TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.
Brief Summary: Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative and pro-apoptotic properties, that has been shown to decrease proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients. However, little is known about its potential beneficial effect on oocyte quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The present study evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).


Options:
A: Live Birth Rate (up to 15 months)
B: semen quality (150 days); sperm motility (150 days); sperm morphology (150 days); sperm concentration (150 days); total sperm count (150 days); semen volume (150 days)
C: Effect of resveratrol on oocyte quality (40 days)
D: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (4 weeks to 9 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.
Brief Summary: Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative and pro-apoptotic properties, that has been shown to decrease proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients. However, little is known about its potential beneficial effect on oocyte quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The present study evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).


Options:
A: Effect of resveratrol on oocyte quality (40 days)
B: Spontaneous clinical pregnancy rate (12 months)
C: Clinical Pregnancy Rate (up to 18 weeks - in average, two weeks after the end of the in vitro fertilization cycle)
D: Live birth (Approximately 10-16 months after randomization, depending on study group.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
Brief Summary: The investigators aimed to assess the ability of a modified version of Behavioral Activation for occupational and social improvement to produce change in: 1. social adjustment, 2. work functioning, 3. avoidance behavior and 4. behavioral activation.


Options:
A: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)
B: Relapse/recurrence of Major Depressive Episode (3, 6, 9, 12, 15 months)
C: Paid Work Hours at Week 12 (Week 12); Paid Work Hours at Week Baseline (Baseline)
D: Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression) (20 weeks after randomization (after acute treatment phase))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Three-arm, Randomized, Open Label, Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.
Brief Summary: This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.


Options:
A: Overall Survival (From date of randomization until death from any cause)
B: Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone (Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months)
C: Incidence of grade 3-5 adverse events (Documentation of AE observed during trial treatment and in follow-up until resolution)
D: Overall Survival (OS) (From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years); Progression Free Survival (PFS) (From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
Brief Summary: Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.

Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.

Hypotheses:

* Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving disease evolution.
* BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
* Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
* The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.


Options:
A: Functioning (social and occupational) (baseline, 12-month)
B: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
C: Number of Patients Hospitalized (1 year after enrollment)
D: Prognosis of patients. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis
Brief Summary: Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis.

Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage.

Hypotheses:

* Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving disease evolution.
* BDNF levels will increase more in the patients receiving individual therapy compared to those without it.
* Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material.
* The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.


Options:
A: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up
B: Prognosis of patients. (6 months)
C: Relapses (9 months); Positive and negative symptoms (change from baseline at 9 month follow-up)
D: Rehospitalizations and psychotic relapse at two years

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
Brief Summary: This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.


Options:
A: Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A) (Week 4); Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B) (Week 4); Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D) (Week 4)
B: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
C: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
D: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
Brief Summary: This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.


Options:
A: Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (12 weeks after the last actual dose of study drug)
B: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned) (End of trial, 12 weeks after last planned dose)
C: Number of Participants With Sustained Virologic Response (SVR) (From follow-up week (FW) 24 up to end of follow-up (EOF))
D: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Community Ambulation After Hip Fracture
Brief Summary: Activity and exercise are believed to be of benefit for reducing disability in older adults, yet the majority of older adults do not participate in regular exercise and is not active. This is especially true for older adults following hip fracture after they complete the usual rehabilitation program.

This study is being done to compare two 16-week supervised multi-part physical therapy programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want to test whether the interventions lead to improvements in a person's ability to walk on their own in the home and in the local community. With this knowledge the investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health.

ANCILLARY STUDY #1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION (CAP-MP) The goal of this ancillary study is to investigate several mechanisms thought to be related to recovery in ambulatory ability after hip fracture. Selected mechanistic pathways are being investigated by obtaining mechanistic measurements of the participants randomized in the University of Maryland, Baltimore (UMB) clinical site of CAP.

ANCILLARY STUDY #2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION The goal of this ancillary study is to analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture. The identified dietary patterns, as well as motivators and barriers to intake, will be assessed for their impact on the rate of return to community ambulation in participants randomized at the University of Connecticut Health Center (UCHC) clinical site of CAP.

ANCILLARY STUDY #3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in participants randomized at the UCHC clinical site of CAP.

ANCILLARY STUDY #4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE The goal of this ancillary study is to understand some of the key muscle mechanisms associated with recovery in community ambulation following hip fracture in response to the two interventions for participants randomized at the Arcadia University (AU) clinical site of CAP.


Options:
A: rate of falls compared between treatment arms
B: Self-efficacy (2, 6, and 12 months post hip fracture); Exercise behavior and activity (2, 6, and 12 months post hip fracture); Subjective reporting of exercise (2, 6, and 12 months post hip fracture)
C: Knee-extension strength in the fractured limb in comparison with the non-fractured limb. (At inclusion, at postoperative day 10 and/or at discharge.)
D: Ability to walk 300 meters or more in six minutes (16 weeks post-randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Safety Study of Electro-acupuncture for Simple Female Stress Urinary Incontinence- a Multicenter, Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.


Options:
A: value difference of 1h pad test, compared with the baseline (the 6 weeks)
B: Change from baseline in mean frequency of micturitions per 24 hours (4, 8 weeks in treatment, 12th and 24th weeks of follow-up)
C: Difference in Incontinence Impact Questionnaire (IIQ-7) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Difference in Overactive Bladder Symptom Score (OABSS) (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Urogenital Distress Inventory (UDI-6) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Differences in daytime frequency (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); incontinence episodes (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Nocturia (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group)
D: Change From Baseline of Urine Leakage Measured by 1-hour Pad Test (Baseline and week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients
Brief Summary: This is a study of the short-term effects of ivacaftor on sweat chloride concentration and lung function in cystic fibrosis (CF) patients who fall outside current FDA approval. This new, first of its kind drug is approved for use only in CF patients with the G551D mutation in whom it safely confers considerable benefits. However, it is highly likely that CF patients with many other mutations can benefit similarly from this drug, some of whom can be identified by phenotype or genotype.

We will enroll up to 30 CF subjects with clinical presentations in which there is one or more signs of residual CF channel function. The signs of residual function include: normal digestion, concentration of chloride in sweat between 55 and 85, or milder than expected CF disease in a CF patient with severe gene mutations. The primary outcome measure will be the difference in sweat chloride concentration measured in subjects on placebo and on ivacaftor. Secondary outcome measured will be lung function.


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
B: Sweat Chloride Concentration (14 +/- 2 days)
C: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
D: Percentage of Predicted Function (Percent-Predicted) of Forced Expiratory Volume in One Second (FEV1) at Baseline (Baseline (Week 1)); Percentage Change From Baseline in Percent-Predicted of FEV1 at Week 48 (End of Treatment (EOT) (Week 48))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
Brief Summary: The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision. This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.


Options:
A: Evidence of change in incidence and frequency of intimate partner physical assault and psychological aggression assessed by questionnaires and clinical interviews. (Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment)
B: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
C: Self-efficacy (Change from Baseline in Self efficacy at 6 months)
D: The proportion of condom protected acts of vaginal and anal intercourse (Up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Randomized Controlled Trial Evaluating the Effect of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on Hypertension Medication Reduction, Blood Pressure Levels and Others Cardiovascular Risk Factors.
Brief Summary: Phase 3, unicentric, randomized clinical trial, with allocation concealment and intention-to-treat analysis to evaluate the efficacy of videolaparoscopic Roux-en-Y Gastroplasty to decrease the prescription of antihypertensive drugs maintaining normal levels of blood pressure, decrease systemic arterial blood pressure and other risk factors for cardiovascular events compared to clinical treatments of patients with arterial hypertension.


Options:
A: Total Body Weight Loss (Enrollment to 12 months)
B: growth disorders (18 years); obesity (18 years)
C: Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg (12 months)
D: Weight (6 months); Weight (12 months); Weight (24 months); Weight (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Addition of a Glucagon-like Peptide-1 to a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and Cardiovascular Disease.
Brief Summary: The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead to greater weight loss than will a calorie-restricted diet alone in subjects who are older (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been selected for study because they are at greatly increased risk to develop type 2 diabetes (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse outcomes.

There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic control in patients with manifest 2DM. However, there is relatively little information as to the potential utility of these compounds in nondiabetic individual at greatly increased risk of 2DM and CVD. This research proposal is aimed at providing some of this information by quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin secretion, insulin action, and multiple CVD risk factors in a very high risk group-older, overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin action.


Options:
A: Change in Weight Reported at 14 Weeks (Baseline and 14 weeks)
B: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); M/I (3-months after a medication washout)
C: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).)
D: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)

Answer: A