TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Dose-escalation Study of the Investigational Trifunctional Bispecific Anti-CD20 x Anti-CD3 Antibody FBTA05 in Combination With Donor Lymphocyte Infusion (DLI) in Patients With CD20 Positive Chronic Lymphocytic Leukemia (CLL), Low and High Grade Non-Hodgkin´s Lymphoma (NHL) After Allogeneic Stem Cell Transplantation
Brief Summary: This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation


Options:
A: Phase I - Identification of the dose limiting toxicity (DLT) (4 weeks after CAR T cell infusion); Phase II - Efficacy (4 weeks after CAR T cell infusion)
B: To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose (Day 0 to 28 for DLT)
C: Phase I: Determination of the maximum tolerated dose (MTD); Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
D: Response rate and toxicity (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS
Brief Summary: Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.


Options:
A: Whole body insulin action (3 months)
B: Live-birth rate (Up to 2 years)
C: Live Birth (as few as 5 months, up to 16 months)
D: Weight loss (One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS
Brief Summary: Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.


Options:
A: Determine the cost-effectiveness of fast track to IVF versus conventional infertility treatment by conducting a randomized clinical trial to compare success rates and costs, as well as the associated complications of treatment. (at end of study)
B: Pregnancy rate (6 months follow-up)
C: Number of ovulating patients (1-2 months)
D: Whole body insulin action (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS
Brief Summary: Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.


Options:
A: Pregnancy rate (6 months follow-up)
B: pregnancy rate (3 momths)
C: Determine the cost-effectiveness of fast track to IVF versus conventional infertility treatment by conducting a randomized clinical trial to compare success rates and costs, as well as the associated complications of treatment. (at end of study)
D: Whole body insulin action (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Berberine on Hormonal and Metabolic Features in Obese Women With PCOS
Brief Summary: Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.


Options:
A: Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ) (24 hours)
B: Weight loss (One year)
C: Live Birth (as few as 5 months, up to 16 months)
D: Whole body insulin action (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop
Brief Summary: The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.


Options:
A: Gait Velocity (6 months); Stroke Impact Scale (SIS) Composite Score (6 months); Device Related Serious Adverse Events (6 months)
B: Ten Meter Walk Test (10mWT) (Week 30)
C: Change in Action Research Arm Test (ARAT) Score (Baseline and 12 weeks)
D: Change in Fugl-Meyer Assessment Scale after training (1) up to 7 weeks, 2) 3 months after participants finish the training); Change in Modified Ashworth Scale after training (1) up to 7 weeks, 2) 3 months after participants finish the training)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Organized Self-Management Support Services for Chronic Depression
Brief Summary: The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.


Options:
A: N/A
B: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
C: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)
D: Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors) (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Podcasting and Mobile Media to Promote Weight Loss and Increase Fruit and Vegetable Intake Among Overweight Adults
Brief Summary: Overweight and obesity play a role in both cancer incidence and survival rates. Many people have found attending weight loss support groups to be time-intensive. Past research has shown electronic media, particularly the Web, to be effective in producing weight loss. The Web, however, lacks portability, which prevents people from accessing the information when it is convenient for them. Providing weight loss information via podcasting (audio files that may be listened to on portable audio players) may allow people to receive weight loss tips anywhere. A previous research study showed that podcasts emphasizing healthy eating and exercise can help people lose weight. This study was short-term and did not include additional social support. The purpose of this research project is to assess the effectiveness of a weight loss intervention delivered through podcasts as compared to the same podcast with added mobile media such as self-monitoring software (such as a pedometer) and support delivered via a social networking site. For this research study, the investigators will conduct a 6-month study in 104 overweight adults to determine if a podcast plus mobile media support leads to greater weight loss than a podcast alone.


Options:
A: Change from baseline in weight at 12 months (Baseline and 12 months)
B: Weight loss (6 months)
C: Percent weight loss: objective (Baseline, 6 Months); Weight (Baseline, 6 Months)
D: %BMIp95 (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Podcasting and Mobile Media to Promote Weight Loss and Increase Fruit and Vegetable Intake Among Overweight Adults
Brief Summary: Overweight and obesity play a role in both cancer incidence and survival rates. Many people have found attending weight loss support groups to be time-intensive. Past research has shown electronic media, particularly the Web, to be effective in producing weight loss. The Web, however, lacks portability, which prevents people from accessing the information when it is convenient for them. Providing weight loss information via podcasting (audio files that may be listened to on portable audio players) may allow people to receive weight loss tips anywhere. A previous research study showed that podcasts emphasizing healthy eating and exercise can help people lose weight. This study was short-term and did not include additional social support. The purpose of this research project is to assess the effectiveness of a weight loss intervention delivered through podcasts as compared to the same podcast with added mobile media such as self-monitoring software (such as a pedometer) and support delivered via a social networking site. For this research study, the investigators will conduct a 6-month study in 104 overweight adults to determine if a podcast plus mobile media support leads to greater weight loss than a podcast alone.


Options:
A: Weight loss (6 months)
B: Waist Circumference (2 Years)
C: body mass index (24 months)
D: Waist Circumference (Month 9); Body Weight (nine month); Body Weight (4 month); Waist Circumference (4 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stop Antibiotics on Procalcitonin Guidance Study
Brief Summary: This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).


Options:
A: Antibiotic use; Length of stay in hospital
B: N/A
C: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
D: Mortality (28 days); Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. (Between day 1 and D28); Mortality (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stop Antibiotics on Procalcitonin Guidance Study
Brief Summary: This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).


Options:
A: All cause mortality (28 days)
B: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
C: Mortality (28 days); Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. (Between day 1 and D28); Mortality (1 year)
D: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Therapy and Cognitive Training in Work Rehabilitation for Persons With Severe Mental Illness. A Randomised Controlled Trial
Brief Summary: This study will compare the effects of cognitive behaviour therapy (CBT) and cognitive training in work rehabilitation of patients with severe mental illness (psychoses).

These interventions will be compared with a matched control group ('treatment as usual'). The patients will be recruited in nine different counties in Norway. During a two-year period around 27-30 patients can be recruited from each county, meaning that each intervention arm will contain approximately 80 patients. The evaluation of the patients will include several validated diagnostic instruments as described below. The counties has been randomised to the two different intervention groups by a neutral institution: 1.group receiving work rehabilitation based on cognitive behaviour therapy, and 2.group receiving cognitive training. The control group will be matched according to gender and age. With Ntotal=160 for the comparison of two groups (80 patients x 2), a 0.05 level of significance and a power of 0.80, a standardised group difference of 0.44 can be detected. The standardised difference detected between supported employment and treatment as usual has been as high as 0.80 in comparable American studies, indicating that N is large enough in the present study.

The participants in each county will be evaluated and followed by a local project coordinator and by a local psychiatrist/psychologist in a District Psychiatric Centre. Written evaluation protocols will be sent anonymously to the research centre for registration. Data will be stored according to current laws of person protection and data security. Pre-post differences in each group, differences between the control group and the intervention groups, and differences between the intervention groups will be tested using a mixed linear model programme.

Research questions The project will compare the effects of CBT oriented work rehabilitation and work rehabilitation with cognitive training with regard to the ability of persons with severe mental disorders to cope with and keep a job. The two intervention arms will be compared with each other and with a matched treatment as usual control group.

Main hypotheses

1. By the end of the project (T2) and by follow up examination (T3) the global psychosocial function of patients will be higher in the CBT work rehabilitation group than in the control group
2. The global psychosocial function of patients at T2 and T3 will be higher in the cognitive training group than in the control group


Options:
A: N/A
B: Change in Program Participation (6, 12, 18, and 24 months); Change in Program Fidelity (6, 12, and 24 months); Change in Participant Weight (Baseline, quarterly through 24 months)
C: The Work Behavior Inventory (Ten months)
D: Depressive symptoms reduction (Measured at months 6 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia
Brief Summary: The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.


Options:
A: Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis (Baseline and 12 weeks); Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis (Baseline and 12 weeks)
B: Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
C: Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks (Baseline, 12 weeks)
D: Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone (Baseline, Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Status: Relative Efficacy of Vitamins D2 and D3
Brief Summary: Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.


Options:
A: Breast Cancer Recurrence (Lifetime)
B: fractures (4 years)
C: Number of Participants Who Develop Hypercalcemia (6 months)
D: AUC for increment in serum 25(OH)D (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Status: Relative Efficacy of Vitamins D2 and D3
Brief Summary: Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.


Options:
A: AUC for increment in serum 25(OH)D (12 weeks)
B: rate of falls compared between treatment arms
C: C peptide
D: Change in Body Weight From Baseline to 12 Months (baseline, 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?
Brief Summary: The inflammatory response after cardiac surgery increases mortality and morbidity. Modified ultrafiltration (MUF) has been shown to decrease the post-cardiac surgery inflammatory response, to improve respiratory function, and cardiac performance in pediatric patients; however, this approach has not been well established in adults. The investigators therefore hypothesized that MUF can decrease the post-cardiac surgery inflammatory response and can improve cardiopulmonary function in adults.


Options:
A: mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection (4 days)
B: Overall clinical improvement after cardiac surgeries. (30 day after surgery)
C: Reduction of systemic inflammatory response (Through study completion, an average of 1 year)
D: Allogenic Blood Product Transfusion Risk (Patients were followed for the duration of hospital stay, an average of 6 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Exercise Program for Early Breast Cancer Survivors
Brief Summary: Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.

Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.


Options:
A: Cognitive-psychosocial functions (3 and 6 months)
B: Changes of health-related physical fitness components (1). (Changes from baseline aerobic capacity at 12 weeks); Changes of health-related physical fitness components (2). (Changes from baseline muscular endurance at 12 weeks); Changes of health-related physical fitness components (3). (Changes from baseline muscular strength at 12 weeks); Changes of health-related physical fitness components (4). (Changes from baseline muscular power at 12 weeks); Changes of health-related physical fitness components (5). (Changes from baseline agility at 12 weeks); Changes of health-related physical fitness components (6). (Changes from baseline flexibility at 12 weeks); Changes of anthropometric parameters (1). (Changes from baseline waist circumference at 12 weeks); Changes of anthropometric parameters (2). (Changes from baseline BMI at 12 weeks); Changes of body composition parameters (1). (Changes from baseline body fat mass at 12 weeks); Changes of body composition parameters (2). (Changes from baseline lean body mass at 12 weeks); Changes of body composition parameters (3). (Changes from baseline percentage body fat at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (1). (Changes from baseline serum levels of DKK1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (2). (Changes from baseline serum levels of Sclerostin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (3). (Changes from baseline serum levels of SFRP1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (4). (Changes from baseline serum levels of β-catenin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (5). (Changes from baseline serum levels of WISP-1 at 12 weeks)
C: Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (At week 16); Improvement of physical fitness, cardiorespiratory fitness, and muscle strength (At week 16); Feasibility of a supervised exercise program for cancer survivors (At week 16); Maintain positive benefits of an exercise intervention (12 weeks post-intervention)
D: Change from baseline in numbers of goal behaviors at 3 months (Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Exercise Program for Early Breast Cancer Survivors
Brief Summary: Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.

Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.


Options:
A: Physical activity questionnaire (International Physical Activity Questionnaire) (Baseline and 6 months)
B: Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (At week 16); Improvement of physical fitness, cardiorespiratory fitness, and muscle strength (At week 16); Feasibility of a supervised exercise program for cancer survivors (At week 16); Maintain positive benefits of an exercise intervention (12 weeks post-intervention)
C: Quality of life (Participants will be followed over 8 weeks)
D: Change in Functional Assessment of Cancer Therapy summary score (physical, emotional, spiritual, and social QOL) (Baseline to up to 6 months); Program compliance as measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months); Program satisfaction measured by Yoga - Daily Practice Calendar and Yoga Class Attendance Record and Yoga Evaluation Form (Up to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Exercise Program for Early Breast Cancer Survivors
Brief Summary: Rationale: Exercise therapy may improve the quality of life of breast cancer survivors.

Purpose: This randomized clinical trial studies exercise therapy and quality of life in postmenopausal early breast cancer survivors receiving aromatase inhibitor therapy.


Options:
A: Weight loss maintenance (6 - 18 months)
B: Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (At week 16); Improvement of physical fitness, cardiorespiratory fitness, and muscle strength (At week 16); Feasibility of a supervised exercise program for cancer survivors (At week 16); Maintain positive benefits of an exercise intervention (12 weeks post-intervention)
C: Change in FACIT-TS questionnaire score (Baseline, 6 months)
D: Exercise behavior

Answer: B