TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
Brief Summary: The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.


Options:
A: Duration of delirium (3 months)
B: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
C: Percentage of Participants With Delirium Using the CAM Over Time (Baseline, hospital interviews, weeks 2, 4 and 6)
D: Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery (Four days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial
Brief Summary: To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.


Options:
A: Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) (24 h postoperatively)
B: Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain], (6 and 24 hours after surgery)
C: VAS pain score
D: Time to discharge patient after surgery (6 hours postoperative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Vitamin A in Fortified Extruded Rice in School Children in Satun, Thailand
Brief Summary: The project aims to evaluate the potential impact triple fortified rice grains, mixed into natural rice grains, can have on vitamin A status if fed to school children in Southern Thailand. Within a 60 day intervention study, changes in vitamin A status in young children fed the fortified rice compared to children consuming non-fortified rice will be assessed.


Options:
A: serum Zn (September 2009-March 2010); Hemoglobin (September 2009-2010); serum retinol (September 2009-March 2010); serum ferritin (September 2009-March 2010); ZPP (September 2009- March 2010)
B: Linear growth velocity (6 to 18 months of age)
C: Cognitive development and performance (1 year)
D: Vitamin A in the entire body (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding Around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine
Brief Summary: Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives:

1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life.
2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.


Options:
A: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
B: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)
C: Laboratory-confirmed episode of severe rotavirus gastroenteritis (From 28 days post-Dose 3 until 117 cases are accrued or when all participating infants reach 2 years of age if 117 cases are not attained)
D: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding Around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine
Brief Summary: Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives:

1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life.
2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.


Options:
A: Occurrence of RV GE
B: Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody (28 days post-vaccination); Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody (28 days post-vaccination)
C: Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
D: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding Around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine
Brief Summary: Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives:

1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life.
2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.


Options:
A: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
B: Endpoint: immunogenicity and reactogenicity; Proportion of subjects with vaccine take
C: Percentage of Participants Developing New Grade >=3 Adverse Events (From study entry until at least 42 days after third vaccination); Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1. (Prior to first vaccination and at least 14 days after third vaccination)
D: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Incidence of Postoperative Cognitive Dysfunction in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia: A Randomized, Controlled Trial
Brief Summary: The use of desflurane in elderly subjects (\>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased POCD compared to sevoflurane if the patient's MAP is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range during general anesthesia.


Options:
A: Number of Participants With Delirium (5 days)
B: POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia (Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.)
C: BIS side difference (intra- and postoperative (day 1))
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
Brief Summary: This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria) in children aged 3-6 years, attending day care centers.Volunteers received either 200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a 1-month follow-up.


Options:
A: Evaluate the efficacy of fermented milk and rice administered daily for a total duration of 3 months on the appearance of common respiratory and gastrointestinal infections in schoolchildren aged between 12 and 48 months. (3 months)
B: N/A
C: Common infections
D: The mean number of episodes and duration of acute diarrheal disease (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Sham Controlled Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures
Brief Summary: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive technique for pain treatment in which bone cement is injected in the fractured vertebra. Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV while an unmasked but controlled RCT found significantly better pain relief after PV at acceptable costs.


Options:
A: To compare the cost-effectivity in the two groups (1 month, 1 year); VAS score in time (1 month, 1 year)
B: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month (1 month after procedure); Patient's Rating of Average Pain at 1 Month (1 month)
C: pain relief (12 months)
D: Patient rated pain intensity (two weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Sham Controlled Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures
Brief Summary: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive technique for pain treatment in which bone cement is injected in the fractured vertebra. Recent RCTs provide conflicting results: two sham-controlled studies show no benefit of PV while an unmasked but controlled RCT found significantly better pain relief after PV at acceptable costs.


Options:
A: Impact into quality of life with the Qualeffo-41 test (Baseline, 2 weeks, 2 months, 6 months and 1 year)
B: Patient rated pain intensity (two weeks)
C: pain relief (12 months)
D: To compare the cost-effectivity in the two groups (1 month, 1 year); VAS score in time (1 month, 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SMART: A Social and Mobile Weight Control Program for Young Adults
Brief Summary: The Social/Mobile Approach to Reduce Weight (SMART) study is a 24-month randomized control trial designed to evaluate the hypothesis that weight status at 24 months will be significantly better for the SMART intervention recipients than for those who receive the comparison condition.


Options:
A: Change in weight status (24 months)
B: Change in weight at 6 months (baseline, 6 months)
C: Weight loss (6 months)
D: Count of Participants Who Completed the Study (Baseline to 6-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Efficacy of Phosphodiesterase-5 Inhibitor Tadalafil in Eisenmenger Syndrome - A Randomised, Placebo Controlled, Double Blind, Crossover Study
Brief Summary: A preliminary observational study by the investigators has shown that tadalafil, a selective phosphodiesterase-5 inhibitor (PDE-5) decreases pulmonary vascular resistance(PVR) in patients of eisenmenger syndrome (ES) resulting in increase in pulmonary blood flow (Qp), systemic oxygen saturation (SaO2), functional class and exercise capacity. The aim of this placebo controlled trial was to assess the effect of the drug on exercise capacity and functional class compared to placebo.


Options:
A: Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort. (Baseline and 60 minutes after drug administered)
B: Combined Outcome End-Point: all-cause mortality or hospital admission for heart failure, worsening of World Health Organization (WHO) functional class, or of the patient global assessment score (Six months)
C: Endurance time (3 months)
D: The primary end point of efficacy was improvement in exercise tolerance as assessed by the un-encouraged 6 minute walk test (6MWT) compared to baseline after 6 weeks of treatment (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of the Dynamics of Sitting Postural Control in Infants With Cerebral Palsy
Brief Summary: The overall goal of this research is to understand the mechanisms underlying the development of postural control in sitting using new methodology, in order to provide a scientific basis for evaluation and treatment of posture and movement disorders in infants with cerebral palsy. The development of early posture control remains poorly understood despite considerable therapeutic effort. Infants with cerebral palsy show their first delays in the acquisition of sitting, with subsequent problems developing adequate posture and movement control. Identifying the delay, determining the nature of the problem, and evaluating the effectiveness of treatment quickly, are vital in the early part of an infant's life, since this is the time of greatest plasticity. Tools from nonlinear dynamics, which are increasingly being used to examine other biological rhythms, are used in this study to analyze postural sway from center of pressure data during the development of sitting postural control.


Options:
A: Gross Motor Function Measure, Sitting Section (2 months)
B: Gross Motor Function Measure-66 (GMFM) (Basline and Post Intervention); 600 Yard Walk-Run Test (Baseline and Post Intervention); 30 Second Walk Test (Basline and Post Intervention); Knee Flexor and Knee Extensor Torque (Basline and Post Intervention); Pediatric Quality of Life Inventory (PedsQL) (Basline and Post Intervention); Pediatric Outcomes Data Collection Instrument (PODCI) (Basline and Post Intervention)
C: Upper extremity functional status (30 minutes)
D: health of children (Pediatric Quality of Life Inventory) (changes from baseline at one and two months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru
Brief Summary: The objective of this study is to compare the effects of a web-based laboratory information system (e-Chasqui) between a network of health establishments with access to e-Chasqui (intervention group) and a network of health establishments without access to e-Chasqui (control group).

The specific aims are:

1. To compare the "laboratory turn-around-time" (from the date a culture or drug susceptibility test (DST) result is obtained to the date the result is obtained at the health center) of samples pertaining to health establishments in the intervention versus the control group.
2. To compare the "clinical turn-around-time" (from the date the DST result is obtained to the date the patient is evaluated by a physician in possession of that result) among multi-drug-resistant tuberculosis (MDR-TB) patients pertaining to health establishments in the intervention versus control group.
3. To compare the laboratory reporting errors (defined as incorrect smear, culture, or DST results) between health establishments in the intervention versus control group.
4. To qualitatively assess the acceptability and usability of e-Chasqui among users in health establishments with access to the system.

The investigators aim to test the following hypotheses:

1. The laboratory turn-around-time for health establishments with e-Chasqui access will be smaller than that for establishments without e-Chasqui access.
2. The clinical turn-around-time for patients pertaining to health establishments with e-Chasqui access will be smaller than that for patients in establishments without e-Chasqui access.
3. Health establishments with e-Chasqui access will have fewer errors compared to those without e-Chasqui access.
4. Factors associated with acceptability and usability of e-Chasqui by systems users can be identified.


Options:
A: Age standardized mortality rates in those aged <60 years. (4 years)
B: Median "Laboratory turn-around-time" (TAT) (Days from the date a culture or drug susceptibility test (DST) result is obtained to the date when the result is obtained at health center); Percent laboratory errors, by type of error for health establishments in the intervention versus the control group. (2.5 years)
C: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
D: MEMS Adherence (12 months follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients
Brief Summary: The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.


Options:
A: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)
B: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 6 months); Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period (From Day 1 up to 6 months)
C: Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms (26 weeks, or 7 days after the last treatment dose, whichever occurred later)
D: Forced expiratory volume in 1 second (FEV1) at final visit. (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tripartite International Research for the Elimination of Trachoma
Brief Summary: Mass antimicrobial administrations have been remarkably successful in reducing the prevalence of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively lower the prevalence of infection, and in some cases may even result in local elimination. Mass treatments cannot be continued forever, due to concerns about cost and antibiotic resistance. The hope has been that other measures such as latrine construction and hygiene programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has yet demonstrated an effect on infection.

1. We hypothesize that Chlamydial infection will return to communities when treatment ends.
2. We hypothesize that infection will be completely eliminated in all communities treated for seven years.
3. We hypothesize that identifying and treating clinically active cases among preschool aged children will delay or even prevent reemergence at a far lower cost than mass treatment of all individuals.


Options:
A: clinical trachoma (1 year)
B: The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 42 months for Aim 1, at 12 months for Aim 2, post-treatment relative to pre-treatment for Aim 3) (42 months)
C: The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and Aim 3) (36 months)
D: Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline (At baseline); Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study
Brief Summary: A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. The current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.


Options:
A: Rehospitalizations and psychotic relapse at two years
B: Relapses (9 months); Positive and negative symptoms (change from baseline at 9 month follow-up)
C: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
D: Functioning (social and occupational) (baseline, 12-month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study
Brief Summary: A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. The current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.


Options:
A: Repeated fatal or non fatal suicidal act (one year)
B: USCD Performance-Based Skills Assessment (2009)
C: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
D: Functioning (social and occupational) (baseline, 12-month)

Answer: D