bioihbjkbjnl/mcl2 huggingface dataset:
Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LX4211 Low Dose; LX4211 High Dose; Placebo
Intervention description: A low dose of LX4211; daily oral intake for 28 days; A high dose of LX4211; daily oral intake for 28 days; Matching placebo dosing with daily oral intake for 28 days
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211
      versus a placebo control in subjects with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females (non-childbearing potential), aged 18-65 years

          -  Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening

          -  Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout

          -  Body mass index < 42 kg/m^2

          -  HbA1c value of 7 to 11%

          -  C-peptide ≥ 1.0 ng/mL

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic
             syndrome, incontinence, or nocturia

          -  Use of any blood glucose lowering agent other than metformin

          -  Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to
             screening

          -  Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the
             Investigator

          -  Positive test result for glutamic acid decarboxylase (GAD) antibody

          -  Surgery within 6 months of screening

          -  Exposure to any investigational agent or participation in any investigational trial
             within 30 days prior to Day 1

          -  Hypersensitivity to an SGLT2 inhibitor

          -  History of drug or alcohol abuse within the last 12 months
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Condition: Infectious Skin Disease; Bacterial Skin Disease
MeSH terms: Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases
Intervention: PTK 0796; Linezolid
Intervention description: PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg; Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets
Intervention MeSH terms: Linezolid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CSSSI

Summary:

      A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of
      complicated skin and skin structure infections (cSSSI).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients, ages 18 years to 80 years

          2. Has an acute complicated skin and skin structure infection

          3. Female patients must not be pregnant at the time of enrollment and must agree to a
             reliable method of birth control during the study and for 30 days following the last
             dose of study drug

        Exclusion Criteria:

          1. Has received an investigational drug within past 1 month

          2. Has been previously enrolled in this protocol

          3. Has received >48 hr of a potentially effective systemic antibiotic immediately prior
             to study drug

          4. Is nursing
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Intervention: Vi-CRM197 vaccine; Pneumococcal conjugate vaccine; Vi Polysaccharide (PS) vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the
      Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid
      Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59
             months of age at enrollment), older infants (9 to 12 months of age at enrollment) and
             infants (6 weeks of age at enrolment).

          -  Written informed consent will be obtained by the parents/ guardians before enrollment
             into the trial.

          -  Infants who have been vaccinated with BCG and HBV at birth and OPV at any time since
             birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib due
             at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: laboratory biomarker analysis; quality-of-life assessment; questionnaire administration; cinacalcet hydrochloride
Intervention description: Correlative study; Ancillary study; Ancillary study; Given PO
Intervention MeSH terms: Cinacalcet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well cinacalcet hydrochloride works in treating men with
      recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering
      prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has
      not responded to previous treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed adenocarcinoma of the
             prostate

          -  For patients who have recurrent disease following surgery as first line therapy
             ("surgical failures")

          -  PSA requirement is 0.2 ng/ml or above

          -  For patients who have recurrent disease following radiation as first line therapy, the
             eligibility follows the "Phoenix criteria", that is, a rise of 2 ng/mL over the PSA
             nadir

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Granulocytes >= 1000/uL

          -  Serum creatinine =< 2.0 mg/dl

          -  Total serum calcium > 9.0 and < 10.5 mg/dl

          -  Total bilirubin =< 2.0 mg/dl

          -  Platelet count >=100,000/uL

          -  Hemoglobin (Hgb) >= 9 g/dL

          -  Total testosterone >= 50 ng/dL

          -  Ability to understand and the willingness to sign a written informed consent document
             (either directly or via a legally authorized representative)

        Exclusion Criteria:

          -  Serious medical illness which would limit survival to less than 3 months

          -  Active, uncontrolled bacterial, viral or fungal infection

          -  Hemorrhagic disorder

          -  Any radiographic evidence of metastatic disease including positive bone scan or
             computed tomography (CT) abdomen/pelvis

          -  History of hypocalcemia or seizure disorder

          -  Patients with known hypersensitivity to any of the components of cinacalcet
             (cinacalcet hydrochloride)
The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sulfonylurea
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Glucose dependent insulinotropic polypeptide; Sulfonylurea compounds; insulin secretion; Sulfonylurea receptor subunit-SUR1; Impaired incretin effect

Summary:

      The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone
      GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP
      channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the
      insulinotropic effect of GIP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus diagnosed according to WHO criteria

          -  Diet and/or metformin treatment

          -  HbA1c > 7,0% for metformin treated patients

          -  HbA1c > 7,5% for diet treated patients

          -  Age: 18 years or older

          -  25 > BMI > 40 kg/m2

          -  Signed informed consent

          -  Sufficient birth control in case of child bearing capacity

        Exclusion Criteria:

          -  Proliferative retinopathy

          -  Diabetic nephropathy with s-creatinine > 130 microM and/or macroalbuminuria

          -  Liver disease (ALAT > 2 x normal value)

          -  CAD (NYHA group III or IV)

          -  Positive screening for islet-cell and/or GAD-65 autoantibodies

          -  Type 1 diabetes i first degree relatives

          -  Gastrointestinal surgery with intestinal resection

          -  Anemia

          -  Pregnancy and/or breastfeeding
Chronic Evaluation of Respicardia Therapy
Condition: Sleep Disordered Breathing; Cheyne Stokes Respiration; Periodic Breathing; Sleep Apnea; Central Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Respiratory Aspiration; Sleep Apnea, Central; Cheyne-Stokes Respiration
Intervention: remedē (TM) system
Intervention description: Implantation of the remedē (TM) system, including implantable pulse generator, stimulation lead, and (optional) sensing lead. Nightly provision of unilateral transvenous phrenic nerve therapy during sleep periods.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sleep Disordered Breathing; Cheyne Stokes Respiration; Periodic Breathing; Sleep Apnea; Central Sleep Apnea

Summary:

      The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve
      stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep
      fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly
      ventricular arrhythmias.

      The study is chronic in nature, such that subjects will undergo the implantation of an
      implantable pulse generator and stimulation lead. A sensing lead may also be placed during
      the initial implant procedure. Subjects will be followed for up to six-months on therapy to
      assess respiratory and heart failure outcomes. Following the six-month therapy visit,
      subjects will enter into a long-term follow-up phase until the completion of the study.

      It is anticipated that data obtained in this study will show that the proposed intervention
      can modify respiration with a low incidence of adverse effects. The results of this trial are
      intended to be used to develop a subsequent protocol for pivotal study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Candidate is at least 18 years old

          -  Candidates with known recent history of Periodic Breathing, as evidenced by an
             overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:

               -  Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr

               -  Predominantly central origin (central apnea events comprise 50% or more of all
                  apnea events)

               -  Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)

        Exclusion Criteria:

          -  Candidates who are pregnant

          -  Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2

          -  Candidates with severe COPD

          -  Candidates with a history of cerebrovascular accident (CVA), myocardial infarction,
             coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention
             (PCI) within the 3 months prior to the study

          -  Candidates with unstable angina

          -  Candidates with history of primary pulmonary hypertension
Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Acalabrutinib; acalabrutinib and pembrolizumab combination
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and
      acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 18 years of age.

          -  Histologically confirmed ovarian epithelial (including fallopian tube and primary
             peritoneal) carcinoma.

          -  Progression of disease after the most recent anticancer treatment. At least 1 prior
             chemotherapy regimen must have included a taxane.

          -  Platinum-sensitive ovarian cancer defined by recurrence or progression of disease > 6
             AND < 24 months after completion of the most recent platinum-based therapy.

          -  Measurable disease as defined by RECIST 1.1.

          -  ECOG performance status of 0 or 1.

          -  Completion of all therapy for the treatment of cancer 2 weeks before the start of
             study therapy and recovered.

        Exclusion Criteria:

          -  Evidence of platinum-refractory ovarian cancer defined as recurrence or progression
             during the first 6 cycles of or < 6 months after the beginning of first-line platinum
             based chemotherapy.

          -  Evidence of platinum-resistant ovarian cancer defined as recurrence or progression
             within 6 months after completing the most recent platinum-based therapy.

          -  More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.

          -  Prior malignancy (other than ovarian cancer), except for adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
             subject has been disease free for ≥ 2 years or which will not limit survival to < 2
             years.

          -  Breastfeeding and pregnant.

          -  Known central nervous system metastases and/or carcinomatous meningitis.

          -  Subjects with active cardiovascular disease not medically controlled or those who have
             had myocardial infarction in the past 6 months..

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
             partial or complete bowel obstruction.
Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
Condition: Pseudoachondroplasia
MeSH terms: Achondroplasia
Intervention: resveratrol; Placebo
Intervention description: 125 mg/day or 5 ml once per day for 90 days; 5 ml once per day for 90 days
Intervention MeSH terms: Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: resveratrol; joint pain

Summary:

      The purpose of this study is to determine if self-administered oral resveratrol can dampen
      joint pain for individuals with pseudoachondroplasia compared to placebo. Another goal of
      this study is to evaluate side effects in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The diagnosis of pseudoachondroplasia is based on clinical assessment either in person
             or by photographic review by skeletal dysplasia specialist (JTH),

          -  Healthy beyond pseudoachondroplasia associated complications,

        Exclusion Criteria:

          -  Current use of resveratrol

          -  Current use of blood thinners, lovastatin, ketoconazole, itraconazole, fexofenadine
             and triazolam.

          -  Other non-pseudoachondroplasia related health conditions, e.g. cancers.

          -  Pregnancy or breastfeeding. Women must use adequate contraception during the study.

          -  Participation in another clinical study and/or using investigational agents.

          -  Use of Non-steroid anti-inflammatory (NSAIDs) or aspirin.

          -  Current use of Alfentanil, Cyclosporine, Dihydroergotamine, Dofetilide, Ergotamine,
             Fentanyl, Flibanserin, Oxycodone, Pimavanserin, Pimozide, Quinidine, Saquinavir,
             Sirolimus, Tacrolimus, Temsirolimus, Theophylline, Tizanidine, Thioridazine,
             Fosphenytoin, Phenytoin or Warfarin.

          -  Baseline level of pain of 2 or higher on 10 point scale.

          -  Platelet count below 50,000 per ul on baseline complete blood count (CBC).
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Baricitinib; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as baricitinib in participants with systemic lupus erythematosus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the
             American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic
             Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.

          -  Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive
             anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory
             at screening.

          -  Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at
             randomization.

          -  Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.

        Exclusion Criteria:

          -  Have active severe lupus nephritis.

          -  Have active severe central nervous system (CNS) lupus.

          -  Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,
             endocrine, hematological, neurological, or neuropsychiatric disorders or any other
             serious and/or unstable illness that, in the opinion of the investigator, could
             constitute an unacceptable risk when taking investigational product or interfere with
             the interpretation of data.

          -  Have a current or recent clinically serious viral, bacterial, fungal, or parasitic
             infection.

          -  Are currently receiving oral corticosteroids at doses >20-milligrams per day of
             prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks
             of planned randomization.

          -  Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory
             drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and
             symptoms of SLE) within 4 weeks of planned randomization.

          -  Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of
             planned randomization.

          -  Have started treatment with or adjusted the dose of an immunosuppressant within 12
             weeks of planned randomization.

          -  Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to
             screening.