bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Patient Resilience on Return to Sport Post ACL Reconstruction Surgery
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Observational

Summary: 
      Despite the large majority of patients that undergo ACL reconstruction reporting successful
      outcomes in regard to tests of knee function, only about 2/3 return to their prior level or
      athletic activity after surgery. A large amount of research has been conducted investigating
      the effects of psychological factors on return to sports after ACL reconstruction; however,
      the specific role of resilience has yet to be solely analyzed. This study aims to determine
      the effect of variations in patient resilience on their return to sports after surgery.
    

Detailed description: 
      Meta-analysis of post ACL reconstruction return to sport suggests that despite approximately
      90% of patients achieving successful outcomes in terms of objectively measurable knee
      function, only 63% return to their pre-injury sport participation rate. This leads one to
      question what factors other than knee function may contribute to such a discrepancy. Prior
      studies have shown psychological factors, such as fear of re-injury, can play in role in
      whether a patient returns to play. However, the role of patient resilience on recovery is
      less clear. This research will examine the effect of patient resilience on post-ACLR return
      to sport. The Brief Resiliency Scale (BRS), a proven method of assessing ability to recover
      from stressful situations, will be used to evaluate patient resilience. The role of
      resilience on recovery post shoulder surgery, as well as rehabilitation in post-operative
      orthopaedic geriatric patients has been examined; however, the effect of resilience on
      specifically ACLR return to sport has yet to be studied.

      This research will provide insight as to how to identify patients at high risk for not
      returning to sport, the first step in improving return to sport outcomes in ACL
      reconstruction patients.
    

Intervention name(s): Brief Resilience Scale
Intervention type(s): Behavioral
Intervention description(s): 6 months post-op, patients will complete the BRS survey as a method of evaluating resilience.
Other intervention name(s): BRS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        English speaking patients 14 yrs of age or older with isolated ACL tear and having
        undergone surgical reconstruction.
      
Keywords: ACL Reconstruction; Return to Sport; Resilience
Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional

Summary: 
      Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in
      pulmonary vascular resistance leading to shortness of breath and exercise intolerance.
      Exercise capacity has been used as the primary endpoint in most recent randomized controlled
      trials evaluating PAH-specific therapies as it correlates with functional class and survival
      in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However, there
      is commonly some discrepancy between significant clinical improvement and minor changes
      (generally <10% from baseline) in 6WMT following therapy. Because important clinical
      decisions are based on patients' functional capacity, a reproducible and sensitive exercise
      test is needed in PAH. The aim of this study was to compare the reproducibility and the
      responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance
      test (CET) following pharmacological therapy in this disease.
    


Intervention name(s): Sildenafil; Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): Sildenafil citrate is a phosphodiesterase type-5 inhibitor. Patients will be assigned to sildenafil (20 mg tid) or placebo per os for 28 days in a randomized, double-blind manner. After a four-week wash-out period, patients will then be crossed over to the alternate therapy for the next 28 days.; Patients will be assigned to sildenafil (20 mg tid) or placebo per os for 28 days in a randomized, double-blind manner. After a four-week wash-out period, patients will then be crossed over to the alternate therapy for the next 28 days.
Other intervention name(s): Revatio; Viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Hypertension; Pulmonary Arterial Hypertension; Exercise; Six-minute walk test; sildenafil
11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is looking at differences in metabolism and functional imaging between pulmonary
      hypertension subjects with normal right ventricular function and persistent right ventricular
      dysfunction.
    

Detailed description: 
      We will measure right ventricular metabolic and structural changes using serial 11C-acetate
      and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo
      imaging procedures at week 0 and week 26 (optional for normal function patients). This is a
      companion imaging trial for patients who are eligible for the treatment trial entitled "A
      randomized, double-blind, placebo controlled, multi-center study to assess the effect of
      ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular
      dysfunction accompanied by a comparative study of cellular metabolism in subjects with
      pulmonary hypertension with and without right ventricular dysfunction". Subjects must enroll
      in companion treatment protocol to qualify for the imaging protocol.

      The cardiac MRI portion of the study continued, but the PET portion of the study was
      discontinued due to funding.

      The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed
      study was registered under NCT02829034.
    

Intervention name(s): 11C-acetate; [18F]Fluoro-2-deoxy-2-D-glucose; Cardiac MRI
Intervention type(s): Drug; Drug; Other
Intervention description(s): For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate; For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG; Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
Other intervention name(s): 18F-FDG
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pulmonary hypertension; right ventricular function; 11C acetate; FDG; ranolazine
A Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative
      Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine,
      Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
    


Intervention name(s): Dapivirine Vaginal Ring-004 and no tampons; Dapivirine Vaginal Ring-004 with tampons; Dapivirine Vaginal Ring-004 with no menses; Dapivirine Vaginal Ring-004 and same ring inserted after menses; Dapivirine Vaginal Ring-004 and new ring inserted after menses
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dapivirine Vaginal Ring-004 for 28 days, with menses, no tampon use (Treatment A),; followed by Dapivirine Vaginal Ring-004 for 28 days, with menses, with tampon use (Treatment B); Dapivirine Vaginal Ring-004 for 28 days, with no menses occurring (Treatment E; treatment period 3).; Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and the same ring re-inserted five days later (estimated completion of menses) (Treatment C); Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and a new ring inserted five days later (estimated completion of menses) (Treatment D)
Other intervention name(s): Treatment A; Treatment B; Treatment E; Treatment C; Treatment D
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Olfactory Deficits in MCI as Predictor of Improved Cognition on Donepezil
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Odor identification deficits, which are a result of early Alzheimer's Disease (AD) pathology
      in the olfactory bulb and tract as well as olfactory projection areas in the medial temporal
      lobe (entorhinal and piriform cortex and hippocampus), lateral and central orbitofrontal
      cortex and several other regions, occur in AD and strongly predict mild cognitive impairment
      (MCI) conversion to AD. Our pilot data, along with converging findings in the literature,
      suggests that odor identification deficits, both incremental change over time and change in
      response to an anticholinergic challenge, may be clinically simple, relatively inexpensive,
      predictors of cognitive improvement with acetylcholinesterase inhibitor (ACheI) treatment
      with potential clinical implications for predicting improvement and monitoring ACheI therapy.
    

Detailed description: 
      In this clinical trial, the investigators will evaluate, treat and follow a broad sample of
      60 adult patients with amnestic MCI at New York State Psychiatric Institute/Columbia
      University Medical Center. Recruitment will be from clinics and/or advertisements. In the
      protocol, all 60 amnestic MCI patients will receive baseline memory and olfactory assessments
      and begin treatment with donepezil. Patients will be followed for a total of 1 year. During
      this time, patients will be monitored closely by the study physician and will receive memory
      and olfactory assessments at weeks 8, 26, and 52. In addition, an olfactory challenge test
      will be done at baseline.

      This project will be of value in the selection of patients with mild cognitive impairment for
      treatment based on the evaluation of olfaction tests to predict response to donepezil and
      other ACheI. Since mild cognitive impairment is widespread and Alzheimer's disease represents
      a major public health problem, this study has considerable public purpose and significance.
    

Intervention name(s): Donepezil; Atropine
Intervention type(s): Drug; Drug
Intervention description(s): Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.; A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians.
Other intervention name(s): Aricept; Atropine sulfate ophthalmic solution 1%
Intervention MeSH terms: Atropine; Donepezil; Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Olfaction; Donepezil; Alzheimer's Disease; Mild Cognitive Impairment; Memory
The Effect of Roux-en-Y Gastric Bypass on Insulin Sensitivity in Type 2 Diabetes
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Gastric bypass surgery induces remission of diabetes within days after surgery, before
      significant weight loss. The aim of the study is to examine whether improved insulin
      sensitivity of muscle and liver contributes to the immediate diabetes resolution.
    

Detailed description: 
      Obesity has become a severe epidemic globally. With the rapid increase in obesity comes a
      pronounced rise in obesity-related disorders, especially type 2 diabetes. Weight loss
      achieved through lifestyle changes improves diabetes, but is very difficult to maintain over
      time. In contrast, Roux-en-Y gastric bypass (RYGB) surgery can induce long-term weight loss
      and remission of diabetes. Surprisingly, the resolution of type 2 diabetes occurs within days
      after surgery and before significant weight loss. The resolution of diabetes must therefore
      be explained by a response to the surgical alterations of the stomach and intestines:
      restriction in gastric volume and bypass of the stomach, duodenum and proximal jejunum.

      Severe insulin resistance in muscle and liver is the common defect in obesity and type 2
      diabetes and may be improved or even reversed shortly after the operation. The aim of this
      study is to examine the acute changes in insulin sensitivity of muscle and liver by using
      hyperinsulinaemic euglycaemic clamp combined with glucose tracer to assess hepatic glucose
      production. Insulin signaling pathways will be studied in biopsies from muscle and
      subcutaneous fat as to explain the molecular basis of the changes in insulin sensitivity
      after RYGB.

      Insulin secretion will be evaluated in response to oral glucose as well as iv
      glucose-glucagon.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are recruited from the outpatient clinic of endocrinology and gastrosurgical
        clinic at Hvidovre University Hospital
      
Biospecimen description: 
      serum, plasma, urine, muscle, subcutaneous fat, visceral fat
    
Keywords: Insulin resistance; Gastric bypass
Metabolomics of the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern
Condition: Dietary Modification; Blood Pressure
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The present record represents a secondary data analysis of the Dietary Approaches to Stop
      Hypertension (DASH) trial. Study data and specimens were accessed through the National Heart,
      Lung, and Blood Institute (NHLBI) Biologic Specimen and Data Repository Coordinating Center
      (BioLINCC). A global, untargeted, metabolomic profile was used to investigate biomarkers of
      the DASH dietary pattern as well as blood pressure change.
    

Detailed description: 
      The present study was conducted in order to: 1) quantify the metabolomic expression of the
      DASH dietary pattern; and 2) examine the relationship between metabolites that reflect the
      DASH dietary pattern and blood pressure change. This secondary data analysis leverages the
      completed DASH trial, a randomized feeding trial (N=459).
    

Intervention name(s): DASH diet; Fruits and vegetables diet; Control diet
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Diet intervention; Diet intervention; Diet intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consisted of men and women (aged 22 years and older) with systolic
        blood pressure <160 mmHg and diastolic blood pressure 80-95 mmHg who were not taking
        antihypertensive medication. The mean age was 44 years, about half were women, and
        approximately 2/3 were black or another race/ethnicity minority. The mean body mass index
        was 28 kg/m2 and mean blood pressure was 132/82 mmHg.
To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      "The primary objective of this study was to demonstrate that co-administering HRV vaccine
      with OPV does not induce a significant decrease in poliovirus immune response one month after
      the third dose of combined vaccines.

      The primary objective was reached if one month after the third dose of polio vaccine, upper
      limit of the 95% CI for the difference in Seroprotection rate between the group B and C
      pooled and (minus) the group A was below 10% for each polio serotype."
    

Detailed description: 
      The study had three groups: Group A: HRV + OPV + DTPa/Hib; Group B: HRV + placebo OPV +
      DTPa-IPV/Hib; Group C: HRV Placebo + OPV + DTPa/Hib. Two cohorts: Subjects enrolled before
      the 2002 RV season were to receive two doses of HRV or placebo at approximately 6 and 10
      weeks of age (first cohort) and subjects enrolled after the 2002 RV season received
      vaccinations at approximately 10 and 14 weeks of age (second cohort). Routine EPI
      vaccinations were to be administered concomitantly with the study vaccines.
    

Intervention name(s): Rotavirus (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Prophylaxis rotavirus
Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118
      [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC)
      tocilizumab treatment in participants with polyarticular-course and systemic juvenile
      idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to
      receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis
      subtype and body weight. Participants will receive the treatment until commercial
      availability of the drug or for a maximum of 5 years, whichever is earlier.
    


Intervention name(s): Tocilizumab
Intervention type(s): Drug
Intervention description(s): 162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (>=) 30 kg: every 2 weeks; sJIA participants <30 kg: every 2 weeks; sJIA participants >/= 30 kg: once weekly
Other intervention name(s): RoActemra, Actemra
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, randomized, vehicle-controlled, double-blind, multi-center study
      assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal spray for
      preventive treatment in subjects with episodic migraine.
    

Detailed description: 
      This is a Prospective, Randomized, Vehicle-controlled, Double-blind, Multi-center, 3-arm
      study assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal
      spray for preventive treatment in subjects with episodic migraine.

      At Screening and Baseline, all subjects must experiences 4-14 migraine days per month and
      3-14 migraine attacks per month and no more than 14 headache days per month in the 3 months
      prior to screening.

      The total duration of the study will be approximately 16 weeks. Participants will report for
      a Screening visit and if all inclusion criteria are met, subjects will go through a one month
      baseline period prior to randomization. Subjects will come in for visits at Day 28 (Week 4),
      Day 56 (Week8), Day 84 (Week12), and Day 112 (Week 16).

      Efficacy will be assessed by change in migraine attacks, days, and hours. Blood and urine
      samples will be collected for standard safety laboratory testing and the effect of the drug
      on inflammatory biomarkers. Safety will be monitored throughout the study.

      Investigators plan to enroll 303 total subjects. Subjects will be randomized 1:1:1 so that an
      equal number of subjects will be treated in each arm of the study.
    

Intervention name(s): B244; Vehicle
Intervention type(s): Biological; Biological
Intervention description(s): B244 Suspension; Vehicle Suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Headache
Equinox Personal Coaching Versus Self-Directed Exercise
Condition: Physical Fitness
Study type: Interventional

Summary: 
      The purpose of this study is to compare the Equinox Personal Coaching exercise training
      method to self-directed exercise training in helping subjects become more fit. Men between 30
      and 44 years of age who exercise on a regular basis and are interested in receiving Equinox
      personal training will be invited to participate. The investigators will enroll 36 subjects
      at University of California, Los Angeles (UCLA), the only site. The hypothesis of this study
      is that subjects randomized to the Personal Coaching Method will result in significantly
      greater lean mass accrual than those randomized to self-directed training over the 12 weeks
      of the study.

      Subjects will have 2 Baseline visits over 1 week, then be randomized to receive either
      Coached training or self-training, which they will do for 12 weeks, then complete two End of
      Study visits over the final week. Visits 1 and 3 include questionnaires, skinfold fat/lean
      body mass measurements, and strength and aerobic performance tests, and will take place at
      Equinox. Visits 2 and 4 include a DEXA scan and ECG, which will take place at UCLA.
    


Intervention name(s): Equinox Personal Coaching
Intervention type(s): Behavioral
Intervention description(s): Specially designed strength and aerobic exercise training program that consists of 36 sessions over 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fitness training; Personal training