TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Vulvar Vestibulitis Trial: Desipramine-Lidocaine
Brief Summary: The Vulvar Vestibulitis Clinical Trial (VVCT) a randomized, placebo-controlled, double blinded clinical trial. We will study the clinical efficacy of four medical treatments for vulvar vestibulitis: topical lidocaine, oral desipramine, combined lidocaine and desipramine, and placebo cream and capsules. Desipramine is a tricyclic antidepressant commonly used by clinicians for treatment of several chronic pain conditions that demonstrates an optimal side effect profile compared to other tricyclic antidepressants. Topical lidocaine has also been found to be beneficial for vulvar vestibulitis treatment in small studies. It is hypothesized that the combined use of oral desipramine and topical lidocaine will be more therapeutically effective than either one by itself and better than placebo.


Options:
A: Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6 (Baseline, week 6); Change from Baseline in Pain Pressure Threshold (PPT) at week 6 (Baseline, week 6); Change from Baseline Brain-derived neurotrophic factor at week 6 (Baseline, week 6)
B: Pain reduction (16 weeks)
C: Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS). (Baseline and 9 months)
D: Primary outcome variable will compare the reported pain of the "Tampon Test" (mean of Weeks -2, -1, and 0), prior to randomization to the reported pain of "Tampon Test" (mean of Weeks 10, 11, and 12). (The dependent (primary outcome) variable will be defined as the percent change of mean "Tampon test" pain of Weeks (10, 11, and 12) from Weeks (-2, -1 and 0).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia
Brief Summary: The objectives of this study is:

* to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months
* document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of incorporating the weekly iron supplementation programme into the normal school activity in intervention schools determine the extent of acceptability and support for the iron supplementation programme by staff at the health centre nearest to the intervention schools
* compare the praziquantel efficacy and schistosomiasis reinfection in children in intervention schools with that of children in control schools following the introduction of weekely iron supplementation over a period of nine months
* determine the impact of weekly iron supplementation on haemoglobin levels of children in intervention schools and compare with children in control schools over a period of nine months


Options:
A: Isotope absorption into blood stream (Day 15); Isotope absorption into blood stream (Day 43)
B: incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) (5 months)
C: Death among children 1-36 months of age
D: Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9; Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9; Blood samples examined for haemoglobin level mont 0 and month 9

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A three year prospective, double blinded, placebo controlled, randomized clinical trial in impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing the conversion to Diabetes.


Options:
A: Reduction in conversion of IGT to diabetes
B: Prevention of Type 2 Diabetes (2.4 years)
C: Liver Histology (Using Kleiner et al Criteria, Hepatology 2005) (At 18 months)
D: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Patient-Oncologist Communication
Brief Summary: RATIONALE: A computer program and education materials may help improve the ability of doctors to communicate with patients.

PURPOSE: This randomized clinical trial is studying how well a computer program together with education materials works in improving communication between doctors and patients with stage IV cancer.


Options:
A: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)
B: Neuropsychiatric symptoms (9 months); Quality of life (9 months)
C: Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool (6 month)
D: Is there a change in patient understanding of prognosis with the addition of a palliative care intervention? (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Patient-Oncologist Communication
Brief Summary: RATIONALE: A computer program and education materials may help improve the ability of doctors to communicate with patients.

PURPOSE: This randomized clinical trial is studying how well a computer program together with education materials works in improving communication between doctors and patients with stage IV cancer.


Options:
A: Physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through validated tools and questionnaires (4 months)
B: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
C: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)
D: impact on patient outcomes of targeted physician communication skills training (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Plant-Based Dietary Intervention in Type 2 Diabetes
Brief Summary: The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.


Options:
A: Change in body weight (measured at Year 2)
B: Hemoglobin A1c (22 weeks)
C: Breast Cancer Recurrence (Lifetime)
D: Body weight reduction (Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Plant-Based Dietary Intervention in Type 2 Diabetes
Brief Summary: The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.


Options:
A: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
B: Laboratory findings and body composition (2 years)
C: body weight (prior to and after 4, 8, and 12 months of dieting)
D: Hemoglobin A1c (22 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Plant-Based Dietary Intervention in Type 2 Diabetes
Brief Summary: The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.


Options:
A: Breast Cancer Recurrence (Lifetime)
B: weight loss
C: Glucose metabolism (Study weeks 0); Glucose metabolism (12 weeks); Glucose metabolism (24 weeks)
D: Hemoglobin A1c (22 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Plant-Based Dietary Intervention in Type 2 Diabetes
Brief Summary: The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.


Options:
A: Change in body weight (measured at Year 2)
B: Breast Cancer Recurrence (Lifetime)
C: Hemoglobin A1c (22 weeks)
D: weight loss

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Plant-Based Dietary Intervention in Type 2 Diabetes
Brief Summary: The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.


Options:
A: total and low-density lipoprotein (LDL) cholesterol; LDL:HDL cholesterol ratio; weight reduction
B: hemoglobin A1C (diabetes management) (assessment at baseline (0 weeks)); hemoglobin A1C (diabetes management) (assessment at 10 weeks); hemoglobin A1C (diabetes management) (assessment at 20 weeks); hemoglobin A1C (diabetes management) (assessment at one-year follow-up); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at baseline (0 weeks)); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at 10 weeks); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assesment at 20 weeks); lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) (assessment at one-year follow-up); body weight (assessment at baseline (0 weeks)); body weight (assessment at 10 weeks); body weight (assessment at 20 weeks); body weight (assessment at one-year follow-up); indices of renal function (serum creatinine, microalbumin) (assessment at baseline (0 weeks)); indices of renal function (serum creatinine, microalbumin) (assessment at 10 weeks); indices of renal function (serum creatinine, microalbumin) (assessment at 20 weeks); indices of renal function (serum creatinine, microalbumin) (assessment at one-year follow-up)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: Hemoglobin A1c (22 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Plant-Based Dietary Intervention in Type 2 Diabetes
Brief Summary: The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.


Options:
A: Death, all-cause (Up to 7 years)
B: weight loss
C: Hemoglobin A1c (22 weeks)
D: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Plant-Based Dietary Intervention in Type 2 Diabetes
Brief Summary: The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.


Options:
A: Hemoglobin A1c (22 weeks)
B: weight loss
C: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
D: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Spiriva® Assessment of FEV1 (SAFE). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Long-term Treatment in Patients With COPD. A One-year Parallel Group, Double-blind, Randomised, Placebo-controlled Study
Brief Summary: The objective of this trial is to evaluate whether the effect of one year (48 weeks) treatment with inhaled tiotropium bromide (Spiriva® - 18 µg once daily) on the change in trough FEV1, compared to placebo in patients with COPD, is affected by smoking status.


Options:
A: The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment. (after 48 weeks of treatment)
B: Change From Baseline in Trough FEV1 After 48 Weeks (10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication); Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL) (Week 48); TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies) (Week 48); COPD Exacerbation Rate, Safety Set (SS) (Combined Studies) (48 weeks)
C: Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. (Day 15)
D: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase (baseline, 96 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis
Brief Summary: The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).

The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.


Options:
A: Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))
B: Symptomatic Venous Thromboembolism; Major Bleeding; Death
C: Number of Patients With Clinically Relevant Bleeding Events (prior to day 90 +/- 5)
D: The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) (From Day 1 to Day 90 (±7 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicenter, Randomised, Parallel, Placebo-Controlled, Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.
Brief Summary: Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.


Options:
A: Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? (1 year); Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? (1 year)
B: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
C: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)
D: Time to First Exacerbation Event Within 48 Weeks (Up to Week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicenter, Randomised, Parallel, Placebo-Controlled, Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.
Brief Summary: Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
C: Sputum Wet and Dry Weight (Produced during each airway clearance therapy session on days 1 and 4)
D: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicenter, Randomised, Parallel, Placebo-Controlled, Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.
Brief Summary: Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.


Options:
A: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
B: Number of pulmonary exacerbations (One year)
C: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)
D: Lung function (FEV1, FVC, FEF25-75)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Protective Mechanisms of Aldosterone Antagonists and Their Effects on Cardiovascular Damage in Chronic Renal Failure: Clinical and Experimental Studies
Brief Summary: The purpose of the present study is to determine if spironolactone is safe and effective in the treatment of cardiovascular complications in hemodialysis patients.


Options:
A: N/A
B: permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension (13 weeks)
C: risk of hyperkalemia (6 months)
D: Iohexol clearance (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Brief Summary: The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.


Options:
A: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030); Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) (From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030)
B: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.
C: Measured throughout the study: Relapse; Time to relapse
D: Alcohol Use Behaviors (Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.); Depressive Symptoms (Average score as measured by participant's report on the Beck Depression Inventory (BDI).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Brief Summary: The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.


Options:
A: Montgomery Asberg Depression Rating Scale (MADRS) (Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).)
B: Time to return to work (12 months)
C: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.
D: Hamilton Rating Scale for Depression (Measured at screening, weeks 1 through 12, and week 36)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether a jugular route leads to a lower rate of complications as compared with a femoral route for catheterization in patients admitted in several intensive care units in France who develop acute renal failure requiring hemodiafiltration or hemodialysis.


Options:
A: Time of insertion without complication
B: Overall mortality (0 to 28 days)
C: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)
D: Number of filters used per hour (24 months)

Answer: A