bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide
Intervention description: Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism

Summary:

      This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on
      serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG
      416).
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject is 18 years of age or older at the time of informed consent.

          -  Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8
             weeks.

          -  Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory
             screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with
             measurements obtained from 3 different calendar weeks in the 4-week screening period
             while receiving cinacalcet.

          -  Subject must have a mean of 3 consecutive central laboratory screening predialysis
             serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3
             different calendar weeks in the 4-week screening period while receiving cinacalcet.

          -  Subject must be on a stable dose of cinacalcet before screening (defined as no dose
             change within the 4 weeks prior to screening).

          -  Other Inclusion Criteria may apply.

        Exclusion Criteria

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 30 days since ending treatment on another investigational device or drug
             study(s).

          -  Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as
             KAI-4169).

          -  Subject has known sensitivity to any of the products or components of AMG 416 to be
             administered during dosing.

          -  Subject is unwilling to use effective contraception during the study, and for women,
             up to a period of up to 3 months after the last dose of AMG 416.

          -  Subject is pregnant or nursing.

          -  Anticipated or scheduled parathyroidectomy during the study period.

          -  Subject has received a parathyroidectomy within 6 months prior to dosing.

          -  Other Exclusion Criteria may apply.
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: SOF; RBV; Peg-IFN
Intervention description: SOF 400 mg tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); Peg-IFN 180 μg administered once weekly by subcutaneous injection
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 534.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 2 (GT-2); HCV genotype 3 (GT-3); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; Ribavirin; Open Label

Summary:

      This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977)
      in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults
      with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study
      and have not achieved sustained virologic response (SVR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infection with HCV

          -  Must have participated in a prior Gilead HCV study

          -  Use of highly effective contraception methods if female of childbearing potential or
             sexually active male

          -  Eligible patients include those in the following

               -  received placebo or Peg-IFN+RBV in a control arm

               -  previously participated in a Gilead-sponsored HCV study and did not attain
                  sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on
                  a regimen containing:

                    -  Sofosbuvir+RBV

                    -  Peg-IFN and/or RBV in combination with one or more Gilead investigational
                       direct-acting agents

        Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Current or prior history of clinical hepatic decompensation

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Chronic use of systemically administered immunosuppressive agents

          -  Active drug abuse

          -  Use of any prohibited concomitant medications
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
Condition: Hepatitis B Virus Infection
MeSH terms: Hepatitis A; Hepatitis B; Herpesviridae Infections; Hepatitis
Intervention: Comparator: modified process hepatitis B vaccine; Comparator: ENGERIX-B™
Intervention description: Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.; ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis B virus

Summary:

      To describe the immunogenicity and safety of modified process hepatitis B vaccine
      administered to renal predialysis and dialysis patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects at least 18 years of age

          -  Laboratory confirmed negative serology result to HbsAg (hepatitis b virus), anti-HBs
             (antibody to hepatitis B surface antigen), and anti HBc (antibody to hepatitis B core
             antigen) within 6 weeks of the initial dose of study vaccine

          -  Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of
             <=30 ml/min

        Exclusion Criteria:

          -  Previous hepatitis B infection, vaccination with any hepatitis B vaccine

          -  Recent febrile illness; hypersensitivity to any component of licensed hepatitis B
             vaccines

          -  Recent administration of immune globulin, licensed inactivated vaccine within 14 days
             or licensed live vaccine within 30 days prior to receipt of first study vaccine

          -  Receipt of investigational drugs or investigational vaccines within 3 months prior

          -  Impairment of immunologic function

          -  Recent use of systemic immunomodulatory medications

          -  Pregnant women, nursing mothers or women planning to become pregnant
Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Intervention: Polyethylene Glycol afternoon; Polyethylene Glycol morning
Intervention description: Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM; Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 136.0
Sex: All
Healthy volunteers: No
Keywords: Afternoon colonoscopy; Morning; Evening; Bowel Preparation; Efficacy; Satisfaction

Summary:

      The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon
      colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day
      of the colonoscopy will be compared with that given on the morning of an afternoon
      colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are
      blinded to the randomization process.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are
             willing to get the procedure done in the afternoon.

        Exclusion Criteria:

          -  Colonoscopy is contraindicated

          -  Prior Colectomy or colon surgery.
Diabetes Prevention Program Outcomes Study
Condition: Diabetes Mellitus; Cancer; CVD
MeSH terms: Diabetes Mellitus
Intervention: DPPOS Group Lifestyle; Metformin; DPPOS Boost Lifestyle; Intensive Lifestyle Group Session
Intervention description: Quarterly group lifestyle sessions; Administered as 850mg twice per day, masked in DPP and open label in DPPOS; In addition to quarterly group, 2 additional classes per year and an annual 15 minute check-up.; 16 session curriculum in group format. In DPP delivered to ILS as individual sessions
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open label phase for metformin
Enrollment: 2779.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: DPP; IGT; Prediabetes; Type 2 diabetes; Macrovascular disease; Microvascular disease; Lifestyle; Metformin; Obesity

Summary:

      The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an
      intensive lifestyle or metformin to prevent or delay the development of diabetes in a high
      risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of
      140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset
      by 58% and metformin reduced diabetes onset by 31%.

      DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable
      DPP participants. This group of participants is nearly 50% minority and represents the
      largest at risk population ever studied. Clinically important research questions remain that
      focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course
      of precisely known new onset diabetes, in particular regarding microvascular disease, CVD
      risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in
      minority populations.

      The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of
      the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and
      high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend
      annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on
      cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and
      import.
    

Eligibility criteria:

        Participation as a volunteer in the Diabetes Prevention Program (DPP).
To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; glimepiride; liraglutide; placebo; placebo; placebo
Intervention description: 1.8 mg for s.c. (under the skin) injection; 8 mg capsule; 1.2 mg for s.c. (under the skin) injection; Glimepiride placebo, 8mg capsule; Liraglutide placebo, 200 mcl; Liraglutide placebo, 300 mcl
Intervention MeSH terms: Liraglutide; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 746.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in North America (the United States of America (USA) and Mexico).

      The trial is designed to evaluate the effects of treatment with liraglutide versus
      glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind
      trial period plus a 52-week open-label extension (week 104) followed by an additional
      156-week continued open-label extension. The total duration of the treatment period is
      planned to be 260 weeks (5 years).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  TTreatment with diet/exercise or with not more than half maximal dose of oral
             anti-diabetic drugs alone for at least 2 months

          -  Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive

          -  OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%,
             inclusive

          -  Body Mass Index (BMI) less than or equal to 45 kg/m^2

        Exclusion Criteria:

          -  Treatment with insulin for the last 3 months, except short-term treatment for
             intercurrent illness

          -  Treatment with any drug that could interfere with the glucose level (besides use of a
             single anti-diabetic compound)

          -  Any serious medical condition
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Condition: Heart Diseases; Arrhythmia; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Heart Diseases
Intervention: THERMOCOOL® SMARTTOUCH™ Catheter
Intervention description: AF Ablation
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Summary:

      The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL®
      SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug
      refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology
      mapping and RF procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had at least 3 atrial fibrillation episodes within 6 months of this study

          -  Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation
             episodes

          -  18 years of age or older

        Exclusion Criteria:

          -  Have had previous ablation for atrial fibrillation

          -  Have take amiodarone within 6 months of this study

          -  Have had any heart surgery within the last 60 days

          -  Have had a heart attack within the last 60 days

          -  Females who are pregnant or breast feeding
Confocal Endomicroscopy for Barrett's Esophagus
Condition: Barrett's Esophagus; Esophageal Adenocarcinoma
MeSH terms: Adenocarcinoma; Barrett Esophagus
Intervention: confocal laser endomicroscopy (CLE); standard endoscopy (EGD)
Intervention description: Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.; Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Barrett's esophagus; Esophageal adenocarcinoma; Endoscopy; Confocal laser endomicroscopy

Summary:

      The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve
      detection of Barrett's esophagus, dysplasia, and early esophageal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Barrett's esophagus or suspected Barrett's-associated neoplasia

          -  Age > 18

          -  Able to give informed consent

        Exclusion Criteria:

          -  Known advanced malignant disease

          -  Allergy to the fluorescent contrast agent fluorescein sodium

          -  Coagulopathy or bleeding disorder
Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®
Condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Intravenous (IV) infusions
Intervention description: Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses
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: 60 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, parallel arm, double-blind study with a total duration of
      subjects' participation of 48 weeks. Approximately 260 participants with relapsing-remitting
      multiple sclerosis will be randomized to receive 12 doses of either PB006 or EU-licensed
      Natalizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients (age ≥18 to 60 years), with relapsing-remitting multiple
             sclerosis (RRMS) defined by the 2010 revised McDonald criteria

          -  At least 1 documented relapse within the previous year and either ≥1 GdE T1-weighted
             brain lesions or ≥9 T2-weighted brain lesions at Screening

          -  Kurtzke Expanded Disability Status Scale (EDSS) score from 0 to 5 (inclusive) at
             Screening

        Exclusion Criteria:

          -  Manifestation of multiple sclerosis (MS) other than relapsing-remitting multiple
             sclerosis (RRMS)

          -  Relapse within the 30 days prior Screening and until administration of the first dose
             of study drug

          -  Prior treatment with natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab,
             cladribine, or other B- and T-cell targeting therapies

          -  Prior total lymphoid irradiation or bone marrow or organ transplantation

          -  Patients with John Cunningham Virus (JCV) index >1.5 at Screening

          -  Past or current Progressive Multi-focal leukoencephalopathy (PML) diagnosis

          -  Severe renal function impairment as defined by serum creatinine values >120 micromol
             per litre
Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Meniscal Allograft
Intervention description: Meniscal allograft
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: allograft; great toe

Summary:

      Using the concept of an implant acting as a spacer and stabilizer, the proposed study will
      evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of
      the great toe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  symptomatic of stage 3 osteoarthritis of the great toe

          -  symptoms recalcitrant to nonoperative management as determined clinically by the
             principal investigator

        Exclusion Criteria:

          -  diabetes mellitus

          -  kidney insufficiency

          -  oa in the adjacent joints

          -  malignancy with in the past 10 yrs

          -  minors (< 18 yrs of age)

          -  pregnant women and fetus

          -  mentally disabled or cognitively impaired individuals
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone propionate; fluticasone propionate/salmeterol
Intervention description: fluticasone propionate 100mcg HFA; fluticasone propionate/salmeterol 100/50mcg HFA
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 351.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: asthma; fluticasone propionate; children; fluticasone propionate/salmeterol

Summary:

      This study is to assess the safety of an investigational drug in children 4 to 11 years of
      age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in
      the morning, and have lung function tests performed.
    

Eligibility criteria:

        Inclusion criteria:

          -  Must have asthma.

          -  Must be currently taking an inhaled corticosteroid.

          -  Must be able to attend 7 clinic visits, of which up to 3 will be in the morning, and
             have lung function tests that are at least 60% of normal (AM FEV1 or PEF).

          -  Have a historical or current FEV1 or PEF reversibility of >=12%.

        Exclusion criteria:

          -  Has ever had life-threatening asthma (for example respiratory arrest, mechanical
             ventilation).

          -  Has a current ear or respiratory tract infection.

          -  Has ever had any other major illnesses (such as cystic fibrosis, heart problems,
             tuberculosis).