bioihbjkbjnl/mcl2 huggingface dataset:
Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LX3305 low dose; LX3305 mid dose; LX3305 high dose; Placebo
Intervention description: A low dose of LX3305; daily oral intake for 12 weeks; A mid dose of LX3305; daily oral intake for 12 weeks; A high dose of LX3305; daily oral intake for 12 weeks; Matching placebo dosing with daily oral intake for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305
      versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 18-75 years old

          -  Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as
             defined by ACR criteria

          -  Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints,
             and serum C-reactive protein level > upper limit of normal

          -  Receiving stable dose of MTX (≥10 mg/wk) and folate supplementation at least 8 weeks
             prior to Day 1

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  RA diagnosis prior to 16 years of age (Juvenile RA)

          -  Lack of response to >3 disease modifying anti-rheumatic drugs (DMARDs) or exposure to
             >1 biologic DMARD

          -  Use of DMARDs other than MTX within 12 weeks prior to Day 1

          -  Intra-articular and/or parenteral corticosteroids within 4 weeks prior to study Day 1

          -  Blood donation or receipt of live vaccine within 4 weeks prior to Day 1

          -  Major surgical procedure within 8 weeks prior to Day 1

          -  Any systemic inflammatory condition, recurrent infection, or current infection other
             than onychomycosis

          -  History of cancer within 5 years prior to Day 1

          -  Presence of hepatic or biliary disease

          -  History of tuberculosis

          -  History of human immunodeficiency virus (HIV)
A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: Pridopidine
Intervention description: 45 mg BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 248.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Huntington's disease, pridopidine

Summary:

      The purpose of the study is to collect and assess long term data on the safety, tolerability,
      and efficacy of pridopidine in patients with Huntington's disease (HD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pride HD completion within the last 6 months, including 2 week follow up period or
             patients who transitioned from the Open HART study or patients who complete future
             safety and efficacy clinical trials of pridopidine. In addition, patients who have
             already completed their defined study period under Open PRIDE HD global or local
             amendments and have discontinued treatment with pridopidine will be allowed to re
             enter the Open PRIDE HD study.

          -  Women of child bearing potential or male participants: Adequate contraception and
             birth control

          -  Good general health

               -  other criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal
             function to PRIDE HD;

          -  Similar concomitant medication restrictions to PRIDE HD.

               -  other criteria apply, please contact the investigator for more information
Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: CTLA-4 Ig; Placebo
Intervention description: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses; Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 6 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: CTLA4-Ig; Abatacept; Beta-cell function; T-cells; DPT-1; treatment; treatment of type 1 diabetes; new onset type 1 diabetes; juvenile diabetes; T1D; diabetes mellitus; Type 1 diabetes TrialNet; TrialNet

Summary:

      The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in
      individuals with new onset T1DM will improve insulin secretion (C-peptide production)
      compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 6-45

          2. Within 3 months (100 days) of diagnosis of T1DM based on ADA criteria

          3. At least one diabetes-related autoantibody

          4. Stimulated C-peptide level >0.2 pmol/ml by MMTT conducted 21 days after diagnosis of
             T1DM and within 37 days of randomization

          5. At least three months from last live immunization received and willing to forgo live
             vaccinations for three months following last dose of study treatment

        Exclusion Criteria:

          1. Immunodeficiency, chronic lymphopenia, active infection, positive PPD result or a
             history of malignancy

          2. Serologic evidence of current or past HIV, Hepatitis B or C

          3. Pregnancy, lactation, or intention of pregnancy while on study

          4. Current use of immunosuppressive agents, or medications known to influence glucose
             tolerance or glycemic control

          5. Current participation in another T1DM treatment study
Oral Testosterone for the Treatment of Hypogonadism in Males
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: TSX-002
Intervention description: TSX-002 are capsules with testosterone as the active ingredient.
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: hypogonadism; Gonadal Disorders; Endocrine System Diseases; Testosterone; Testosterone enanthate; Testosterone undecanoate; Testosterone 17 beta-cypionate; Methyltestosterone; Androgens; Hormones; Hormones,; Hormone Substitutes,; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Therapeutic Uses; Anabolic Agents; dihydrotestosterone

Summary:

      Low testosterone is a condition that occurs when the body is unable to produce sufficient
      quantities of testosterone. The medical name for low testosterone is hypogonadism.
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
      energy and mood swings. The goal of testosterone replacement therapy is to return
      testosterone levels to the normal range and relieve symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two separate
             10 am samples one week apart),

          -  18-70 years old,

          -  Willing and able to provide informed consent and to participate in all 3 periods of
             the study.

          -  BMI < 35 kg/m2.

        Exclusion Criteria:

          -  Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease,
             Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel
             syndrome, Lactose intolerance);

          -  Alcoholics or substance abuse;

          -  Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA
             (prostate-specific antigen)> 4 ng/ml;

          -  Congestive Heart Failure, uncontrolled (NYHC >1);

          -  Uncontrolled sleep apnea;

          -  Topical or injectable testosterone replacement therapy (any kind including
             dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;

          -  Testopel excluded if within 2 years;

          -  Aveed excluded if within past 6 months;

          -  Hematocrit > 50.
A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: ABT-450; ABT-267; ribavirin; ritonavir
Intervention description: tablets; tablets; tablets; capsules
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Genotype 1; Genotype 2; Genotype 3; Hepatitis C Virus; ABT-450/r; Ribavirin; ABT-267; Ombitasvir; Paritaprevir

Summary:

      The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of
      ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve
      participants with genotype 1, 2 or 3 chronic HCV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who had a body mass index 18 to < 35 kg/m^2.

          -  Females were either postmenopausal for at least 2 years, surgically sterile, or
             willing to use at least 2 effective forms of birth control.

          -  Males must have been surgically sterile or agreed to use at least 2 effective forms of
             birth control throughout the course of the study.

          -  Participants were in a condition of general good health, other than the HCV infection.

          -  Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a
             plasma HCV RNA > 50,000 IU/mL, and FibroTest score <= 0.72 and aspartate
             aminotransferase (AST) to platelet ratio index <= 2, Fibroscan® result of < 9.6
             kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.

        Exclusion Criteria:

          -  Positive drug screen

          -  Previous use of anti-HCV agents

          -  History of cardiac disease

          -  History of uncontrolled diabetes or diabetes requiring insulin

          -  Abnormal laboratory results

          -  Females who were pregnant or planned to become pregnant within 6 months after their
             last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant
             or would become pregnant within 6 months after their last dose of study drug/RBV

          -  Positive test result for hepatitis B surface antigen (HBsAg) or anti-human
             immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at
             screening.
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Condition: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive; Asperger Syndrome
Intervention: Memantine Hydrochloride (HCl)
Intervention description: Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 906.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS); Memantine; Pediatric Disorder

Summary:

      The purpose of this study is to evaluate the safety and tolerability of memantine in
      pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive
      Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for
      participation in a follow-up randomized withdrawal study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients.

          2. Age of 6-12.

          3. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
             Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive
             Developmental Disorder Not Otherwise Specified (PDD-NOS)

          4. Have a family that is sufficiently organized and stable to guarantee adequate safety
             monitoring and continuous attendance to clinic visits for the duration of the study

        Exclusion Criteria:

          1. Have enrolled in Study MEM-MD-57A

          2. Medical conditions that might interfere with the conduct of the study, confound
             interpretation of the study results, or endanger the patient's well-being.

          3. Participation in any other clinical investigation using an experimental drug within 30
             days of screening.

          4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's
             Disorder, and PDD-NOS.

          5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise
             specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder
             within the past 6 months
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
Condition: Overactive Bladder With Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge
Intervention: URO-902; Placebo
Intervention description: intradetrusor injection; intradetrusor injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: Female
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: URO-902; hMaxi-K; pVAX/hSlo; Overactive Bladder; Urge Urinary Incontinence

Summary:

      This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902
      24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with
      placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up
      to 48 weeks post-dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has symptoms of Overactive Bladder (OAB) (frequency and urgency) with Urge
             Urinary Incontinence (UUI) for a period of at least 6 months prior to screening.

          -  Participant experiences ≥ 1 episode of UUI per day.

          -  Participant has not been adequately managed with ≥ 1 oral or transdermal pharmacologic
             therapies for the treatment of their OAB symptoms.

        Exclusion Criteria:

          -  Participant has symptoms of OAB due to any known neurological reason (e.g., spinal
             cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease,
             Parkinson's disease, etc).

          -  Participant has a predominance of stress incontinence in the opinion of the
             investigator, determined by participant history.

          -  Participant currently uses or plans to use medications or therapies to treat symptoms
             of OAB, including nocturia.

          -  Participants who have previously been treated with onabotulinumtoxinA for urological
             indications within 12 months of starting the Screening Bladder Diary, or any other
             toxin for urological indications, regardless of when treated (participants treated
             with onabotulinumtoxinA or other toxins for non-urological indications are eligible,
             regardless of when treated)
Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: Lidocaine Releasing Intravesical System - LiRIS®; LiRIS Placebo; Sham Cystoscopy Procedure
Intervention description: Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.; LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.; Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
Intervention MeSH terms: Lidocaine
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: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system,
      is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into
      the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via
      cystoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women age 18 and over

          -  Diagnosed with Interstitial Cystitis as defined by protocol

          -  Able and willing to complete questionnaires and diary

          -  Able to comply with visit schedule including Day 14 Removal visit

          -  Completion of blinded study prior to enrolling in unblinded part of study

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Bladder or urethra anatomical feature that would prevent the safe indwelling or
             insertion of the investigational product

          -  History or presence of any condition that would make it difficult to evaluate symptoms

          -  Did not complete blinded study (unblinded part of study only)
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Vericiguat (BAY1021189) (1.25 mg); Vericiguat (BAY1021189) (5 mg); Placebo
Intervention description: 1.25 mg BAY1021189 tablets; 5 mg BAY1021189 tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 477.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Worsening Heart Failure; Heart Failure with Preserved Ejection Fraction

Summary:

      Objective of the study is to find the optimal dose of the once daily oral soluble guanylate
      cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard
      diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous
             diuretic treatment for HF without hospitalization) with initiation of study treatment
             after clinical stabilization

          -  Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization

        Exclusion Criteria:

          -  Intravenous inotropes at any time after hospitalization
Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: ACC-001; QS-21; ACC-001; QS-21; PBS
Intervention description: IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12; IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12; IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12; IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12; IM injection, Day 1, month 3, 6, 9, 12
Intervention MeSH terms: Saponin QA-21V1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Phase IIa; multiple ascending dose study of ACC-001

Summary:

      The study is to evaluate the safety, tolerability and whether there is an immune system
      response to multiple doses of ACC-001 with or without the use of a substance that may
      increase the response to the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of mild to moderate Alzheimer's Disease

          -  Mini Mental Status Exam (MMSE) of 16-26

        Exclusion Criteria:

          -  Significant Neurological Disease

          -  Major Psychiatric Disorder

          -  Clinically significant systemic illness