bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Phase 3 Long-Term Safety Study of Migalastat
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: migalastat hydrochloride
Intervention description: Oral capsule QOD
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat

Summary:

      This was a long-term, open-label study of migalastat (123 milligrams [mg] of migalastat
      [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) in participants with Fabry
      disease who completed treatment in a previous monotherapy trial with migalastat.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed migalastat treatment in a previous Fabry disease protocol

          -  Both male and female participants were enrolled

          -  Age 16 years or older

          -  Male and female participants had to agree to use protocol-identified acceptable
             contraception

        Exclusion Criteria:

          -  Estimated glomerular filtration rate (eGFR) in the previous study was <30
             milliliters/minute/1.73 square meters (mL/min/1.73 m^2) unless there was a measured
             GFR available within 3 m of the Baseline Visit that was >30 mL/min/1.73 m^2

          -  Had undergone, or was scheduled to undergo, kidney transplantation or was currently on
             dialysis

          -  Pregnant or breast feeding

          -  Treated with another investigational drug (except migalastat) within 30 days of study
             start

          -  Unable to comply with study requirements, or deemed otherwise unsuitable for study
             entry, in the opinion of the investigator

          -  Had documented transient ischemic attack, stroke, unstable angina, or myocardial
             infarction within the 12 m before the Baseline Visit

          -  Had clinically significant, unstable cardiac disease in the opinion of the
             investigator

          -  Had a history of allergy or sensitivity to migalastat (including excipients) or to
             other iminosugars

          -  Required treatment with Glyset (miglitol) or Zavesca (miglustat)

          -  Had any intercurrent illness or condition that may have precluded the participant from
             fulfilling the protocol requirements

          -  Had a severe or unsuitable concomitant medical condition

          -  Had a clinically significant abnormal laboratory value and a clinically significant
             electrocardiogram finding at the Baseline Visit.
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Condition: Epilepsy; Partial Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam
Intervention description: First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Intervention MeSH terms: Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Keppra; Levetiracetam; Children; Epilepsy; Partial Seizures

Summary:

      Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses
      up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese
      pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with
      1 or 2 anti-epileptic drug(s).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6
             months

          -  The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4
             weeks prior to Baseline and must have at least 8 partial seizures during the 8-week
             prospective Baseline Period

          -  Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

        Exclusion Criteria:

          -  The patient has a treatable seizure etiology

          -  The patient has Epilepsy secondary to a progressive cerebral disease or any other
             progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner
             diseases

          -  The patient has a history of status Epilepticus during the 3 months prior to Visit 1

          -  The patient has a past and present history of pseudo seizures

          -  The patient has a current diagnosis of Lennox-Gastaut syndrome
Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression
Condition: Covid19; Progression
MeSH terms: COVID-19; Disease Progression
Intervention: HCQ
Intervention description: Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization rules were designed by Dr. Wasim Alamgir together with principal investigators and implemented by an independent statistician who was not involved in data analysis. Stratified random sampling was applied to stratify all eligible patients according to age, gender and comorbidities. Computerized random number generator was used and allocation was done in 2:1 sequence. Cards with each group assignment number randomly generated by computer were placed in sequentially numbered envelopes that were opened as the patients were enrolled
Masking: None (Open Label)
Masking description: Neither patients, nor investigators, nor statisticians were masked to treatment assignment. Lab staff who performed sampling for PCR, basic blood tests and other routine measurement were unaware of treatment information.
Enrollment: 540.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COVID-19; viral clearance; , mild infection; disease progression; trial; HCQ

Summary:

      Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in
      reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.

      Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate
      Phase: Phase III
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild Corona virus disease (COVID-19)

          -  PCR confirmed infection

          -  Hospital admitted patients

        Exclusion Criteria:

          -  Moderate, severe and critical COVID-19

          -  day 0 CRP greater than 6mg/dl, ALC < 1000 or evidence of infiltrates on X-ray chest

          -  comorbidity with life expectancy less than 6 months

          -  Contraindications to HCQ therapy
A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8mg/kg iv every 4 weeks for 24 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, open label study will assess the safety and efficacy, with regard to
      reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to
      severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4
      weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the
      study may continue with their treatment together with tocilizumab.The anticipated time on
      study treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients,>=18 years of age;

          -  rheumatoid arthritis diagnosed >8 weeks and <4 years prior to baseline;

          -  naive to, or not responding well to, methotrexate;

          -  swollen joint count >=8 (66 joint count) and tender joint count>=8 (68 joint count) at
             screening and baseline.

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than rheumatoid arthritis;

          -  patients with functional class IV rheumatoid arthritis;

          -  history of, or current, inflammatory joint disease other than rheumatoid arthritis, or
             other systemic autoimmune disorder.
Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin (MK0431); Sitagliptin; Placebo; Placebo; Metformin - Rescue
Intervention description: Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.; Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.; Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.; Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.; Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 741.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to determine the safety and efficacy of an
      investigational drug in patients with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes mellitus

          -  Patient is not pregnant or breastfeeding

          -  Male or female patient unlikely to conceive

          -  Patient not on an antihyperglycemic drug

        Exclusion Criteria:

          -  Patient has history of type 1 diabetes mellitus

          -  Patient has history of ketoacidosis

          -  Patient requires insulin within 8 weeks prior to start of study

          -  Patient on weight loss program and is not in maintenance phase

          -  Patient taking weight loss medication within 8 weeks prior to start of study

          -  Patient on or likely to require = 14 days or repeated courses of corticosteroids

          -  Patient taking immunosuppressive/immunomodulating medication

          -  Patient taking digoxin or other cardiac medication

          -  Patient has undergone surgical general anesthesia within 30 days prior to start of
             study

          -  Patient taking investigational drug within 8 weeks prior to start of study

          -  Patient is diagnosed with liver disease

          -  Patient has chronic myopathy, progressive neurological/neuromuscular disorder

          -  Patient has with severe cardiac conditions within the last 6 months

          -  Patient is Human immunodeficiency virus (HIV) positive

          -  Patient has hematological disorder

          -  Patient has history of malignancy

          -  Patient has history of alcohol or drug abuse within the past 3 years
Antibiotic Study for Dental Implants
Condition: Periodontitis
MeSH terms: Periodontitis; Peri-Implantitis
Intervention: Minocycline HCl
Intervention description: 1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial
Intervention MeSH terms: Anti-Bacterial Agents; Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Peri-implantitis; antibiotic

Summary:

      This study is for people at least 21 years old who have signs of problems, like swollen gums
      and shrinking bones, by dental implants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 years of age and good general health

          -  appropriately documented Informed Consent

          -  willing to adhere to the study schedule, prohibitions and restrictions specified in
             the protocol

          -  female subjects must meet the pregnancy and contraceptive requirements

          -  must have oral health appropriate for study inclusion

        Exclusion Criteria:

          -  oral health inappropriate for study inclusion

          -  females self-reporting pregnancy or lactation, or having a positive urine pregnancy
             result

          -  reporting any of the following conditions:

          -  allergy to a tetracycline-class drug

          -  systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental
             procedures

          -  active systemic infectious disease such as hepatitis, human immunodeficiency virus
             (HIV) or tuberculosis

          -  diagnosed with clinically significant or unstable organic disease, or compromised
             healing potential, heart murmurs, histories of rheumatic fever, valvular disease or
             prosthetic joint replacement

          -  participation in a dental clinical trial or use of an investigational drug within 30
             days of enrollment

          -  employees of the Investigator or study center, with direct involvement in the proposed
             study or other studies, as well as family members of the employees or the Investigator

          -  anyone who the investigator determines should not be included in the study for any
             reason that could compromise safety or the analysis of study results
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
Condition: Hypercholesterolemia; Atherosclerotic Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: ETC-1002; Placebo
Intervention description: ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided); Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin 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: 2230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; cholesterol; heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL

Summary:

      The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated
      versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is
      not adequately controlled by their current therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C ≥ 70 mg/dL

          -  High cardiovascular risk (diagnosis of HeFH or ASCVD)

          -  Be on maximally tolerated lipid-modifying therapy

        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
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Vaccines, Pneumococcal
Intervention: 13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine; Pentavac
Intervention description: Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.; Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.; The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 613.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Vaccine

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine pediatric vaccines in France.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month-old infants.

          -  Available for the entire study period.

        Exclusion criteria:

        · Known contraindication to vaccines.
PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CT-P10; Rituxan; MabThera
Intervention description: 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion; US-licensed reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion; EU-approved reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 384.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10,
      Rituxan and MabThera in Patients with Rheumatoid Arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is male or female between 18 and 75 years old, inclusive.

          2. Patient has a diagnosis of RA according to the revised 1987 ACR classification
             criteria (Arnett et al 1988) for at least 6 months prior to randomization.

          3. Patient has active disease as defined by the presence of 6 or more swollen joints (of
             66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL
             (≥15 mg/L) or an ESR ≥28 mm/hour.

          4. Patient has experienced an inadequate response to previous or current treatment with
             the anti-TNF agents infliximab

          5. Patient has a proper discontinuation period after treatment with interleukin-1
             receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept.

        Exclusion Criteria:

          1. Patient has taken more than 2 biologic agents.

          2. Patient has previously been administered Rituximab or participated in a Rituximab
             biosimilar study.

          3. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized
             proteins.

          4. Patient has current or past history of chronic infection with hepatitis B, hepatitis
             C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive
             result to the screening test for these infections.

          5. Patient has an infection requiring oral antibiotics 2 weeks before randomization,
             parenteral injection of antibiotics 4 weeks before randomization, other serious
             infection 6 months before randomization, a history of recurrent herpes zoster or other
             chronic or recurrent infection 6 weeks before randomization.
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Condition: HER2-positive Carcinoma of Breast
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab
Intervention description: Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
Intervention MeSH terms: Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 562.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will determine whether CT-P6 and Herceptin are equivalent in patients with
      early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the
      pathologic complete response rate will be equivalent in patients treated with neoadjuvant
      CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to
      10 cycles of therapy in the adjuvant setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who has histologically confirmed and newly diagnosed breast cancer

          -  Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC
             (American Joint Committee on Cancer) Breast Cancer Staging 7th edition

          -  Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC
             (immuno-histochemistry).

        Exclusion Criteria:

          -  Patient who has bilateral breast cancer

          -  Patient who has received prior treatment for breast cancer, including chemotherapy,
             biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any
             prior therapy with anthracyclines.