TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence
Brief Summary: Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.


Options:
A: Vaginal infections (60 weeks)
B: "Much Better" or "Very Much Better" on PGI-I at 3 Months (Outcome was measured at three months following randomization.); No Bothersome Stress Incontinence Symptoms at 3 Months (Outcome was measured at three months following randomization.)
C: subjective prolapse associated symptoms (measured with the validated German pelvic floor questionnaire) (change from baseline POP Score at 6 weeks after treatment)
D: Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study
Brief Summary: This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss \[TBWL\] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.


Options:
A: Weight (6 months); Weight (12 months); Weight (24 months); Weight (36 months)
B: Primary Safety Endpoint (12 months); Primary Efficacy Endpoint (12 months); Co-Primary Efficacy Endpoint (12 months)
C: Change of body mass index (Baseline, at 12 months after surgery)
D: Percent change in body mass index from baseline measurement. (Calculated at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years).); Change in number of participants achieving remission from baseline Type II diabetes. (Determined at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years).); Change in number of participants achieving remission from baseline Hypertension. (Determined at each study time point following baseline (i.e., 6 months, 1 year, and annually thereafter through 10 years).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 12 Month, Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Certican® Based Regimen Either in Combination With Cyclosporin A or Tacrolimus
Brief Summary: This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.


Options:
A: Incidence of CMV disease (1 year)
B: Plasma Creatinine (6 months)
C: To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR); Non-inferiority of the composite of graft loss and death at 52 weeks
D: Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens (One year post transplant)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. To explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac.


Options:
A: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. (12 weeks)
B: NIH-CPSI score (12 weeks)
C: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score (6 weeks)
D: Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks (Baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Task Sharing to Improve Post Abortion Care at District Health Care Level- Trial in Uganda
Brief Summary: Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care (PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe PAC is the lack of providers. So far technical training has been mainly limited to physicians. The long-term goal of this project is to provide evidence based information that will contribute to the development of strategies to increase women's access to high level post- abortion care at primary health care level provided by midlevel providers in Uganda. A task shift to midlevel provider in providing treatment of incomplete abortion will increase access to safe PAC and is a key to Millenium Development Goal 5. Misoprostol treatment of incomplete abortion remains underused and in accessible to a majority of women in Uganda because national regulations restricts its prescription and supervision to doctors. However, the safety of misoprostol treatment should make it amenable to provision by midlevel providers. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care. A direct economic impact can also be expected due to reduced treatment costs of complications from unsafely induced abortion and incomplete abortions. The involvement of midlevel providers in medical treatment of incomplete abortion has previously not been systematically evaluated in African primary health care setting.


Options:
A: Number of surgical evacuation in each group (during de study)
B: Complete abortion (14 days)
C: Success rate of abortion (24 hours); Interval to abortion (24 hours)
D: Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.) (Day 8 from first misoprostol dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Task Sharing to Improve Post Abortion Care at District Health Care Level- Trial in Uganda
Brief Summary: Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care (PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe PAC is the lack of providers. So far technical training has been mainly limited to physicians. The long-term goal of this project is to provide evidence based information that will contribute to the development of strategies to increase women's access to high level post- abortion care at primary health care level provided by midlevel providers in Uganda. A task shift to midlevel provider in providing treatment of incomplete abortion will increase access to safe PAC and is a key to Millenium Development Goal 5. Misoprostol treatment of incomplete abortion remains underused and in accessible to a majority of women in Uganda because national regulations restricts its prescription and supervision to doctors. However, the safety of misoprostol treatment should make it amenable to provision by midlevel providers. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care. A direct economic impact can also be expected due to reduced treatment costs of complications from unsafely induced abortion and incomplete abortions. The involvement of midlevel providers in medical treatment of incomplete abortion has previously not been systematically evaluated in African primary health care setting.


Options:
A: Complete abortion (14 days)
B: doxycycline side effects (24 hours)
C: Complete abortion without recourse to surgical intervention. (follow up visit 7 days after initial treatment)
D: Number of surgical evacuation in each group (during de study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Task Sharing to Improve Post Abortion Care at District Health Care Level- Trial in Uganda
Brief Summary: Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care (PAC) for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe PAC is the lack of providers. So far technical training has been mainly limited to physicians. The long-term goal of this project is to provide evidence based information that will contribute to the development of strategies to increase women's access to high level post- abortion care at primary health care level provided by midlevel providers in Uganda. A task shift to midlevel provider in providing treatment of incomplete abortion will increase access to safe PAC and is a key to Millenium Development Goal 5. Misoprostol treatment of incomplete abortion remains underused and in accessible to a majority of women in Uganda because national regulations restricts its prescription and supervision to doctors. However, the safety of misoprostol treatment should make it amenable to provision by midlevel providers. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care. A direct economic impact can also be expected due to reduced treatment costs of complications from unsafely induced abortion and incomplete abortions. The involvement of midlevel providers in medical treatment of incomplete abortion has previously not been systematically evaluated in African primary health care setting.


Options:
A: Complete evacuation (six weeks after initial treatment)
B: Efficacy (At 10-14 days follow up)
C: Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection (7 days)
D: Complete abortion (14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Promotion Coaching/Vaccine for Homeless Parolees
Brief Summary: The purpose of this study is to conduct a prospective, three-group study that randomly assigns 700 parolees, in a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, one-on-one coaching and the HAV/HBV vaccine.


Options:
A: Primary Outcome Measure (3 years)
B: Primary Outcome Measure (5 years); Primary Outcome Measure (5 years); Primary Outcome Measure (5 years)
C: Abstinence (3 month follow up); Abstinence (6 month follow up); Abstinence (9 month follow up); Abstinence (12 month follow up); Abstinence (18 month follow up); Abstinence (24 month follow up); Cocaine Urine Toxicology (3 month follow up); Cocaine Urine Toxicology (6 month follow up); Cocaine Urine Toxicology (9 month follow up); Cocaine Urine Toxicology (12 month follow up); Cocaine Urine Toxicology (18 month follow up); Cocaine Urine Toxicology (24 month follow up); Comparison Across Groups in Societal Costs (24 months); Net Saving/Spending Comparisons Across Groups From Provider Perspective (24 months); Net Comparisons of Savings and Spendings Across Groups From Societal Perspective (24 months); Percent Days Cocaine Use (3 months (approximately study days 1 - 90)); Percent Days Cocaine Use (6 months (approproximately study days 91 - 180)); Percent Days Cocaine Use (9 months (approximately study days 181 - 270)); Percent Days Cocaine Use (12 months (approximately study days 271 - 365)); Percent Days Cocaine Use (18 months (approximately study days 366 - 546)); Percent Days Cocaine Use (24 months (approximately study days 547 - 730)); Percent Days Abstinent (3 months (approximately study days 1 - 90)); Percent Days Abstinent (6 months (approximately study days 91 - 180)); Percent Days Abstinent (9 months (approximately study days 181 - 270)); Percent Days Abstinent (12 months (approximately study days 271 - 365)); Percent Days Abstinent (18 months (approximately days 366 - 546)); Percent Days Abstinent (24 months (approximately study days 547 - 730))
D: Recurrence of intimate partner violence (18 months); Health-specific quality of life (18 months); Harms of screening and/or usual care (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Promotion Coaching/Vaccine for Homeless Parolees
Brief Summary: The purpose of this study is to conduct a prospective, three-group study that randomly assigns 700 parolees, in a community residential drug treatment program, to enter one of three groups: 1) a PCPC (Parolee Comprehensive Care + Phone Coaching Program), which includes nurse case management and specialized hepatitis education sessions and the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone); 2) a Parolee Brief Hepatitis Education + HBV vaccination + Phone Coaching (PBCP) Program, which includes brief hepatitis/HIV education, HAV/HBV vaccination and coach-facilitated mentoring; or 3) a Usual Care (UC) control program, which includes brief general health information, one-on-one coaching and the HAV/HBV vaccine.


Options:
A: Primary Outcome Measure (5 years); Primary Outcome Measure (5 years); Primary Outcome Measure (5 years)
B: Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. (Changes from baseline until endpoint at week 5)
C: Rates of HIV Seroconversion (From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years); Renal Toxicity (Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years); Adverse Events (Up to 6.9 years)
D: CTCR Baseline & Follow-Up Protocol (CTCR Protocol) (Baseline and at 3, 6, 12, and 18 months); Colorado Department of Corrections Record Information System (CDOC-RIS) (At 6, 12, and 18 months); Biological Specimens (At 12 and 18 months); Diagnostic Interview Survey-IV (DIS-IV) (At baseline); Beck Depression Inventory-II (BDI-II) (At baseline and 3, 6, 12, and 18 months); Symptom Checklist 90-R (SCL90-R) (At baseline and 3, 6, 12, and 18 months); Rosenberg Self-Esteem (R-SES) (At baseline and 3, 6, 12, and 18 months); Measures of Social Network (adapted) (At baseline and 3, 6, 12, and 18 months); Client Assessment Inventory (CAI) & Staff Assessment Summary (SAS) (At 3 and 6 months); Therapeutic Community Scale of Essential Elements Questionnaire(SEEQ) (administered monthly over the first six months of the project and quarterly thereafter); Treatment Services Review (TSR) (administered monthly over the first six months of the project and quarterly thereafter); Program Monitoring Form (PMF) (administered monthly over the first six months of the project and quarterly thereafter)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Patient and Family Centered Care in Advanced Critical Illness
Brief Summary: One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care unit (ICU), typically following decisions made by surrogate decision makers to forego life prolonging treatment. A large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.\[8, 9\] Although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.\[10, 11\]

In a pilot project, the investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates.


Options:
A: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
B: Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) (From time of hospital discharge up to 60 days)
C: Hospital Anxiety and Depression Scale (At 6 months)
D: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Brief Summary: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.


Options:
A: Progression Free Survival (PFS) (From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)); Overall Survival (OS) (From randomization to date of death (Assessed up to September 2016, approximately 39 months)); Rate of Overall Survival (6, 12, and 24 months); Rate of Progression-Free Survival (6, 12, and 24 months)
B: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
C: Recurrence-free Survival (RFS) (Up to ~32.7 months)
D: Relapse-free survival (RFS) (Up to 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Brief Summary: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.


Options:
A: Relapse-free survival (RFS) (Up to 1 year)
B: Progression Free Survival (PFS) (From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)); Overall Survival (OS) (From randomization to date of death (Assessed up to September 2016, approximately 39 months)); Rate of Overall Survival (6, 12, and 24 months); Rate of Progression-Free Survival (6, 12, and 24 months)
C: Progression-Free Survival (PFS) as Assessed by the Investigator (From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years))
D: Overall Survival (OS) (24 months)

Answer: B