bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen
      sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration
      for 36 hours under fasted conditions
    


Intervention name(s): Naproxen Sodium, (BAY H6689); Naprelan, (BAY H6689)
Intervention type(s): Drug; Drug
Intervention description(s): One dose of Naproxen sodium extended release 660 mg under fasting conditions; One dose of Naprelan 500 mg (2 tablets) under fasting conditions
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Naproxen Sodium
Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block
Condition: Pain
Study type: Interventional

Summary: 
      Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous
      dexamethasone increases the analgesic duration of a single-shot interscalene block with
      ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two
      different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration
      of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is
      equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot
      interscalene block with ropivacaine.
    

Detailed description: 
      75 patients will be randomly assigned to three groups:

        -  D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter
           scalene block

        -  D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter
           scalene block

        -  C: control: Normal saline 20cc I.V., immediately after inter scalene block. These
           patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.

      All patients will have their surgery under regional anesthesia only provided by the inter
      scalene plexus block, with ropivacaine 0.5% 20cc.

      In the postoperative period, patients will be given analgesic medication on an as needed
      basis. They will be instructed to take the first analgesic medication once postoperative
      shoulder pain has reached >3/10. They will note the time and day at which this outcome
      occurs.
    

Intervention name(s): Dexamethasone; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v.
Other intervention name(s): decadron
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Testosterone Antidepressant Augmentation in Women
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive
      symptoms in women with Major Depressive Disorder (MDD) and antidepressant
      partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women
      with MDD and antidepressant partial/nonresponse, and low-dose testosterone augmentation
      improves fatigue and sexual dysfunction.
    


Intervention name(s): Testosterone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): AndroFeme 1(testosterone 1% w/v cream)
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder (MDD)
Glucose Measurement Using Microneedle Patches
Condition: Diabetes
Study type: Interventional

Summary: 
      This study will compare three glucose measurement techniques among diabetic children and
      adolescents. The study seeks to determine if a microneedle patch (made from biocompatible
      polymers or metal), versus a lancet or intravenous catheter, would be a preferable option for
      monitoring glucose levels among the diabetic pediatric population.
    

Detailed description: 
      Fifteen children and adolescents with diabetes will be tested for their glucose measurements
      comparing interstitial fluid collected via a microneedle patch (made from biocompatible
      polymers or metal), versus the standard of care blood sample (lancet), and lab grade blood
      draw (intravenous catheter). Samples will be taken hourly from all three devices for four
      hours. All four measurements will be compared against each other to see how close they are
      with measuring the glucose values. Each participant will be asked to rate their apprehension
      prior to receiving each method for blood or interstitial fluid collection as well as the pain
      associated with each method immediately after collection.
    

Intervention name(s): Microneedle patch; Intravenous (IV) catheter; Lancet
Intervention type(s): Device; Device; Device
Intervention description(s): The microneedle patch will collect interstitial fluid to be tested for glucose level. The microneedles are made from biocompatible polymers or metal. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.; The intravenous (IV) catheter will collect venous blood to be tested for glucose level. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.; The lancet will collect capillary blood to be tested for glucose level. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatrics; Endocrinology; Adolescent; Microneedle
Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better
      pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and
      Total Narcotic use in the hospital will be evaluated.
    

Detailed description: 
      Subjects recruited into the study will undergo surgery as scheduled. During the procedure
      they will receive a TAP Block with one of the pain medications. TAP Block in the experimental
      arm will be performed with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of
      bupivacaine diluted in 55 mL of normal saline. The control arm will have a TAP Block
      performed with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline. These doses
      are consistent with prior studies of TAP Block with liposomal bupivacaine. Subjects will be
      monitored for pain as per standard of care and will be given pain medication as needed.

      Subject Recruitment and Screening Patients will be recruited from the Ochsner Colorectal
      Surgery Clinic at the time of a preoperative visit.

      Study Procedures

      Screening & Baseline Visit After obtaining informed consent the subjects relevant medical and
      surgical history will be documented. Demographics and vitals will be documented. Current use
      of pain medication will be recorded. A physical exam will be performed.

      Day of Surgery Routine vital signs will be obtained preoperatively. During the operation
      subject will receive a TAP Block containing their randomized local injection mixture as
      described above. Following surgery the subject will recover the PACU and pain medication will
      be provided on demand. Initial postoperative vital signs and pain scores will be obtained at
      this time.

      Post-Operative Course Postoperatively subject will have regularly scheduled vital signs and
      pain scores obtained, and recorded for study use. Narcotic and non-narcotic pain medication
      will be provided on demand; dosages will be recorded for study use. Subjects will be followed
      until they are discharged at which time study participation will be complete.
    

Intervention name(s): Pain Scale; Exparel Injectable Product; Bupivacaine Injection
Intervention type(s): Other; Drug; Drug
Intervention description(s): Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days); Given at the beginning of the surgery for post-operative pain management; Given at the beginning of the surgery for post-operative pain management
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial
Condition: Breast Cancer; Invasive Breast Carcinoma
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This clinical trial studies the feasibility of implementing various adaptive training
      exercise programs to improve cardiorespiratory fitness in patients after receiving breast
      cancer treatment. Information from this study may help researchers better understand how to
      implement adaptive training interventions to improve cardiorespiratory fitness in patients
      after receiving breast cancer treatment.
    

Detailed description: 
      OUTLINE: Patients are randomized to the interventional groups or control group.

      INTERVENTION GROUPS: Patients are randomized to 1 of 2 interventional arms.

      ARM I: Patients participate in aerobic exercise (AE) sessions 3 times per week for 12 weeks.
      After 12-weeks, non-responders participate in combined AE and resistance exercise (RE)
      sessions for an additional 12 weeks, while responders continue participating in the AE
      sessions alone for an additional 12 weeks.

      ARM II: Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks,
      non-responders may participate in a further 12-weeks of combined AE and RE sessions, while
      responders continue participating in the RE sessions alone for an additional 12 weeks.

      CONTROL GROUP: After 24 weeks, patients receive a digital copy of the 12-week AE sessions and
      12-week RE sessions and an outline of sessions for 24 weeks.
    

Intervention name(s): Aerobic Exercise Intervention; Resistance Exercise Intervention; Exercise Intervention: Digital copies and outline of sessions; Questionnaire Administration; Quality-of-Life Assessment
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Participate in aerobic exercise intervention; Participate in resistance exercise intervention; Receive digital copy of AE and RE sessions and an outline of sessions; Ancillary studies; Ancillary studies
Other intervention name(s): Quality of Life Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: breast cancer; exercise; fatigue; fitness; aerobic; survivor
Craniosacral Therapy for Concussion Symptoms
Condition: Post-Concussion Syndrome
MeSH terms: Post-Concussion Syndrome; Syndrome
Study type: Observational

Summary: 
      This study investigated the utilization of CranioSacral Therapy (CST) in patients with
      Post-Concussion Syndrome (PCS) and capture patient-reported perceptions of their lived
      experiences of treatment effect upon their symptoms. The first part part was a 10 year chart
      review of patients who sought out CST to capture data from the medical records. The second
      part was an anonymous post treatment survey.
    


Intervention name(s): Craniosacral Therapy
Intervention type(s): Other
Intervention description(s): The Upledger method of applying both specific and non-specific manual therapy of gentle, sustained, non-invasive stretch to soft tissues of fascia, meninges and osseous attachments. Fluid exchange is also believed to be a resulting result of CST. Treatment is applied to myofascial and osseous sites over the entire body, tending to specific and unique constellation of tissue restrictions and osseous compressions of soft tissue.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Ten year retrospective chart review of patients who received craniosacral therapy
        addressing symptoms post concussion
The Effect of Tang Ning Tongluo Formula in Type 2 Diabetics Clinical Analysis
Condition: General Disorders and Administration Site Conditions
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this retrospective study is to review and describe safety and efficacy of Tang
      Ning Tong Luo capsule.
    

Detailed description: 
      The aim of this retrospective study is to review and describe safety and efficacy of Tang
      Ning Tong Luo capsule,a traditional Chinese Miao medicine, in Type 2 Diabetics.
    

Intervention name(s): Tangning Tongluo Capsule
Intervention type(s): Drug
Intervention description(s): Taken drugs 3 times a day, with each time 3 grains
Other intervention name(s): TNTL Capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chocolate's Effect on the Cerebral Vasculature
Condition: Cerebral Vasculature
Study type: Observational

Summary: 
      The popularity of chocolate can largely be attributed to its mood elevating properties,
      research shows that it contains antioxidants that also provide physical health benefits. Dark
      chocolate, in particular, contains high levels of an antioxidant called epicatechin, which is
      known to cause changes in blood vessels by relaxing them and increasing blood flow.

      Little is know about the immediate effects of chocolate consumption, or the differences
      between milk and dark chocolate with regards to these effects. The project will investigate
      the effect of a single bar of dark or milk chocolate upon blood flow to the brain, using
      simple ultrasound tests.
    


Intervention name(s): cocoa
Intervention type(s): Other
Intervention description(s): 70% versus 34%
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy controls
      
Keywords: Determine effect on cerebral vasculature
A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Observational

Summary: 
      RAZORBILL is an observational, multicenter, multinational, open-label, study designed
      primarily to investigate the influence of automated OCT image enrichment with segmentation
      information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs
    

Detailed description: 
      The main goal of this study is to assess to what degree disease activity assessment is
      influenced and supported by the enrichment of OCT images with segmentation information (i.e.
      by identification, highlighting and quantification of pathological fluid compartments
      associated with neovascular activity).

      The study comprises a prospective data collection phase and a retrospective analysis of OCT
      images phase. The prospective observation period per patient will be up to 12 months.

      The study will include 424 patients (naïve patients and patients who have been pre-treated
      with licensed anti-VEGFs not more than 3 years) being treated for nAMD with brolucizumab,
      ranibizumab, or aflibercept according to the respective drug label. Patients will be enrolled
      at approximately 20 centers across 5 countries.
    

Intervention name(s): brolucizumab; ranibizumab; aflibercept
Intervention type(s): Drug; Drug; Drug
Intervention description(s): There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.; There is no treatment allocation. Patients administered Ranibizumab by prescription that have started before inclusion of the patient into the study will be enrolled.; There is no treatment allocation. Patients administered Aflibercept by prescription that have started before inclusion of the patient into the study will be enrolled.
Intervention MeSH terms: Ranibizumab; Aflibercept
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Subjects being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to
        the respective drug label.
      
Keywords: nAMD; Neovascular Age-Related Macular Degeneration; anti-VEGF; RAZORBILL; optical coherence tomography; OCT; Artificial Intelligence; Machine learning; Automatic OCT segmentation
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering
      of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol
      esters (PS-ester), consumed within dairy products.
    

Detailed description: 
      Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline)
      completed the double-blind, randomized, crossover study.
    

Intervention name(s): WD-PS intervention phase; PS-Ester intervention phase; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2g/d of free plant sterol in 100g yogurt; 2g/d of free plant sterol in 100g yogurt; 100g/d yogurt with no added plant sterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a new medication called vamorolone is safe
      and well-tolerated by boys with Duchenne muscular dystrophy (DMD) ages ≥ 4 and < 7 years old.
    

Detailed description: 
      This study will evaluate the safety and tolerability of a new steroid-like medication called
      vamorolone in boys with DMD ages ≥ 4 years and < 7 years. Enrolled participants will take the
      study medication for 14 days followed by a 14 day follow-up period. The potential
      effectiveness of vamorolone in treating DMD will also be explored.
    

Intervention name(s): Vamorolone 0.25 mg/kg/day; Vamorolone 0.75 mg/kg/day; Vamorolone 2.0 mg/kg/day; Vamorolone 6.0 mg/kg/day
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of 0.25 mg/kg/day daily for 14 days.; Oral administration of 0.75 mg/kg/day daily for 14 days.; Oral administration of 2.0 mg/kg/day daily for 14 days.; Oral administration of 6 mg/kg/day daily for 14 days.
Other intervention name(s): VBP15; VBP15; VBP15; VBP15
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duchenne Muscular Dystrophy; vamorolone
Metabolic Manipulation in Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Conventional measures used for the treatment of chronic heart failure act predominantly by
      reducing the work performed by the heart. In a recent study, the investigators showed that
      one drug (perhexiline) substantially improved symptoms and cardiac function in heart failure.
      The investigators wish to confirm these findings and test whether or not this drug acts by
      altering the heart's energy source thus augmenting the energetic status and work efficiency
      of the heart.
    

Detailed description: 
      Perhexiline maleate is an antianginal agent which increases the efficiency of energy
      production by shifting substrate utilisation from free fatty acids towards glucose. We showed
      that perhexiline therapy was highly effective in improving exercise capacity, symptoms and
      cardiac function in patients with systolic heart failure of both ischaemic and non ischaemic
      aetiology. Perhexiline acts by inhibiting both carnitine palmitoyl transferase-1 (CPT-1) and
      CPT-2, which are key enzymes in mitochondrial free fatty acid uptake. This leads to increased
      myocardial glucose substrate utilization. Further we wish to ascertain whether or not this
      drug improves cardiac energetics and efficiency by altering substrate utilization. In this
      proposal we will assess the cardiac function (by cardiac Magnetic Resonance Imaging MRI),
      cardiac energetic status (by cardiac Magnetic Resonance Spectroscopy MRS), cardiac efficiency
      (via pressure-volume loops) and substrate utilization (via left and right heart
      catheterization), following one month of perhexiline therapy or placebo in patients with
      symptomatic idiopathic dilated cardiomyopathy on optimal conventional heart failure
      medications. An interim analysis is planned after 20 patients.
    

Intervention name(s): Perhexiline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg o bd; 1 tablet bd
Other intervention name(s): Pexsig
Intervention MeSH terms: Perhexiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: perhexiline; idiopathic dilated cardiomyopathy; magnetic resonance spectroscopy; cardiac energetics