TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use
Brief Summary: The specific aim of this pilot study is to estimate the impact of a new digital health service on the uptake of family planning among Kenyan women with an unmet need for contraception. Enrolled women will be randomized to a control arm or an encouragement arm that will receive a special invitation to try the new service.


Options:
A: MV Coverage at 12 months of age (12 months of age)
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: To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. (at participant post-partum visit)
D: Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study (4-months post-encouragement)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial
Brief Summary: Participants will be recruited for inclusion at a routine adjustment appointment prior to planned removal of the appliances. Following removal of the appliances, consenting participants will be randomly allocated to one of two groups by computer-generated random allocation. Allocation will be concealed from the treating clinician using of an opaque sealed envelope system. Standard stone model records will be available for all participants following removal of the appliances (T0).

Participants in both groups will have follow-up scheduled for 3 (T1), 6 (T2) and 12 (T3) months following removal of the braces. All participants will be instructed to wear standard clear, plastic (Essix-type) retainers on a full-time basis for 6 months, followed by night-time wear for a further 6 months. A micro-electronic timer will be integrated within the upper Essix-type retainer. All participants will be given standard advice at each recall visit.

Participants in the intervention group will receive tailored electronic reminders in the form of a mobile application. The frequency and content of the reminders will be informed by qualitative interviews involving participants from an allied trial, and from posts related to orthodontic retainers shared on social media. Instructions on the necessary duration of retention, maintenance of retainers, departmental details, allied to advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear will be included. Also, information related the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application. Participants in the control group will not receive additional reminders. Treating clinicians will be kept blind to the study group.

All patients failing an appointment will be sent another. Those wishing to withdraw from the trial may do so at any point without affecting continuing care with records taken at the point of withdrawal from the study with data analysis on an intention to treat basis.

Thereafter, patient experiences with electronic reminders will be evaluated on a subset of participants using one-to-one interviews.


Options:
A: Stability (From debonding (T1), and after 6, 12, 24, 36 and 60 months in retention phase (T4, T5, T6, T7, and T8 respectively))
B: Compliance of retainer wear (3 months)
C: Changes in Tooth Position (Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1))
D: Wear of removable retainer per day (hours) in the intervention and the control groups (3 months - 6 months - 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis : A Single-blind Randomized Controlled Trial.
Brief Summary: Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.


Options:
A: Numeric Rating Scale (NRS) (6 months); Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up. (6 months and 12 months)
B: Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline (Baseline (Day 1)); Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12 (Month 12)
C: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months post-intervention (6 months post-intervention.)
D: pain assessment by VAS scale (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Trial on Efficacy and Safety of a Formula Salt With Very Low Sodium (Manlikang) in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension in Community
Brief Summary: This study is a single arm trial with before-after comparison design. Three groups of patients with hypertension will be recruited: not taking antihypertension drugs and having normal renal function, taking antihypertension drugs and having normal renal function, and having abnormal renal function without regards of antihypertension drugs use. Each group includes 30 patients. Based on renal function test, the investigators provide the Manlikang containing potassium chloride to patients with normal renal function, and provide the Manlikang not containing potassium chloride to patients with abnormal renal function. All hypertension patients will use the formula salt with very low sodium (Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks. The primary outcome will be the decrease of patients' systolic blood pressure at the end of the trial.


Options:
A: Systolic Blood Pressure (three months)
B: Stroke (5 years)
C: Absolute difference between systolic blood pressure values determined with an oscillometric cuff device and an iPhone 4s (Delta mmHg) (1 day)
D: the change of systolic pressure (baseline and 6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Brief Summary: This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).


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: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)
C: Absolute Change in Lung Clearance Index 2.5 (LCI2.5) Through Week 8 (From baseline through Week 8)
D: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Brief Summary: This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).


Options:
A: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)
B: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
C: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
D: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Brief Summary: This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).


Options:
A: Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in treatment period up to safety follow-up (up to 28 days)); Parts D, E and F: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose of study drug in TC treatment period up to 28 days after last dose of study drug (up to 5 weeks)); Part D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part E: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29); Part F: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline through Day 29)
B: Maximum Observed Concentration (Cmax) of VX-659, TEZ, and IVA (Day 1 and Day 15); Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, and IVA (Day 8 and Day 15); Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of VX-659, TEZ, and IVA (Day 1 and Day 15)
C: Part A: Observed Plasma Concentrations From 3-4 Hours (C3-4hr) of LUM and IVA (Day 1 and Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of LUM and IVA (Pre-dose at Day 8 and Day 15); Part B : Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 26)
D: Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites (From Day 1 through Day 15); Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Day 43); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Canadian Study on the Association of Pessary With Progesterone
Brief Summary: Prematurity is the leading cause of neonatal morbidity causing more than 1 million deaths worldwide per year. In 2012, a randomized controlled trial (RCT) testing "pessary" (silicone ring placed around the cervix) versus "no pessary" in patients with a short cervix showed a 4-fold reduction in the rate of spontaneous prematurity \<34 weeks of gestation and a reduction in perinatal morbidity and mortality. This result was not found in a subsequent RCT and another study on the subject had to be stopped in the face of slow recruitment. Currently, the obstetric scientific community believes that other RCTs are needed before using the pessary in the clinic as a therapeutic option to prevent prematurity in the presence of a short cervix. However, before starting a large RCT, it is important to test the feasibility of recruitment.


Options:
A: Spontaneous delivery before 34 completed weeks (Each 6 months)
B: Recruitment feasibility (Up to 24 weeks (18 to 42 weeks of gestation))
C: Child's birth and survival（rate） (34+0 weeks)
D: preterm birth before 34 weeks of gestation rate in singleton pregnancies (up to 20 weeks from recruitment); preterm birth before 32 weeks of gestation rate in twin pregnancies (up to 20 weeks from recruitment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
Brief Summary: This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.


Options:
A: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)
B: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
C: Composite of Safety and Effectiveness (3 months)
D: The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
Brief Summary: This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.


Options:
A: Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups (6 months post randomization)
B: To investigate if typical abdominal pain of IBS can be ameliorated by SCS? (According to protocol for 26 weeks)
C: Composite of Safety and Effectiveness (3 months)
D: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
Brief Summary: This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.


Options:
A: Responder Rate (3 months post-activation)
B: Usual pain intensity in lower extremity(ies) (Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
C: Composite of Safety and Effectiveness (3 months)
D: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Anesthesia Management in Endovascular Therapy for Ischemic Stroke: A Multicenter Randomised Study
Brief Summary: Objective of the study: to assess whether pharmacological sedation or general anesthesia for treatment of anterior circulation ischemic stroke with endovascular mechanical thrombectomy is associated with difference in morbidity (neurological outcome and peri-procedural complications).


Options:
A: composite of functional independence at 3 months and absence of medical complication occurring by day 7 after endovascular therapy for anterior circulation AIS (Day 90)
B: Growth of DWI lesion (48-72 hours)
C: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
D: Score on the modified Rankin scale (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)
Brief Summary: This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled safety and efficacy study. Blood samples will be collected from a subset of enrolled study participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will be followed for primary and secondary outcomes for the duration of their hospitalization. Serious study drug-related adverse events will be collected for 7 days after the last dose of study drug.


Options:
A: Incidence of Low Cardiac Output Syndrome (LCOS) (first 48 hours after cardiac intensive care unit (CICU) admission post-op)
B: Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery. (36 hours)
C: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
D: Number of Participants at Each Global Rank Endpoint Based Upon Their Most-severe Outcome (Until hospital discharge, up to 4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #599 - Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)
Brief Summary: The goal of the proposed study is to determine whether a liberal transfusion strategy (transfusion trigger at Hb \< 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb \< 7 gm/dl).


Options:
A: A Composite of In-hospital Postoperative Morbidity and Mortality (After surgery until hosptal discharge)
B: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)
C: Mortality (90 day)
D: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. (90 days after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #599 - Transfusion Trigger After Operations in High Cardiac Risk Patients (TOP)
Brief Summary: The goal of the proposed study is to determine whether a liberal transfusion strategy (transfusion trigger at Hb \< 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb \< 7 gm/dl).


Options:
A: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
B: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. (90 days after randomization)
C: Postoperative Functional mobility; Restricting factors for functional mobility
D: Hemoglobin difference (14 days)

Answer: B