TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Induction of Labour in Pre-eclamptic Women: a Randomised Trial Comparing the Foley Balloon Catheter With Oral Misoprostol
Brief Summary: Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with pre-eclampsia. The only cure, however, comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings, but their relative risks and benefits are not known. These interventions could optimize the care pathway for women needing induction of labour. This is especially important in low resource settings where improvement is most needed and the potential to reduce the maternal and neonatal mortality and morbidity is the greatest. The ideal induction agent would result in a relatively short induction to delivery interval without risk to fetus and with low rates of emergency caesarean section. The induction to delivery interval is especially important in pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery. Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley catheter as an induction agent has been persistently questioned. This study will identify the risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two low cost induction methods.


Options:
A: Attainment of vaginal delivery within 24 hours. (24 hours)
B: The Time Interval From Induction to Delivery: All Participants (Day 1); Time (Hours) From Induction to Delivery: Nulliparous (Day 1); Time (Hours) From Induction to Delivery: Multiparous (Day 1); Time From Induction to Delivery: VD (Day 1); Time From Induction to Delivery: CD (Day 1); Per Treatment Protocol: Time (Hours) From Induction to Delivery (day 1)
C: Average Time in Hours From Insertion of the Catheter Until Delivery (At the end of the study)
D: induction time to delivery (Time from induction to delivery, average 12-28 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: E-Cuidate: Effectiveness of a Telerehabilitation System in Women Breast Cancer Survivors
Brief Summary: Background: Cancer is increasingly viewed as a chronic disease and therefore there is a growing need for long-term treatments. Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increases the prevalence of conditions associated to unhealthy life-style.

Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short and long-term effects telehealth program.

Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio Hospital and associations of breast cancer patients in Granada. Patients will be randomized to receive the online rehabilitation group (n=36) or usual care (control) group (n=36). Telerehabilitation group will receive an eight-week online intervention and control group receive recommendations about usual care.

Discussion: The investigators study attempts to increase the level of fitness and reduce musculoskeletal disorders in breast cancer patients through a strategy for care based on telerehabilitation to promote therapeutic exercise.


Options:
A: Menopausal symptoms (6 months)
B: Quality of life (Participants will be followed over 8 weeks)
C: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)
D: Patient perception and pattern of change (3 months of training followed by 6 and 12 months of no formal training)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: E-Cuidate: Effectiveness of a Telerehabilitation System in Women Breast Cancer Survivors
Brief Summary: Background: Cancer is increasingly viewed as a chronic disease and therefore there is a growing need for long-term treatments. Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increases the prevalence of conditions associated to unhealthy life-style.

Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short and long-term effects telehealth program.

Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio Hospital and associations of breast cancer patients in Granada. Patients will be randomized to receive the online rehabilitation group (n=36) or usual care (control) group (n=36). Telerehabilitation group will receive an eight-week online intervention and control group receive recommendations about usual care.

Discussion: The investigators study attempts to increase the level of fitness and reduce musculoskeletal disorders in breast cancer patients through a strategy for care based on telerehabilitation to promote therapeutic exercise.


Options:
A: bone health (baseline, 12 months)
B: Fatigue as measured by the Brief Fatigue Inventory (prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.)
C: N/A
D: Quality of life (Participants will be followed over 8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Accuracy of SPD Persona LH Assay When Compared to Ultrasound Observed Ovulation and Other Indices of Ovulation
Brief Summary: This study will examine the performance of the Persona assays in identifying the time when risk of pregnancy is highest by comparing results to ultrasound observed ovulation and other indices of ovulation.


Options:
A: Collection of early pregnancy urine samples. (60 days)
B: Unintended Pregnancies (1, 3, 6, and 12 months)
C: Ultrasound (Participants will be followed for one menstrual cycle, anticipated average of four weeks.)
D: Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention. (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension
Brief Summary: The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years.

A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.


Options:
A: Mesh attachment interval (Intraoperative placement of mesh - approximately 30 minutes to 2 hours)
B: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
C: anatomic outcomes,graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life,subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy (One year)
D: Cumulative Failure (6 Months through 36 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Task Shifting and Blood Pressure Control in Ghana: A Cluster-Randomized Trial
Brief Summary: The goal of this study is to evaluate the comparative effectiveness of the World Health Organization Package targeted at Cardiovascular (CV) risk assessment and hypertension control, delivered by Community Health Nurses as part of Ghana's Community based Health Planning and Services program, versus provision of health insurance coverage, on blood pressure reduction. Findings from this study will provide policy makers and other stakeholders needed information to recommend efficient cost-effective policy with regards to comprehensive CV risk reduction in patients with hypertension in low resource settings.


Options:
A: Reduction in total cholesterol in the entire SHCS population (18 months)
B: Mean change in systolic Blood Pressure (BP) (Baseline to 12 months)
C: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
D: Framingham Risk Score (15 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
Brief Summary: This is a phase III trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival.

There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF concentrations in 172 persons conducted from August 2013 to August 2014. See NCT03002012.


Options:
A: Mortality (2 years)
B: Mortality (26 weeks from study entry)
C: Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug (Day 100); Number of Dose-limiting Toxicities Attributed to Treatment Regimens (Day 100)
D: Survival (18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain: A Randomized Clinical Trial
Brief Summary: The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment program for chronic low back pain supported by information and communication technologies


Options:
A: Change over time in Catastrophizing (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in (Dis)ability/ pain screening (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in Work ability (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in Functioning (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU)
B: Duration of recruitment (6 months); Patient adherence to app use (first 8 weeks post-randomisation)
C: Change in catastrophizing cognitions (T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1)
D: Change in Disability: Change in the Roland-Morris Questionnaire (five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).); Change in Pain measured by Numerical Rating Scale (NRS) (five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda
Brief Summary: Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and transmitted mainly through sexual intercourse between an HIV infected and uninfected person. Uganda is ranked among 28 top per capita alcohol consumers in the world and second in Africa. in the general population, Alcohol consumption is associated with increased sexual transmission risks for HIV. Data on alcohol consumption and its impact on sexual behaviors and HIV disease progression among HIV infected persons, the persons able to transmit HIV are lacking in this setting.

Objectives: To estimate the prevalence of alcohol consumption among HIV infected persons, assess associations between alcohol and CD4 cell count as well as evaluate the effect of alcohol motivational intervention counseling on alcohol consumption and the subsequent practice of risky sexual behaviors, among HIV infected persons.

Methodology: Using both cross-sectional and longitudinal methods,persons living with HIV/AIDS (PLWHA) attending the Infectious Diseases Institute Clinic (IDI clinic) will be recruited, baseline alcohol consumption evaluated, and eligible subjects reporting alcohol consumption will be randomized to receive either Standard positive prevention counseling alone or in addition to alcohol motivation intervention counseling. Sexual risk behaviors and alcohol consumption will be evaluated at 3 and 6 months and compared between randomization arms.


Options:
A: Drug use (Six Months)
B: Reduction in injury recidivism (August 2011); Reduction in alcohol intake (August 2011); Reduction in alcohol problems (August 2011)
C: Change in alcohol consumption Score as assessed by the AUDIT-C tool . (6 months)
D: Treatment Utilization; Substance Abuse

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda
Brief Summary: Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and transmitted mainly through sexual intercourse between an HIV infected and uninfected person. Uganda is ranked among 28 top per capita alcohol consumers in the world and second in Africa. in the general population, Alcohol consumption is associated with increased sexual transmission risks for HIV. Data on alcohol consumption and its impact on sexual behaviors and HIV disease progression among HIV infected persons, the persons able to transmit HIV are lacking in this setting.

Objectives: To estimate the prevalence of alcohol consumption among HIV infected persons, assess associations between alcohol and CD4 cell count as well as evaluate the effect of alcohol motivational intervention counseling on alcohol consumption and the subsequent practice of risky sexual behaviors, among HIV infected persons.

Methodology: Using both cross-sectional and longitudinal methods,persons living with HIV/AIDS (PLWHA) attending the Infectious Diseases Institute Clinic (IDI clinic) will be recruited, baseline alcohol consumption evaluated, and eligible subjects reporting alcohol consumption will be randomized to receive either Standard positive prevention counseling alone or in addition to alcohol motivation intervention counseling. Sexual risk behaviors and alcohol consumption will be evaluated at 3 and 6 months and compared between randomization arms.


Options:
A: Change in alcohol consumption Score as assessed by the AUDIT-C tool . (6 months)
B: Alcohol use and STI/HIV infection (up to 12 months)
C: Percentage of Women Who Test Ethyl Glucuronide (EtG) Negative (3-, 6-, and 9-month post-baseline)
D: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda
Brief Summary: Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and transmitted mainly through sexual intercourse between an HIV infected and uninfected person. Uganda is ranked among 28 top per capita alcohol consumers in the world and second in Africa. in the general population, Alcohol consumption is associated with increased sexual transmission risks for HIV. Data on alcohol consumption and its impact on sexual behaviors and HIV disease progression among HIV infected persons, the persons able to transmit HIV are lacking in this setting.

Objectives: To estimate the prevalence of alcohol consumption among HIV infected persons, assess associations between alcohol and CD4 cell count as well as evaluate the effect of alcohol motivational intervention counseling on alcohol consumption and the subsequent practice of risky sexual behaviors, among HIV infected persons.

Methodology: Using both cross-sectional and longitudinal methods,persons living with HIV/AIDS (PLWHA) attending the Infectious Diseases Institute Clinic (IDI clinic) will be recruited, baseline alcohol consumption evaluated, and eligible subjects reporting alcohol consumption will be randomized to receive either Standard positive prevention counseling alone or in addition to alcohol motivation intervention counseling. Sexual risk behaviors and alcohol consumption will be evaluated at 3 and 6 months and compared between randomization arms.


Options:
A: Change in alcohol consumption Score as assessed by the AUDIT-C tool . (6 months)
B: HSCL 25 (Symptoms were assessed at baseline); HSCL 25 (3-month follow-up); HSCL 25 (Assessment at 12-month-follow-up)
C: Depression - Patient Health Questionnaire (1 week post-intervention)
D: Change on Beck Depression Inventory-II (Screening; baseline, 6-8 weeks after baseline and 4 months after baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line
Brief Summary: Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.


Options:
A: progression free survival (12 months)
B: Progression Free Survival (PFS) (every 12 weeks until progression or up to 30 months, thereafter every 6 months)
C: Progression-Free Survival (8 Months on average)
D: Progression-free survival (Apr 2013)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line
Brief Summary: Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.


Options:
A: Phase Ib: Dose Limiting Toxicities of Dose of Pazopanib and Fosbretabulin (4 weeks after starting treatment (1 cycle)); Phase II: Progressive disease (Progressive disease (average of 4 months from start of treatment) measured by RECIST)
B: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
C: progression free survival (12 months)
D: To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (every 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line
Brief Summary: Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.


Options:
A: progression free survival (12 months)
B: objective response rate (one year)
C: To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications (Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.)
D: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Soy Fiber Improves Weight Loss And Lipid Profile In Overweight And Obese Adults: A Randomized Controlled Trial
Brief Summary: The aim of this study is to examine the effects of soy fiber on body weight, body composition and blood lipids in overweight and obese participants.


Options:
A: Primary Outcome Measures Described Below (December 2011)
B: Change in Fat Mass at 12 Weeks (Value at 12 weeks minus value at baseline)
C: weight loss (12 weeks)
D: Oxidized LDL (After 4 and 6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) With Placebo for the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
Brief Summary: The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the rate of progression of geographic atrophy compared to placebo in subjects with dry age-related macular degeneration.


Options:
A: Change from baseline in the total area of the GA lesion(s) (24 months)
B: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24 (At the end of month 24)
C: N/A
D: N/A

Answer: A