bioihbjkbjnl/mcl2 huggingface dataset:
Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: albiglutide; placebo
Intervention description: subcutaneous injection; subcutaneous injection
Intervention MeSH terms: rGLP-1 protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: glucose clamp; hypoglycemia

Summary:

      This is a stepped glucose clamp study designed to investigate the effect of treatment with
      albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in
      subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given
      prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate
      that albiglutide increases insulin secretion and decreases glucagon levels in a
      glucose-dependent manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than
             10 years before Screening

          -  HbA1c <10% at Screening for subjects who do not require washout of existing OAD or <9%
             at Screening for subjects who do require washout from existing OAD

          -  Body mass index in range 28 kg/m2 to40 kg/m2

        Exclusion Criteria:

          -  History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis

          -  History of significant gastrointestinal surgery,

          -  History of significant cardiovascular disease

          -  History of a seizure disorder

          -  Documented hypertension or hypotension

          -  Use of oral antidiabetic agents, except for metformin, within 14 days before
             investigational product administration.

          -  Current hepatic disease or abnormal liver function tests

          -  Positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus
             infection 1 or 2

          -  History of regular alcohol consumption (exceeding 7 drinks/week for women or 14
             drinks/week for men)

          -  Female subject is pregnant (confirmed by laboratory testing), lactating, or less than
             6 weeks postpartum

          -  Known allergy to any GLP-1 analog or excipients of albiglutide, Baker's yeast, or
             insulin

          -  History of type 1 diabetes,

          -  Prior exposure to GLP-1 agents, including albiglutide

          -  Blood donation over 500 mL within 8 weeks before Screening
Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Condition: Stage III Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Chemotherapy; ERBITUX; Radiotherapy
Intervention description: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles); The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes; 66 Gy (2 Gy by fraction, 5 fractions by week)
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell
      lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising
      association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-squamous stage III non-small cell lung cancer

          -  measurable disease (RECIST 1.1)

          -  ECOG performance status 0-1

          -  normal organ and marrow function

        Exclusion Criteria:

          -  prior chest radiation therapy

          -  history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma
             in situ of the cervix) within the last five years.

          -  Prior therapy with known specific inhibitors of the EGFR.

          -  history of severe allergic reaction to prior therapy with monoclonal antibodies
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Condition: Stress Urinary Incontinence; Cell Therapy
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: autologous muscle cell injection
Intervention description: Injection of autologous muscle cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a clinical investigation approved by US FDA and Canadian Health Authority to study
      the safety and potential effectiveness of the autologous muscle cells for the treatment of
      stress urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has SUI with normal detrusor activity confirmed with urodynamics

          -  Patient has bladder capacity >200 mL

          -  Patient's incontinence has not shown any improvement for at least -6 months

          -  Patient has failed prior treatments (e.g., behavior modification, bladder exercises,
             biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or
             drug therapy)

        Exclusion Criteria:

          -  Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or
             other significant pelvic floor abnormalities with high pressure instability

          -  Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)

          -  Patient has uncontrolled diabetes

          -  Patient is pregnant, lactating, or plans to become pregnant during the course of the
             study

          -  Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI
             ≥40) and would not be expected to benefit from treatment

          -  Patient has current or acute conditions involving cystitis or urethritis

          -  Patient is scheduled to receive radiation treatment to the vicinity

          -  Patients with a history of radiation treatment to the urethra or adjacent structures
A Study of Fibrocaps in Liver Surgery in the Netherlands
Condition: Postoperative Hemorrhage
MeSH terms: Hemorrhage; Postoperative Hemorrhage
Intervention: Fibrocaps (fibrin sealant); Gelatin sponge
Intervention description: human thrombin and fibrinogen topical powder; absorbable gelatin sponge for topical use
Intervention MeSH terms: Fibrin Tissue Adhesive; Fibrin Foam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and
      safety trial in subjects undergoing open liver resection surgery. The study will enroll 42
      eligible subjects and be conducted at 4 sites in the Netherlands.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥ 18 years of age

          2. Subjects who are able and willing to provide written and signed informed consent

          3. Willing to use a medically accepted form of contraception from the time of consent to
             completion of all follow-up study visits

          4. Has a life expectancy of at least one year

          5. Presence of mild or moderate bleeding/oozing and control by conventional surgical
             techniques including but not limited to suture, ligature, and cautery is ineffective
             or impractical

        Exclusion Criteria:

          1. Pregnant or lactating women

          2. Has a known intolerance to blood products or to Fibrocaps components

          3. Unwilling to receive human blood products

          4. Subject has a known allergy to porcine gelatin

          5. Has a mental or physical condition that would, in the opinion of the Investigator,
             place the subject at an unacceptable risk or render the subject unable to meet the
             requirements of the protocol

          6. Currently participating or has participated in another clinical study involving
             another investigational agent within 4 weeks of the planned date of surgery, or is
             planning participation in another clinical trial during the 4 weeks after surgery

          7. Has any clinically-significant coagulation disorder that may interfere with the
             assessment of efficacy or pose a safety risk to the subject according to the
             Investigator

          8. Platelets(PLT) < 100 x109 PLT/L during screening

          9. Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening

         10. International Normalized Ratio (INR) > 2.5 during screening
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Placebo; dalcetrapib
Intervention description: po daily for 36 weeks; 600mg po daily for 36 weeks
Intervention MeSH terms: Dalcetrapib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 476.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the safety, tolerability and efficacy of RO4607381 in patients with
      coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive
      either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by
      flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time
      on study treatment is up to 12 months, and the target sample size is up to 500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  CHD or CHD risk equivalent;

          -  appropriately treated for accepted LDL-C level.

        Exclusion Criteria:

          -  treatment with drugs raising HDL-C (eg niacin, fibrates);

          -  uncontrolled hypertension;

          -  recent (within 3 months) clinically significant coronary events, transient ischemic
             attacks or cerebrovascular accident;

          -  severe anemia;

          -  poorly controlled diabetes.
Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
Condition: Metastatic Breast Cancer; Thyroid Dysfunction
MeSH terms: Breast Neoplasms
Intervention: Triiodothyronine (T3)
Intervention description: Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Triiodothyronine (T3) - IND Exempt
Masking: None (Open Label)
Masking description: N/A (not applicable)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 105 Years
Healthy volunteers: No

Summary:

      Up to one third of breast cancer patients have hypothyroidism or hyperthyroidism. L-thyroxine
      (T4), or Synthroid, is the most commonly prescribed agent for the management of
      hypothyroidism in the US. However, there are data suggesting that triiodothyronine (T3) may
      have benefits in preventing disease progression over l-thyroxine (T4).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 18

          -  Male or female with diagnosis of metastatic breast carcinoma and documented history of
             hypothyroidism .

          -  TSH level within normal range at baseline

          -  Life expectancy estimated > 3 months

          -  Ability and willingness to provide informed consent

        Exclusion Criteria:

          -  Life expectancy estimated to be less than 3 months

          -  Is currently pregnant or intends to become pregnant during the duration of the study

          -  Active angina, New York Heart Association (NYHA) advanced [Class III/IV] congestive
             heart failure, or uncontrolled cardiac arrhythmia within 6 months of enrollment

          -  History of thyrotoxicosis

          -  History of adrenal insufficiency

          -  Hypersensitivity to any active or extraneous constituents in Triiodothyronine
             (T3)/liothyronine sodium
Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: pemetrexed; cyclophosphamide; doxorubicin; docetaxel
Intervention description: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4); 600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4); 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4); 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 257.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      An open-label randomized Phase II study in order to explore two different sequential
      anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable
      breast cancer (T2-T4/N0-2/M0).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of primary early breast cancer, tumor size greater
             than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.

          -  Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).

          -  Adequate organ function (bone marrow, hepatic, renal, cardiac).

        Exclusion Criteria:

          -  Prior anthracyclines as part of prior anticancer therapy.

          -  Concurrent antitumor therapy.

          -  Second primary malignancy.

          -  Serious concomitant systemic disorder.

          -  Pre-existing sensorial or motor neuropathy

               -  Grade 1.
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Condition: Acquired Hyperinsulinemic Hypoglycemia
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia
Intervention: Avexitide
Intervention description: Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post Bariatric Hypoglycemia; avexitide; Post-Bariatric Hypoglycemia; Post-gastrectomy hypoglycemia; Post gastrectomy hypoglycemia; Post-esophagectomy hypoglycemia; Post esophagectomy hypoglycemia; Post-Nissen Fundoplication hypoglycemia; Post Nissen Fundoplication hypoglycemia; Exendin (9-39); Exendin 9-39

Summary:

      The primary goal of this study is to evaluate the safety and efficacy of two different dosing
      regimens of an investigational drug called Avexitide in treating low blood sugar in patients
      with Acquired Hyperinsulinemic Hypoglycemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy,
             esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of
             Screening

          -  History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as
             documented in the medical record.

          -  Body mass index (BMI) of up to 40 kg/m2

          -  If female, must not be breastfeeding and must have a negative urine pregnancy test
             result

        Exclusion Criteria:

          -  Major surgery within 6 months before randomization.

          -  History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g.,
             insulin autoimmune hypoglycemia).

          -  Use of agents that may interfere with glucose metabolism
Amantadine to Speed Awakening After Cardiac Arrest
Condition: Coma; Heart Arrest; Anoxia
MeSH terms: Heart Arrest
Intervention: Amantadine; Placebo
Intervention description: 100mg twice per day for 7 days at 0600 and 1200; Placebo comparator
Intervention MeSH terms: Amantadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart arrest; resuscitation; seizures; hypothermia, induced; Amantadine

Summary:

      This study evaluates if amantadine will increase the rate of awakening in patients
      resuscitated from cardiac arrest but comatose (not following commands) after their
      resuscitation. Half of the participants will receive amantadine and the other will receive
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non traumatic cardiac arrest

          -  Age 18 and older

          -  Defibrillation and/or chest compressions by healthcare providers

          -  Return of spontaneous circulation

        Exclusion Criteria:

          -  Written do not attempt resuscitation (DNAR) reported to providers before randomization

          -  Known prisoner or pregnancy

          -  Lack of motor response to pain and absent N20 response on somatosensory evoked
             potentials prior to randomization

          -  Initial CT demonstrating brain edema (defined as grey white ratio <1.2)

          -  Presence of malignant pattern on EEG at time of randomization

          -  Next of kin unwilling to provide supportive care for at least one week after
             enrollment

          -  Presently using other dopaminergic agent
Infant TB Infection Prevention Study
Condition: Tuberculosis
MeSH terms: Infections; Tuberculosis
Intervention: Isoniazid
Intervention description: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.
Intervention MeSH terms: Isoniazid
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: M. tuberculosis infection; isoniazid; HIV-exposed infants

Summary:

      Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium
      tuberculosis infection in HIV-exposed uninfected (HEU) infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV exposed infants

          -  Aged 6 weeks within (+ 4 weeks)

          -  Born to HIV-infected mothers

          -  Not premature and over 2.5 kg

        Exclusion Criteria:

          -  Infants with known exposure to active TB in household

          -  Premature and < 2.5 kg
Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: REGN910-3; Intravitreal Aflibercept Injection (IAI)
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 365.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to compare the efficacy of intravitreal
      (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including
             juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as
             assessed by a central reading center

          2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the
             study eye.

          3. Willing and able to comply with clinic visits and study-related procedures.

          4. Provide signed informed consent.

        Key Exclusion Criteria:

          1. Evidence of CNV due to any cause other than AMD in either eye

          2. Prior IVT anti-VEGF in the study eye

          3. Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in
             either eye in diabetic patients

          4. Any history of macular hole of stage 2 and above in the study eye
Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia
Condition: Congenital Hyperinsulinism (CHI); Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia; Hyperinsulinism
Intervention: 18 F-DOPA
Intervention description: 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Healthy volunteers: No
Keywords: Congenital Hyperinsulinism (CHI); hyperinsulinism; Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI); CHI; PHHI; Pancreatectomy; 18F-DOPA; PET/CT scan

Summary:

      Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these
      children may require surgery to remove part or all of their pancreas. In this study,
      researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine
      (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery.
      Eligible participants in this study will have positron emission tomography/computerized
      tomography (PET/CT) scans with F-DOPA prior to surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants and children with a clinical diagnosis of hyperinsulinism who are suspected to
             have focal disease and are surgical candidates for pancreatectomy

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Any other major illness or condition that might substantially increase the risk
             associated with the subject's participation in this study.