TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effectiveness of Early Interventions for Non-specific Low Back Pain: A Randomized Controlled Study Investigating Medical Yoga, Exercise Therapy and Evidence Based Advice
Brief Summary: This randomized controlled study will evaluate the cost effectiveness of a yoga intervention compared to two evidence based programs; giving advice to stay active and guided exercise sessions. The first active program includes a six week standardized strength training program where the participants are personally instructed by a trained physiotherapist. The second active program is a six week standardized kundalini yoga program with group sessions twice a week lead by an experienced yoga instructor. Both programs consist of two exercise sessions per week and lasts for six weeks. After six weeks the participants are instructed to continue practicing their program twice a week on their own. The hypothesis are that a kundalini yoga program as an early intervention for Low Back Pain (LBP) is more cost effective than the two other interventions studied.

Participants were recruited through the occupational health services and by advertisement in the local press. Study subjects eligible for inclusion were informed of the study either by health care personnel at the occupational health care centers or by a research assistant at the Karolinska Institutet. Subjects were informed that if they were eligible to participate in the study they would be given the opportunity to participate in one of three approaches for treatment of neck and back pain.


Options:
A: Number of Days on Sick Leave (12 MONTHS)
B: N/A
C: N/A
D: Lumbar spine flexion changes (baseline (day 1) to post-test (day 5)); Expectation of pain changes (baseline (day 1) to post-test (day 5)); Expectation of harm changes (baseline (day 1) to post-test (day 5))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effectiveness of Early Interventions for Non-specific Low Back Pain: A Randomized Controlled Study Investigating Medical Yoga, Exercise Therapy and Evidence Based Advice
Brief Summary: This randomized controlled study will evaluate the cost effectiveness of a yoga intervention compared to two evidence based programs; giving advice to stay active and guided exercise sessions. The first active program includes a six week standardized strength training program where the participants are personally instructed by a trained physiotherapist. The second active program is a six week standardized kundalini yoga program with group sessions twice a week lead by an experienced yoga instructor. Both programs consist of two exercise sessions per week and lasts for six weeks. After six weeks the participants are instructed to continue practicing their program twice a week on their own. The hypothesis are that a kundalini yoga program as an early intervention for Low Back Pain (LBP) is more cost effective than the two other interventions studied.

Participants were recruited through the occupational health services and by advertisement in the local press. Study subjects eligible for inclusion were informed of the study either by health care personnel at the occupational health care centers or by a research assistant at the Karolinska Institutet. Subjects were informed that if they were eligible to participate in the study they would be given the opportunity to participate in one of three approaches for treatment of neck and back pain.


Options:
A: N/A
B: Change from baseline in low back pain (Baseline, 6 weeks, 12 weeks, 24 weeks); Change from baseline in back-related function (Baseline, 6 weeks, 12 weeks, 24 weeks)
C: Back-related function (6 months); Pain (6 months)
D: Number of Days on Sick Leave (12 MONTHS)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or carboplatin at a lower dose every week) is more effective than standard chemotherapy (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian cancer. The investigators also want to see if weekly chemotherapy causes more or fewer side-effects than standard chemotherapy.


Options:
A: quality of life (weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy); progression free survival (every 6 months)
B: Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient. (6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm); Stage 1: Safety assessed as the rate of any ≥ grade 3 toxicity experienced per patient. (6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm); Stage 2: Progression Free Survival rate at 9 months after randomisation (9 months after first 62 patients randomised per arm); Stage 3: Progression Free Survival (PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.); Stage 3: Overall Survival (PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.)
C: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Dose-optimized, Double-blind, Randomized, Placebo-controlled Study To Evaluate The Efficacy Of Nwp09 In Pediatric Patients With Attention Deficit Hyperactivity Disorder (Adhd) In A Laboratory Classroom
Brief Summary: The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD


Options:
A: Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9). (12-hours from 8:00 am to 8:00 pm)
B: The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit. (7 weeks)
C: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points (0.75 up to 13 hours post-dose)
D: Change from Baseline in Clinician-administered ADHD-5-Rating Scale (Baseline week 2, weeks 3-6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Meditation or Exercise for Preventing Acute Respiratory Infection (MEPARI-2)
Brief Summary: The primary goal of this project is to determine whether behavioral training in mindfulness meditation or moderate intensity sustained exercise will lead to reductions in acute respiratory infection (ARI) illness, such as common cold and influenza like illness. Specifically, this project aims to:

1. Determine whether an 8-week training program in mindfulness meditation, as compared to the control group, will lead to significant reductions in incidence, duration, and severity of ARI illness.
2. Determine whether an 8-week training program in moderate intensity sustained exercise, as compared to the control group, will lead to reductions in incidence, duration, and severity of ARI illness.
3. Assess whether any observed reductions in ARI illness are accompanied by fewer ARI-related health care visits and less time lost to productive work (reduced absenteeism).
4. Compare the potential benefits of mindfulness meditation to those from moderate intensity sustained exercise.
5. Discern potential mediating factors and causal pathways that might help explain how these interventions lead to improved ARI illness-related outcomes.

The investigators' preliminary findings suggest substantial benefit of these interventions in terms of reduced incidence, duration and severity of ARI illness, with corresponding reductions in days of work lost to illness. If the proposed research confirms these findings, there will be major implications for public and private health-related policy and practice, as well as for scientific knowledge regarding health maintenance and disease prevention.


Options:
A: URI frequency (3 months); URI duration (3 months); UTI severity (3 months)
B: Severity-weighted Total Days of ARI Illness (8 months)
C: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)
D: To determine whether standardized rehabilitation therapy will decrease hospital length of stay. (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Brief Summary: Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and brain magnetic resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory effects on patients undergoing carotid artery stenting.


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)
C: objective signs of tissue or neurovascular injury (180 days after treatment); levels of plasma biomarkers (180-day)
D: Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death. (Within six months after carotid artery stenting); Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. (Within 48 hours after carotid artery stenting.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Brief Summary: Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and brain magnetic resonance imaging (MRI) to determine whether RIPC has neuro-protective and anti-inflammatory effects on patients undergoing carotid artery stenting.


Options:
A: Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death. (Within six months after carotid artery stenting); Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. (Within 48 hours after carotid artery stenting.)
B: Reduction in myocardial infarction (4 to 5 years)
C: Troponin I Elevation Above the Upper Reference Limit (URL) (Within 3 days of the vascular operation)
D: Serum troponin levels (3 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of the Combination of Ipilimumab and Fotemustine in Patients With Unresectable Locally Advanced or Metastatic Malignant Melanoma
Brief Summary: This study is designed to assess the safety and efficacy of a combination of ipilimumab and fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma.


Options:
A: Assess the pathologic complete response rate (absence of viable tumor on histologic assessment) (5 years)
B: Overall Survival (OS) (From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.); Overall Survival (OS) Rate (From randomization to 6 months and or to 12 months)
C: Overall Survival (Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.)
D: The immune response disease control rate (irDCR) using the immune-related (ir) tumor response criteria of the combination of ipilimumab and fotemustine in patients with unresectable locally advanced or metastatic melanoma. (Weeks 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMAN ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA. The MESOT-TREM-2012
Brief Summary: RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.

PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.


Options:
A: Feasibility in terms of 90-day progression-free survival
B: % of patients with controled disease (responder and stable patients) at 6 months (3-month)
C: To determine the objective response (Weeks 24)
D: Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) (Weeks 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMAN ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA. The MESOT-TREM-2012
Brief Summary: RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.

PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.


Options:
A: Event-free survival (Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years)
B: Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS (Every 3 months up to two years)
C: To determine the objective response (Weeks 24)
D: Overall Survival (OS) (From date of treatment start until date of death from any cause, up to 5 years 5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension
Brief Summary: The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension


Options:
A: Change in systolic blood pressure (ABPM mean value) (6 months)
B: Absolute change in office systolic blood pressure(SBP) (at 6 months)
C: Change in BP (measured by ABPM) (6 months)
D: Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. (Through 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension
Brief Summary: The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension


Options:
A: Change in systolic blood pressure (ABPM mean value) (6 months)
B: 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)
C: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement for Smoking Cessation During Pregnancy
Brief Summary: This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).


Options:
A: Biochemically-validated smoking cessation (middle and late pregnancy)
B: Cotinine validated quit rates.
C: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days (32-34 weeks gestation (Visit 6))
D: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nicotine Replacement for Smoking Cessation During Pregnancy
Brief Summary: This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).


Options:
A: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
B: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days (32-34 weeks gestation (Visit 6))
C: Biochemically-validated smoking cessation (middle and late pregnancy)
D: Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. (from the first administration of nicotine/placebo patch until delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
Brief Summary: This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.


Options:
A: Proportion of patients with complete healing of reference ulcer (24 weeks)
B: Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (Weekly, over 12 Weeks or until wound closure, which ever occurred first)
C: Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (12 Weeks)
D: Wound Closure (16 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus
Brief Summary: Objective:

* To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients.
* To assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (PHCT) and patients and their relatives) to improve the health results in people with T2DM.

Methodology:

Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands. Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures: HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm. Intervention: G1: Interventions on the patients: Educational and habit modification group program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge about the disease and their abilities; b) Computer-based clinical decision support system; c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group. Patients receive only the usual care.


Options:
A: 1. ADEs; 2. duration of ameliorable medication side effects; 3. health goal adherence rates; 4. diabetes outcomes; 5. familial risk factor documentation rates; 6. user satisfaction surveys; 7. user metrics
B: Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice (12 months)
C: Physical activity measured with an accelerometer, pedometer en the International Physical Activity Questionnaire (IPAQ) (At baseline, after the intervention (at 6 months) and one year after baseline); Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height (At baseline, after the intervention (at 6 months) and one year after baseline); Blood samples taken to determine:HBA1C, glucose, insulin, leptin, c-peptide, IGF-1, total cholesterol, HDL-c, LDL-C, triglycerides, APo-B, high sensitive C-reactive protein, vrij-t, DHEAS Oestradiol, Shbg, LH, FSH (At baseline, after the intervention (six months) and one year after baseline); Dexa scan (At baseline, after the intervention (six months) and one year after baseline)
D: Change in Glycosylated hemoglobin (HbA1c) (Baseline and 12 months)

Answer: D