bioihbjkbjnl/mcl2 huggingface dataset:
Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam (ucb 34714)
Intervention description: 10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 853.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Brivaracetam; Epilepsy; long term

Summary:

      This trial, evaluating the long-term safety and tolerability of brivaracetam, will give
      subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity
      to continue the treatment. The study will also evaluate the maintenance of efficacy over time
      of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures
      (PGS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female subjects from 16 years (where legally permitted and ethically accepted) or
             18 years onwards suffering from epilepsy and having completed a previous study with
             brivaracetam as adjunctive treatment, which allowed access to this study

          -  Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in
             previous brivaracetam studies / programs which allow access to the present study

          -  Subjects with ULD: inpatients or outpatients with epilepsy who were treated with
             brivaracetam in previous studies / programs which allow access to the present study

          -  Subjects for whom the Investigator believes a reasonable benefit from the long-term
             administration of brivaracetam may be expected

        Exclusion Criteria:

          -  Severe medical, neurological and psychiatric disorders, or laboratory values which may
             have an impact on the safety of the subject

          -  Poor compliance with visit schedule or medication intake in previous brivaracetam
             study

          -  Participation in any clinical study of another investigational drug or device during
             the study

          -  Pregnant or lactating woman
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Intervention: G-Pen (glucagon injection); Lilly Glucagon (glucagon injection [rDNA origin])
Intervention description: 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector; 1 mg of Lilly glucagon reconstituted from lyophilized powder
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen
      (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for
      hypoglycemia rescue of adult patients with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with type 1 diabetes mellitus for at least 24 months

          -  usage of daily insulin treatment

          -  random serum C-peptide concentration < 0.5 ng/mL

        Exclusion Criteria:

          -  pregnant or nursing

          -  HbA1c >9.0%

          -  renal insufficiency

          -  hepatic synthetic insufficiency

          -  aspartate or alanine aminotransferase > 3 times the upper limit of normal

          -  hematocrit less than or equal to 30%

          -  use of > 2.0 U/kg total insulin dose per day

          -  inadequate bilateral venous access in both arms

          -  congestive heart failure, New York Heart Association class II, III or IV

          -  active malignancy within 5 years, except basal cell or squamous cell skin cancers

          -  history of breast cancer or malignant melanoma

          -  major surgical operation within 30 days

          -  current seizure disorder.

          -  current bleeding disorder, treatment with warfarin, or platelet count below 50,000

          -  history of pheochromocytoma or disorder with increased risk of pheochromocytoma

          -  history of insulinoma

          -  history of glycogen storage disease.

          -  positive for HIV, hepatitis C virus or active hepatitis B virus infection

          -  whole blood donation of 1 pint (500 mL) within 8 weeks

          -  active substance or alcohol abuse

          -  administration of glucagon within 28 days

          -  participation in other studies involving an investigational drug or device within 30
             days
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
Condition: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: bempedoic acid; placebo
Intervention description: bempedoic acid 180 mg tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided); Matching placebo tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 779.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; cholesterol; familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL

Summary:

      The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo
      in patients with high cardiovascular risk and elevated LDL cholesterol not adequately
      controlled by their current therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C ≥100 mg/dL

          -  High cardiovascular risk (diagnosis of HeFH and/or ASCVD)

          -  Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated
             statin either alone or in combination with other LMTs

        Exclusion Criteria:

          -  Total fasting triglyceride ≥500 mg/dL

          -  Renal dysfunction or nephrotic syndrome or history of nephritis

          -  Body Mass Index (BMI) ≥50kg/m2

          -  Significant cardiovascular disease or cardiovascular event in the past 3 months
Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: Chitosan; Isosorbide dinitrate; Placebo
Intervention description: Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine; Isosorbide dinitrate (ISDN), is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate; placebo
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Chitosan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: diabetic foot ulcers; chitosan; isosorbide dinitrate spray

Summary:

      The prevalence of diabetic foot ulceration in the diabetic population is 4-10%; the condition
      is more frequent in elder patients. It is estimated that about 5% of all patients with
      diabetes present a history of foot ulceration, while the lifetime risk of diabetic patients
      developing this complication is 15%. The majority (60-80%) of foot ulcers will heal, while
      10-15% of them will remain active, and 5-24% of them will finally lead to limb amputation
      within a period of 6-18 months after the first evaluation , 2 out of 3 patients with a limb
      amputation could also be involved in a new amputation in the next year; higher or in the
      other leg , Eighty-five percent of lower-limb amputations in patients with diabetes are
      preceded by foot ulceration. The management of chronic diabetic foot ulcers (DFU) suggests
      multi-disciplinary approaches including control of diabetes, orthotic shoe wear, off-loading
      device, wound care and surgery in selected cases. However, treatment of DFU remains
      challenging because of unsatisfactory results from surgical and non-surgical treatments. Many
      adjunctive therapies are designed to improve the care of DFU including negative pressure
      wound therapy , ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB)
      Hyperbaric oxygen and acellular matrix product among others.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with diabetic foot ulcers in grade I and II of the classification of Wagner

          -  with leg arm index> 0.8 and

          -  without specific treatment for foot ulcers referred to the experimental and clinical

        Exclusion Criteria:

          -  Patients with another type of topical medication

          -  patients with diabetic foot ulcers in grade III and

          -  with leg arm index <0.8
Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis
Condition: Bile Acid Synthesis Defect
Intervention: Cholic Acid
Intervention description: 10-15 mg/kg body weight/day supplied in 50 or 250 mg Cholic Acid Capsules
Intervention MeSH terms: Cholic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Healthy volunteers: No
Keywords: Cholic Acid; Inborn Error; Bile Acid Metabolism; Inborn Error of Bile Acid Synthesis

Summary:

      The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic
      acid in subjects with identified inborn errors of bile acid synthesis.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects who received cholic acid through CCHMC protocols 91-10-10 or CAC-002-01 and meet
        the following criteria are eligible for study participation.

          1. The subject and/or parent/legal guardian must have provided informed consent prior to
             study start.

          2. The subject must have a diagnosis of an inborn error of bile acid synthesis.

          3. The subject must be willing and able to comply with all study assessments and
             procedures.

          4. Subjects with other organ dysfunction will not be excluded
The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth
Condition: Primary Teeth; Microbial Colonization; Caries; Dental Caries in Children
MeSH terms: Communicable Diseases; Infections; Dental Caries
Intervention: Nanosilver Fluoride (NSF); Silver diamine fluoride
Intervention description: Optimized synthesis of Nanosilver Fluoride; Silver Diamine Fluoride
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 1 Year
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nano silver fluoride; silver diamine fluoride; antibacterial; caries arrest; microbiology; primary teeth; pediatric; clinical trial; nanosilver; SDF

Summary:

      To assess the antibacterial effect of Nanosilver Fluoride (NSF) in relation to caries
      activity in dentin caries lesions of primary teeth in comparison to Silver Diamine Fluoride
      (SDF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The presence of at least one active carious lesion on a primary tooth.

          -  Completion of an informed consent to participate in the study.

        Exclusion criteria:

          -  Children reporting spontaneous or elicited pain from caries or showing any signs of
             pulpal infection, swelling, abscess, obvious discoloration of the tooth, or premature
             mobility.

          -  Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes
             within the last 2 weeks.

          -  Children presenting with special health care needs or undergoing medical treatment for
             chronic or acute diseases affecting salivary flow.

          -  Allergy or sensitivity to silver or any of the materials included in the study.

          -  Child weight less than 10 Kg (to avoid concerns for toxicity).
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
Condition: Immunologic Deficiency Syndromes
MeSH terms: Immunologic Deficiency Syndromes
Intervention: GC5107
Intervention description: GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 2 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune
      Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency
             Disease as defined by IUIS (International Union of Immunological Societies) and
             require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia

          -  Male or Female, ages 2 to 70 years

          -  The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day
             intervals for at least 3 months prior to this study

          -  At least 2 documented IgG trough levels of ≥ 500 mg/dL are obtained at two infusion
             cycles (21 or 28 days) within 12 months prior to study enrollment

        Exclusion Criteria:

          -  Subject has secondary immunodeficiency

          -  Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin

          -  Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass
             deficiency or isolated IgA deficiency with known anti-IgA antibodies

          -  History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG

          -  Subject has a lifetime history of at least one thrombotic event including deep vein
             thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks,
             or myocardial infarction

          -  Subject has received blood products other than human albumin or human immunoglobulin
             within 12 months prior to enrollment
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Condition: Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Treatment I; Treatment II; Treatment III
Intervention description: Sunpharma1505 and Placebo; Sunpharma1505 and Placebo; Reference1505 and Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects
      with active rheumatoid arthritis who are experiencing a flare/exacerbation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects able and willing to give written informed consent and is available for entire
             study.

          2. Male or female ≥ 18 years old

          3. Willing and able to comply with the study protocol visits, assessments and accessible
             for follow up

          4. Known Diagnosed Rheumatoid arthritis

          5. Subjects of child bearing potential should be non-lactating and must be practicing an
             acceptable method of birth control as judged by the Investigator

        Exclusion Criteria:

          1. Subjects who are pregnant or intend to become pregnant during the study

          2. Subject with positive hepatitis panel and / or anti-hepatitis B core antibodies, and /
             or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency
             virus (HIV) antibody.

          3. Known sensitivity to any component of the study drug or previous hypersensitivity
             reaction or other clinically significant reaction to IV medications, biologic therapy
             or IV radiocontrast agents.

          4. Active infection requiring systemic treatment

          5. Planned surgery during the study period or had undergone major surgery within the 60
             Days prior to the Screening visit.
A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: oseltamivir; placebo
Intervention description: Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days; Placebo matched to oseltamivir po twice daily for 10 days
Intervention MeSH terms: Oseltamivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      This 2-arm study will investigate the safety and tolerability of oseltamivir for the
      treatment of influenza in immunocompromised participants and characterize the effects of
      oseltamivir in immunocompromised participants on the development of resistant influenza
      virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be
      randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily
      orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po
      depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken,
      and safety evaluations made, at intervals during the study. The anticipated time on study
      medication is 10 days and the anticipated time on study is 40 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours
             prior to first dose

          -  Immunocompromised participants with primary or secondary immunodeficiency

          -  Symptoms suggestive of influenza-like illness

          -  Use of an effective contraceptive, as specified by protocol; women of childbearing
             potential cannot be pregnant or breastfeeding

        Exclusion Criteria:

          -  Influenza vaccination with live attenuated vaccine in the 2 weeks prior to
             randomization

          -  Antiviral treatment for influenza in 2 weeks prior to randomization

          -  Severe hepatic impairment

          -  Any current renal replacement therapy

          -  Any gastrointestinal disorders which may interfere with the absorption of oseltamivir

          -  Participation in a study with an investigational drug from 4 weeks prior to study
             start until study end