TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
Brief Summary: Amid consistently worsening suicide rates, in 2012 the U.S.Surgeon General's National Strategy for Suicide Prevention proposed to "change the narrative" about suicide prevention to include a focus on promoting hope and belongingness. Despite hopelessness and thwarted belongingness being among the most replicated risk factors for suicide, many widely implemented suicide prevention efforts instead emphasize the identification of acute suicide risk and referral to mental health treatment services. However, there are very few health service interventions known to reduce suicides among those identified as high risk. Those interventions shown to be effective have not achieved the wide scale implementation necessary to alter the trend of increasing suicide deaths. New interventions are needed, and one promising, scalable intervention with a novel approach to addressing the risk factors advocated by the Surgeon General is peer mentorship. A peer mentorship intervention, PREVAIL, has been piloted in a two-site randomized controlled trial (N=70) and is acceptable and feasible with enrollment of nearly half of eligible high-risk patients, mean completion of over 6 mentorship sessions, and 85% of sessions meeting fidelity standards for addressing the intended targets of hope and belongingness.

The aims of this hybrid effectiveness-implementation study are:

Specific Aim 1: Determine the effectiveness of the PREVAIL peer mentorship intervention for reducing suicide attempts and suicidal ideation among recently hospitalized adult psychiatric patients at high risk for suicide.

Specific Aim 2: Examine the mechanisms of peer mentorship by measuring the effects of PREVAIL on potential mediators,including hope and belongingness.

Specific Aim 3: Identify barriers and facilitators to implementation of PREVAIL.


Options:
A: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)
B: The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period (12 months)
C: Change in BPD (Borderline Personality Disorder) behaviors (8-weeks)
D: suicide reattempt (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis
Brief Summary: It is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. Since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and pulmonary function. Considering the relation between diaphragm which is one of the core muscles, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. Thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.


Options:
A: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline Forced Vital Capacity (FVC) at 8 weeks (Eight weeks); Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks (Eight weeks); Change from baseline Peak Expiratory Flow (PEF) at 8 weeks (Eight weeks); Change from baseline maximum inspiratory pressure at 8 weeks (Eight weeks); Change from baseline maximum expiratory pressure at 8 weeks (Eight weeks); Change from baseline distance covered in six-minute walk test at 8 weeks (Eight weeks)
B: Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. (baseline and 6 months)
C: Change from baseline Posture at 4 weeks (Baseline and after 4 weeks of training); Change from baseline Health-related quality of life at 4 weeks (Baseline and after 4 weeks of training)
D: Physical activity (Measured at baseline, 6, and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inspiratory Muscle Training on Postural Stability, Balance, Pulmonary Function and Functional Capacity in Children With Cystic Fibrosis
Brief Summary: It is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. Mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. Since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. Inspiratory muscle training (IMT) is shown to improve diaphragm strength and pulmonary function. Considering the relation between diaphragm which is one of the core muscles, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. Thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
B: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (Baseline - immediately post exercise - 45min post exercise)
C: Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24 (Baseline, Week 24)
D: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline Forced Vital Capacity (FVC) at 8 weeks (Eight weeks); Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks (Eight weeks); Change from baseline Peak Expiratory Flow (PEF) at 8 weeks (Eight weeks); Change from baseline maximum inspiratory pressure at 8 weeks (Eight weeks); Change from baseline maximum expiratory pressure at 8 weeks (Eight weeks); Change from baseline distance covered in six-minute walk test at 8 weeks (Eight weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.
Brief Summary: Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.


Options:
A: Association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation (Within first 7 days after transplant); Association of mRNA expression of proinflammatory mediatros in the transplanted organ in the immediate pre and post-reperfusion period with subsequent incidence of acute rejection and expression of genes involved in cell mediated immunity (12 months after transplant)
B: Early graft injury (During the first week postoperatively (absolute and relative delta))
C: The incidence of symptomatic non-anastomotic biliary strictures (NAS) (6 months)
D: Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery (Day 7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cheese Consumption and Human Microvascular Function
Brief Summary: Increased dairy intake is associated with improved measures of blood vessel health. Dairy cheese, however, is often high in sodium. Dietary sodium can impair blood vessel function. The researchers examine if and how natural cheese may protect against impairments in blood vessel function caused by sodium. For this study, participants complete four 8-day controlled feeding periods in which they eat cheese (6 oz/day) or no cheese during a low-sodium or high-sodium base-diet. The participants complete baseline experiments while on their normal personal diet and then repeat experiments at the end of each controlled feeding period. In some of our experiments, the researchers use a technique called "microdialysis" (MD). With MD, the researchers perfuse some research drugs into the skin on the forearm through tiny tubing that mimics capillaries. These MD drugs mimic or block substances the body naturally makes to control the small blood vessels in the skin. The drugs remain in nickel-sized areas around the tubing and do not go into the rest of the body. The researchers also use a standard technique called "flow mediated dilation" (FMD) that uses blood pressure cuffs and ultrasound to look at the health of larger blood vessels in the body. FMD includes placing a small tablet of nitroglycerin under the tongue during part of the test.


Options:
A: Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
B: 24-h urinary sodium (4.5 month)
C: laser Doppler blood flow (8 weeks)
D: Blood Pressure Variability (Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)); Blood Pressure Reactivity - Handgrip exercise (Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Open-label Study to Compare the Effectiveness of the Fixed Dose Combination of FF/UMEC/VI (Using the Connected Inhaler System) With the Combination of FP/SAL Plus Tiotropium (Without the Connected Inhaler System) in Participants With Inadequately Controlled Asthma
Brief Summary: Asthma is a common, chronic respiratory disease affecting 1-18 percent of the population. It is accepted that much of the uncontrolled asthma is due to poor adherence and asthma outcomes in such cases may improve simply by increasing adherence to available treatments. GlaxoSmithKline (GSK) has developed a sensor, which clips on to the ELLIPTA® dry powder inhaler (DPI). This will inform subjects if/when they have taken their medication that is in the ELLIPTA inhaler, as well as other information, including: asthma management strategies, tracking of symptoms, asthma triggers, medication reminders and daily asthma forecasts. The sensors, application (app), and provider portal that provide data are subsequently described as the CIS. The combination of once-daily FF/UMEC/VI with the CIS will improve the disease management and adherence. Thus, this study is designed to study the effectiveness and adherence of single inhaler triple therapy (SITT) of FF/UMEC/VI with the CIS as compared to multiple inhaler triple therapy (MITT) of the combination of FP/SAL plus TIO without CIS in subjects with inadequately controlled asthma. The study randomization will be stratified by pre-study inhaled corticosteroids (ICS) dosage strength (mid- or high-dose). Subjects will be randomized in a 1:1 ratio to receive either FF/UMEC/VI delivered via the ELLIPTA DPI with the CIS or FP/SAL delivered via the DISKUS® DPI (with sensor only) plus TIO delivered via the RESPIMAT inhaler (without sensor). The maximum study duration will be approximately 29 weeks, which comprised of prescreen/ screening/ randomization period of up to 4 weeks, 24-week treatment period and a 1-week follow-up period. Approximately 1006 subjects will be randomized in the study. ELLIPTA and DISKUS are registered trademarks of GlaxoSmithKline (GSK) group of companies.


Options:
A: The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) (Baseline to Week 12)
B: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)
C: Percentage of subjects who have an asthma control test (ACT) total score of >=20 (Up to 24 weeks); Percentage of subjects with an increase from Baseline of >=3 in ACT total score (Baseline and up to 24 weeks)
D: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PediCRaFT: Pediatric Crohn's Disease Fecal Microbiota Transplant Pilot Study
Brief Summary: The objective of this study is to assess the feasibility of a novel colonic and oral fecal microbiota transplantation protocol for the treatment of active pediatric Crohn's disease (CD). Specifically, we will test the hypothesis that a protocol of combination fecal microbiota colonoscopic infusion and oral microbiota capsules (OMC), using live fecal material from anonymous unrelated donors, can improve the disease activity of pediatric CD patients.


Options:
A: Safety (up to 6 mo post FMT)
B: Clinical Cure (8 weeks)
C: Incidence of treatment-emergent adverse events (3 months)
D: Monthly Recruitment Rate (30 weeks); Dropout Rate Post Enrolment (30 weeks); Rate of Patient Protocol Adherence (30 weeks); Rate of Adverse Events (30 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Anchor Versus Suturing for Attachment of Vaginal Mesh in Minimally Invasive Sacrocolpopexy
Brief Summary: 1. PRIMARY OBJECTIVE: To assess the effect of absorbable anchor compared to suturing for mesh attachment to vagina in robotic assisted sacrocolpopexy on the length of surgery for this portion of the procedure.
2. SECONDARY OBJECTIVES:

   i. To assess intraoperative and ii. postoperative complication rates, iii. Intraoperative 10 cm visual analog scale (VAS), to subjectively assess surgeon satisfaction with the technique iv. post-operative Pelvic Organ Prolapse Quantification (POPQ) evaluation for anatomic failure and v. a VAS of the vaginal walls overall appearance


Options:
A: Mesh Attachment Time (Assessed at one time point, during the participants surgery.)
B: Comparison of surgical time (Up to four months (2 weeks before surgery until 3 months post-surgery).)
C: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
D: Surgical Failure (6 months and 1, 2, 3, 4, and 5 years); Recruitment Into E-OPTIMAL (At 24 Months post OPTIMAL Treatment); Retention in E-OPTIMAL (3, 4, and 5 Years Post OPTIMAL Treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of SMS and Interactive Reminders to Improve Timely Immunization Coverage: A Randomized Controlled Trial
Brief Summary: Pakistan has one of the highest infant mortality rates in the world. One child in eleven dies before their fifth birthday. In part, this is due to the low coverage rate of routine childhood immunizations. Since Pakistan is a Low Middle Income Country (LMIC) it is essential that an immunization intervention be developed that is suitable for its socioeconomic setting. The tele-density of Pakistan exceeds 70% and the cost of SMS in Pakistan is very low. Moreover the use of SMS in the country has broadened beyond the conventional use of peer-peer chat to include social networking, SMS banking, delivery tracking, advertising, business, disaster management, and identity verification. This study will utilise this prevalence of mobile phones to assess whether simple and interactive sms reminders can serve to increase childhood immunization coverage and timeliness.

The pilot study will be carried out only in 2 EPI (Extended program on Immunization) centers at Korangi. The pilot will determine whether automated text messages produce increased immunization coverage in the reminder groups compared to the control group. 656 participants will be enrolled at Penta-1 and will be followed up until measles-2 vaccination. The results of proposed pilot will provide the basis for a large scale-up study in urban and rural settings in Pakistan.


Options:
A: Adherence to PrEP (Baseline to Week 48)
B: MV Coverage at 12 months of age (12 months of age)
C: Measles - 2 Completion (When the participants reach 2 years of age)
D: Exhaled Carbon Monoxide Levels (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of SMS and Interactive Reminders to Improve Timely Immunization Coverage: A Randomized Controlled Trial
Brief Summary: Pakistan has one of the highest infant mortality rates in the world. One child in eleven dies before their fifth birthday. In part, this is due to the low coverage rate of routine childhood immunizations. Since Pakistan is a Low Middle Income Country (LMIC) it is essential that an immunization intervention be developed that is suitable for its socioeconomic setting. The tele-density of Pakistan exceeds 70% and the cost of SMS in Pakistan is very low. Moreover the use of SMS in the country has broadened beyond the conventional use of peer-peer chat to include social networking, SMS banking, delivery tracking, advertising, business, disaster management, and identity verification. This study will utilise this prevalence of mobile phones to assess whether simple and interactive sms reminders can serve to increase childhood immunization coverage and timeliness.

The pilot study will be carried out only in 2 EPI (Extended program on Immunization) centers at Korangi. The pilot will determine whether automated text messages produce increased immunization coverage in the reminder groups compared to the control group. 656 participants will be enrolled at Penta-1 and will be followed up until measles-2 vaccination. The results of proposed pilot will provide the basis for a large scale-up study in urban and rural settings in Pakistan.


Options:
A: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
B: Adherence to PrEP (Baseline to Week 48)
C: Measles - 2 Completion (When the participants reach 2 years of age)
D: Contraceptive knowledge score (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of SMS and Interactive Reminders to Improve Timely Immunization Coverage: A Randomized Controlled Trial
Brief Summary: Pakistan has one of the highest infant mortality rates in the world. One child in eleven dies before their fifth birthday. In part, this is due to the low coverage rate of routine childhood immunizations. Since Pakistan is a Low Middle Income Country (LMIC) it is essential that an immunization intervention be developed that is suitable for its socioeconomic setting. The tele-density of Pakistan exceeds 70% and the cost of SMS in Pakistan is very low. Moreover the use of SMS in the country has broadened beyond the conventional use of peer-peer chat to include social networking, SMS banking, delivery tracking, advertising, business, disaster management, and identity verification. This study will utilise this prevalence of mobile phones to assess whether simple and interactive sms reminders can serve to increase childhood immunization coverage and timeliness.

The pilot study will be carried out only in 2 EPI (Extended program on Immunization) centers at Korangi. The pilot will determine whether automated text messages produce increased immunization coverage in the reminder groups compared to the control group. 656 participants will be enrolled at Penta-1 and will be followed up until measles-2 vaccination. The results of proposed pilot will provide the basis for a large scale-up study in urban and rural settings in Pakistan.


Options:
A: Proportion of timely and complete vaccine uptake after ISAP SMS Intervention (12 months)
B: Completion of vaccine primary series (12 months of age)
C: Measles - 2 Completion (When the participants reach 2 years of age)
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: Use of SMS and Interactive Reminders to Improve Timely Immunization Coverage: A Randomized Controlled Trial
Brief Summary: Pakistan has one of the highest infant mortality rates in the world. One child in eleven dies before their fifth birthday. In part, this is due to the low coverage rate of routine childhood immunizations. Since Pakistan is a Low Middle Income Country (LMIC) it is essential that an immunization intervention be developed that is suitable for its socioeconomic setting. The tele-density of Pakistan exceeds 70% and the cost of SMS in Pakistan is very low. Moreover the use of SMS in the country has broadened beyond the conventional use of peer-peer chat to include social networking, SMS banking, delivery tracking, advertising, business, disaster management, and identity verification. This study will utilise this prevalence of mobile phones to assess whether simple and interactive sms reminders can serve to increase childhood immunization coverage and timeliness.

The pilot study will be carried out only in 2 EPI (Extended program on Immunization) centers at Korangi. The pilot will determine whether automated text messages produce increased immunization coverage in the reminder groups compared to the control group. 656 participants will be enrolled at Penta-1 and will be followed up until measles-2 vaccination. The results of proposed pilot will provide the basis for a large scale-up study in urban and rural settings in Pakistan.


Options:
A: Initiation of Long acting reversible contraception method (6 months)
B: Excessive weight gain (0-6 months)
C: Measles - 2 Completion (When the participants reach 2 years of age)
D: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)

Answer: C