TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Multi-center, Randomized Controlled Trial Comparing Pregnancy Outcomes Following Selection and Single Embryo Transfer (SET) Based on Preimplantation Genetic Screening (PGS) by Next Generation Sequencing (NGS) Versus Standard Morphological Assessment
Brief Summary: The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos will be vitrified and a single embryo transfer (SET) will be performed with either screened or unscreened embryos depending on randomization.


Options:
A: Live birth rate per randomized patient (single embryo transfer vs. 2 embryo transfer) (2 years)
B: Sustained Implantation Rate Per Embryo Transferred (Within 1 year)
C: Ongoing Pregnancy (Gestational Age of 20 Weeks)
D: To improve live birth rates. (up to 1 year after birth); To assess the prediction value of having no euploid oocytes in future ART cycles. (Up to 1 year after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: Change in self-care behaviour measured with the validated European Heart Failure Self Care Behaviour Scale(EHFScB scale) (at 3, 6 and 12 months); Change in health related quality of life measured with the generic short-form health survey with 36 questions (SF36), EuroQol five Dimensions (EQ-5D) and the disease-specific Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at 3, 6 and 12 months)
B: Improvement tolerance capacity (4 months and 6 months)
C: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
D: Time to composite all-cause readmissions/emergency department (ED) visits/death at 3 months (Within 3 months of hospital discharge); Time to composite all-cause readmissions/emergency department (ED) visits/death at 30 days (Within 30 days of hospital discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)
B: Improvement tolerance capacity (4 months and 6 months)
C: Chronic Respiratory Disease Questionnaire (CRQ) (12 weeks)
D: 30 day readmission rate (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: Improvement tolerance capacity (4 months and 6 months)
B: Prevalence of latent heart failure and COPD. (6 months)
C: Mortality or readmission (one year)
D: Trough FEV1 after 12 weeks of treatment (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: Improvement tolerance capacity (4 months and 6 months)
B: Change in the distance walked at a 6MWT measured at week 12 (12 weeks)
C: Measure of physical activity (Change from Baseline to Week 12)
D: Clinical health, including lung function and respiratory symptoms (Measured at baseline and every 3 months for 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: The number of ED presentations (1 year after randomization.)
B: Re-hospitalizations (During the 30days after discharge)
C: Health-Related quality of life (12 months)
D: Improvement tolerance capacity (4 months and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: Improvement in physical activity (1 month)
B: Functional performance (12 weeks)
C: Improvement tolerance capacity (4 months and 6 months)
D: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: HF-specific quality of life (baseline, midpoint, endpoint, 6mo); functional capacity (baseline and endpoint); Walking Test (baseline, midpoint, endpoint)
B: 6 Minute Walk Test (up to 3 months)
C: Exercise Capacity (20 weeks)
D: Improvement tolerance capacity (4 months and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: disease-specific health-related quality of life (HRQoL) (two years)
B: Improvement tolerance capacity (4 months and 6 months)
C: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
D: The combined number of hospital admissions and ED visits for a COPD exacerbation (6-month follow-up period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Innovative Multidisciplinary Telehealth Program in COPD and CHF Patients: a Randomized Control Trial.
Brief Summary: The aim of this randomized control study is to determine the feasibility and efficacy of an innovative multidisciplinary telehealth program in chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) patients. 120 patients (1:1) will be included in the study and followed for 4 months and for additional 2 months of follow-up. The primary outcome is to improve tolerance capacity


Options:
A: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. (3 years)
B: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
C: Improvement tolerance capacity (4 months and 6 months)
D: Changes in EQ ED From Baseline to 3 Months Endpoint (Baseline and change at 3 months); Changes in the Symptom Burden of Disease From Baseline to 3 Months (Baseline with change at 3 months); Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint (Baseline and change at 3 months); Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint (Baseline and change at 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
Brief Summary: The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif.

The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.


Options:
A: Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period (Day 1 to Month 4); Injection-Related Adverse Event Rate Per Year in the Extension Period (Month 5 up to Month 10); Injection-Related Adverse Events in the Extension Period (Month 5 up to Month 10)
B: Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h) (2 weeks)
C: Neurofilament light chain in the cerebrospinal fluid (CSF) (0-48 weeks)
D: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Perinatal Anal Incontinence Through Early Pelvic Floor Muscle Training: a Prospective Pilot Study
Brief Summary: Anal incontinence affects up to 20% of gravid women during and immediately after pregnancy. It can lead to embarrassment, poor self-image, lifestyle changes, in addition to poor hygiene and increased risk for genitourinary tract infection. These women suffer from a combination of loss of fecal and/or flatal control, with increasing frequency as pregnancy progresses. Though anal incontinence may subside in the postpartum period, a subset of women will have continued anal incontinence or recurrence of anal incontinence with subsequent pregnancies or as they age. As of December 2012, only one study has explored the effects of pelvic floor muscle training (PFMT) on reducing the development of this condition in the pregnant population. However, that study took place in Scandinavia with little demographic correlation to a US population and lacked postpartum followup. Although their results showed little effect of PFMT on anal incontinence, they recommended further research to be performed prior to making definitive conclusions.

Multiple studies have explored the effects of PFMT on urinary incontinence, and the general consensus shows a positive benefit, with a 50% incidence reduction. This study will serve as an initial test to explore whether such a positive relationship holds for anal incontinence throughout pregnancy and postpartum period for a diverse population. The format will be a prospective feasibility trial comprised of a one-time intensive in-person pelvic floor muscle training course at the first prenatal visit with at home instructions for continued exercise. This group will be compared to a control group which receives a hand-out regarding PFMT but no personalized instruction. The progress of the participants and their symptoms of incontinence will be monitored during pregnancy and at the postpartum visit using standardized validated pelvic floor questionnaires, based on previously designed surveys. A sample size of 100 parous women ages 20-35 year old will be randomized to an intervention and "control or standard therapy" group. The investigators' hypothesis is that the intervention group will show a 50% risk reduction, similar to the urinary incontinence studies. The results of this study will then allow us to design a broader intervention study for which to study the effects of PFMT and anal incontinence during pregnancy and the postpartum period.


Options:
A: Incidence of fecal and/or flatal incontinence (3 months (1st trimester)); Incidence of fecal and/or flatal incontinence (6 months (2nd trimester)); Incidence of fecal and/or flatal incontinence (9 months (3rd trimester))
B: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) (15 weeks)
C: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
D: Placental weight (At delivery); Fetal birth weight (At delivery); Change from baseline in maternal gestational weight (38-42 weeks of gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Application of Appropriate Technology for Myopia Prevention and Control
Brief Summary: The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors in northeast China.


Options:
A: Refractive Error Progression (3 years)
B: Changes in uncorrected visual acuity (Baseline, Month 6, Month 12)
C: Changes in Cycloplegic Autorefraction in One Year. (One year)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study About The Effects of Indirect-Moxibustion on Bladder- Functional Improvement and Symptoms Management in Patients With Overactive Bladder: A Randomized Controlled Trial
Brief Summary: This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (OAB) patients.


Options:
A: Proportion of Women Who Meet Definition of Success (8 months)
B: Overactive bladder-validated 8-questions (4 weeks)
C: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
D: Mean number of incontinence episodes (Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality
Brief Summary: Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in maternal and under five year old mortality. Evidence exists that a large proportion of newborn mortality globally and in Cambodia is attributable to infections and sepsis. The study proposes a package intervention to address infection control in the perinatal period in facilities and to improve the timeliness of referral of newborns with suspected infections to appropriate health facilities for treatment through upgrading of hygiene practices in facilities and linking of community based volunteers with health facilities and families in the community setting.

By delivering a coordinated intervention that combines improved education for health center midwives, village health care workers, and mothers of newborns, along with improved care coordination with increase in number of interactions (points of contact) between mothers and health care personnel, the investigators will see improved knowledge of newborn danger signs among mothers and health care workers, more rapid case detection of significant newborn illnesses, and more rapid and appropriate referral of ill newborns.

The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are different from those reported in Western cultures, and that Staphylococcus aureus will be a common pathogen as described in neighboring Laos. The investigators will evaluate the causes of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.


Options:
A: % of mothers who know at last 3 danger signs (2 years); % of VHSG who know 6 danger signs (2 years); % of families who seek care from an appropriate facility (2 years); Time between onset of suspected danger signs and referral to appropriate facility (2 years); Improved hygiene behavior by family (2 years); Improved infection control behavior among HC staff (2 years)
B: score on Hospital Consumer Assessment of Healthcare Provers and Systems (HCAPS) survey (2 months)
C: Parents breastfeeding self efficacy (7 days post partum)
D: Number of eligible participants who consent and complete study intervention (1-4 days postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality
Brief Summary: Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in maternal and under five year old mortality. Evidence exists that a large proportion of newborn mortality globally and in Cambodia is attributable to infections and sepsis. The study proposes a package intervention to address infection control in the perinatal period in facilities and to improve the timeliness of referral of newborns with suspected infections to appropriate health facilities for treatment through upgrading of hygiene practices in facilities and linking of community based volunteers with health facilities and families in the community setting.

By delivering a coordinated intervention that combines improved education for health center midwives, village health care workers, and mothers of newborns, along with improved care coordination with increase in number of interactions (points of contact) between mothers and health care personnel, the investigators will see improved knowledge of newborn danger signs among mothers and health care workers, more rapid case detection of significant newborn illnesses, and more rapid and appropriate referral of ill newborns.

The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are different from those reported in Western cultures, and that Staphylococcus aureus will be a common pathogen as described in neighboring Laos. The investigators will evaluate the causes of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.


Options:
A: Neonatal mortality from post enrolment to 28 days (From post enrolment to 28 days); Early infant mortality from post enrolment to 6 months of age (From post enrolment to 6 months)
B: % of mothers who know at last 3 danger signs (2 years); % of VHSG who know 6 danger signs (2 years); % of families who seek care from an appropriate facility (2 years); Time between onset of suspected danger signs and referral to appropriate facility (2 years); Improved hygiene behavior by family (2 years); Improved infection control behavior among HC staff (2 years)
C: Reduction in perinatal and neonatal mortality (3 years)
D: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial
Brief Summary: This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.


Options:
A: Treatment Satisfaction (End of treatment (seven weeks after baseline))
B: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
C: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
D: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)

Answer: B