TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)
Brief Summary: The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood.

The infants born between July 1st and December 31st in 2007 with the gestational age between 33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April 2008. The infants were unintentionally divided into two groups, either palivizumab treated or untreated group at the enrollment, because the timing for palivizumab prophylaxis were already ended.

The study infants will be followed up until the age of 3 with recording the incidence of either parent reported or physician diagnosed recurrent wheezing.

The difference of the incidence of the recurrent wheezing between the groups will be analyzed with Kaplan-Meier method.


Options:
A: The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy (For three years)
B: Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge (3 weeks)
C: Number of Subjects Reporting Serious Adverse Events (SAEs) (Day 0 - Day 150); Number of Subjects Reporting Adverse Events (AEs) (Day 0 - Day 150); Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs. (Day 0 - Day 150)
D: Cumulative incidence of recurrent wheezing confirmed by physicians (two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)
Brief Summary: The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood.

The infants born between July 1st and December 31st in 2007 with the gestational age between 33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April 2008. The infants were unintentionally divided into two groups, either palivizumab treated or untreated group at the enrollment, because the timing for palivizumab prophylaxis were already ended.

The study infants will be followed up until the age of 3 with recording the incidence of either parent reported or physician diagnosed recurrent wheezing.

The difference of the incidence of the recurrent wheezing between the groups will be analyzed with Kaplan-Meier method.


Options:
A: Cumulative incidence of recurrent wheezing confirmed by physicians (two years)
B: Clinical Cure: Respiratory rate below age specific cut-off (<50 bpm in infants <12 months and <40 bpm in 12 - 59 months of age).
C: Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization (From study Day 0 through study Day 150)
D: Cumulative Treatment failure (Day 0-3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion Imaging
Brief Summary: The purpose of this study is to investigate the effectiveness of a drug called ambrisentan, approved by the FDA for use in pulmonary hypertension (a condition where there is increased pressure in the right side of the heart) in scleroderma patients, to see if this medicine may be beneficial in relieving and/or preventing Raynaud's flares in you and other patients like you. This medicine may have some short-term and long-term benefits in persons with scleroderma


Options:
A: 6 minute walk distance change from baseline to Week 16 (16 weeks)
B: Change from Baseline to Week 16 in 6-Minute Walk Test distance (Week 16); Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest (Week 16)
C: Digital Micro-vascular Flow (Baseline and 12 weeks)
D: Change from baseline to End-of-Study in 6-minute walk distance.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion Imaging
Brief Summary: The purpose of this study is to investigate the effectiveness of a drug called ambrisentan, approved by the FDA for use in pulmonary hypertension (a condition where there is increased pressure in the right side of the heart) in scleroderma patients, to see if this medicine may be beneficial in relieving and/or preventing Raynaud's flares in you and other patients like you. This medicine may have some short-term and long-term benefits in persons with scleroderma


Options:
A: Frequently Reported (15% or More Overall) Adverse Events by Severity (Baseline to Week 295); Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN) (Baseline to Week 295)
B: Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria. (6 weekly)
C: Digital Micro-vascular Flow (Baseline and 12 weeks)
D: Change from baseline to End-of-Study in 6-minute walk distance.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Polidocanol Injectable Foam 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Brief Summary: Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Options:
A: Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) (8 weeks)
B: Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) (Week 8)
C: The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks (Baseline to 8 weeks)
D: anatomical success rate (absence or obliteration of GSV on US examination) (3 months, 1 and 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an Emergency Obstetric and Neonatal Care (EmONC) Intervention Package to Reduce Adverse Pregnancy Outcomes in Low Resource Settings (The EmONC Trial)
Brief Summary: The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in \>28 week or \>1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.


Options:
A: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (7 days post delivery)
B: Neonatal mortality (7 days)
C: Knowledge test by written test as multiple-choice questions (MCQ). (The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period)
D: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (Baseline, Midline (6 months), Endline (12 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an Emergency Obstetric and Neonatal Care (EmONC) Intervention Package to Reduce Adverse Pregnancy Outcomes in Low Resource Settings (The EmONC Trial)
Brief Summary: The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in \>28 week or \>1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.


Options:
A: Neonatal mortality from post enrolment to 28 days (From post enrolment to 28 days); Early infant mortality from post enrolment to 6 months of age (From post enrolment to 6 months)
B: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (7 days post delivery)
C: Neonatal mortality rate
D: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of an Emergency Obstetric and Neonatal Care (EmONC) Intervention Package to Reduce Adverse Pregnancy Outcomes in Low Resource Settings (The EmONC Trial)
Brief Summary: The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in \>28 week or \>1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.


Options:
A: Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
B: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) (Birth to 28 days)
C: Perinatal mortality (12 months)
D: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (7 days post delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Brief Summary: Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or end-stage renal disease. Its intensity ranges from sporadic discomfort to complete restlessness during both the day- and night-time and its distribution varies significantly over time. Many attempts have been made to relieve this bothersome symptom in affected patients, however with generally limited success. Incidence of UP varies widely between studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the 1980s to a 22% in the 2000s) (Gunal AI).

We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in our centre. In addition to neuropathic pain, several of our patients have complained of pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved. Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to assess the effectiveness of Pregabalin in chronic UP.


Options:
A: Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale (8 weeks)
B: Severity of Pruritis as measured by a visual analogue scale (VAS) (3 months)
C: Reduction of UP by more than 50% after Pregabalin administration (2012)
D: Subjective measurement of reduction in pruritus (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.
Brief Summary: OBJECTIVES

Primary objective:

The primary objective of the trial is to determine the safety of adjuvant treatment with cisplatin plus gemcitabine for a period of 6 months after curative resection of cholangiocellular carcinoma

Secondary objectives:

Secondary objectives of the trial are to assess the feasibility and efficacy of the adjuvant therapy and to determine duration of response and patterns of failure compared to historical controls without postoperative treatment

Exploratory objectives:

To obtain blood samples and tumor tissue after resection for establishment and characterization of new cholangiocarcinoma cell lines and tumor antigens. Other aims are identification of tumor specific antibodies from blood samples, and characterization of tumor antigens with consecutive development of new specific immunological therapies, e.g. cancer-testis antigens (CTA) for tumor vaccination.

* Trial with medicinal product


Options:
A: Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 (One year)
B: Progression-free survival (12 months)
C: overall survival (24 months)
D: Disease free survival (DFS) (Disease free survival rate at 24 months (DFSR@24))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) Following a Two-Week Washout Period
Brief Summary: This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.


Options:
A: death due to cardiac arrhythmias or as sudden cardiac death defined as any deaths coded as "cardiac arrest, cause unknown" or "cardiac arrhythmia" without any exclusions (2 years)
B: Change in Serum Phosphorus From Baseline to End of Treatment (Baseline and day 28)
C: Serum phosphorus levels at 8 weeks. (8 weeks)
D: Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind,Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of Subcutaneously Administered REGN727 in Healthy Volunteers
Brief Summary: This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by an injection under the skin at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Options:
A: The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (visit 4 (day 1) to visit 16 (day 148))
B: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.
C: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
D: Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (Baseline, Week 12); Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (Baseline, Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind,Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of Subcutaneously Administered REGN727 in Healthy Volunteers
Brief Summary: This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by an injection under the skin at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis (From Baseline to Week 52)
B: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
C: Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization (Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.)
D: Number of Participants With Adverse Events (From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind,Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of Subcutaneously Administered REGN727 in Healthy Volunteers
Brief Summary: This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by an injection under the skin at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Options:
A: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
B: Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))
C: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event (From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years))
D: Number of Participants With Adverse Events (52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis
Brief Summary: The purpose of this study is to determine if memantine is effective in the treatment on cognitive disorders of Relapsing - Remitting multiple sclerosis. m


Options:
A: N/A
B: ADAScog/11 (change from Baseline to 12 months of treatment)
C: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
D: Pace Auditory Serial Addition Test(P.A.S.A.T) (+1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Tolerability of Palonosetron and Dexamethasone Plus Fosaprepitant or Placebo in Patients Receiving Radiotherapy and Weekly Cisplatin.
Brief Summary: GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.

The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.


Options:
A: A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). (Overall (in the 120 hours following initiation of cisplatin chemotherapy).)
B: Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen (0 to 120 hours in the first cycle of chemotherapy)
C: To compare fosaprepitant dimeglumine, palonosetron, and dexamethasone with palonosetron, dexamethasone, and placebo with respect to efficacy; the proportion of subjects with no vomiting during five weeks of radiotherapy and concomitant weekly cisplatin. (35 days)
D: The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy). (Days 1 through 6.)

Answer: C