bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Intervention: Mexiletine; Placebo
Intervention description: 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months; 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
Intervention MeSH terms: Mexiletine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Myotonic Dystrophy; Myotonic Dystrophy Type 1 (DM1); Muscular Dystrophy; Mexiletine

Summary:

      The purpose of this study is to investigate the effects of mexiletine treatment for 6 months
      on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning,
      cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of DM1, confirmed by DM1 genetic mutation

          -  Ability to walk 30 feet (assistance with cane and/or leg bracing permitted)

          -  Presence of grip myotonia

        Exclusion Criteria:

          -  Congenital DM1

          -  Treatment with Mexiletine within past 8 weeks

          -  Second or third degree heart block, atrial flutter, atrial fibrillation, ventricular
             arrhythmias, or is receiving medication for treatment of a cardiac arrhythmia

          -  Receiving another antimyotonia drug

          -  Liver or kidney disease requiring ongoing treatment

          -  Has a seizure disorder

          -  Is pregnant or lactating

          -  Had severe depression within 3 months or a history of suicide ideation

          -  Has any one of the following medical conditions: uncontrolled diabetes mellitus,
             congestive heart failure, symptomatic cardiomyopathy, symptomatic coronary artery
             disease, cancer (other than skin cancer) less than five years previously, multiple
             sclerosis, or other serious medical illness.

          -  Drug or alcohol abuse within 3 months

          -  Coexistence of another neuromuscular disease

          -  Is unable to give informed consent

          -  Severe arthritis or other medical condition (besides DM1) that would significantly
             impact ambulation
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
Condition: Opioid Abuse
MeSH terms: Opioid-Related Disorders
Intervention: Acurox 5/30mg taken first; Oxycodone 5mg taken first
Intervention description: followed by oxycodone 5mg with 48 hour washout; followed by Acurox 5/30mg with 48 hour washout
Intervention MeSH terms: Oxycodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence

Summary:

      The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual
      recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40
      mg alone in subjects with a history of opioid abuse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female between 18 and 55 years of age

          -  Subject meets DSM-IV Criteria for the Diagnosis of Opioid Substance Abuse and subject
             is unlikely to experience an idiosyncratic reaction or respiratory depression after
             ingesting 40 mg of oxycodone

          -  Body weight is not more than 20% above or below ideal body weight

          -  Subject agrees to abstain from any Rx or OTC drugs (except as authorized by the
             Investigator) or alcohol

          -  Subject is in generally good health

          -  Subject is reliable, willing, cooperative, able to communicate effectively, and has a
             minimum of a 6th grade reading level

          -  Subject has an acceptable score on the MMSE for cognitive impairment

          -  For women of child-bearing potential: woman is not pregnant and not nursing, and is
             practicing an acceptable method of birth control

        Exclusion Criteria:

          -  Subject has a disease that may endanger the subject or the validity of the data

          -  Subject is currently physically dependent on opiates or alcohol

          -  Subject was exposed to any investigational drug within 30 days prior to the inpatient
             phase

          -  Subject has a history of hypersensitivity to any drug, or a known allergy to any
             component of the study drug formulation

          -  Subject has a positive urine drug screen for a non-opiate drug

          -  Subject has a predisposing condition that may place the subject at risk for receiving
             niacin or oxycodone, or confound the study analyses

          -  Subject ingested niacin at doses higher than SDI within 14 days prior to the inpatient
             phase

          -  Subject has an abnormal bleeding tendency
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
Condition: Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
MeSH terms: Cytomegalovirus Infections
Intervention: ASP0113; Placebo
Intervention description: intramuscular injection; intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASP0113; Cytomegalovirus (CMV); Kidney Transplantation

Summary:

      The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in
      reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects
      receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of
      ASP0113 in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CMV negative subject having received a CMV seropositive kidney (living or deceased)

          -  Participant started valganciclovir or ganciclovir within 10 days of transplant and had
             received it through Randomization.

        Exclusion Criteria:

          -  Participant underwent a course of CMV-specific prophylactic therapy with antiviral
             drugs with a duration of greater than 100 days.

          -  Participant had received from one month prior to transplant or planned to receive CMV
             immunoglobulin.

          -  Participant had CMV viremia or CMV disease from time of transplant until time of
             Randomization.
A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
Condition: Spinal Fusion
Intervention: Ketamine; Saline
Intervention description: 0.12 mg/kg/hr of ketamine post surgery; Saline will be administered at the same rate as the ketamine infusion.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 129.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The aim of the proposed study is to examine the effectiveness of low dose postoperative
      ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid
      naïve patients after major spine surgery. Primary endpoints of the study are to determine the
      effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain
      and opioid requirements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult and teenage (>/=16) male or female who will undergo surgery for multilevel (>4
             level) spinal fusion from a posterior approach with general anesthesia, and who are
             fluent English speakers such that they can complete the pain score and satisfaction
             questionnaires whose scores are a critical outcome variable.

          -  If female, subject is non-lactating and is either:

          -  Not of childbearing potential

          -  Of childbearing potential but is not pregnant at time of baseline as determined by
             pre-surgical pregnancy testing.

          -  Subject is ASA physical status 1, 2, or 3.

        Exclusion Criteria:

          -  anxiety

          -  psychiatric disorder

          -  Allergy or sensitivity to ketamine or dilaudid

          -  Deemed un-acceptable by study team

          -  Cognitively impaired (by history)

          -  Subject requires chronic antipsychotic medication

          -  Subject known to be in liver failure

          -  Subject for whom opioids or ketamine are contraindicated

          -  Patients with narrow angle glaucoma

          -  Patients with a history of psychosis
Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Intervention: SOF/VEL/VOX
Intervention description: Administered once daily with food.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and
      confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX)
      fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV)
      infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Consent of parent or legal guardian required

          -  Chronic HCV infection

          -  Screening laboratory values within defined thresholds

          -  Individuals must have a determination of prior treatment status:

               -  DAA-naive is defined as either:

                    -  Treatment naive with no prior exposure to any interferon (IFN), ribavirin
                       (RBV), or approved or experimental HCV-specific DAA

                    -  Treatment experienced with an IFN-based regimen and no prior exposure to an
                       approved or experimental HCV-specific DAA

               -  DAA-experienced is defined as prior exposure to a regimen including any DAA (eg,
                  non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B
                  nucleotide/nucleoside inhibitor)

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or
             hepatitis B virus (HBV)

          -  Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal
             hemorrhage)

          -  Pregnant or nursing females

          -  Known hypersensitivity to study medication

          -  Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: DAR-901; Sterile saline placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 625.0
Sex: All
Minimum age: 13 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine

Summary:

      DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed
      with BCG to determine if immunization reduces the risk of TB infection
    

Eligibility criteria:

        Inclusion Criteria: Negative IGRA at baseline -

        Exclusion Criteria: Pregnancy, serious underlying disease

        -
Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Intervention: atorvastatin; Placebo
Intervention description: Atorvastatin is an oral cholesterol-lowering medication commonly referred to as statin therapy.; oral drug of similar appearance to atorvastatin
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: early diffuse scleroderma; Raynaud

Summary:

      The purpose of this study is to learn about the effect atorvastatin on blood vessel function
      and Raynaud symptoms in patients with early diffuse systemic sclerosis.

      Systemic sclerosis is a disease characterized by blood vessel injury, immune system
      activation and fibrosis. Blood vessel injury is thought to be important early in the disease.
      Blood vessel complications of systemic sclerosis include Raynaud phenomena, finger and toe
      ulcers, and pulmonary hypertension. While atorvastatin reduces cholesterol, it is recognized
      to have many effects beyond cholesterol reduction. These include improvement of blood vessel
      function and reduction of fibrosis. We hypothesize that treatment with atorvastatin over 16
      weeks will improve blood vessel function and Raynaud symptom in patients with early diffuse
      systemic sclerosis. We hope that by targeting therapy early in the disease we may delay blood
      vessel changes and improve Raynaud symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. early diffuse scleroderma (< 3 years from the first scleroderma-related symptom)

          2. Raynaud phenomenon

          3. no use of lipid-lowering medication within 60 days

        Exclusion Criteria:

          1. pregnancy

          2. renal or kidney dysfunction (creatinine < 2.0 mg/dL or creatinine clearance < 60
             c/min)

          3. diabetes mellitus

          4. known cardiovascular disease or a prior history of stroke

          5. history of liver disease

          6. new or changed dose of calcium channel blockers (CCB) and angiotensin receptor
             blockers (ARBs) in the last 4 weeks

          7. known allergy or adverse reaction to the atorvastatin or another statin drug
Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET
Condition: Gastroenteropancreatic Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Intervention: Lanreotide Autogel 120 mg; Temozolomide (TMZ)
Intervention description: Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days).; Temozolomide capsule (variable dose). 150 mg/m2 per day for 5 days in the first month. 200 mg/m2 per day for 5 days in months 2, 3, 4, 5 and 6.
Intervention MeSH terms: Temozolomide; Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the efficacy and tolerability of the combination of
      Lanreotide Autogel 120 mg and Temozolomide in patients with progressive
      gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All
      progressive tumours classified according to Response Evaluation Criteria In Solid Tumours
      (RECIST, 1.1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study related procedures

          -  Inoperable, Gastro-Entero-Pancreatic-Neuroendocrine Tumour G1 or G2 (Proliferation
             Index, Ki67-Index: 0 to ≤20%) confirmed by pathological/histological assessment

          -  Progressive disease within 12 months before inclusion (RECIST 1.1: increase of >20%
             tumour load; by Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)

          -  Measurable disease according to RECIST 1.1.

          -  Metastatic disease confirmed by CT/MRI.

          -  Functioning or non-functioning NET (G1, G2).

          -  Positive Octreo-Scan (≥ Grade 2 Krenning scale) or positive DOTA
             (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid)-TATE (Tyr3-Thre8-Octreotide
             or DOTA-Tyr3-octreotate)/TOC (Tyr3-octreotide) -PET (Positron-Emission-Tomography) -CT
             within 12 months prior to screening

        Exclusion Criteria:

          -  Has the diagnosis of Insulinoma

          -  Has a diagnosis of a multiple endocrine neoplasia (MEN)
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
Condition: Cystitis, Interstitial; Ulcer
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: LiRIS®; LiRIS Placebo
Intervention description: LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.; LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with
      Hunner's lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

        Exclusion Criteria:

          -  Previous treatment with LiRIS®

          -  Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Placebo; dalcetrapib
Intervention description: po daily for 36 weeks; 600mg po daily for 36 weeks
Intervention MeSH terms: Dalcetrapib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 476.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the safety, tolerability and efficacy of RO4607381 in patients with
      coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive
      either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by
      flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time
      on study treatment is up to 12 months, and the target sample size is up to 500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  CHD or CHD risk equivalent;

          -  appropriately treated for accepted LDL-C level.

        Exclusion Criteria:

          -  treatment with drugs raising HDL-C (eg niacin, fibrates);

          -  uncontrolled hypertension;

          -  recent (within 3 months) clinically significant coronary events, transient ischemic
             attacks or cerebrovascular accident;

          -  severe anemia;

          -  poorly controlled diabetes.