TrialPanorama/Dataset huggingface dataset:
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: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)
C: 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)
D: Measles - 2 Completion (When the participants reach 2 years of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Randomised, Parallel Group Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Relvar/Breo ELLIPTA Therapy, in Asthmatic Subjects With Poor Control
Brief Summary: GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to the subject via an application (app) on smart phone and will be reviewed by the subject's health care professional (HCP) via an online dashboard. The sensors, app, dashboard and systems to provide data comprise the CIS. This study will be the first to evaluate the effect of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers during the run-in period, which may last for up to 3 months. Eligible subjects will then be randomized into five treatment arms depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for the study is approximately 6 months and there will be a follow-up period one week post last visit. The total duration of a subject in the study will be approximately 9 months. RELVAR, BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.


Options:
A: Adherence rate (at three months)
B: Proportion of Days Covered (PDC) (6 months post start of intervention)
C: Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; ("Cohort 1: Data on Maintenance Use Supplied to Participant and HCP" and"Cohort 5: no Data Supplied to Participant or HCP") (Month 4 to Month 6)
D: Asthma Control Test (ACT) (12 month follow-up assessment); Frequency of Urgent Health Utilization (the 12 month study period); 12 Month Rate of Medication Use (Over a 12 month study period); Frequency of Asthma-related Hospitalizations (the 12 month study period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.
Brief Summary: This study evaluates the effect of the medical device "Excilor® Forte" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.


Options:
A: Change from baseline in area of infected nail (9 months)
B: Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail (After 30, 60, 120 and 180 days of treatment)
C: Measurement of Antifungal Activity of Loceryl Nail Lacquer (Week 12)
D: Percentage of patients who achieve clinical cure (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centered Stepped Wedge Cluster Randomized Controlled Trial of the De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle for Ventilated Critically Ill Patients
Brief Summary: The objective of the CHORAL study is to evaluate the de-adoption of oral chlorhexidine and the introduction of a bundle of oral care practices on selected outcomes in critically ill mechanically ventilated adults.


Options:
A: N/A
B: Development of VAP (Clinical Pulmonary Infection Score) (Baseline up to 5 days)
C: ICU-Ecology (27 months)
D: Intensive Care Unit (ICU) Mortality (14 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center, Placebo-Controlled Trial of Oral High-Molecular Weight Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias
Brief Summary: This is a single center, double-blinded, placebo-controlled, randomized Phase II trial to determine whether oral hyaluronic acid will prevent aromatase inhibitor (AI)-associated arthralgias. Subjects must have ER/PR-positive breast cancer tumor with history of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) which resolved after cessation of their AI (anastrazole or letrozole) within 90 days of enrollment. Subjects will be stratified by initial AI, thus within each initial AI, subjects will be randomized to receive either the experimental treatment (hyaluronic acid) or placebo. Subjects will begin the assigned treatment for 2 weeks prior to transitioning to the second AI. Evaluations will be taken at baseline, 6 weeks (1 month on study drug and AI), 14 weeks (3 months on study drug and AI), and at 26 weeks (6 months on study drug and AI). Treatment with hyaluronic acid and placebo will last for 26 weeks total.


Options:
A: Change in pain score based on the Brief Pain Inventory (BPI) (Baseline to up to 6 months)
B: Difference in mean change in joint pain between HA and placebo groups (14 weeks)
C: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
D: Arthralgia incidence, defined as proportion of the baseline population (those who have taken ≥ 9 doses of aromatase inhibitor [AI]) in which new or worsening joint pain or stiffness is observed at 1, 3, and 12 months after beginning AI therapy (12 months); Time to onset of arthralgia (continuous variable in weeks) among baseline population (12 months); Arthralgia point prevalence, defined as proportion of the baseline population with a score of ≥ 2 on any one dimension of the outcome measure at 1, 3, and 12 months after beginning AI therapy (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.


Options:
A: Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
B: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 (Week 12, as compared to Week 0 (baseline))
C: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
D: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.


Options:
A: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 (Week 12, as compared to Week 0 (baseline))
B: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (At Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16 (At Week 16)
C: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R (Week 16 of Period R)
D: Change in Vascular Inflammation (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Total Cholesterol (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Cholesterol Efflux (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Insulin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Adiponectin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Leptin (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log C-reactive Protein (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha (Baseline - Week 12); Change in Cardiometabolic Biomarkers: Log Interleukin 6 (Baseline - Week 12); Change in Cardiometabolic Biomarkers: GlycA (Baseline - Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition, Arsenic and Cognitive Function in Children
Brief Summary: The main goals of this study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). The investigators will also explore whether folate and B12 can mitigate arsenic-related decrements in cognitive abilities.


Options:
A: Change of urine arsenic metabolites between baseline and week 8 (baseline, week 8)
B: Infant Mortality Through 6 mo of Age (6-months post-birth)
C: blood arsenic concentrations (24 weeks)
D: Change in arsenic methylation (Up to 12 Weeks); Change in in blood arsenic (Up to 12 Weeks); Change in blood monomethyl arsenic (Up to 12 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry
Brief Summary: The FinnValve investigators planned a nationwide registry to investigate the early and late outcome of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients with aortic valve stenosis performed from 2008 to 2017 at five Finnish University Hospitals. Data will be collected in a dedicated electronic case report form.


Options:
A: Death (From the index procedure till the end of the follow-up period (December 2017))
B: To demonstrate that daptomycin is not inferior to comparator in the treatment of S. aureus bacteremia and IE as assessed by the Independent External Adjudication Committee (IEAC) Outcome at Test of Cure (TOC) in the Intention-to-Treat (ITT) population.
C: The primary endpoint is a composite endpoint including all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen (Approximately 7 months. From randomisation until 6 months after end of study medication)
D: Proportion of patients with negative blood cultures. (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Psycho-social Support Training by School Teachers on Improving Mental Health and Hope of School Going Adolescents in Earthquake Affected Districts in Nepal
Brief Summary: Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression which could become worse in the aftermath of disasters. However, hope can help adolescents cope with the challenges better. For resource poor disaster prone settings, school teachers can provide timely psycho-social support that could improve mental health and hope among adolescents.

Nepal is a disaster prone country that faced a devastating earthquake in 2015 that claimed thousands of lives and left many homeless which could have affected the mental health of adolescents.This study was conducted in schools of Dhading, a severely earthquake affected district and schools of Myagdi, a least affected district by earthquake in Nepal. The intervention focused on training school teachers on psycho-social support for adolescents.


Options:
A: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
B: children's behavior problems and health (Change from baseline to 6-, 12-, 18-, and 24 month follow up)
C: physical violence (Assessed at 10-week follow-up)
D: Changes in thyroid morphology and thyroid function tests in morbidly obese patients following significant weight loss after bariatric surgery (> 3 month or when relevant weight loss has been achieved)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Psycho-social Support Training by School Teachers on Improving Mental Health and Hope of School Going Adolescents in Earthquake Affected Districts in Nepal
Brief Summary: Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression which could become worse in the aftermath of disasters. However, hope can help adolescents cope with the challenges better. For resource poor disaster prone settings, school teachers can provide timely psycho-social support that could improve mental health and hope among adolescents.

Nepal is a disaster prone country that faced a devastating earthquake in 2015 that claimed thousands of lives and left many homeless which could have affected the mental health of adolescents.This study was conducted in schools of Dhading, a severely earthquake affected district and schools of Myagdi, a least affected district by earthquake in Nepal. The intervention focused on training school teachers on psycho-social support for adolescents.


Options:
A: Patient Health Questionnaire (PHQ-9) (8 weeks); WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (8 weeks)
B: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
C: Change in body pain index using Body Pain Inventory (At recruitment, right before and after the intervention and 12 weeks afterwards); Change in Impact of Events Scale (At recruitment, right before and after the intervention and 12 weeks afterwards)
D: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Psycho-social Support Training by School Teachers on Improving Mental Health and Hope of School Going Adolescents in Earthquake Affected Districts in Nepal
Brief Summary: Adolescents are prone to mental health problems such as post-traumatic stress disorder (PTSD) and depression which could become worse in the aftermath of disasters. However, hope can help adolescents cope with the challenges better. For resource poor disaster prone settings, school teachers can provide timely psycho-social support that could improve mental health and hope among adolescents.

Nepal is a disaster prone country that faced a devastating earthquake in 2015 that claimed thousands of lives and left many homeless which could have affected the mental health of adolescents.This study was conducted in schools of Dhading, a severely earthquake affected district and schools of Myagdi, a least affected district by earthquake in Nepal. The intervention focused on training school teachers on psycho-social support for adolescents.


Options:
A: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
B: Depression - Patient Health Questionnaire (1 week post-intervention)
C: Stunting (One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline); Cognitive function (End line (after one year); Amendment: BSID-III at year two (extension) endline)
D: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. (Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Double Dummy, Randomised, Multicentre, Two Arm Parallel Group Study to Assess the Efficacy and Safety of FLUTIFORM® pMDI (2 Puffs Bid) vs Seretide® pMDI (2 Puffs Bid) in Subjects Aged ≥12 Years With Moderate to Severe Persistent, Reversible Asthma
Brief Summary: A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FLUTIFORM® pMDI (2 puffs bid) vs Seretide® pMDI (2 puffs bid) in subjects aged ≥12 years with moderate to severe persistent, reversible asthma.


Options:
A: The primary efficacy endpoint is the change in pre dose Forced Expiratory Volume in one second (FEV1) from baseline to 2-hours post dose FEV1 at Week 12. (12 weeks)
B: Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry. (12 weeks)
C: Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period (3 weeks)
D: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4) (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices
Brief Summary: Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection


Options:
A: Treatment failure (5 days)
B: N/A
C: Number of patients with controlled bleeding (6 months)
D: Survival (10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study to Describe the Glycaemic Variability of Insulin Glargine 300U/ml Versus NPH (Neutral Protamine Hagedorn) in the Insulin-naïve Type 2 Diabetes Patients Following a Patient-adjusted Insulin Algorithm in Hong Kong
Brief Summary: This is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1) pilot study.The study will compare glycemic variability in patients treated with insulin glargine U300/ml insulin versus conventional (NPH) insulin using a self titration algorithm.50 type 2 diabetes patients who are newly started on insulin will be recruited. They will be randomly allocated to either insulin glargine U300 or NPH insulin for 26 weeks. All subjects will follow a insulin-self titration algorithm. The study will consist of 9 visits over 26 weeks. Blood glucose variability will be collected by CGM for 7 consecutive days at baseline (week -1) and at week 24.Secondary endpoints other than data on glycemic variability, including HbA1c, fasting plasma glucose, inflammatory markers will be measured during three periods (week 0, week 12 and week 24).


Options:
A: Glycemic variability (24 weeks)
B: Weight change (6 months)
C: HbA1c (after 48 weeks of treatment)
D: Body weight loss (after 26 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
Brief Summary: Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.


Options:
A: Cortical oxy-haemoglobin increase (During the procedure)
B: N/A
C: Pain Profile (During the Procedure)
D: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)

Answer: A