bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery
Condition: Hip Fracture; Osteoarthritis; Femur Head Necrosis
MeSH terms: Femur Head Necrosis; Necrosis; Hip Fractures
Intervention: Essential amino acid supplement; Ketoconazole; Placebo
Intervention description: 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.; 200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.; Placebo for Ketoconazole
Intervention MeSH terms: Ketoconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 40.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hip Replacement Arthroplasty; Hip Replacement Surgery; Hip Surgery; Hip Rehabilitation; Avascular Necrosis; Knee replacement surgery; Total knee arthroplasty

Summary:

      The purpose of this study is to determine the effects of two postoperative interventions
      designed to preserve muscle protein after major hip or knee surgery.
    

Eligibility criteria:

        Inclusion Criteria for All Participants:

          -  Scheduled for surgery because of osteoarthritis, avascular necrosis, fracture, or
             revision of total joint replacement in the hip or knee

        Exclusion Criteria for All Participants:

          -  Taking insulin, thiazolidinediones (TZD), or metformin

          -  Kidney insufficiency, as indicated by serum creatinine of more than 2.0 mg/dl

          -  Recently treated cancer other than basal cell carcinoma

          -  Any other condition or event that would be considered as reason for exclusion by the
             study investigators

          -  Pregnancy

        Exclusion Criteria for Experiment 1 Participants:

          -  Severe hypertension as indicated by requiring more than two drugs for blood pressure
             control

          -  History of hypo- or hypercoagulation disorders, including individuals who have taken
             warfarin (Coumadin)

          -  Atrial fibrillation, angina, or congestive heart failure

        Exclusion Criteria for Experiment 2 Participants:

          -  Liver disease or abnormal liver function tests

          -  HIV infected

          -  Active hepatitis

          -  Any uncontrolled metabolic disease, including liver or kidney disease

          -  Taking medications that use the cytochrome P450 pathway for metabolism and unable to
             discontinue their use for the duration of the study

          -  Require certain medications. More information on this criterion can be found in the
             protocol.

          -  Gastrointestinal absorption disorders that affect nutrient uptake
Remodulin® to Oral Treprostinil Transition
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: UT-15C SR
Intervention description: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
Intervention MeSH terms: Treprostinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 15 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; UT-15C SR; PAH

Summary:

      This multi-center, open-label study will assess the tolerability and safety of transitioning
      subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV)
      or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR)
      tablets).

      This study will consist of an in-hospital transition phase, dose optimization/evaluation
      phase, and follow up phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis
             of PAH

          -  Have stable disease as confirmed by recent right heart catheterization and a Baseline
             6MWD of at least 250 meters

          -  Have been receiving Remodulin for at least 90 days and at a stable dose for at least
             30 days prior to the Baseline visit; the dose of Remodulin must be between 25-75
             ng/kg/min, inclusive

          -  Must be also receiving an endothelin receptor antagonist (ERA) and/or a
             phosphodiesterase-5 inhibitor (PDE-5i) for at least 90 days and have been at a stable
             dose for at least 30 days prior to Baseline

        Exclusion Criteria:

          -  WHO functional class III and IV subjects will be excluded
Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: CoQ10
Intervention description: Capsules containing 300 mg of CoQ10 or matching placebo taken orally twice a day. All participant will start on a dosage of 600 mg/day in divided doses, increasing weekly by 600 mg/day to a maximum dosage of 2400 mg/day at week 4. Dosage should be stable from week 4 until week 20.
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10
      in pre-manifest participants carrying the CAGn expansion for Huntington's Disease (HD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants will be positive for the CAGn expansion in the Huntingtin gene (>36
             repeats) and be pre-manifest by virtue of scoring 3 or less on diagnostic confidence
             level (Question 17 of the UHDRS)

          -  Participants will have received genetic testing prior to enrollment through a standard
             pre-manifest testing protocol.

          -  18 years of age or older.

          -  Concomitant medications are permitted with the exception of CoQ10, creatine > 5g/day
             and warfarin.

        Exclusion Criteria:

          -  History of intolerability to CoQ10.

          -  CoQ10 use within 60 days prior to randomization.

          -  Unstable medical or psychiatric illness;

          -  Substance abuse within one year of the baseline visit.

          -  Pregnancy, breastfeeding or lack of reliable contraception in women of childbearing
             age.

          -  Subjects with known allergy to FD&C #6 yellow food coloring.
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: LIK066; Placebo
Intervention description: LIK066 will be supplied in different doses as tablets to be taken orally daily.; Placebo will be supplied as tablets to be taken daily orally.
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Parallel Assignment
Enrollment: 126.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Obesity disease; Over weight; T2DM; interventional study; Weight loss

Summary:

      The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to
      support dose selection for Phase 3 development in Japanese adults with obesity disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with obesity disease and inadequately controlled body weight with diet and/or
             exercise

          -  BMI ≥ 25 kg/m^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35
             kg/m^2 at least one obesity-related comorbidity

          -  Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0%

          -  Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female

          -  Visceral fat area ≥ 100 cm^2

          -  Agreement to comply with the study-required life-style intervention and treatment
             during the full duration of the study

        Exclusion Criteria:

          -  Pregnancy or lactating women

          -  Use of pharmacologically active weight-loss medications

          -  Bariatric surgery

          -  Ketoacidosis, lactic acidosis, hyperosmolar coma

          -  Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to
             screening

          -  Gastro-intestinal (GI) disorders associated with chronic diarrhea

          -  Congestive heart failure, New York Heart Association (NYHA) class III or IV
Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer
Condition: Prostate Adenocarcinoma; PSA Progression; Recurrent Prostate Carcinoma
MeSH terms: Prostatic Neoplasms; Adenocarcinoma; Disease Progression
Intervention: Gallium Ga 68 DOTA-NeoBOMB1; Gallium Ga 68 PSMA-R2
Intervention description: Administered intravenously (IV); Administered intravenously (IV)
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2
      positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing
      participants with prostate cancer that has come back. Diagnostic procedures, such as gallium
      Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate
      cancer and find out how far the disease has spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven prostate adenocarcinoma.

          -  Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or
             radiation therapy (external beam or brachytherapy).

             a. Post radical prostatectomy (RP) - American Urological Association (AUA)
             recommendation.

             (i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical
             prostatectomy.

        (ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements
        greater than 0.2 ng/mL).

        b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology
        (ASTRO)-Phoenix consensus definition.

        (i) A rise of PSA measurement of 2 or more ng/mL over the nadir.

          -  Able to provide written consent.

          -  Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
             [ECOG]/World Health Organization [WHO] equivalent).

        Exclusion Criteria:

          -  Inability to lie still for the entire imaging time.

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance.

          -  Known allergy, hypersensitivity, or intolerance to the investigational product or its
             excipients.

          -  Metallic implants (contraindicated for magnetic resonance imaging [MRI]).
DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury
Condition: Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hyperkinesis; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries
Intervention: IV Propranolol and Per Tube Clonidine; Placebo
Intervention description: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days; Placebo IV q6h and Per Tube q12, both for 7 days
Intervention MeSH terms: Propranolol; Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 16 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Sympathetic Hyperactivity; Traumatic Brain Injury; Agitation; Severe TBI; TBI; Catecholamines; Heart rate variability; Adrenergic alpha-Agonists; Adrenergic beta-Antagonists; Cognitive Impairment

Summary:

      The investigators intend to determine the effect of adrenergic blockade on 1) short-term
      physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe
      Traumatic Brain Injury (TBI).

      The primary hypothesis is that adrenergic blockade after severe TBI will be associated with
      increased ventilator-free days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 16 years to 64 years

          -  Glasgow Coma Scale score less than or equal to 8 (Severe TBI) with injury on CT

          -  Screen within 24 hours of injury

        Exclusion Criteria:

          -  Pre-existing heart disease (i.e. coronary heart disease)

          -  Pre-existing cardiac dysrhythmia

          -  Allergy to study drugs

          -  Penetrating brain injury

          -  Pre-existing brain dysfunction (i.e. prior severe TBI, debilitating stroke)

          -  Impending brain herniation (i.e. loss of bilateral corneal reflexes)

          -  Craniectomy or craniotomy

          -  Spinal cord injury

          -  Myocardial injury

          -  Severe liver disease

          -  Current use of beta-blockers and/or alpha-2-agonist

          -  Withdrawal of care expected in 24 hours

          -  Prisoners

          -  Pregnant women

          -  Unable to follow-up through final visit
Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
Condition: Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation; Dermatillomania
MeSH terms: Dermatitis; Self-Injurious Behavior
Intervention: Lamictal (lamotrigine); Placebo
Intervention description: once daily from beginning to end of study. Dosage varies.; daily
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation

Summary:

      The goal of the proposed study is to evaluate the comparative efficacy of Lamictal
      (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation
      will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching
      placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective
      than placebo in patients with neurotic excoriation. The proposed study will provide needed
      data on the treatment of a disabling disorder that currently lacks a clearly effective
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age 18-65;

          2. current diagnosis of neurotic excoriation.

        Exclusion Criteria:

          1. unstable medical illness or clinically significant abnormalities on prestudy
             laboratory tests or physical examination;

          2. history of seizures;

          3. myocardial infarction within 6 months;

          4. current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential;

          5. a need for medication other than Lamictal with possible psychotropic effects or
             unfavorable interactions with Lamictal;

          6. clinically significant suicidality;

          7. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any
             other DSM-IV psychotic disorder;

          8. current or recent (past 3 months) DSM-IV substance abuse or dependence;

          9. illegal substance use within 2 weeks of study initiation;

         10. initiation of psychotherapy or behavior therapy from a mental health professional
             within 3 months prior to study baseline;

         11. previous treatment with Lamictal (lamotrigine);

         12. treatment with investigational medication or depot neuroleptics within 3 months, with
             fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study
             baseline;

         13. current treatment with an anti-epileptic medication.
Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Condition: Symptomatic Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Intervention: Vanoxerine; Placebo
Intervention description: single oral dose; single oral dose
Intervention MeSH terms: Vanoxerine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vanoxerine; atrial fibrillation; atrial flutter; a-fib

Summary:

      Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in
      a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or
      flutter of recent onset to normal sinus rhythm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  provide written informed consent,

          -  male or female 18 years of age or greater; women of child bearing potential must use
             adequate contraception

          -  symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by
             symptoms

          -  AF/AFL documented by ECG at the start of study drug administration

        Exclusion Criteria:

          -  Systolic blood pressure <100 mmHg.

          -  Average heart rate <50 bpm.

          -  Average QTcF (Fridericia correction) >440 ms.

          -  Average QRS interval >140 ms.

          -  Paced atrial or ventricular rhythm on ECG.

          -  Serum potassium <3.5 meq/L (may be corrected prior to randomization).

          -  Received another intravenous Class I or Class III antiarrhythmic drug within prior 3
             days.

          -  received amiodarone (oral or IV) in prior 3 months.

          -  Clinical evidence or history of acute coronary syndrome within 30 days prior to
             randomization.

          -  Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.

          -  Rheumatic mitral stenosis with valve area of <1.5 cm2.

          -  Untreated hyperthyroidism.

          -  Acute pericarditis.

          -  AF/AFL as a result of surgery within the last 7 days

          -  History of failed electrical cardioversion

          -  History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).

          -  History or family history of long QT syndrome.

          -  History of ventricular tachycardia requiring drug or device therapy.

          -  History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart
             failure not related to rapid ventricular response AF.

          -  Ejection fraction (EF) of 35% or less.
A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2944876; Exenatide extended-release; Placebo; Metformin
Intervention description: Administered SC; Administered SC; Administered SC; Oral
Intervention MeSH terms: Metformin; Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Weight loss

Summary:

      The main purpose of this study is to compare the safety and effectiveness of the study drug
      known as LY2944876 to exenatide extended-release and placebo in participants with type 2
      diabetes mellitus. All drugs will be given by an injection under the skin. Participants
      remain on stable doses of metformin, as prescribed by their personal investigator if they
      were on metformin at study entry. Participants' involvement in the study is expected to last
      about 30 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women with diabetes mellitus Type 2

          -  Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable
             dose of metformin (≥1000 mg/day) for 3 months prior to screening

          -  Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

        Exclusion Criteria:

          -  Women of child bearing potential

          -  Participants who have used thiazolidinediones within 3 months prior to screening, or
             any other drugs for treatment of hyperglycemia (except metformin) within the prior 2
             months

          -  Participants who have used insulin for diabetic control for more than 6 consecutive
             days within the prior year

          -  Participants with impaired renal function (serum creatinine >124 micromole per liter
             (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in
             men)