bioihbjkbjnl/mcl2 huggingface dataset:
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: OPC-41061
Intervention description: orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
Intervention MeSH terms: Tolvaptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Healthy volunteers: No
Keywords: ADPKD; Tolvaptan

Summary:

      Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral
      administrations at doses of 15 mg twice daily in patients with ADPKD who completed the
      preceding dose-finding study (156-04-001).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed 5-day repeated administrations and the follow-up observation in
             the preceding study (156-04-001)

          -  Patients in whom the safety of repeated administration was confirmed based on the
             investigator's reports from the preceding study (156-04-001)

        Exclusion Criteria:

          -  Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening
             examination

          -  Patients with any of the following complications

               -  Uncontrolled hypertension

               -  Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg.
                  cirrhosis)"

          -  Patients with any of the following complications or history thereof

               -  Clinically significant drug allergies (anaphylaxis) or hypersensitivity
                  (especially, hypersensitivity to benzazepine derivatives or suspected
                  hypersensitivity thereto)

               -  Inability to personally give consent due to a mental disease "

          -  Patients with SBP (in sitting position) <90 mm Hg (at screening examination)

          -  Patients with history of massive bleeding or bleeding tendency

          -  Patients with a history of drug or alcohol abuse within 6 months prior to the
             screening examination

          -  Pregnant women, lactating women, or women who may become or plan to become pregnant

          -  Patients who received any investigational drug other than OPC-41061 within 30 days
             prior to commencement of administration of OPC-41061

          -  Any patient who, in the opinion of the principle investigator or attending
             investigators, should not participate in the study
Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men
Condition: Cortisol Resistance; Negative Feedback; ACTH; Mineralcorticoid; Glucocorticoid
Intervention: Mifepristone; Placebo; Spironolactone; Combined; Dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Spironolactone; Mifepristone; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 51.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cortical Resistance; ACTH; Glucocorticoid; Mifepristone; SPIRONOLACTONE; Exercise; Hypothalamic-Pituitary-Adrenal Axis; Healthy Volunteer; HV

Summary:

      This study proposes to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in
      younger endurance trained and sedentary men, and in older sedentary men.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Men aged 18 to 30 years of age are required for the young endurance trained and sedentary
        groups; men aged 65-80 years for the older study group, who will meet criteria for
        sedentary men below. Women and children are excluded to enhance homogeneity of responses
        and avoid the influence of menstrual cyclicity on the HPA axis.

        Sedentary:

          -  Less than one hour physical activity per week for three years

          -  No change in exercise anticipated for 6 weeks

        Trained:

          -  Greater than 45km (28 miles) running per week for at least 3 months

          -  No change in exercise anticipated for 6 weeks

        For all participants:

          -  All races

          -  Sleep-wake cycle with sleeping at night, wakening between 5 and 8 AM

          -  BMI between 18 and 25 kg/M2

          -  Normal TSH and free T4

        EXCLUSION CRITERIA:

        For all participants:

          -  Sleep disorders as assessed by sleep apnea questionnaire

          -  Smoking

          -  No more than 2 servings of alcohol daily

          -  Medications known to affect the HPA axis or steroid metabolism, including narcotics,
             Glucocorticoids, megace or CYP3A4 modulators

          -  History of psychiatric or endocrine disorders

          -  Marijuana or other illicit drug use

          -  Recent appendicular or skeletal injury

          -  Uncontrolled hypertension

          -  Chronic pain requiring daily medication

          -  Current treatment with medications related to mineralocorticoid function such as
             potassium, ACE-inhibitors, ARBs, diuretics, spironolactone

          -  Frailty score of 4-7 on the Canadian Study of Health and Aging frailty scale (Rockman
             2005)

          -  Overtraining syndrome will be an exclusion and will be assessed by questionnaire

          -  Abnormal creatinine level (greater than 1.2 mg/dl)

          -  Liver function tests greater than two fold normal

          -  Benzodiazepine use
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABI-H2158; Placebo; Entecavir (ETV)
Intervention description: 3 X 100 mg tablets for oral administration; Sugar pill manufactured to mimic the ABI-H2158 tablets; 0.5 mg tablet for oral administration
Intervention MeSH terms: Entecavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HBV; hepatitis B

Summary:

      This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of
      ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in
      participants with chronic hepatitis B virus (HBV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index of 18 - 36 kg/m^2 and body weight ≥45 kg

          -  HBeAg ≥500 IU/mL at Screening

          -  In good general health except for chronic HBV infection for ≥6 months documented, for
             example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6
             months apart

          -  Lack of cirrhosis or advanced liver disease

        Exclusion Criteria:

          -  Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir,
             standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an
             investigational agent for HBV infection

          -  History or evidence of advanced liver disease or hepatic decompensation (including
             jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices,
             hepatic encephalopathy)

          -  History or presence of clinically significant medical conditions requiring frequent
             medical management or pharmacologic or surgical treatment
Combination of Danazole With Berberine in the Treatment of ITP
Condition: Corticosteroid-resistant or Relapsed ITP
Intervention: Berberine plus danazol
Intervention description: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
Intervention MeSH terms: Danazol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: corticosteroid-resistant or relapsed ITP; Danazole; berberine

Summary:

      A prospective, multicenter, open-label, Phase II, single arm, trial performed in 6
      departments of hematology in China
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed

          2. Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L
             combined with bleeding manifestation

          3. Subject is ≥ 18 years and ≤80years

          4. Subject has signed and dated written informed consent.

          5. Fertile patients must use effective contraception during treatment and observational
             period

          6. Negative pregnancy test

        Exclusion Criteria:

          1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL

          2. Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL
             and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper
             limit of normal

          3. Have a New York Heart Classification III or IV heart disease

          4. Have a history of severe psychiatric disorder or are unable to comply with study and
             follow-up procedures

          5. Have active hepatitis B or hepatitis C infection

          6. Have a HIV infection

          7. Have active infection requiring antibiotic therapy within 7 days prior to study entry

          8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12
             months of receiving study drug

          9. Previous treatment with rituximab

         10. Previous splenectomy

         11. Had previous or concomitant malignant disease

         12. Not willing to participate in the study.

         13. Expected survival of < 2 years

         14. Intolerant to murine antibodies

         15. Immunosuppressive treatment within the last month

         16. Connective tissue disease

         17. Autoimmune hemolytic anemia

         18. Patients currently involved in another clinical trial with evaluation of drug
             treatment
A Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Samidorphan (Low Dose); Samidorphan (Medium Dose); Samidorphan (High Dose); Placebo; Olanzapine
Intervention description: Tablets taken once daily; Tablets taken once daily; Tablets taken once daily; Tablets taken once daily; Tablets taken once daily
Intervention MeSH terms: Naltrexone; Olanzapine; ALKS-33
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 347.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Schizophrenia; Olanzapine; Samidorphan; Alkermes

Summary:

      This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted
      in 2 parts. The study duration for each subject will be approximately 33 weeks and will
      include 25 study visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 50 years, inclusive

          -  Body mass index (BMI) of 17-30 kg/m2, inclusive

          -  Diagnosis of schizophrenia that is clinically stable

        Exclusion Criteria:

          -  Initiated 1st antipsychotic treatment within the past 12 months and/or has had
             symptoms lasting <2 years

          -  Current diagnosis of alcohol or drug use disorder, moderate or severe

          -  Clinically significant or unstable medical illness, condition, or disorder

          -  Pregnant or breastfeeding

          -  Significant changes in diet or exercise regimen or plans to join a weight management
             program during the study

          -  Opioid medications taken within 14 days and/or need to take opioid medication during
             the study period

          -  History of hypersensitivity to or intolerance of olanzapine

          -  Use of olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more
             than 1 week during the past year
TExT-MED + FANS Full Trial
Condition: Diabetes
Intervention: TExT-MED; FANS
Intervention description: messages designed to inspire motivation and behavior change; SMS delivered messages to family members to improve social support
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mobile health; social support; health disparity; Latino

Summary:

      This is an intervention to study incorporating social support into mHealth interventions for
      low-income, ED patients with diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18

          -  HbA1c>8.5

          -  Social support person identified and contacted

        Exclusion Criteria:

          -  unable to consent

          -  does not speak/read English or Spanish
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
Condition: Pain
Intervention: Lactated Ringers; Triamcinolone hexacetonide
Intervention description: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.; 1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
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: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: facial pain; temporomandibular joint; arthrocentesis; steroid

Summary:

      The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid
      injection is more efficacious than a placebo injection based on standard pain and physical
      measures that are recorded before and after treatment.

      All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical
      care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing
      followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this
      is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc
      (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A
      pregnancy test (urine test) will be conducted on all women of child-bearing age to verify
      that the patient is not pregnant before the rinsing procedure. The patient will fill out a
      short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  18-80 years of age

          -  TMJ arthralgia

          -  Masticatory myalgia

          -  TMJ sounds

          -  History of at least 6 weeks use of occlusal appliance therapy

        Exclusion Criteria:

          -  Contraindication to sedation including pregnancy or medical history

          -  History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy

          -  History of steroidal injection into TMJ

          -  History of trauma to TMJ

          -  TMJ pain longer than 3 years

          -  History of narcotic drug use on a scheduled basis

          -  Current active infection
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: JBT-101 (lenabasum); Placebo
Intervention description: Subjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84.; Subjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84.
Intervention MeSH terms: Lenabasum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: JBT-101, Lenabasum, Cystic Fibrosis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent
             with the CF phenotype and 1 or more of the following criteria:

               1. Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine
                  iontophoresis test;

               2. Two well-characterized mutations in the CFTR gene

          -  FEV1 ≥ 40% predicted corrected

          -  Stable treatment of CF for 14 days before Visit 1

        Exclusion Criteria:

          -  Severe or unstable CF, such as:

               1. Intravenous antibiotic treatment within 14 days before Visit 1

               2. Treatment with any corticosteroids > 10 mg per day or > 20 mg every other day
                  oral prednisone or equivalent within 14 days before Visit 1

          -  Any one of the following values for laboratory tests at Screening:

               1. A positive pregnancy test (or at Visit 1);

               2. Hemoglobin < 10 g/dL

               3. Neutrophils < 1.0 x 10~9/L

               4. Platelets < 75 x 10~9/L

               5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation

               6. Serum transaminases > 2.5 x upper normal limit

               7. Total bilirubin ≥ 1.5 x upper limit of normal

          -  Any other condition that, in the opinion of the Principal Investigator, is clinically
             significant and may put the subject at greater safety risk, influence response to
             study product, or interfere with study assessments.
Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol (Cimzia®)
Intervention description: Pharmaceutical Form: Solution for injection in pre-filled syringe
Route of Administration: Subcutaneous use
Dose and Administration details :
2 x 1 mL Certolizumab Pegol at Week 0, followed by
1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate to severe chronic plaque psoriasis; anti TNF α; CDP 870; Cimzia®; certolizumab pegol; retreatment

Summary:

      The primary objective is to assess differences in PASI scores between Week 12 of Study C87040
      [NCT00245765] and Week 12 of re-treatment in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject having responded to treatment at Week 12 in study C87040 and having relapsed
             during the follow-up period

          -  Female subjects either postmenopausal for at least one year, surgically incapable of
             childbearing, or effectively practising an acceptable method of contraception.Subjects
             agreed to continue using adequate contraception during the study and for 12 weeks
             after the last dose of CDP870

        Exclusion Criteria:

          -  Subjects with erythrodermic, guttate, generalized pustular form of psoriasis

          -  Any recent serious or life-threatening infection or any current sign or symptom that
             may indicate an infection (e.g., fever, cough)

          -  Positive hepatitis B surface antigen test and /or hepatitis C antibody test results

          -  Positive human immunodeficiency virus (HIV) test result

          -  White blood cell counts less than 4000 per cubic millimeter or more than 20000 per
             cubic millimeter

          -  Suspected or diagnosed demyelinating disease of the central nervous system (e.g.
             multiple sclerosis or optic neuritis)

          -  Systemic Lupus Erythematosus

          -  Participation in a clinical study within the past 3 months except Study C87040

          -  Any other condition, which in the Investigator's judgment would make the subject
             unsuitable for inclusion in the study
Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals
Condition: Cancer Diagnosis; Diagnostic Techniques and Procedures; Diagnostic Imaging
Intervention: F-18 FDG; Ga-68-DOTA-TATE; Positron Emission Tomography / Computed Tomography (PET/CT) Scan; Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Intervention description: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging; Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging; Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.; Scan using a NOVEL GE PET/MRI scanner.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants receive both scans.
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial studies how well positron emission tomography (PET)/computed tomography
      (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with
      cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of
      cancer and other types of cancers.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Cancer diagnosis

          -  Capable of complying with study procedures

          -  Able to remain still for duration of imaging procedure (approximately 90 minutes
             total)

          -  Written informed consent

        EXCLUSION CRITERIA

          -  Pregnant or nursing

          -  Metallic implants

          -  Impaired renal function