TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Linkage of Alcohol Abusers to Primary Care
Brief Summary: The objective of this study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns.


Options:
A: Alcohol and drug use (3, 6, and 12 months after baseline); Alcohol and drug-related problems (3, 6, and 12 months after baseline); Nights Hospitalized (3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled); Emergency department visits (3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled)
B: Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) (Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)); Drinking Timeline Follow-back Interview (TFBI) (Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up))
C: Severity of Alcohol Use (ASI Alcohol Composite Scores) (Administered at baseline and 3 months, 6 months and 12 months post baseline.); ASI Drug Composite Score (1 year)
D: Drug abstinence

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized Trial
Brief Summary: Scleroderma is a systemic disorder categorized as an immunologically mediated disease that causes collagen deposition of skin and visceral organs. The molecular pathogenesis of scleroderma has been elusive, although vasculopathy and immune mediated mechanisms are thought to be important. Once extensive cutaneous or visceral disease occurs, prognosis is significantly shorter than the general population. Although various treatments have been tried, none of them seems to have changed the natural history of scleroderma. Standard dose immunosuppressive treatment has been disappointing. Recently, cyclophosphamide at 1-2 mg/kg/day orally or 800-1400 mg intravenous (IV) monthly for 6-9 months has proven effective in treatment of scleroderma alveolitis (1). Recent phase I studies of immunoablation with autologous peripheral blood stem cell transplantation (PBSCT) showed some promising data, but the exact efficacy is undetermined (2,3). We now propose, as a phase II randomized study, autologous unmanipulated PBSCT versus pulse cyclophosphamide in patients with systemic scleroderma.


Options:
A: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)
B: Forced Vital Capacity (12 months)
C: Global Rank Composite Score (GRCS) (Month 54, ITT) (54 Months Post-Randomization)
D: Time to Treatment Failure (12 months); Disease Improvement (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II Trial
Brief Summary: This study is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune system), followed by return of their previously collected stem cells will result in improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.


Options:
A: Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections>2 cm directly related to the fistula tract treated, as measured by MRI (healing) (weeks 1, 4, 12 and 24. Week 26 in patients with a second dose)
B: Survival (6 months, then yearly x 5 years after transplant)
C: Proportion patients in sustained disease remission (1 year)
D: Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy (Six weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting.
Brief Summary: Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Zinc is a potentially important immunomodulator or nutraceutical which may have great impact as therapeutic agent in conditions like diarrhea and pneumonia. The issue is whether and how zinc should be introduced in primary health care programs for treatment of acute diarrhea. A practical, sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national programs is therefore required. This study aimed to address this issue.


Options:
A: N/A
B: Incidence of diarrhea (weekly)
C: N/A
D: To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children (20 months (Jan 2005 to Sep 2006)); - Reduction in visits to health care providers for treatment of illness (20 months (Jan 2005 to Sep 2006)); - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses (20 months (Jan 2005 to Sep 2006)); - Increase in ORS use during diarrhea in the intervention communities. (20 months (Jan 2005 to Sep 2006))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting.
Brief Summary: Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Zinc is a potentially important immunomodulator or nutraceutical which may have great impact as therapeutic agent in conditions like diarrhea and pneumonia. The issue is whether and how zinc should be introduced in primary health care programs for treatment of acute diarrhea. A practical, sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national programs is therefore required. This study aimed to address this issue.


Options:
A: To evaluate innate and adaptive immune response.; Future occurrence of acute diarrhoea, ARI and impetigo.
B: To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children (20 months (Jan 2005 to Sep 2006)); - Reduction in visits to health care providers for treatment of illness (20 months (Jan 2005 to Sep 2006)); - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses (20 months (Jan 2005 to Sep 2006)); - Increase in ORS use during diarrhea in the intervention communities. (20 months (Jan 2005 to Sep 2006))
C: N/A
D: Stool output (g/kg/24h); Duration of diarrhoea (days).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: "A Randomized, Double-Blind, Placebo-Controlled Study of Divalproex Extended Release Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to- Severe Hypomania or Mild Mania"
Brief Summary: The purpose of this research study is to evaluate the safety, tolerability, and efficacy of divalproex extended release compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Divalproex extended release is approved by the United States Food and Drug Administration (FDA) for the treatment of epilepsy and for prevention of migraine headaches.


Options:
A: Change from baseline to the final evaluation in Y-MRS score.
B: The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study. (August 2012)
C: The primary outcome measure will be change in hypomanic/manic symptoms from baseline to endpoint. (8 weeks)
D: Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Brief Summary: The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.


Options:
A: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)
B: Time from randomization to the primary action point (monotherapy failure).
C: Composite of cardiovascular events which were defined as death from a cardiovascular cause, death from any cause, nonfatal myocardial infarction, nonfatal stroke or arterial revascularization
D: Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. (Baseline, 3 months, 6 months and 12 months); Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. (Baseline, 3 months, 6 months, and 12 months.); Differences in Coronary Flow Reserve at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. (Baseline, 3 months, 6 months, and 12 months.); Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R. (Baseline, 3 months, 6 months, and 12 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Brief Summary: The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.


Options:
A: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)
B: HbA1c Change From Baseline to Week 24 (Baseline and week 24)
C: Time from randomization to the primary action point (monotherapy failure).
D: The First 3-point Major Adverse Cardiovascular Events (3P-MACE) (From randomization until individual day of trial completion, up to 432 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Brief Summary: The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.


Options:
A: Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan (Mean patient duration of 5.8 years); Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide (Mean patient duration of 4.2 years); Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.6 years); Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide (Mean patient duration of 5.8 years)
B: Time from randomization to the primary action point (monotherapy failure).
C: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)
D: Prevention of Type 2 Diabetes (2.4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Brief Summary: The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.


Options:
A: Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 (Baseline, week 18)
B: Time from randomization to the primary action point (monotherapy failure).
C: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
D: Plasma liraglutide concentration (pmol/L) (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction (REPAIR - AMI)
Brief Summary: Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel.

The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.


Options:
A: Change in global left ventricular function in quantitative LV angiography after 4 months. (baseline to 4 months)
B: Safety as measured by holter monitor, laboratory assessments, and cardiac MRI (6 months)
C: difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up (6 months)
D: myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),; Ejection fraction (%) evaluated by 2D echocardiography;

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Rituximab on the Progression of Type 1 Diabetes in New Onset Subjects
Brief Summary: Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot maintain proper blood glucose levels in response to daily activities such as eating or exercise. With fewer insulin producing cells blood glucose increases, causing hunger, thirst, and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta cells have already been destroyed. However, this also means that between 10-20% of these cells remain that continue to produce insulin.

Scientists have learned that two types of immune cells, B cells and T cells, are involved in causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells that make insulin. Although they don't attack insulin producing cells, B cells may be what trigger the T cells to attack.

This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration (FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the immune system are well understood through its use in organ transplantation. Research has shown that rituximab might be helpful in treating other conditions caused by T cells and B cells, including type 1 diabetes. The goal of this study is to find out if rituximab can preserve residual insulin secretion and prevent further beta cell destruction in type 1 diabetes.


Options:
A: Change in Clinical Activity Score (CAS) (baseline, 6 months after the first infusion)
B: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year (When all participants complete the 1 year visit)
C: Percentage of Participants Who Were Proptosis Responders at Week 24 (Week 24)
D: Responder Status at Week 24 (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Rituximab on the Progression of Type 1 Diabetes in New Onset Subjects
Brief Summary: Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot maintain proper blood glucose levels in response to daily activities such as eating or exercise. With fewer insulin producing cells blood glucose increases, causing hunger, thirst, and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta cells have already been destroyed. However, this also means that between 10-20% of these cells remain that continue to produce insulin.

Scientists have learned that two types of immune cells, B cells and T cells, are involved in causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells that make insulin. Although they don't attack insulin producing cells, B cells may be what trigger the T cells to attack.

This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration (FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the immune system are well understood through its use in organ transplantation. Research has shown that rituximab might be helpful in treating other conditions caused by T cells and B cells, including type 1 diabetes. The goal of this study is to find out if rituximab can preserve residual insulin secretion and prevent further beta cell destruction in type 1 diabetes.


Options:
A: Time to Confirmed Disease Progression (CDP) (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)); Percentage of Participants With CDP (96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression))
B: Time to treatment failure (TTF) at 3 years (3 years)
C: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year (When all participants complete the 1 year visit)
D: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Brief Summary: The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.


Options:
A: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) (Week 12 (Day IP-85)); Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 (Month 12 (Day MP-365)); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation (Day OL-1 through the end of the OL); OL; Number of Participants With AEs of Special Interest (Day OL-1 through Day OL-729); OL; Number of Participants With Physical Examination Findings (Day OL-1 through Day OL-729); OL; Number of Participants With Marked Hematology Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities (Day OL-1 through Day OL-729)
B: N/A
C: Safety and tolerability of AVX-470 over 28 days of treatment (5 weeks)
D: Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 (Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Suicide in Primary Care Elderly: Collaborative Trial
Brief Summary: The purpose of this study was to determine the effect of a primary care intervention on reducing suicidal ideation and depression in older patients.


Options:
A: N/A
B: Hamilton Depression Rating Scale; Scale for Suicide Ideation
C: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
D: EPDS (3 and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Selenium and Immune Function
Brief Summary: The aim of the study is to investigate the relationship between dose and form of selenium on immune function, and to identify functional markers of selenium status.


Options:
A: Cellular and Humoral Immune Response (12 weeks)
B: Outcomes assessed will be based on the ongoing ocular examination and historical data that will be obtained at each visit. The visual acuity data and the photographic documentation of the two diseases will be of particular importance. (5 years)
C: Retinal blood flow (in total 8x on 2 study days)
D: Cardiovascular disease; Cancer

Answer: A