bioihbjkbjnl/mcl2 huggingface dataset:
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: PRO-067; GAAP Ofteno®
Intervention description: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.; 1 drop QD during 30 days Active comparator, reference medication.
Intervention MeSH terms: Latanoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Latanoprost; Glaucoma; Ocular hypertension; Crossover study

Summary:

      Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by
      Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensive
      therapy in subjects with primary open angle glaucoma or ocular hypertension.

      Study design: a multicentric, prospective, crossover (2x2), double blind clinical study.
      Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.
      Patients in the period 1: In the first sequence 60 patients will be assigned to receive the
      ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop per day (QD) during 30 days
      and the second sequence 60 patients will be assigned to receive the ophthalmic solution:
      PRO-067 1 drop QD during 30 days in the same period. Washout period: 21 hours. Patients in
      the period 2: the pharmacological intervention change to the opposite therapy for 30 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male

          -  Age: ≥18 years old

          -  Patients with primary open angle glaucoma with mild to moderate damage or ocular
             hypertension that were sufficiently controlled with GAAP Ofteno® (latanoprost 0.005%)
             within the last 60 days

          -  Signed Informed Consent Form

        Exclusion Criteria:

          -  Subjects with unique eye

          -  Subjects with visual acuity < 20/200

          -  Another kind of glaucoma disease different to primary open angle glaucoma

          -  corneal disturbances with impossibility to measure the intraocular pressure

          -  retinal alterations without control or progressive retinal disease with high risk to
             lost vision
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
Condition: Keratosis, Actinic
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Tirbanibulin ointment 1%
Intervention description: Applied topically for 5 days over a field of approximately 100 cm^2 on the face or balding scalp with AK.
Intervention MeSH terms: Tirbanibulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety, tolerability and treatment effect of
      tirbanibulin ointment 1% when applied to a field of approximately 100 cm^2 on the face or
      balding scalp.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids,
             and inside nostrils and ears) that measures approximately 100 cm^2 (eg, mid face) and
             contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK)
             lesions within the TF

          -  Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the
             use of tanning beds, to the face or scalp during the study

          -  Ability to understand the purpose and risks of the trial, willingness and ability to
             comply with the protocol, and provided written informed consent in accordance with
             institutional and regulatory guidelines

        Exclusion Criteria:

          -  Presence in the TF of

               1. Clinically atypical and/or rapidly changing AK lesions in the TF

               2. Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on
                  2 previous occasions) and/or cutaneous horn

               3. Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria)

               4. History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell
                  carcinoma (BCC), or other malignant tumors in the TF

               5. Any other dermatological disease that causes difficulty with examination

          -  Previous treatment with tirbanibulin ointment 1%.

          -  Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day
             57

          -  Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic
             therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8
             weeks prior to the Screening visit

          -  Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months
             prior to the Screening visit
Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks); Placebo (prefilled syringe, weekly IV administration)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225
      mg of Rapastinel compared to placebo in the prevention of relapse in participants with major
      depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria: -

          -  Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test

        Exclusion Criteria: -

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

          -  1.Schizophrenia spectrum or other psychotic disorder

          -  2.Bipolar or related disorder

          -  3.Major neurocognitive disorder

          -  4.Neurodevelopmental disorder of greater than mild severity or of a severity that
             impacts the participant's ability to consent, follow study directions, or otherwise
             safely participate in the study

          -  5.Dissociative disorder

          -  6.Posttraumatic stress disorder

          -  7.MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator
Collection of Bone Marrow From Donors Treated With or Without Filgrastim
Condition: Healthy Stem Cell Donor; No Evidence of Disease
Intervention: Bone Marrow Donation; Filgrastim; Laboratory Biomarker Analysis
Intervention description: Undergo bone marrow harvest; Given subcutaneously; Optional correlative studies
Intervention MeSH terms: Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This randomized clinical trial is studying the side effects of collection of bone marrow from
      donors treated with or without filgrastim. Giving colony-stimulating factors, such as
      filgrastim (G-CSF), to donors helps the stem cells move from the bone marrow to the blood so
      they can be collected and stored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Appropriately human leukocyte antigen (HLA)-matched (HLA, A, B, DRB1 identical or
             antigen mismatched [i.e., 5/6 or 6/6 antigens matched]) sibling of the bone marrow
             recipient enrolled on COG-ASCT0631

          -  Adequate size relative to the recipient (i.e., harvesting the maximum of 20 cc/kg from
             the donor would result in a bone marrow graft that will provide an adequate cell and
             volume dose to the recipient, in the opinion of the treating physician)

          -  Enrolled on the COG Umbrella Long-Term Follow-Up Study COG-ALTE05N1

          -  Not pregnant or nursing

          -  No human immunodeficiency virus (HIV) positivity

          -  No sickle cell trait or sickle cell anemia/disease

          -  Not at an increased risk from bone marrow donation after filgrastim administration due
             to a pre-existing medical condition, as determined by an independent physician
             separate from the research team

          -  None of the following:

               -  Active infection, especially pulmonary

               -  Splenomegaly or a history of splenic injury

               -  Active or recent pulmonary disease (i.e., pneumonia within the past 4 weeks)

               -  A condition that would make the donor unsuitable to donate, as determined by an
                  independent physician separate from the research team

          -  No autoimmune disease
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL
Intervention description: SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC)
      for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

          -  Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)

          -  HCV treatment-naive or treatment-experienced

          -  Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to
             exclude hepatocellular carcinoma (HCC)

        Key Exclusion Criteria:

          -  Current or prior history of clinically-significant illness (other than HCV),
             gastrointestinal disorder, clinical hepatic decompensation, or post-operative
             condition that could interfere with the absorption of the study drug

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of a non HCV etiology

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661 Plus Ivacaftor Combination; Ivacaftor; VX-661 Plus Ivacaftor Combination Placebo; Ivacaftor placebo
Intervention description: FDC tablet, oral use; Tablet, oral use; FDC tablet, oral use; Tablet, oral use
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 510.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Homozygous for the F508del CFTR Mutation

Summary:

      This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter
      study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane
      conductance regulator (CFTR) gene mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del CFTR mutation, genotype to be confirmed at the Screening
             Visit

          -  Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative
             pilocarpine iontophoresis

          -  Forced expiratory volume at one second (FEV1) ≥40% and ≤90% of predicted normal for
             age, sex, and height during screening

          -  Stable CF disease as judged by the investigator

          -  Willing to remain on a stable CF medication regimen through Week 24 or, if applicable,
             the Safety Follow up Visit

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
             (first dose of study drug)

          -  Pregnant or nursing females (females of childbearing potential must have a negative
             pregnancy test at Screening and Day 1)

          -  Sexually active participants of reproductive potential who are not willing to follow
             the contraception requirements
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
Condition: Epilepsy; Partial-onset Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide
Intervention description: Strength: Lacosamide (LCM) 50 mg, LCM 100 mg
Formulation: Tablet
Frequency: twice daily during the study period (until the date of approval)
At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 473.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Lacosamide; Epilepsy; Partial-onset Seizures

Summary:

      The purpose of this trial is to evaluate the safety and tolerability of long-term
      administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with
      Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]

        Exclusion Criteria:

          -  Subjects who withdrew from EP0008 [NCT01710657]
A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide
Intervention description: Injected subcutaneously s.c. (under the skin) once daily.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 635.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety
      of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Japanese subjects at least 20 years of age at the time of informed
             consent

          -  Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to
             screening

          -  HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)

          -  Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is
             defined as unchanged medication and unchanged dose) for for at least 60 days before
             screening according to approved Japanese labelling

        Exclusion Criteria:

          -  Treatment with insulin within 12 weeks prior to screening

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 60 days before screening

          -  Screening calcitonin equal or above 50 ng/l

          -  History of pancreatitis (acute or chronic)

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia type 2 (MEN 2)

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV

          -  Within the past 180 days any of the following: myocardial infarction, stroke or
             hospitalisation for unstable angina and/or transient ischemic attack

          -  Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous
             cell skin cancer, polyps and in-situ carcinomas)

          -  Any condition which, in the opinion of the investigator might jeopardise subject's
             safety or compliance with the protocol
16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab; Placebo secukinumab
Intervention description: AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).; Placebo to AIN457 (Secukinumab)
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection

Summary:

      The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year
      efficacy, safety and tolerability data in subjects with active AS despite current or previous
      NSAID, DMARD and/or anti-TNF therapy.
    

Eligibility criteria:

        Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the
        Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria:
        pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI,
        previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any
        biological immunomodulating agent excluding TNF antagonists, previous cell depleting
        therapy.
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
Condition: HIV
Intervention: Atazanavir Sulphate; Ritonavir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 3 Months
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Pediatric

Summary:

      The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a
      regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse
      transcriptase inhibitor in pediatric patients aged ≥3 months to <11 years.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria:

          -  Confirmed HIV-1 infection diagnosed by protocol criteria

          -  Screening HIV RNA level ≥1000 copies/mL

          -  ≥3 months to <11 years of age at time of first treatment

          -  Antiretroviral-naive or -experienced

          -  At screening, all participants must have genotypic sensitivity to atazanavir and at
             least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved
             for pediatric use at the local country.

          -  Antiretroviral-experienced patients must also have documented phenotypic sensitivity
             at screening to atazanavir (Fold Change in susceptibility <2.2) and to at least 2
             NRTIs that are approved in their country

        Key Exclusion Criteria:

          -  Experienced participants who received atazanavir or atazanavir/ritonavir at any time
             prior to study enrollment or who have a history of 2 or more protease inhibitor
             failures

          -  Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to
             study medications

          -  Cardiac rhythm abnormalities

          -  Need for tenofovir

          -  Weight <5 or ≥35kg

          -  >Grade 2 abnormality in aspartate transaminase/alanine transaminase levels

          -  Coinfection with either hepatitis B or C virus

          -  Any active Centers for Disease Control and Prevention Category C clinical condition