bioihbjkbjnl/mcl2 huggingface dataset:
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
Condition: Secondary Hyperparathyroidism; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Cinacalcet; Placebo
Intervention description: Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg daily (QD), once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.; Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg QD, once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.
Intervention MeSH terms: Cinacalcet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3883.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cinacalcet HCl; Cinacalcet; AMG 073; Sensipar; Mimpara; Calcimimetic; Hemodialysis; CKD; Secondary hyperparathyroidism (HPT)

Summary:

      The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or
      Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD)
      patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion:≥ 18 years of age

          -  Treated with maintenance hemodialysis - PTH ≥ 300 pg/mL (31.8 pmol/L)

          -  serum calcium ≥ 8.4mg/dL (2.1 mmol/L)

          -  Ca x P ≥ 45 mg2*/dL2 (3.63 mmol2/L2)

        Exclusion Criteria: - Exclusion:

          -  Parathyroidectomy in the 12 weeks before the date of informed consent

          -  Received therapy with cinacalcet within 3 months of randomization

          -  Hospitalization within 12 weeks of randomization for any of the following events: a.
             Myocardial ischemia b. Unstable angina c. Heart Failure (HF) (including any unplanned
             presentation to a health care facility that would require mechanical intervention
             [i.e., unplanned dialysis treatment]) d. Peripheral vascular disease (other than
             dialysis vascular access revision) e. Stroke

          -  History of seizure within 12 weeks prior to randomization

          -  Scheduled date for kidney transplant from a known living donor

          -  Anticipated parathyroidectomy within 6 months after randomization

               -  in all instances, the 2 refers to squared.
A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: ABT-450/ritonavir; ABT-333; ABT-267
Intervention description: ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.; Drug is not administered -- this study is follow-up for participants previously receiving the drug.; Drug is not administered -- this study is follow-up for participants previously receiving the drug.
Intervention MeSH terms: Ritonavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Hepatitis C virus; Direct Acting Antiviral; Sustained Virologic Response; Hepatitis C; Persistence of treatment-emergent substitutions

Summary:

      A follow-up study to assess resistance and durability of response to 3 experimental drugs
      ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3
      clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV).
      Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998
      (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389
      (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and
      M14-103 (NCT01911845).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior
             AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND.

          -  The interval between the last dose of the AbbVie DAA therapy from the previous
             clinical study and enrollment in Study M13-102 must be no longer than 2 years.

          -  The subject must voluntarily sign and date the informed consent form.

          -  Subject completed the post-treatment period of an eligible prior study.

        Exclusion Criteria:

          -  The investigator considers the subject unsuitable for the study for any reasons.

          -  Receipt of any investigational product from Day 1 and while enrolled in this study.
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
Condition: Venous Thromboembolism
MeSH terms: Renal Insufficiency; Thromboembolism; Venous Thromboembolism
Intervention: 15mg DU-176b; 30mg DU-176b; Fondaparinux
Intervention MeSH terms: PENTA; Edoxaban; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: anticoagulant; DU-176b; edoxaban; factor Xa; oral; orthopedic surgery of lower limbs; severe renal impairment

Summary:

      To assess the safety and pharmacokinetics of DU-176b administered to patients with severe
      renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b
      administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of
      the lower limbs.

      For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of
      the lower limbs will be compared with that of fondaparinux.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with SRI or MiRI undergoing orthopedic surgery of the lower limbs

        Exclusion Criteria:

          -  Patients who are on hemodialysis or are scheduled to undergo hemodialysis during the
             study period

          -  Patients who are at a significantly high risk for bleeding or thromboembolism

          -  Patients who are receiving another antithrombotic therapy and are unable to suspend
             the therapy

          -  Patients who have evidence of hepatic function test abnormalities
Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Montelukast Oral Granules (OG); Montelukast Chewable Tablets (CT)
Intervention description: Montelukast 4 mg in one sachet; Montelukast 5 mg in one tablet
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 1 Year
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the
      treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The
      primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets
      (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weight ≥8 kg

          -  Diagnosis of PAR and has symptoms of PAR at Visit 1

        Exclusion Criteria:

          -  Past or present medical history of asthma

          -  Diagosis of acute rhinitis, simple rhinitis, rhinitis congestive, rhinitis atrophic,
             sinusitis with purulent nasal discharge, rhinitis medicamentosa or nonallergic
             rhinitis (e.g. vasomotor rhinitis, eosinophilic rhinitis)

          -  Started hyposensitization therapy or non-specific immunotherapy within 6 months prior
             to Visit 1

          -  Medical history of inferior concha mucosal resection, submucous resection of inferior
             turbinates or other surgery aimed at reduction and/or modulation of nasal mucosa
             (including electrocoagulation, cryoextraction or application of trichloroacetic acid)

          -  Clinically significant, active disease of the cardiovascular or hematologic systems or
             uncontrolled hypertension (1 to 5 year olds: >120/70 mmHg; 6 to 9 year olds: >130/80
             mmHg; 10 to 15 year olds: >140/85 mmHg)

          -  Medical history of stunted growth

          -  Serious drug allergy

          -  Treated with other clinical study drug within 3 months prior to Visit 1
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Condition: Lymphoma; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone; Dexamethasone (Oral); Dexamethasone (IV); Elotuzumab (BMS-901608; HuLuc63)
Intervention description: Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug; On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug.
On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug; On weeks without Elotuzumab dosing: Not Applicable (N/A)
On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Elotuzumab; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 646.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether the addition of Elotuzumab to
      Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Documented progression from most recent line of therapy

          -  1-3 prior lines of therapy

          -  Measurable disease

          -  Life expectancy ≥3 months

          -  Prior treatment with Lenalidomide permitted if:

               1. Best response achieved was ≥Partial Response (PR)

               2. Patient was not refractory

               3. Patient did not discontinue due to a Grade ≥3 related adverse event

               4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9
                  months between the last dose of Lenalidomide and progression

        Exclusion Criteria:

          -  Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma

          -  Active plasma cell leukemia

          -  Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Japanese Encephalitis purified inactivated vaccine (IC51); Placebo
Intervention description: IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28; Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2675.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine
      IC51 with an inactive control in healthy subjects aged > or = 18 years
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Written informed consent obtained prior to study entry

        Exclusion Criteria:

          -  Use of any other investigational or non-registered drug or vaccine in addition to the
             study vaccine during the study period or within 30 days preceding the first dose of
             study vaccine

          -  History of any previous JE vaccination (e.g. JE-VAX®)

          -  Immunodeficiency including post-organ-transplantation or immunosuppressive therapy

          -  A family history of congenital or hereditary immunodeficiency

          -  History of autoimmune disease

          -  Any acute infections within 2 weeks prior to enrollment

          -  Known or suspected HIV Infection

          -  Pregnancy, lactation or unreliable contraception in female subjects
Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Condition: Herpes Simplex Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Intervention: Zicam (Ionic zinc); placebo
Intervention description: 33mmol/l of ionic zinc; placebo swab
Intervention MeSH terms: Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cold sores; Zinc; HSL; Herpes simple labialis

Summary:

      Evaluate the effectiveness of a topical preparation of zinc to treat cold sores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a history of HSL with at least 2 episodes/year for the past two years
             that have proceeded beyond the prodromal (initial) stage

          -  Male or female subjects between 18 and 65 years of age

          -  Symptoms or signs of HSL for less than one day (max. 36 hours from onset of symptoms
             to first visit)

          -  Confirmation of HSL by a clinician at the study site

          -  Willing to comply with study instructions and sign an informed consent

        Exclusion Criteria:

          -  HSL symptoms or signs for more than one day

          -  Cold sore outbreak within the past 2 weeks

          -  Previous participation in this clinical trial

          -  Topical or oral antiviral drug use in the past 1 week

          -  Immune deficiency (HIV positive), chronic steroid therapy, present anti-neoplastic or
             radiation therapy, Hodgkin's disease, splenectomy, leukemia, myeloma, lymphoma, or
             another condition/drug per judgment of attending health care professional) or
             currently taking immune suppressive drugs. Previous organ or bone marrow transplant.

          -  Pregnancy or lactation

          -  Unable to travel to the clinic area for the required visits

          -  Apparent inability to understand or follow the instructions associated with the
             clinical study

          -  History of adverse events to the study material or facial cosmetics
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Bepotastine besilate; Placebo
Intervention description: Two TAU-284 5mg tablets will be taken orally twice a day; Two Placebo tablets will be taken orally twice a day
Intervention MeSH terms: Bepotastine besilate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 473.0
Sex: All
Minimum age: 7 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: TAU-284; Bepotastine besilate; Histamine H1 receptor antagonists; children

Summary:

      The objectives of this study are: to confirm the superiority of TAU-284 over placebo after
      two weeks of administration to pediatric patients with perennial allergic rhinitis and to
      investigate safety of TAU-284.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged between 7 and 15 years

          -  Patients who have received a diagnosis of perennial allergic rhinitis according to the
             diagnostic criteria

          -  Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the
             basis of symptoms recorded in the nasal allergy diary during the observation period
             etc.

        Exclusion Criteria:

          -  Patients with vasomotor rhinitis or eosinophilic rhinitis

          -  Patients who have concurrent nasal disease that may affect the efficacy of TAU-284

          -  Patients with a history of any of the nasal surgical procedures

          -  Patients who have a positive result for pollen antigens which are dispersed during the
             study period

          -  Patients who have a positive result for dog dander or cat dander antigen and have a
             chance to touch dogs or cats.

          -  Patients with current or previous history of drug allergy

          -  Patients who concurrently have renal function abnormalities that may cause safety
             problems etc.
Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis
Condition: Strongyloides Stercoralis Infection
MeSH terms: Infections; Strongyloidiasis
Intervention: Moxidectin 2 mg; Ivermectin 3 mg; Placebo
Intervention description: Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.; Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.; Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
Intervention MeSH terms: Ivermectin; Moxidectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel study with 2 treatment arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded (Participant and Care provider) Additionally, the principal investigator and the statistician will be blinded.
PK substudy is single-blinded (Participant)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study is an extension to the study StrongMoxi NCT04056325 and entails modifications based
      on the outcome of NCT04056325 part A.

      The study is a phase 3, double-blinded and randomized clinical trial conducted in Cambodia.
      It aims at providing evidence on efficacy, safety and pharmacokinetic measures of 8 mg of
      moxidectin compared to 200 μg/kg ivermectin in adults infected with S. stercoralis. The
      efficacy of the treatment will be assessed by collecting three stool samples once
      per-treatment and once 21-28 days post-treatment. The stool samples will be analyzed by a
      quantitative duplicate Baermann assay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (18-65 years)

          -  Infected with S. stercoralis (positive)

          -  Absence of major systemic illnesses

          -  Written informed consent

        Exclusion Criteria:

          -  Any abnormal medical conditions or chronic disease

          -  Negative diagnostic result for S. stercoralis

          -  No written informed consent by the individual.

          -  Pregnant and lactating women.

          -  Recent use of an anthelmintic drug (within past 4 weeks)

          -  Attending other clinical trials during the study

          -  Known allergy to study medications (i.e. moxidectin, ivermectin)

          -  Currently taking medications with known interaction (i.e. for warfarin)