TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: VocalizationTechnique During the Second Period of Labor Versus Usual Care for Prevention of Perineal Trauma: Randomized Clinical Trial
Brief Summary: A randomized open-label trial will be conducted to evaluate the effect of vocalization as a perineal protection maneuver during the second period of labor. The study will be carried out in the "Espaço Aconchego" sector of the IMIP, which has a team of obstetrical nurses, medical coordination and physiotherapeutic support. The study population will consist of low-risk parturients, with no prior cesarean indication, admitted to the sector. Those parturients who meet the inclusion criteria, after signing the Informed Consent Term, will be allocated to two groups: Group A (experimental) and Group B (control). Group A will be stimulated to keep the glottis minimally open during spontaneous pushing and to emit sounds when exhaling (vocalization), and Group B will undergo usual routine. Study outcomes will be evaluated by assistents immediately after delivery. After 24 hours of delivery, the conditions of the perineum will be assessed by inspection and palpation of the region,evaluating the presence of edema or other abnormality.


Options:
A: PERINEAL LACERATION Primary outcome: 1. Perineal laceration - present or absent (1 hour postpartum)
B: Number of patients with perineal tears (perineal tears are evaluated within 1 hour of delivery)
C: Perineal rupture grade III-IV (anal sphincter tears) (At delivery - within minutes - hours of randomization)
D: Grade I and II rupture during delivery (time at the delivery department (up to 12 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial
Brief Summary: This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content.

This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age.

The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.


Options:
A: Human milk glycans (Change from day 2 to day 366)
B: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
C: Feeding tolerance (Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment))
D: NEC onset (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Apatinib Combined Capecitabine Versus Capecitabine Alone for Adjuvant Therapy in Patients After Biliary Carcinoma Surgery: a Prospective Randomized Controlled Study
Brief Summary: It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.


Options:
A: Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 (One year)
B: overall survival (24 months)
C: Progression-free survival (12 months)
D: Disease free survival (DFS) (Disease free survival rate at 24 months (DFSR@24))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Safety and Efficacy of Tisagenlecleucel in Pediatric Subjects With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma (NHL)
Brief Summary: The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and Burkitt Leukemia.

For pediatric patients who have r/r B-NHL including Burkitt Lymphoma and Burkitt Leukemia, survival rates are dismal, only \~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.


Options:
A: Overall Response Rate (ORR) as Determined by Local Investigator (6 months post-tisagenlecleucel infusion)
B: Phase I - Identification of the dose limiting toxicity (DLT) (4 weeks after CAR T cell infusion); Phase II - Efficacy (4 weeks after CAR T cell infusion)
C: maximum tolerated dose (MTD) (2 years); safety (2 years)
D: Incidence of adverse events (Up to 15 years); Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT) (Up to 30 days post-infusion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PRIDE SSA - Partnerships in Research to Implement and Disseminate Sustainable and Scalable Evidence Based Practices in Sub-Saharan Africa
Brief Summary: Global mental health (MH) and substance use disorders prevention, treatment and research gaps require that efficacious treatments be scaled-up, leveraging existing platforms. In tandem, participation of Ministries ready to apply evidence-inform policies must sustain them over time. PRIDE SSA may generate templates for other low- and middle-income countries (LMICs) by conducting a state of the art scale up study in Mozambique and by establishing a collaborative research network of nascent research "Seed Teams." Such "Seed Teams," trained by the capacity building component, may work across the region to build capacity and conduct implementation research to sustainably scale-up MH services. Scale Up Research (Mozambique) in MH and substance use disorders will evaluate strategies and costs of scaling up an innovative, integrated, sustainable, stepped-care community approach. The scale up study will leverage: (1) Mozambique's task-shifting strategy of training psychiatric technicians (PsyTs) to provide MH care, (2) the WHO-funded epilepsy community care program successfully implemented in 5 Provinces, now primed for scale-up by the Health Ministry. The cost-effective approach redefines work roles without requiring new human resources. Importantly, it comports with the Health Ministry's plan to implement prevention and treatment for all MH conditions, rather than single disorders. The model employs evidence-based practices (EBPs; e.g. Psychopharmacology; Interpersonal Therapy), already in use by PsyTs to: a) establish a sustainable program delivered and supervised by non-MH professionals, overseen by MH specialists; b) provide community screening, care and/or referrals for all MH disorders; and c) use implementation tools to monitor sustainability. This collaborative network will scale-up a cost-effective, sustainable program and inform policy.


Options:
A: Change in anxiety (Baseline & at 2 weeks)
B: 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)
C: Change in Reach (implementation) (Change from Baseline in Reach at 12 months); Cost (Cost of implementing each arm will be calculated through study completion, an average of 2 years)
D: Unprotected vaginal and anal sex (Baseline); Unprotected vaginal and anal sex (6 month follow-up); Unprotected vaginal and anal sex (12-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community I-STAR Mozambique: Community Implementation of SBIRT Using Technology for Alcohol Use Reduction in Mozambique
Brief Summary: Hazardous drinking (HD) is a major public health burden worldwide with significant morbidity and mortality. To reduce HD, the World Health Organization (WHO) recommends using Screening, Brief Intervention, Referral to Treatment (SBIRT). Mobile health technology (mHealth), such as the mSBIRT app, is a promising tool for widespread cost-effective delivery of evidence-based HDS by community health workers (CHWs) because of its potential to increase fidelity, effectiveness, and sustainability. Community I-STAR Mozambique comprises three phases: 1) mSBIRT adaptation, 2) a cluster-randomized trial, and 3) scale-up of the most cost-effective intervention. Community I-STAR Mozambique will scale-up a cost effective, sustainable program and inform policy applicable to Mozambique and other LMICs.


Options:
A: Implementation - Reach (From baseline to 6 months); Clinical Effectiveness - AUDIT (From baseline to 6 months)
B: Age-appropriate Social-Emotional Development of Children Under 2 Years (6 months post-intervention); Maternal Depression/Anxiety (6 months post-intervention)
C: Zarit Burden Inventory-4 (3 months)
D: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16); Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 (Week 16)
B: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)
C: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) (Week 16); The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) (Baseline and Week 16)
D: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Controlled Trial Comparing Different Needles for Oocyte's Retrieval.
Brief Summary: In the early stages of assisted reproductive technologies (ART), oocyte retrieval was performed via laparoscopy, a cumbersome and expensive process requiring general anesthesia. Today, transvaginal oocyte retrieval for ART is a routine procedure performed under ultrasound guidance. Double-lumen retrieval needles, which are capable of flushing ovarian follicles, were developed to overcome the possibility of oocyte retention within the ovarian follicles and retrieval collection system. Single lumen needles have been introduced and are routinely used by most groups due to their supposed ability to retrieve the same number of oocytes in a shorter operation time.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: Proportion of mature oocytes retrieved (day of intervention)
C: Number of retrieved oocytes per procedure (through study completion, 9 months)
D: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS (2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Brief Summary: Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.


Options:
A: Knowledge of Reproductive Health True/False Quiz of 20 questions (5-6 months after baseline and then again 14-16 months after baseline); Sexual behavior (14-16 months after baseline)
B: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)
C: Highly-effective contraceptive use (6 months postpartum)
D: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Brief Summary: Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.


Options:
A: Viral load (6 months post-randomization)
B: Unprotected sex, no contraceptive (6-week post-baseline (in the past 6 weeks)); Unprotected sex, no highly effective contraceptive (6-week post-baseline (in the past 6 weeks))
C: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
D: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Brief Summary: Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.


Options:
A: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
B: contraceptive continuation (6 months)
C: Adherence to ART and HIV RNA suppression (6,12 months)
D: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Brief Summary: Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.


Options:
A: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
B: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
C: Self-reported adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (12 months post-partum); Adherence on antiretroviral therapy (infant) (12 months post-partum); Retention in care (12 months post-partum); Adherence on antiretroviral therapy (dried blood spots) (12 months post-partum)
D: Percent of children immunized (Up to 12 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Brief Summary: Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.


Options:
A: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
B: Change in Exclusive Breastfeeding Rate (2 weeks after birth); Change in Exclusive Breastfeeding Rate (3 months after birth); Change in Exclusive Breastfeeding Rate (6 months after birth)
C: Full on time early vaccination coverage (OPV0 and BCG) (First month of life)
D: Exclusive breastfeeding duration (Six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Brief Summary: Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.


Options:
A: fat tissue (6 months)
B: Smoking Abstinence (3 months)
C: Postpartum Contraceptive Uptake (Through study completion, an average of six months); Skilled Birth (Through study completion, an average of six months); Immunisation (Through study completion, an average of six months)
D: Improvement in the recall of LMP date among enrolled participants in the intervention arms compared to control arm (12 months after enrollment); Increased accuracy of LMP-based gestational age measurement, as compared to USG (12 months after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Mindful Awareness Practices in Pediatric Residency Training
Brief Summary: This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees.


Options:
A: Significant score reduction at the Perceived Stress Scale (T0 inclusion); Significant score reduction at the Perceived Stress Scale (T1 (3-month follow-up)); Significant score reduction at the Perceived Stress Scale (T1 (up to 8 weeks treatment)); Significant score reduction at the Perceived Stress Scale (T2 (6-month follow-up))
B: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))
C: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)
D: Differences in Burnout as measured by the Maslach Burnout Inventory Score (MBI). (At the time of enrollment and at 1 month, 3 months, 6 months after enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Mindful Awareness Practices in Pediatric Residency Training
Brief Summary: This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees.


Options:
A: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
B: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)
C: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
D: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Mindful Awareness Practices in Pediatric Residency Training
Brief Summary: This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees.


Options:
A: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)
B: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
C: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))
D: Perceived Stress (3 months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Mindful Awareness Practices in Pediatric Residency Training
Brief Summary: This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees.


Options:
A: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))
B: Perceived Stress (3 months post-intervention)
C: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
D: Change in Aggression (baseline, post-intervention (week 8), 3-month followup, 6-month followup)

Answer: A