bioihbjkbjnl/mcl2 huggingface dataset:
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
Condition: Chronic Obstructive Pulmonary Disease; Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD2423; Placebo to AZD2423
Intervention description: 100 mg oral treatment once daily for 28 days; Oral treatment once daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Respiratory disease; Chronic Obstructive Pulmonary Disease

Summary:

      The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients
      with chronic obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of non-child bearing potential. Only women of non-child bearing
             potential are included in the study i.e. women who are permanently or surgically
             sterilised or post menopausal.

          -  Between 40 and 80 years of age at Visit 1

          -  Clinical diagnosis of COPD (GOLD stage 2 or 3)

          -  FEV1/FVC <70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator
             (GOLD stage 2 or 3)

          -  Current or ex-smokers

        Exclusion Criteria:

          -  Any clinically significant disease or disorder (including history of abnormal immune
             function) which, in the opinion of the Investigator, may either put the subject at
             risk or influence the way the drug works

          -  Any lung disease other than COPD, recent respiratory infections which have not
             resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.

          -  Any abnormal findings in physical examination, blood or urine test results, vital
             signs or ECG at Visit 1 that may put the subject at risk during the study, affect
             their ability to take part or influence the results of the study

          -  Immunisation with a live vaccine within 3 months or other vaccination within 30 days
             before planned start of treatment

          -  Worsening of COPD symptoms within 4 weeks prior to start of study needing
             hospitalisation, oral steroids or antibiotics.
Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer
Condition: Thyroid Neoplasms
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: AG-013736
Intervention description: AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VEGFR inhibitor; tyrosine kinase inhibitor; anti-angiogenic; carcinoma; papillary; follicular; medullary; anaplastic

Summary:

      The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer
      that is resistant to radioactive iodine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer

          -  At least 1 measurable target lesion, as defined by RECIST

        Exclusion Criteria:

          -  Thyroid lymphoma

          -  Previous treatment with anti-angiogenesis agents

          -  No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.
A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: BMS-986036; BMS-986036; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 184.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: First Line Therapy; NASH

Summary:

      The purpose of this study is to determine whether BMS-986036 is effective in the treatment of
      subjects with Non-alcoholic Steatohepatitis (NASH).
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male or female between 21 and 75 years old

          -  Body Mass Index (BMI) of 25 or more

        Exclusion Criteria:

          -  Chronic Liver disease other than NASH

          -  Uncontrolled diabetes

          -  Any major surgery within 6 weeks of screening

          -  Unable to self-administer under the skin injections

          -  Any bone trauma, fracture or bone surgery within 8 weeks of screening
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: 21mg transdermal nicotine patch (Nicoderm CQ); 1mg nicotine nasal spray; placebo nasal spray
Intervention description: 21mg transdermal nicotine patch; two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.; saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: alcohol; nicotine; smoking cessation; smoking cessation medications

Summary:

      This study examines the effect of combined nicotine replacement therapy (transdermal patch +
      nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and
      self-administration behavior.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21 and over

          -  Able to read and write in English

          -  Smoker

          -  Heavy drinker

        Exclusion Criteria:

          -  Any significant current medical or psychiatric conditions that would contraindicate
             the consumption of alcohol or nicotine

          -  Significant hepatocellular injury

          -  Positive test result at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal, or evidence of severe mental illness

          -  Prescription of any psychotropic drug in the 30 days prior to study enrollment

          -  Blood donation within the past 8 weeks

          -  Individuals who are seeking treatment for drinking or smoking who have attempted to
             quit drinking or smoking within the past 3 months

          -  Specific exclusions for administration of nicotine nasal spray not specified above
             including nasal polyps, chronic nasal congestion, allergies, sinusitis

          -  Specific exclusions for administration of nicotine patch not specified above including
             history of dermatoses

          -  Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior
             adverse reaction to nicotine spray

          -  Participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current study
Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa
Condition: Dystrophic Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica
Intervention: Granulocyte Colony Stimulating Factor (GCSF)
Intervention description: G-CSF 10mcg/kg/d SQ for 7 days
Intervention MeSH terms: Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Healthy volunteers: No

Summary:

      This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is
      effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one
      course of treatment with the study drug. The course will be 7 days in length. After receiving
      GCSF, patients will be followed at 7 and 30 days following the discontinuation of the drug.
      Thirty day follow up can be done via telephone communication with the patient or family.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Each patient must have the diagnosis of severe generalized recessive dystrophic EB
             (formerly known as Hallopeau-Siemens RDEB) confirmed by clinical criteria and either
             of the following:

               1. transmission electron microscopy

               2. immunofluorescence antigenic mapping and type VII collagen monoclonal antibody
                  staining

               3. COL7A1 mutational analysis

        Exclusion Criteria:

          -  The patient must not have a history of squamous cell carcinoma or any internal
             malignancy.

          -  Female patients who are pregnant.

          -  Patients with active signs and symptoms of infection.
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: Bevacizumab; Gemcitabine; Carboplatin
Intervention description: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.; A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Intervention MeSH terms: Bevacizumab; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; platinum sensitive cancer; fallopian tube cancer; peritoneal cancer

Summary:

      The purpose of this study is to test the effectiveness, safety and tolerability of the drug
      combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed
      with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cancer of the ovaries, fallopian tube or abdominal lining has come back after more
             than 6 months from the last platinum based chemotherapy treatment.

          -  Disease must be detected by CT or CA125 level must be elevated or cancerous ascites
             must be present.

          -  History of at least one therapy of platinum based chemotherapy.

        Exclusion Criteria:

          -  Participation in another experimental drug study

          -  Heart disease or high blood pressure

          -  History of a stroke within the past 6 months

          -  Vascular disease, or bleeding problems

          -  Brain cancer

          -  Major Surgical Procedure within 28 days prior to start date

          -  Minor surgical procedures within 7 days prior to start date

          -  Pregnant or lactating

          -  Abdominal or bowel problems like bleeding

          -  History of abdominal fistula, GI perforation or Intra-abdominal abscess

          -  Serious, non-healing wound, ulcer or bone fracture

          -  Acute hepatitis

          -  Active infections requiring antibiotics

          -  Inability to comply with study or follow up procedures
A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection
Condition: COVID 19; Coronavirus
MeSH terms: COVID-19
Intervention: Fluvoxamine; Placebo
Intervention description: Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.; Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
Intervention MeSH terms: Fluvoxamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID 19; fluvoxamine

Summary:

      The purpose of this research study is to determine if a drug called fluvoxamine can be used
      early in the course of the COVID-19 infection to prevent more serious complications like
      shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the
      treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of
      COVID-19 is considered investigational, which means the US Food and Drug Administration has
      not approved it for this use.

      This study is fully-remote, which means that there is no face-to-face contact; study
      materials including study drug will be shipped to participants' houses. Only residents of
      Missouri and Illinois may participate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and woman age 18 and older;

          2. Not hospitalized;

          3. Has recently tested SARS-CoV-2 (COVID-19 virus) positive.

          4. Currently symptomatic with one or more of one or more of the following symptoms:
             fever, cough, myalgia, mild dyspnea, diarrhea, vomiting, anosmia (inability to smell),
             ageusia (inability to taste), sore throat.

          5. Able to provide informed consent.

        Exclusion Criteria:

          1. Illness severe enough to require hospitalization or already meeting study's primary
             endpoint for clinical worsening.

          2. Unstable medical comorbidities including, but not limited to: Severe underlying lung
             disease (COPD on home oxygen, interstitial lung disease, pulmonary hypertension),
             decompensated cirrhosis, Congestive heart failure (stage 3 or 4 per patient report
             and/or medical records).

          3. Immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose
             steroids (>20mg prednisone per day)

          4. Unable to provide informed consent (eg moderate-severe dementia diagnosis)

          5. Unable to perform the study procedures
Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: New formulation adalimumab
Intervention description: New formulation adalimumab 40 mg every other week
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed
      to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed
      new adalimumab formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not
             developed any discontinuation criteria from that study.

          2. If female, subject is either not of childbearing potential, defined as postmenopausal
             for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
             oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an
             approved method of birth control throughout the study and for 150 days after last dose
             of study drug. Examples of approved methods of birth control include the following
             (see local informed consent for more detail):

               -  Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);

               -  Hormonal contraceptives for 90 days prior to study drug administration;

               -  A vasectomized partner.

          3. Subjects must be able and willing to self-administer subcutaneous (SC) injections or
             have a qualified person available to administer SC injections.

          4. Subject is judged to be in good general health as determined by the Principal
             Investigator based upon the results of medical history, physical examination,
             laboratory profile performed at Baseline.

          5. Subjects must be able and willing to provide written informed consent and to comply
             with the requirements of this study protocol.

        Exclusion Criteria:

          1. Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with
             ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the
             infection has been successfully treated.

          2. Subject currently uses or plans to use anti-retroviral therapy at any time during the
             study.

          3. Subject plans to use any live vaccine during the study.

          4. Positive pregnancy test at Baseline (Week 0).

          5. Subject is considered by the investigator, for any reason, to be an unsuitable
             candidate for the study.
Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: NVXT topical; Placebo (Vehicle) Topical
Intervention description: topical treatment; Placebo (Vehicle) Topical
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical
      Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical
      product in Patients with Mild to Moderate Onychomycosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of onychomycosis of the target toenail (defined as one of the
             infected great toenails).

        Exclusion Criteria:

          -  Females who are pregnant, lactating or likely to become pregnant during the study.
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab; Ipilimumab
Intervention description: Specific dose on specific days; Specific dose on specific days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the effectiveness of re-induction with Nivolumab
      combined with ipilimumab.
    

Eligibility criteria:

        Inclusion Criteria:

        -Participants and Target Disease Characteristics- -

          -  Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after
             induction with ipilimumab and nivolumab

          -  Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be
             submitted for embedded tissue block or tumor tissue.

        Age and Reproduction Sexually active males with WOCBP must agree to instructions for
        contraception and fetal protection.

        WOCBP need to use contraception throughout the study and for 5 months post treatment.

        Exclusion Criteria autoimmune disease statement

          -  Active central nervous system metastases

          -  Participants with an active autoimmune disease, diabetes mellitus, skin disorders,
             hyperthyroidism requiring hormone treatments are permitted to enroll.

          -  Any major surgery 28 days before 1st treatment Concomitant Therapy

          -  participants that have received a live vaccine within 30 days of treatment.

          -  use of investigational agent or device with in 28 days before first dosage study
             treatment.

        Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and
        Reproduction