TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
Brief Summary: Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.

Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.


Options:
A: Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks) (pretreatment, postreatment and follow-up(15 days))
B: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)
C: Immediate reduction in pain intensity (at ED discharge (within 3 hours from ED admission))
D: muscle contractility (30 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
Brief Summary: Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.

Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.


Options:
A: return to work rate (week)
B: N/A
C: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)
D: Efficiency of the 3 programs (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
Brief Summary: Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.

Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.


Options:
A: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
B: Sickness absence days (Low back (LB) specific, other than LB, total) (6, 12, 24, 36, 48 months); Low back pain (VAS) (0, 3, 6, 12, 24 months); Disability (Roland Morris 18) (0, 3, 6, 12, 24 months); Quality of Life (15-D) (0, 3, 6, 12, 24 months)
C: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)
D: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial
Brief Summary: Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.

Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.

HYPOTHESIS:

Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.


Options:
A: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration (Baseline and (time weighted average over) 60 Minutes)
B: FEV1
C: Length of stay in hospital
D: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (4 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial
Brief Summary: Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.

Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.

HYPOTHESIS:

Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.


Options:
A: Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration (within the first 60 minutes after administration)
B: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (4 hours)
C: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration (Baseline and (time weighted average over) 60 Minutes)
D: Therapeutic failure rate (From randomization at discharge from the Emergency Department to day 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial
Brief Summary: Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.

Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.

HYPOTHESIS:

Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.


Options:
A: To describe the percentage of patients with asthma who will be controlled after 8 weeks of treatment with montelukast used in combination with inhaled corticosteroids (8 weeks)
B: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (4 hours)
C: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)
D: Daily asthma symptom score

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Investigate the Effect of a Structured Educational Programme on Physical Activity Levels and Glucose Tolerance in People With Impaired Glucose Tolerance
Brief Summary: This study is a three-armed randomised controlled trial that aims to determine the effect of a structured educational programme on physical activity levels and glucose tolerance in individuals with impaired glucose tolerance (IGT). The educational programme is designed to promote physical activity by targeting perceptions and knowledge of IGT, exercise self-efficacy, and self-regulatory skills. The study will also investigate whether the effectiveness of the educational programme at promoting self-regulatory skills and physical activity is enhanced by the inclusion of a pedometer and personalised step/day goals.


Options:
A: 2-hour glucose (2 hours)
B: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
C: Changes in weight (6, 12, 19 and 24 months from baseline)
D: incidence rate of DM (Follow-up in 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine (VCIV) to Prevent Culture Confirmed Influenza Infection (CCII)
Brief Summary: The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.


Options:
A: occurrence of confirmed influenza
B: Safety (28 days)
C: Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens (21 days to 180 days after the date of vaccination); The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values (21 Days after vaccination)
D: Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains (6 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery
Brief Summary: The objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive remote superficial femoral artery endarterectomy can be considered in patients presenting with a long occlusion of the superficial femoral artery.


Options:
A: Target Lesion Percent Stenosis (1 year)
B: Freedom From Target Lesion Revascularization (TLR) (6 months); Freedom From Major Adverse Events (MAE) (30 days)
C: (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass (5 year)
D: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery
Brief Summary: The objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive remote superficial femoral artery endarterectomy can be considered in patients presenting with a long occlusion of the superficial femoral artery.


Options:
A: Primary (and -assisted) patency (5 years); Quality of life (5 years)
B: (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass (5 year)
C: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
D: Clinical improvement (12 Month Post Operatively); Patency rate (12 Month Post Operatively); Cost effectiveness (12 Month Post Operatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
Brief Summary: The purpose of this study is to determine if using school-based telemedicine for diabetes support and education in students with type 1 diabetes in grades K-8 can lead to improvement in control of diabetes and improved satisfaction of all caregivers.


Options:
A: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)
B: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
C: hemoglobin A1c (1 year)
D: Appropriateness of Decision to Treat or Not Treat With Thrombolytics (potentially within 3 hours of symptom onset)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions
Brief Summary: Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.

Secondary objectives are to evaluate:

* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
* The safety of riferminogene pecaplasmid in the study population.


Options:
A: Survival without major amputation (6 months after implantation)
B: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)
C: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)
D: Complete wound closure rate at week 8 of treatment (week 9)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions
Brief Summary: Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.

Secondary objectives are to evaluate:

* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
* The safety of riferminogene pecaplasmid in the study population.


Options:
A: Change in the measurement of pain-free walking distance (PWD) on treadmill (3 months and 6 months after the first injection of Neovasculgen®.)
B: Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site (3 to 8 days after amputation)
C: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)
D: Tissue perfusion as measured by TcPO2 (6 months)

Answer: C