TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of Alive & Thrive's Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia
Brief Summary: Alive \& Thrive is an initiative that aims to scale up nutrition to save lives, prevent illness, and ensure healthy growth and development through improved infant young child feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive \& Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase complementary feeding practices (minimum dietary diversity and minimum meal frequency) while sustaining exclusive breastfeeding rate among children less than two years of age. The impact evaluation uses a cluster-randomized design where 20 geographic clusters (woredas/districts) were randomized to two study arms - 10 intervention areas and 10 comparison areas. Repeated cross-sectional baseline and endline surveys will be used to assess program impact.


Options:
A: Exclusive breastfeeding among children aged 0-5.9 months in the intervention areas only (2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017); Minimum dietary diversity among children aged 6-23.9 months (2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017); Minimum meal frequency of (semi) solid or soft foods among children aged 6-23.9 months (2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017)
B: Prevalence of underweight among children 0-23 months; Prevalence of stunting among children 0-23 months; Prevalence of wasting among children 0-23 months; Prevalence of anemia among children 12-23 months
C: Excessive weight gain (0-6 months)
D: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis
Brief Summary: This is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and DF≥32.


Options:
A: Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8) (Day 1, Day 8, Day 29, and Day 90)
B: Survival (One year)
C: Survival rates (12 weeks)
D: The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis. (1 Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Study of ACTR087, Autologous T Lymphocytes Expressing Antibody Coupled T-cell Receptors (CD16V-41BB-CD3ζ), in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20-Positive B-Cell Lymphoma
Brief Summary: This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and efficacy of an autologous T-cell product expressing ACTR in combination with rituximab in subjects with refractory or relapsed CD20+ B-cell lymphoma.


Options:
A: To assess the safety of allogeneic anti-CD19 CAR (4-5 weeks after first dose)
B: Number of patients with treatment related adverse events as assessed by CTCAE v4. (2 years); Overall Response Rate (28 days); Feasibility of CD19 CAR T cell production as defined by number of products successfully meeting release criteria (12 days)
C: Number of Participants With Dose Limiting Toxicities (DLTs) (Within 28 days of T-cell infusion); Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background (28 days post T cell infusion); Number of Days of Quantifiable CD19 CAR Post T-cell Infusion (28 days post T cell infusion)
D: Safety as assessed by dose limiting toxicities (DLTs) (28 days); Safety as assessed by determination of the maximum tolerated dose (MTD) (24 months); Safety as assessed by determination of the recommended phase 2 dose (RP2D) (24 months); Safety as assessed by and adverse events, laboratory assessments and physical examinations (24 months); Safety as assessed by mini-mental state examination (MMSE) (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Brief Summary: The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.


Options:
A: Vaginal delivery (24 hours); Hyperstimulation syndrome (24 hours); Cesarean section (3 days); Severe neonatal morbidity or perinatal death (28 days); Serious maternal morbidity or maternal death (42)
B: success rate of cervical ripening in labor induction (12 hours after intervention)
C: Time to Active Labor (from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.)
D: Time to Delivery (from study entry until delivery- anticipated 3 days); Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications (from study entry until delivery- anticipated 3 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Web-Based CBT for Rape Victims
Brief Summary: Rape is unfortunately a common experience among women, affecting between 13 and 20%. In addition, up to 50% of all rape victims experience significant and persistent psychological distress. While cognitive-behavioral interventions have been found to be successful at alleviating distress among victims; the majority do not seek out these services, often because of feelings of stigma and self-blame. One potential method for circumventing these barriers is through online administered treatment. Thus, the current project is designed to conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media, cognitive-behavioral, online intervention tailored specifically for rape victims. The effectiveness of this program at ameliorating distress among college women who have experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated. Reductions in psychological distress was the primary outcome and was assessed at post-intervention and at three and six month follow-up periods. The effectiveness of the intervention was compared to a psycho-educational website.


Options:
A: Change in PTSD symptoms (PTSD Symptom Scale Interview) (Change in PTSD symptoms from baseline to 3 months post intervention)
B: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (12 weeks); Timeline Followback Heavy Episodic Drinking Episodes (12 weeks)
C: Clinician Assessed Severity of PTSD (Baseline, 16, 24 and 32 weeks)
D: Severity of mental health symptoms (previous 4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Web-Based CBT for Rape Victims
Brief Summary: Rape is unfortunately a common experience among women, affecting between 13 and 20%. In addition, up to 50% of all rape victims experience significant and persistent psychological distress. While cognitive-behavioral interventions have been found to be successful at alleviating distress among victims; the majority do not seek out these services, often because of feelings of stigma and self-blame. One potential method for circumventing these barriers is through online administered treatment. Thus, the current project is designed to conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media, cognitive-behavioral, online intervention tailored specifically for rape victims. The effectiveness of this program at ameliorating distress among college women who have experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated. Reductions in psychological distress was the primary outcome and was assessed at post-intervention and at three and six month follow-up periods. The effectiveness of the intervention was compared to a psycho-educational website.


Options:
A: Change in PTSD symptoms (PTSD Symptom Scale Interview) (Change in PTSD symptoms from baseline to 3 months post intervention)
B: CAPS for PTSD symptoms and ASI for substance use (pre, mid treatment, post, 3-month follow-up, 6-month follow-up)
C: Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery (36 weeks)
D: Change in Clinician Administered PTSD Scale; Re-experiencing (Baseline, Week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly
Brief Summary: The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. It is important to continue and progress the functional training that already started at the hospital, while the patients are transferred to short-term stays in a nursing home before they are returning to home. The aim presently is to examine the effects of a functional training program by a RCT design, initiated by the physiotherapist and performed by the nurses, on physical functioning while the patients are at short term stays in primary health care.


Options:
A: Gait Velocity (Discharge (Average Duration of Hospital Stay is 3 weeks))
B: Number of fallers (one year)
C: Change in the performance-based Short physical performance battery (SPPB) (Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
D: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly
Brief Summary: The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. It is important to continue and progress the functional training that already started at the hospital, while the patients are transferred to short-term stays in a nursing home before they are returning to home. The aim presently is to examine the effects of a functional training program by a RCT design, initiated by the physiotherapist and performed by the nurses, on physical functioning while the patients are at short term stays in primary health care.


Options:
A: Change in the performance-based Short physical performance battery (SPPB) (Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
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: Proprietary Information - Exploratory (Non-Confirmatory) Trial
D: Lower extremity function (Short Physical Performance Battery (SPPB) (Change from baseline will be assessed at 6 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly
Brief Summary: The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. It is important to continue and progress the functional training that already started at the hospital, while the patients are transferred to short-term stays in a nursing home before they are returning to home. The aim presently is to examine the effects of a functional training program by a RCT design, initiated by the physiotherapist and performed by the nurses, on physical functioning while the patients are at short term stays in primary health care.


Options:
A: Self-rated degree of patient participation in rehabilitation (At discharge from in-patienten rehabilitation, on average 14 days)
B: Quality of life (2 years)
C: Change in the performance-based Short physical performance battery (SPPB) (Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
D: Quality of life (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-center, Randomized, 2-arm, Open-label Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent-naive Hemodialysis Chronic Kidney Disease Patients With Anemia
Brief Summary: The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.


Options:
A: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) (Weeks 40 to 52)
B: Hemoglobin (Hb) Response rate (Up to Week 24)
C: Mean area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Area under concentration-time curve from time 0 to infinity (AUCinf) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Maximum observed concentration (Cmax) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Time to maximum observed concentration (Tmax) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Terminal half-life (t½) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Apparent clearance (CL/F) or clearance (CL) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Apparent volume of distribution (Vd/F) or volume of distribution (Vd) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Tmax for vadadustat metabolite(s) (Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose); AUClast for vadadustat metabolite(s) (Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose); AUCinf for vadadustat metabolite(s) (Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose); Cmax for vadadustat metabolite(s) (Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose); Serum erythropoietin concentration for the erythropoiesis-stimulating agent treatment group (Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose)
D: Percentage of Participants Achieving a Successful Hemoglobin Response (Weeks 19 and 20)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial
Brief Summary: Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.


Options:
A: Surgical site infection rate (30 days)
B: Post-operative wound infection (6 weeks post-operative)
C: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
D: Post-operative Seroma Formation (Two weeks following drain removal)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial
Brief Summary: Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.


Options:
A: Groin Wound Complication (30 days)
B: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)
C: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
D: Surgical site infection rate (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial
Brief Summary: Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.


Options:
A: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
B: Number of Participants With Wound Complications (Four weeks after cesarean section)
C: Surgical site infection rate (30 days)
D: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial
Brief Summary: Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.


Options:
A: Incidence of wound management complications (90 days); Incidence of wound management complications in groups treated with different types of postopNPWT (90 days)
B: Surgical site infection rate (30 days)
C: Wound infection rate (Wounds will be checked at 3 month follow-up)
D: Post-operative wound infection (6 weeks post-operative)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-center, Open-label Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
Brief Summary: The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal dialysis chronic kidney disease patients with anemia.


Options:
A: Percentage of Participants Achieving a Successful Hemoglobin Response (Weeks 19 and 20)
B: Hemoglobin (Hb) Response Rate from Week 18 to Week 24 (Up to Week 24)
C: Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO (Up to Day 57)
D: Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 (Baseline (Day 1) and Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an mHealth SMS Dialogue Strategy to Meet Women's and Couples' Postpartum Contraceptive Needs in Kenya
Brief Summary: Meeting women's need for postpartum family planning is has been acknowledged as a global priority in maternal and child health. The prevention of unintended pregnancies in sub-Saharan African countries, which carry the highest global burdens of maternal mortality and HIV infection, is projected to substantially decrease maternal and neonatal morbidity and mortality. Many barriers to contraceptive uptake exist, both within and outside of the postpartum time period, and include socio-cultural, economic, and supply-side factors. Furthermore, while the importance of engaging men in family planning programs has been acknowledged for decades, few interventions have succeeded in increasing male involvement in family planning while maintaining a focus on women's empowerment. Innovative approaches to meeting the family planning needs of women and couples are urgently needed.

Public health interventions are increasingly incorporating mobile health (mHealth) approaches using short message service (SMS) technology in low-income countries, approaches that have demonstrated benefit among various reproductive health outcomes. The investigators hypothesize that personalized, bidirectional SMS dialogue with individual women and couples will increase postpartum contraceptive uptake, thereby decreasing unmet need for family planning in Kenya. The investigators have collaborated with the University of Washington (UW) Department of Computer Science and Engineering (CSE) along with Kenyan telecommunication providers to develop a hybrid messaging system that allows for innovative bidirectional SMS messaging. This system has been used successfully in maternal child health (MCH) clinics in Kenya. In qualitative research, women in Kenya have expressed a strong desire for mHealth support to provide additional education, counseling and reminders to supplement counseling by health workers.

The investigators propose a randomized controlled trial (RCT) comparing the effects of bidirectional SMS dialogue vs. control on highly effective contraceptive use at 6 months postpartum among HIV negative women and couples in Nyanza Province, Kenya. Data from this RCT and accompanying qualitative study will contribute to innovative, scale-able strategies to address unmet need for contraception and increase male involvement in family planning.


Options:
A: Percentage of Women With Triage Pap Smears at 120 Days After HPV Results (120 days)
B: Clinic attendance for pills pick up (six months.)
C: Uptake of the timed appointment provided by the screening service (Usually within a month (Individual timed appointment is provided by the screening service))
D: Highly-effective contraceptive use (6 months postpartum)

Answer: D