TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Compliance and Usability of the Nexus (S9) CPAP System in Sleep Disordered Breathing
Brief Summary: Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve the comfort of the delivered air and to alleviate nasal dryness/congestion.

The latest design of a CPAP device, known as Nexus (S9), encompasses new features including an improved humidification system (heated tube and climate control), reduced noise, improved comfort of breathing, and a new user interface.

This study will assess whether compliance on CPAP therapy is improved on the Nexus (S9) CPAP, and will assess the usability of the Nexus (S9) CPAP


Options:
A: Apnea-Hypopnea Index (Baseline and 180 Days)
B: subjective sleepiness and other OSAS symptoms (3 months, 1 year, 2 years); quality of life (3 months, 1 year, 2 years); percentage of withdrawal and cross-over to other CPAP mode (3 months, 1 year, 2 years); objective vigilance (3 months, 1 year, 2 years); blood pressure (3 months, 1 year, 2 years); cost/utility ratios (3 months, 1 year, 2 years)
C: Compliance on CPAP (12 weeks)
D: proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Music as an Auxiliary Analgesic and Anxiolytic During First Trimester Abortion
Brief Summary: Most first trimester abortions are performed under local anesthesia using either manual or electric vacuum suction aspiration. The majority of women undergoing these procedures experience some amount of pain and anxiety. The investigators seek to understand if the provision of music during first trimester abortion will reduce pain and anxiety associated with this procedure. This study will involve the use of music during first trimester abortion as an additional method of pain and anxiety control. The investigators will recruit women seeking a first trimester suction aspiration procedure primarily for elective pregnancy termination or for other related indications such as an abnormal pregnancy, inevitable abortion, or retained products of conception. Participation will be voluntary and include informed consent. Recruited women will be divided into two groups: control group (no music) and intervention (music) group. All subjects will receive routine care and standard pain control measures, including local anesthesia, during their procedure. Those assigned to the intervention group will receive a portable digital music player (iPOD™ Nano) with headphones to listen to during their procedure. All subjects will complete preoperative and postoperative pain and anxiety questionnaires in addition to a patient satisfaction survey at the end of their visit. The provider will also assess and record the subject's pain experienced during the procedure. The investigators will also measure preoperative and postoperative vital signs on all participants. Subjects will be compensated for their time and study participation will not affect any care received at the clinic. Upon completion of their visit, there will be no additional followup for this study.


Options:
A: Pain and anxiety experienced during first trimester abortion. (1 day. Outcome measured immediately after procedure without additional follow-up.)
B: Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale (At time of cervical dilation, 30 minutes after lidocaine administration)
C: Level of Pain During Specific Time Intervals Throughout D&C Procedure. (Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure)
D: Pain at Time of Uterine Evacuation (During the procedure on Study Day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double Blind, Factorial Design, Phase IV Trial to Compare the Efficacy and Safety of Cilostazol Long-term Treatment With Aspirin in Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage for the Prevention of Cerebral Hemorrhage and Cardiovascular Events and to Compare the Preventive Effect of Probucol in the Same Patient Group With Non-drug User Group for the Prevention of Cardiovascular Events
Brief Summary: Through this study, the investigators are to prove that Cilostazol effectively prevent cardiovascular events in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects.

The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the risk of cerebral hemorrhage without increase of cardiovascular events compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.

This study will prove the superiority of cilostazol on the prevention of cerebral hemorrhagic events without increasing the cardiovascular events against aspirin and the superiority of probucol on the prevention of overall cardiovascular events.


Options:
A: Composite of all fatal or non-fatal major cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events (within 24 months after randomization.)
B: Time to the first occurrence of cerebral hemorrhage (time since randomization; follow-up period is 1.0 to 5.5 years); Time to the first occurence of composite cardiovascular events (time since randomization; follow-up period is 1.0 to 5.5 years)
C: Combined endpoint: stroke OR systemic cardioembolic event OR clinically significant bleeding OR cardiovascular death OR procedure or device-related complications (From the date of randomization until the date of 6 month follow-up visit of the last enrolled patient)
D: BP Study: Efficacy (3 months from randomisation); BP Study: Feasibility (3 months from randomisation); BP Study: Safety (3 months from randomisation); Imaging Study: Efficacy (12 months from randomisation); Imaging Study: Safety (12 months from randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Developmental and Augmented Intervention for Facilitating Expressive Language
Brief Summary: This study will contrast two experimental treatment conditions by testing whether joint attention/joint engagement intervention using spoken communication (JAE-EMT) results in better outcomes than joint attention/joint engagement intervention that is instead supplemented with an individualized AAC system (JAE-AAC). Thus, the skills of joint attention/joint engagement (JAE) remain foundational to developing expressive language but the difference in the two treatments will be between whether the JAE is administered through the more traditional spoken means (EMT) or through an augmentative and alternative communication device (AAC).


Options:
A: Reduction in autism severity as measured by the Autism Diagnostic Observation Scale (ADOS) (1 year)
B: Behavioral profiles (6 to 12 months); Immune markers (6 to 12 months); Sleep/EEG findings (6 to 12 months); Neuroimaging findings (6 to 12 months); Other laboratory findings (6 to 12 months); Genetic abnormalities (6 to 12 months)
C: Number of words used spontaneously during language sample (3 months)
D: Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks (Baseline, 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Brief Summary: The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation group, and Amiodarone group. All patients were scheduled followed up before discharge and at 3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour Holter and transthoracic echocardiography were used to determine the rhythm and cardiac hemodynamic status.


Options:
A: At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography (1 year)
B: Freedom From Atrial Fibrillation (Measured at Month 12)
C: Rate of Device Related Serious Adverse Events (Discharge/30 days Post Procedure); Percent of Patients With Complete Occlusion of the Left Atrial Appendage. (3 Months Post Procedure)
D: Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points. (Baseline, 3, 6, and 12 months after operation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer
Brief Summary: This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.


Options:
A: Progression Free Survival (PFS) in the Randomized Phase (From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks))
B: Recurrence-free survival
C: Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone (Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months)
D: Rate of pathological complete remissions (20 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Partner Assistance in Learning and Performing Skin Self-Examination
Brief Summary: This study is a behavioral science study designed to identify aspects of the dyadic relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing melanoma. The patient is randomized to receive the educational intervention either as a solo learner or with the partner.


Options:
A: Decisional Conflict in Patients With Diabetes (This outcome is measured at 0, 6 and 12 months.)
B: Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits (6 months following intervention a chart audit will be conducted to determine if CRCS was completed.)
C: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
D: Mean Number of Skin Examinations Without Partner Over 4 Months (4 months); Mean Number of Skin Examinations With Partner Over 4 Months (4 months); Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating to Target for Patients With Hypertension
Brief Summary: Patients with poorly controlled hypertension will have improved hypertensive control with telephone coaching and with telephone coaching combined with home-titration of medications.


Options:
A: N/A
B: Systolic blood pressure (6 months)
C: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)
D: - unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months; - lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months; -health care visits for HIV primary care in the past 6 months; -90% or more adherence to HIV medication yesterday and in the past week

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]
Brief Summary: The purpose of this study is to see if a computer counseling tool helps Spanish-speaking people living with HIV to have safer sex and to do well on their HIV medicines.


Options:
A: New Advance Care Planning Documentation in the Medical Record at 15 Months (15 months after study enrollment)
B: Body weight (4 months); Physical activity (4 months); Caloric intake (4 month)
C: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months (6 and 12 months)
D: ART adherence (Every 3 months up to 12 months); HIV-1 viral load (Every 3 months up to 12 months); Sexual risks (Every 3 months up to 12 months); Clinic visit adherence (Every 3 months up to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevalence of Chronic Airway Onstruction in a Subject Population With a History of Cigarette Smoking in a Primary Care Setting
Brief Summary: This is a cross-sectional study to determine the prevalence of symptomatic airway obstruction using the LFQ as a screening tool in primary care patients with a history of cigarette smoking and to provide descriptive data of this patient population. The study design is multicenter, cross-sectional, and involves a single visit. This study is not intended to evaluate the efficacy or safety of any investigational products. Following completion of written informed consent, eligible study subjects will complete a single study visit encompassing all required study assessments. Study subjects will not receive blinded study medication for evaluations of efficacy and safety.

All eligible patients will complete a self-administered Web survey that will include the LFQ. To meet both the primary and secondary aims, all patients with LFQ ≤ 18 (current cut-off for obstruction), as well as 5% of patients who score \> 18, will be candidates for spirometric assessment. Only this subset of patients will undergo pulmonary function tests. Albuterol will be self-administered for determination of post-bronchodilator forced expiratory volume in one-second (FEV1)/forced vital capacity (FVC) ratio and post-bronchodilator FEV1 percentage of predicted normal. The study will end when 800 patients have been assessed spirometrically or 3,000 patients have completed the LFQ (whichever criterion is achieved first).

Prior to implementation of the full study, a pilot study will be conducted at two of the chosen study sites to pretest the proposed study procedures.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
B: AUC (0-4hrs, sGAW after morning dose of medication at day 14)
C: Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination (2 weeks)
D: The primary outcome for this study will be the proportion of subjects at risk for airway obstruction as measured by the LFQ (LFQ total score ≤ 18) and confirmed by spirometry. (4-Month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevalence of Chronic Airway Onstruction in a Subject Population With a History of Cigarette Smoking in a Primary Care Setting
Brief Summary: This is a cross-sectional study to determine the prevalence of symptomatic airway obstruction using the LFQ as a screening tool in primary care patients with a history of cigarette smoking and to provide descriptive data of this patient population. The study design is multicenter, cross-sectional, and involves a single visit. This study is not intended to evaluate the efficacy or safety of any investigational products. Following completion of written informed consent, eligible study subjects will complete a single study visit encompassing all required study assessments. Study subjects will not receive blinded study medication for evaluations of efficacy and safety.

All eligible patients will complete a self-administered Web survey that will include the LFQ. To meet both the primary and secondary aims, all patients with LFQ ≤ 18 (current cut-off for obstruction), as well as 5% of patients who score \> 18, will be candidates for spirometric assessment. Only this subset of patients will undergo pulmonary function tests. Albuterol will be self-administered for determination of post-bronchodilator forced expiratory volume in one-second (FEV1)/forced vital capacity (FVC) ratio and post-bronchodilator FEV1 percentage of predicted normal. The study will end when 800 patients have been assessed spirometrically or 3,000 patients have completed the LFQ (whichever criterion is achieved first).

Prior to implementation of the full study, a pilot study will be conducted at two of the chosen study sites to pretest the proposed study procedures.


Options:
A: Percentage of Participants Who Were Able to Remain on the Randomized Treatment (24 weeks)
B: Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint (Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant))
C: The primary outcome for this study will be the proportion of subjects at risk for airway obstruction as measured by the LFQ (LFQ total score ≤ 18) and confirmed by spirometry. (4-Month)
D: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose (Baseline to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Recruitment Maneuver Increases Oxygenation After Intubation in Hypoxemic ICU Patients: a Randomized Controlled Study
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver immediately after intubation in hypoxemic patients.


Options:
A: Development of ARDS (28 days)
B: Oxygenation (PaO2) measured 5 min after the onset of mechanical ventilation (5 min after the onset of mechanical ventilation)
C: Hospital Mortality
D: 60 day mortality (60 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment
Brief Summary: The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.


Options:
A: Time to Loss of Therapeutic Response (LTR) (From baseline Visit 3 (week 5) to Visit 7 (week 17))
B: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)); Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 (7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d))
C: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
D: Composite responder analysis based on pain and patient global status, with or without physical function.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment
Brief Summary: The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.


Options:
A: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
B: Time to Loss of Therapeutic Response (LTR) (From baseline Visit 3 (week 5) to Visit 7 (week 17))
C: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
D: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Single Intravenous Dose, Ascending Dose Level Study of the Safety, Tolerability and Pharmacokinetics of GLYX-13 in Normal Healthy Volunteers
Brief Summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single IV dose of GLYX-13, an N-Methyl-D-aspartate (NMDA) receptor glycine site functional partial agonist, in normal, healthy human volunteers.


Options:
A: Panel A and B: Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Day 8- Analysis of Covariance (ANCOVA) Analysis (Baseline (Day 1) and Endpoint (Day 8) of Period 1); Panel A and B: Change From Baseline (Day 8) in Montgomery Asberg Depression Rating Scale Total Score at Day 15- ANCOVA Analysis (Baseline (Day 8) and Endpoint (Day 15) of Period 2)
B: Observed and laboratory-confirmed safety (four weeks)
C: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) (Up to 7 days following the last dose of study drug (Up to 23 days)); Part 1: Number of Participants With Serious Adverse Events (SAEs) (Up to 30 days following the last dose of study drug (Up to 46 days)); Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 16 days)); Part 2: Number of Participants With AEs (Up to 7 days following the last dose of study drug (Up to 35 days)); Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 28 days))
D: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (Baseline to week 3)

Answer: B