bioihbjkbjnl/mcl2 huggingface dataset:
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Intervention: LPCN 1021
Intervention description: Oral testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult
      hypogonadal male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6
             and 10 AM, on two separate days at approximately the same time of day, following an
             appropriate washout of current androgen replacement therapy.

          2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary
             hypogonadal (congenital or acquired).

          3. Naïve to androgen replacement or has discontinued current treatment and completed
             adequate washout of prior androgen therapy. Washout must be completed prior to
             collection of baseline serum T samples to determine study eligibility.

        Exclusion Criteria:

          1. History of significant sensitivity or allergy to androgens, or product excipients.

          2. Clinically significant findings in the pre-study examinations including abnormal
             breast examination requiring follow-up.

          3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).

          4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.

          5. Clinically significant abnormal laboratory value, in the opinion of the investigator,
             in serum chemistry, hematology, or urinalysis

          6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human
             immunodeficiency virus antibodies (HIV Ab).

          7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical
             procedure that might interfere with gastrointestinal motility, pH or absorption.

          8. History of any clinically significant illness, infection, or surgical procedure within
             1 month prior to study drug administration.

          9. History of stroke or myocardial infarction within the past 5 years.

         10. History of or current or suspected prostate or breast cancer.

         11. History of untreated and severe obstructive sleep apnea.

         12. History of long QT syndrome (QTc > 450) or unexplained sudden death in a first degree
             relative (parent, sibling, or child).
Perindopril Amlodipine for the Treatment of Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: XOMA 985; Amlodipine Besylate; Perindopril Erbumine
Intervention description: PERa/AMLb capsule taken once daily by mouth for six weeks; AMLb capsule taken once daily by mouth for six weeks; PERe capsule taken once daily by mouth for six weeks
Intervention MeSH terms: Amlodipine; Perindopril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 837.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypertension; Essential Hypertension

Summary:

      The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination
      drug compared to two other drugs (monotherapies) in controlling hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Essential hypertension

          -  For female subjects, a negative serum pregnancy test

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Night shift workers whose work hours include midnight to 4:00 a.m.

          -  Secondary hypertension

          -  An arm size that precludes the use of the digital blood pressure monitor cuff (arm
             size > 42 cm)

          -  Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal
             artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal
             transplant subjects

          -  Female subjects who are pregnant, planning to become pregnant

          -  History of malignancy within 5 years

          -  Primary aldosteronism

          -  Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or
             hemodynamically relevant stenosis of the aortic or mitral valve

          -  Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina

          -  Known hypersensitivity to any component of the study drugs

        Other protocol-defined inclusion/exclusion criteria may apply
Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: CVT-301
Intervention MeSH terms: Levodopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 325.0
Sex: All
Minimum age: 30 Years
Maximum age: 86 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes

Summary:

      This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of
      CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor
      fluctuations (OFF episodes). All patients will receive active treatment, but patients will be
      blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study
      for those patients who participated in that study and remain eligible for this study. In
      addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009
      (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as
      CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;

          -  Hoehn and Yahr Stage 1-3 in an "on" state;

          -  Require levodopa-containing medication regimen at least 3 times during the waking day;

          -  Experience motor fluctuations with a minimum of 2 hours of average daily "off" time
             per waking day (excluding early morning "off" time) and demonstrate levodopa
             responsiveness;

          -  Are on stable PD medication regimen;

          -  Total daily levodopa (LD) dose <1600 mg/day;

          -  Able to perform a spirometry maneuver in the ON and OFF states

          -  Normal cognition confirmed by Mini Mental State Examination (MMSE) score ≥25 ;

        Exclusion Criteria:

          -  Pregnant or lactating females;

          -  Previous surgery for PD or plan to have stereotactic surgery during the study period.
             Patients who have had deep brain stimulation [DBS] will also be excluded unless the
             procedure was performed more than 6 months prior to study enrollment.

          -  History of psychotic symptoms requiring treatment, or suicide ideation or attempt
             within last year;

          -  Known contraindication to the use of levodopa;

          -  Any significant condition, severe concurrent disease, abnormality or finding that
             would make patients unsuitable or may compromise patient safety;

          -  Any any contraindication to performing routine spirometry.
Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: Chitosan; Isosorbide dinitrate; Placebo
Intervention description: Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine; Isosorbide dinitrate (ISDN), is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate; placebo
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Chitosan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: diabetic foot ulcers; chitosan; isosorbide dinitrate spray

Summary:

      The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition
      is more frequent in elder patients. It is estimated that about 5% of all patients with
      diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients
      developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while
      10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation
      within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb
      amputation could also be involved in a new amputation in the next year; higher or in the
      other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are
      preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests
      multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading
      device, wound care and surgery in selected cases. However, treatment of DFU remains
      challenging because of unsatisfactory results from surgical and non-surgical treatments. Many
      adjunctive therapies are designed to improve the care of DFU including negative pressure
      wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB)
      Hyperbaric oxygen and acellular matrix product among others.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with diabetic foot ulcers in grade I and II of the classification of Wagner

          -  with leg arm index> 0.8 and

          -  without specific treatment for foot ulcers referred to the experimental and clinical

        Exclusion Criteria:

          -  Patients with another type of topical medication

          -  patients with diabetic foot ulcers in grade III and

          -  with leg arm index <0.8
MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Velcade (Bortezomib); Thalidomide; Dexamethasone
Intervention MeSH terms: Thalidomide; Dexamethasone; Bortezomib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Velcade; Autologous transplantation; Relapse; Disease progress

Summary:

      This is an international study in adult patients diagnosed with multiple myeloma who have
      already received at least one autologous stem cell transplantation and who have responded but
      later progressed, or relapsed, at least one year after transplantation.

      Eligible patients will be randomly assigned to one of two treatments: either Velcade plus
      Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.

      Thalidomide and Velcade are two new agents that have recently become available for the
      treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to
      test the hypothesis that the combination treatment with Velcade plus Thalidomide plus
      Dexamethasone will result in a longer time to progression (measure of time after the disease
      is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 years-of-age

          -  Multiple myeloma with evaluable disease

          -  Relapsing or having a progressive disease

          -  Karnofsky performance status > 50 %

          -  Life expectancy of at least 3 months

          -  Female of child-bearing potential must have a method of birth control and a negative
             serum or urine beta--human chorionic gonadotropin (β-HCG) pregnancy test at screening
             and all through the study

          -  Male must use contraception

          -  Voluntary written informed consent

        Exclusion Criteria:

          -  Non-secretory multiple myeloma

          -  Platelet count < 40,000 X 10^9/L

          -  Absolute neutrophil count <1.0 X 10^9/L

          -  Creatinine clearance <30 mL/minute

          -  Peripheral neuropathy >= Grade 2

          -  Seropositive for HIV, or active hepatitis A, B or C infection

          -  Pregnant or breastfeeding female

          -  Patient has hypersensitivity to bortezomib, boron or mannitol

          -  Other investigational drugs

          -  Serious medical or psychiatric illness

          -  Previous or concurrent malignancies at other sites

          -  Poorly controlled hypertension, uncontrolled or severe cardiovascular disease or
             uncontrolled diabetes mellitus
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ublituximab; Teriflunomide; Oral Placebo; IV Placebo
Intervention description: Administered as an IV infusion.; Film coated tablets administered orally.; Administered orally.; Administered as an IV Infusion.
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, double-blinded, active-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded, active-controlled study
Enrollment: 545.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96
      weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral
      placebo compared to 14 mg oral teriflunomide/IV placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing multiple sclerosis (RMS) (McDonald Criteria 2010)

          -  Active disease

          -  Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening

        Exclusion Criteria:

          -  Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed
             treatment

          -  Treatment with the following therapies at any time prior to randomization:
             alemtuzumab, natalizumab, teriflunomide, leflunomide and Stem cell transplantation

          -  Diagnosed with primary progressive multiple sclerosis (PPMS)

          -  Pregnant or nursing
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects
Condition: Infection, Human Immunodeficiency Virus I
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: GW873140
Intervention description: 400 mg twice daily
Intervention MeSH terms: Aplaviroc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1 GW873140 CCR5 antagonist experienced

Summary:

      The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist
      GW873140 or placebo in combination with an optimized background regimen in
      treatment-experienced HIV-infected subjects with R5-tropic virus
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infected.

          -  Screening viral load at least 5000copies/mL.

          -  R5-tropic only virus at screening.

          -  Total prior antiretroviral experience of at least 3 months and documented resistance
             to at least one drug in each of the following classes: nucleoside reverse
             transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors
             (NNRTI), and protease inhibitors (PI).

          -  Stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks
             before screening.

          -  Able to receive a ritonavir-boosted protease inhibitor during treatment studies.

          -  Women of childbearing potential must use specific forms of contraception.

        Exclusion criteria:

          -  Acute laboratory abnormalities.

          -  History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any
             chronic liver disease. Screening liver function tests will be used to determine
             eligibility.

          -  R5/X4-tropic, X4-tropic only, or non-phenotypeable virus at screening.

          -  Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of
             treatment study.

          -  Pregnancy or breastfeeding women.

          -  Recent participation in an experimental drug trial.

          -  Prior use of a CCR5 or CXCR4 antagonist.

          -  Significant ECG abnormalities or significant history of active pancreatitis,
             hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe
             illness.

          -  Current use of certain medications may exclude participation in this study.

          -  Additional qualifying criteria and laboratory test requirements to be assessed by
             study physician.
Established Status Epilepticus Treatment Trial
Condition: Benzodiazepine Refractory Status Epilepticus
MeSH terms: Status Epilepticus
Intervention: Fosphenytoin; Levetiracetam; Valproic acid
Intervention MeSH terms: Fosphenytoin; Levetiracetam; Valproic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: ESETT had 478 enrollments. They were 16 re-enrollers. This was an EFIC trial so all consents happened after treatment and all enrollments went through the same process of consent even if they were re-enrolled. Some information presented here only includes the first 400 patients since there was a prespecified stopping rule and the trial stopped early for futility.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 478.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: status epilepticus, refractory, benzodiazepine, fosphenytoin, levetiracetam, valproic acid

Summary:

      The primary objective is to determine the most effective and/or the least effective treatment
      of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There
      are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and
      valproic acid (VPA).

      The second objective is comparison of three drugs with respect to secondary outcomes.

      The final objective is to ensure that the trial is informative for treatment of established
      SE in children by describing the effectiveness, safety, and rate of adverse reactions of
      these drugs in children.
    

Eligibility criteria:

        Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to
        treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose
        of a benzo was administered in the 5-30 minutes prior to study drug administration. The
        doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2
        years or older

        Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a
        second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in
        the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties
        other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the
        MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder;
        Known liver disease; Known severe renal impairment; Known allergy or other known
        contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia < 50 mg/dL; Hyperglycemia > 400
        mg/dL; Cardiac arrest and post-anoxic seizures
Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Abatacept
Intervention description: IV solution, IV, 10 mg/Kg, Once monthly, 1 year; IV solution, IV, 5 mg/Kg, Once monthly, 1 year
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NOS

Summary:

      The purpose of this exploratory sub-study was to evaluate from a clinical perspective the
      impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in
      subjects who had achieved remission (Disease Activity Score 28 [DAS 28]-erythrocyte
      sedimentation rate [ESR] < 2.6) at Day 701 of study IM101023.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed the main study, are willing to participate and have a DAS
             28 ESR score of < 2.6 on Day 701 of the main study

        Exclusion Criteria:

          -  None
Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: pantoprazole
Intervention MeSH terms: Pantoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 1 Day
Maximum age: 12 Months
Healthy volunteers: No
Keywords: Safety

Summary:

      The purpose of this study is to provide additional information on safety and tolerability
      after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331
      study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study
             (NCT00259012) Study.

        Exclusion Criteria:

          -  Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.