TrialPanorama/Dataset huggingface dataset:
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: Vaccines received (Electronic Health Record) (up to a year of follow up)
B: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
C: Highly-effective contraceptive use (6 months postpartum)
D: MV Coverage at 12 months of age (12 months of age)

Answer: C
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: Attendance for Early infant diagnosis (EID) of HIV (1 year); Early identification of HEI at Reproductive and Child Health (RCH) Clinic (1 year); Antenatal care (ANC) visits (1 year); Facility delivery (1 year); Post natal care (PNC) visits (1 year); Nevirapine (NVP) at delivery (1 year)
B: To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. (at participant post-partum visit)
C: Highly-effective contraceptive use (6 months postpartum)
D: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)

Answer: C
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: Percent of children immunized (Up to 12 months of age)
B: Rate of Premature birth (before 37 weeks gestation)
C: Highly-effective contraceptive use (6 months postpartum)
D: Skilled Delivery (1 year)

Answer: C
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: Highly-effective contraceptive use (6 months postpartum)
B: Acceptability of at least one method of effective contraception (4 months)
C: Viral load (6 months post-randomization)
D: Use of long acting and reversible contraceptive at 4 months (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture: A Randomized Controlled Trial
Brief Summary: The study is a parallel-group single blinded randomized controlled trial, examining the effect of exercise on physical function in older women with osteoporosis and a history of vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the intervention group and the control group. The intervention will follow newly developed exercise recommendations for people with osteoporosis and vertebral fractures, which states the balance- and strength exercises should be performed at least twice a week. The intervention is a group exercise session circuit program lasting for 12 weeks. The participants will be tested at baseline, and followed up at 3 months and 6 months.


Options:
A: 10 meter habitual walking speed (Up to 18 months)
B: Back pain (Baseline and six months)
C: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)
D: The primary outcome measure is actual LBP, as measured with an "11 point box scale". (10 weeks and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Pregabalin to Decrease Pain During Medical Abortion: a Randomized Controlled Trial
Brief Summary: Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.


Options:
A: Maximum Pain Score Over Study Period (Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours))
B: Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention. (Within 1 week)
C: 11-point Visual Analog Scale for Pain (1-2 weeks)
D: • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain). (2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA, GZ402666) and Alglucosidase Alfa in Treatment naïve Patients With Late-onset Pompe Disease
Brief Summary: Primary Objective:

To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa.

Secondary Objective:

To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12).


Options:
A: Number of Participants With a Change in Creatine Kinase (CK) Reflecting Worsening of Muscle Involvement (Any point up to week 52); Number of Participants With a Change in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Bilirubin Representing Liver Toxicity (Any point up to week 52)
B: PAP: Change From Baseline in Percent Predicted FVC in Upright Position at Week 49 (Baseline, Week 49)
C: Summary of Patients Reporting Treatment-Emergent Adverse Events (weeks 0-78); Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline (weeks 0, 78); Percent of Predicted Forced Vital Capacity (FVC) (weeks 0, 78); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC) (weeks 0, 12 and 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax) (weeks 0, 12, 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax) (weeks 0, 12, 52)
D: Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0 to 2.5 years); Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0); Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0, Week 104); Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0); Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0, Week 104)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients
Brief Summary: The purpose of this study is to assess the impact of text message reminders on adherence to medications and exercise in patients recently discharged from the hospital after a myocardial infarction (MI).


Options:
A: Medication adherence (12 months); Exercise frequency (12 months)
B: exercise tolerance (1 year); exercise tolerance (12 weeks)
C: Maximal oxygen consumption (At baseline and after 6 months)
D: Change in the levels of physical fitness (Baseline, 12 week follow - up (end of intervention), 6 months after the completion of the intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients
Brief Summary: The purpose of this study is to assess the impact of text message reminders on adherence to medications and exercise in patients recently discharged from the hospital after a myocardial infarction (MI).


Options:
A: Medication Adherence Score (2 months)
B: Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol (Baseline and 12 months); Differences in physiological variables depending on taking medications: Systolic Blood pressure (Baseline and 12 months); Differences in physiological variables depending on taking medications: Heart Rate (Baseline and 12 months)
C: Escore of combined risk factor control (6 months)
D: Medication adherence (12 months); Exercise frequency (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of a Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
Brief Summary: The investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures related to the uptake of mobile-health (mHealth) technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a non-invasive MRI as a therapeutic response biomarker.


Options:
A: Change in weight status (24 months)
B: Study Recruitment: Interest in Participation (Baseline); Study Recruitment: Screened for Eligibility (Baseline); Study Recruitment: Eligibility (Baseline); Study Recruitment: Enrollment (Baseline); Retention (Week 24); Treatment Satisfaction/Acceptability (Week 24)
C: Weight Change From Baseline to 24 Weeks (24 weeks)
D: Physical Activity directly measured by wearable devices Daily STEPS Count (Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma
Brief Summary: Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show that this drug works by helping improve the body's immune response to help fight cancer. Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth and/or spreading of cancer.


Options:
A: Phase II: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression (PFS was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.); Phase III: Overall Survival Defined as Time From Randomization to the Date of Death From Any Cause (Survival was monitored continuously throughout the study and during follow-up. Patients were evaluated for each cycle, 4 weeks after discontinuation, every 12 weeks until progression, and then every 24 weeks until death, an average of 16.2 months.)
B: Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) (Dose Escalation: Baseline up to Week 3); Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (Ovarian Cancer Efficacy Expansion: Baseline up to Day 620); Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931); Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871); Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (HNSCC Efficacy Expansion: Baseline up to Day 1072)
C: Survival (24 months)
D: Overall Survival (OS) (From randomization to the date of death (Up to 40 Months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre Controlled, Randomized Clinical Trial to Compare the Efficacy and Safety of Ambulatory Treatment of Mild Acute Diverticulitis Without Antibiotics With the Standard Treatment With Antibiotics
Brief Summary: Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.


Options:
A: Readmission ratio (3 months)
B: discharge without complications +/- antibiotic therapy (Within 30 days after discharge)
C: Time-to-full-recovery (6 months follow-up)
D: Treatment Failure (4-6 weeks)

Answer: A