bioihbjkbjnl/mcl2 huggingface dataset:
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: BMS-945429 Placebo; BMS-945429; BMS-945429; BMS-945429; BMS-945429; Methotrexate; Methotrexate; Methotrexate Placebo; Methotrexate; Adalimumab Placebo; Adalimumab
Intervention description: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only; Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only; Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks; Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48; Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks; Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only; Tablets, Oral, 15 mg, Weekly, 48 weeks; Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only; Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only; Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks; Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effective dose of BMS-945429 in subjects with
      inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid
      Arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inadequate response to Methotrexate

          -  Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of
             at least 15 mg and stable dose for 4 weeks prior to randomization

          -  American College of Rheumatology (ACR) global function status class 1-3

          -  Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand
             or wrist

          -  High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

        Exclusion Criteria:

          -  Previously received or currently receiving concomitant biologic therapy
A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Condition: Hot Flashes
MeSH terms: Hot Flashes
Intervention: RAD1901; RAD1901; RAD1901; RAD1901; Placebo
Intervention description: 10 mg Oral once a day for 28 days.; 25 mg Oral once a day for 28 days; 50 mg Oral once a day for 28 days.; 100 mg Oral once a day for 28 days; Placebo Oral once a day for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: Female
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hot flashes; hot flushes; vasomotor symptoms; postmenopausal

Summary:

      The purpose of this study is to determine whether RAD1901 is effective in decreasing hot
      flashes in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or
             50 per week.

          2. Be in good general health as determined by medical history, physical examination, and
             inclusion procedures and is without evidence of any clinically significant
             abnormalities.

          3. Have a normal pelvic assessment with no clinically significant signs on examination
             and pelvic ultrasound.

          4. Have a normal mammogram at the time of study screening.

        Exclusion Criteria:

          1. A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular,
             gastrointestinal, endocrine, central nervous system, hematologic, immunologic or
             metabolic diseases to a degree that would compromise patient safety or interfere with
             the interpretation of study data. A history of active presence of thrombophlebitis,
             thrombosis, thromboembolic disorders.

          2. A history of active presence of stroke, transient ischemic attack (TIA), heart attack
             or ischemic heart disease.

          3. Unexplained vaginal bleeding within the 3 months prior to study entry.
Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients
Condition: Melanoma
MeSH terms: Melanoma
Intervention: AZD6244; Dacarbazine; Placebo
Intervention description: oral capsules, 75mg twice daily; 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle; Placebo
Intervention MeSH terms: Dacarbazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: BRAF mutation positive; advanced melanoma; Advanced cutaneous melanoma; Unknown primary melanoma

Summary:

      To assess the efficacy in terms of overall survival of AZD6244 in combination with
      dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation
      positive advanced cutaneous or unknown primary melanoma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological confirmation of advanced (inoperable stage III and stage
             IV) cutaneous or unknown primary melanoma

          -  Tumor sample confirmed as BRAF mutation positive

        Exclusion Criteria:

          -  Diagnosis of uveal or mucosal melanoma

          -  Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK

          -  Having received an investigational drug within 30 days of starting treatment, or have
             not recovered from side effects of an investigational drug
Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
Condition: Iron Deficiency; Iron Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Citrate; Placebo
Intervention description: Dose depends on serum phosphorus levels collected at each study visit.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD; Chronic Kidney Disease; Phosphorus; Iron Deficiency; Iron Deficiency Anemia; Elevated Phosphorus

Summary:

      The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and
      effective treatment for the management of serum phosphorus levels and iron deficiency in
      anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of
      treatment is approximately 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage III to V Chronic Kidney Disease

          -  Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization

          -  Ferritin 300 ng/mL or less

          -  Transferrin Saturation (TSAT) 30% or less

          -  Hemoglobin >9.0 and <12.0 g/dL

          -  Must consume a minimum of 2 meals per day

        Exclusion Criteria:

          -  Parathyroidectomy within 24 weeks of study

          -  gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study

          -  Requirement for dialysis or kidney injury within 8 weeks of study

          -  Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating
             Agent, blood transfusions, and Sensipar during the study

          -  Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals

          -  Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins

          -  History of hemochromatosis

          -  Allergy to iron products

          -  History of malignancy in last 5 years
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
Condition: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
MeSH terms: Sinusitis; Chronic Disease
Intervention: LYR-210; Sham comparator
Intervention description: A single administration of LYR-210 depot; Sham comparator
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

Summary:

      This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to
      Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic
      Sinusitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CS.

          -  Two trials of medical treatments for CS in the past.

          -  Minimum CS symptom score.

          -  Ability to tolerate topical anesthesia.

          -  Has been informed of the nature of the study and has provided written informed consent
             as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the
             respective clinical site.

          -  Agrees to comply with all study requirements.

        Exclusion Criteria:

          -  Have undergone previous sinus surgery.

          -  Pregnant or breast feeding.

          -  Known history of hypersensitivity or intolerance to corticosteroids.

          -  History or clinical evidence or suspicion of invasive fungal sinusitis, allergic
             fungal rhinosinusitis, or atrophic rhinitis.

          -  Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning
             serum cortisol level at screening outside of the normal range.

          -  Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening
             visit.

          -  Past or present functional vision in only one eye.

          -  Has cataracts

          -  Past, present, or planned organ transplant or chemotherapy with immunosuppression.

          -  Currently participating in an investigational drug or device study
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Condition: Enterocolitis Clostridium Difficile Recurrent
MeSH terms: Clostridium Infections; Enterocolitis; Recurrence
Intervention: RBX2660 (microbiota suspension); Placebo
Intervention description: A suspension of intestinal microbes; A suspension of saline and cryoprotectant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; C diff; CDI; CDAD; Fecal transplant; Fecal Microbiota Transplant; Diarrhea; FMT; Microbiota restoration therapy; Microbiota suspension; Fecal bacteriotherapy; C diff diarrhea

Summary:

      This is the first prospective, multi-center, double-blinded, randomized controlled study of a
      microbiota suspension derived from intestinal microbes. Patients who have had at least two
      recurrences of C. difficile infection (CDI) after a primary episode and have completed at
      least two rounds of standard-of-care oral antibiotic therapy or have had at least two
      episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients
      whose CDI returns in less than 8 weeks after the last assigned study treatment may be
      eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years

          -  Medical record documentation of recurrent CDI either: a) at least two recurrences
             after a primary episode and has completed at least two rounds of standard-of-care oral
             antibiotic therapy or b) has had at least two episodes of severe CDI resulting in
             hospitalization.

          -  Documented history that the subject's recurrent CDI is controlled while on antibiotics
             even if the subject is not currently on antibiotics.

          -  A positive stool test for the presence of C. difficile within 60 days prior to
             enrollment.

        Exclusion Criteria:

          -  A known history of continued C. difficile diarrhea while taking on a course of
             antibiotics prescribed for CDI treatment.

          -  Requires antibiotic therapy for a condition other than recurrent CDI.

          -  Previous fecal transplant prior to study enrollment.

          -  History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's
             disease, or microscopic colitis.

          -  History of irritable bowel syndrome (IBS).

          -  History of chronic diarrhea.

          -  History of celiac disease.

          -  Colostomy.

          -  Planned surgery requiring perioperative antibiotics within 6 months of study
             enrollment.

          -  Life expectancy of < 12 months.

          -  Compromised immune system.
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Condition: Gastric Cancer; Cancer of the Stomach; Esophagogastric Junction
MeSH terms: Stomach Neoplasms
Intervention: BMS-986213; Nivolumab; XELOX; FOLFOX; SOX
Intervention description: Relatlimab + Nivolumab specified dose on specified days; Specified dose on specified days; Oxaliplatin + capecitabine; Oxaliplatin + leucovorin + fluorouracil; Oxaliplatin + tegafur/gimeracil/oteracil potassium
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of investigational drug
      relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable,
      untreated, locally advanced or metastatic gastric or GEJ cancer.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

          -  Histologically- or cytologically-confirmed diagnosis of unresectable and either
             locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma

          -  No prior treatment with systemic treatment (including HER 2 inhibitors) given as
             primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ
             adenocarcinoma

          -  Tumor tissue must be provided for biomarker analyses

        Exclusion Criteria:

          -  Participants with HER2 positive status

          -  Participants with known untreated central nervous system (CNS) metastases

          -  Uncontrolled or significant cardiovascular disease

        Other protocol defined inclusion/exclusion criteria could apply
Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy
Condition: Spinal and Bulbar Muscular Atrophy
MeSH terms: Muscular Atrophy; Bulbo-Spinal Atrophy, X-Linked; Atrophy
Intervention: BVS857; Placebo
Intervention description: BVS857 lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..; Placebo lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh
      muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genetic diagnosis of SBMA with symptomatic muscle weakness

          -  Able to complete 2 minute timed walk

          -  Serum IGF-1 level less than or equal to 170 ng/mL

        Key Exclusion Criteria:

          -  Medically treated diabetes mellitus or known history of hypoglycemia

          -  History of Bell's palsy

          -  Treatment with systemic steroids > 10 mg/day (or equivalent dose); androgens or
             androgen reducing agents; systemic beta agonists; or other muscle anabolic drugs
             within the previous 3 months

          -  History of cancer, other than non-melanomatous skin cancer

          -  Retinopathy

          -  Papilledema Other protocol defined inclusion/exclusion criteria may apply
Exeantide in Type 2 Diabetes on Insulin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: exenatide 5 mcg; exenatide 10 mcg; placebo
Intervention description: exenatide 5 mcg; exenatide 10 mcg; saline sq
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: type 2 diabetes; obesity

Summary:

      Exenatide has been shown to result in better glycemic control in type II diabetes patients.
      Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to
      decreased inflammation by virtue of better glycemic control and weight loss.

      The purpose of this study is to determine if the addition of Exenatide to diabetic patients
      will reduce the requirements of insulin particularly the short acting insulin. Exenatide may
      also lead to decreased inflammation by virtue of better glycemic control and weight loss, or
      an independent effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 20-75 years of age inclusive.

          -  Type 2 diabetes

          -  On insulin therapy

          -  HbA1c ≥7.5% and ≤ 9%

          -  BMI ≥ 30 kg/m2

          -  Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants
             will be allowed as long as they are on stable doses of these compounds and the dosage
             in not changed during the study.

        Exclusion Criteria:

          -  Coronary event or procedure (myocardial infarction, unstable angina, coronary artery
             bypass, surgery or coronary angioplasty) in the previous four weeks

          -  Pregnancy

          -  Hepatic disease (abnormal LFT's)

          -  Use of DPP4 inhibitors.

          -  Renal impairment (serum creatinine > 1.5)

          -  Participation in any other concurrent clinical trial

          -  Any other life-threatening, non-cardiac disease

          -  Uncontrolled hypertension (BP > 160/100 mm of Hg)

          -  Congestive Heart Failure.

          -  Use of an investigational agent or therapeutic regimen within 30 days of study
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)
Condition: Hypothalamic Injury-induced Obesity (HIO)
MeSH terms: Obesity; Wounds and Injuries
Intervention: Tesofensine/Metoprolol; Placebo
Intervention description: During Part 1 subjects will be randomized to treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol (active medication); During Part 1 subjects will be randomized to matching placebo tesofensine and placebo metoprolol
Intervention MeSH terms: Metoprolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Double-blind, randomized, placebo-controlled, single- center study followed by an open-label
      extension period.

      • The study will have two parts:

        -  Part 1: 24 weeks double-blind treatment (DB), followed by

        -  Part 2: 24 weeks open-label extension (OLE) - all subjects still participating at the
           end of Part 1 will be given an option to continue for additional 24 weeks on the active
           drug if evaluated eligible by the Investigator
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities

          -  Males and females, aged 18-75

          -  Confirmed diagnosis of HIO

          -  BMI ≥27 kg/m2 (where overweight is related to the HIO)

        Exclusion Criteria:

          -  Blood Pressure (BP) ≥160/90 mmHg

          -  Heart rate (HR) ≥ 90, <50 bpm

          -  Type 1 diabetes, Cushings disease, acromegaly, hypophysitis, infiltrative diseases or
             Prader-Willi syndrome

          -  Heart failure New York Heart Association (NYHA) level II or greater, decompensated
             heart failure

          -  Previous myocardial infarction or stroke within the last 5 years
Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium
Condition: Pterygium
MeSH terms: Pterygium
Intervention: CBT-001 single dose; Vehicle; CBT-001 Multi-dose
Intervention description: One drop in the study administered one time; One drop in the study administered three times daily (TID) for 4 weeks; One drop in the study administered three times daily (TID) for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24)

      Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup
      (n=51)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary pterygium with moderate vascularity (Pterygium Hyperemia Grading Scale ≥ 3)

        Exclusion Criteria:

          -  Active ocular disease, corneal abnormalities other than pterygium, active ocular
             infection, or any ocular pathology unrelated to pterygium in either eye that could
             affect the assessment of the pterygium

          -  History of ocular herpes disease in either eye

          -  Any ocular surgical procedure within the last 3 months

          -  Female patients who are pregnant, nursing, or planning a pregnancy during the study