bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
Condition: Growth Disorder; Idiopathic Short Stature
MeSH terms: Dwarfism; Growth Disorders
Intervention: somatropin
Intervention description: A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety
      of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained from subject's parents or legally acceptable representative
             before any trial-related activities. (Trial-related activities are any procedure that
             would not have been performed during normal management of the subject.)

          -  Pre-pubertal status (males aged from 4 to 11 [both inclusive], females aged from 4 to
             9 [both inclusive]): an absence of breast development in females (Tanner 1 only) and
             testicular volume below 4 mL in males

          -  Growth hormone level above 10 ng/mL following a stimulation test (test result within 6
             months from screening can be used)

          -  Height below 3 percentile

          -  Bone age below or equal to 12 year

          -  Epiphyses confirmed as open in patients at least 10 years or more of age

        Exclusion Criteria:

          -  Known presence of one or more pituitary hormone deficiencies (ACTH
             (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating
             hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone))

          -  Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or
             untreated)

          -  Specific types of growth failure including, but not limited to, known chromosomal
             abnormalities associated with growth failure and altered sensitivity to growth hormone

          -  Bone age is advanced over chronological age more than 3 years

          -  Active malignancy, CNS (central nervous system) trauma, active chemotherapy or
             radiation therapy for neoplasia

          -  Prior history of intracranial hypertension

          -  Hypertrophic cardiomyopathy
Methotrexate-Inadequate Response Autoinjector Device Sub Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to implement a substudy in approximately 120 rheumatoid
      arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax
      and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC)
      Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled
      syringe.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects who have been treated in the long term (LT) with open-label SC Abatacept for
             at least 3 months

          -  Must continue to meet inclusion criteria specified in main IM101-174 Study Protocol

        Exclusion Criteria:

          -  Participation in previous device substudy (implemented by Amendment 10)

          -  Must continue to meet exclusion criteria specified in main IM101-174 Study Protocol
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Ferric Carboxymaltose (FCM)
Intervention description: maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Anemia; CKD; Chronic Kidney Disease; Iron; Maintenance Dose

Summary:

      The primary objective of this study is to evaluate the long term safety and tolerability of
      an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of
      non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension
      to protocol 1VIT04004 (NCT00317239).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who completed or discontinued Protocol 1VIT04004

        Exclusion Criteria:

          -  Known hypersensitivity reaction to VIT-45

          -  Anemia not related to CKD

          -  Chronic, serious infection

          -  Recent IV iron other than study drug in past 12 weeks

          -  Recent blood loss within the last 12 weeks

          -  Need for surgery or dialysis

          -  Female subjects who are pregnant or lactating
Comparison of Two Different Doses of Azithromycin for Treatment of Yaws
Condition: Yaws
MeSH terms: Yaws
Intervention: Azithromycin
Intervention description: Comparison of two different dosing strategies for the treatment of yaws
Intervention MeSH terms: Azithromycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 583.0
Sex: Male
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The study will be a single blinded, randomized, controlled open label non-inferiority phase
      III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The
      ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg
      dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws
      patients will be included in the study. Patients will be randomized to receive treatment with
      the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg
      azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The
      follow-up period of patients will be 6 months. Assessments before, during and after the
      antibiotic treatment will include full medical history, clinical assessment of the lesion
      and, laboratory investigations. The primary efficacy parameters are healing of the lesion at
      4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 6 to 16 years

          -  Clinical lesion consistent with primary or secondary yaws -Primary ulcer or papilloma

          -  Dually-Positive Chembio DPP Syphilis Screen & Confirm

          -  Informed Consent and Assent (for children 12-16 years)

        Exclusion Criteria:

          1. Known allergy to azithromycin or macrolides.

          2. Treatment with long-acting penicillin or alternative antibiotic with activity against
             T. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline,
             amoxicillin).

          3. Patients with current treatment with any drugs likely to interact with the study
             medication.

          4. Patients who are unable to take oral medication or having gastrointestinal disease
             likely to interfere with drug absorption.

          5. Patients who may not be able to comply with the requirements of the study protocol
             including follow up visits.

          6. Patients who are not willing to give informed consent (patient and/or parent/legal
             representative), or who withdraw consent.
Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer
Condition: Malignant Pleural Effusion
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion
Intervention: Bevacizumab; Cisplatin
Intervention description: Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week; Cisplatin 30mg,intrapleural administration,each 2 week
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Bevacizumab;; non-small cell lung cancer;; malignant pleural effusion;; intrapleural administration

Summary:

      To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment
      for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with advanced recurrent or progressive NSCLC proven cytohistologically

          -  Karnofsky performance status (KPS) ≥60

          -  Life expectancy ≥ 2 months

          -  No history of severe diseases of major organs including liver, heart, and kidney

          -  No previous intrapleural therapy

          -  Written informed consent

        Exclusion Criteria:

          -  Active thoracic cavity or systemic bleeding

          -  Active pleural or systemic infection.

          -  Known sensitivity to Bevacizumab or Cisplatin

          -  Refusal to participate in the study.
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: SEL; Placebo to match SEL 6 mg; Placebo to match SEL 18 mg
Intervention description: Tablets administered orally once daily; Tablets administered orally once daily; Tablets administered orally once daily
Intervention MeSH terms: Selonsertib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 883.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can
      cause fibrosis regression and reduce associated complications in adults with cirrhosis due to
      NASH.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH
             Clinical Research Network (CRN) classification, in the opinion of the central reader

          -  Has the following laboratory parameters at the screening visit, as determined by the
             central laboratory:

               -  Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)

               -  Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the
                  Cockcroft-Gault equation

               -  HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to
                  be resulted)

               -  International normalised ratio (INR) ≤ 1.4, unless due to therapeutic
                  anti-coagulation

               -  Platelet count ≥ 100,000/μL

        Key Exclusion Criteria:

          -  Prior history of decompensated liver disease including clinical ascites, hepatic
             encephalopathy (HE), or variceal bleeding

          -  Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic
             anti-coagulation

          -  Model for End-stage Liver Disease (MELD) score > 12, as determined at screening,
             unless due to therapeutic anti-coagulation

          -  Other causes of liver disease including, but not limited to, alcoholic liver disease,
             hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson
             disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history
             and/or centralized review of liver histology.

          -  History of liver transplantation

          -  Current or history of hepatocellular carcinoma (HCC)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Progesterone vs Placebo Therapy for Women With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Progesterone Lozenges; Matched Placebo Lozenges
Intervention description: 200mg Progesterone Lozenges; Matched Placebo Lozenges
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Randomization was carried out separately for women with and without catamenial epilepsy, 2:1 to progesterone or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 294.0
Sex: Female
Minimum age: 13 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Epilepsy; Seizure; Hormone; Progesterone; Catamenial

Summary:

      The purpose of this investigation was to determine if cyclic adjunctive progesterone
      supplement is superior to placebo in the treatment of intractable seizures in women with and
      without catamenial epilepsy.
    

Eligibility criteria:

        INCLUSION:

          1. Subject must be between the ages of 13 and 45.

          2. Subject must have a history of seizures (documented by EEG).

          3. Subject must have had at least 2 seizures or auras per month during the past 3 months.

          4. Subject must be on stable antiepileptic drug therapy for at least 2 months.

          5. Subject must have cycle intervals between 21 and 35 days during 6 months prior to
             entry.

        EXCLUSION:

          1. Subject that is pregnant or lactating.

          2. Subject that is on major tranquilizers, antidepressant medications, or reproductive
             hormones.

          3. Subject that is unable to document seizures.

          4. Subject that has progressive neurological or systemic disorder or > 2-fold elevation
             in liver enzyme levels
Japan Statin Treatment Against Recurrent Stroke (J-STARS)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Pravastatin
Intervention MeSH terms: Pravastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1578.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: stroke; brain ischemia; cerebrovascular accident; statin; hydroxymethylglutaryl-CoA reductase inhibitors; cholesterol; hypercholesterolemia; hyperlipidemia; multicenter studies; prospective studies; endpoint determination; randomized controlled trials; recurrence; pravastatin

Summary:

      Although hyperlipidemia is not always the risk factor of stroke, inhibition of
      3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke
      in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol
      lowering should be expected to attenuate inflammation and atherosclerosis. The present study
      hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with
      safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset

          -  Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of
             statin within previous 30 days

          -  Able to visit outpatient department

          -  Informed consent on the form.

        Exclusion Criteria:

          -  Ischemic stroke of other determined cause according to the TOAST classification

          -  Ischemic heart disease and necessary to use statin

          -  Hemorrhagic disorders

          -  Platelet count <=100,000/ul within 3 months prior to study start

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3
             months prior to study start

          -  Serum creatinine >=2.0mg/dl within 3 months prior to study start

          -  A scheduled operation

          -  The presence of malignant disorder
Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: Nilotinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GIST; Imatinib; Sunitinib; Gastrointestinal; Stromal; Tumors

Summary:

      This study will evaluate the preliminary efficacy of nilotinib in pretreated patients
      (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and
             therefore not amenable to surgery or combined modality with curative intent.

          -  Radiologically confirmed disease progression during imatinib therapy at a dose of at
             least 400 mg daily and/or radiologically confirmed disease progression during
             sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients
             with prior additional investigational treatment of GIST prior to study entry can be
             included.)

          -  At least one measurable site of disease on CT/MRI as defined by RECIST criteria.

        Exclusion Criteria:

          -  Prior treatment with nilotinib.

          -  Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks
             for nitrosurea or mitomycin C) prior to Visit 1.

          -  Prior or concomitant malignancies requiring active treatment other than GIST with the
             exception of previous or concomitant basal cell skin cancer, previous cervical
             carcinoma in situ.

          -  Impaired cardiac function at visit 1

          -  Patients with severe and/or uncontrolled concurrent medical disease that in the
             opinion of the investigator could cause unacceptable safety risks or compromise
             compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI
             disease that may significantly alter the absorption of the study drugs, uncontrolled
             diabetes.

        Other protocol-defined inclusion/exclusion criteria may apply
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
Condition: Alopecia
MeSH terms: Alopecia
Intervention: PRFM treatment
Intervention description: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: alopecia

Summary:

      Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active
      production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal
      findings of improvement of hair appearance after PRFM injection in the scalp suggest that
      PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly
      basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density
      will be assessed by comparing pre- and post-treatment photographs and non-invasive
      measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18- 75 years old

          -  frontal and/or crown alopecia

        Exclusion Criteria:

          -  bleeding disorder
A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Placebo; Platinum chemotherapy (cisplatin or carboplatin); erlotinib [Tarceva]; gemcitabine
Intervention description: po on days 15-28 of each 4 week cycle until disease progression; cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles; 150mg po on days 15-28 of each 4 week cycle until disease progression; 1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles
Intervention MeSH terms: Carboplatin; Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or
      placebo, plus platinum-based therapy, as first line treatment in patients with advanced or
      recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine
      (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1,
      followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a
      total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on
      study treatment is until disease progression, and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  advanced (stage IIIB/IV)non-small cell lung cancer;

          -  measurable disease;

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

        Exclusion Criteria:

          -  prior exposure to agents directed at the HER axis;

          -  prior chemotherapy or systemic anti-tumor therapy after advanced disease;

          -  unstable systemic disease;

          -  any other malignancy within last 5 years, except cured basal cell cancer of skin or
             cured cancer in situ of cervix;

          -  brain metastasis or spinal cord compression.