TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
Brief Summary: The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation.


Options:
A: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (weeks 1-3)
B: Levels of progesterone in the mid-luteal phase. (up to 1-1½years.)
C: ongoing pregnancy rate (1 year)
D: Pituitary Response to GnRH (Peak hormone level within 2 hours post GnRH doses); Effect of Estrogen on Pituitary Response to GnRH (Peak hormone level within 2 hours post GnRH doses)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction
Brief Summary: The overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a myocardial infarction (MI).


Options:
A: BDI-II score at 6 months (Baseline, 3 months, 6 months, 9 months , 12 months)
B: Hamilton Rating Scale for Depression (HAM-D-17) (12 weeks post-randomization)
C: Perceived control measure by Control Attitude Scale (3 months)
D: Change in Depression (difference between the intervention and the control group) (At baseline and 3 months later (after intervention)); Change in Anxiety (difference between the intervention and the control group) (At baseline and 3 months later (after intervention))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction
Brief Summary: The overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a myocardial infarction (MI).


Options:
A: Perceived control measure by Control Attitude Scale (3 months)
B: Change in Depression (difference between the intervention and the control group) (At baseline and 3 months later (after intervention)); Change in Anxiety (difference between the intervention and the control group) (At baseline and 3 months later (after intervention))
C: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)
D: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction
Brief Summary: The overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a myocardial infarction (MI).


Options:
A: Change in Depression (difference between the intervention and the control group) (At baseline and 3 months later (after intervention)); Change in Anxiety (difference between the intervention and the control group) (At baseline and 3 months later (after intervention))
B: Score on the Hamilton Depression Rating Scale-17 item (24 weeks)
C: Symptoms of depression (3 months)
D: Beck Depression Inventory-II (BDI-II) (Change from baseline to 10 weeks (post-treatment))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia
Brief Summary: The aim of this randomized controlled study is to investigate if medication reviews performed by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive failure.

Four hundred and sixty patients will be recruited and randomized to control (usual care) and intervention group (enhanced service in which a pharmacist is part of the health care team).

Six months after the last patient of the 460 has been discharged the study will be closed. Data about the number of readmissions and visits to the emergency room will be collected during the six-month follow-up and also, the costs associated with each visit or admission. Time until institutionalization will be compared between intervention group and control group.


Options:
A: Number of Patients Readmitted Because of Drug Related Reasons (Six months follow-up)
B: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)
C: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
D: Days outside hospital until an eventual first readmission (12 months after hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Manipulative Treatment of Children With Neck and Back Pain. A Randomised Controlled Trial of 1200 Children From 3rd to 7th Grade
Brief Summary: The purpose of this study is to determine the effect of manipulative treatment of children with neck and back pain. Because manipulation is the most frequently used treatment of musculoskeletal complaints in children, and an increasing number of Danish children see a chiropractor, it appears obvious to start the search for evidence by examining the effect of this treatment.


Options:
A: PATIENT-RATED LOW BACK PAIN (3 and 12 months)
B: Accrual rates; Compliance with therapy; Acceptability of exercise program; Degree of conditioning of subjects at baseline; Proportion of completed exercise tests and questionnaires; Dropout rates; Estimates of the effect sizes for exercise tests and questionnaire data
C: Childhood Health Assessment Questionaire (CHAQ) (8 weeks); Canadian Occupational Performance Measure (COPM) (8 weeks)
D: Number of recurrences during the follow-up period. (2 1/2 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Randomized Study with Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer
Brief Summary: This Phase III trial aims to:

Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.

To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.


Options:
A: locoregional recurrence-free survival (2 years); number of patients with grade 3 toxicity or more (2 years)
B: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))
C: Overall Response Rate (ORR) (Up to 36 months); Response to Treatment (Up to 36 months)
D: Local Regional Control Rate at 2 Years (from study day 1 to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Cancer Disparities Among Latinos in Texas
Brief Summary: The goal of this research study is to learn if a wellness program can help improve diet and physical activity levels and encourage smoking cessation in Latino individuals who are overweight.


Options:
A: Body weight (4 months); Physical activity (4 months); Caloric intake (4 month)
B: Glycemic Control (12 months.)
C: Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction (6 months)
D: Hemoglobin A1c (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension
Brief Summary: INSPiRED is a multicenter parallel-group trial comparing usual medical treatment (control group) or usual medical treatment plus renal denervation (intervention). In both groups adherence will be monitored both before randomization and during 36 months of follow-up.


Options:
A: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) (The primary endpoint has been assessed 6 months after randomization.); Change in Glomerular Filtration Rate (This endpoint has been assessed 6 months after randomization.)
B: To provide confirmation that renal denervation is safe and feasible. (3 years)
C: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (From baseline to 3 months post-procedure)
D: Change in atrial fibrillation burden (from Baseline and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension
Brief Summary: INSPiRED is a multicenter parallel-group trial comparing usual medical treatment (control group) or usual medical treatment plus renal denervation (intervention). In both groups adherence will be monitored both before randomization and during 36 months of follow-up.


Options:
A: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (From baseline to 6 months post-procedure)
B: Blood Pressure Reduction (3 months)
C: Change in systolic blood pressure (ABPM mean value) (6 months)
D: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) (The primary endpoint has been assessed 6 months after randomization.); Change in Glomerular Filtration Rate (This endpoint has been assessed 6 months after randomization.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms
Brief Summary: Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.


Options:
A: Addiction Severity Index (ASI) - Alcohol (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Addiction Severity Index (ASI) - Drugs (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Change on Urine Drug Test (change) (Baseline, 2 months, 4 months, 6 months, 12 months)
B: Feasibility of attrition (12 Months)
C: Smoking Abstinence (2 weeks post quit day)
D: Pain severity, pain functional interference (Baseline, immediately following treatment, and at 3 month follow-up); Opioid craving (Baseline, immediately following treatment, and at 3 month follow-up); Opioid misuse behaviors (Baseline, immediately following treatment, and at 3 month follow-up); Well-being (Baseline, immediately following treatment, and at 3 month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization
Brief Summary: In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.


Options:
A: Prevalence of atopic disease in infant (two years)
B: Changes in Body Toxin Levels (Before and after the 25 day intervention period.)
C: Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts (Weekly during the first 6 months after birth)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study
Brief Summary: The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.


Options:
A: Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week (baseline and week 8)
B: Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms (baseline and 4 week)
C: Frequency and intensity of abdominal pain (Eight weeks)
D: Abdominal Pain Frequency (16 weeks from the enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
Brief Summary: To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.


Options:
A: Composite of all strokes and non-CNS systemic embolism.
B: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
C: Bleeding Events (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)); Creatinine (12 weeks according to protocol.(baseline to week 12 visit)); Alanine Aminotransferase (ALAT) (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)); Bilirubin (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit))
D: Percentage of Patients With Any Adverse Event (AE) (From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
Brief Summary: To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.


Options:
A: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)
B: Time to First Adjudicated ISTH MBE or CRNMBE (up to 30 months)
C: Percentage of Patients With Any Adverse Event (AE) (From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))
D: Number of participants with newly onset of symptomatic venous thromboembolism (VTE) (Up to 12 months); Number of clinically relevant bleedings (Up to 2 days after last dose)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve
Brief Summary: To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.


Options:
A: Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1 (Week 1); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2 (Week 2); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4 (Week 4); Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12 (Week 12)
B: Percentage of Patients With Any Adverse Event (AE) (From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))
C: Anticoagulation-related quality of life (Four months)
D: Proportion of INR values which are in therapeutic range

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
Brief Summary: The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.


Options:
A: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)
B: Serum fasting glucose values. (Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation))
C: Gestational diabetes diagnosis assessed through glucose tolerance test. (28 weeks gestational age)
D: Glycemic control (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Portable Mantram Meditation for Veterans With Military Related PTSD
Brief Summary: The aim of this study was to determine the usefulness of a portable, meditation-based intervention called the Mantram Repetition Program (MRP) for Veterans with military-related posttraumatic stress disorder (PTSD). This study compared the individual delivery of the MRP to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego, California, and Bedford, Massachusetts.


Options:
A: PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up (Baseline, Weeks 3, 6, 9 and 17)
B: Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment (Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE)
C: Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); baseline to 2 months post-treatment.); PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version] (Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.)
D: Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) (Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial
Brief Summary: The use of foley catheter was tested many times and proved to be effective for induction of labour.


Options:
A: Time Of Start Of Induction Of Labor To Delivery (Hours)
B: Number of Participants With a Need for Cesarean Delivery (Induction to delivery)
C: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))
D: caesarean section rate (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Foley Catheter Plus Vaginal Isosorbide Mononitrate Versus Vaginal Misoprostol for Induction of Labour:a Randomised Controlled Trial
Brief Summary: The use of foley catheter was tested many times and proved to be effective for induction of labour.


Options:
A: Caesarean section rate for non-reassuring fetal status. (Up to 2 days after cervical ripening)
B: caesarean section rate (1 year)
C: Rate of vaginal delivery within 24 hours (within 24 hours)
D: feasibility of randomised Induction of Labour Trial in Out-patient setting (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Oscillation for ARDS Treated Early (OSCILLATE) Trial
Brief Summary: What is the effect of early high frequency oscillation (HFO) versus a lung-protective conventional ventilation (CV) strategy (using HFO only as rescue therapy), on all-cause hospital mortality among patients with severe early acute respiratory distress syndrome (ARDS)?


Options:
A: 28-day mortality from all causes (28 days)
B: Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization (8-10 days post-randomization); Survival to days 28 and 60 post-randomization and to Hospital Discharge (28 days to more than 60 days post-randomization)
C: All-cause hospital mortality (Randomised patients will be ventilated according to their assigned ventilation strategy for up to 60 days, until they die on the ventilator or are successfully (for >24 hours) liberated from mechanical ventilation.)
D: Survival to days 28 and 60 post-randomization, and to Hospital Discharge (28 days to more than 60 days post-randomization)

Answer: C