TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients
Brief Summary: The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).


Options:
A: Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria (From Day 1, first dose to end of Week 12)
B: Recurrence Free Survival (RFS) (From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.)
C: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
D: Progression Free Survival (PFS) (Baseline up to 36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial on Comparison of Cervical Spine Motion During Tracheal Intubation Using Direct Laryngoscope Versus C-MAC Videolaryngoscope in Simulated Immobilized Cervical Spine
Brief Summary: The aim of the study is to compare the effect of the C-MAC videolaryngoscope intubation technique vs. the conventional direct laryngoscope intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.


Options:
A: Intubation Time (At intubation)
B: Proportion of successful orotracheal intubation at first laryngoscopy (intubation procedure, an expected average of 15 minutes)
C: Required dose of opioid to counteract nociceptive stimulation (1 hour)
D: Maximum cervical spine motion (degree) (During tracheal intubation time, an expected average of 90 seconds)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility & Effect of a Tele-rehabilitation Program for Chronic Obstructive Pulmonary Disease vs. Standard Rehabilitation
Brief Summary: Introduction In order to guarantee chronic patients and elderly a high quality service from health care organizations in the coming decades, new technologies have been implemented to treat patients from a distance. There is still a need for more studies on the efficacy and cost-effectiveness of tele-rehabilitation (TR) and its long-term effects needs also to be determined. To guarantee individuals with chronic obstructive pulmonary diseases (COPD) a high quality service from health care organizations in the coming decades and economically save the national health systems for an expensive bill for the treatment of COPD, new actions plans has to be taken into use. Hereby, more patients can be treated with less human resources while still sustaining or even improving today's services. The importance of such welfare action plans has to maintain a high quality of service that individuals with COPD are willing to accept. Here, TR seems to be a good welfare action plans. Despite proof of improved cost-effectiveness, no studies support the benefits of TR in COPD patient with respect to adherence, security, treatment efficacy and improved quality of life.

Aim To assess and compare the feasibility and effect of a tele-rehabilitation program with a new and innovative TR platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with COPD.

Method and material The study is a prospective randomized controlled trial comparing the effects of tele-rehabilitation and conventional rehabilitation in patients with severe COPD. 54 patients fulfilling the inclusion criteria will be randomized in two groups to either a 8 week tele-rehabilitation program or a conventional COPD rehabilitation program at the hospital. Participants will be tested at baseline, 8 weeks, 3 and 6 months after cessation of the training programs. In the intervention group, a real- and a virtual physiotherapist agent will facilitate the rehabilitation.

Ethical considerations This study will not pose any risk to the patient as compared to current practice. Participation is voluntary and the patient may at any time withdraw from the study without consequences for future care or treatment. The questionnaires and the test methods used are clinically recognized instruments. Signed informed consent will be obtained from the all participants after verbal and written information and before the study starts. The study will not be initiated before approval from the Ethics Committee and the Data Protection Agency has been obtained. The study will follow the general research ethical rules as expressed in the Helsinki Declaration II.


Options:
A: 6 minute walk test (measured at week 8)
B: 6 Minutes Walk Test (9 weeks)
C: Steps per day as mean over one week from baseline until the treatment end (Every day for 6 months)
D: Daily number of steps (changes from baseline to 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol
Brief Summary: This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.


Options:
A: Quit Rate (4 months)
B: Number of Participants With Smoking Cessation (12 WEEK)
C: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
D: smoking cessation (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol
Brief Summary: This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.


Options:
A: Toxicant Exposure (6 weeks)
B: Number of Participants With Smoking Cessation (12 WEEK)
C: Acute electronic cigarette vaping effects on arterial stiffness. (7 minutes); Acute electronic cigarette vaping effects on endothelial integrity. (7 minutes); Chronic electronic cigarette vaping effects on arterial stiffness. (1 month); Chronic electronic cigarette vaping effects on endothelial integrity. (1 month); Chronic electronic cigarette vaping effects on platelet aggregation. (1 month); Chronic electronic cigarette vaping effects on high-shear stress-dependent platelet function. (1 month)
D: verified abstinence 6 months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol
Brief Summary: This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.


Options:
A: Number of Participants With a Quit Attempt (6 months)
B: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
C: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
D: Number of Participants With Smoking Cessation (12 WEEK)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol
Brief Summary: This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.


Options:
A: Toxicant Exposure (6 weeks)
B: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
C: Number of Participants With Smoking Cessation (12 WEEK)
D: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol
Brief Summary: This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.


Options:
A: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)
B: Number of Participants With Smoking Cessation (12 WEEK)
C: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
D: Endothelial dysfunction (up to 24 weeks); Oxidative stress (up to 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol
Brief Summary: This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.


Options:
A: Levels of High Density Lipoprotein C (HDL-C). (26 Weeks); Levels of White Blood Cells (WBC). (26 Weeks); Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1). (26 Weeks); Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1). (26 Weeks); Concentrations of 11-dehydrothromboxane B2 (11-DTXB2). (26 Weeks); Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α). (26 Weeks); Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL). (26 Weeks); Percent Change From Baseline of Carboxyhemoglobin (COHb) (26 Weeks)
B: Number of Participants With Smoking Cessation (12 WEEK)
C: Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 12 (Week 12); Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 12 (Week 12); Change in Markers of Exposure and Potential Harm from Weeks 0 to 12 (Week 12); Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 12 (Week 12); Change in tobacco usage diary from Weeks 0 to 4 (Week 4); Change in Urinary Tobacco Exposure Biomarkers from Weeks 0 to 24 (Week 24); Change in Blood Tobacco Exposure Biomarkers from Weeks 0 to 24 (Week 24); Change in Markers of Exposure and Potential Harm from Weeks 0 to 24 (Week 24); Change in daily tobacco usage diary from Weeks 4 to 8 (Week 8); Change in daily tobacco usage diary from Weeks 8 to 12 (Week 12); Change in daily tobacco usage diary from Weeks 12 to 16 (Week 16); Change in daily tobacco usage diary from Weeks 16 to 20 (Week 20); Change in daily tobacco usage diary from Weeks 20 to 24 (Week 24); Change in health status scores from self-administered questionnaires on COPD-related disease from Weeks 0 to 24 (Week 24)
D: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) (5 days); Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) (5 days); Concentration of S-phenylmercapturic Acid (S-PMA) (5 days); Levels of Carboxyhemoglobin (COHb) (5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Glove-loaded Foley's Catheter Tamponade to Reducing Blood Loss During Cesarean Delivery for Complete Placenta Previa: a Randomized Controlled Trial
Brief Summary: Objective: To investigate the effect of A glove-loaded Foley's catheter tamponade versus stepwise uterine devascularization on blood loss during cesarean section (CS) in patients with complete placenta previa.


Options:
A: the incidence of postpartum hemorrhage (24 hour)
B: intraoperative blood loss (during the operation)
C: Estimation of blood loss: (during the operation)
D: Proportion of women who received at least 3 RBC units for the treatment of PPH and /or who had a calculated peripartum blood loss > 1000 ml. (1 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Brief Summary: This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.


Options:
A: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 (Week 36)
B: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 (Week 36)
C: Treatment success (After six months from onset of treatment)
D: Change in scalp surface area affected over time (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tisagenlecleucel Versus Standard of Care in Adult Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma: A Randomized, Open Label, Phase III Trial (BELINDA)
Brief Summary: This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.


Options:
A: maximum tolerated dose (MTD) (2 years); safety (2 years)
B: CAR T cell persistence (At week 1 and 5, there after every 3 months post treatment up to 24 months)
C: Event-free Survival (EFS) Per Blinded Independent Review Committee (BIRC) Assessment (appro. 24 months)
D: Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators (First infusion date up to maximum duration of 32.7 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions
Brief Summary: Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. As a consequence, asylum seekers and refugees are extremely vulnerable to some common mental health conditions, i.e., post-traumatic stress disorder, anxiety, depression and other forms of disabling psychological distress. The World Health Organization has developed a new 5-session self-help intervention called Self-Help Plus (SH+) for managing stress and coping with adversity. SH+ has been evaluated in RCTs in low- and middle-income countries, however, there is no rigorous evidence on its cost-effectiveness in preventing the onset of mental disorders in HIC.

Objectives To evaluate the effectiveness and cost-effectiveness of the SH+ in asylum seekers and refugees with psychological distress resettled in six sites of five European countries (Italy, Austria, Germany, Finland, and two sites in the UK), as compared with enhanced treatment as usual (ETAU). The primary outcome is the reduction in the incidence of any mental disorders. Secondary outcomes are mental health symptoms, psychological functioning, well-being, drop-out rates, and economic outcomes.

Design This is a multicentre parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ or the ETAU.

Methodology Asylum seekers and refugees who screen positive at the General Health Questionnaire (≥ 3) and without a formal diagnosis of any psychiatric disorders according to the M.I.N.I. International Neuropsychiatric Interview will enter the study. After random allocation they will receive the SH+ or the ETAU. Assessments will be performed by masked assessors immediately after intervention, at 6 months, and a 12 months after randomization.

Time frame The recruitment phase will last 12 months. After the screening, eligible participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up. The SH+ delivery will be conducted in around 5 weeks.

Expected outcomes A reduction in the incidence of psychiatric diagnoses at 6-month follow-up, and a general improvement in mental health symptoms, psychological functioning, well-being, and economic outcomes at each assessment.


Options:
A: HIV sero-incidence (24 months post-baseline)
B: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
C: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
D: Parenting practices (One month and six months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.


Options:
A: Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12 (Week 0 to Week 12)
B: Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) (Week 12)
C: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
D: Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) (Weeks 4, 8 12, and 16 (Period B)); Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) (Weeks 4, 8, 12, and 16 (Period B)); Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C)); Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) (Baseline and Weeks 4, 8, and 16 (Period C))

Answer: B