TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
Brief Summary: PTSD is a common consequence of war, for soldiers and civilians. PTSD results in hyperarousal, avoidance, numbing, and re-experiencing, causing persistent decreased quality of life. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health. Within health care, mindfulness is taught as an 8-week course called Mindfulness-Based Stress Reduction (MBSR). MBSR is unstudied for PTSD. We propose to assess the feasibility of MBSR as an intervention for PTSD, since it may affect hypervigilance, avoidance, and reactivity associated with this disorder.

Specific Aims: Aim 1: Assess the feasibility of recruiting and retaining a sample of veterans with PTSD to complete a study protocol that involves randomization to usual care or usual care plus MBSR. Aim 2: Apply measures of PTSD symptom severity, depression and quality of life before and after randomization, to assess whether there is evidence of benefit and whether MBSR warrants further study for PTSD, and allow calculation of standardized effect sizes. Aim 3: Apply a validated measure of mindfulness before and after treatment. Aim 4: Explore the relationship between PTSD symptoms, mindfulness score, and frequency of meditation practice.


Options:
A: Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up (Baseline to 2 months post second experimental session)
B: PTSD symptom score (baseline, after MBSR and 4 months later)
C: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)
D: outcome (within study timeframe)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effective Strategy to Evaluate Veterans With Sleep Apnea
Brief Summary: This research study is comparing home and in-laboratory testing of veterans with suspected obstructive sleep apnea, a common breathing disorder during sleep. It is hoped that home testing will be equally effective in improving quality of life but have lower cost than in-lab testing. These findings will allow veterans to have greater access to diagnosis and treatment of their sleep apnea.


Options:
A: Acceptance of CPAP treatment (from diagnosis to effective treatment)
B: Objective CPAP Use (12 months)
C: Cost (Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years.)
D: CPAP usage (12-week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study of 3 Dosages of JNJ-31001074 in the Treatment of Adult Subjects With Attention-Deficit/Hyperactivity Disorder
Brief Summary: The purpose of this study is to evaluate the efficacy and safety/tolerability of 3 different dosages of JNJ-31001074 compared with placebo in adult patients with attention-deficit/hyperactivity disorder (ADHD).


Options:
A: Change from baseline in the ADHD rating scale total score (Through Day 42)
B: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
C: Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment (Baseline 1 to End of Period 1 (Week 9)); Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment (Baseline 1 to End of Period 1 (Week 9)); Percentage of Participants With Treatment Failures During Period 3 (Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40)
D: Number of Participants With Adverse Events, Serious Adverse Events and Deaths. (Week 40 - Week 66)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of the Effectiveness of Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease: a Double-blind, Placebo-controlled Randomised Trial
Brief Summary: The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD).


Options:
A: 1) Major Bleeding Episodes (Up to 35 days); Change in Platelet Count (Up to 35 days)
B: Patient controlled analgesia (PCA)diamorphine or morphine consumption (4 days)
C: To determine whether there is a difference in time to first occurrence of a large improvement in daily average pain intensity between a High Demand/Low Infusion (HDLI) dosing vs. Low Demand/High Infusion (LDHI) dosing for parenteral opioid. (Pain Intensity will be assessed 3 times a day between the hours of 7 AM and 7 PM on each day of the hospital stay)
D: Reduction in time to resolution of vaso-occlusive crisis (Up to 7 days or resolution)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Secondary Transmission of Human Influenza by Promoting Handwashing With Soap: The Bangladesh Interruption of Secondary Transmission of Influenza Study (BISTIS)
Brief Summary: The next influenza pandemic is expected to spread rapidly in resource-poor settings. Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via large-particle respiratory droplets is believed to be mediated by close contact between infected and susceptible persons or contact with droplet-contaminated fomites. Close contact between infected and susceptible persons may consist of skin-to-skin contact (e.g., via hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by the infected person). Airborne transmission, which is expected to result in transmission over long distances (\>1 meter) and which would be mediated by ventilation, is believed to be uncommon. Therefore, the greatest risk of transmission from personal contact comes from those people who are closest to an index case, such as contacts living in the same household. There are, to date, no published estimates of the secondary attack ratio of influenza among household contacts of index case-patients in low-income countries. Moreover, the investigators do not have data on the risk factors for secondary transmission of influenza from index case-patients to their household contacts. There is some data for the benefits of promoting handwashing with soap on the risk of all-cause acute respiratory illness among children \< 15 years old in a resource-poor setting in Pakistan. But, the investigators do not have evidence that promoting handwashing with soap will acutely reduce the risk of secondary transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to assess the following:

* The secondary attack ratio of influenza among household contacts of an index case-patient with influenza
* The risk factors for secondary transmission of influenza from an index case-patient to household contacts
* The impact of promoting handwashing with soap on the risk of secondary transmission of influenza from an index case-patient to household contacts
* The impact of handwashing promotion on handwashing behavior six months after intervention
* The impact of handwashing promotion on the prevalence of respiratory infections, diarrhea and influenza


Options:
A: the episodes due to respiratory tract infections (8 moth); The episodes due to gastroenteritis (8 month)
B: the incidence rates of influenza infection (Until 3 months gargling)
C: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)
D: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Secondary Transmission of Human Influenza by Promoting Handwashing With Soap: The Bangladesh Interruption of Secondary Transmission of Influenza Study (BISTIS)
Brief Summary: The next influenza pandemic is expected to spread rapidly in resource-poor settings. Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via large-particle respiratory droplets is believed to be mediated by close contact between infected and susceptible persons or contact with droplet-contaminated fomites. Close contact between infected and susceptible persons may consist of skin-to-skin contact (e.g., via hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by the infected person). Airborne transmission, which is expected to result in transmission over long distances (\>1 meter) and which would be mediated by ventilation, is believed to be uncommon. Therefore, the greatest risk of transmission from personal contact comes from those people who are closest to an index case, such as contacts living in the same household. There are, to date, no published estimates of the secondary attack ratio of influenza among household contacts of index case-patients in low-income countries. Moreover, the investigators do not have data on the risk factors for secondary transmission of influenza from index case-patients to their household contacts. There is some data for the benefits of promoting handwashing with soap on the risk of all-cause acute respiratory illness among children \< 15 years old in a resource-poor setting in Pakistan. But, the investigators do not have evidence that promoting handwashing with soap will acutely reduce the risk of secondary transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to assess the following:

* The secondary attack ratio of influenza among household contacts of an index case-patient with influenza
* The risk factors for secondary transmission of influenza from an index case-patient to household contacts
* The impact of promoting handwashing with soap on the risk of secondary transmission of influenza from an index case-patient to household contacts
* The impact of handwashing promotion on handwashing behavior six months after intervention
* The impact of handwashing promotion on the prevalence of respiratory infections, diarrhea and influenza


Options:
A: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)
B: Secondary infection with influenza of the household members who are healthy at the start of the study
C: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events (60 weeks)
D: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of a Live, Attenuated Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1-Infected Mothers
Brief Summary: Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries. Annually, rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care, 25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of deaths occur in developing countries. Although rotavirus infection is not more common in HIV-infected children, it complicates their care and interferes with their nutrition. Chances of death by these infections can be greater in HIV-infected children when they also suffer from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate, RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.


Options:
A: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo (Within 42 days following any dose of RotaTeq™/placebo); Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination (At least 14 days following the 3rd vaccination through the first full rotavirus season)
B: 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)
C: Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
D: Hospitalization for gastroenteritis (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of a Live, Attenuated Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1-Infected Mothers
Brief Summary: Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries. Annually, rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care, 25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of deaths occur in developing countries. Although rotavirus infection is not more common in HIV-infected children, it complicates their care and interferes with their nutrition. Chances of death by these infections can be greater in HIV-infected children when they also suffer from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate, RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.


Options:
A: Seroprotection for each polio serotype 1 month after the 3rd dose.
B: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
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: Rotavirus vaccine lots Immunogenicity (Four weeks after the third dose of vaccination); Immunogenicity of UIP vaccines (Four weeks after the third dose of vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of a Live, Attenuated Rotavirus Vaccine (RotaTeq™) in HIV-1 Infected and Uninfected Children Born to HIV-1-Infected Mothers
Brief Summary: Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries. Annually, rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care, 25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of deaths occur in developing countries. Although rotavirus infection is not more common in HIV-infected children, it complicates their care and interferes with their nutrition. Chances of death by these infections can be greater in HIV-infected children when they also suffer from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate, RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.


Options:
A: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
B: 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)
C: Seropositivity as anti-rotavirus IgA concentration >/= 20 U/ml (6, 10, 14 and 18 weeks)
D: 116E rotavirus vaccine (6,10 and 14 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: European Post Market Study: A Prospective, Randomized, Controlled, Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema
Brief Summary: The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.


Options:
A: The difference between the response rates of the treatment and control groups. (3-months post randomization)
B: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years)
C: mortality (3 months); Hospital stay (2 months); Forced expiratory volume in one second (24 months); Residual volume (24 months); Modified Medical research Council Dyspnea index (24 months)
D: Lung Volume Change (30 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: European Post Market Study: A Prospective, Randomized, Controlled, Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema
Brief Summary: The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.


Options:
A: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years post treatment)
B: The difference between the response rates of the treatment and control groups. (3-months post randomization)
C: Forced expiratory volume in 1-second (FEV1) compared to active comparator (Year 1); Quality of Life (SGRQ) (Year 1)
D: 1. Systemic inflammation 2. Vascular function (Before and 3 months after surgery/no surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Seroquel XR for the Management of Borderline Personality Disorder (BPD)
Brief Summary: The Primary objective of this study is to evaluate Seroquel XR in the treatment of borderline personality disorder (BPD). As in many initial randomized control trials, the study will be of relatively short duration - 8 weeks - to assess effectiveness and safety while maximizing retention. The specific aim is to determine if Seroquel XR is superior to placebo. The primary outcome measure will be a statistically significant difference between Seroquel XR compared to placebo on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), an objective rating scale that addresses the severity of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of the illness. As there is the recent development of an extended release form of Seroquel (Seroquel XR) (Schulz et al. 2007), the new compound may offer several advantages in this study. Therefore, the hypothesis of this study is that both doses of Seroquel XR (see below) will be superior to placebo in an 8-week randomized trial as assessed by the ZAN-BPD.

To achieve the Primary Objective of this study, two doses of Seroquel XR will be tested - 150 mg/d and 300 mg/d. Thus, the study will be able to assess the effect of Seroquel XR compared to placebo and to explore a dose effect.


Options:
A: PTSD Symptoms (CAPS, SCID, PDS, IESR) (1.5 years)
B: Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (baseline, weekly until week 8); Montgomery-Åsberg Depression Rating Scale (MADRS) (baseline to 8 weeks); Borderline Evaluation of Severity Over Time (BEST) (Baseline to 8 weeks); Overt Aggression Scale - Modified (OAS-M) (Change from Baseline Overt Aggression Scale - Modified to 8 weeks); Global Assessment of Functioning Scale (GAF) (Change in Global Assessment of Functioning from Baseline to 8 weeks); Barratt Impulsiveness Scale (BIS) (Change in Impulsiveness from Baseline to 8 weeks); Symptom Checklist -90-Revised (SCL-90-R) (Change in psychological problems and symptoms from Baseline to 8 weeks); Young Mania Rating Scale (YMS) (Change in manic symptoms from Baseline to 8 weeks); Sheehan Disability Scale (SDS) (Change in functional impairment from Baseline to 8 weeks)
C: Beck scale for suicidal ideation (six months)
D: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)

Answer: B