TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbetocin at Cesarean Delivery for Labor Arrest: A Dose Finding Study
Brief Summary: In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national clinical guidelines on important women's health issues, recommended that a bolus of carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be used to achieve the same degree of uterine contractility with less side effects. So far, the ideal dose to be used in cesarean sections for labouring women who have failure to progress in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not descending the birth canal) has not been determined. This study is designed to determine the minimum carbetocin dose required during cesarean delivery for 'failure to progress' to achieve the best effect.


Options:
A: Maximal uterine tone (within the first 5 minutes after cord clamping)
B: Blood loss (During surgery)
C: need for additional uterotonics (30 minutes)
D: Uterine tone. (2 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbetocin at Cesarean Delivery for Labor Arrest: A Dose Finding Study
Brief Summary: In 2009, the Society of Obstetricians and Gynecologists Canada, which produces national clinical guidelines on important women's health issues, recommended that a bolus of carbetocin 100 mcg into your vein should be used at elective cesarean delivery instead of oxytocin infusion for the prevention of bleeding after you deliver your baby. Similar to oxytocin, carbetocin has side effects that are dose-related. Although 100 mcg has been the recommend dose, studies in nonlaboring women suggest that doses lower than 100 mcg may be used to achieve the same degree of uterine contractility with less side effects. So far, the ideal dose to be used in cesarean sections for labouring women who have failure to progress in labour (failure of your cervix to dilate adequately to 10cm or the baby's head not descending the birth canal) has not been determined. This study is designed to determine the minimum carbetocin dose required during cesarean delivery for 'failure to progress' to achieve the best effect.


Options:
A: Incidence of PPH (24 hours after birth)
B: Blood loss (During surgery)
C: Estimated Blood loss (24 hours)
D: need for additional uterotonics (30 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma
Brief Summary: Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot study aims to provide effect size estimates and justification, clinical trial and intervention feasibility data, and procedural materials for a full-scale randomized controlled trial that will determine the efficacy and mechanisms of action of the Dietary Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled asthma.


Options:
A: N/A
B: 7-item Juniper Asthma Control Questionnaire (ACQ) (6-months post-randomizaton)
C: Hemoglobin A1c (22 weeks)
D: weight loss

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma
Brief Summary: Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot study aims to provide effect size estimates and justification, clinical trial and intervention feasibility data, and procedural materials for a full-scale randomized controlled trial that will determine the efficacy and mechanisms of action of the Dietary Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled asthma.


Options:
A: 7-item Juniper Asthma Control Questionnaire (ACQ) (6-months post-randomizaton)
B: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)
C: Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (Baseline to 24 Weeks)
D: asthma free days (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma
Brief Summary: Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot study aims to provide effect size estimates and justification, clinical trial and intervention feasibility data, and procedural materials for a full-scale randomized controlled trial that will determine the efficacy and mechanisms of action of the Dietary Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled asthma.


Options:
A: 7-item Juniper Asthma Control Questionnaire (ACQ) (6-months post-randomizaton)
B: Change in Juniper Asthma Control Score (ACS) (Measured at Weeks 0, 4, 8, 12, 24)
C: Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (Baseline to 24 Weeks)
D: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma
Brief Summary: Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot study aims to provide effect size estimates and justification, clinical trial and intervention feasibility data, and procedural materials for a full-scale randomized controlled trial that will determine the efficacy and mechanisms of action of the Dietary Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled asthma.


Options:
A: 7-item Juniper Asthma Control Questionnaire (ACQ) (6-months post-randomizaton)
B: Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion (Baseline to 24 Weeks)
C: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)
D: Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) (Average follow-up 10.1 years); Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer (Average follow-up 10.1 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.
Brief Summary: The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.


Options:
A: initial PAED score (During 1 minutes after PACU admission)
B: G Power software was used to calculate the sample size of the study. (5 days)
C: technical quality of the LP, classified as success or failure. (immediate)
D: Neonatal Salivary Cortisol Level (Approximately 2 hours before and 15 minutes after the procedure); Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool (CRIES assessment completed prior to the procedure and post procedure.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Sildenafil on Pulmonary Arterial Pressure in Patients With Heart Failure With Preserved Ejection Fraction ( HFpEF) and Pulmonary Hypertension
Brief Summary: Aim of the study is to investigate whether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output (CO) and in improvement of exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF) with pulmonary hypertension ( PH).


Options:
A: Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12) (Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12))
B: Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization (baseline and 12 weeks)
C: Pulmonary hemodynamics (1 year)
D: 6 minutes walking distance

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-Management Support in Primary Care
Brief Summary: Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated.

In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.

The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.


Options:
A: General Self-Efficacy Scale (GSE) (Baseline, 8 Weeks, 12 Months)
B: Whitely Index (Measured immediately post-treatment and at Months 6 and 12 post-treatment)
C: Perceived quality of life (Change from baseline in quality of life at 12 months after the intervention)
D: Physical health measured with The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (aggregate score of the scales physical functioning, bodily pain and vitality) (Measured at baseline and months 4 (end of treatment), 10 and 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection
Brief Summary: This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.


Options:
A: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
B: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)
C: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Baseline to Week 12)
D: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients
Brief Summary: The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.


Options:
A: Fugl-Meyer Assessment (FMA) (At baseline and immediately after the completion of intervention); Motor Status Scale (MSS) (At baseline and immediately after the completion of intervention); Modified Ashworth Scale (MAS) (At baseline and immediately after the completion of intervention); MyotonPRO (At baseline and immediately after the completion of intervention); Muscle metabolism (NIRS) (At baseline and immediately after the completion of intervention); Box and Block Test (BBT) (At baseline and immediately after the completion of intervention); Revised Nottingham Sensory Assessment (RNSA) (At baseline and immediately after the completion of intervention); Functional Independence Measure (FIM) (At baseline and immediately after the completion of intervention); Motor Activity Log (MAL) (At baseline, immediately after the completion of intervention, at a 6-month follow up); ABILHAND Questionnaire (At baseline, immediately after the completion of intervention, at a 6-month follow up); Adelaide Activities Profile (AAP) (At baseline, immediately after the completion of intervention, at a 6-month follow up); EQ-5D-5L (At baseline and immediately after the completion of intervention); Accelerometers (At baseline, immediately after the completion of intervention, at a 6-month follow-up.); Functional magnetic resonance imaging (fMRI) (At baseline and immediately after the completion of intervention); Kinematic analysis (At baseline and immediately after the completion of intervention); Inflammatory markers (At baseline and immediately after the completion of intervention); Oxidative stress markers (At baseline and immediately after the completion of intervention); Erythrocyte deformability (At baseline and immediately after the completion of intervention); Blood glucose indicators (At baseline and immediately after the completion of intervention)
B: Fugl-Meyer Upper Extremity (A week prior to treatment beginning)
C: Subjective Index of Physical and Social Outcome (SIPSO) (Change from baseline to 3 months.); Nottingham Extended Activities of Daily Living (NEADL) (Change from baseline to 3 months.)
D: Median Change in Upper Extremity Fugl Meyer Assessment Score (baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients
Brief Summary: The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.


Options:
A: Motor learning improvement with tDCS (Improvement on motor learning were recorded from baseline to 4 weeks after the intervention)
B: Median Change in Upper Extremity Fugl Meyer Assessment Score (baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention))
C: Four Square Step Test (Change from Baseline in Risk of Falls at 3 months)
D: maximum voluntary isometric strength of knee extensors (2 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation in the Irritable Bowel Syndrome - a Randomized Cross-over Trial
Brief Summary: To elucidate Spinal Cord Stimulation (SCS) as treatment for IBS. An SCS system with a 4-polar electrode at the T5-8 level is implanted. In a randomized, cross-over study design, active stimulation is compared to a period without stimulation, with an ensuing tailing stimulation period, twice as long. Patients recorded average pain level, pain attacks, number of diarrheas and global quality of life. At the end of the study patients can choose to retain their SCS stimulation system or have it removed.

The outcome of the present trial will show whether SCS is a useful treatment of IBS. The long-term follow-up will show the continuous amelioration of SCS over at least six months.


Options:
A: Mean VAS Back Pain (7 Day Subject VAS Pain Diary) (6 months post randomisation)
B: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
C: The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.
D: To investigate if typical abdominal pain of IBS can be ameliorated by SCS? (According to protocol for 26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation in the Irritable Bowel Syndrome - a Randomized Cross-over Trial
Brief Summary: To elucidate Spinal Cord Stimulation (SCS) as treatment for IBS. An SCS system with a 4-polar electrode at the T5-8 level is implanted. In a randomized, cross-over study design, active stimulation is compared to a period without stimulation, with an ensuing tailing stimulation period, twice as long. Patients recorded average pain level, pain attacks, number of diarrheas and global quality of life. At the end of the study patients can choose to retain their SCS stimulation system or have it removed.

The outcome of the present trial will show whether SCS is a useful treatment of IBS. The long-term follow-up will show the continuous amelioration of SCS over at least six months.


Options:
A: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
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: Change in Visual Analog Scale (VAS) score (Pre-implant visit, up to approximately 2 weeks)
D: To investigate if typical abdominal pain of IBS can be ameliorated by SCS? (According to protocol for 26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation in the Irritable Bowel Syndrome - a Randomized Cross-over Trial
Brief Summary: To elucidate Spinal Cord Stimulation (SCS) as treatment for IBS. An SCS system with a 4-polar electrode at the T5-8 level is implanted. In a randomized, cross-over study design, active stimulation is compared to a period without stimulation, with an ensuing tailing stimulation period, twice as long. Patients recorded average pain level, pain attacks, number of diarrheas and global quality of life. At the end of the study patients can choose to retain their SCS stimulation system or have it removed.

The outcome of the present trial will show whether SCS is a useful treatment of IBS. The long-term follow-up will show the continuous amelioration of SCS over at least six months.


Options:
A: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
B: To investigate if typical abdominal pain of IBS can be ameliorated by SCS? (According to protocol for 26 weeks)
C: Changes in pain (6 months)
D: Visual Analogic Scale Low Back pain (Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness of Management Strategies for Acute Low Back Pain
Brief Summary: Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.


Options:
A: Oswestry Disability Index (3 months)
B: Modified Oswestry Disability Index (12 months)
C: Change in functional limitations and symptoms measured with the Oswestry Disability Index (ODI) version 2.1 (Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up)
D: Change from baseline on the Modified Oswestry Disability Index (ODI) (Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months); Change from baseline on the Numeric Pain Rating Scale (NPRS) (Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Three-arm, 16 Week, Adaptive Phase III Clinical Study to Investigate the Efficacy and Safety of LAS41008 vs LASW1835 and vs Placebo in Patients With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis


Options:
A: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)
B: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
C: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
D: Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) (Week 12); Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) (Week 12)

Answer: A