bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: MSTT1041A; Placebo
Intervention description: MSTT1041A will be administered as subcutaneous injections.; Placebo matched with MSTT1041A.
Intervention MeSH terms: Astegolimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm
      study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with
      placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving
      medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following
      additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier
      (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The
      total duration of this study for each participant is approximately 70 weeks including
      screening, run-in, treatment, and follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of 18 to 38 kilogram/square meter (kg/m^2) and weight >= 40 kg
             at screening

          -  Documented physician-diagnosed asthma

          -  On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed
             controller medication

          -  Forced expiratory volume in 1 second (FEV1) of 40% to 80% of predicted

          -  Evidence of uncontrolled asthma

          -  Use of contraceptive measures

        Exclusion Criteria:

          -  Diagnosis of mimics of asthma

          -  Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma chronic obstructive
             pulmonary disease overlap syndrome, or bronchiolitis, as determined by the
             investigator

          -  Pregnant or lactating, or intending to become pregnant during the study or within 20
             weeks after the last dose of MSTT1041A

          -  Recent history of smoking

          -  History or evidence of substance abuse that would pose a risk to participants safety,
             interfere with the conduct of the study, have an impact on the study results

          -  Asthma exacerbation within 4 weeks prior to screening

          -  Intubation for respiratory failure due to asthma within 12 months prior to screening

          -  Comorbid conditions that may interfere with evaluation of investigational medicinal
             product

          -  Known sensitivity to any of the active substances or their excipients to be
             administered during dosing

          -  Positive pregnancy test
Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation
Condition: Graft Versus Host Disease; GVHD
MeSH terms: Graft vs Host Disease
Intervention: tacrolimus; sirolimus; fludarabine; busulfex
Intervention description: Given orally just prior to and following stem cell transplant; Given orally just prior to and following stem cell transplant; Given once daily over 30 minutes for 4 days; Given intravenously over 3 hours for 4 days
Intervention MeSH terms: Sirolimus; Fludarabine; Busulfan; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-myeloablative peripheral blood stem cell; PBSCT; tacrolimus; sirolimus

Summary:

      The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how
      effective it is in preventing graft versus host disease (GVHD)in patients that have received
      non-myeloablative peripheral blood stem cell transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with hematologic malignancies who are at a high risk of complications after
             conventional transplantation

          -  Availability of a related donor who is identical at 6 HLA loci

          -  Greater than 18 years of age

          -  Performance status 0-2

          -  Life expectancy of > 100 days

        Exclusion Criteria:

          -  Pregnancy

          -  Evidence of HIV infection

          -  Heart failure uncontrolled medication

          -  Total bilirubin > 2.0mg/dl that is due to hepatocellular dysfunction

          -  AST >90

          -  Serum Creatinine >2.0

          -  Cholesterol > 300mg/dl while adequately treated
FACBC Prostate Therapy Response
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: FACBC PET-CT; MRI, CT, or Bone Scan
Intervention description: Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.; Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Imaging; Nuclear medicine; Oncology; Radiology; Urogenital disorders

Summary:

      The purpose of this study is to assess if using
      anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will
      be useful in determining if participants are responding to chemotherapy treatment.
      Investigators will enroll participants whose cancer has been treated with hormone therapy and
      now the cancer is not responding to the treatment (castration -resistant), and so therefore
      will be started on chemotherapy. Investigators aim to enroll thirty participants in this
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary or recurrent castration resistant prostate carcinoma with skeletal and/or
             nodal involvement not currently undergoing systemic chemotherapy who are about to
             commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted
             therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or
             Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)

          -  Ability to lie still for PET scanning

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Age less than 18 years

          -  Inability to lie still for PET scanning

          -  Inability provide written informed consent

          -  Currently undergoing chemotherapy for organ confined or systemic disease. This does
             not preclude patients who had previously received upfront docetaxel in the hormone
             sensitive setting.
Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria
Condition: Cystinuria
MeSH terms: Cystinuria
Intervention: Tiopronin
Intervention description: Phase 1: No medication, Phase 2: 500mg PO daily x 7 days (total 500mg), Phase 3: 500mg PO BID x 7 days (total 1g), Phase 4: 1g PO BID x 7 days (total 2g)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the minimum effective dose of the cysteine binding
      thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine
      solubility in the urine, in patients with cystinuria to evaluate the effect of escalating
      doses of cystine binding thiol drugs on the cystine capacity of the urine. The overall goal
      will be to help guide therapy and ultimately minimize unnecessary side effects caused by
      larger dosages.

      Cystinuria is a rare genetic disease that can lead to significant morbidity in affected
      patients due to the recurrent nature of the disease. This study will follow the levels of
      urine cystine capacity in order to help guide treatment and to use lower than usually
      prescribed Tiopronin doses to decrease the potential side effects while maintaining
      therapeutic benefit. This will increase adherence with the medications by decreasing the
      burden of the large number of pills that need to be taken daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a confirmed laboratory diagnosis of cystinuria who meet the following
             criteria: (1) stone analysis demonstrating cystine as a component, or (2) increased
             urinary cystine excretion (>250mg/24hrs in adults).

          -  A medical regimen that includes Tiopronin.

          -  Willing to use a medically accepted form of birth control, if female and of child
             bearing- potential

          -  Ability to reliably urinate in a collection vessel and measure urine volume.

          -  Ability to give informed consent.

          -  Documentation of a stable complete blood count (CBC) and urinalysis (UA) in the six
             month period prior to the date of enrollment.

          -  Enrollment in Rare Kidney Stone Consortium (RKSC) Protocol 6401 (Cystinuria Registry)

        Exclusion Criteria:

          -  Women who are pregnant, breastfeeding, or trying to become pregnant

          -  Patients with renal colic

          -  Patients who are scheduled to undergo a surgical procedure

          -  Inability to give informed consent
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK0736; MK0916; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of two investigational
      drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with
      hypertension (high blood pressure).

      This is an early phase trial and some specific protocol information is proprietary and not
      publicly available at this time. (Full information is available to trial participants).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hypertension systolic blood pressure (SBP) </= 160mm Hg and diastolic blood pressure
             (DBP): 90-105mm Hg

        Exclusion Criteria:

          -  Pre-menopausal women

          -  patients currently taking more than two (2) blood pressure lowering medications

          -  Body Mas Index (BMI)>40 kg/m2 (morbidly obese patients)

          -  History of Alcohol abuse (<3 Years)

          -  History of diabetes,chronic kidney disease, Active liver disease, recent heart attack
             or stroke
A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y
Condition: Painful Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: GRT3938Y; Placebo
Intervention description: Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.; Overencapsulated tablets of placebo, 16 weeks treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 553.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Analgesia; Diabetic Neuropathy; Neuropathic pain; Painful; Chronic pain

Summary:

      This trial is assessing the analgesic efficacy and safety of a new central analgesic in
      subjects with pain due to diabetic peripheral neuropathy (DPN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symmetrical painful diabetic peripheral neuropathy

        Exclusion Criteria:

          -  History of hypersensitivity, allergy or contraindication to opioids and acetaminophen

          -  Confounding painful conditions

          -  Significant vascular disease

          -  History or risk of seizure

          -  Chronic disease that might effect drug absorption, distribution, metabolism, or
             excretion

          -  Female subjects who are being pregnant or breastfeeding

          -  Evidence or history of alcohol, medication, or drug abuse
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
Condition: Hepatitis C
MeSH terms: Infections; Hepatitis C; Hepatitis
Intervention: SOF; PEG; RBV
Intervention description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 2 (GT-2); HCV genotype 3 (GT-3); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; Treatment-Naïve; GS-7977; Ribavirin; RBV; Peginterferon Alfa 2a; PEG; Additional relevant MeSH terms:; Hepatitis; Hepatitis A; Hepatitis, Chronic; Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Peginterferon alfa-2a; Interferon-alpha; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Physiological Effects of Drugs

Summary:

      This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir
      (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12
      weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have
      previously failed prior treatment with an interferon-based regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infection with genotype 2 or 3 HCV infection

          -  Cirrhosis determination

          -  Individual is treatment-experienced

          -  Screening laboratory values within defined thresholds

          -  Individual has not been treated with any investigational drug or device within 30 days
             of the Screening visit

          -  Use of highly effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase

          -  Pregnant or nursing female or male with pregnant female partner

          -  Current or prior history of clinical hepatic decompensation

          -  History of clinically-significant illness or any other major medical disorder that may
             interfere with treatment, assessment, or compliance with the study protocol

          -  Excessive alcohol ingestion or significant drug abuse
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Intervention: Serelaxin; Placebo
Intervention description: Intravenous infusion; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Acute heart failure (AHF),; Japanese,; Safety and tolerability, Pharmacokinetics,; Renal Impairment

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety,
      tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and
      30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy,
      in approximately 45 Japanese AHF patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Written informed consent must be obtained before any study-specific assessment is
             performed.

          -  Male or female ≥20 years of age, with body weight ≥30 kg and ≤160 kg

          -  Hospitalized for AHF; AHF is defined as including all of the followings measured at
             any time between presentation (including the emergency department) and the end of
             screening:

          -  Dyspnea at rest or with minimal exertion

          -  Pulmonary congestion on chest radiograph

          -  BNP ≥350 pg/mL or NT-proBNP ≥1,400 pg/mL

          -  SBP ≥125 mmHg at the start and at the end of screening

          -  Able to be randomized within 16 hours from presentation to the hospital, including the
             emergency department

          -  Received intravenous (IV) furosemide of at least 40 mg (or equivalent) at any time
             between presentation (this include outpatient clinic, ambulance, or hospital including
             emergency department) and the start of screening for the study for the treatment of
             the current acute heart failure (HF) episode.

          -  Impaired renal function defined as an estimated glomerular filtration rate (eGFR)
             between presentation and randomization of ≥ 25 and≤ 75 mL/min/1.73 m2, calculated
             using the Japanese formula

        Key Exclusion Criteria:

          -  Dyspnea primarily due to non-cardiac causes

          -  Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV
             anti-microbial treatment

          -  Clinical evidence of acute coronary syndrome currently or within 30 days prior to
             enrollment.

          -  AHF due to significant arrhythmias, which include any of the following: sustained
             ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per
             minute, or atrial fibrillation/flutter with sustained ventricular response of >130
             beats per minute.
Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: Perifosine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: relapsed Waldenstrom's Macroglobulinemia; refractory Waldenstrom's Macroglobulinemia; WM; perifosine

Summary:

      Waldenström's Macroglobulinemia (lymphoplasmacytic lymphoma, WM) remains incurable with
      limited therapeutic options and notably absent FDA approved therapy with any WM indication.
      Therefore, there is a need to identify new therapeutic agents for WM patients both in the
      upfront and relapsed/refractory setting. The purpose of this research study is to assess the
      efficacy of perifosine in patients with relapsed or refractory WM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Must have received prior therapy for their WM and have relapsed or refractory WM. Any
             number of prior therapies is acceptable

          -  Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum
             IgM level of equal to or greater than 2 times the ULN and over 10% of
             lymphoplasmacytic cells in bone marrow

          -  ECOG Performance Status 0,1, or 2

          -  Laboratory values as described in the protocol

          -  Life expectancy of greater than 12 weeks

        Exclusion Criteria:

          -  Uncontrolled infection

          -  Other active malignancies

          -  CNS involvement

          -  Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or
             corticosteroids less than 2 weeks prior to registration.

          -  Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
             considered investigational

          -  Pregnant or nursing women

          -  Known to be HIV positive

          -  Radiation therapy less than 2 weeks prior to registration
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: CJC-1134-PC; Placebo
Intervention description: 1.5 or 2.0 mg CJC-1134-PC; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin

Summary:

      This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.

      The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment
      with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin
      monotherapy.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  BMI: 27 to 45 kg/m2

          -  Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator

          -  Stable life-style, i.e. diet & physical activity, as determined by the Investigator

          -  Stable metformin daily dose ≥1000 mg for at least 3 months

          -  Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%