TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors
Brief Summary: This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).


Options:
A: Progression Free Survival (PFS) (From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death)
B: Progression Free Survival (PFS) (up to approx. 18 months)
C: Proportion of Patients Alive and Progression-free at 6 Months (6 months)
D: Progression Free Survival (PFS) (7 months after the last patient enrolled)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy: a Randomized Double-blind Trial (ERIKA Study)
Brief Summary: Study Objective: To assess the value of Rivaroxaban for the prevention of venous thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of reference.

Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of the type and duration of the procedure, will be eligible for the study.

Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing two arms:

* (R-7d) Rivaroxaban (10 mg od os) for 7 days
* (PL-7d) Placebo for 7 days.

Follow-up: 3-month period after the randomization

Standard of Reference:Placebo will be the standard of reference in accordance to international guidelines

Study length May 2012-December 2012

Total patients number: 500 patients

Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at least one of the following events, objectively proven (by means of CCDU; multi-slice chest TC-angio; autopsy, if necessary, or clinical ground):

* All-cause mortality
* Symptomatic VTE
* Asymptomatic proximal DVT

Secondary Efficacy End-point:

• Combined incidence of all DVT plus symptomatic PE

Primary Safety End-point: Incidence of major bleedings.

Secondary Safety End-point: Overall incidence of bleeding


Options:
A: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (3-month period); Major Bleedings (3 months)
D: Aberrant Behavior Checklist (ABC) irritability score (Baseline and 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy: a Randomized Double-blind Trial (ERIKA Study)
Brief Summary: Study Objective: To assess the value of Rivaroxaban for the prevention of venous thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of reference.

Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of the type and duration of the procedure, will be eligible for the study.

Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing two arms:

* (R-7d) Rivaroxaban (10 mg od os) for 7 days
* (PL-7d) Placebo for 7 days.

Follow-up: 3-month period after the randomization

Standard of Reference:Placebo will be the standard of reference in accordance to international guidelines

Study length May 2012-December 2012

Total patients number: 500 patients

Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at least one of the following events, objectively proven (by means of CCDU; multi-slice chest TC-angio; autopsy, if necessary, or clinical ground):

* All-cause mortality
* Symptomatic VTE
* Asymptomatic proximal DVT

Secondary Efficacy End-point:

• Combined incidence of all DVT plus symptomatic PE

Primary Safety End-point: Incidence of major bleedings.

Secondary Safety End-point: Overall incidence of bleeding


Options:
A: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
B: Symptomatic deep venous thrombosis (DVT) (3 Months); Pulmonary Embolism (PE) (3 months); Major Bleeding (3 months)
C: Aberrant Behavior Checklist (ABC) irritability score (Baseline and 3 months)
D: Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality (3-month period); Major Bleedings (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.

This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.


Options:
A: Skin colonisation in cfu/cm2 at the insertion site; Colonisation of the CVC-tip, positivity by definition of number cfu/5cm > 15 (Maki-method); Incidence of catheter-associated bloodstream infection (For the duration of catheter placement plus 2 days)
B: Prevention of catheter colonization
C: Major catheter related infection
D: Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings (48 hours); Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies (48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
Brief Summary: Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.


Options:
A: The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention. (Month 12 or Final Visit)
B: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses (18 months study duration per subject (4 3-month intermittent treatment courses))
C: Uterine Volume (6 months)
D: percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received (From baseline to end of each PGL4001 treatment (3months treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)
Brief Summary: Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.


Options:
A: 2-year survival without cerebral palsy (2 years)
B: Ductus diameter mm/kg (at postnatal age of 5 days); Cumulative dosage of morphine (at postnatal age of 5 days)
C: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)
D: Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) (36 weeks PMA)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)
Brief Summary: Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.


Options:
A: success rate in closing PDA using paracetamol in comparison to ibuprofen. (at Visit 3 (day 3).)
B: 2-year survival without cerebral palsy (2 years)
C: Successful rate in closing PDA of ibuprofen administered at high or standard dose. (Between 84 and 96 hours of life)
D: closure of PDA (6 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS
Brief Summary: The purpose of this study is to determine whether weekly text-messages improve retention in care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).


Options:
A: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
B: Viral load (6 months post-randomization)
C: Patient retention in care (12 months)
D: SDCAS (3 months, 6 months, 9 months, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS
Brief Summary: The purpose of this study is to determine whether weekly text-messages improve retention in care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).


Options:
A: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
B: Patient retention in care (12 months)
C: Plasma HIV-1 viral load (six months)
D: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS
Brief Summary: The purpose of this study is to determine whether weekly text-messages improve retention in care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).


Options:
A: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
B: Proportion of men failing to return for a post-operative clinic visit at 7 days. (7 days); Proportion of men who report resumption of sexual activity before 42 days post-circumcision. (42 days)
C: Patient retention in care (12 months)
D: Initiation of Long acting reversible contraception method (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WelTel Retain: Promoting Engagement in Pre-ART HIV Care Through SMS
Brief Summary: The purpose of this study is to determine whether weekly text-messages improve retention in care of HIV-infected individuals who are not yet eligible for antiretroviral therapy (ART).


Options:
A: To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. (at participant post-partum visit)
B: Rate of Premature birth (before 37 weeks gestation)
C: The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. (~ 6 months); Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR (~ 6 months)
D: Patient retention in care (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Monitoring Secondhand Smoke Exposure in Buildings in Armenia: Controlled Trial
Brief Summary: This study was designed to test the hypothesis whether a novel intervention that uses motivational interviewing along with immediate feedback and follow-up counseling calls is effective in educating the household members about the health hazards of smoking and secondhand smoke exposure and reducing children exposure to secondhand smoke at households in Armenia.

The study was a randomized control trial with two arms: intervention and control groups.

The sample population for the study included households with a non-smoking mother and at least one child 2 to 6 years of age residing with at least one daily smoker. The study team recruited the households through pediatrician's offices in polyclinics (primary healthcare facilities) utilizing multistage random sampling. Trained interviewers made two baseline (one week apart) and two 4-month follow-up household visits to conduct measurements, interviews and intervention. Measurements included surveys, air nicotine monitoring in homes and hair samples from children to assess changes in nicotine concentration over time.

SHS concentration was estimated by sampling vapor-phase nicotine using a filter badge treated with sodium bisulfate. Airborne nicotine monitors were used in all homes to measure SHS concentration at baseline and 4 month follow-up. At least one monitor was used in each home, preferably in the main room in which the family congregates.

Personal exposure to SHS in 2-6 years old children was assessed using biological samples of hair. A small sample of hair (approximately 30 - 50 strands, 2-3 cm) was cut near the hair root from the back of the scalp where there is the most uniform growth pattern between individuals which minimizes the variability of the results.

The intervention included an in-person counseling session with distribution of a tailored educational brochure and demonstration/feedback measurement of indoor PM2.5 (at second baseline visit); it also included one and two months follow-up counseling calls. The control group received only a brief educational leaflet on the hazards of second-hand smoke exposure.


Options:
A: change in child's hair nicotine concentration (baseline and 4-month follow-up); change in air nicotine concentration (baseline and 4-month follow-up)
B: Smoking Status (2 months after the end of home visits; after the end of the phone calls (4 months). The 6 month follow-up occurred approximately 2 months after the four month assessment and the 12 month assessment occurred 6 months after the 6 month assessment.)
C: Child exposure to tobacco smoke - hair nicotine (Baseline, 6 months post-intervention)
D: child urine cotinine (baseline to 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in patients with diabetes.


Options:
A: change in severity of depressive symptoms (change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months)
B: Smoking Abstinence (End of Treatment (8 weeks))
C: Functional connectivity on fMRI (8 weeks)
D: The Dutch Eating Behavior Questionnaire (Baseline in experimental and control groups.); The Dutch Eating Behavior Questionnaire (Post-treatment 8 weeks from baseline in experimental and control groups); The Dutch Eating Behavior Questionnaire (twelve-months follow-up in experimental and control groups)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Long-term Cell-phone Based Home Exercise on Biomarkers, Skeletal Muscle and Mortality in Patients With COPD
Brief Summary: Background: Moderate-intensity exercise training improves skeletal muscle aerobic capacity and increased oxidative enzyme activity, as well as exercise tolerance in Chronic Obstructive Pulmonary Disease (COPD) patients.

Design: To investigate the home-based exercise training program can reduce inflammatory biomarkers in COPD.

Setting: Conducted from January 2007 to December 2007 at a tertiary medical center, Chang Gung Memorial Hospital, Taiwan.

Patients: Moderate to severe COPD receiving home exercise training, 12 using mobile phone assistance and 14 with free walk, were assessed for 6 months.

Measurements: Incremental shuttle walk test (ISWT), spirometry, strength of limb muscles, C-reactive protein (CRP) and inflammatory cytokines.


Options:
A: Mortality or readmission (one year)
B: inflammatory cytokines (6 months); C-reactive protein (CRP) (6 months); Incremental shuttle walk test (ISWT) (6 months); spirometry (6 months); strength of limb muscles (6 months)
C: The number of ED presentations (1 year after randomization.)
D: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study
Brief Summary: An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low tacrolimus for the immunosuppression in renal transplantation in the elderly.

To evaluate the pharmacokinetics of immunosuppressants that have been little studied in this population.

To evaluate whether the polymorphism of the genes that determine the expression of metabolizing enzymes and transporters of xenobiotics interfere in the elderly, also in the younger population, absorption and metabolism of immunosuppressants.

To evaluate the potential minimization of immunosuppression in this population refers to how does the re-population of peripheral lymphocytes, in this age group, after the use of lymphocyte-depleting agents such as thymoglobulin and subsequently maintained with two regimes.

Clarify which markers of renal filtration exist today, cystatin C and serum creatinine, is the right to monitor renal function in elderly transplanted.


Options:
A: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis (12 months); Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints (12 months)
B: Evaluation of functional graft (The study is planned to analyze all patients at the end of the fifth year after transplantation. However, an interim analysis will be done at the end of each year.)
C: Incidence and severity of acute rejection episodes (1 year)
D: Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra). (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Brief Summary: The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.


Options:
A: Percentage of Participants With New Vertebral Fractures Through Month 24 (24 months); Percentage of Participants With a Clinical Fracture at the Primary Analysis (The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).)
B: Number of Participants With New Vertebral Fractures at 18 Months (18 months)
C: Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.; Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
D: 1.Changes of calcification score of coronary arteries and aorta; 2.Changes of bone density

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Contact Tracing Trial Comparing the Diagnostic Performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in Combination With a Double Blind Randomized Split Body Safety Assessment of C-Tb Versus 2 T.U. Tuberculin PPD RT23 SSI
Brief Summary: Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.

We are investigating a new skin test named C-Tb. Like the current tuberculin skin test (PPD), the C-Tb test is injected just under the skin and will, when positive, show redness and/or swelling at the injection site while a negative test will leave no reactions.

The aim of this trial is to test the C-Tb skin test in volunteers. The volunteers are divided into four groups:

* Negative control group: Must have no history of exposure to a person with tuberculosis disease.
* Occasional contact: Must be in contact with a person with tuberculosis disease between 6 hours/week and 6 hours/day
* Close contact: Must be in close contact with a person with tuberculosis disease for more than 6 hours/day for at least five days
* Positive control group: Must have a confirmed tuberculosis disease within the last 3 years.

The goals of this clinical trial are:

* To compare the C-Tb test to a blood test, the QuantiFERON test.
* To compare the C-Tb test to the PPD test that is currently being used.
* To assess the safety of the C-Tb test.


Options:
A: To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives) (Onset from the injection(s) to 28 days after the injections); To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients (Onset from the injection(s) to 28 days after the injections)
B: All-cause mortality 12 weeks after inclusion (12 weeks)
C: Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics (18 months); Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms (36 months)
D: To demonstrate an increasing trend in C-Tb test positivity across the four study groups, with 'positivity' defined as an induration ≥ 5 mm (Onset between the injections and 28 days after the injections)

Answer: D