TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS
Brief Summary: Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2) quality of life will be rated higher in the varenicline and counseling group versus the placebo and counseling group, and there will be no significant differences between treatment arms in terms of the frequency of severe varenicline-related side effects; and 3) improved affect and reduced cognitive impairment will mediate the effect of varenicline therapy on quit rates.


Options:
A: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
B: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
C: Point Prevalence Tobacco Abstinence (Week 12); Point Prevalence Tobacco Abstinence (Week 24)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Brief Summary: A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.


Options:
A: Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment (12 months)
B: BCVA in EDTRS values (24 months)
C: Absence of subretinal fluid on OCT scan (6-8 weeks after treatment)
D: Safety of Intravitreal Aflibercept Injection (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
Brief Summary: One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS in resource-constrained settings is the failure of ART-eligible patients to complete the steps required to initiate treatment. The high rate of loss to care of patients who are treatment-eligible at HIV diagnosis may be due in part to the large number of steps required between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In South Africa, these steps usually require approximately four clinic visits over a period of 2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses among those eligible for ART is to simplify and condense the steps required for starting treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and tuberculosis (TB) diagnosis are available. These technologies can be combined with changes to clinic schedules to allow all steps required for ART initiation under South African guidelines (lab tests, physical exam, education) to take place on the day the patient presents for an HIV test.

This study is a randomized strategy evaluation of the feasibility, effectiveness, and cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults who come to a South African clinic for an HIV test, consent to study participation, and are eligible for ART will be randomized 1:1 to rapid ART initiation or to standard care. Those who are assigned to rapid ART initiation will have the possibility of receiving their first dose of ARVs as early as the same day, while those who are assigned to standard care will follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive pregnant women, which has recently become the standard of care in South Africa, will also be assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a retrospective comparison group. The primary study outcome for non-pregnant adults will be remaining alive, in care and virally suppressed 10 months after having a positive HIV test at the study site or making a first HIV-related visit. The primary study outcome for pregnant women will be adherence to ART until delivery. The cost effectiveness of the rapid initiation strategy will be assessed as the cost per patient achieving the primary outcome for each population.


Options:
A: Survival rate (At the end of the study)
B: Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. (1 month and 12 months after testing)
C: Survival (At 36 months)
D: Proportion non-pregnant subjects virally suppressed at routine six-month viral load (10 months after study enrollment); Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery (Up to 9 months after study enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Brief Summary: The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis


Options:
A: Percent Coefficient of Fat Absorption (CFA%) (Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods)
B: To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%) (72 hrs)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Coefficient of Fat Absorption over 72 hours (CFA-72h) (72 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Brief Summary: The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis


Options:
A: Coefficient of Fat Absorption (%) (5 days)
B: Incremental gain in weight, length, and head circumference (one year)
C: To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%) (72 hrs)
D: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Brief Summary: The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis


Options:
A: Second-phase insulin response during GPA test (5 hours)
B: Coefficient of Fat Absorption over 72 hours (CFA-72h) (72 hours)
C: Coefficient of Fat Absorption (%) (5 days)
D: To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%) (72 hrs)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man
Brief Summary: The purpose of this study is to compare three treatments to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.


Options:
A: Change in BMI from baseline (18 months and 36 months); Change in Insulin resistance from baseline (3; 6; 9; 12; 15; 18; 24; 30 and 36 months)
B: Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine. (28 weeks)
C: N/A
D: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (From randomization up to 6 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Upper Trapezius Myofascial Trigger Points- a Randomized Intervention Study
Brief Summary: In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.


Options:
A: muscle contractility (30 minutes)
B: Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks) (pretreatment, postreatment and follow-up(15 days))
C: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)
D: Immediate reduction in pain intensity (at ED discharge (within 3 hours from ED admission))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Telemedicine Follow-up Care in Primary Health Care Versus Traditional Follow-up in Specialist Health Care on the Healing Time for Diabetes-related Foot Ulcers - a Cluster-randomized Controlled Trial
Brief Summary: This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.


Options:
A: Intervention-related adverse events (1 day)
B: Number of participants that stay in Canadian Cardiovascular Society (CCS) Functional Classification of Angina I and II as a measure of safety (within one year after discharge)
C: healing time for leg ulcer and/or diabetes related foot ulcer (one year)
D: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Telemedicine Follow-up Care in Primary Health Care Versus Traditional Follow-up in Specialist Health Care on the Healing Time for Diabetes-related Foot Ulcers - a Cluster-randomized Controlled Trial
Brief Summary: This study will investigate whether telemedicine follow-up care for people with diabetes-related foot ulcers and people with leg ulcers (without diabetes) in municipal primary health care in collaboration with specialist health care is an equivalent alternative to traditional outpatient clinical follow-up in specialist health care (noninferiority trial) in relation to healing time.


Options:
A: Acceptability and utility of the ProAsk intervention (12 months)
B: delayed bathing of baby (24 months)
C: Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence (Day 1); Patient discussion on mental health (Day 1)
D: healing time for leg ulcer and/or diabetes related foot ulcer (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management
Brief Summary: Randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard laryngoscopy. Patients who are going to be intubated using standard laryngoscopy will be randomized to have their first intubation attempt done using either standard laryngoscopy or the C-MAC video laryngoscope. Subsequent attempts will be at the discretion of the treating physician.


Options:
A: First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device. (During intubation procedure up to 1 hour); Time to Intubation (From the time the first device entered the patients mouth until successful intubation up to 1 hour)
B: CERVICAL MOTIONS (January 2011 and December 2012)
C: Required dose of opioid to counteract nociceptive stimulation (1 hour)
D: Success Rate (10 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic Treatment: a Non-interventional, Observational Study.
Brief Summary: This non-interventional, observational study evaluates the efficacy of Targinact with regard to quality of life in daily clinical practice in Belgium compared to the previous analgesic treatment.


Options:
A: Assess the efficacy of Targinact® treatment (12 weeks)
B: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
C: Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. (2 weeks)
D: Rescue-free laxation response (Within 4 hours after at least 2 of the first 4 doses (the first week of treatment).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic Treatment: a Non-interventional, Observational Study.
Brief Summary: This non-interventional, observational study evaluates the efficacy of Targinact with regard to quality of life in daily clinical practice in Belgium compared to the previous analgesic treatment.


Options:
A: Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3) (4weeks)
B: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
C: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
D: Assess the efficacy of Targinact® treatment (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Brief Summary: To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.


Options:
A: Occurrence (yes or no) of agitation-related adverse events (at the end of treatment (22 days max))
B: Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 (Baseline and month 6)
C: alcohol consumption (12 weeks)
D: Total alcohol abstinence; cumulative abstinence duration (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Brief Summary: To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.


Options:
A: Total alcohol abstinence; cumulative abstinence duration (12 weeks)
B: Change in Average Daily Alcohol Consumption (Change from Baseline to 6 Months)
C: Total abstinence from alcohol and cumulative abstinence duration (13-16 weeks (depending on the individually tolerated baclofen dose))
D: alcohol consumption (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Observational Study of Male Circumcision Using the PrePex Device in Routine Clinical Settings in Kenya
Brief Summary: The study will measure the incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment. To assure complete ascertainment of AEs, study-specific forms will be used to collect standardized data from the circumcision visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will revert to routine practice (two follow-up visits) for the remaining 375 cases.


Options:
A: Procedure time (9 weeks)
B: HIV incidence (2 years); surgical complications (2 years)
C: The incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment. (42 days)
D: Measure the protective effect of medicalized male circumcision on HIV infection (M3, M12 and M21)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial on the Effects of Recreational Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy: The FC Prostate Study
Brief Summary: Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced Prostate Cancer (PC).

The musculoskeletal toxicity associated with ADT is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.

Numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer.

Within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health.

It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of PC patients receiving ADT treatment.


Options:
A: bone health (baseline, 12 months)
B: Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. (Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
C: Change in Physical activity Levels From Baseline to Month 1 and Month 3 (baseline, 1 month, 3 months)
D: Change in QoL between baseline and postintervention. (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Brief Summary: The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.

The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.


Options:
A: Lumen Late Loss (9 months)
B: MACE (12 months)
C: Three groups of stents implanted in patients with acute coronary syndrome (stent-graft, sirolimus and bare metal), did not differ regarding the incidence of major adverse cardiac events.
D: to determine the efficacy of paclitaxel eluting stent compared to conventional bare stent in terms of restenosis (12 months); to determine the effect of tirofiban administered prior to PCI but 120 minutes after thrombolytic on the epicardial and myocardial flow after mechanical revascularization in patients with STEMI (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study
Brief Summary: The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.


Options:
A: Superiority is defined as a statistically greater reduction of the mean change from baseline to endpoint (after 12 weeks of treatment) in the Liebowitz Social Anxiety Scale (LSAS) total score.
B: Change in Liebowitz Social Anxiety Scale (LSAS) - total score (Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks)
C: Subjective Unit of Discomfort Scale (Once before and again 10 minutes after intranasal dosing with PH94B spray, during exposure to a public speaking challenge)
D: To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.

Answer: B