bioihbjkbjnl/mcl2 huggingface dataset:
Testosterone for Peripheral Vascular Disease
Condition: Hypogonadism; Peripheral Vascular Disease; Type 2 Diabetes
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Diabetes Mellitus, Type 2; Hypogonadism
Intervention: Testosterone; saline
Intervention description: Sustanon- 200mg- Intramuscular testosterone every 2 weeks; Saline injection every two weeks
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Testosterone; Hypogonadism; Diabetes; PVD; RCT

Summary:

      There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels
      in men.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 2 diabetes mellitus.

          2. Serum testosterone 12 nmol/L or less on two consecutive samples taken on different
             days and symptoms compatible with hypogonadism.

          3. Peripheral vascular disease as defined by

               -  previous diagnosis by a specialist vascular surgeon OR

               -  ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal
                  complications (non-healing arterial foot ulcer or gangrene).

          4. Agreement to maintain antihypertensive and antilipid treatments at prior doses during
             3 month duration of study.

          5. Ability to give written informed consent after verbal and written explanation in the
             English language.

          6. Ability to comply with all study requirements.

        Exclusion Criteria:

          1. Current or previous breast cancer.

          2. Current or previous prostate cancer.

          3. Raised prostate specific antigen (PSA) or abnormal per rectal examination unless
             prostate cancer excluded after specialist urology opinion.

          4. Severe symptoms of benign prostatic hypertrophy ('prostatism')

          5. Treatment with testosterone in the 3 months prior to the trial.

          6. Investigational drug treatment in the 3 months prior to the trial.
Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate
Intervention description: capsules administered according to the prevailing product label
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastrointestinal event

Summary:

      The primary objective of this study is to evaluate the effect of symptomatic therapies on
      gastrointestinal-related events reported by participants with relapsing-remitting multiple
      sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice
      setting.

      The secondary objectives of this study in this study population are as follows: to evaluate
      gastrointestinal-related events requiring symptomatic therapy and the role of those therapies
      over time; to evaluate gastrointestinal-related events that lead to a physician's decision to
      manage the events with BG00012 dose modification; and to evaluate gastrointestinal-related
      events that lead to BG00012 discontinuation after the use of symptomatic therapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to the
             current McDonald Criteria and satisfy the therapeutic indication as described in the
             official local registration for Tecfidera (dimethyl fumarate)

          -  Naïve to dimethyl fumarate and fumaric acid esters

        Key Exclusion Criteria:

          -  Female subjects who are currently pregnant or breastfeeding or who are considering
             becoming pregnant while in the study

          -  History of significant gastrointestinal disease (e.g., irritable bowel disease, peptic
             ulcer disease, history of major gastrointestinal surgeries), or chronic use of
             gastrointestinal-related symptomatic therapy as determined by the Investigator (or ≥ 7
             consecutive days of gastrointestinal-related symptomatic therapy

          -  Known active malignancies

          -  History of anaphylaxis or severe allergic reactions or known drug hypersensitivity

          -  Current use of B vitamin supplements

          -  In the opinion of the Investigator, blood test values suggestive of a low lymphocyte
             count or renal or hepatic impairment, as described in the product label precautions
             for use

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Adolescent Fibromyalgia Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: placebo; pregabalin (Lyrica)
Intervention description: matching placebo capsules twice daily.; 75-450mg/day pregabalin dose optimised at start of study
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: juvenile primary fibromyalgia syndrome; pediatric fibromyalgia; pregabalin; and Lyrica

Summary:

      This study will compare pregabalin with placebo over a 15 week period in adolescents with
      fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of fibromyalgia

          -  12-17 years of age

        Exclusion Criteria:

          -  Patients with other pain conditions

          -  Previous treatment with pregabalin

          -  Patients taking excluded medication
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
Condition: Acute Upper Respiratory Track Infection
MeSH terms: Infections
Intervention: Guaifenesin; Placebo
Intervention description: 1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days; Placebo bid for 7 days
Intervention MeSH terms: Phenylpropanolamine; Pseudoephedrine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1179.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acute Upper Respiratory Track Infection Who Seek Treatment

Summary:

      The purpose of this study is to determine if treatment with Mucinex D lowers the use of
      antibiotics in the treatment of upper respiratory infection when compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms
             diagnostic for an acute upper respiratory tract infection within the last 5 days

        Exclusion Criteria:

          -  patients who had chronic, recurring respiratory signs and symptoms due to conditions
             such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in
             the investigator's opinion, confounded interpretation of symptom ratings for the acute
             upper respiratory infection. Also excluded were patients with a fever greater than 101
             degrees F.
Study Evaluating InductOs in Diaphyseal Tibia Fractures
Condition: Tibial Fractures
MeSH terms: Fractures, Bone; Tibial Fractures
Intervention: InductOs
Intervention description: InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open Diaphyseal Tibia Fractures

Summary:

      Demonstrate a larger proportion of subjects with healed fractures among subjects treated with
      InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed,
      locked intramedullary nailing alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with acute open tibial shaft fractures (Gustilo Type I, II, IIIA, or IIIB)
             who require surgical management with reamed, statically locked intramedullary nail
             fixation and who are at low risk for amputation.

          -  Subjects should be at least 18 years of age, be skeletally mature, and be able to
             provide written informed consent.

          -  Initial fracture stabilization and wound debridement should occur within 1 day after
             injury and DFC should occur within 14 days after injury.

        Exclusion Criteria:

          -  Planned treatment for the fracture should not include further procedures to promote
             fracture healing. After 16 weeks have elapsed since DFC, unanticipated procedures to
             promote fracture healing are permitted as clinically indicated.

          -  Presence of fracture distraction > 2 mm following definitive fracture fixation.

          -  Presence of purulent drainage from the fracture site or evidence of active
             osteomyelitis.
Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
Condition: Detrusor Hyperreflexia
MeSH terms: Reflex, Abnormal
Intervention: Oxybutynin; Oxybutynin
Intervention description: 1.3, 2.6, 3.9 mg/day transdermal; 5 to 15 mg/day immediate release or extended release tablets, or syrup
Intervention MeSH terms: Mandelic Acids; Oxybutynin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and effectiveness of an anticholinergic drug treatment
      administered by transdermal patch to treat overactive bladder in children who have a
      neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric patient with a diagnosis of detrusor overactivity associated with a
             neurological condition;

          -  Use clean intermittent catheterization

          -  On stable dose of oral oxybutynin before participation

        Exclusion Criteria:

          -  Have one or more treatable conditions, other than neurogenic bladder dysfunction, that
             may cause urinary incontinence or urgency

          -  Have any medical condition that precludes their participation in the study or may
             confound the outcome of the study
OptiVol® Care Pathway
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Monthly Review Arm; Quarterly Review Arm
Intervention description: Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.; Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1682.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Failure; Implantable Cardioverter Defibrillator (ICD); Cardiac Resynchronization Therapy with Defibrillator (CRT D); OptiVol®

Summary:

      Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized,
      multi-center, post-market clinical trial in the United States. The purpose of this clinical
      trial is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol
      for initiation of clinical action. It is hypothesized that monthly review of Cardiac Compass
      Trends with OptiVol will shorten time to clinical action as compared to quarterly review.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject (or subject's legally authorized representative) is willing and able to sign
             and date written consent form and Authorization for Access to and Use of Health
             Information

          -  Subject is at least 18 years of age

          -  Subject is willing and able to comply with Clinical Investigation Plan

          -  Subject is willing and able to transmit data using Medtronic CareLink® Network

          -  Subject has market released right atrial (RA) (if applicable), right ventricular (RV),
             and left ventricular (LV) (if applicable) leads and one of the following generators
             implanted: Concerto® CRT-D - Model C154DWK, Virtuoso® DR ICD - Model D154AWG,
             Virtuoso® VR ICD - Model D154VWC, Consulta™ CRT-D - Model D224TRK, Secura™ DR ICD -
             Model D224DRG, Secura™ VR ICD - Model D224VRC, or any future market released Medtronic
             generator with wireless telemetry, Cardiac Compass with OptiVol Fluid Status
             Monitoring, and that is supported by the Medtronic CareLink Network

        Exclusion Criteria:

          -  Subject is enrolled in a concurrent study with the exception of a study approved by
             the Medtronic Clinical Trial Leader prior to enrollment

          -  Subject has life expectancy of less than 1 year
FAST as a Treatment for Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Encore Tongue Suspension System
Intervention description: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: obstructive sleep apnea; tongue suspension

Summary:

      The objective of this study is to assess the feasibility and safety of tongue suspension
      using the Siesta Medical Encore Tongue Suspension System for the treatment of obstructive
      sleep apnea (OSA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of moderate obstructive sleep apnea (AHI 5-30/hour) measured
             within 12 months prior to the planned procedure

          -  Age >/= 20 and >/= 65

          -  Body Mass Index ,/= 32 (kg/m^2)

          -  Patient offered CPAP and has refused of failed to continue CPAP treatment or is not
             compliant with CPAP

          -  Signed informed consent to participate in this study

        Exclusion Criteria:

          -  Prior OSA surgery

          -  Active systemic infection

          -  Allergy to any medication used during implantation

          -  Previous history of neck or upper respiratory tract

          -  Significant dysphagia or speech disorder

        Anatomical

          -  Identified obvious palatal stenosis

          -  Enlarged tonsils (3+)

          -  Anatomy unable to accommodate the implant

        Other

          -  Other medical, social, or psychological problems that , in the opinion of the
             investigator, precludes the patient from receiving this treatment and the procedures
             and evaluations pre- and post-treatment

          -  Enrollment in another pharmacological or medical device study that may effect or bias
             the results of this clinical study

          -  Unable and/or not willing to comply with treatment follow-up requirements

          -  Pregnancy (Female subjects of childbearing potential must have a negative pregnancy
             test prior to enrollment
Effects of Linagliptin on Endothelial Function
Condition: Type 2 Diabetes; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Linagliptin; Placebo
Intervention description: The subject will receive Linagliptin 5mg orally once daily for 12 weeks.; The subject will receive placebo orally once daily for 12 weeks.
Intervention MeSH terms: Linagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is planned to evaluate if linagliptin can improve endothelial function in patients
      with type 2 diabetes mellitus. In addition, the effect of linagliptin on arginine
      bioavailability ratios and postchallenge glycaemic control will be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 40 to 80 years

          -  Early diabetes (postchallenge diabetes (2h glucose >200 mg/dl or type 2 diabetes
             treated with diet only or on a stable dose of metformin monotherapy)

          -  Coronary atherosclerosis (diagnosed via coronary angiography or coronary computer
             tomography)

        Exclusion Criteria:

          -  Acute coronary syndrome or cerebrovascular event within the previous 4 weeks

          -  Body Mass Index (BMI) > 35 kg/m2

          -  HbA1c <6.0% (42 mmol/mol)

          -  Serum creatinine > 2.5 mg/dl

          -  Aspartate Transaminase (AST)/Alanine Transaminase (ALT)>3x upper limit of normal

          -  HbA1c >9.0% (>75 mmol/mol)

          -  Heart failure > New York Heart Association (NYHA) class II

          -  Uncontrolled hypertension (blood pressure > 165 / 100 mmHg)

          -  Treatment with orally administered steroids

          -  New onset statin or Angiotensin Converting Enzym- (ACE-) inhibitor within the previous
             6 weeks

          -  Known Malignancy

          -  Pregnancy or breast feeding women.
Single-shot TAP Block vs Continuous TAP Block
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: TAP-C; TAP-S
Intervention description: TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.; Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transversus abdominis plane block

Summary:

      The purpose of this study is to determine whether continuous transversus abdominis plane
      (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor
      nephrectomy
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy subject undergoing laparoscopic live donor nephrectomy

          -  (ASA) American Society of Anesthesiologists class 1 or 2

          -  Age 18 or older, male or female

          -  Desires TAP block for postoperative pain control

        Exclusion criteria:

          -  Any contraindication for TAP block - single or continuous

          -  History of substance abuse

          -  Any physical, mental or medical conditions which, in the opinion of the investigators,
             may confound quantifying postoperative pain resulting from surgery.

          -  Known allergy or other contraindications to the study medications (Ropivacaine, Normal
             Saline, Hydromorphone, Oxycodone and Acetaminophen)
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
Condition: Renal Function and Chronic Allograft Vasculopathy
MeSH terms: Vascular Diseases
Intervention: Cyclosporine; Mycophenolate mofetil; Corticosteroids; Everolimus; Anti Thymocyte Globulin
Intervention description: Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3); Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11; Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.; Everolimus 0.75 mg twice a day as starting dose up to a target blood level: 3-6 ng/mL (7-11 weeks) and 6-10 ng/mL for remaining of study; Induction therapy, Anti Thymocyte Globulin (ATG): 1-2 mg/kg/day during 3-5 days for control and everolimus groups after transplant surgery and prior to randomization.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Antilymphocyte Serum
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A controlled, randomized, open-label, multicenter study evaluating if early initiation of
      everolimus and early elimination of cyclosporine in de novo heart transplant recipients can
      improve long-term renal function and slow down the progression of chronic allograft
      vasculopathy
    

Eligibility criteria:

        De novo heart transplant recipients who had received induction therapy with antithomocyte
        globulin (ATG) were eligible for inclusion.

        Recipients of multi-organ transplants or a previous transplant were excluded, as were those
        with a donor aged > 70 years, cold ischemia time >6 hours, patients with severe systemic
        infection, recipients of ABO incompatible transplants, patients with severe
        hypercholesterolemia (>350mg/dL) or hypertriglyceridemia (>750 mg/dL), patients with past
        (<5 years). In order to continue in the study after week 7-11 (period 1), patients had to
        complete first 7-11 weeks on randomized immunosuppression and none of the following
        criteria should be present: Ongoing rejection treatment or experience of one grade 3R
        rejection or two or more grade 2R rejections during first 7-11 weeks.