bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABT-122
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Tolerability; Methotrexate; Safety

Summary:

      This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of
      ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to
      methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized
      controlled trial, in which participants had been randomized to receive 1 of 3 doses of
      ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab
      40 mg EOW given on background methotrexate.
    

Eligibility criteria:

        Inclusion Criteria: - Subjects who have completed the preceding Study M12-963 (ABT-122)
        randomized controlled study and have not developed any discontinuation criteria, as defined
        in Study M12-963.

          -  If female, subject must meet one of the following criteria:

               1. Postmenopausal (defined as no menses for at least 1 year).

               2. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
                  hysterectomy).

               3. Practicing appropriate birth control, from the time of enrollment in this study
                  until at least 150 days after the last dose of study drug.

          -  Male who agrees to follow one of the protocol-specified pregnancy avoidance measures,
             including refraining from donating sperm, for up to 150 days post last dose of study
             drug.

          -  Subjects must voluntarily sign and date an informed consent, approved by an
             Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the
             initiation of any screening or study-specific procedures.

          -  Subject is judged to be in good health as determined by the Investigator based on the
             results of medical history, physical examination and laboratory profile performed.

        Exclusion Criteria: - Pregnant or breastfeeding female.

          -  Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14
             days.

          -  Anticipated requirement or receipt of any live vaccine during study participation
             including up to 120 days after the last dose of study drug.

          -  Current enrollment in another investigational study; with the exception of Study
             M12-963, which is required.

          -  Consideration by the Investigator, for any reason, that the subject is an unsuitable
             candidate to receive ABT-122.
68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer
Condition: Prostate Carcinoma
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-DOTA-Bombesin; Magnetic Resonance Imaging (MRI) scan; Positron Emission Tomography (PET) scan
Intervention description: 68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is [4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl]-acetyl.
68Ga-DOTA-Bombesin is administered intravenously (IV)
Intervention MeSH terms: Bombesin
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent
      for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively
      PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called
      68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces.
      The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and
      attaching to tumor cells, which may help doctors recognize differences between tumor and
      healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside
      the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow
      doctors to identify smaller tumors than standard imaging.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Provides written informed consent

          -  Known diagnosis of prostate cancer

          -  Patient has suspected recurrence based on biochemical data [prostate-specific antigen
             (PSA) > 2 ng/mL]

          -  Able to remain still for duration of each imaging procedure (about one hour)

        EXCLUSION CRITERIA

          -  Unable to provide informed consent

          -  Inability to lie still for the entire imaging time

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance

          -  Metallic implants
A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-05175157; Placebo
Intervention description: PF-05175157 will be administered at 200 mg twice a day for 43 days.; Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Pharmacodynamics; Safety & Tolerability

Summary:

      This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of
      oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have been diagnosed with type 2 diabetes mellitus by a medical
             professional according to the American Diabetes Association guidelines.

          -  Hemoglobin A1c of ≥7 and ≤10.0% in subjects who are metformin-naive or have not taken
             metformin for 2 months or Hemoglobin A1c of ≥6.5 and ≤9.5% in subjects who are
             metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin
             and are willing to discontinue metformin in a 8-week washout period.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine (other
             than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic,
             psychiatric or neurologic disease.

          -  A waist circumference which makes fitting imto the bore of the MR scanner impossible.

        Subjects with history of dry eye, known ocular or systemic disease that affect the sclera
        or cornea.
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
Condition: Eyelash Hypotrichosis
MeSH terms: Hypotrichosis
Intervention: bimatoprost ophthalmic solution 0.005%; bimatoprost ophthalmic solution 0.015%; bimatoprost ophthalmic solution 0.03%
Intervention description: One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin); One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin); One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
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: 30 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or
      0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the
      upper eyelid margins in increasing eyelash prominence
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or
             not enough) of the eyelashes

          -  Eyelash prominence assessment of minimal or moderate

        Exclusion Criteria:

          -  Any eye disease or abnormality

          -  Any permanent eyeliner or eyelash implants of any kind

          -  Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application
             during the 3 months prior to study entry

          -  Any use of prescription eyelash growth products

          -  Any use of over the counter eyelash growth products during the 6 months prior to
             baseline

          -  Any use of treatments that may affect hair growth during the 6 months prior to
             baseline
Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: Macitentan; Placebo
Intervention description: oral tablet, 10 mg once daily; matching placebo
Intervention MeSH terms: Macitentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pre- and post-capillary pulmonary hypertension; CpcPH

Summary:

      Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of
      subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left
      ventricular dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and Females >=18 years of age

          2. Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to
             left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)

          3. Optimized diuretic therapy

        Exclusion Criteria:

          1. Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice
             classification)

          2. Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs),
             Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
Pentoxifylline Therapy in Biliary Atresia
Condition: Biliary Atresia
MeSH terms: Biliary Atresia
Intervention: Pentoxifylline
Intervention description: 20 mg/kg/day divided in 3 doses, given orally for 90 days
Intervention MeSH terms: Pentoxifylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Maximum age: 180 Days
Healthy volunteers: No
Keywords: Biliary Atresia; Pentoxifylline; Trental; Serum bilirubin; Conjugated bilirubin; Liver transplantation; Fibrosis

Summary:

      The purpose of this study is to determine whether pentoxifylline reduces liver damage in
      infants with biliary atresia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  0-180 days old

          -  Diagnosed with biliary atresia through liver biopsy and/or intra-operative
             cholangiogram

          -  No previous Kasai portoenterostomy performed at another institution

          -  Able to take medications orally

          -  Legal guardian signs consent after understanding risks and investigational nature of
             study

        Exclusion Criteria:

          -  Infants greater than 180 days old

          -  Infants receiving a Kasai portoenterostomy at another institution

          -  Infants unable to take medications orally
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
Condition: Liver Cirrhosis, Biliary
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Intervention: INT-747; Ursodeoxycholic Acid (URSO); Placebo
Intervention description: Once a day (QD) by mouth (PO); Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.; Placebo
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PBC, Primary Biliary Cirrhosis, Liver,

Summary:

      The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels
      in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 18 to 70 years.

          -  Stable dose of ursodeoxycholic acid (URSO, UDCA) for at least 6 months prior to
             screening.

          -  Female patients must be postmenopausal, surgically sterile, or prepared to use 2
             methods of contraception with all sexual partners during the study and for 14 days
             after the end of dosing.

          -  Male patients must be prepared to use 2 methods of contraception with all sexual
             partners during the study and for 14 days after the end of the dosing.

          -  Proven or likely PBC, as demonstrated by the patient presenting with at least 2 of the
             following 3 diagnostic factors:

               1. History of increased AP levels for at least 6 months prior to Day 0

               2. Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or
                  PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)

               3. Liver biopsy consistent with PBC.

          -  Screening AP value between 1.5 and 10 × ULN.

        Exclusion Criteria:

          -  Administration of the following drugs at any time during the 3 months prior to
             screening for the study: colchicine, methotrexate, azathioprine, or systemic
             corticosteroids.

          -  Screening conjugated (direct) bilirubin >2 × ULN.

          -  Screening ALT or AST >5 × ULN.

          -  Screening serum creatinine >1.5 mg/dL (133 mol/L).

          -  History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy,
             or poorly controlled ascites).

          -  History or presence of other concomitant liver diseases including hepatitis due to
             hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC),
             alcoholic liver disease, definite autoimmune liver disease or biopsy proven
             nonalcoholic steatohepatitis (NASH).

          -  Pregnancy.
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
Condition: Hypogonadism; Kallmann Syndrome
MeSH terms: Kallmann Syndrome; Hypogonadism
Intervention: Testicular biopsy; gonadotropin releasing hormone (GnRH); follicle stimulating hormone (FSH)
Intervention description: Outpatient surgical procedure.; Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels); 75 IU subcutaneous injection daily for four months.
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Male reproduction hormones; Hypogonadotropic hypogonadism; FSH; LH; GnRH

Summary:

      Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small
      testicular size, low testosterone levels, no history of puberty, and infertility. These men
      lack a hormone called gonadotropin releasing hormone (GnRH) that stimulates the development
      and maturation of the testes. This study will investigate the impact of hormonal treatments
      on men with IHH. The goal of hormonal therapy is to maximize the potential fertility in these
      individuals.
    

Eligibility criteria:

        Inclusion Criteria

          -  no history of spontaneous puberty

          -  clinical hypogonadism

          -  infantile testes (< 3 ml)

          -  no reproductive hormone therapy except testosterone

          -  Complete absence of normal LH pulses during 12-hour baseline frequent blood sampling
             and serum testosterone < 100 ng/dl

          -  Normal testing of the anterior pituitary gland

          -  Negative MRI of the hypothalamic-pituitary area

        Exclusion Criteria

          -  Prior therapy with gonadotropins (FSH, hCG, or GnRH)
Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; CP-690,550; CP-690,550; Placebo
Intervention description: Oral tablets administered at a dose of 5 mg BID for 6 weeks; Oral tablets administered at a dose of 15 mg BID for 6 weeks; 30 mg BID for 6 weeks; Placebo tablets
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: oral JAK inhibitor; clinical trial; joint diseases; anti-Inflammatory agents; rheumatic diseases; DMARD; Antirheumatic Agents; Autoimmune Diseases; Immune System Diseases

Summary:

      The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550
      monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6
      weeks for the treatment of the signs and symptoms of subjects with active rheumatoid
      arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has a history of inadequate response to at least 1, but no more than 4, of
             the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide,
             cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)

        Exclusion Criteria:

          -  Current Therapy With Any DMARD Or Biologic
Dose Finding Study to Treat High Phosphate Levels in the Blood.
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: AZD1722; Placebo
Intervention description: AZD1722, oral tablet; Placebo bid, double dummy technique
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: S-phosphate, hyperphosphatemia, hemodialysis, ESRD

Summary:

      Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks
      treatment period
    

Eligibility criteria:

        Inclusion Criteria:

          1. Females and males aged ≥18 years

          2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months

          3. Prescribed and taking at least 3 doses of phosphate binder per day

          4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58
             mmol/L (inclusive) at screening

          5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening

          6. For randomization in the study, after up to 3 weeks wash out of phosphate binders,
             patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but
             below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48
             mmol/L) vs pre wash out

        Exclusion Criteria:

          1. Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points
             during clinical routine monitoring for the 3 preceding months before screening visit.

          2. Serum parathyroid hormone >1200 pg/mL

          3. Significant metabolic acidosis

          4. Clinical signs of hypovolemia at randomization

             -