bioihbjkbjnl/mcl2 huggingface dataset:
Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: BMS-955176; EFV; TDF/FTC
Intervention description: HIV Maturation Inhibitor; EFV; TDF/FTC
Intervention MeSH terms: BMS-955176
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find at least one dose of BMS-955176 that will be safe,
      effective and tolerable for HIV-1 infected treatment naive adults.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Men and non-pregnant women, at least 18 years of age

          -  Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week
             of an antiretroviral drug

          -  Plasma HIV-1 RNA ≥ 1000 copies/mL

          -  CD4 T-cell count > 200 cells/mm3

        Exclusion Criteria:

          -  Resistance or partial resistance to any study drug determined by tests at Screening

          -  Current or historical genotypic and/or phenotypic drug resistance testing showing
             certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors

          -  Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)

          -  Blood tests that indicate normal liver function

          -  Hemoglobin < 8.0 g/dL, platelets < 50,000 cells/mm3
A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
Condition: Chagas Disease
MeSH terms: Chagas Disease
Intervention: Posaconazole; Placebo for posaconazole; Benznidazole
Intervention description: POS 40 mg/mL oral suspension; Placebo oral suspension; BNZ 100 mg oral tablet
Intervention MeSH terms: Posaconazole; Benzonidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of
      asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg
      twice daily improves therapeutic response compared to placebo in participants with a
      diagnosis of asymptomatic chronic Chagas disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following
        tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked
        immunoabsorbent assay (ELISA)

          -  Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi

          -  Must have a normal 12-lead electrocardiogram (ECG)

          -  Must have a normal 2-D echocardiogram

          -  Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring

          -  Female participants of childbearing age must be using a medically accepted method of
             birth control before beginning study drug treatment and must agree to continue its use
             during the study, or must have been surgically sterilized

          -  Female participants of childbearing potential must have a negative serum beta-human
             chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine
             pregnancy test at Baseline or within 72 hours before the start of study drug

        Exclusion Criteria:

          -  Are breastfeeding, pregnant, or planning to become pregnant

          -  Body weight <60 kg

          -  Have an immunodeficiency or are immunosuppressed

          -  History of megacolon with obstipation or megaesophagus with severe swallowing
             impairment.

          -  Have previously received treatment with benznidazole or nifurtimox

          -  Known allergy/sensitivity to azoles

          -  Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater
             than 2.5 times the upper limit of normal at Screening

          -  Has serum creatinine >2.5 mg/dL or 200 micromoles at Screening

          -  Has a history of severe alcohol abuse within two years from Screening

          -  Is taking any of the prohibited medication
A Multi-center 12-week Study of HMS5552 in T2DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: HMS5552; HMS5552; HMS5552; HMS5552; Placebo
Intervention description: 75mgQD; 100mgQD; 50mgBID; 75mgBID; QD/BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 258.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GKA,T2DM,HMS5552

Summary:

      This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type
      2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will
      receive placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male & female, 40~75 years old

          2. T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3
             months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone

          3. HbA1c 7.5~10.5% at screening and pre-randomization

          4. Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening,
             and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization

          5. BMI: 19~30kg/m^2 & TG<5.5mmol/L

        Exclusion Criteria:

          1. T1D，secondary DM, pre-DM

          2. kidney diseases or eGFR MDRD<60ml/min/1.73m^2

          3. unstable CVDs

          4. liver diseases

          5. mental or CNS diseases
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
Condition: Cure Rate
MeSH terms: Malaria
Intervention: KAE609; KAE609; KAE609; KAE609
Intervention description: KAE609 75mg single dose; KAE609 150mg single dose; KAE609 225mg single dose; KAE609 300mg single dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: parasitemia

Summary:

      This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria
      patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg,
      225mg and 300mg/day
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients aged 20 to 60 years

          -  Presence of mono-infection of P. falciparum

          -  Weight between 40 kg to 90 kg

        Exclusion Criteria:

          -  Patients with signs and symptoms of severe/complicated malaria

          -  Mixed Plasmodium infection

          -  Presence of other serious or chronic clinical condition requiring hospitalization.

          -  Severe malnutrition

          -  Significant chronic medical conditions which in the opinion of the investigator
             preclude enrollment into the study
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Condition: Smallpox
MeSH terms: Smallpox
Intervention: Vaccinia virus: ACAM2000 smallpox vaccine; vaccinia virus (calf lymph): Dryvax
Intervention description: Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml; Group 5 dose: 1.0x10-8th PFU/ml
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Maximum age: 29 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smallpox

Summary:

      The purpose of this study is to examine the safety and the effectiveness of a new vaccine for
      the prevention of the disease, smallpox.
    

Eligibility criteria:

        Inclusion criteria:

          -  females must not be pregnant, lactating and must agree to use an effective form of
             birth control for the 30 days following vaccination or unable to bear children.

          -  agree to be available for the entire study and agree to comply with all requirements.

        Exclusion criteria:

          -  military service prior to 1989.

          -  history of previous smallpox vaccination.

          -  children 1 year of age or younger in the household or be in close contact

          -  smallpox vaccination within ten years

          -  known or suspected human immunodeficiency virus (HIV) infection, primary
             immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use
             of immunosuppressive or anti-neoplastic drugs or have a household member or intimate
             contact with the conditions listed above.

          -  renal disease

          -  current or past history of eczema or a household member or direct contact who has
             eczema.

          -  known allergy or past allergic reactions to latex gloves or to antibiotics which
             include neomycin, streptomycin, chlortetracycline, and polymyxin B

          -  known allergy or past allergic reaction to blood products.

          -  known allergy to cidofovir or sulfa-containing drugs.

          -  history of allergic phenomena following smallpox vaccination in the past, including
             urticaria, erythema multiforme, or Stevens-Johnson syndrome.

          -  transfusion of blood or treatment with any blood product.

          -  current or history of drug or alcohol abuse

          -  inoculation with any other live vaccine or participating in another drug or vaccine
             trial within 30 days of enrollment.
Extension Study to Assess the Safety and Efficacy of Pasireotide in Participants With Cushing's Disease
Condition: Cushing Disease
MeSH terms: ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion
Intervention: Pasireotide
Intervention description: Pasireotide 600 μg or 900 μg was administered as an SC injection.
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cushing's disease; ACTH; Cortisol; ACTH dependent Cushing's disease

Summary:

      Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic
      hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and
      efficacy of pasireotide in participants with Cushing's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed the 15 days of Pasireotide treatment in the
             CSOM230B2208 study and have achieved normalization of 24-hour urinary free cortisol.
             Participants who did not achieve normalization of 24 -hour urinary free cortisol may
             be enrolled if in the opinion of the investigator the participant is getting
             significant clinical benefits from treatment with Pasireotide .

          -  The participant did not experience any unacceptable adverse events of tolerability
             issues during the original 15 day treatment.

          -  Female participants of childbearing potential who have not undergone clinically
             documented total hysterectomy and/or ovariectomy or tubal ligation must agree to use
             barrier contraception throughout the course of the extension study, and for one month
             after the study has ended.

        Exclusion Criteria:

          -  Participant who have developed poorly controlled diabetes mellitus as indicated by
             ketoacidosis or hemoglobin (Hgb) A1C (HgbA1C) > 10 since starting [study
             CSOM230B2208].

          -  Participant with persistent alanine aminotransferase (ALT)/ aspartate transaminase
             (AST) or alkaline phosphatase levels more than 2.5X upper limit of normal (ULN), serum
             creatinine > 2.0 X ULN, serum bilirubin > 2 X ULN.

          -  Participant with abnormal coagulation (Prothrombin time (PT) and partial
             thromboplastin time (PTT) elevated by 30% above normal limits), white blood cells
             (WBC) <3.0x1'000'000'000/L; Hgb <12.0g/dL for females, Hgb <13.0g/dL for males; PLT
             <100x1'000'000'000/L.

        Other protocol-defined inclusion / exclusion criteria may apply.
Staying Well: A Clinical Trial of Mindfulness-Based Stress Reduction and Education Groups for HIV
Condition: HIV
Intervention: Mindfulness-Based Stress Reduction (MBSR); HIV-education and self-management workshop
Intervention description: 8 week MBSR course; 8-week group covering a variety of educational topics about managing HIV infection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Meditation; Stress; Randomized Controlled Trial; Complementary Therapies; MBSR; Not on ART medications

Summary:

      To examine the effects of Mindfulness-Based Stress Reduction (MBSR) and education groups on
      HIV (Human Immunodeficiency Syndrome) infection. Key outcomes include CD4 and viral load,
      stress hormones, depression and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV+

          -  Viral Load>100

          -  CD4 T-Cells>250

          -  Not on Antiretroviral therapy (ART)

          -  Ability to Speak English

          -  Stable address/living situation

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  Use of ART within the past 120 days

          -  Any substance abuse,mental health or medical condition that the opinion of the
             Principal Investigator (PI) would make it difficult for the potential participant to
             participate in the intervention

          -  Plans to start ART in the next 12 months

          -  Previous MBSR training and/or current practice

          -  Current use or use in past 6 months (mos.) of chemotherapy or immunomodulator drugs,
             including oral steroids or plans to start in the next 12 mos.

          -  Initiation of new class of psychiatric medication in past 2 months.
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
Condition: Acute Episode of Overt Hepatic Encephalopathy; Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases; Hyperammonemia
Intervention: ornithine phenylacetate; placebo intravenous infusion
Intervention description: Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation; Placebo for continuous IV infusion that is visually identical to the experimental product
Intervention MeSH terms: Phenylacetic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: While the study was double-blind (participant and investigator blinded), the care provider and outcomes assessor were also blinded.
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hepatic encephalopathy; hyperammonemia; cirrhosis; ornithine phenylacetate; OCR-002

Summary:

      The purpose of this study is to determine whether ornithine phenylacetate can speed recovery
      from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized with an acute episode of hepatic encephalopathy as complication of
             cirrhosis

          -  Elevated venous ammonia

        Exclusion Criteria:

          -  Renal failure with serum creatinine > 3 mg/dL or need for dialysis

          -  Molecular Adsorbent Recirculation System utilized

          -  Pregnancy or breastfeeding
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Heart Attack
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Selatogrel 8 mg; Selatogrel 16 mg
Intervention description: Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water and further diluted with 1 mL sodium chloride (NaCl) 0.9%.; Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The goal of this study is to find out how fast a drug called selatogrel (ACT-246475) can
      prevent platelets from binding together. This study will also help to find out more about the
      safety of this new drug. The drug selatogrel (ACT-246475) will be used in 2 different doses
      (8 mg or 16 mg) and will be administered in the thigh.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Informed consent obtained prior to any study-mandated procedure,

          -  Males aged from 18 to 85 and postmenopausal females aged up to 85 years,

          -  Onset of symptoms of AMI of more than 30 min and less than 6 hours prior to
             randomization,

          -  Subjects presenting a type I AMI including STEMI or NSTEMI.

        Main Exclusion Criteria:

          -  Cardiogenic shock or severe hemodynamic instability,

          -  Cardiopulmonary resuscitation,

          -  Loading dose of any oral P2Y12 receptor antagonist prior to randomization,

          -  Planned fibrinolytic therapy or any fibrinolytic therapy administered within 24 h
             prior to randomization,

          -  Known platelet disorders (e.g., thromboasthenia, thrombocytopenia, von Willebrand
             disease).

          -  Active internal bleeding, or bleeding diathesis or conditions associated with high
             risk of bleeding.

          -  Known clinically important anemia.

          -  Oral anticoagulation therapy within 7 days prior to randomization
Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS
Condition: Pain, Acute
MeSH terms: Acute Pain
Intervention: S-Ibuprofen; Vehicle
Intervention description: Topical Gel 5%; Vehicle Gel
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: active gel and matching vehicle control gel
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel
      5%
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of pain/soreness after exercise

          -  BMI between 18-30

          -  negative drug, alcohol, pregnancy screens

          -  other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  upper extremity workout in last 3 months

          -  job or hobby requiring heavy lifting

          -  history of muscle disorders

          -  allergy or intolerance to NSAID or study drug

          -  history of recent pain medication use

          -  other protocol-defined exclusion criteria may apply
TLESR-impedance Study in Patients
Condition: Reflux Episodes
Intervention: AZD3355; Placebo
Intervention description: 65 mg capsules, oral, 3 single doses; capsules, oral, 3 single doses
Intervention MeSH terms: Lesogaberan
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GERD; transient lower esophageal sphincter relaxations (TLESRs); reflux

Summary:

      The purpose of the study is to compare frequency and content of reflux episodes in patients
      with gastroesophageal reflux disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written consent

          -  GERD patients, age 18-70 years, females must be postmenopausal or surgically
             sterilised

          -  6 months history of GERD and incomplete response to PPI treatment

        Exclusion Criteria:

          -  Insufficient symptom burden of the reflux disease evaluated by questionnaires

          -  S-creatinine >1.2 times upper limit of normal

          -  History of heart disease

          -  Prior surgery of the upper GI tract