bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
Condition: HIV-1-infection
Intervention: GS-9131; BIC; TAF; ARV regimen; DRV; RTV
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI); Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Intervention MeSH terms: GS-9131
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the short-term antiviral potency of
      GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered
      once daily with the existing failing antiretroviral (ARV) regimen as demonstrated by the
      proportion of participants achieving human immunodeficiency virus ribonucleic acid (HIV-1
      RNA) > 0.5 log10 decreases from baseline after up to 14 days of therapy in HIV-1 positive,
      ARV treatment experienced adult participants with nucleos(t)ide resistant virus.

      This is a two-part study. Part 1 consists of three cohorts: 2 Sentinel Cohorts and 1
      Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an
      optional open-label extension.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Plasma HIV-1 RNA ≥ 500 copies/mL at screening Visit

          -  Currently taking a failing ARV regimen that contains 2 NRTIs and a NNRTI

          -  No prior or current ARV regimens containing integrase inhibitor (INSTI) or protease
             inhibitor (PI)

          -  Screening genotype must show at least the protocol defined resistance mutation profile

        Key Exclusion Criteria:

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to Day 1

          -  Participation in any other clinical trial, including observational studies, without
             prior approval from the sponsor is prohibited while participating in this trial

          -  Use of an investigational drug other than the study drug

          -  Individuals with chronic hepatitis B virus (HBV) infection are not permitted to
             participate

          -  Active tuberculosis infection

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Intervention: AGN-195263 0.1%; AGN-195263 0.03%; AGN-195263 0.01%; AGN-195263 Vehicle
Intervention description: 1 drop of AGN-195263 0.1% instilled in each eye twice daily.; 1 drop of AGN-195263 0.03% instilled in each eye twice daily.; 1 drop of AGN-195263 0.01% instilled in each eye twice daily.; 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 232.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in
      patients with meibomian gland dysfunction (MGD) in the eyelids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meibomian gland dysfunction in both eyes

          -  Best-corrected visual acuity of 20/40 or better in each eye

        Exclusion Criteria:

          -  Known or suspected prostate cancer

          -  History of breast cancer

          -  Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior
             to the screening visit, or anticipated use during the study

          -  Contact lens wear in either eye during any portion of the study

          -  Unable to instill eye drops correctly

          -  History of corneal refractive surgery in either eye within 1 year
Pilot Study of COR-1 in Heart Failure
Condition: Cardiomyopathy, Dilated
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Intervention: 0.9 % sodium chloride; COR-1; Standard therapy for heart failure
Intervention description: Monthly intravenous injection for 6 months; Monthly intravenous injection for 6 months; All patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Anti-beta1-receptor autoantibodies; COR-1; Heart failure

Summary:

      The purpose of this study is to investigate the effect of COR-1 in combination with standard
      therapy in patients with heart failure. The safety and tolerability of COR-1 will also be
      assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed heart failure due to dilated cardiomyopathy with left ventricular ejection
             fraction < 45%

          -  Presence of anti-beta1-receptor autoantibodies

          -  New York Heart Association (NYHA) class II to III heart failure

          -  Symptomatic heart failure for >1 year and < 8 years

          -  Treatment with adequate doses of angiotensin converting enzyme inhibitors or
             angiotensin II receptor blockers, beta-blockers, and optional aldosterone antagonists
             according to guidelines for at least six months (with the exception of lack of
             tolerability of any of these drugs) and at stable doses for 2 months prior to
             screening

        Exclusion Criteria:

          -  Ischemic heart disease characterized by >= 50% coronary artery stenosis and/or history
             of myocardial infarction

          -  Third or higher degree valvular defect

          -  Any disease requiring immunosuppressive drugs (except for <= 5 mg/day
             prednisone-equivalent dose) or any clinically relevant disorder of the immune system

          -  History of severe allergies and increased risk for anaphylactic shock (e.g., bronchial
             asthma)

          -  History of, or currently active illness, considered to be clinically significant by
             the Investigator or any other illness that the Investigator considers should exclude
             the patient from the study or that could interfere with the interpretation of the
             study results
IBUPAP Study for Pain Management in Children
Condition: Pain Management
Intervention: Ibuprofen; APAP
Intervention description: Oral Ibuprofen at 10 mg/kg dose; Oral APAP at 15mg/kg dose
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Current literature supports ibuprofen and APAP are the most commonly used analgesics in the
      pediatric ED for acute traumatic/non-traumatic pain. However, the analgesic benefits of
      combination ibuprofen and APAP in this specific setting does not exist, but instead only as
      it applies to pediatric patients with postoperative pain. Thus, we have designed a
      double-blind, randomized, controlled clinical trial to evaluate analgesic efficacy, safety
      and feasibility of combination therapy to potentially broaden its clinical application in the
      pediatric ED. The investigators' hypothesize that combination oral ibuprofen and APAP therapy
      is superior to either drug alone and is an excellent analgesic modality for controlling acute
      traumatic/non-traumatic pain in the pediatric ED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 3-17 years old presenting to the pediatric ED

          -  treating physician deems patient required ibuprofen Tylenol or both for pain relief

        Exclusion Criteria:

          -  documented or suspected pregnancy, (2)

          -  parental refusal,

          -  allergies to NSAIDS or APAP

          -  inability to tolerate oral medications or contraindications to oral medication route

          -  received analgesics within 4 hours prior to ED presentation

          -  inability to use pain scales
Radioactive Iodide Therapy for Pediatric Graves' Disease
Condition: Graves' Disease
MeSH terms: Graves Disease
Intervention: RAI treatment; ATD Group
Intervention description: Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).; Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Hyperthyroidism; Antithyroid drugs; Cancer; Dosimetry; Children

Summary:

      The investigators hypothesize that 131I is an effective therapy for children with Graves'
      Disease (GD) and will not be associated with long-term cancer risks when used in older
      children, but may be associated with excessive levels of whole body radiation in young
      children. To address issues of 131I safety and cancer risk in the pediatric population, the
      investigators propose to: (1) Perform dosimetry to assess whole body radiation exposure
      following 131I therapy in children treated for GD (2) the investigators will assess
      chromosome translocation as related to age and dose of 131I.

      It is anticipated that these studies will provide new insights into RIA use in children and
      provide important information about radiation exposure associated 131I use in children. As
      such, these studies are expected to result in new recommendations for 131I use in the
      treatment of pediatric GD.

      Funding Source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of GD based on initial laboratory studies showing a suppressed TSH (i.e.
             <0.01); high total T3, high total T4 and/or free T4 level; an elevated thyroid
             stimulating immunoglobulin (TSI) titer; increased and diffuse uptake of 123I, 131I, or
             99Tc in the thyroid gland.

          2. Age <18 years at the time of GD disease diagnosis.

          3. Non-smoking parents.

        Exclusion Criteria:

          1. > 18 years.

          2. Smoking parents.
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: AG-013736; gemcitabine; cisplatin
Intervention description: AG-013736 5 mg tablets orally, twice daily, until disease progression; 200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles; 1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles
Intervention MeSH terms: Gemcitabine; Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AG-013736; axitinib; cisplatin; gemcitabine; NSCLC; squamous cell; lung cancer

Summary:

      This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows
      activity and is safe in patients with squamous type of non-small cell lung cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with
             malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV,
             or recurrent disease after definitive local therapy

          -  Candidate for primary treatment with cisplatin and gemcitabine

          -  Presence of measurable disease by RECIST

          -  Adequate organ function as defined by the following criteria: ECOG performance status
             of 0 or 1

        Exclusion Criteria:

          -  Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.

          -  One or more lung lesions with cavitation, or any lesion invading or abutting a major
             blood vessel as assessed by CT or MRI.

          -  History of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1
             week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment

          -  NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment

          -  Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure
             readings taken at least 1 hour apart.

          -  Untreated brain metastases.

          -  Need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), NSAID or
             other medications known to inhibit platelet function.
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: 18F-EF5; Pretreatment PET/CT-scan (performed two times)
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: 18F-EF5; PET/CT; Reproducibility

Summary:

      The results of previous studies suggest further development of [18F]EF5 as a PET tracer for
      imaging hypoxia. This is a non-randomized prospective study to obtain information on
      reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Performance status: Karnofsky score 70 or better or WHO performance status 2 or better

          -  Diagnosis: Histological, cytological and clinical findings are consistent with
             squamous cell carcinoma of the head and neck

          -  Primary tumor diameter as determined clinically or from contrast enhanced CT or
             T1-weighed MRI scan must be at least 15 mm

          -  Patients with nodal neck metastases of head and neck cancer are eligible

          -  Mental status: Patients must be able to understand the meaning of the study

          -  The patient must sign the appropriate Ethical Committee (EC) approved informed consent
             documents in the presence of the designated staff

          -  Patient, if female, must not be pregnant or lactating at the time of the study

        Exclusion Criteria:

          -  Patient must have no history of serious haematologic, cardiovascular, liver or kidney
             disease.

          -  Patient must have no history of previous chemotherapy or biological therapy or RT for
             treatment of head and neck cancer.

          -  Patient must not have an uncontrolled serious infection

          -  Patients with organ metastases in liver, bone, brain or lung.
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
Condition: Cushing's Syndrome; Ectopic Corticotropin Syndrome; Adrenal Adenoma; Adrenal Carcinoma; AIMAH; PPNAD
MeSH terms: Adenoma; Adrenocortical Adenoma; Adrenocortical Carcinoma; ACTH Syndrome, Ectopic; Cushing Syndrome; Syndrome
Intervention: Osilodrostat
Intervention description: Osirodrostat 1mg, 5mg & 10mg in the form of film-coated tablets was used for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Cushing's syndrome; osilodrostat; LCI699; ectopic corticotropin syndrome; adrenal adenoma; adrenal carcinoma; ACTH-Independent Macronodular Adrenal Hyperplasia; AIMAH; Primary Pigmented Nodular Adrenal Dysplasia; PPNAD

Summary:

      The study aim was to investigate the efficacy and safety of Osilodrostat in patients with
      Cushing's syndrome due to causes other than Cushing's disease in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with confirmed Cushing's syndrome [i.e. ectopic corticotropin syndrome,
             adrenal adenoma, adrenal carcinoma, ACTH-Independent Macronodular Adrenal Hyperplasia
             (AIMAH), or Primary Pigmented Nodular Adrenal Dysplasia (PPNAD)]

          -  For patients on medical treatment for hypercortisolism due to Cushing's syndrome, the
             washout periods had to be completed prior to baseline efficacy assessments

        Exclusion Criteria:

          -  Patients with Cushing's disease

          -  History of hypersensitivity to osilodrostat or to drugs of similar chemical classes

          -  History of malignancy of any organ system, treated or untreated, within the past 5
             years

          -  Patients receiving treatment for within 4 weeks or ≤5 x half-life of the agent
             (whichever is longer) before first dose of osilodrostat

          -  Patients with risk factors for QTc prolongation or Torsade de Pointes
A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Vandetanib; FOLFIRI
Intervention description: once daily oral tablet two doses; Intravenous infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colon Cancer; Rectal Cancer

Summary:

      The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™
      (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer
      in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed colorectal cancer

          -  Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen
             defined as:

          -  Progression on or following treatment for metastatic colorectal cancer

          -  Progression within 12 months of adjuvant chemotherapy for colorectal cancer

        Exclusion Criteria:

          -  Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg,
             erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab,
             bevacizumab.

          -  Previous adjuvant therapy with irinotecan within 12 months of randomization

          -  More than one prior course of chemotherapy for treatment of metastatic colorectal
             cancer.
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Condition: Status Epilepticus; Convulsive Status EPILEPTICUS; Non Convulsive Status Epilepticus; Epilepsy
MeSH terms: Status Epilepticus
Intervention: IV Ganaxolone active; IV Placebo, non-active
Intervention description: IV; IV
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind study that will randomize subjects to ganaxolone or placebo in a 1:1 ratio as adjunctive therapy to their standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effectiveness and safety of an investigational drug, IV
      ganaxolone, as adjunctive therapy to standard of care to treat subjects with status
      epilepticus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 12 years of age and older

          -  Clinical and/or electrographic seizures

        Exclusion Criteria:

          -  Life expectancy of less than 24 hours

          -  Anoxic brain injury as primary cause of SE

          -  Recent (<24 hour) traumatic brain injury as the primary cause of SE

          -  Administered anesthesia for the treatment of SE