TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Treatment of High Blood Pressure
Brief Summary: This study is an NIH-funded clinical trial conducted at Duke Medical Center evaluating the effects of the DASH diet alone and combined with a behavioral weight loss program on blood pressure and various vascular measures. Eligible patients must be unmedicated with blood pressure values ranging from approximately 130/85 to 159/99. Our primary hypothesis are as follows: (1) The DASH diet alone and combined with a behavioral weight management program will result in greater BP reductions than Usual Care controls at the end of the 4 month treatment period; (2) The DASH diet in combination with a behavioral weight management program will be more effective in lowering BP than the DASH diet alone; (3) The DASH diet alone and the DASH diet combined with the behavioral weight management program will result in greater improvements in cardiac, metabolic, and vascular function compared to the control condition; and (4) The combined DASH diet and weight management intervention also will be the most effective treatment in maintaining BP reductions at 1-year follow-up.


Options:
A: Changes in Mediterranean diet scale (6, 12, and 24 months)
B: Changes in glucose metabolism, changes in transcriptomic and metabolomic profiles (By 2010)
C: Blood pressure (4 months)
D: Glucose metabolism (Study weeks 0); Glucose metabolism (12 weeks); Glucose metabolism (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Treatment of High Blood Pressure
Brief Summary: This study is an NIH-funded clinical trial conducted at Duke Medical Center evaluating the effects of the DASH diet alone and combined with a behavioral weight loss program on blood pressure and various vascular measures. Eligible patients must be unmedicated with blood pressure values ranging from approximately 130/85 to 159/99. Our primary hypothesis are as follows: (1) The DASH diet alone and combined with a behavioral weight management program will result in greater BP reductions than Usual Care controls at the end of the 4 month treatment period; (2) The DASH diet in combination with a behavioral weight management program will be more effective in lowering BP than the DASH diet alone; (3) The DASH diet alone and the DASH diet combined with the behavioral weight management program will result in greater improvements in cardiac, metabolic, and vascular function compared to the control condition; and (4) The combined DASH diet and weight management intervention also will be the most effective treatment in maintaining BP reductions at 1-year follow-up.


Options:
A: N/A
B: Blood pressure (4 months)
C: For adults: body weight loss maintenance (6 Month)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SEND Trial The Role of Selective Neck Dissection Used Electively in Patients With Early Oral Squamous Cell Carcinoma (1-3cm Primary Size) and No Clinical Evidence of Lymph Node Metastases in the Neck
Brief Summary: RATIONALE: Surgery may be an effective treatment for oral cancer. It is not yet known whether surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to remove the tumor alone in treating patients with early-stage oral cancer.

PURPOSE: This randomized clinical trial is comparing two types of neck surgery to see how well they work in treating patients with early stage oral cancer.


Options:
A: Spinal accessary nerve function (2 years)
B: Overall Survival (Percentage of Participants Alive) (From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.)
C: Recurrence-free survival (5 years)
D: Overall survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dortmund Intervention Trial for Optimization of Infant Nutrition
Brief Summary: The objective of this study is to determine the influence of an increase of meat in complementary food on iron status and the effect of an exchange of vegetable oil in the same food on the status of omega-3 fatty acids in infants in the second six months of life.


Options:
A: Incidence of Stunting of Linear Growth (18 months of age)
B: Serum/plasma concentrations of B12, choline, and betaine (6 months); Serum/plasma concentrations of polyunsaturated fatty acids (PUFAs) and amino acids (6 months)
C: Linear growth velocity (6 to 18 months of age)
D: Sum of Omega-3 Fatty Acid Pattern in Plasma (at the end of the tenth month of life); Parameters of Iron Status in Blood (at the end of the fourth, seventh, tenth month of life)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Should the Surgeon or the General Practitioner (GP) Follow up Patients After Surgery for Colon Cancer? A Randomized Controlled Trial Focusing on Quality of Life, Cost-effectiveness and Serious Clinical Events.
Brief Summary: The purpose of this study is to clarify cost effectiveness and quality of life issues among colon cancer patients followed up in a hospital setting or by their GP's.Statement of study hypothesis:Postoperative follow up of colon cancer patients (according to national guidelines) by general practitioners will not have any influence on patients' quality of life. There will not be observed any increase in serious clinical events and cost effectiveness will be improved.


Options:
A: Quality of life; EORTC-QLQ-C30 and EQ 5D (2 years)
B: Patient satisfaction with follow-up care (up to 60 months after completion of primary treatment); Costs-effectiveness (assessed at 60 months after completion of primary treatment)
C: Overall Survival (5 years)
D: UWQOL v4 QoL (Post-Treatment 1 Year Review Clinic)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Should the Surgeon or the General Practitioner (GP) Follow up Patients After Surgery for Colon Cancer? A Randomized Controlled Trial Focusing on Quality of Life, Cost-effectiveness and Serious Clinical Events.
Brief Summary: The purpose of this study is to clarify cost effectiveness and quality of life issues among colon cancer patients followed up in a hospital setting or by their GP's.Statement of study hypothesis:Postoperative follow up of colon cancer patients (according to national guidelines) by general practitioners will not have any influence on patients' quality of life. There will not be observed any increase in serious clinical events and cost effectiveness will be improved.


Options:
A: Quality of life; EORTC-QLQ-C30 and EQ 5D (2 years)
B: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)
C: Overall and cancer-specific mortality (5 years)
D: Overall Survival (OS) (5-year OS); Health Related Quality of Life (Yearly assessment over 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Co-morbid Obesity and Major Depressive Disorder
Brief Summary: This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight.


Options:
A: Endothelium-dependent flow mediated dilation (Baseline / week 32-36 of gestation)
B: HAMD-17
C: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
D: Change in body weight and the trend in body weight over time (Measured at Month 6 and Years 1 and 2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Double-Blind, Placebo-Controlled, Crossover Study Evaluating Aprepitant in Combination With a 5HT3 & Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-Based Chemotherapy Regimen
Brief Summary: Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. This study will compare the addition of aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV prophylaxis in a double-blind, randomized, crossover study design.


Options:
A: Complete Response. (Participants were evaluated from start of treatment through day 8 of cycle 2.)
B: Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen (0 to 120 hours in the first cycle of chemotherapy)
C: Patient diary recording nausea, emesis, food ingestion, and rescue therapy (From initiating administration of anticancer agents to day 6 (120 hours))
D: Overall complete response (no emesis and no rescue therapy) (During and post chemotherapy (0-120 h))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects With Lupus Nephritis in Combination With Mycophenolate Mofetil Therapy.
Brief Summary: The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International; operational oversight was provided by ZymoGenetics.


Options:
A: Number of Participants With Complete Response (Week 24)
B: Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response (At Week 52)
C: Number of patients with reduction in proteinuria (measurement of total urine protein greater than 0.5 g/24-hours, or a urine protein to creatinine ratio greater than 0.5 mg/mg) (Baseline to Week 24)
D: remission rate (month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine When Administered During the Moderate-Severe Migraine Pain, Studies 1 and 2 of 2
Brief Summary: Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)


Options:
A: Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose (From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).)
B: Score on a 4-pt migraine pain scale for a single menstrual migraine attack (2 to 48 hours)
C: Trexima will be evaluated for efficacy as an acute treatment for migraine based on its superiority over placebo at 2 hours for: a) pain relief (no or mild pain), b) incidence of photophobia, c) incidence of phonophobia and d) incidence of nausea.
D: Trexima will be evaluated for efficacy as an acute treatment for migraine based on its superiority over placebo at 2 hours for: a) pain relief (no or mild pain), b) incidence of photophobia, c) incidence of phonophobia and d) incidence of nausea.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
Brief Summary: This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.


Options:
A: Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (Baseline and 4 weeks (or last observation after Baseline))
B: Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests. (8 weeks)
C: cognition (six weeks)
D: Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint (Baseline and Endpoint (Week 24 or last observation after baseline))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Brief Summary: The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.


Options:
A: Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment (Baseline to 8 weeks)
B: Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF) (8 weeks)
C: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
D: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investigation of BotheR And Quality of Life iN subjecTs With OAB
Brief Summary: Evaluate the effect of VESIcare® on symptom bother for subjects with OAB


Options:
A: Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score (Baseline and 12 Weeks)
B: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)
C: Change in the total weekly number of incontinence episodes (Baseline to Treatment Week 12/Premature Discontinuation)
D: Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants (Baseline (BL); Week 12); CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants (Baseline; Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise-based Motivational Interviewing for Fibromyalgia
Brief Summary: Fibromyalgia (FMS), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, affects 2% of the general population. Drug therapy for FMS is largely symptomatic as there is not yet a complete understanding of the pathogenesis of the disease. In the past 17 years, supervised aerobic exercise has emerged as an important treatment modality to improve pain, aerobic capacity, function, and well-being. Individuals who are able to adhere to exercise almost always maintain the symptomatic benefits of exercise. Unfortunately, the rate of exercise adherence six months after the completion of a well-structured supervised exercise program is disappointingly low. Furthermore, although the efficacy of supervised aerobic exercise in the research setting is well documented, the applicability of such intervention in the clinic setting is doubtful. Therefore, we propose to conduct the Research to Encourage Exercise for Fibromyalgia (REEF), a randomized attention-controlled trial whose primary aim is to evaluate the efficacy of telephone-delivered motivational interviewing (MI) to encourage exercise, in improving exercise adherence and self-report physical function (co-primary outcome measures) for FMS patients. REEF will enroll 200 FMS patients, randomizing them to either the MI group or the attention-control (AC) group. Participants from each group will receive a total of 6 telephone calls within a 12-week period. Prior to the phone calls, participants from both groups will receive an individualized exercise prescription and 2 supervised exercise training sessions to get them started on an exercise program. All subjects will undergo comprehensive outcome assessment at baseline, week 12, week 24, and week 36. The secondary aim of this proposal is to determine the mediators between MI and improvement in self-report physical function. The proposed research is significant because our focus is the promotion of adherence to an exercise program, of adequate intensity, in order to maximize functioning and well-being for patients with FMS. The use of a predominantly home-based exercise program and telephone-delivered MI by a trained licensed practice nurse (LPN) could potentially make the proposed intervention more accessible to the greater majority of FMS patients. Furthermore, if proven efficacious, MI could readily be applied to other chronically painful conditions (e.g. chronic back pain).


Options:
A: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)
B: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
C: Muscle function (2010-2013)
D: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise-based Motivational Interviewing for Fibromyalgia
Brief Summary: Fibromyalgia (FMS), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, affects 2% of the general population. Drug therapy for FMS is largely symptomatic as there is not yet a complete understanding of the pathogenesis of the disease. In the past 17 years, supervised aerobic exercise has emerged as an important treatment modality to improve pain, aerobic capacity, function, and well-being. Individuals who are able to adhere to exercise almost always maintain the symptomatic benefits of exercise. Unfortunately, the rate of exercise adherence six months after the completion of a well-structured supervised exercise program is disappointingly low. Furthermore, although the efficacy of supervised aerobic exercise in the research setting is well documented, the applicability of such intervention in the clinic setting is doubtful. Therefore, we propose to conduct the Research to Encourage Exercise for Fibromyalgia (REEF), a randomized attention-controlled trial whose primary aim is to evaluate the efficacy of telephone-delivered motivational interviewing (MI) to encourage exercise, in improving exercise adherence and self-report physical function (co-primary outcome measures) for FMS patients. REEF will enroll 200 FMS patients, randomizing them to either the MI group or the attention-control (AC) group. Participants from each group will receive a total of 6 telephone calls within a 12-week period. Prior to the phone calls, participants from both groups will receive an individualized exercise prescription and 2 supervised exercise training sessions to get them started on an exercise program. All subjects will undergo comprehensive outcome assessment at baseline, week 12, week 24, and week 36. The secondary aim of this proposal is to determine the mediators between MI and improvement in self-report physical function. The proposed research is significant because our focus is the promotion of adherence to an exercise program, of adequate intensity, in order to maximize functioning and well-being for patients with FMS. The use of a predominantly home-based exercise program and telephone-delivered MI by a trained licensed practice nurse (LPN) could potentially make the proposed intervention more accessible to the greater majority of FMS patients. Furthermore, if proven efficacious, MI could readily be applied to other chronically painful conditions (e.g. chronic back pain).


Options:
A: Ambulatory Pain (Higher Values Indicate Greater Pain) (Baseline and after 12-weeks); Ambulatory Fatigue, Higher Values Indicate Greater Fatigue (Baseline and after 12-weeks)
B: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
C: Muscle function (2010-2013)
D: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)

Answer: D