TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Oily Fish in Pregnancy on Markers and Manifestations of Allergic Diseases in Infants at Risk of Atopy
Brief Summary: The number of infants and children with allergic disease (dermatitis, allergies, asthma) has increased over the last several decades. This may be related to changes in diet. It is now thought that children become sensitised to allergens very early in life maybe even before they are born. Some studies show that a high omega-3 fat intake by mothers decreases risk of sensitisation in their babies. There is a biological mechanism to explain this. Omega-3 fats are found in oily fish like salmon. In the UK pregnant women are recommended to eat oily fish twice per week. However, consumption of oily fish is known to be low in pregnant women in the UK. This study sets out to identify the effects of increasing salmon intake in pregnant women. The hypothesis being investigated is that : increased consumption of oily fish during pregnancy by women at risk of having offspring who will develop atopy will increase their omega-3 fat and antioxidant status and that of their developing baby and will ameliorate the development of atopic markers and manifestations in the infants.


Options:
A: Primary outcome is measuring of infant CNS maturity to 18 months of age (18 months)
B: Birth size (Birth); Gestational age (Birth); Changes in visual evoked potentials (3 and 6 months of age); Changes in infant weight (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes in infant height (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes In infant head circumference (Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age); Changes in auditory evoked potentials (1 and 3 months of age); Changes in child development score (1, 1.5 and 5 years of age); Changes in Hearts and Flowers Stroop Test (5 years of age)
C: Omega-3 fatty acid status in maternal and umbilical cord plasma (Weeks 20, 34 and 38 of pregnancy and at birth (in cord))
D: percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood (labour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Micronutrient Supplementation in Conjunction With Standard Anti-Tuberculosis Therapy in Paediatric (6 Months-15 Years) New Pulmonary Tuberculosis Patients
Brief Summary: A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN) combined, but neither of them alone, significantly increased weight gain during Tuberculosis (TB) treatment. There was a substantially larger beneficial effect on survival amongst those who received the combination of Zn and MN compared with those who received either Zn alone or MN alone. These exciting preliminary findings require further confirmation, as the data on mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn supplementation has not been assessed in children with TB. Studies are urgently needed to evaluate the therapeutic potential of nutritional interventions on treatment outcome in children with TB. Simple and inexpensive nutritional interventions may substantially impact TB-related child morbidity and mortality in high-burden settings. The investigators thus, propose a randomized, double blind, controlled trial that will measure the effect of multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed childhood pulmonary TB patients in Delhi.


Options:
A: Mortality (weekly); Incidence of disease requiring hospitalization; Morbidity and hospitalization (weekly)
B: Change in Z score for weight and improvement in X ray film (6 months)
C: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children (6 months)
D: Serum vitamin D levels (6 months); Tuberculin Skin Test conversion (6 monhs)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Micronutrient Supplementation in Conjunction With Standard Anti-Tuberculosis Therapy in Paediatric (6 Months-15 Years) New Pulmonary Tuberculosis Patients
Brief Summary: A recent trial in adults has demonstrated that zinc (Zn) and other Multiminerals (MN) combined, but neither of them alone, significantly increased weight gain during Tuberculosis (TB) treatment. There was a substantially larger beneficial effect on survival amongst those who received the combination of Zn and MN compared with those who received either Zn alone or MN alone. These exciting preliminary findings require further confirmation, as the data on mortality reduction was based on a post-hoc subgroup-analysis. Effects of MN and Zn supplementation has not been assessed in children with TB. Studies are urgently needed to evaluate the therapeutic potential of nutritional interventions on treatment outcome in children with TB. Simple and inexpensive nutritional interventions may substantially impact TB-related child morbidity and mortality in high-burden settings. The investigators thus, propose a randomized, double blind, controlled trial that will measure the effect of multi-vitamin/mineral supplementation on the efficacy of anti-TB treatment in newly diagnosed childhood pulmonary TB patients in Delhi.


Options:
A: Final outcome according to WHO (8 months)
B: Change in Z score for weight and improvement in X ray film (6 months)
C: Proportion of pulmonary TB patients who are culture negative at 1 month (1 month); Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months. (2 months)
D: The primary outcome for this intent-to-treat trial is the time to Mycobacterium tuberculosis sputum culture conversion to negative (Up to 16 weeks from therapy start date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial
Brief Summary: Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.


Options:
A: 24-hour Voiding Frequency (post-treatment (week 8))
B: Change from baseline in maximum cystometric capacity (4 Weeks)
C: Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4 (Week 16)
D: improvement of symptom domain means decreased frequency to less than 8 micturitions per 24 hours, no urgency noted per 24 hrs and less that 3 wakening at bedtime for micturation. (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of Different Formulations of GSK Biologicals' Herpes Zoster Vaccine 1437173A When Administered Twice in Adults Aged 50 Years and Older
Brief Summary: The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.


Options:
A: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
B: Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers (One month after the second vaccination (Month 3)); Anti-glycoprotein E (gE) Antibody Concentrations (One month after the second vaccination (Month 3)); Anti-VZV Antibody Concentrations (One month after the second vaccination (Month 3))
C: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 (4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3))
D: Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). (At Month 30 after the first vaccination.); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 30 after the first vaccination); Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination); Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). (At Month 42 after the first vaccination)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Supplemental Parenteral Nutrition (SPN) on Infection Rate, Duration of Mechanical Ventilation and Rehabilitation in Intensive Care Unit Patients: A Quality Control Program for the Implementing of New Nutrition Guidelines
Brief Summary: Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a standard of care. However, EN alone is often associated with insufficient energy intakes and increased complication rates. Recently the investigators proposed to decrease this deficit by combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient (\< 60% of their predicted energy needs) at day 3 after admission in the ICU.

Objective: This study aims at: a/ investigating if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines.

Study design: Prospective, controlled, randomized clinical study.

Study site: Service of Intensive Care, Geneva University Hospital.

Patient population: 220 ICU patients to be included: expected length of stay \> 5 days, expected survival \> 7 days, no contraindication to EN, obtained informed consent from themselves or their next of keen.

Exclusion criteria: refusal of consent, age \< 18 years, short bowel syndrome, significant persistent gastrointestinal dysfunction with ileus, high output proximal fistula (\> 1,5 liter/d), patients receiving PN.

Nutrition: At day 3 after admission, if energy input is \< 60%; patients are randomized into either the "Control group" (EN alone) or the "SPN group" (EN + PN) to reach 100% of their predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved according to our local practice by insulin administration.

Study endpoints:

* Primary: nosocomial infections (CDC criteria)
* Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic free days, ICU complications (extra-renal epuration, neurological, cardiac and respiratory complications), energy and protein balance, 28 days clinical outcome.


Options:
A: Documented Infection Rate (20 days)
B: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)
C: Ventilator-free days (day 28)
D: Septic complication (average of one week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Supplemental Parenteral Nutrition (SPN) on Infection Rate, Duration of Mechanical Ventilation and Rehabilitation in Intensive Care Unit Patients: A Quality Control Program for the Implementing of New Nutrition Guidelines
Brief Summary: Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a standard of care. However, EN alone is often associated with insufficient energy intakes and increased complication rates. Recently the investigators proposed to decrease this deficit by combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient (\< 60% of their predicted energy needs) at day 3 after admission in the ICU.

Objective: This study aims at: a/ investigating if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines.

Study design: Prospective, controlled, randomized clinical study.

Study site: Service of Intensive Care, Geneva University Hospital.

Patient population: 220 ICU patients to be included: expected length of stay \> 5 days, expected survival \> 7 days, no contraindication to EN, obtained informed consent from themselves or their next of keen.

Exclusion criteria: refusal of consent, age \< 18 years, short bowel syndrome, significant persistent gastrointestinal dysfunction with ileus, high output proximal fistula (\> 1,5 liter/d), patients receiving PN.

Nutrition: At day 3 after admission, if energy input is \< 60%; patients are randomized into either the "Control group" (EN alone) or the "SPN group" (EN + PN) to reach 100% of their predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved according to our local practice by insulin administration.

Study endpoints:

* Primary: nosocomial infections (CDC criteria)
* Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic free days, ICU complications (extra-renal epuration, neurological, cardiac and respiratory complications), energy and protein balance, 28 days clinical outcome.


Options:
A: Calorie & Protein Intake 7 Days Post Randomization (7 days post randomization); Calorie & Protein Intake in First 27 Days (first 27 days)
B: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)
C: Documented Infection Rate (20 days)
D: Total energy amount delivered (First 7 days of the study period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Timing of PDA Closure and Respiratory Outcome in Premature Infants
Brief Summary: The investigators propose the present study with the following aims:

* to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen treatment at the onset of clinical symptoms is superior to late ibuprofen treatment only when symptoms of a hemodynamically significant PDA are present in the evolution of bronchopulmonary dysplasia (BPD) defined as duration of supplemental oxygen exposure during the first 28 days
* to determine whether early PDA treatment with ibuprofen will be superior to late treatment with ibuprofen in efficacy of PDA closure, need for rescue therapy, need for PDA ligation and incidence of major complications of prematurity.

Hypothesis: Early pharmacologic closure of PDA with ibuprofen will improve respiratory course and reduce BPD as reflected by a reduction in duration of supplemental oxygen during the first 28 days of age vs. late pharmacologic treatment with ibuprofen.

Outcome variables: The primary outcome of this study is the number of days spent on supplemental oxygen by each infant during the first 28 days.

Other outcomes to be determined between groups include:

* Mortality
* Other respiratory variables: total days on supplemental oxygen, days on mechanical ventilation, oxygen dependence at 36 weeks post menstrual age, age at final extubation.
* Other respiratory complications: pneumothorax, pulmonary interstitial emphysema, need for high frequency ventilation, pulmonary hypertension
* Efficacy of PDA closure: number of courses of medication required, need for ligation
* Other neonatal complications: intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intestinal perforation, sepsis, renal dysfunction (oliguria, elevated creatinine)
* Time to achieving full enteral feedings, time to regain birth weight, weight at discharge.
* Length of hospital stay


Options:
A: Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits) (through hospital discharge (approximately 6 months unless death occurs first))
B: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)
C: Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) (36 weeks PMA)
D: 2-year survival without cerebral palsy (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Timing of PDA Closure and Respiratory Outcome in Premature Infants
Brief Summary: The investigators propose the present study with the following aims:

* to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen treatment at the onset of clinical symptoms is superior to late ibuprofen treatment only when symptoms of a hemodynamically significant PDA are present in the evolution of bronchopulmonary dysplasia (BPD) defined as duration of supplemental oxygen exposure during the first 28 days
* to determine whether early PDA treatment with ibuprofen will be superior to late treatment with ibuprofen in efficacy of PDA closure, need for rescue therapy, need for PDA ligation and incidence of major complications of prematurity.

Hypothesis: Early pharmacologic closure of PDA with ibuprofen will improve respiratory course and reduce BPD as reflected by a reduction in duration of supplemental oxygen during the first 28 days of age vs. late pharmacologic treatment with ibuprofen.

Outcome variables: The primary outcome of this study is the number of days spent on supplemental oxygen by each infant during the first 28 days.

Other outcomes to be determined between groups include:

* Mortality
* Other respiratory variables: total days on supplemental oxygen, days on mechanical ventilation, oxygen dependence at 36 weeks post menstrual age, age at final extubation.
* Other respiratory complications: pneumothorax, pulmonary interstitial emphysema, need for high frequency ventilation, pulmonary hypertension
* Efficacy of PDA closure: number of courses of medication required, need for ligation
* Other neonatal complications: intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intestinal perforation, sepsis, renal dysfunction (oliguria, elevated creatinine)
* Time to achieving full enteral feedings, time to regain birth weight, weight at discharge.
* Length of hospital stay


Options:
A: closure of PDA (6 days)
B: Successful rate in closing PDA of ibuprofen administered at high or standard dose. (Between 84 and 96 hours of life)
C: Days Spent on Supplemental Oxygen During the First 28 Days. (28 days of life)
D: rate of ductal closure

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-arm, International, Multi-center Trial Investigating the Efficacy and Safety of Ofatumumab Retreatment and Maintenance in CLL Patients Who Progressed Following Response or Stable Disease After Ofatumumab Treatment in Hx-CD20-406
Brief Summary: The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).


Options:
A: Number of Participants With Treatment Emergent Adverse Events (AEs) (From first dose to within 30 days of last dose of PCI-32765)
B: Progression Free Survival (PFS) (up to 50 months); Number of Participants With a Response (7 months)
C: Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines (Start of treatment (Week 0/Visit 2) until Week 52)
D: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC) (From the randomization date up to 60 months post the randomization date.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy
Brief Summary: The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should non-selectively stop the RPE leakage.


Options:
A: Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment (12 months)
B: Serial changes in ETDRS letterscore (3 months)
C: Absence of subretinal fluid on OCT scan (6-8 weeks after treatment)
D: BCVA in EDTRS values (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study
Brief Summary: This is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes. Subjects will be current cigarette smokers or history of regular smokers.


Options:
A: tobacco related knowledge post program (at the end of the program (+ 1 DAY POST THE PROGRAM)); tobacco cessation related skills difference between the 2 groups (at the end of the program (+ 1 DAY AFTER THE PROGRAM))
B: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
C: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
D: Smoking Abstinence (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study
Brief Summary: This is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes. Subjects will be current cigarette smokers or history of regular smokers.


Options:
A: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
B: smoking cessation (52 weeks)
C: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
D: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)

Answer: A