TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Double Blind Placebo Controlled Pilot Study of Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
Brief Summary: This is a randomized double-blind placebo controlled trial which aims to evaluate the efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS. Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids to Treatment as Usual in an operationalized ARMS population in Pakistan:


Options:
A: Transition to psychotic disorder (12 Months)
B: Cognitive performance, as measured by a neuropsychological battery (Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up)
C: Brief Assessment of Cognition in Schizophrenia (BACS) (6 and 12 months)
D: Transition to PANSS defined first-episode psychosis (Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Double Blind Placebo Controlled Pilot Study of Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
Brief Summary: This is a randomized double-blind placebo controlled trial which aims to evaluate the efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS. Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids to Treatment as Usual in an operationalized ARMS population in Pakistan:


Options:
A: Transition to psychotic disorder (12 Months)
B: MRI disease activity measured by the number of new T1-enhancing lesions during the six months of treatment.; MRI disease activity measured by the number of new T1-hypo-intensive lesions (black holes) after 24 months of treatment.
C: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
D: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis: PATIENT-UC
Brief Summary: Hospitalized patients with ulcerative colitis (UC) are at increased risk for a variety of complications such as infections, venous thrombosis, and surgery. The literature has revealed significant variation in the quality of care to hospitalized UC patients. As a result, guidelines for the management of these patients have been developed. However, the update of guidelines are variable. Admission to hospital can also have significant impact on quality of life due to interruptions in life commitments and lost sense of control of disease. Maintaining a sense of self-control of disease and active participation in care has been shown to be valuable among individuals with chronic diseases. The investigators propose the development of a multi-site, patient centred initiative aimed at improving clinical and patient-centered outcomes through an educational iPad based tool for patients admitted to hospital with ulcerative colitis.


Options:
A: Overall length of stay (1 year); Percentage of patients undergoing colectomy (1 year)
B: Harvey Bradshaw Index (12 months); Inflammatory Bowel Disease Questionnaire (12 months)
C: Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations) (up to 2 years)
D: The St Mark's faecal incontinence score (0-24 scale) (At 6 months from recruitment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Recruiting to Clinical Trials on the Telephone
Brief Summary: This study examined the use of the telephone for the purpose of informing expectant mothers about a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers who were contacted for participation in a vaccination trial (the Calmette study, NCT01694108) were randomized to receive information by telephone or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about the study and satisfaction with the information process. The outcome was measured using a questionnaire two weeks after the information was provided and two and a half months after birth.


Options:
A: total communication score (2 weeks after information was given)
B: safety (local and systemic reactogenicity, lab tests, AEs)
C: N/A
D: compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP (Nasal Continuous Positive Airway Pressure) in Preterm Infants With Mild to Moderate Respiratory Distress Syndrome (RDS): a Randomized Clinical Trial.
Brief Summary: Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the following treatments as non invasive respiratory support if they develop mild to moderate Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2) HHHFNC providing a flow 4-6 l/min.

The aim of the study is to assess efficacy and safety of relative "new" form of respiratory support (HHHFNC) versus a more common one (NCPAP).


Options:
A: Mean esophageal pressure (3.5 hours)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: number of patients needing intubation and mechanical ventilation within 72 hrs from the beginning of the study mode (within 72 hrs from the beginning of the study mode)
D: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cross-linking for Corneal Ulcers Treatment Trial
Brief Summary: The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone.

The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.


Options:
A: Time to Re-epithelialization (Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete)
B: Microbiological Cure on Repeat Culture (4 to 24 hours after enrollment)
C: Time to re-epithelialization of the corneal surface (28 days)
D: Healing (Three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Clinical Effectiveness of Freezing All Embryos Followed by Frozen Thawed Embryo Transfer Compared to Fresh Embryo Transfer, in Women Undergoing In-vitro Fertilization Treatment
Brief Summary: The objective of the present randomized controlled study is to compare clinical effectiveness and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared to fresh embryo transfer, in women undergoing IVF treatment.


Options:
A: Live birth rate (up to 24 weeks)
B: Ongoing pregnancy (12 weeks of gestation)
C: live birth rate (10 months for group A, 12 months for group B)
D: Clinical Pregnancy (7-8 weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: QuitAdvisorDDS: A Point-of-Care Tobacco Cessation Tool for Dental Settings
Brief Summary: Using a single-arm trial design, this study will examine the feasibility and acceptability of evaluating QuitAdvisorDDS, a clinical decision support software application designed to facilitate implementation of evidence-based tobacco treatment interventions into the dental setting. The study will examine the feasibility and acceptability of evaluating the impact of the QuitAdvisorDDS tool on patient outcomes related to tobacco use and cessation attempts as well as provider knowledge, attitudes, and practices regarding tobacco treatment. Practitioners (dentists and hygienists) will complete surveys at baseline and follow-up, while patients will complete surveys at baseline and 1-month follow-up. An embedded substudy will also evaluate the feasibility and acceptability of collecting biospecimens (saliva) to serve as biochemical verification of smoking status.


Options:
A: Primary Patient Acceptability A: Rate of Patient Wanting Provider to Use QA-DDS (Immediately Post-Consultation up to 1 week); Primary Patient Acceptability B: Rate of Patient Wanting to Use QA-DDS Patient Portal (1-Month Follow-Up); Primary Patient Feasibility A: Rate of Patient Completion of 1-Month Follow-Up Survey (1-Month Follow-Up)
B: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
C: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
D: effectiveness (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensity-dependent Impacts of Training on Growth Factors BDNF and Cognitive Functions in Persons With Multiple Sclerosis - a Single-center Randomized Controlled Trial
Brief Summary: Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS) progressively develop impaired functional capacity and show reduced physical activity and cognitive decline compared to healthy controls. The primary aims of rehabilitation in pwMS are therefore to increase levels of activity and participation leading to increase independence of the participants. In general exercise ranges from passive physiotherapy-based interventions to submaximal endurance training sessions. Current recommendations advise pwMS that exercise should be matched with the individual performance capacities. Exercise training in pwMS then has the potential to target and improve many components outlined in the ICF-model.

Cytokines and neurotrophic factors have received increased attention in MS research and addressed the brain-derived neurotrophic factor (BDNF) as an important mediator of neuronal regeneration linking the effects of exercise with MS pathogenesis. Data show positive connections between elevated neurotrophin concentrations, induction of neuroplasticity, recovery of the motor and cognitive functions and the applied training intensities. Similarly, intensive and progressive exercise bouts seem to have greater benefits on cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with dementia. Therefore, specific exercise prescriptions may be necessary for targeting the specific impairments also in pwMS.

This study aims to evaluate two different training modalities (intensive versus normal) in pwMS. It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS. Based on the findings that higher training intensities facilitate greater benefits, it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations.

The results will to help to clearer understand the benefits of each type of exercise conveyed for pwMS and will assist in the development of patient-specific exercise prescriptions.


Options:
A: Efficacy of cognitive rehabilitation on quality of life at short term. (10 weeks); Efficacy of cognitive rehabilitation on quality of life at long term. (34 weeks)
B: A composite derived from a standardized battery of neuropsychological tests (12weeks)
C: Neuropsychological Assessment (Baseline assessment, and Week 3)
D: Neurotrophic Factor BDNF (3-weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial
Brief Summary: Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial

Trial acronym: PANSAID

Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.

Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.

Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.

Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.

Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.


Options:
A: Cumulative use of morphine as assessed within first 48 hours after surgery (first 48 hours)
B: Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS). (72 hours)
C: Total morphine consumption (At 48 hour postoperative)
D: Morphine consumption the first 24 hours postoperatively (0-24 hours postoperatively); Serious adverse events (0-90 days postoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Effects of Mindfulness on Impulsive Eating, Motivation Toward Exercise, and Weight Loss in Obese Patients: Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate the efficacy of a daily 12-month computerized mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED) on: impulsive eating, motivation toward exercise, and weight loss.


Options:
A: Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale) (From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
B: Changes in Body Mass Index (BMI) measured by Bio-electrical Impedance Analysis (TANITA) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in eating habits estimated by 24h recall and PREDIMED questionnaire (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in the level of physical exercise estimated by the International Physical Activity Questionnaire (IPAQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in emotional eating estimated by the Dutch Eating Behaviour Questionnaire (DEBQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in the quality of life estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in weight self-stigma estimated by the Weight Self-Stigma Questionnaire (WSSQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up)
C: Change from Baseline in Toronto Mindfulness Scale at 8 weeks (baseline and 8 weeks)
D: Psychological Flexibility (AAQ-2) (Change from Baseline in Psychological Flexibility at 8.5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
Brief Summary: The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.


Options:
A: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)
B: Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. (7 assessments within 12 month treatment period)
C: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
D: Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26 (26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Study Evaluating Brentuximab Vedotin in Combination With Nivolumab in Patients With Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy
Brief Summary: The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)


Options:
A: Objective Response Rate by Independent Review Group (up to 12 months)
B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
C: Number of Participants With Adverse Events (AEs) (Up to 28.9 months); Complete Remission Rate (Up to 3.42 months)
D: Progression free survival (PFS) (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A
Brief Summary: This study assessed the efficacy and safety of anti-influenza immune plasma, as an addition to standard of care antivirals, in participants hospitalized with severe influenza A infection.


Options:
A: Number of Patients in Each of 6 Clinical Status Categories on Day 7 (Assessed on Day 7)
B: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)
C: Clinical Status at Day 7 (Day 7)
D: Mortality (From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A
Brief Summary: This study assessed the efficacy and safety of anti-influenza immune plasma, as an addition to standard of care antivirals, in participants hospitalized with severe influenza A infection.


Options:
A: Category Changes in the "7-Ordinal Scale" (15 days)
B: Requirement for invasive ventilation (through study completion up to 28 days)
C: Clinical Status at Day 7 (Day 7)
D: Clinical changes in COVID-19 symptoms (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A
Brief Summary: This study assessed the efficacy and safety of anti-influenza immune plasma, as an addition to standard of care antivirals, in participants hospitalized with severe influenza A infection.


Options:
A: N/A
B: Clinical Status at Day 7 (Day 7)
C: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)
D: Number of Patients in Each of 6 Clinical Status Categories on Day 7 (Assessed on Day 7)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A
Brief Summary: This study assessed the efficacy and safety of anti-influenza immune plasma, as an addition to standard of care antivirals, in participants hospitalized with severe influenza A infection.


Options:
A: Phase 2a: XAV-19 antibody titers (Day 8); Phase 2a: Adverse events of XAV-19 (Day 29); Phase 2b: To evaluate the efficacy of XAV-19 + standard-of-care (Soc) therapy compared with placebo + Soc therapy for treatment of COVID-19 assessed by the proportion of patients who die or develop respiratory failure between baseline and Day 15. (Day 15)
B: Hospitalization rate (safety and efficacy) (Day 28); SARS-CoV-2 viral load (safety and efficacy) (Day 7)
C: Clinical Status at Day 7 (Day 7)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A
Brief Summary: This study assessed the efficacy and safety of anti-influenza immune plasma, as an addition to standard of care antivirals, in participants hospitalized with severe influenza A infection.


Options:
A: Mortality (Up to 28 days); Viral Load (Day 0, Day 3, Day 5, and Day 7); Serum Antibody Titers (Day 0, Day 3, Day 5, and Day 7)
B: Clinical Status at Day 7 (Day 7)
C: death (within 7 days)
D: 28 Days mortality (28 days); Requirement of supplemental oxygen support (28 days); Number of days on assisted ventilation (28 days); Days to step down (28 days); Days to Hospital Discharge (28 days); Adverse events during hospital stay (28 days); Change in C-Reactive Protein (CRP) levels (28 days); Change in neutrophil lymphocyte ratio (28 days)

Answer: B