TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Nursing Home Pain Management Algorithm Clinical Trial
Brief Summary: Pain assessment and management deficiencies in nursing homes (NHs) are well documented. Unrelieved pain in this setting results in poorer resident outcomes, including depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm coupled with intense diffusion strategies in improving pain, physical function and depression among NH residents. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.


Options:
A: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
B: Change in the Cornell Scale for Depression in Dementia (CSDD) (Week -2, week 0, week 6 and week 13)
C: Cohen-Mansfield Agitation Inventory - long form (CMAI) (CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.)
D: Change from Baseline in Pain at 3 months (3 months); Change from Baseline in Pain at 6 months (6 months post intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
Brief Summary: the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV


Options:
A: Sustained Virological Response (SVR12) (60 weeks)
B: Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population. (Follow-up Week 24)
C: Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients) (Baseline and up to 4 weeks); Occurrence of Adverse Events (AEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period (from day 1 and up to 4 weeks + 4 days washout); Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time (Baseline and up to 4 weeks)
D: Percentage of Participants With Sustained Viral Response (SVR) at Week 72 (Week 72)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
Brief Summary: the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV


Options:
A: Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population. (Follow-up Week 24)
B: Sustained Virological Response (SVR12) (60 weeks)
C: Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis (Day 28); Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses) (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis (Day 28); Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses (Day 28); Number of Participants With HCV Genotype 1 With Virologic Response (Day 7, 14 and 21); Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale (Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)); Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period (Up to Day 28); Change From Baseline in QTcF Interval at Day 2 and 28 (Baseline (Day 1, Pre-dose ), Day 2 and Day 28)
D: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Amoxicillin Versus Benzyl Penicillin for Severe Childhood Pneumonia Amongst Inpatients: An Open Label Randomised Controlled Non-inferiority Trial
Brief Summary: This study seeks to determine whether clinical outcome following initial treatment of severe pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin. The study will also provide an estimate of the proportion of Kenyan children with severe pneumonia who fail treatment with a single antibiotic.


Options:
A: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end-of-therapy (EOT))
B: Treatment Failure at 48 Hours (Two Full Days After Enrollment) (48 hours)
C: Treatment failure (within 48 hours)
D: Adverse Events (Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of a Delivery System on the Efficacy of a Probiotic Intervention
Brief Summary: In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human volunteers. In addition to providing information about the relative efficacy of the delivery vehicles on probiotic function it will provide novel information about the influence of the yogurt smoothie alone (control) on all the parameters measured.


Options:
A: Number of Participants With Positive Blood Culture for L Reuteri (Participants are followed an average of 36 days); Mean Daily Temperature (Study days 1-5, 8,12, 15, 18, 28, and 36)
B: Common infections in children
C: N/A
D: Gastrointestinal transit time (Weeks 4, 10, 16, 22)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial
Brief Summary: Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.


Options:
A: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))
B: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
C: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
D: Positive and Negative Syndrome Scale - Excited Component (Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study
Brief Summary: The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.


Options:
A: Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment (Day 0, Week 12)
B: Difference between treatment groups in responder rates. (3 Months)
C: Patient's Global Impression of Change (PGIC)
D: Pain intensity (between the first visit and three months after the beginning of the strategy.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study
Brief Summary: The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.


Options:
A: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)
B: Patient's Global Impression of Change (PGIC)
C: Difference between treatment groups in responder rates. (3 Months)
D: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study
Brief Summary: The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.


Options:
A: Patient's Global Impression of Change (PGIC)
B: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
C: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)
D: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PRINCESS - Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study
Brief Summary: Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest patients has recently been published in the PRINCE-study in Circulation 2010.

The main purpose of this study is to determine whether prehospital intra-nasal cooling initiated during resuscitation, in addition to systemic cooling at hospital, increases neurological intact survival measured as cerebral performance category score (CPC-score)at 90 days in witnessed cardiac arrests outside hospital.


Options:
A: Achieve Return of Spontaneous Circulation (ROSC) (1-hour after arrest); Survived to Hospital Discharge (30 days after arrest); Survived Neurologically-Intact (30-days after arrest)
B: Number Alive at Hospital Discharge (at hospital discharge)
C: Neurologically intact survival (CPC-cerebral performance categories scale 1-2) (90 days after cardiac arrest)
D: All-cause mortality (Maximum follow-up with a minimum of 180 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome
Brief Summary: A prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP III). After a written informed consent, women will be randomly treated for 6 months with hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40 treated with myo-inositol 2 g twice per day and forty treated with placebo for six months. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance.


Options:
A: An improvement of endothelial function as measured by flow-mediated dilation (FMD) (1 month)
B: percentage reduction of women with metabolic syndrome (at baseline and after 6 months.)
C: N/A
D: endothelial function (acute (2 hours), chronic (2 and 4 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression
Brief Summary: This pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression.


Options:
A: Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification (4 weeks prior to Baseline); Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions (12 weeks)
B: PHQ9 Depression Score (3 months post-partm)
C: At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS) (8 week & 12 months)
D: Change from baseline in Patient Health Questionnaire (PHQ-9) (Weekly during treatment period of 12 weeks); Change from baseline in Patient Health Questionnaire (PHQ-9) (24 hours); Change from baseline in Patient Health Questionnaire (PHQ-9) (12 months); Change from baseline in Patient Health Questionnaire (PHQ-9) (24 months); Change from baseline in Patient Health Questionnaire (PHQ-9) (Monthly, 0-24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial
Brief Summary: This study investigated the efficacy of an exercise and counseling intervention for depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of intervention: individually delivered exercise and counseling (for smoking cessation and physical activity) or control: health education contact control condition.


Options:
A: Adherence to the Mediterranean Diet, physical activity, stress management, and smoking cessation protocols (Measured at baseline, 6, 12, and 24 months); Hemoglobin A1c (Measured at baseline, 6, 12, and 24 months)
B: Salivary Cotinine (12 months posttreatment)
C: Evaluation of smoking cessation verified by expired air carbon monoxide (12 weeks after baseline)
D: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial
Brief Summary: This study investigated the efficacy of an exercise and counseling intervention for depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of intervention: individually delivered exercise and counseling (for smoking cessation and physical activity) or control: health education contact control condition.


Options:
A: Summarization of safety data in smokers treated with either varenicline or placebo.
B: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
C: Evaluation of smoking cessation verified by expired air carbon monoxide (12 weeks after baseline)
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial
Brief Summary: This study investigated the efficacy of an exercise and counseling intervention for depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of intervention: individually delivered exercise and counseling (for smoking cessation and physical activity) or control: health education contact control condition.


Options:
A: child urine cotinine (baseline to 16 weeks)
B: The Symptom Check List 90 (SCL90-r), The Alcohol Use Disorder Identification Test (AUDIT), The Drug Use Disorder Identification Test (DUDIT). (Change during 6 and 12 months follow-up)
C: 7-day Point Prevalence Smoking Abstinence at 8 Weeks (8 weeks); 7-day Point Prevalence Smoking Abstinence at 16 Weeks (16 Weeks); 7-day Point Prevalence Smoking Abstinence at 26 Weeks (26 Weeks)
D: Evaluation of smoking cessation verified by expired air carbon monoxide (12 weeks after baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Dementia: Life- and Personcentered Help in Germany
Brief Summary: Caring for people with dementia and treating them is a major challenge for the health care system in Germany. Among the challenges for population-based health care research are (a) identification and early recognition, (b) multimorbidity and (c) the integration of persons with dementia into the health care system. One setting which is identified to meet the challenges is the primary care setting and there especially the general physician. There have been a few interventional studies, which have been restricted to selective samples and have been conducted in inpatient settings.

The purpose of this study is to test the efficacy of implementing a subsidiary support system for persons with dementia living at home. This subsidiary support system is initiated by a Dementia Care Manager (DCM), a nurse with dementia-specific advanced training. The main goals are to improve quality of life and health care of the person with dementia and reduce caregiver´s burden.

The study is a general physician based cluster-randomised controlled intervention trial. A population based sample of general physicians will be asked to participate in a systematic screening trial to identify people with dementia in primary care in Mecklenburg Western Pommerania (MV), a federal state in Germany. Upon identification the people will be asked to participate in the DelpHi-MV study and after having given written informed consent will then be assigned to an intervention and a control group. Identification of people with dementia will be achieved by a short screening questionnaire in the physician's office. An extended in-depth data assessment will be conducted after inclusion into the study and then annually to measure the course of the people's health. Data assessment will be done at the people's homes.

People assigned to the intervention group will receive an intervention provided by "Dementia Care Manager". The Dementia Care Manager is a specialised nurse that is going into the person's home to manage the care of dementia as well as caring for the person's relative/ or carer.


Options:
A: Change in Quality of Life (one year after baseline assessment); Change in Caregiver Burden (one year after baseline assessment); Change in Behavioral and Psychological Symptoms of Dementia (one year after baseline assessment); Change in Medical Treatment With Antidementia Drugs (one year after baseline assessment); Reduction of Potential Inapropriate Medication (PIM) (one year after baseline assessment)
B: Emergency medical visits (12 months after hospital discharge)
C: Medication Appropriateness Index (MAI) score (Change from baseline MAI score at 6 months)
D: Number of unplanned hospital admissions (Recruitment - 6 months post intervention); Number of A&E attendances (Recruitment - 6 months post intervention); Number of GP consultations (Recruitment - 6 months post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Advanced Lung and Non-colorectal Gastrointestinal Malignancies
Brief Summary: The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.


Options:
A: Neuropsychiatric symptoms (9 months); Quality of life (9 months)
B: Post Traumatic Stress Disorder (90 days after baseline)
C: Functional Assessment of Cancer Therapy (Quality of Life Measure) (12 weeks)
D: Number of empathic statements and responses to patients' expressions of negative emotion (Postintervention audio recordings and follow-up surveys)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Transcervical Foley Balloon Compared to Controlled Release Prostaglandin (Cervidil) for Labor Induction and Cervical Ripening in Term and Near Term Women
Brief Summary: OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction.

HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).


Options:
A: Delivery rate (proportion) (Within 24 hours)
B: Time Of Start Of Induction Of Labor To Delivery (Hours)
C: Time From Start of Labor Induction to Vaginal Delivery (72 hours)
D: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)

Answer: B