bioihbjkbjnl/mcl2 huggingface dataset:
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MEDI4736
Intervention description: MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.
Intervention MeSH terms: Durvalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 446.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1

Summary:

      A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or
      Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 18 years.

          -  Documented evidence of NSCLC (stage IIIB/IV disease)

          -  Disease progression or recurrence after both a platinum-based chemotherapy and at
             least 1 additional regimen for treatment of NSCLC

          -  World Health Organisation (WHO) Performance Status of 0 or 1

          -  Estimated life expectancy of more than 12 weeks

          -  Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane
             staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane
             staining (Cohort 3))

        Exclusion Criteria:

          -  Prior exposure to any anti-PD-1 or anti-PD-L1 antibody

          -  Brain metastases or spinal cord compression or unless asymptomatic, treated and stable
             (not requiring steroids).

          -  Active or prior autoimmune disease or history of immunodeficiency

          -  Evidence of severe or uncontrolled systemic diseases, including active bleeding
             diatheses or active infections including hepatitis B, C and HIV.

          -  Evidence of uncontrolled illness such as symptomatic congestive heart failure,
             uncontrolled hypertension or unstable angina pectoris.

          -  Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.

          -  Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous
             immunotherapy agent, or any unresolved irAE >Grade 1

          -  Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative
             colitis)
Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
Condition: Adenocarcinoma; Non-small Cell Lung Cancer
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Intervention: Erlotinib
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tarceva; Erlotinib; OSI-774; Adenocarcinoma; Advanced Lung Cancer

Summary:

      The purpose of this trial is to figure out what effects (good or bad) the investigational
      drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated
      adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Diagnosis of adenocarcinoma of the lung

          -  Patient has had at least one core biopsy of her tumor

          -  Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of
             her tumor

          -  Stage four (IV) or three (III) B non-small cell lung cancer

          -  Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less
             cigarettes in her lifetime while a former smoker is defined as a person who has quit
             smoking one or more years ago.

          -  Three or more weeks since last radiation therapy

          -  Three or more weeks since last major surgery

          -  Must at least be able to walk and capable of taking care of herself although unable to
             carry out work activities

          -  Life expectancy of 8 weeks or more

          -  Blood tests that show kidneys, liver and bone marrow to be working adequately

          -  Women of child-bearing potential must agree to use adequate contraception prior to
             study entry and for the entire time enrolled in study

        Exclusion Criteria:

          -  Prior exposure to Tarceva (OSI-774, erlotinib)

          -  Uncontrolled central nervous system problems

          -  Prior chemotherapy regimen

          -  Difficulty swallowing

          -  A disease or disorder that interferes with ability to digest and absorb food

          -  Incomplete healing of previous oncologic or other major surgery

          -  Significant medical history or unstable medical condition such as heart failure,
             active infection, uncontrolled high blood pressure

          -  Pregnant or breast feeding

          -  A medical condition that could make it unsafe for patient to participate in this study
t-PA Prophylaxis to Prevent Catheter-associated Thrombosis and Infection
Condition: Central Venous Catheter Thrombosis; Central Venous Catheter Associated Bloodstream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis; Thrombosis; Upper Extremity Deep Vein Thrombosis
Intervention: alteplase (recombinant t-PA); Heparin
Intervention description: Medication administered to dwell in central venous catheter; Medication administered to dwell in central venous catheter
Intervention MeSH terms: Heparin; Tissue Plasminogen Activator
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Centralized pharmacy will prepare and blind the study drug (t-PA) and the control (heparin)
Enrollment: 20.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to test feasibility of concept, consent and enrollment
      rates, and mechanics of study designed to assess if intra-catheter dwells of tissue
      plasminogen activator (t-PA) is effective in decreasing the rate of clinically diagnosed
      central line associated blood stream infection (CLABSI) or venous thromboembolism (VTE) in
      central venous catheters (CVC) compared to standard of care heparin dwell.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 0 - ≤ 18 years old

          -  PICU admission

          -  CVC placed within 72 hours of enrollment (tunneled such as peripherally inserted
             central catheter (PICC), Broviac or Hickman, or untunneled) and in place during
             hospitalization

        Exclusion Criteria:

          -  Pregnancy

          -  Non-English-speaking subjects and/or parent/guardian

          -  Platelet count < 20,000

          -  Active CVC infection-defined as positive blood culture from the in -situ CVC at time
             of enrollment

          -  Current radiographically confirmed VTE

          -  Currently receiving treatment doses of anticoagulation (heparin infusion >15U/kg/hr,
             enoxaparin injections >=2mg/kg/day or >=60mg/day)

          -  CVC diameter <1.9 Fr

          -  Current or previous diagnosis of Heparin Induced Thrombocytopenia or allergy to
             heparin or t-PA

          -  Med-a-port catheters
A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Donidalorsen; Placebo
Intervention description: Donidalorsen administered SC; Placebo matching solution administered SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Part A was randomized, double-blind; Part B was open-label.
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IONIS PKK-LRx; Donidalorsen

Summary:

      The purpose of this study was to evaluate the clinical efficacy, safety, and tolerability of
      donidalorsen in participants with hereditary angioedema (HAE) type 1 (HAE-1), HAE type 2
      (HAE-2), or HAE with normal C1-inhibitor (C1-INH) and to evaluate the effect of donidalorsen
      on plasma prekallikrein (PKK) and other relevant biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of HAE-1/HAE-2 (for inclusion in Part A) or HAE-nC1-INH (for
             inclusion in Part B)

          -  Participants must have experienced a minimum of 2 HAE attacks (assessed by the
             Angioedema Activity Score [AAS] and confirmed by the investigator) during the
             screening period

          -  Access to, and the ability to use, ≥ 1 acute medication(s) to treat angioedema attacks

        Exclusion Criteria:

          -  Anticipated use of short-term prophylaxis for angioedema attacks for a pre-planned
             procedure during the screening or study periods

          -  Concurrent diagnosis of any other type of recurrent angioedema, including acquired or
             idiopathic angioedema

          -  Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C,
             or chronic hepatitis B

          -  Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or
             carcinoma in situ of the cervix that has been successfully treated

          -  Treatment with another investigational drug or biological agent within 1 month or 5
             half-lives, whichever is longer, of screening

          -  Exposure to any of the following medications:

               -  Angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing
                  medications with systemic absorption (such as oral contraceptive or hormonal
                  replacement therapy) within 4 weeks prior to screening

               -  Chronic prophylaxis with Lanadelumab within 10 weeks prior to screening

               -  Oligonucleotides (including small interfering ribonucleic acid [RNA]) within 4
                  months of screening (if single dose received) or within 12 months of screening
                  (if multiple doses received)
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Intervention: Gymnema Sylvestre; Placebo
Intervention description: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner; Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 30 Years
Maximum age: 59 Years
Healthy volunteers: No
Keywords: Gymnema Sylvestre; Glycemic control

Summary:

      Prediabetes (PD) was defined as an state in which glucose levels are above normal but not
      enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as
      impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c
      (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the
      prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with
      IGT, it is expected that by 2035 this number will increase to 417 million people affected.
      Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including:
      increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose
      utilization in various ways and inhibition of glucose uptake in the intestine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI: 25.0-34.99 kg / m2.

          -  Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)

          -  Written informed consent.

          -  body weight stable over the last 3 months.

          -  Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the
             time of laboratory tests.

          -  Women who are not contemplated get pregnant within the next 6 months.

        Exclusion Criteria:

          -  Women pregnant or breastfeeding.

          -  Physical or mental disability that makes it impossible to perform the intervention.

          -  Diagnosis of hypertension or heart failure.

          -  Smokers.

          -  Untreated thyroid disease.

          -  Consumption of oral agents or other medications or supplements with proven properties
             that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin,
             lipid-lowering).

          -  Diagnosis of liver disease or elevation twice of the upper normal value of liver
             enzymes.

          -  Diagnosis of renal disease or creatinine > 1.5 mg / dl.

          -  Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or
             2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.

          -  Total Cholesterol ≥ 280 mg/dL.

          -  Triglycerides ≥ 300 mg/dL.

          -  Known allergy to calcined magnesia or Gymnema sylvestre.
Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.
Condition: Wet Macular Degeneration; Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Wet Macular Degeneration; Edema
Intervention: Dorzolamide-timolol
Intervention description: On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
Intervention MeSH terms: Timolol; Dorzolamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dorzolamide-timolol; topical aqueous suppression; neovascular age-related macular degeneration; macular edema; intravitreal injection; anti-vascular endothelial growth factor

Summary:

      This study seeks to evaluate the effect of topical aqueous suppression on the anatomic and
      functional response to intravitreal anti-vascular endothelial growth factor (VEGF) injections
      in non-responders with wet age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina.

          2. Volunteer patients age 18 years and older.

          3. Healthy enough to participate in the study.

          4. Willing and able to consent to participation in the study.

          5. Diagnosis of wet age-related macular degeneration

          6. Prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months
             and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during
             this period

          7. Injection of the same anti-VEGF agent for at least two visits prior to study
             enrollment

          8. Fixed interval between at least two visits prior to study enrollment

        Exclusion Criteria:

          1. History of uveitis

          2. Any ophthalmic surgery within previous 6 months, including cataract extraction.

          3. Any history of vitrectomy

          4. History of any glaucoma drop usage or prior glaucoma surgery

          5. Systemic diuretic or corticosteroid usage

          6. Any contraindication (bradycardia, decompensated heart failure, or reactive

          7. airway disease) for topical use of a beta-blocker

          8. Any history of sulfonamide allergy

             -
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: certolizumab pegol; certolizumab pegol
Intervention description: 400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg; 200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; Cimzia®; Crohn's Disease; Children and Adolescents with Crohn's Disease

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of
      certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely
      active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK),
      and immunogenicity of CZP treatment in children and adolescents with moderately to severely
      active Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who completed the C87035 study (NCT00899678) through Week 62 or assessments
             when their participation in C87035 was terminated when the study was stopped by UBC

          -  Subject completed all assessments required for Week 62/Visit 23 at the time of
             termination

          -  Subjects maintain stable regimen of concomitant medications for Crohn's Disease (CD)
             throughout study

        Exclusion Criteria:

          -  Subject who did not complete the C87035 study (Week 62 Visit), was terminated or did
             not complete all of the Week 62 assessments when their participation from C87035 was
             terminated when the study was stopped by UCB but did not complete all assessments
             required for Week 62/Visit 23 at the time of termination
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Tetrahydrobiopterin (BH4); Antioxidant Cocktail
Intervention description: 12 week intervention; 12 week intervention
Intervention MeSH terms: Vitamins; Vitamin E; Thioctic Acid; Antioxidants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Flow-Mediated Dilation; Kuvan; Antioxidant; FEV1

Summary:

      Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among the
      top five leading causes of death worldwide. Although COPD is a disease of the lungs, recent
      evidence indicates that COPD is associated with multiple systemic consequences including
      vascular endothelial dysfunction. Recently, it has been suggested that more patients with
      COPD die from cardiovascular disease and coronary heart disease than of direct pulmonary
      complications. Examination of the mechanisms that contribute to a reduction nitric oxide (NO)
      bioavailability resulting in vascular endothelial dysfunction in patients with COPD are
      important as endothelial dysfunction has been indicated to be an independent predictor of
      future atherosclerotic cardiovascular disease and events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with medically diagnosed COPD

          -  apparently healthy controls

        Exclusion Criteria:

          -  FEV1/FVC >0.7 (normal lung function in patients only)

          -  Clinical diagnosis of heart disease or diabetes

          -  Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)

          -  uncontrolled high blood pressure

          -  high blood pressure in your lungs

          -  thyroid problems

          -  Fluid in the lungs

          -  Sleep apnea

          -  Anemia

          -  Raynaud's Phenomenon

          -  GI bleeding

          -  Gangrene of the digits

          -  History of low platelets or coagulopathies

          -  Phenylketonuria (PKU)

          -  Any allergy to Kuvan