TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Repeat Dose, Open Label, Parallel Group, Multi-center Study to Evaluate the Effect of Daprodustat Compared to Darbepoetin Alfa on Forearm Blood Flow in Participants With Anemia of Chronic Kidney Disease That Are Not Dialysis Dependent
Brief Summary: Daprodustat has demonstrated an ability to effectively raise hemoglobin concentrations with lower erythropoietin (EPO) levels than those observed after administration of recombinant human erythropoietin (rhEPOs). Therefore, daprodustat has the potential to treat anemia of chronic kidney disease (CKD) with a lower cardiovascular (CV) risk than is observed with the rhEPOs. While the effect of rhEPOs on endothelial function has been assessed, to date the effect of daprodustat or other prolyl hydroxylase inhibitor (PHI) compounds on endothelial function has not. Therefore, the purpose of this study is to compare the effect of daprodustat to darbepoetin alfa on endothelial function by assessing FBF in participants with anemia of CKD by using venous occlusion plethysmography as a means to estimate the potential for daprodustat to have a lower risk of CV events as compared to rhEPO.

This study will use a randomized, repeat dose, open label, parallel group design, in adult, not on-dialysis, male and female participants with anemia of CKD that are currently not treated with rhEPOs.

The study will comprise of three study periods: a screening period starting up to 30 days prior to Day 1, a 42 day (6 week) treatment period, and a follow-up visit up to 14 days later. The total duration of participants involvement is up to 14 weeks (including screening and follow up visit). Approximately 50 participants will be randomized to either daprodustat or darbepoetin alfa.


Options:
A: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) (Up to 4.3 person-years for CV follow-up time period); Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
B: Change in FBF Ratio in Response to Acetylcholine (Day 1 to Day 42) (Day 1 to Day 42)
C: Rate of rise in Hb (Hemoglobin) level (g/dL/week) (Up to 8 weeks); Responder rate: proportion of responders among the subjects (Week 21 to 24)
D: Change From Baseline in Hemoglobin (Hgb) at Week 4 (Baseline (Week -4, Week-2 and Day 1) and Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Brief Summary: This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.


Options:
A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 up to 28 Days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100))
B: Number of Participants With Treatment Emergent Adverse Events. (84 days of treatment)
C: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 100)
D: Treatment Period: 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 196)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Brief Summary: This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.


Options:
A: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
B: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
C: 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)
D: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 up to 28 Days After Last Dose of Study Drug or to the Completion of Study Participation Date, Whichever Occurs First in the Current Study 659-105 (up to Week 100))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of a Reproductive Life Planning Tool at the Pediatric Well-Baby Visit With Postpartum Women
Brief Summary: Improved access to timely health care and contraception in the postpartum (PP) period is needed to reduce unintended pregnancies and help women achieve desired birth spacing. While the routine 6-week visit has historically been considered the place for women to discuss and receive contraception, many women, particularly low-income women, do not attend the postpartum visit. A novel approach to increasing receipt of PP care and contraception is the adoption of a reproductive life planning tool. Explorations of the use of a self-administered Reproductive Life Plan Tool (RLPT) by pediatricians in the context of the Well-Baby Visit (WBV) with postpartum mothers, holds great promise.

The objective of this study is to determine whether use of a simple self-administered Reproductive Life Plan Tool at the 2-month WBV increases the proportion of postpartum women receiving woman's health care and contraception at 6-months PP, compared to women not exposed to such an intervention. The two specific aims of the project are: 1) To determine if introducing a self-administered Reproductive Life Planning Tool (RLPT) with postpartum mothers during the 2-month WBV will increase the proportion of women receiving a well-woman primary care health visit by 6 months postpartum; and if introducing a self-administered Reproductive Life Planning Tool (RLPT) will increase utilization rates of contraception by 6 months postpartum. 2) To assess patient-, provider-, and systems-level barriers and facilitators to integrating a self-administered Reproductive Life Planning Tool (RLPT) designed to facilitate referral of postpartum women for primary well-woman care in the context of a pediatric clinic.

The investigators hypothesize that exposure to a self-administered RLPT combined with a conversation with a pediatrician during a 2-month WBV will increase use of well-woman primary health care during the postpartum period as well as receipt of contraception, by 6-months postpartum. If successful, the results of this study have great potential to inform clinical and public health practice to increase women's use of health care and contraception in the postpartum period.


Options:
A: Postpartum Clinic Attendance (assessed at 12 weeks postpartum)
B: Change in receipt of primary care services - self report (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection)); Change in receipt of primary care services - EMR review (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection))
C: score on Hospital Consumer Assessment of Healthcare Provers and Systems (HCAPS) survey (2 months)
D: Change in Post-natal depression (6 weeks following child birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Inhaler Technique Education in Elderly Patients With Asthma or COPD: Impact on Disease Exacerbations - a Protocol for a Single-blinded Randomised Controlled Trial
Brief Summary: Introduction COPD and Asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients.

Methods and Analysis A multicentre single-blinded RCT will be set, comparing a placebo-device training programme versus usual care, with a one-year follow-up, in elderly patients with Asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions Chi-squared test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.

Discussion The investigators expect to confirm that inhaler performance education will significantly reduce exacerbation rate and improve clinical and functional control.

Ethics and dissemination:

Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor stop earlier criteria. Identity of all participants will be protected. Results will be presented in scientific meeting and published in peer-reviewed journals.


Options:
A: Number of unscheduled hospital days (up to 12 months)
B: Improvement tolerance capacity (4 months and 6 months)
C: Adverse events (Evaluation at 12 months.)
D: Rate of adherence (2 months and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Inhaler Technique Education in Elderly Patients With Asthma or COPD: Impact on Disease Exacerbations - a Protocol for a Single-blinded Randomised Controlled Trial
Brief Summary: Introduction COPD and Asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients.

Methods and Analysis A multicentre single-blinded RCT will be set, comparing a placebo-device training programme versus usual care, with a one-year follow-up, in elderly patients with Asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions Chi-squared test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.

Discussion The investigators expect to confirm that inhaler performance education will significantly reduce exacerbation rate and improve clinical and functional control.

Ethics and dissemination:

Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor stop earlier criteria. Identity of all participants will be protected. Results will be presented in scientific meeting and published in peer-reviewed journals.


Options:
A: Adverse events (Evaluation at 12 months.)
B: Hospital readmission within 30 days of discharge (30 days)
C: medication(Roflumilas) history taking (16 weeks)
D: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis: A Phase II Randomized Placebo Controlled Trial
Brief Summary: Benralizumab will be used in a placebo controlled randomized study to treat severe chronic rhinosinusitis with nasal polyps


Options:
A: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Week 52); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Week 52)
B: Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 (Baseline, Week 16)
C: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
D: Change in Nasal Polyp Score (Week 5 and Week 25)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: LACunar Intervention (LACI-2) Trial-2: Assessment of Safety and Efficacy of Cilostazol and Isosorbide Mononitrate to Prevent Recurrent Lacunar Stroke and Progression of Cerebral Small Vessel Disease.
Brief Summary: About 35,000 people each year in the UK have a type of stroke, called 'lacunar' or 'small vessel' stroke, which is different to other common types of stroke and for which there is no proven treatment. It is thought that small vessel stroke is caused by damage to the lining of the tiny blood vessels deep inside the brain that stops them functioning normally. This not only causes stroke but, perhaps more importantly, causes problems with thinking and walking, possibly causing up to 45% of all dementias either on its own, or mixed with Alzheimer's disease (about 350,000 patients in the UK). Some drugs that are commonly used in other blood vessel diseases may help improve small vessel function and prevent worsening of brain damage. One drug (cilostazol) has been tested in patients with stroke in the Asia Pacific countries but not on dementia; the other drug (isosorbide mononitrate) is widely used in the UK for heart disease but not stroke. The investigators want to set up a clinical trial to test if the study methods are practical so that patients and trial centres can follow the procedures, and to confirm how many patients have more stroke-like symptoms or experience worsening of their thinking skills. This information is needed to be sure that a very large clinical trial to find out if these drugs can prevent worsening of small vessel disease will be possible.


Options:
A: new silent brain infarctions (24 months)
B: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
C: Feasibility of Phase III Trial (36 months (24 Months Recruitment + 12 months Follow Up))
D: The primary endpoint is death from any cause or incident, dementia or persistent physical disability. (every 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optokinetic Stimulation for the Treatment of Hemispatial Neglect - Safety and Efficacy Studies
Brief Summary: Hemispatial neglect is a disorder where the patient has difficulty attending to objects and information in the left side of space, which occurs following strokes to the right side of the brain. This project is designed to help us understand how optokinetic stimulation treats the symptoms of hemispatial neglect.


Options:
A: Change in Behavioural Inattention Test (BIT) (6 months post intervention)
B: Unilateral neglect (Change of baseline to 3-week and to follow-up at 6-week); Allocentric and egocentric neglect (Change of baseline to 3-week and to follow-up at 6-week); Functional performance related to unilateral neglect (Change of baseline to 3-week and to follow-up at 6-week)
C: Change in Hemispatial neglect scores (After 1 hour of OKS); Change in Hemispatial neglect scores (After 1 hour of OKS); Effect of OKS on vision (After 1 hour of OKS); Effect of OKS on vision (After 1 hour of OKS)
D: Change in Sunnybrook Neglect Assessment Procedure (SNAP) (Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial (CONNECT)
Brief Summary: The purpose of this study is to measure changes in smoking behavior during and following sampling of an e-cigarette product. E-cigarettes are classified by the US Food and Drug Administration (FDA) as a tobacco product, though they contain no tobacco. Unlike regular cigarettes, which are burned (creating smoke that is inhaled), e-cigarettes include a heating element that vaporizes nicotine. E-cigarettes are likely much safer than conventional cigarettes, but they may not be entirely safe. We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette manufacturer provides support of any kind to this study. There is no requirement to quit smoking in this study, nor is there any requirement to use e-cigarettes.


Options:
A: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
B: E-cig Use at End of Sampling Period (at week 4)
C: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
D: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Music Intervention for Agitation Reduction in the Pediatric Intensive Care Unit
Brief Summary: The objective of this study is to administer music therapy to patients in the pediatric intensive care unit (PICU) in order to observe how music affects patient agitation, vital signs, and overall recovery in the unit.


Options:
A: delirium outcome (duration of ICU stay(average duration 5 days))
B: Average Daily Dexmedetomidine mcg/kg/Day (from time of first acupuncture/sham treatment till time of extubation); Average Daily Morphine Equivalents (mg/kg/Day) (from time of first acupuncture/sham treatment till time of extubation); Average Daily Midazolam Equivalents (mg/kg/Day) (from time of first acupuncture/sham treatment till time of extubation); Average Daily Sedation Score (from time of first acupuncture/sham treatment till time of extubation)
C: Richmond Agitation-Sedation Scale (RASS) (3 days)
D: Acceptability and feasibility of the comfort intervention (Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intrauterine Insemination With Letrozole Versus Intrauterine Insemination in Natural Cycle. A Randomised Controlled Trial
Brief Summary: Rationale: Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, investigators found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. Investigators therefore perform a randomized clinical trial (RCT) on the subject in the Centre of Reproductive Medicine, Peking University Third Hospital, Beijing, China.

Objective: To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment.

Study design Randomized clinical trial.

Study population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI.

Intervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3-5 for 5 days. Investigators will treat the couples for 3 cycles, with a time horizon of 4 months.

Main study parameters/endpoints Primary outcome is ongoing pregnancy leading to live birth. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications and patients' costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future subfertile couples.


Options:
A: Ovulation Rate (3 months)
B: ongoing pregnancy (3 months)
C: Live birth rate (Up to 14 months)
D: Ovulation Occurence (12 weeks); Ovulation Frequency (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up of Patients Treated in VeClose Study (Five Years)
Brief Summary: The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).


Options:
A: Generic Quality of life - Short Form-36 (1 week, 6 weeks, 3 months, 1 year, 2 years)
B: Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585). (5 years)
C: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)
D: Ulcer Healing - 12 w (12 weeks); Ulcer Healing - 24 w (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up of Patients Treated in VeClose Study (Five Years)
Brief Summary: The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).


Options:
A: Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks. (52 weeks)
B: Comparative Duplex Ultrasound (Immediately Post-procedure)
C: long-term QoL follow-up of patients after UGFS and surgical stripping (6-10 years follow-up)
D: Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585). (5 years)

Answer: D