TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349
Brief Summary: The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week.

The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin.

The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine.

The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin.

Target enrollment is 2500 participants. Each study participant will remain in the study for 18 months in order to include at least 12 months of evaluation of whether the participant's TB recurs.


Options:
A: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay (Day 1)
B: Treatment time (Up to 8 weeks)
C: TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) (Twelve months after treatment assignment); TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) (Twelve months after treatment assignment); Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen (Regimen 1 2HRZE/4HR) Compared to Experimental Regimens, Regimen 3 (2HPZM/2HPM) and Regimen 2 (2HPZ/2HP) (Safety Analysis Population) (Four months and up to 14 days after last does of after study treatment (Regimen 2 and 3) or Six months and up to 14 days after last does of after study treatment (Regimen 1))
D: Sensitivity and specificity (10 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial
Brief Summary: This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment


Options:
A: Difference in VAS between ACB and placebo during active 45 degrees knee flexion (45 minutes)
B: The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block (24 h postoperatively)
C: Timed Up and Go test (2-3 days post srugery)
D: Pain-score (VAS), patient standing (2 hours postoperative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Adipokines and Calorie Restriction in Multiple Sclerosis Patients
Brief Summary: The investigators hypothesize that adipokine (soluble molecules produced by the adipose tissue) levels are altered in MS compared to control subjects. Additionally, the investigators hypothesize that calorie restriction (CR) will improve clinical recovery from an MS relapse, ameliorate the adipokine and metabolic-inflammatory profile in MS, and enhance immune-regulatory mechanisms.

This is a pilot study to determine the effects of CR in MS patients during an acute MS relapse (Acute CR phase) and for 6 months afterwards (Chronic CR phase). Calorie restriction will be achieved by following a regimen of alternate day fasting. The investigators will evaluate clinical outcomes and blood biomarkers at different time points.


Options:
A: Body weight (12 weeks)
B: Blood biomarkers (After two weeks, 3 and 6 months); Blood biomarkers (After two weeks, 3 and 6 months); Blood biomarker (After two weeks, 3 and 6 months); Blood biomarker (After two weeks, 3 and 6 months)
C: Endothelium Dependent Dilation (6 weeks)
D: Change in Glucose Tolerance (Before and after 5 weeks on each feeding schedule)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-term Effects of Chest Physiotherapy on Ventilation Inhomogeneity in Non-CF Bronchiectasis
Brief Summary: This study will investigate the effects of on technique of chest physiotherapy on pulmonary function. Effects of pulmonary function will be measured by the spirometry, body plethysmography and by the multiple breath nitrogen washout technique.


Options:
A: weight of sputum that was expectorated (12 months)
B: Change of Lung Clearance Index (LCI) (up to 80 minutes)
C: Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight (24 hours)
D: Wet sputum production (45 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya
Brief Summary: The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.


Options:
A: Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)
B: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)
C: PCR-Corrected ACPR at Day 28 (Day 28)
D: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 (Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya
Brief Summary: The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.


Options:
A: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)
B: Evaluation and identification of hepatic safety events, including raised liver function tests (Assessment up to Day 28.)
C: result of PCR (42 day)
D: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya
Brief Summary: The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.


Options:
A: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)
B: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
C: Adherence (Day 4)
D: Comparison of peak plasma concentration of Dihydroartemisinin in the two studied formulations (DHA plasma samples will be collected on the first day of study drug administration at 20, 30, 40, 60, 100, 200 and 300 minutes post-dose); Comparison of area under the plasma concentration versus time curve of Dihydroartemisinin in the two studied formulations. (DHA plasma samples will be collected on the first day of study drug administration at 20, 30, 40, 60, 100, 200 and 300 minutes post-dose); Comparison of peak plasma concentration of Piperaquine in the two studied formulations (PQP plasma samples will be collected on day 0 of treatment at 40, 80, 280, 720 minutes, then on day 1 at 24 hours and on day 2 at 40, 80, 280, 720 minutes after the last drug administration and then 24, 120, 288 and 456 hours); Comparison of area under the plasma concentration versus time curve of Piperaquine in the two studied formulations. (PQP plasma samples will be collected on day 0 of treatment at 40, 80, 280, 720 minutes, then on day 1 at 24 hours and on day 2 at 40, 80, 280, 720 minutes after the last drug administration and then 24, 120, 288 and 456 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive
Brief Summary: This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.


Options:
A: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
B: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 8 (Study Baseline, Through Week 8)
C: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 Through Safety Follow-up (up to Day 75 for Part 1 and up to Day 85 for Part 2)); Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline Through Day 29)
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8 (Baseline, Through Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration
Brief Summary: There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. Investigators planned to evaluate the impact of a low-cost package of community-based interventions implemented through government sector lady health workers (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on perinatal and neonatal outcomes in a sub-population of the remote mountainous district of Gilgit, Northern Pakistan.

A community-based package for use by LHWs and CHWs geared towards prevention and promotion of maternal and newborn health practices and services will be developed based on formative research in the study district. The package will include promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level. The health workers will be trained in recognition of danger sign that warrant referral to health care service. LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period. In addition to this, community mobilization activities included formation of CHCs and creation of support for the uptake of the interventions. Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area. The intervention areas will receive the intervention package in addition to the routine standard health services. Outcome measures will include changes in maternal and newborn-care practices and perinatal and neonatal mortality rates between the intervention and control areas.


Options:
A: Reduction in perinatal and neonatal mortality (3 years)
B: Treatment failure (Seven days)
C: Neonatal mortality rate
D: Newborn survival (to 28 days) (July 2010 to June 2013)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration
Brief Summary: There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. Investigators planned to evaluate the impact of a low-cost package of community-based interventions implemented through government sector lady health workers (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on perinatal and neonatal outcomes in a sub-population of the remote mountainous district of Gilgit, Northern Pakistan.

A community-based package for use by LHWs and CHWs geared towards prevention and promotion of maternal and newborn health practices and services will be developed based on formative research in the study district. The package will include promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level. The health workers will be trained in recognition of danger sign that warrant referral to health care service. LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period. In addition to this, community mobilization activities included formation of CHCs and creation of support for the uptake of the interventions. Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area. The intervention areas will receive the intervention package in addition to the routine standard health services. Outcome measures will include changes in maternal and newborn-care practices and perinatal and neonatal mortality rates between the intervention and control areas.


Options:
A: Infant Gestational Age (Time of delivery)
B: Sexual behavior risk (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Lab tested STDs (Measured at 3rd trimester); Rapid repeat pregnancy (Measured at Months 6 and 12 postpartum); Low birthweight (Measured at delivery); Preterm labor (Measured at delivery); Breastfeeding (Measured at Months 6 and 12 postpartum)
C: Mean change in Edinburgh Postpartum Depression Scale (EPDS) Scores from baseline to post intervention and 1-month follow-up (Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group)
D: Reduction in perinatal and neonatal mortality (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers
Brief Summary: The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.

In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers who have been recruited from users of text4baby - the first large scale mobile health application in the United States. Developed and operated by Voxiva and Healthy Mothers, Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and delivered more than 150 million health messages to them including messages encouraging them not to smoke during pregnancy and referring them to quit lines.

Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher levels of knowledge about the dangers of second hand smoke and the benefits of smoking cessation for mothers and their infants than text4baby only users.

Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly higher rates of calling a quit line, discussions with their health provider and/or use of cessation counseling than those who receive Text4baby alone.

Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more favorable quitting outcomes compared with text4baby alone.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Biometrically confirmed abstinence (3-6 months); Quitline call rates (1-6 months); Knowledge as measured by survey items (1-6 months)
C: Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) (3 months); Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) (3 months); Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) (12 months); Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) (12 months); Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) (12 months); Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) (12 months)
D: Completion of vaccine primary series (12 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers
Brief Summary: The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.

In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers who have been recruited from users of text4baby - the first large scale mobile health application in the United States. Developed and operated by Voxiva and Healthy Mothers, Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and delivered more than 150 million health messages to them including messages encouraging them not to smoke during pregnancy and referring them to quit lines.

Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher levels of knowledge about the dangers of second hand smoke and the benefits of smoking cessation for mothers and their infants than text4baby only users.

Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly higher rates of calling a quit line, discussions with their health provider and/or use of cessation counseling than those who receive Text4baby alone.

Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more favorable quitting outcomes compared with text4baby alone.


Options:
A: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)
B: HPV completion rate (One Year)
C: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
D: Biometrically confirmed abstinence (3-6 months); Quitline call rates (1-6 months); Knowledge as measured by survey items (1-6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers
Brief Summary: The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke.

In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers who have been recruited from users of text4baby - the first large scale mobile health application in the United States. Developed and operated by Voxiva and Healthy Mothers, Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and delivered more than 150 million health messages to them including messages encouraging them not to smoke during pregnancy and referring them to quit lines.

Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher levels of knowledge about the dangers of second hand smoke and the benefits of smoking cessation for mothers and their infants than text4baby only users.

Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly higher rates of calling a quit line, discussions with their health provider and/or use of cessation counseling than those who receive Text4baby alone.

Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more favorable quitting outcomes compared with text4baby alone.


Options:
A: Biometrically confirmed abstinence (3-6 months); Quitline call rates (1-6 months); Knowledge as measured by survey items (1-6 months)
B: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)
C: ANC (Assess the recommend number of ANC (4 ANC) coverage 18 months after intervention); PNC (Assess the recommend number of PNC (3 ANC) coverage 18 months after intervention); Contraceptive prevalence rate (CPR) (Assess the Contraceptive prevalence rate (CPR) at the end of intervention of 18 months.); EPI coverage (Assess the EPI vaccination coverage at the end of the intervention of 18 months)
D: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)

Answer: A