Lumefantrine at Steady-state in Healthy HIV-negative Subjects | DDI Coartem | INTERVENTIONAL | COMPLETED | 2012-11-19T00:00:00 | null | null | null | [
"PHASE1"
] | 33 | 18 | 55 | ALL | true | The purpose of this study is to investigate the pharmacokinetic interaction between etravirine and artemether/lumefantrine and darunavir/ritonavir and artemether/lumefantrine in healthy Human Immunodeficiency Virus- (HIV-)negative patients. 'Pharmacokinetic interaction' means that one medication can influence the absorption and elimination from the body of the other medication. | This is a Phase I, partially randomized, open-label, single-center, two-way, two-period cross-over study to investigate the pharmacokinetic interaction between etravirine (ETR) or darunavir/ritonavir (DRV/rtv) and the antimalarial drugs artemether/lumefantrine at steady-state in healthy human immunodeficiency virus (HIV)-negative patients. The study population will consist of 32 healthy patients, equally divided over 2 panels. Patients in Panel 1 will be treated with ETR and artemether/lumefantrine; patients in Panel 2 will be treated with DRV/rtv and artemether/lumefantrine. Treatment A will consist of 3 days of treatment with artemether/lumefantrine. Treatment B will consist of 200 mg ETR twice daily (b.i.d.) (Panel 1) or 600/100 mg DRV/rtv b.i.d. (Panel 2) from Day 1 to Day 21 with a single dose of ETR (Panel 1) or DRV/rtv (Panel 2) in the morning on Day 22. From Day 8, 3 days of treatment with artemether/lumefantrine. In a first stage of treatment in Panel 2, only 4 patients will be allowed to start Treatment B. Based on the ECG results of the first 4 patients with evaluable ECG data after assessments on Day 11 (66 hours after the combined intake of DRV/rtv and artemether/lumefantrine), the Sponsor will decide whether additional patients can be allowed to start Treatment B. There will be a washout period of at least 4 weeks between Treatments A and B. Half of the patients of Panel 1 (8 patients) and Panel 2 (8 patients) will be randomized to sequence AB and half will be randomized to sequence BA. Randomization in Panel 2 will occur in two steps. In Step 1, 4 patients will be allocated to sequence BA and evaluated for QTc prolongation. Based on the outcome of their ECG results, the Sponsor will decide whether the remainder of patients will be randomized in Step 2, i.e. 4 patients to BA and 8 patients to AB (1:2 randomization). Serial pharmacokinetic assessments will be determined for Panels 1 and 2 in Treatments A and B for artemether and its metabolite dihydroartemisinin (DHA) after the first intake of artemether/lumefantrine over 8 hours and after the last intake of artemether/lumefantrine over 72 hours (3 days), and for lumefantrine after the last intake of artemether/lumefantrine over 264 hours (11 days). Serial pharmacokinetic assessments will be determined for ETR (Panel 1) or DRV and rtv (Panel 2) over the 12-hour dosing interval on Day 8 (after the morning intake) and Day 11 (after the last dose of artemether/lumefantrine) of Treatment B. All ETR, DRV/rtv and artemether/lumefantrine treatments will be administered under fed conditions and will be taken within 10 minutes after completion of a meal. Safety and tolerability evaluations will be recorded on an ongoing basis. | Inclusion Criteria:
* if of childbearing potential or if male, use a highly effective method of birth control.
* Able to comply with protocol requirements.
* A BMI (weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included.
* healthy on the basis of a medical evaluation
* Non-smoking for at least 3 months prior to selection.
Exclusion Criteria:
* previously demonstrated clinically significant allergy, hypersensitivity or intolerance to any of the investigational medications or its excipients
* Use of concomitant medication, including over-the-counter products and dietary supplements.
* Having participated in more than 1 study (single or multiple dose) with ETR (TMC125), DRV (TMC114), dapivirine (TMC120) and/or rilpivirine (TMC278, formerly known as R278474), or having developed a rash, erythema or urticaria while participating in a study with the aforementioned compounds.
* A positive pregnancy test or breast feeding at screening or on Day 1.
* Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements | Janssen Pharmaceutica N.V., Belgium | INDUSTRY | {
"id": "CR018409",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2013-06-11T00:00:00 | {
"date": "2013-06-13",
"type": "ESTIMATED"
} | {
"date": "2013-06-13",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
} | [
"HIV"
] | ["HIV", "pharmacokinetic interaction", "healthy HIV-negative person"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "effect of ETR or DRV/rtv on the plasma concentrations of artemether, lumefantrine and dihydroartemisinin",
"timeFrame": "Treatment A: Day 1-2 & Day 4-15; Treatment B: Day 8-9 & Day 11-22"
},
{
"description": null,
"measure": "effect of ETR or DRV/rtv on the Area under the concentration-time curve (AUC) in plasma for artemether, lumefantrine and dihydroartemisinin",
"timeFrame": "Treatment A: Day 1-2 & Day 4-15; Treatment B: Day 8-9 & 11-22"
},
{
"description": null,
"measure": "Plasma concentrations of ETR, DRV and rtv",
"timeFrame": "Treatment B: Day 8 & Day 11"
},
{
"description": null,
"measure": "Area under the concentration-time curve (AUC) in plasma for ETR, DRV and rtv",
"timeFrame": "Treatment B: Day 8 & Day 11"
}
],
"secondary": [
{
"description": null,
"measure": "Number of Participants with Adverse Events as a Measure of Safety and Tolerability",
"timeFrame": "at screening, during treatment and at day 7 and 30, 31 or 32 after last study medication intake"
},
{
"description": null,
"measure": "Profile of pharmacokinetics of ETR by cytochrome P450 (CYP)2C9 and CYP2C19 genotype",
"timeFrame": "Treatment B: Day 8"
},
{
"description": null,
"measure": "Profile of pharmacokinetics of artemether and DHA after single and multiple dose(s)",
"timeFrame": "Treatment A: Day 1-2 & Day 4-7"
}
]
} | null | [{"pmid": "23441978", "type": "RESULT", "citation": "Kakuda TN, DeMasi R, van Delft Y, Mohammed P. Pharmacokinetic interaction between etravirine or darunavir/ritonavir and artemether/lumefantrine in healthy volunteers: a two-panel, two-way, two-period, randomized trial. HIV Med. 2013 Aug;14(7):421-9. doi: 10.1111/hiv.12019. Epub 2013 Feb 26."}] | {"versionHolder": "2025-06-18"} | {
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"abbrev": "BXS",
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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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"relevance": "LOW"
}
],
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"id": "D019438",
"term": "Ritonavir"
},
{
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"term": "Darunavir"
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{
"id": "D000078102",
"term": "Lumefantrine"
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"term": "Artemether"
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"term": "Etravirine"
},
{
"id": "D000077611",
"term": "Artemether, Lumefantrine Drug Combination"
}
]
} | {
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"id": "D019438",
"term": "Ritonavir"
},
{
"id": "D000069454",
"term": "Darunavir"
},
{
"id": "D000078102",
"term": "Lumefantrine"
},
{
"id": "D000077549",
"term": "Artemether"
},
{
"id": "C451734",
"term": "Etravirine"
},
{
"id": "D000077611",
"term": "Artemether, Lumefantrine Drug Combination"
}
]
} |
NCT05425966 | null | Adapting a Web-Based Professional Development for Mexican School Mental Health Providers Delivering Evidence-Based Intervention for ADHD and ODD | Adapting a Remote Training for Mexican School Clinicians Delivering Evidence-Based Intervention for ADHD and ODD | None | INTERVENTIONAL | COMPLETED | 2022-06-15T00:00:00 | null | 2022-06-30T00:00:00 | 2022-06-30T00:00:00 | [
"NA"
] | 67 | 5 | null | ALL | false | Neurodevelopmental disorders of inattention and disruptive behavior, such as Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD), are among the most common youth mental health conditions across cultures. An efficacious and feasible solution to improving affected youth's ADHD/ODD is training existing school clinicians to deliver evidence-based intervention with fidelity. Despite initial promising results of training school clinicians to treat ADHD/ODD in settings suffering from high unmet need, such as Mexico, scalability is limited by a lack of researchers with capacity to train, monitor, and evaluate school clinicians in such efforts on a large scale. Thus, there is a need to develop more feasible interventions and training programs for school clinicians, as well as create a system with capacity for scalable training and evaluation, to combat the widespread impact ofADHD/ODD worldwide. Converting interventions and school clinician professional development programs for fully-remote delivery allows for more flexibility, accessibility, affordability, scalability, and promise for ongoing consultation than in-person options. Supporting scalable training for school clinicians could address a significant public health concern in Mexico, as only 14% of Mexican youth with mental health disorders receive treatment and less than half of those treated receive more than minimally adequate care. The study team is uniquely suited for this effort, given that they developed the only known school-homeADHD/ODD evidence-based intervention in Latin America-and-have developed a web-based training for U.S. school clinicians with promising preliminary results. The study team's prior studies and high levels of unmet need make Mexico an ideal location for this proposal; however, lessons learned could be used to expand scalable school clinician training for evidence-based intervention in other settings and/or for other disorders. Thus, this study focuses on conducting an open-trial of the fully-remote program and make iterative changes. It is predicted that: H1) school clinicians trained remotely will be satisfied and show improved evidence-based practice skills; H2)families and teachers participating remotely will be satisfied and youth will show improved ADHD/ODD; H3) observation/feedback from a 3-school open-trial will guide iterative changes to the remote program. | null | Inclusion Criteria:
* Students meeting the following criteria are eligible:
* at least six inattention symptoms and/or six hyperactive/impulsive symptoms endorsed by parent or teacher as occurring often or very often,
* at least one area of impairment rated as concerning by both parent and teacher, and
* a parent and teacher agreeing to participate.
* Students taking medication are eligible as long as regimens were stable.
* Parents and teachers and school clinicians of participating are eligible to participate.
Exclusion Criteria:
All Participants: Anyone who does not speak and read Spanish will be excluded, given that all informed consent, measurement, and activity procedures will be conducted in Spanish.
Child Participants
* Children taking medication will be eligible for screening after the child has been on a stable medication regimen for at least one month (to minimize chance that treatment effects are due to medication and not the proposed program).
* Presence of conditions that are incompatible with this study's treatment.
* severe visual or hearing impairment,
* severe language delay,
* psychosis,
* Child does not read or speak Spanish (inability to complete assessment measures or participate in group treatments).
* Child is in an all-day special education classroom. Children in these classrooms are frequently receiving intensive behavior modification programs and assistance such that the teacher consultation component would be expected to require modification for use in these settings. | University of California, San Francisco | OTHER | {
"id": "CLSRFUERTE",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-06-15T00:00:00 | {
"date": "2024-03-18",
"type": "ACTUAL"
} | {
"date": "2022-06-21",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"ADHD",
"Oppositional Defiant Disorder"
] | null | null | [
{
"city": "San Francisco",
"country": "United States",
"facility": "UCSF",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California"
}
] | [
{
"class": "NIH",
"name": "National Institute of Mental Health (NIMH)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined Type Symptom Severity Score",
"timeFrame": "Baseline and post treatment (8 weeks)"
},
{
"description": null,
"measure": "Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined Type Symptom Severity Score",
"timeFrame": "Baseline and post treatment (8 weeks)"
},
{
"description": null,
"measure": "Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score",
"timeFrame": "Baseline and post treatment (8 weeks)"
},
{
"description": null,
"measure": "Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score",
"timeFrame": "Baseline and post treatment (8 weeks)"
},
{
"description": null,
"measure": "Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score",
"timeFrame": "Baseline and post treatment (8 weeks)"
},
{
"description": null,
"measure": "Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score",
"timeFrame": "Baseline and post treatment (8 weeks)"
}
],
"secondary": null
} | [
{
"affiliation": "University of California, San Francisco",
"name": "Lauren M Haack, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D019958",
"term": "Attention Deficit and Disruptive Behavior Disorders"
},
{
"id": "D065886",
"term": "Neurodevelopmental Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
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"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"asFound": "Oppositional Defiant Disorder",
"id": "M3271",
"name": "Oppositional Defiant Disorder",
"relevance": "HIGH"
},
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"id": "M4594",
"name": "Attention Deficit Disorder with Hyperactivity",
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},
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},
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"id": "M14473",
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}
],
"meshes": [
{
"id": "D000096865",
"term": "Oppositional Defiant Disorder"
}
]
} | null | {
"conditions": [
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"term": "Oppositional Defiant Disorder"
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],
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} |
NCT01654666 | null | Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting | Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting | None | INTERVENTIONAL | COMPLETED | 2012-07-23T00:00:00 | null | null | null | [
"PHASE2"
] | 189 | 18 | 80 | ALL | false | Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and brain magnetic resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory effects on patients undergoing carotid artery stenting. | BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in Carotid Artery Stenting. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Our previous study found no significant protection to the patients who received once RIPC before Carotid Artery Stenting. In order to investigate whether long-term RIPC before Carotid Artery Stenting can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.
DESIGNING: About 189 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1:1 ratio to RIPC group, sham RIPC group and conventional Carotid Artery Stenting group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least two weeks before carotid artery stenting. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least two weeks before carotid artery stenting. Patients in the control group receive conventional carotid artery stenting without RIPC or sham RIPC treatment. Cerebral injury is assessed by serum S-100B and Neuron specific enolase (NSE), systematic inflammation is assessed by serum high-sensitivity C-reactive protein (hs-CRP). Post-treatment infarctions, both symptomatic and asymptomatic, are detected by diffusion-weighted imaging (DWI) and clinical outcomes are determined by cerebrovascular events, cardiac events or death. | Inclusion Criteria:
1. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 60% (Based on NASCET Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
2. Tolerance to any of the study medications, including clopidogrel, aspirin and statins;
3. Can cooperate with and complete brain MRI examination;
4. Has a negative pregnancy test within 7 days before randomization and no childbearing potential;
5. Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs;
6. No hemorrhagic tendency;
7. Stable vital sign, normal renal and hepatic functions;
8. Informed consent.
Exclusion Criteria:
1. Evolving stroke;
2. Prior major ipsilateral stroke, if likely to confound study endpoints;
3. Severe dementia;
4. Hemorrhagic conversion of an ischemic stroke within the past 60 days;
5. Chronic atrial fibrillation;
6. Myocardial infarction within previous 30 days;
7. Inability to understand and cooperate with study procedures or provide informed consent;
8. Participating in other device or drug trial that has not completed the required protocol follow-up period;
9. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe;
10. High risk candidates defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST);
11. Any vascular, extremity soft tissue or orthopedic injury that may contraindicate bilateral arm ischemic preconditioning (e.g. superficial wounds and fractures of the arm);
12. Blood pressure cannot be controlled lower than 200 mmHg by medications;
13. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion). | Capital Medical University | OTHER | {
"id": "RIPC2012",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-07-28T00:00:00 | {
"date": "2015-11-11",
"type": "ESTIMATED"
} | {
"date": "2012-08-01",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Carotid Artery Stenosis"
] | ["Remote ischemic preconditioning", "Stroke secondary prevention", "Carotid artery stenting", "Carotid stenosis", "Inflammation"] | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Baojun Hou",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.",
"timeFrame": "Within six months after carotid artery stenting"
},
{
"description": null,
"measure": "Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.",
"timeFrame": "Within 48 hours after carotid artery stenting."
}
],
"secondary": [
{
"description": null,
"measure": "Serum High-sensitive C-reactive Protein (Hs-CRP).",
"timeFrame": "Baseline, on admission, and 1 and 24 hours after carotid artery stenting."
},
{
"description": null,
"measure": "Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.",
"timeFrame": "From baseline to 6 months after treatment."
},
{
"description": null,
"measure": "Serum Neuron Specific Enolase (NSE) Levels.",
"timeFrame": "Baseline, on admission, and 1 and 24 hours after carotid artery stenting."
},
{
"description": null,
"measure": "Serum S-100B Levels.",
"timeFrame": "Baseline, on admission, and 1 and 24 hours after carotid artery stenting."
}
]
} | [
{
"affiliation": "Capital Medical University",
"name": "Xunming Ji M.D., Ph.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "28174194", "type": "DERIVED", "citation": "Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D002340",
"term": "Carotid Artery Diseases"
},
{
"id": "D002561",
"term": "Cerebrovascular Disorders"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D001157",
"term": "Arterial Occlusive Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M12307",
"name": "Neoplasm Metastasis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10293",
"name": "Inflammation",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6475",
"name": "Constriction, Pathologic",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22306",
"name": "Stroke",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10543",
"name": "Ischemia",
"relevance": "LOW"
},
{
"asFound": "Carotid Artery Stenosis",
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"name": "Carotid Stenosis",
"relevance": "HIGH"
},
{
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},
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"asFound": null,
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"relevance": "LOW"
},
{
"asFound": null,
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"name": "Brain Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5742",
"name": "Central Nervous System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4465",
"name": "Arterial Occlusive Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D016893",
"term": "Carotid Stenosis"
}
]
} | null | {
"conditions": [
{
"id": "D016893",
"term": "Carotid Stenosis"
}
],
"interventions": null
} |
NCT02619266 | null | The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers | The Traditional Chinese Medicine Department of Xin Qiao Hospital | None | INTERVENTIONAL | UNKNOWN | 2015-11-23T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 160 | 18 | null | ALL | false | This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers. | Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture. | Inclusion Criteria:
1. Diagnosed gastrointestinal tand lung cancers;
2. Age ≥18 years;
3. Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;
4. Had a history of weight loss ≥5% within 6 moths;
5. Maintained oral intake;
6. Signed the informed consent.
Exclusion Criteria:
1. Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;
2. Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;
3. Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);
4. Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)
5. Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;
6. Lifetime expected less than 3 months. | Xinqiao Hospital of Chongqing | OTHER | {
"id": "2014YLC32",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-11-27T00:00:00 | {
"date": "2015-12-04",
"type": "ESTIMATED"
} | {
"date": "2015-12-02",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Anorexia",
"Cancer Cachexia"
] | ["Cancer Anorexia Cachexia Syndrome", "Acupuncture", "Megestrol acetate", "Poor Appetite", "Anorexia", "Randomized Controlled Trial"] | null | [
{
"city": "Jiangbei",
"country": "China",
"facility": "Chongqing TCM Hospital",
"geoPoint": null,
"state": "Chongqing"
},
{
"city": "Shapingba",
"country": "China",
"facility": "XinQiao Hosiptal",
"geoPoint": {
"lat": 29.16792,
"lon": 109.40029
},
"state": "Chongqing"
},
{
"city": "Shapingba",
"country": "China",
"facility": "Donghua Hosiptal",
"geoPoint": {
"lat": 29.16792,
"lon": 109.40029
},
"state": "Chongqing"
},
{
"city": "Yuzhong",
"country": "China",
"facility": "Daping Hospital",
"geoPoint": null,
"state": "Chongqing"
}
] | [
{
"class": "OTHER",
"name": "Chengdu University of Traditional Chinese Medicine"
}
] | null | {
"other": [
{
"description": null,
"measure": "Edmonton Symptom Assessment Scale",
"timeFrame": "Baseline, the days 8 and 15."
},
{
"description": null,
"measure": "The Questionnaire of Acupuncture-related Events(QAE)",
"timeFrame": "Baseline and the days 7"
}
],
"primary": [
{
"description": null,
"measure": "Appetite Visual Analog Scale",
"timeFrame": "Baseline, the days 8 and 15."
}
],
"secondary": [
{
"description": null,
"measure": "Council of Nutrition appetite questionnaire (CNAQ)",
"timeFrame": "Baseline, the days 8 and 15."
},
{
"description": null,
"measure": "Caloric intake",
"timeFrame": "Baseline, the days 8 and 15."
},
{
"description": null,
"measure": "Functional Assessment of Anorexia/Cachexia Therapy",
"timeFrame": "Baseline, the days 8 and 15."
},
{
"description": null,
"measure": "Nutritional status",
"timeFrame": "Baseline, the days 8 and 15."
}
]
} | [
{
"affiliation": "Chengdu University of Traditional Chinese Medicine",
"name": "Yong Tang, PhD",
"role": "STUDY_CHAIR"
},
{
"affiliation": "Xinqiao Hospital",
"name": "Chaoting Zhao, MD",
"role": "STUDY_DIRECTOR"
},
{
"affiliation": "Xinqiao Hospital",
"name": "Haiou Luo, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "23439759", "type": "BACKGROUND", "citation": "Del Fabbro E, Dev R, Hui D, Palmer L, Bruera E. Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: a double-blind placebo-controlled trial. J Clin Oncol. 2013 Apr 1;31(10):1271-6. doi: 10.1200/JCO.2012.43.6766. Epub 2013 Feb 25."}, {"pmid": "12506181", "type": "BACKGROUND", "citation": "Bruera E, Strasser F, Palmer JL, Willey J, Calder K, Amyotte G, Baracos V. Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: a double-blind, placebo-controlled study. J Clin Oncol. 2003 Jan 1;21(1):129-34. doi: 10.1200/JCO.2003.01.101."}, {"pmid": "2205358", "type": "BACKGROUND", "citation": "Bruera E, Macmillan K, Kuehn N, Hanson J, MacDonald RN. A controlled trial of megestrol acetate on appetite, caloric intake, nutritional status, and other symptoms in patients with advanced cancer. Cancer. 1990 Sep 15;66(6):1279-82. doi: 10.1002/1097-0142(19900915)66:63.0.co;2-r."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Signs and Symptoms, Digestive"
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{
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"term": "Weight Loss"
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{
"id": "D001836",
"term": "Body Weight Changes"
},
{
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"term": "Body Weight"
},
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"term": "Thinness"
},
{
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"term": "Metabolic Diseases"
},
{
"id": "D009748",
"term": "Nutrition Disorders"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
}
],
"browseLeaves": [
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"id": "M11172",
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"relevance": "LOW"
},
{
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"id": "M16355",
"name": "Syndrome",
"relevance": "LOW"
},
{
"asFound": "Anorexia",
"id": "M4181",
"name": "Anorexia",
"relevance": "HIGH"
},
{
"asFound": "Cachexia",
"id": "M21265",
"name": "Wasting Syndrome",
"relevance": "HIGH"
},
{
"asFound": "Cachexia",
"id": "M5363",
"name": "Cachexia",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M15622",
"name": "Signs and Symptoms, Digestive",
"relevance": "LOW"
},
{
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"name": "Body Weight",
"relevance": "LOW"
},
{
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"id": "M18102",
"name": "Weight Loss",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5115",
"name": "Body Weight Changes",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16614",
"name": "Thinness",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11639",
"name": "Metabolic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12684",
"name": "Nutrition Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D019282",
"term": "Wasting Syndrome"
},
{
"id": "D000855",
"term": "Anorexia"
},
{
"id": "D002100",
"term": "Cachexia"
}
]
} | {
"ancestors": [
{
"id": "D003278",
"term": "Contraceptives, Oral, Hormonal"
},
{
"id": "D003276",
"term": "Contraceptives, Oral"
},
{
"id": "D003271",
"term": "Contraceptive Agents, Female"
},
{
"id": "D003270",
"term": "Contraceptive Agents"
},
{
"id": "D012102",
"term": "Reproductive Control Agents"
},
{
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"term": "Physiological Effects of Drugs"
},
{
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"term": "Contraceptive Agents, Hormonal"
},
{
"id": "D003280",
"term": "Contraceptives, Oral, Synthetic"
},
{
"id": "D018931",
"term": "Antineoplastic Agents, Hormonal"
},
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D019167",
"term": "Appetite Stimulants"
},
{
"id": "D000697",
"term": "Central Nervous System Stimulants"
}
],
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "Repr",
"name": "Reproductive Control Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "CNSSti",
"name": "Central Nervous System Stimulants"
}
],
"browseLeaves": [
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"asFound": "Open Angle Glaucoma",
"id": "M11518",
"name": "Megestrol",
"relevance": "HIGH"
},
{
"asFound": "PVI",
"id": "M21272",
"name": "Megestrol Acetate",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6494",
"name": "Contraceptive Agents",
"relevance": "LOW"
},
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"id": "M6500",
"name": "Contraceptives, Oral",
"relevance": "LOW"
},
{
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"id": "M6502",
"name": "Contraceptives, Oral, Hormonal",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6495",
"name": "Contraceptive Agents, Female",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2116",
"name": "Contraceptive Agents, Hormonal",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20966",
"name": "Antineoplastic Agents, Hormonal",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4029",
"name": "Central Nervous System Stimulants",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008535",
"term": "Megestrol"
},
{
"id": "D019290",
"term": "Megestrol Acetate"
}
]
} | {
"conditions": [
{
"id": "D019282",
"term": "Wasting Syndrome"
},
{
"id": "D000855",
"term": "Anorexia"
},
{
"id": "D002100",
"term": "Cachexia"
}
],
"interventions": [
{
"id": "D008535",
"term": "Megestrol"
},
{
"id": "D019290",
"term": "Megestrol Acetate"
}
]
} |
NCT04939766 | null | Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life | Impact of the Use of a Closed-loop Insulin Therapy on the Burden of the Diabetes and the Quality of Life in Type 1 Diabetic Patients With Continuous Glucose Monitoring (CGM) | IMPLIQUE | INTERVENTIONAL | UNKNOWN | 2021-06-16T00:00:00 | null | null | null | [
"NA"
] | 250 | 13 | null | ALL | false | The use by diabetes patients of real-time Continuous Glucose Monitoring (CGM) system is becoming widespread and has changed diabetic practice. Automated closed-loop (CL) insulin therapy has come of age. This major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes.
Questions remain about patients' perception and acceptance on this automatisation of the management of their glycemic variability.
Thus this study is built to evaluate the impact of the activation of the closed-loop on quality of life and burden of their diabetes in patients with type 1 diabetes under CSII. | This cohort study will follow patients with type 1 diabetes undergoing under continuous subcutaneous insulin infusion (CSII) with Continuous Glucose Monitoring (GCM). After inclusion visit, there's a 20 days' period to assess their quality of life and perception of the burden of their diabetes and confirm their eligibility to the closer-loop. During this 20 days' period, patients should complete all the self-questionnaires.
Then, during the 2d visit, the closed-loop will be activated by the diabetologist for a 6 months follow-up including six visits with 3 phone contacts (at week 1, week 2 and week 6) then 2 direct visits at 3 months and 6 months.
The 3 phone contacts are mainly planned, as recommended in French guidelines, to ensure the good use of the device and to detect or prevent any unexpected events.
The 2 visits at 3 and 6 months, are planned to assess the glycemic variability using Continuous Glucose Monitoring data and to collect perception of the patients via the 2 main criteria self questionnaires (Quality of life and burden to be filled-in by patients at 3 and 6 months) and all perception dimensions by all the self questionnaires.
Main results will provide data on the evolution of quality of life and burden of diabetes by comparison between scores at 6 months and baseline, and evolution of glycemic variability. | Inclusion Criteria:
* Type 1 diabetic patients undergoing a CSII therapy for at least 6 months and using Tandem t:slim X2 for at least 4 weeks.
* Patient using CGM for 6 months including Dexcon G6 for at least 4 weeks.
* Eligible patient (according to French Society recommendations) for activation of the closed loop
* Informed Patient accepting the computer processing of their medical data.
* Patient correctly completing the 2 main self questionnaires
* Patient with HbA1c below 11%
Exclusion Criteria:
* Pregnancy or Lactation during the study
* Patient with a diabetic retinopathy not controlled by laser
* Patient suffering from a disease or undertaking a treatment altering glucose metabolism | VitalAire | INDUSTRY | {
"id": "2021-A00005-36",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-06-24T00:00:00 | {
"date": "2021-06-25",
"type": "ACTUAL"
} | {
"date": "2021-06-25",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Longitudinal cohort study with a 6 months follow-up evaluation evaluating in type 1 diabetic patients under CSII the impact of closed loop use on quality of life and burden using different validated self questionnaires.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Quality of Life",
"Burden, Dependency"
] | ["Continuous subcutaneous insulin infusion", "Diabetes type 1", "Closed loop"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in Quality of life following activation of closed loop",
"timeFrame": "Score comparison between Baseline and 6 months after activation of closed loop"
},
{
"description": null,
"measure": "Change in burden of diabetes following activation of closed loop",
"timeFrame": "Score comparison between Baseline and 6 months after activation of closed loop"
}
],
"secondary": [
{
"description": null,
"measure": "Perception of patients",
"timeFrame": "Before and 6 months after activation of closed loop"
},
{
"description": null,
"measure": "Glycemic variability",
"timeFrame": "Before, 3 months and 6 months after activation of closed loop"
}
]
} | [
{
"affiliation": "University Hospital, Caen",
"name": "Yves Reznik, MD PHD",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "33152550", "type": "BACKGROUND", "citation": "Tubiana-Rufi N, Schaepelynck P, Franc S, Chaillous L, Joubert M, Renard E, Reznik Y, Abettan C, Bismuth E, Beltrand J, Bonnemaison E, Borot S, Charpentier G, Delemer B, Desserprix A, Durain D, Farret A, Filhol N, Guerci B, Guilhem I, Guillot C, Jeandidier N, Lablanche S, Leroy R, Melki V, Munch M, Penfornis A, Picard S, Place J, Riveline JP, Serusclat P, Sola-Gazagnes A, Thivolet C, Hanaire H, Benhamou PY; SFD SFD Paramedical SFE SFEDP AJD FFD FENAREDIAM and CNP-EDN. Practical implementation of automated closed-loop insulin delivery: A French position statement. Diabetes Metab. 2021 May;47(3):101206. doi: 10.1016/j.diabet.2020.10.004. Epub 2020 Nov 2."}] | {"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"
},
{
"abbrev": "BC20",
"name": "Immune System Diseases"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M7115",
"name": "Diabetes Mellitus",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7117",
"name": "Diabetes Mellitus, Type 1",
"relevance": "LOW"
},
{
"asFound": "Quality of Life",
"id": "T6034",
"name": "Quality of Life",
"relevance": "HIGH"
}
],
"meshes": null
} | {
"ancestors": [
{
"id": "D007004",
"term": "Hypoglycemic Agents"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
{
"abbrev": "Hypo",
"name": "Hypoglycemic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Given",
"id": "M10365",
"name": "Insulin",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M173166",
"name": "Insulin, Globin Zinc",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10054",
"name": "Hypoglycemic Agents",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007328",
"term": "Insulin"
}
]
} | {
"conditions": [],
"interventions": [
{
"id": "D007328",
"term": "Insulin"
}
]
} |
NCT02029066 | null | Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis | An Open-label, Single Dose, Pharmacokinetic Study of SR-T100 Gel (Containing 2.3% Solamargine in Solanum Undatum Plant Extract) in Patients With Actinic Keratosis | None | INTERVENTIONAL | COMPLETED | 2013-10-31T00:00:00 | null | null | null | [
"PHASE1"
] | 2 | 20 | null | ALL | false | This study is designed to evaluate the pharmacokinetics of solamargine of SR-T100 gel. As safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body temperature) will be recorded. | In the study period, a single dose of 2 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract) in 100 cm2 skin area covered by an occlusive dressing will be administered. Sampling Time Schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 20, 24, 36 hours after dosing. | Inclusion Criteria:
1. Male or female is 20 years of age or above.
2. Patient has AK lesions located within a 100 cm2 contiguous or non-contiguous treatment area.
3. Patient has at least one clinical confirmed AK lesion within the selected treatment area before.
Exclusion Criteria:
1. Patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon, cytotoxic drugs.
2. Patient had treated with topical 5-FU, diclofenac gel, imiquimod, ingenol mebutate, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
3. Patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
4. Patient had received any of the following treatments on the treatment area in the 6 months before study treatment initiation: psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, chemical peel.
5. Patient had used any topical preparations, such as sunscreens, moisturizers, body oils, or alpha or beta hydroxyl acids, in the treatment area within 24 hours before and during the study course.
6. Use of any medication, including over the counter products, herb medicine and dietary supplements such as vitamins, which would interfere with study results, within one week before and during the study course.
7. Patient is known to be hypersensitive to the study medication.
8. Female who is pregnant, breast-feeding or considering becoming pregnant while on the study.
9. Donation of 500 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing.
10. Patient had used of any investigational drug within the past 30 days before enrollment.
11. Patient has any dermatological disease and/or condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area (5 cm distances from treatment area). | G&E Herbal Biotechnology Co., LTD | INDUSTRY | {
"id": "GESRTAKC",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-01-05T00:00:00 | {
"date": "2015-08-13",
"type": "ESTIMATED"
} | {
"date": "2014-01-07",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": null,
"timePerspective": null
} | [
"Actinic Keratosis"
] | ["actinic keratosis", "SR-T100", "pharmacokinetics"] | null | [
{
"city": "Tainan",
"country": "Taiwan",
"facility": "National Cheng Kung University Hospital",
"geoPoint": {
"lat": 22.99083,
"lon": 120.21333
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To assess the delivery of SR-T100 from the topical gel by determining the plasma solamargine levels in subjects with AK within a 100 cm^2 treatment area.",
"timeFrame": "33 days"
}
],
"secondary": [
{
"description": null,
"measure": "Safety parameters (medical history, clinical examinations, laboratory tests and adverse events) will be recorded and reported as appropriate.",
"timeFrame": "33 days and 7 days follow up period after complete study."
}
]
} | [
{
"affiliation": "National Cheng-Kung University Hospital",
"name": "Hamm-Ming Sheu, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012871",
"term": "Skin Diseases"
},
{
"id": "D011230",
"term": "Precancerous Conditions"
},
{
"id": "D009369",
"term": "Neoplasms"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
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"asFound": "Actinic Keratosis",
"id": "M28268",
"name": "Keratosis, Actinic",
"relevance": "HIGH"
},
{
"asFound": "Keratosis",
"id": "M10668",
"name": "Keratosis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M15674",
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"relevance": "LOW"
},
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"term": "Keratosis, Actinic"
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NCT03128866 | null | Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery | Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA) | None | INTERVENTIONAL | RECRUITING | 2017-04-21T00:00:00 | null | 2026-05-31T00:00:00 | 2026-05-31T00:00:00 | [
"EARLY_PHASE1"
] | 80 | null | null | ALL | false | This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery. | PRIMARY OBJECTIVES:
I. To determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss.
SECONDARY OBJECTIVES:
I. To determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week.
II. To determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7.
III. To determine if use of tranexamic acid has an effect on complication, length of intensive care unit (ICU), and hospital stays.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TRANEXAMIC ACID): Patients receive tranexamic acid intravenously (IV) over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.
ARM II (NO TRANEXAMIC ACID): Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 7 days. | Inclusion Criteria:
* Both pediatric and adult patients can be eligible to participate
* Cognitively impaired and non-English speakers can be eligible to participate.
* Both male and female patients must have a pelvic tumor and are scheduled to have surgery at University of Texas (UT) Monroe Dunaway (MD) Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption
Exclusion Criteria:
* Patient with a history of genetic prothrombotic state
* Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis
* Patients with thrombosis of the planned site of resection will not be excluded if the thrombus is caused directly by tumor burden or outflow obstruction
* Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment
* Patients will not be eligible if they have a history of color vision defects
* Patients will not be eligible if they have a history of retinal vein or artery occlusion
* Patients will not be eligible if they have a history of intracranial hemorrhage in past 6 months
* Patients will not be eligible if they have a history of hypersensitivity to tranexamic acid
* Patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (estimated glomerular filtration rate \[eGFR\] \< 45 mL/min/1.73m2)
* Patients will not be eligible if they present or have a history of seizure disorder | M.D. Anderson Cancer Center | OTHER | {
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"date": "2025-04-02",
"type": "ACTUAL"
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"date": "2017-04-25",
"type": "ACTUAL"
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"ADULT",
"OLDER_ADULT"
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"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
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] | null | null | [
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"city": "Houston",
"country": "United States",
"facility": "M D Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
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"state": "Texas"
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"class": "NIH",
"name": "National Cancer Institute (NCI)"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss",
"timeFrame": "During first post-operative week"
}
],
"secondary": [
{
"description": null,
"measure": "Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets",
"timeFrame": "At the time of procedure"
},
{
"description": null,
"measure": "Total number of units of PRBCs, FFP, cryoprecipitate, and platelets",
"timeFrame": "During first post-operative week"
},
{
"description": null,
"measure": "Thromboelastography (TEG)",
"timeFrame": "At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure"
},
{
"description": null,
"measure": "Change in laboratory measurements",
"timeFrame": "Baseline up to 7 days post-surgery"
},
{
"description": null,
"measure": "Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding)",
"timeFrame": "Up to 7 days post-surgery"
},
{
"description": null,
"measure": "Length of ICU and hospital stay",
"timeFrame": "Up to 7 days post-surgery"
}
]
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"affiliation": "M.D. Anderson Cancer Center",
"name": "Valerae O Lewis",
"role": "PRINCIPAL_INVESTIGATOR"
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"term": "Pathologic Processes"
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],
"browseBranches": [
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"name": "Symptoms and General Pathology"
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"name": "All Conditions"
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NCT05740566 | null | Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer | A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy | DeLLphi-304 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2023-02-07T00:00:00 | null | 2025-01-29T00:00:00 | 2027-07-29T00:00:00 | [
"PHASE3"
] | 509 | 18 | null | ALL | false | The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS). | null | Inclusion Criteria:
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
* Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
* Participants who progressed or recurred following 1 platinum-based regimen.
* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
* Minimum life expectancy of 12 weeks.
* Adequate organ function.
Exclusion Criteria:
* Disease Related
* Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
* Diagnosis or evidence of leptomeningeal disease.
* Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.
* Other Medical Conditions
* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
* History of solid organ transplantation.
* History of other malignancy within the past 2 years, with exceptions defined in the protocol.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months prior to first dose of study treatment.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
* Presence or history of viral infection based on criteria per protocol.
* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
* Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Prior/Concomitant Therapy
* Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.
* Prior therapy with any selective inhibitor of the DLL3 pathway.
* Participant received more than one prior systemic therapy regimen for SCLC.
* Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
* Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
* Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
* Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
* Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
* Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
* Major surgical procedures within 28 days prior to first dose of study treatment.
* Live and live-attenuated vaccines within 14 days prior to the start of study treatment.
* Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Diagnostic Assessments
* Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, with exceptions defined in the protocol.
* Other Exclusions
* Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
* Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
* Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab.
* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.
* Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
* Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.
* Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.
* Participant has known sensitivity or is contraindicated to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.
* History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician that would pose a risk to the subject safety or interfere with the study evaluation.. | Amgen | INDUSTRY | {
"id": "20210004",
"link": null,
"type": null
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"nctId": "NCT06064500",
"statusForNctId": "APPROVED_FOR_MARKETING"
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"date": "2025-05-18",
"type": "ACTUAL"
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"date": "2023-02-23",
"type": "ACTUAL"
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NCT03095066 | null | Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury (TBI). | None | INTERVENTIONAL | COMPLETED | 2017-03-23T00:00:00 | null | 2022-08-22T00:00:00 | 2022-08-31T00:00:00 | [
"PHASE2"
] | 168 | 18 | 75 | ALL | false | This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI). | Eligible participants for this study must have a diagnosis of neurobehavioral disinhibition including aggression, agitation, and irritability that persists after brain injury.
This is a multicenter, randomized, placebo-controlled study, consisting of up to 12 weeks of treatment. | Inclusion Criteria:
* Participants with TBI
* Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness
* Score of ≥4 on the mCGI-S scale and the Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric Inventory (NPI) scale at screening and baseline
* Participants with a reliable caregiver
Exclusion Criteria:
* Participants with significant symptoms of a major depressive disorder
* Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY | {
"id": "17-AVP-786-205",
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"date": "2017-03-29",
"type": "ACTUAL"
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NCT06009666 | null | Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema | Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data | None | OBSERVATIONAL | COMPLETED | 2023-02-03T00:00:00 | null | 2022-04-01T00:00:00 | 2022-11-01T00:00:00 | null | 72 | 18 | 75 | FEMALE | true | The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements. | Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed. | Inclusion Criteria:
For the patient group
* between the ages of 18-75
* diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy
* being stage 0-1-2 lymphedema according to ISL staging For the control group
* between the ages of 18-75
* no history of breast cancer
Exclusion Criteria:
* History of surgery in the assessment area
* History of trauma at the assessment site
* Active infection in the assessment area
* Presence of congenital or acquired malformations at the assessment site
* Primary lymphedema
* those with any medical condition that may cause edema, such as advanced heart or kidney failure | Marmara University | OTHER | {
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} | Unknown | {
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] | In our study, individuals with breast cancer-related lymphedema diagnosis followed by Marmara University Pendik Training and Research Hospital Physical Medicine and Rehabilitation Department were included in the patient group, while upper extremity data of healthy volunteers without a known lymphedema history were controlled by one-to-one matching, considering the dominant and lymphedema sides of the patient group. included in the group. | NON_PROBABILITY_SAMPLE | false | {
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} | [
"Lymphedema of Upper Arm",
"Stiffness of Hand, Not Elsewhere Classified",
"Evaluations, Diagnostic Self"
] | null | null | [
{
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"country": "Turkey",
"facility": "Canan Şanal-Toprak",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
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"geoPoint": {
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"lon": 28.94966
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"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "B Mode Ultrasonography Measurements",
"timeFrame": "Day 0"
},
{
"description": null,
"measure": "Shear Wave Elastography Measurements",
"timeFrame": "Day 0"
},
{
"description": null,
"measure": "B Mode Ultrasonography Measurements",
"timeFrame": "Day 0"
}
],
"secondary": [
{
"description": null,
"measure": "Association of USG and SWE Measurements With Symptoms",
"timeFrame": "Day 0"
},
{
"description": null,
"measure": "Association of USG and SWE Measurements With Functionality",
"timeFrame": "Day 0"
},
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"measure": "Association of USG and SWE Measurements With Participation İn Daily Life",
"timeFrame": "Day 0"
},
{
"description": null,
"measure": "Association of USG and SWE Measurements With Volume Measurements",
"timeFrame": "Day 0"
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]
} | [
{
"affiliation": "Marmara University",
"name": "CANAN ŞANAL TOPRAK",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D008206",
"term": "Lymphatic Diseases"
},
{
"id": "D011183",
"term": "Postoperative Complications"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
},
{
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"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
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"id": "M5220",
"name": "Breast Neoplasms",
"relevance": "LOW"
},
{
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"name": "Lymphedema",
"relevance": "HIGH"
},
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"id": "M1071",
"name": "Breast Cancer Lymphedema",
"relevance": "HIGH"
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{
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"id": "M11203",
"name": "Lymphatic Diseases",
"relevance": "LOW"
},
{
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"id": "M14065",
"name": "Postoperative Complications",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008209",
"term": "Lymphedema"
},
{
"id": "D000072656",
"term": "Breast Cancer Lymphedema"
}
]
} | null | {
"conditions": [
{
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"term": "Lymphedema"
},
{
"id": "D000072656",
"term": "Breast Cancer Lymphedema"
}
],
"interventions": null
} |
NCT01394666 | null | Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML) | Treatment Patterns and Associated Outcomes in Chronic Phase (CP) Chronic Myelogenous Leukemia (CML) Patients Who Fail Imatinib 400 mg Daily | None | OBSERVATIONAL | COMPLETED | 2011-07-08T00:00:00 | null | null | null | null | 150 | 18 | null | ALL | false | The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting. | Time Perspective: Retrospective and Prospective | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
* Adult patients (18 years or older) in Chronic phase CML patients who have been treated with Imatinib 400 mg and have failed. | Bristol-Myers Squibb | INDUSTRY | {
"id": "CA180-240",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2011-07-13T00:00:00 | {
"date": "2016-07-11",
"type": "ESTIMATED"
} | {
"date": "2011-07-14",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Primary care clinic, academic and community oncology centers | PROBABILITY_SAMPLE | false | {
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"timePerspective": "RETROSPECTIVE"
} | [
"Chronic Myeloid Leukemia"
] | null | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily",
"timeFrame": "At 3 months post treatment change"
},
{
"description": null,
"measure": "Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily",
"timeFrame": "At 6 months post treatment change"
},
{
"description": null,
"measure": "Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily",
"timeFrame": "At 12 months post treatment change"
}
],
"secondary": [
{
"description": null,
"measure": "Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily",
"timeFrame": "Baseline"
},
{
"description": null,
"measure": "Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily",
"timeFrame": "3 months after start of treatment"
},
{
"description": null,
"measure": "Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily",
"timeFrame": "6 months after start of treatment"
},
{
"description": null,
"measure": "Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily",
"timeFrame": "12 months after start of treatment"
},
{
"description": null,
"measure": "Best response rates achieved by patients if no CCyR",
"timeFrame": "Baseline"
},
{
"description": null,
"measure": "Best response rates achieved by patients if no CCyR",
"timeFrame": "3 months after start of treatment"
},
{
"description": null,
"measure": "Best response rates achieved by patients if no CCyR",
"timeFrame": "6 months after start of treatment"
},
{
"description": null,
"measure": "Best response rates achieved by patients if no CCyR",
"timeFrame": "12 months after start of treatment"
}
]
} | [
{
"affiliation": "Bristol-Myers Squibb",
"name": "Bristol-Myers Squibb",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D009196",
"term": "Myeloproliferative Disorders"
},
{
"id": "D001855",
"term": "Bone Marrow Diseases"
},
{
"id": "D002908",
"term": "Chronic Disease"
},
{
"id": "D020969",
"term": "Disease Attributes"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
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"name": "Blood and Lymph Conditions"
},
{
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"name": "All Conditions"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
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"name": "Rare Diseases"
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],
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},
{
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"id": "M10955",
"name": "Leukemia, Myeloid",
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},
{
"asFound": "Chronic myelogenous leukemia",
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"name": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive",
"relevance": "HIGH"
},
{
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"name": "Leukemia, Myeloid, Chronic-Phase",
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},
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},
{
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"id": "M12149",
"name": "Myeloproliferative Disorders",
"relevance": "LOW"
},
{
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"relevance": "LOW"
},
{
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"id": "M6147",
"name": "Chronic Disease",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22700",
"name": "Disease Attributes",
"relevance": "LOW"
},
{
"asFound": "Myelogenous Leukemia",
"id": "T3995",
"name": "Myeloid Leukemia",
"relevance": "HIGH"
},
{
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"id": "T1303",
"name": "Chronic Graft Versus Host Disease",
"relevance": "LOW"
},
{
"asFound": "Chronic Myeloid Leukemia",
"id": "T1309",
"name": "Chronic Myeloid Leukemia",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "T1311",
"name": "Chronic Myeloproliferative Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007938",
"term": "Leukemia"
},
{
"id": "D007951",
"term": "Leukemia, Myeloid"
},
{
"id": "D015464",
"term": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive"
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]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M324",
"name": "Imatinib Mesylate",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D007938",
"term": "Leukemia"
},
{
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"term": "Leukemia, Myeloid"
},
{
"id": "D015464",
"term": "Leukemia, Myelogenous, Chronic, BCR-ABL Positive"
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],
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} |
NCT02763566 | null | A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer | MONARCH plus | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | 2016-05-04T00:00:00 | null | 2019-03-29T00:00:00 | null | [
"PHASE3"
] | 463 | 18 | null | FEMALE | false | The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer. | null | Inclusion Criteria:
* Have a diagnosis of HR+, HER2- breast cancer. Although not required as a protocol procedure, metastatic disease should be considered for biopsy whenever possible to reassess hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status if clinically indicated.
* To fulfill the requirement for HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least 1 of the HRs (estrogen receptor \[ER\], progesterone receptor \[PgR\]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined in the relevant ASCO/CAP guidelines.
* Meet either Inclusion Criterion (2a) or Inclusion Criterion (2b). Participants meeting Inclusion Criterion 2a will be enrolled in Cohort A and participants meeting Inclusion Criterion 2b will be enrolled in Cohort B.
* (2a) Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.
* Relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and have received no prior endocrine therapy for locoregionally recurrent or metastatic disease (Note: prior adjuvant endocrine therapy for localized disease may have included, but is not limited to, anti-estrogens or aromatase inhibitors. In addition, a participant may be enrolled if she has received ≤2 weeks of NSAI in this disease setting immediately preceding screening and agrees to discontinue NSAI until study treatment initiation.) OR
* Presented with de novo metastatic breast cancer (mBC) and not received any prior endocrine therapy. OR
* Relapsed with radiologic evidence of progression less than 1 year from completion of or while receiving adjuvant endocrine therapy (except for letrozole or anastrozole) and have received no prior endocrine therapy for locoregionally recurrent or metastatic disease.
* (2b) Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.
* Relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression OR
* Relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression OR
* Relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as firstline endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease OR
* Presented with de novo metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease.
* Have postmenopausal status defined as meeting at least 1 of the following:
* Prior bilateral oophorectomy
* Age ≥60 years
* Age \<60 years and amenorrheic for at least 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone (FSH) and estradiol levels in the postmenopausal range.
* Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1:
* Measurable disease
* Nonmeasurable bone-only disease. Nonmeasurable bone-only disease may include any of the following: blastic bone lesions, lytic bone lesions without a measurable soft tissue component, or mixed lytic-blastic bone lesions without a measurable soft tissue component.
* Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology (ECOG) scale.
* Have adequate organ function, including:
* Hematologic: absolute neutrophil count (ANC) ≥1.5 × 109/Liter (L), platelets
≥100 × 109/L, and hemoglobin ≥8 g/deciliter (dL). Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the erythrocyte transfusion.
* Hepatic: Total bilirubin ≤1.5 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
≤3.0 times ULN (or ALT and AST ≤5 times ULN if liver metastases are present).
* Renal: serum creatinine ≤1.5 times ULN.
* Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.
* Are able to swallow capsules.
* Are reliable, willing to be available for the duration of the study, and willing to follow study procedures.
Exclusion Criteria:
* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. Visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
* Have inflammatory breast cancer.
* Have clinical evidence or a history of central nervous system (CNS) metastasis. Screening test is not required for enrollment.
* Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer. (Note: Participants may be enrolled if they received prior \[neo\]adjuvant chemotherapy for localized disease.)
* Have received prior treatment with everolimus or fulvestrant (for Cohort B only).
* Have received prior treatment with any cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) inhibitor (or participated in any CDK4 and CDK6 inhibitor clinical trial for which treatment assignment is still blinded).
* Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents \<7 days prior to randomization.
* Are currently enrolled in a clinical trial involving an investigational product (IP) or non-approved use of a drug or device (other than the IP/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. If a participant is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the investigator and Eli Lilly and Company (Lilly) clinical research physician (CRP) is required to establish eligibility.
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively.
* Have had major surgery within 14 days prior to randomization to allow for post-operative healing of the surgical wound and site(s).
* Have received recent (within 28 days prior to randomization) live attenuated vaccines such as yellow fever vaccine.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (eg, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis).
* Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
* Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
* Have received an autologous or allogeneic stem-cell transplant.
* Have clinical evidence of active bacterial or fungal infection or active viral infection that, in the judgment of the investigator, would preclude participation in this study (eg, human immunodeficiency virus \[HIV\] or viral hepatitis). Screening test is not required for enrollment. | Eli Lilly and Company | INDUSTRY | {
"id": "15530",
"link": null,
"type": null
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"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-05-04T00:00:00 | {
"date": "2025-04-20",
"type": "ACTUAL"
} | {
"date": "2016-05-05",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
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"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"observationalModel": null,
"primaryPurpose": "TREATMENT",
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},
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"geoPoint": {
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}
] | null | null | {
"other": null,
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"description": null,
"measure": "Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)",
"timeFrame": "Randomization to Measured Progressive Disease or Death (up to 26 Months)"
}
],
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},
{
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"measure": "Overall Survival (OS)",
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},
{
"description": null,
"measure": "Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]",
"timeFrame": "Randomization to Measured Progressive Disease (up to 26 Months)"
},
{
"description": null,
"measure": "Duration of Response (DoR)",
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},
{
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"measure": "Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]",
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},
{
"description": null,
"measure": "Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months [Clinical Benefit Rate (CBR)]",
"timeFrame": "Randomization to Measured Progressive Disease (up to 26 Months)"
},
{
"description": null,
"measure": "Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)",
"timeFrame": "Baseline through 19 Months"
},
{
"description": null,
"measure": "Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20)",
"timeFrame": "C1D1 post dose, C2D1 post dose, C3D1 predose, C4D1 predose"
}
]
} | [
{
"affiliation": "Eli Lilly and Company",
"name": "Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "33149768", "type": "DERIVED", "citation": "Zhang QY, Sun T, Yin YM, Li HP, Yan M, Tong ZS, Oppermann CP, Liu YP, Costa R, Li M, Cheng Y, Ouyang QC, Chen X, Liao N, Wu XH, Wang XJ, Feng JF, Hegg R, Kanakasetty GB, Coccia-Portugal MA, Han RB, Lu Y, Chi HD, Jiang ZF, Hu XC. MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020 Oct 22;12:1758835920963925. doi: 10.1177/1758835920963925. eCollection 2020."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D001941",
"term": "Breast Diseases"
},
{
"id": "D012871",
"term": "Skin Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
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"name": "Neoplasms"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
}
],
"browseLeaves": [
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"asFound": null,
"id": "M14850",
"name": "Recurrence",
"relevance": "LOW"
},
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"id": "M5220",
"name": "Breast Neoplasms",
"relevance": "HIGH"
},
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"id": "M5218",
"name": "Breast Diseases",
"relevance": "LOW"
},
{
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"id": "M15674",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D001943",
"term": "Breast Neoplasms"
}
]
} | {
"ancestors": [
{
"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D047072",
"term": "Aromatase Inhibitors"
},
{
"id": "D065088",
"term": "Steroid Synthesis Inhibitors"
},
{
"id": "D004791",
"term": "Enzyme Inhibitors"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D004965",
"term": "Estrogen Antagonists"
},
{
"id": "D006727",
"term": "Hormone Antagonists"
},
{
"id": "D006730",
"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
},
{
"id": "D018931",
"term": "Antineoplastic Agents, Hormonal"
},
{
"id": "D065171",
"term": "Estrogen Receptor Antagonists"
}
],
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Consultation",
"id": "M1723",
"name": "Fulvestrant",
"relevance": "HIGH"
},
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"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": "Docetaxel",
"id": "M1743",
"name": "Letrozole",
"relevance": "HIGH"
},
{
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},
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],
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{
"id": "D001943",
"term": "Breast Neoplasms"
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],
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{
"id": "D000077289",
"term": "Letrozole"
},
{
"id": "D000077267",
"term": "Fulvestrant"
},
{
"id": "D000077384",
"term": "Anastrozole"
}
]
} |
NCT04892966 | null | TXI for the Recognition of Adenomas in Colonoscopy | Texture and Color Enhancement Imaging (TXI) Versus Standard White-light (WLI) Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial | TRACK | INTERVENTIONAL | COMPLETED | 2021-05-03T00:00:00 | null | 2022-04-30T00:00:00 | 2022-09-30T00:00:00 | [
"NA"
] | 747 | 40 | null | ALL | true | This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time. | null | Inclusion criteria:
- All \>40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance
Exclusion criteria:
* patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).
* Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent. | University of Roma La Sapienza | OTHER | {
"id": "TRACK_GA",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-05-18T00:00:00 | {
"date": "2022-11-03",
"type": "ACTUAL"
} | {
"date": "2021-05-19",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Colorectal Polyp"
] | null | null | [
{
"city": "Ariccia",
"country": "Italy",
"facility": "Ospedale Dei Castelli",
"geoPoint": {
"lat": 41.72063,
"lon": 12.6723
},
"state": "Rome"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Adenoma Detection Rate (ADR)",
"timeFrame": "1 year"
}
],
"secondary": [
{
"description": null,
"measure": "Advanced ADR",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "proximal and flat adenomas detection rate",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Withdrawal time",
"timeFrame": "1 year"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009375",
"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
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"term": "Neoplasms"
}
],
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{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "All",
"name": "All Conditions"
},
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "Adenoma",
"id": "M3591",
"name": "Adenoma",
"relevance": "HIGH"
},
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"asFound": null,
"id": "M14011",
"name": "Polyps",
"relevance": "LOW"
},
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"id": "M12320",
"name": "Neoplasms, Glandular and Epithelial",
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},
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"id": "M12315",
"name": "Neoplasms by Histologic Type",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000236",
"term": "Adenoma"
}
]
} | null | {
"conditions": [
{
"id": "D000236",
"term": "Adenoma"
}
],
"interventions": null
} |
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