bioihbjkbjnl/mcl2 huggingface dataset:
A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro
Condition: Diabetes Mellitus: Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Technosphere® Insulin Inhalation Powder; Technosphere Insulin® Inhalation Powder; RAA Population
Intervention description: TI Inhalation Powder, two 15 U cartridges; TI Inhalation Powder, one 30 U cartridge; RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Diabetic adult male, diabetic adult female

Summary:

      28 subjects to be enrolled for a screening period, 3 dosing visits & a follow-up visit.
      Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one
      30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin
      analogue).
    

Eligibility criteria:

        Inclusion Criteria:

        Males and Females > 18 and < 60 years of age Clinical diagnosis of type 1 diabetes mellitus
        with stable anti-diabetic regimen for at least 90 days prior to Screening BMI of < 30 kg/m2
        Non-smokers (never smoked or former smokers (> 6 months since cessation) Pulmonary Function
        Testing (FEV1 > 70%, FEV1/FVC > 70%, TLC > 80% DLco [unc] > 70% of Predicted Written
        Informed consent

        Exclusion Criteria:

        Two or more severe hypoglycemic episodes within 6 months of Screening/Visit 1 Severe
        complications of diabetes Previous exposure to any inhaled insulin product other than TI
        inhalation Powder or similar formulation Inability to perform PFT maneuvers meeting
        recommended American Thoracic Society (ATS) standards of acceptability and repeatability
        criteria Respiratory tract infection within 8 weeks prior to Screening/Visit 1 History of
        chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other
        clinically important pulmonary disease (eg. Obstructive sleep apnea), confirmed by
        pulmonary function testing, and/or radiologic findings Major organ system diseases
        including seizures, heart failure, uncontrolled hypertension, cancer within the past 5
        years, liver disease, anemia or autoimmune disorder Clinically significant abnormalities on
        screening laboratory evaluation Female subjects who are pregnant, lactating, or planning to
        become pregnant during the clinical trial period or not practicing adequate birth control
        Unable and/or unlikely to comprehend how to use the investigational device in this study or
        to follow study instructions
A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: BIBW 2992; Cetuximab
Intervention description: Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management; Patients receive cetuximab intravenously, once a week, every week
Intervention MeSH terms: Cetuximab; Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase II study is open to patients with metastatic colorectal cancer who have tried but
      failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have
      received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab,
      panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral
      oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or
      cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all
      receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW
      2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the
      effectiveness of BIBW 2992 in patients with KRAS mutated cancer.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with metastatic colorectal cancer who have failed both oxaliplatin- and
             irinotecan-based regimens

          2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene
             homolog) mutation testing and other biomarker analyses.

        Exclusion criteria:

          1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules
             or antibodies.

          2. Biological treatment (including Bevacizumab or any other antiangiogenic agents) during
             the trial is not allowed.

          3. Known pre-existing interstitial lung disease.

          4. Planned major surgical procedures during the trial period.
The Effect of Nebulized Albuterol on Donor Oxygenation
Condition: Brain Death; Organ Donor; Pulmonary Edema
MeSH terms: Pulmonary Edema; Brain Death
Intervention: Albuterol; Saline
Intervention description: 5 mg nebulized q4h; 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 506.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: brain death; organ donor; pulmonary edema; albuterol; hypoxia; lung transplantation; infiltrates

Summary:

      The purpose of this study is to test the effectiveness of albuterol versus placebo with the
      following specific aims: a) Treatment of brain dead organ donors with albuterol will reduce
      pulmonary edema, improve donor oxygenation, and increase the number of lungs available for
      transplantation, b) Developing a blood test to predict the development of primary graft
      dysfunction in lung transplant recipients, and c) treating brain dead organ donors with
      albuterol will decrease markers of primary graft dysfunction and lead to improved lung
      transplant recipient outcomes and to higher rates of lungs suitable for transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Brain death

          -  Consent for lung donation and donor research

          -  Release from coroner or medical examiner

        Exclusion Criteria

          -  Age less than 14 years
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
Condition: MELAS
MeSH terms: MELAS Syndrome; Mitochondrial Encephalomyopathies; Acidosis; Acidosis, Lactic
Intervention: IW-6463 Tablets
Intervention description: IW-6463 tablets administered orally (daily)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-arm study with daily dosing for up to 29 days.
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mitochondrial disease

Summary:

      This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults
      diagnosed with MELAS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Prior genetic confirmation of a known mitochondrial disease mutation

          2. Neurological features of MELAS (can be based on medical history)

          3. Elevated plasma lactate levels at Screening Visit (≥1.0 mmol/L)

          4. Women of childbearing potential must have a negative pregnancy test prior to
             randomization and must agree to use protocol-specified contraception from the
             Screening Visit through 90 days after the final dose of study drug.

          5. Male participants must be surgically sterile by vasectomy (conducted ≥60 days before
             the Screening Visit or confirmed via sperm analysis) or must agree to use
             protocol-specified contraception and agree to refrain from sperm donation from the
             Screening Visit through 90 days after the final dose of study drug.

          6. Other inclusion criteria per protocol

        Exclusion Criteria:

          1. Positive pregnancy test at Screening or on Day 1

          2. Hypotension defined as systolic blood pressure (BP) ≤90 mmHg or diastolic BP ≤60 mmHg
             at Screening or predose at Day 1

          3. Hypertension defined as systolic BP >160 mmHg or diastolic BP >100 mmHg, at Screening
             or predose at Day 1

          4. Uncontrolled diabetes

          5. Severe gastrointestinal dysmotility as determined by the investigator that may impact
             compliance and/or oral drug administration, absorption and exposure.

          6. Unable to fast for 3-4 hours after a meal

          7. Unable or unwilling to adhere to the study schedule, lifestyle restrictions,
             assessment requirements or, in the clinical judgment of the investigator, is otherwise
             not suitable for study participation.

          8. Current or past history of clinically significant cardiomyopathy and/or cardiac
             conduction abnormality

          9. Used any nicotine-containing products (eg, cigarettes, e-cigarettes, vape pens,
             cigars) within 1 month of enrollment

         10. Other exclusion criteria per protocol
Crossover Trial of AD036 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: AD036; Atomoxetine; Placebo
Intervention description: Oral administration before bed; Oral administration before bed; Oral administration before bed
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to
      examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with
      obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.

          -  AHI 10 to <20, or AHI ≥20 if meets PSG criteria

        Exclusion Criteria:

          -  History of narcolepsy.

          -  Clinically significant craniofacial malformation.

          -  Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery
             disease or cardiac failure) or hypertension requiring more than 2 medications for
             control. A medication for these purposes is defined by dosage form, such that a
             combination antihypertensive medication is considered 1 medication

          -  CPAP should not be used for at least 2 weeks prior to first study PSG

          -  History of using oral or nasal devices for the treatment of OSA may enroll as long as
             the devices are not used during participation in the study.
Daratumumab in Treatment of PGNMID and C3 GN
Condition: Membranoproliferative Glomerulonephritis
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranoproliferative
Intervention: Daratumumab
Intervention description: Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
Intervention MeSH terms: Daratumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to see if daratumumab is safe and effective in the treatment of
      proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3
      glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease
      in the kidney due to the production of abnormal proteins. There are no known standard
      effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy.
      These diseases are caused by abnormal production of proteins (monoclonals) by abnormal
      clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma
      a disease which also caused by over production of monoclonal proteins from abnormal clones.
      Everyone in this study will receive daratumumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years of age

          -  Renal biopsy read at Mayo Clinic confirming the diagnosis of PGNMID or C3 GN

          -  In cases of C3GN serum electrophoresis with immunofixation should confirm presence of
             monoclonal gammopathy

          -  Proteinuria ≥ 1000 mg over 24 hours

          -  eGFR ≥ 20 mL/min/SA

          -  Subjects able and willing to give informed consent

        Exclusion Criteria:

          -  Pregnancy

          -  Hepatitis B or C, HIV

          -  Multiple myeloma

          -  Anemia with Hgb < 8.5 g/dL

          -  Thrombocytopenia with platelet count < 100,000

          -  Leukopenia with WBC < 3.5

          -  Any other disease, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that may affect the
             interpretation of the results or render the patient at high risk from treatment
             complication

          -  Unable to provide consent

          -  Patients receiving therapy with oral prednisone or glucocorticoid equivalent in the
             last 6 weeks

          -  Patients who had received immunosuppressive therapy including cyclophosphamide, MMF,
             cyclosporine, tacrolimus or azathioprine in the last 3 months

          -  Patients who received rituximab previously with CD20 count of zero at the time of
             enrollment
High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Oxepa; Jevity 1.5; Jevity 1.0
Intervention description: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.; Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.; Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amyotrophic Lateral Sclerosis; ALS; Motor Neuron Disease; MND; Fat; Lipid; Cholesterol; Omega-3 fatty acid; Diet; Tube feed; Gastrostomy; PEG; Adults with Amyotrophic Lateral Sclerosis (ALS)

Summary:

      The purpose of this study is to determine the safety, tolerability, and preliminary efficacy
      of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic
      lateral sclerosis (ALS) (Lou Gehrig's disease).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of ALS

          2. Male or female subjects aged 18 years or older

          3. Must already be tolerating tube feedings through either a gastrostomy tube (G-tube or
             PEG) or jejunostomy tube (J-tube)

          4. Must require non-invasive ventilation (BIPAP) for less than 10 hours/day

          5. Women of childbearing potential must have a negative pregnancy test at screening and
             be non-lactating.

        Exclusion Criteria:

          1. History of hepatitis including non-alcoholic steatohepatitis (NASH), cholecystectomy,
             prior biliary disease such as gallstones

          2. History of diabetes

          3. History of prior myocardial infarction or stroke

          4. Laboratory values: Screening alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) greater than 2.0 times the upper limit of normal or total
             bilirubin greater than 1.5 times the upper limit of normal

          5. Allergy to soy, fish, or milk products
Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: MTX 12.5; MTX 25; Adalimumab
Intervention description: once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or >9).
Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab; once weekly oral dosing with MTX 25 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or >9).
Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab; Subjects will receive 18 weekly doses of adalimumab
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Moderately to severely active Ulcerative Colitis

Summary:

      Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate
      interaction in subjects with moderately to severely active ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females. Females of child bearing potential must
             have a negative serum pregnancy test prior to randomization, and must use a hormonal
             (oral, implantable or injectable) or barrier method of birth control throughout the
             study. Females unable to bear children must have documentation of such in the source
             records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum
             of one year since the last menstrual period]).

          -  Diagnosis of UC confirmed by established criteria, regardless of disease duration.

          -  Moderate to severely active UC, defined by a modified Mayo Score ≥6, with confirmed
             endoscopic activity by central reader (Mayo endoscopic subscore ≥2).

          -  Require initiation with adalimumab for induction of remission.

          -  Ability of subject to swallow study drug capsules.

          -  Ability of subject to participate fully in all aspects of this clinical trial.

          -  Written informed consent must be obtained and documented.

        Exclusion Criteria:

          -  Prior treatment with a TNF antagonist or biological therapy.

          -  Prior treatment with MTX.

          -  Disease limited to the rectum (proctitis).

          -  Documented presence of antibodies against adalimumab.

          -  Contraindication for anti-TNF or MTX therapy.

          -  Contraindication for endoscopy.

          -  Ostomy.

          -  Planned surgery.
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: AGN-150998; ranibizumab; Sham Injection
Intervention description: AGN-150998 Intravitreal injection.; Ranibizumab 0.5 mg given by intravitreal injection.; Stage 3: Sham injection at Weeks 12 and 16.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 271.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of
      the safety of AGN-150998 administered as a single intravitreal injection to patients with
      advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are
      randomized, double-masked, comparisons of the safety and treatment effects on retinal edema
      and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive
      patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a
      fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest
      tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on
      retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of
      AGN-150998.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Exudative age-related macular degeneration

          -  Best-corrected visual acuity between 20/32 and 20/320 in the study eye

        Exclusion Criteria:

          -  Near-sightedness of 8 diopters or more

          -  Uncontrolled glaucoma in the study eye

          -  Cataract surgery or Lasik within the last 3 months

          -  Any active ocular infection or inflammation