bioihbjkbjnl/mcl2 huggingface dataset:
Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Platelet-Rich Plasma; rehabilitation exercises
Intervention description: Autologous Platelet-Rich Plasma will be applied by a intra-articular injections; Patients would been shown rehabilitation exercises, to perform them at home
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Platelet-rich plasma; Osteoarthritis

Summary:

      The investigators include patients attending the outpatient clinic in the area of Orthopedics
      and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which
      treatment is medical. Patients will be divided into two groups. In both groups, they will be
      given verbal, clear and detailed information on the approach to follow, the intra-articular
      application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first
      group will be held single application, while in the second group three applications will be
      made at an interval of two weeks each. Both groups will be assessed before and after
      application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western
      Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 90 years

          -  Patients with no previous treatment

          -  Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic
             findings)

        Exclusion Criteria:

          -  Age <18 and > 90 years

          -  Patients with Knee osteoarthritis grade 3-4 ( Kellgren-Lawrence based on radiographic
             findings)

          -  Patients with asociated Rheumatic syndromes

          -  Patients with anticoagulant therapy

          -  Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions,
             immunodepressed, or infections

          -  Pregnant patients

          -  Patients with prosthetic or orthotic.

          -  Patients with hemoglobin values < 11g/dl , platelets < 150,000/μL
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide once weekly; insulin glargine
Intervention description: subcutaneous injection, 2.0mg, once a week;; subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 427.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly

Summary:

      The objectives of this clinical trial are to compare the effects of exenatide once weekly and
      insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  present with type 2 diabetes mellitus

          -  HbA1c between 7.1% and 11.0% inclusive

          -  body mass index (BMI) of >18kg/m2 and <35kg/m2, inclusive

          -  treated with a stable dose regimen of either of biguanide (BG) alone, BG +
             thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to
             study start

        Exclusion Criteria:

          -  Have received chronic (>14 consecutive days) systemic adrenocorticosteroid therapy by
             oral, intravenous, or intramuscular route or intraarticular steroid injection within 4
             weeks prior to study start.

          -  Have been treated with drugs that promote weight loss within 90 days prior to study
             start.

          -  Have been treated with drugs that directly affect gastrointestinal motility for > 21
             consecutive days within 90 days prior to study start.

          -  Have had prior exposure to exenatide BID or QW or participated in the clinical trial
             of exenatide BID or QW (including the case that the study drug was not administered).

          -  Have been treated for >2 consecutive weeks with any of the following excluded
             medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4
             (DPP-4) inhibitors, GLP-1 analogs

          -  Have received treatment within 30 days prior to study start drug that has not received
             regulatory approval for any indication.

          -  Are currently enrolled in any other clinical study or participated in and completed
             the clinical study within 30 days prior to study start.

          -  Have donated blood within 30 days prior to study start.
BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaseron, BAY86-5046)
Intervention description: Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase; Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 468.0
Sex: All
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No

Summary:

      This study will primarily compare the long-term effects of an early and continued treatment
      with Betaferon/Betaseron (patients who were treated with active medication during the
      double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple
      Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with
      placebo during the double-blind BENEFIT study).

      Analyses are based on the integrated data of the initial BENEFIT study and this follow-up
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS
             or by completing 24 months

        Exclusion Criteria:

          -  No participation in the initial BENEFIT study
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Bevacizumab; Temsirolimus; Bevacizumab; Interferon-Alfa 9MU
Intervention description: Bevacizumab 10 mg/kg intravenous (IV) q8wks; Temsirolimus 25 mg IV weekly; Bevacizumab 10 mg/kg intravenous (IV) q8wks; Interferon-Alfa 9MU SC TIW
Intervention MeSH terms: Interferons; Interferon-alpha; Sirolimus; Bevacizumab; Temsirolimus; MTOR Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 791.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: temsirolimus; renal cell carcinoma; kidney cancer; urogenital cancer

Summary:

      Primary objective: Comparison of independently assessed progression free survival (PFS) in
      subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab +
      Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response
      rate (independently assessed), and overall survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically and/or cytologically confirmed to have advanced renal cell carcinoma
             (RCC)

          -  Majority component of conventional clear-cell type is mandatory

          -  At least 1 measurable lesion (per RECIST)

        Exclusion Criteria:

          -  Prior systemic treatment for RCC

          -  Evidence of current or prior central nervous system (CNS) metastases

          -  Cardiovascular disease

          -  Pregnant or nursing women

          -  Additional criteria applies
Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
Condition: Idiopathic Short Stature
MeSH terms: Dwarfism
Intervention: DA-3002
Intervention MeSH terms: Hormones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 4 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: growth hormone

Summary:

      Growth hormone therapy will improve the height of idiopathic short statured children.
      DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to
      non-treatment group in efficacy and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronological Age ≥ 4

          -  Bone Age <11 (for girls) and <13 (for boys)

          -  Height <3rd percentile for age

          -  normal thyroid function

        Exclusion Criteria:

          -  endocrine and/or metabolic disorders

          -  growth failure caused by other disorders

          -  previous use of drugs that could interfere with Growth Hormone treatment
A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib; Placebo; Pemetrexed; Cisplatin
Intervention description: Investigational Drug; Matching placebo as comparator; Chemotherapy (concomitant therapy); Chemotherapy (concomitant therapy)
Intervention MeSH terms: Pemetrexed; Gefitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Non Small Cell Lung Cancer; Gefitinib; Pemetrexed; Treatment Beyond Progression

Summary:

      The purpose of this study is to assess the efficacy and safety of gefitinib in patients who
      have progressed on first line gefitinib, comparing continuing gefitinib in addition to
      cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed
      combination chemotherapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged 18 years or older (For Japan only- male or female
             patients aged 20 years or older)

          -  Cytological or histological confirmation of NSCLC other than predominantly squamous
             cell histology with an activating EGFR TK mutation as determined locally

          -  Patients with documented 'acquired resistance' on first line gefitinib

          -  Patients suitable to start cisplatin based pemetrexed combination chemotherapy.

          -  Provision of informed consent prior to any study specific procedures.

        Exclusion Criteria:

          -  Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib).
             Palliative bone radiotherapy must be completed at least 2 weeks before start of study
             treatment with no persistent radiation toxicity).

          -  Past medical history of interstitial lung disease, drug-induced interstitial disease,
             radiation pneumonitis which required steroid treatment or any evidence of clinically
             active interstitial lung disease

          -  Other co-existing malignancies or malignancies diagnosed within the last 5 years, with
             the exception of basal cell carcinoma or cervical cancer in situ or completely
             resected intramucosal gastric cancer

          -  Any evidence of severe of uncontrolled systemic disease Treatment with an
             investigational drug within 4 weeks before randomization
Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1053.0
Sex: All
Minimum age: 68 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pneumococcal conjugate vaccine; vaccine

Summary:

      To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly
      subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide
      vaccine (23vPS) at least 3 years before study enrollment.
    

Eligibility criteria:

        MAIN INCLUSION CRITERIA:

          -  Male or female aged 68 years or older

          -  Determined by medical history, physical examination, and clinical judgment to be
             eligible for the study

          -  Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years
             before study enrollment

        MAIN EXCLUSION CRITERIA:

          -  Known history of severe reaction to a vaccine

          -  Documented S pneumoniae infection within the past 5 years.

          -  Known or suspected immunodeficiency or receiving treatment with immunosuppressive
             therapy including cytotoxic agents or systemic corticosteroids

          -  Serious chronic disorder including metastatic malignancy, severe chronic obstructive
             pulmonary disease requiring supplemental oxygen, end-stage renal disease with or
             without dialysis, clinically unstable cardiac disease, or any other disorder that in
             the investigator's opinion precludes the subject from participating in the study.
Evaluation of Galcanezumab in the Prevention of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1117.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug known as
      galcanezumab in participants with chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

        Main Study:

          -  Have a diagnosis of chronic migraine as defined by International Headache Society
             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines
             (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
             screening, and migraine onset prior to age 50.

        Israel addendum:

          -  Participants must have completed all phases of main study, including the 4-month
             post-treatment follow-up phase, during which no investigational product was
             administered.

          -  Participants also must be considered by the investigator to have benefited from
             galcanezumab treatment and must have exhausted alternative therapies for the
             prevention of migraine.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to galcanezumab or another calcitonin gene-related
             peptide (CGRP) antibody.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to galcanezumab.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults
Condition: Obesity
MeSH terms: Obesity
Intervention: VI-0521; VI-0521; Placebo matched phentermine/topiramate
Intervention description: 3.75 mg phentermine/23 mg topiramate; 15 mg phentermine/92 mg topiramate; Placebo matched phentermine/topiramate
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1267.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Obesity, morbid obesity

Summary:

      The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521
      compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) ≥ 35 kg/m2

          -  Informed consent

          -  70 years of age or less

          -  Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications

          -  Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension

          -  Fasting blood glucose level of ≤ 110 mg/dL

        Exclusion Criteria:

          -  Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months

          -  Clinically significant renal, hepatic or psychiatric disease

          -  Unstable thyroid disease or replacement therapy

          -  Nephrolithiasis

          -  Obesity of known genetic or endocrine origin

          -  Participation in a formal weight loss program or lifestyle intervention

          -  History of glaucoma or intraocular pressure

          -  Pregnancy or breastfeeding

          -  Alcohol abuse

          -  Smoking cessation within previous 3 months or plans to quit smoking during study

          -  Eating disorders

          -  Cholelithiasis within past 6 months

          -  Excluded medications

          -  Type 2 diabetes

          -  Previous bariatric surgery

          -  History of bipolar disorder or psychosis
A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol; FCM
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2014.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iron deficiency anemia; IDA; ferumoxytol; ferric carboxymaltose; FCM; Injectafer; Feraheme; Ferinject

Summary:

      To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g
      of IV ferric carboxymaltose (FCM).
    

Eligibility criteria:

        Key Inclusion Criteria include:

          -  Participants with IDA and in whom IV iron treatment is indicated and defined as:

               -  Participants with documented hemoglobin <12.0 g per deciliter (dL) for females
                  and <14.0 g/dL for males within 60 days of dosing And

               -  Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100
                  nanograms (ng) per mL within 60 days of dosing

          -  Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be
             tolerated, or for whom oral iron is considered medically inappropriate (as per oral
             iron history questionnaire)

          -  All participants (male and female) of childbearing potential who are sexually active
             who agree to routinely use adequate contraception from randomization throughout the
             duration of the study

        Key Exclusion Criteria include:

          -  Known hypersensitivity reaction to any component of ferumoxytol or FCM

          -  History of allergy to an IV iron

          -  History of multiple drug allergies

          -  Participants with dialysis-dependent chronic kidney disease

          -  Hemoglobin ≤7.0 g/dL

          -  Female participants who are pregnant, intend to become pregnant, are breastfeeding,
             have a positive serum/urine pregnancy test or not willing to use effective
             contraceptive precautions during the study (including females of childbearing
             potential who are partners of male participants)
Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
Condition: Anesthesia
Intervention: Normal Saline; Lactated Ringer; Normosol-R Inj
Intervention description: IV infusion of 0.9% NaCl throughout surgery.; IV infusion of lactated ringer throughout surgery.; IV infusion of Normosol throughout surgery.
Intervention MeSH terms: Plasma-lyte 148
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 10 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      During major surgical procedures, intravascular volume is maintained with the administration
      of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three
      of these fluids are in common clinical use for this purpose. As large volumes of NS may
      result in a dilutional acidosis and an increasing base deficit, it may cloud clinical
      decision making when resuscitative efforts are guided by acid-base status on routine arterial
      blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base
      and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids
      for intraoperative resuscitation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major surgical procedure requiring arterial access

        Exclusion Criteria:

          -  Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid
             solutions.