TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Trial of Vasopressin Treatment for Social Deficits in Children With Autism
Brief Summary: Researchers at the Stanford University School of Medicine are seeking participants for a study examining the effectiveness of vasopressin, a neuropeptide, in treating children with autism spectrum disorder. Difficulty with social interactions is characteristic of people with autism, who often have problems interpreting facial expressions or maintaining eye contact while talking with someone. There are currently no effective medicines available to treat social problems in individuals with autism. Neuropeptides, such as vasopressin and oxytocin, are molecules used by neurons in the brain to communicate with one another. Vasopressin is closely related to oxytocin, which is currently being tested as a treatment for autism, and has been shown to enhance social functioning in animals. Animal studies have shown that when the proper functioning of vasopressin is experimentally altered, animals develop a variety of social deficits, including impaired memory for peers and a reduced interest in social interaction. Researchers found that when vasopressin was administered to mice with a genetically induced form of autism, their social functioning improved. Vasopressin is already approved by the Food and Drug Administration for use in humans, and has proved to be a successful treatment for some common pediatric conditions, including bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and memory in people who do not have autism. The researchers will test the effects of vasopressin on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study will last four weeks for each participant. Participants will receive either vasopressin or a placebo nasal spray. At the end of this phase of the study, those who received the placebo will have the option of participating in a four-week trial during which they will be given vasopressin. Stanford is the only site for the study. Participants do not need to live locally but will need to come to the Stanford University Department of Psychiatry and Behavioral Sciences for study visits.


Options:
A: Clinical Global Improvement (Week 12)
B: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
C: Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score (Baseline to Week 12)
D: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Technology-Assisted Drug Treatment and Relapse Prevention in Federally Qualified Health Centers (FQHCs)
Brief Summary: Implementing a mobile-phone based system for drug use disorders in primary care settings.


Options:
A: antiretroviral treatment (primary) (6 months)
B: Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence (Day 1); Patient discussion on mental health (Day 1)
C: Implementation Status (up to 3 years); Any Drinking Days in Last 30 Days (6 months); Risky Drinking Days in the Last 30 Days (6 months); Illicit Drug-use Within the Last 30 Days (6 months); Overall Quality of Life (6 months); Physical Subscale Quality of Life (6 months); Mental Subscale Quality of Life (6 months); Patient Had Any Drink Within the Last 30 Days (6 months); Patient Had Illicit Drug Use Within the Last 30 Days (6 months); Patient Had Any Drink or Drug Use Within the Last 30 Days (6 months); Patients, Within the Last 6 Months Have Received Other Addiction Treatment (6 months); Patients Partook in HIV Risky Behavior in the Last 6 Months (6 months); Patients Partook in HIV Testing in the Last 6 Months (6 months)
D: Change in IPV assessments (Screening and at 2 months post-birth.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Guided and Unguided CBT for Social Anxiety Disorder and/or Panic Disorder Via the Internet and a Smartphone Application
Brief Summary: BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a tailored smartphone application. The effect of added therapist support will also be studied.

METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to one of three treatment arms: (1) smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without therapist support; or (3) an active waiting list control group with delayed treatment. After the 10 week treatment period, the control group (3) will receive the same treatment as group (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment and two follow-up assessments (12 and 24 months).

HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be superior to the unguided form in reducing anxiety levels, and that both delivery modes will be superior to an active waiting-list control group.


Options:
A: Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) (5-year follow-up)
B: Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)); Social Phobia Inventory (SPIN) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37))
C: The Generalised Anxiety Disorder 7-item (GAD-7) (Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.)
D: Liebowitz Social Anxiety Scale (LSAS)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Guided and Unguided CBT for Social Anxiety Disorder and/or Panic Disorder Via the Internet and a Smartphone Application
Brief Summary: BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a tailored smartphone application. The effect of added therapist support will also be studied.

METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to one of three treatment arms: (1) smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without therapist support; or (3) an active waiting list control group with delayed treatment. After the 10 week treatment period, the control group (3) will receive the same treatment as group (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment and two follow-up assessments (12 and 24 months).

HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be superior to the unguided form in reducing anxiety levels, and that both delivery modes will be superior to an active waiting-list control group.


Options:
A: Brief Pain Inventory (Pain) (1 year)
B: Re-hospitalizations (During the 30days after discharge)
C: Child BMI
D: The Generalised Anxiety Disorder 7-item (GAD-7) (Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of this study is to evaluate the potential benefits in implantation, clinical pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment. Including a follow up on possible pregnancy complications and data on children at birth.

Further it is planned to aspirate secretions from the uterus and take blood samples during the treatment, which presumably can provide information about the mechanisms underlying the possible effect of the treatment.


Options:
A: Pregnancy Rate (12 weeks)
B: Rate of clinical pregnancy (Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.)
C: Clinical Pregnancy Rate (Five weeks gestation, as dated from the egg retrieval)
D: pregnancy rates (individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Exercise Tolerance and Quality of Life in Patients Awaiting Lung Resection by Video-assisted Thoracic Surgery
Brief Summary: The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.


Options:
A: Feasibility of a planned Nordic life style intervention (Five years)
B: Exercise Tolerance (Exercise tolerance 3 weeks after hospital discharge); Exercise Tolerance (Exercise tolerance 3 months after surgery)
C: Patient rated physical functioning (at 8 weeks and 24 weeks)
D: Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Exercise Tolerance and Quality of Life in Patients Awaiting Lung Resection by Video-assisted Thoracic Surgery
Brief Summary: The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.


Options:
A: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)
B: Exercise Tolerance (Exercise tolerance 3 weeks after hospital discharge); Exercise Tolerance (Exercise tolerance 3 months after surgery)
C: A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy (30 days after surgery)
D: Six minute walking test (up to 12 months postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception
Brief Summary: The purpose of this study is to see how often women who come to a family planning clinic for emergency contraception, the morning after pill, are willing to use either the copper IUD or the levonorgestrel IUD. The investigators will also see if pregnancies occur in those choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.


Options:
A: Initiation of long term contraception with 6 month postpartum (6 month)
B: Pregnancy (efficacy) (until follow-up about one week after next menses)
C: Pregnancy rates in first month after IUD insertion (4 weeks)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception
Brief Summary: The purpose of this study is to see how often women who come to a family planning clinic for emergency contraception, the morning after pill, are willing to use either the copper IUD or the levonorgestrel IUD. The investigators will also see if pregnancies occur in those choosing the levonorgestrel IUD and if people continue to use the IUD for 1 year.


Options:
A: Pregnancy rates in first month after IUD insertion (4 weeks)
B: Number of Participants With Pregnancy (Within 72 hours of unprotected Intercourse)
C: Pregnancy (efficacy) (until follow-up about one week after next menses)
D: Initiation of long term contraception with 6 month postpartum (6 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Self-management Through Adherence Among Heart Failure Patients
Brief Summary: Non-adherence to self-management behaviors is prevalent and accounts for hospital readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to activate and engage HF patients in managing their own care is uncertain. Yet post-acute care service that is vital to improve HF patients' self-management adherence and HF outcomes is suboptimal in rural hospitals (primarily critical access hospitals). The investigators central hypothesis is that patients with higher activation level will have significantly better self-management adherence. This study will test whether Patient AcTivated Care at Home (PATCH) will improve self-management adherence and health outcome (reduced hospital readmissions), as well as the feasibility to translate the research findings to a home based post-acute care service in rural communities.


Options:
A: Patients with confirmed DRA after discharge from the index hospitalisation (12 months)
B: Appropriate medicine adherence (During entire study period (24 months))
C: Change from Baseline in self-management adherence at 3 and 6 months (3 and 6 months following intervention)
D: Medication Adherence (12 months); Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Self-management Through Adherence Among Heart Failure Patients
Brief Summary: Non-adherence to self-management behaviors is prevalent and accounts for hospital readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to activate and engage HF patients in managing their own care is uncertain. Yet post-acute care service that is vital to improve HF patients' self-management adherence and HF outcomes is suboptimal in rural hospitals (primarily critical access hospitals). The investigators central hypothesis is that patients with higher activation level will have significantly better self-management adherence. This study will test whether Patient AcTivated Care at Home (PATCH) will improve self-management adherence and health outcome (reduced hospital readmissions), as well as the feasibility to translate the research findings to a home based post-acute care service in rural communities.


Options:
A: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)
B: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
C: Change from Baseline in self-management adherence at 3 and 6 months (3 and 6 months following intervention)
D: Reduction of the SCORE Risk Score (6 months after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect Evaluation of Individual Placement and Support (IPS)
Brief Summary: Roughly one third of disability pensions issued in Norway are classified as mental and behavioral disorders. The proposed study aims to evaluate the effect of an innovative intervention for returning people with moderate to severe mental health disorders to work: Individual Placement and Support (IPS).


Options:
A: To determine the effectiveness of SE/IPS in terms of vocational outcomes, such as employment rate, monthly income, job-tenure and working hours compared to stepwise rehabilitation available, for people with SMI in a Swedish context (6 months, 18 months, and 24 months (6 months after end of intervention))
B: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))
C: Depression severity as measured by Beck Depression Inventory-II (BDI2) (4 months post-randomization); Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month (4 months post-randomization)
D: Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect Evaluation of Individual Placement and Support (IPS)
Brief Summary: Roughly one third of disability pensions issued in Norway are classified as mental and behavioral disorders. The proposed study aims to evaluate the effect of an innovative intervention for returning people with moderate to severe mental health disorders to work: Individual Placement and Support (IPS).


Options:
A: sucessful employment for one day in the open labour market
B: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
C: Schizophrenia symptoms (Measured at Year 1); Vocational functioning (Measured at Year 2); Schizophrenia symptoms (Measured at Year 2); Quality of life (Measured at Year 2); Quality of life (Measured at Year 1); Vocational functioning (Measured at Year 1)
D: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
Brief Summary: The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.


Options:
A: Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months (Every 6 months- baseline, 6 month and 12 month)
B: Energy expenditure (calories burned) (2 days)
C: Total fat oxidation in response to eTRF (Week 1 or Week 5); Total fat oxidation in response to mTRF (Week 1 or Week 5); Insulin sensitivity in response to eTRF (Week 1 or Week 5); Insulin sensitivity in response to mTRF (Week 1 or Week 5); Glucose control in response to eTRF (Week 1 or Week 5); Glucose control in response to mTRF (Week 1 or Week 5)
D: Body weight (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ASP3550 Phase III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -
Brief Summary: To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.


Options:
A: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) (After treatment of 12 weeks compared to Baseline); Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) (After treatment of 12 weeks compared to Baseline)
B: Cumulative castration rate of treatment in terms of serum testosterone level (Up to one year of the treatment)
C: Intratumoral androgen levels (Week 12)
D: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 (After treatment of 12 weeks compared to Baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ASP1517 Phase 2 Clinical Trial -A Multi-center, Randomized, Parallel Groups, Placebo-controlled, Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-
Brief Summary: This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.


Options:
A: Hemoglobin level (24 weeks)
B: Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period (Pre-treatment; Week 6)
C: Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7. (Week 7)
D: Rate of rise in Hb (g/dL/week) at Week 6 (Baseline and at 6 weeks after dosing)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.


Options:
A: FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks); Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis) (Week 12)
C: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))
D: FEV1 AUC0-3h Response (baseline and 12 weeks); Trough FEV1 Response (Change From Baseline) (baseline and 12 weeks); St. George's Respiratory Questionnaire (SGRQ) Total Score (12 weeks treatment)

Answer: D