TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi
Brief Summary: The purpose of this study is to determine whether the addition of zidovudine (ZDV) and lamivudine (3TC) at the onset of labor and for up to seven days postpartum to single-dose nevirapine (NVP) is associated with a lower prevalence of NVP-resistant HIV compared to single-dose NVP without ZDV+3TC.


Options:
A: Weight gain during the 12-month follow-up (in grams)
B: Change in Length for Age (Once per month for 6 months, then once after 12 months.)
C: Prevalence of Malaria Defined as Positive Placental Blood Smear (Delivery); Prevalence of Malaria Defined as Positive Placental Blood PCR (Delivery)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Administration of Intravenous Proton Pump Inhibitor Prior to Endoscopy [APPE] in Patients With Upper Gastrointestinal Bleeding; a Double-Blind Placebo-Controlled Randomised Study.
Brief Summary: To evaluate if intravenous PPI infusion, when administered prior to endoscopy, hastens resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces the need for endoscopic treatment. Clot stabilization may itself sustain control of bleeding before endoscopy. These may translate into improved patients'outcome and survival.

To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers.


Options:
A: Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo (Within 72 hours)
B: Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy (one year)
C: early intranvenous infusion of a high-dose poton-pump inhibitor before endoscopy would have a therapeutic effect on bleeding ulcers, reduce the need for endoscopic therapy, and result in improved clinical outcomes.
D: recurrent bleeding (within 28 days after the first bleeding event)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Childhood Acute Lymphoblastic Leukemia
Brief Summary: The purpose of this study is to reduce the side-effects and discomfort of anti-leukemia therapy, to attain long-term control of the disease and to hopefully eradicate it.


Options:
A: Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogram (Baseline); Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides) (Baseline)
B: Diffusing capacity of the lungs for carbon monoxide (DLCO) (One year post therapy)
C: -To evaluate the efficacy and safety of doxorubicin with or without dexrazoxane; -To determine the efficacy of hyperfractionated radiation plus standard intrathecal chemotherapy compared with intensive intrathecal chemotherapy alone in standard risk patients.; -To compare the relative efficacy and toxicity of E.coli and Erwinia asparaginase; -To compare the relative efficacy and toxicity of cranial radiation delivered in once-daily versus twice-daily fractions in high risk patinets.
D: To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. (25 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Open Label Blinded Endpoint Multicenter Study in Patients With Coronary Artery Disease to Assess the LDL Lowering Effect of Switching to Ezetimibe (+) Simvastatin for Cholesterol Lowering, Compared the Dose of the Statin Used.
Brief Summary: In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (\> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipid parameters, safety and LDL-subfractions will be measured.


Options:
A: Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo (Median follow-up 4.9 years)
B: Changing LDL Cholesterol (36 months)
C: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline and Week 12); Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 (Baseline and Weeks 10 and 12)
D: Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment. (after 12 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Parent-Youth Teamwork in Pediatric Asthma Management
Brief Summary: The purpose of this research study is to examine the effectiveness of a parent-youth teamwork treatment and an asthma education treatment in helping children use their asthma medicines correctly. We also want to learn about how these treatments affect parental involvement in asthma care, parent and youth relationships, and children's health care.


Options:
A: Pediatric Asthma Quality of Life Questionnaire (PAQLQ) (9 months post camp); Asthma Control Questions (9 months post camp)
B: Number of Participants With Unscheduled Use of Healthcare (1 year)
C: medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome
D: asthma medication adherence (before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Parent-Youth Teamwork in Pediatric Asthma Management
Brief Summary: The purpose of this research study is to examine the effectiveness of a parent-youth teamwork treatment and an asthma education treatment in helping children use their asthma medicines correctly. We also want to learn about how these treatments affect parental involvement in asthma care, parent and youth relationships, and children's health care.


Options:
A: Medication Adherence (12 months)
B: medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome
C: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)
D: number of subjects who achieved Total asthma Control: Period 2 (Up to Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia
Brief Summary: Abstract

Biliary atresia (BA) is an idiopathic, progressive, and fatal disease if untreated. Since Kasai first introduced the operation for BA in 1959, there have been encouraging results in treating this disease. Ascending cholangitis is a frequent and often recurrent complication. It may worsen the prognosis, with an increase in mortality, secondary failure of restoration of bile flow, and possible exacerbation of portal hypertension. For patients who have had restoration of bile flow with a timely portoenterostomy, the recurrence of ascending cholangitis is the single most significant variable pertaining to long-term prognosis. Patients with multiple episodes of ascending cholangitis are more likely to require liver transplantation than those without multiple recurrences. Therefore, the prevention of cholangitis is crucial in the management of patients who have had a Kasai portoenterostomy.

Some oral antibiotics, like trimethoprim-sulfamethoxazole (TMP/SMZ) and neomycin have showed the effect to prevent against ascending cholangitis. But, we should consider the problem of drug resistance after long-term use of antibiotics. Is there any better and safer treatment? Probiotics are live microorganisms, which have beneficial effects on human health. Many studies have showed that probiotics have effects to treat or prevent intestinal infection or inflammation even for patient after liver transplantation. The aim of this study is to investigate the possibility of use of probiotics in prophylaxis of ascending cholangitis.

We want to enroll 20 BA patients aged 0 to 3 years, who had a Kasai operation. Ten patients are treated with neomycin (25 mg/kg/d, qid, 4 days a week). Another 10 patients receive Lactobacillus casei rhamnosus, Lcr 35 (8x108 CFU/day, bid) The duration of treatment is 6 months. Bacterial cultures of stool are performed before treatment and 1 month, 3 months and 6 months after treatment to evaluate the change of intestinal flora. Another 10 BA patients, from 1991 to 1996, aged 0 to 3 years, without prophylaxis after portoenterostomy, were served as the historical control group. Comparisons of the episodes of cholangitis, time to the first episode, and body weight change are made among the three groups.


Options:
A: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
B: Liver Enzymes(ALT) (7 days after probiotics)
C: episodes of cholangitis (6 months after intervention)
D: Alaninaminotransferase (ALT) (28 weeks); Liver fibrosis (28 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation, Brain Function and Early Schizophrenia
Brief Summary: This study will determine the effectiveness of cognitive enhancement therapy (CET) in treating cognitive abnormalities in people experiencing the early stages of schizophrenia.


Options:
A: Independent Living Skills Survey (ILSS) (Baseline, 18 mos.)
B: Functional Assessment Short Test (FAST) (Baseline); Functional Assessment Short Test (FAST) (6 months); Functional Assessment Short Test (FAST) (12 months)
C: sucessful employment for one day in the open labour market
D: Clinical, neuropsychological, and functional outcomes (Measured at Years 1 and 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Treadmill Training in Establishing Walking After Stroke
Brief Summary: Being able to walk is a major determinant of whether a patient returns home after stroke or lives in residential care. For the family, the loss of the stroke sufferer from everyday life is a catastrophic event. For the community, the costs of being unable to walk after stroke are exorbitant, involving a lifetime of residential care. Therefore, an increase in the proportion of stroke patients who regain walking ability will be a significant advance.

This trial will determine, in patients early after stroke who are unable to walk, whether training walking using a treadmill with partial weight support via an overhead harness will be more effective than current intervention in (i) establishing more independent walking, reducing the time taken to achieve independent walking, and improving the quality of independent walking, and (ii) improving walking capacity and participation 6 months later.


Options:
A: Proportion of participants walking independently (defined for the purposes of this study as'being able to walk 15 m continuously across flat ground without any aids'). (Within 6 months)
B: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
C: Improvement ín motor function among patients in each group
D: walking speed (meters/second); walking distance (distance walked in 6-minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Treadmill Training in Establishing Walking After Stroke
Brief Summary: Being able to walk is a major determinant of whether a patient returns home after stroke or lives in residential care. For the family, the loss of the stroke sufferer from everyday life is a catastrophic event. For the community, the costs of being unable to walk after stroke are exorbitant, involving a lifetime of residential care. Therefore, an increase in the proportion of stroke patients who regain walking ability will be a significant advance.

This trial will determine, in patients early after stroke who are unable to walk, whether training walking using a treadmill with partial weight support via an overhead harness will be more effective than current intervention in (i) establishing more independent walking, reducing the time taken to achieve independent walking, and improving the quality of independent walking, and (ii) improving walking capacity and participation 6 months later.


Options:
A: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)
B: Proportion of participants walking independently (defined for the purposes of this study as'being able to walk 15 m continuously across flat ground without any aids'). (Within 6 months)
C: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
D: Difference in physical activity scale for the elderly (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Treadmill Training in Establishing Walking After Stroke
Brief Summary: Being able to walk is a major determinant of whether a patient returns home after stroke or lives in residential care. For the family, the loss of the stroke sufferer from everyday life is a catastrophic event. For the community, the costs of being unable to walk after stroke are exorbitant, involving a lifetime of residential care. Therefore, an increase in the proportion of stroke patients who regain walking ability will be a significant advance.

This trial will determine, in patients early after stroke who are unable to walk, whether training walking using a treadmill with partial weight support via an overhead harness will be more effective than current intervention in (i) establishing more independent walking, reducing the time taken to achieve independent walking, and improving the quality of independent walking, and (ii) improving walking capacity and participation 6 months later.


Options:
A: Proportion of participants walking independently (defined for the purposes of this study as'being able to walk 15 m continuously across flat ground without any aids'). (Within 6 months)
B: Self selected over ground gait speed - 5 metre walk test (8 week follow up)
C: walking speed (meters/second); walking distance (distance walked in 6-minutes)
D: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (12 months post-stroke); Walking Speed: Measured During a 10-meter Walk (Baseline and 12 months post-stroke)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments
Brief Summary: The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.


Options:
A: Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) (From day of randomization to 36 weeks post menstrual age); Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) (From day of randomization to 22-26 months corrected age)
B: dichotomous variable: survival without BPD at 36 weeks PMA. (add 8 to12)
C: Enrollment and completion of 60 infants (1 year)
D: Total Cerebral Volume as Measured by Volumetric Brain MRI (38 weeks postmenstrual age (PMA))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ARVs to Prevent Breastmilk HIV:Viral and Immune Responses
Brief Summary: Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important research priority. To this end, clinical trials are underway to evaluate the efficacy of HAART (zidovudine, lamivudine, nevirapine) during late pregnancy/lactation versus zidovudine/nevirapine peripartum for prevention of breastmilk HIV-1 transmission. It is important to understand the mechanism of effect of these antiretroviral (ARV) strategies on prevention of breastmilk HIV-1 transmission.

This phase II trial will compare HAART vs peripartum zidovudine/nevirapine for effect on breastmilk HIV-1, breastmilk HIV-1 specific immune responses, and infant HIV-1 specific immune responses.

100 pregnant HIV-1 seropositive women in Nairobi with CD4 counts between 200 to 500 who have chosen to breastfeed will receive either ARV regimen. Mother-infant pairs will be followed for 1 year after delivery. Home visits will be conducted in the first month (\~10 visits) to collect 2-5 mls of breastmilk per visit. Mother-infant pairs will be seen in the study clinic with maternal blood and breastmilk and infant blood collected at months 1, 3, and 6 for HIV-1 and HIV-1 Elispot assays. Breastmilk HIV-1 RNA and DNA levels will be quantified in Dr. Overbaugh's laboratory in Seattle and Elispot assays conducted in Nairobi with validation of a subset in Dr. Rowland-Jones laboratory in Oxford. Viral loads, decay curves, half-life, and re-population following ARV cessation will be estimated for each regimen and regimens compared. These studies will provide insight into the viral and immune responses to ARV regimens proposed for prevention of breastfeeding HIV-1 transmission and will be important for rational design of future interventions. After taking into account, estimated loss to follow-up, the targeted sample size with outcome data was 80 women, 40 in each trial arm, estimating undetectable breast milk HIV-1 RNA levels in the HAART arm and median breast milk HIV-1 RNA levels of 3.0 log10 in women receiving ZDV/NVP.


Options:
A: A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. (9 months)
B: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
C: HIV infection rate of infants (6 months of age); Safety of the regimens for HIV-infected mothers and their breast-fed infants (Through 12 months post-partum)
D: Outcome 1: Serial HIV-1 RNA Levels in Breastmilk. (Weeks 0, 1, 2, 3 and 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition, Allergy, Mucosal Immunology and Intestinal Microbiota (NAMI): Pre-, Peri- and Postnatal Programming and Origins of Disease: Early Targeting the Epidemics of Allergy and Overweight
Brief Summary: Combined programme: Nutrition, Allergy, Mucosal immunology and Intestinal microbiota (NAMI) was created with the objective to reverse the rising trend of chronic inflammatory diseases, such as allergic disease and obesity, by control of the internal and external environments of the infant. To approach this problem, the project aims to characterize

* how immunology is regulated during pregnancy and early infancy,
* how the immune interaction between mother and child is influenced by nutritional and microbial factors, and
* how the regulation is related to disease risk.


Options:
A: N/A
B: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
C: weight loss
D: 7-item Juniper Asthma Control Questionnaire (ACQ) (6-months post-randomizaton)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition, Allergy, Mucosal Immunology and Intestinal Microbiota (NAMI): Pre-, Peri- and Postnatal Programming and Origins of Disease: Early Targeting the Epidemics of Allergy and Overweight
Brief Summary: Combined programme: Nutrition, Allergy, Mucosal immunology and Intestinal microbiota (NAMI) was created with the objective to reverse the rising trend of chronic inflammatory diseases, such as allergic disease and obesity, by control of the internal and external environments of the infant. To approach this problem, the project aims to characterize

* how immunology is regulated during pregnancy and early infancy,
* how the immune interaction between mother and child is influenced by nutritional and microbial factors, and
* how the regulation is related to disease risk.


Options:
A: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
B: Presence of probiotic in the stool (weeks 0-12); Adverse events (duration of study - through study completion)
C: Duration of crying (minutes per day) (21 days); Reduction on the daily average crying time >50% during the study (21 days)
D: Reduction of the onset of gaseous colic, regurgitation and of constipation. (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition, Allergy, Mucosal Immunology and Intestinal Microbiota (NAMI): Pre-, Peri- and Postnatal Programming and Origins of Disease: Early Targeting the Epidemics of Allergy and Overweight
Brief Summary: Combined programme: Nutrition, Allergy, Mucosal immunology and Intestinal microbiota (NAMI) was created with the objective to reverse the rising trend of chronic inflammatory diseases, such as allergic disease and obesity, by control of the internal and external environments of the infant. To approach this problem, the project aims to characterize

* how immunology is regulated during pregnancy and early infancy,
* how the immune interaction between mother and child is influenced by nutritional and microbial factors, and
* how the regulation is related to disease risk.


Options:
A: Effect of VSL#3 probiotic administration on breast milk (2 months)
B: Spontaneous premature birth (<37, <35, <32 weeks of pregnancy) (24 weeks)
C: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
D: Gestational weight gain (week 36-37 of pregnancy); Change in glucose levels (Oral glucose tolerance test) (baseline (week 14-20) and 27-30 of pregnancy)

Answer: C