bioihbjkbjnl/mcl2 huggingface dataset:
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
Condition: Ureter Injury
Intervention: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%; Saline spray
Intervention description: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium
      0.8% Solution for injection provides a visualization advantage compared to saline when used
      as an aid in the determination of ureteral patency
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between ≥ 18 and ≤ 85 years old.

          -  Subjects who signed written, IRB approved, informed consent form.

          -  Subjects scheduled for urological or gynecological surgical procedures in which the
             patency of the ureter must be assessed by the surgeon during the procedure

        Exclusion Criteria:

          -  Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30
             mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only
             1 kidney.

          -  Subjects with known severe hypersensitivity reactions to IC or other dyes including
             contrast agents.

          -  Known history of drug or alcohol abuse within 6 months prior to the time of screening
             visit.

          -  Subjects, as assessed by the Investigator, with conditions/concomitant diseases
             precluding their safe participation in this study (e.g. major systemic diseases).

          -  Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is
             uncooperative or has a condition that could lead to non-compliance with the study
             procedures.

          -  Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist,
             study coordinator, other staff or relative thereof directly involved in the conduct of
             the protocol;

          -  Subjects with life expectancy < 6 months;

          -  Requirement for concomitant treatment that could bias primary evaluation.

          -  Subjects who are pregnant or breast-feeding.
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Epiduo/Tactuo; vehicle gel; doxycycline 200mg; Isotretinoin
Intervention description: topical to the face, once daily in the evening; topical to the face, once daily in the evening; oral, 2 capsules once daily in the morning with aglass of water and with food; oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
Intervention MeSH terms: Doxycycline; Isotretinoin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 266.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group
      comparison study in subjects with severe acne vulgaris on the face.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject of any race, aged 12 to 35 years inclusive

          2. Subject weighing between 50 and 110 kg

          3. Subject with severe acne (IGA at least 4), which in the opinion of the investigator is
             appropriate for treatment with oral isotretinoin (severe nodular acne, severe
             inflammatory acne, recalcitrant acne; all unresponsive to conventional first line
             therapies)

          4. Subject with at least 5 nodules on the face

        Exclusion Criteria:

          1. Subject with clinically abnormal results to blood testings performed at screening

          2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced
             acne, etc.), pyoderma faciale, sinus tracks

          3. Female subject who is pregnant, nursing or planning a pregnancy during the study

          4. Subject with known history of hepatic and/or renal insufficiency, to be confirmed by
             blood testings

          5. Subject with known metabolic or structural bone disease (for 12-17 years old
             population)

          6. Subject with bowel disease and/or with hypervitaminosis A

          7. Subject who presents with treated or untreated depression or has a history of
             depression including a family history of major depression

          8. Subject with a wash-out period from baseline for topical treatment on the face less
             than : Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other
             anti-inflammatory drugs or other acne treatments (2 weeks); Cosmetic procedures (1
             week); Photodynamic therapy and laser therapy for acne (3 months)

          9. Subject with a wash-out period from baseline for systemic treatment less than:
             Corticosteroids, antibiotics (4 weeks),Progesterone for contraception (3 months);
             Spironolactone(3 months); Other acne treatments (6 months);Cyproterone acetate(6
             months)
MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: MP0420; Placebo; Remdesivir
Intervention description: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains.; Commercially available 0.9% sodium chloride solution; Antiviral agent
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; COVID 19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Diseases; Nidovirales Infections; SARS-CoV-2; SARS Coronavirus; ACTIV-3; ACTIV3; TICO

Summary:

      This study looks at the safety and effectiveness of MP0420 in treating COVID-19 in people who
      have been hospitalized with the infection. Participants in the study will be treated with
      either MP0420 plus current standard of care (SOC), or with placebo plus current SOC. This is
      ACTIV-3/TICO Treatment Trial H5.
    

Eligibility criteria:

        Inclusion Criteria: Refer to the master protocol (NCT04501978)

        Exclusion Criteria: Refer to the master protocol (NCT04501978)

        Additional Exclusion Criteria:

          1. Pregnant women

          2. Nursing mothers

          3. Women of child-bearing potential who are unwilling to acknowledge the strong advice to
             abstain from sexual intercourse with men or practice appropriate contraception through
             11 weeks after receiving MP0420/placebo

          4. Men who are unwilling to acknowledge the strong advice to abstain from sexual
             intercourse with women of child-bearing potential or to use barrier contraception
             through 11 weeks after receiving MP0420/placebo.
A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-445/TEZ/IVA; TEZ/IVA; IVA; Placebo; Placebo
Intervention description: Participants received VX-445/TEZ/IVA orally once daily in the morning.; Participants received TEZ/IVA orally once daily in the morning.; Participants received IVA orally once daily in the evening.; Participants received placebo matched to VX-445/TEZ/IVA orally once daily in the morning.; Participants received placebo matched TEZ/IVA orally once daily in the morning.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor
      (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the
      F508del mutation (F/F)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for the F508del mutation (F/F)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
Condition: Precocious Puberty
MeSH terms: Puberty, Precocious
Intervention: Triptorelin pamoate 11.25mg (Decapeptyl® SR)
Intervention description: One intra muscular injection at day 1 and month 3.
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the
      delay of premature onset of puberty in girls less than 9 years and boys less than 10 years.
      This is measured by assessing the proportion of children who have a suppressed Luteinizing
      Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after
      injection with triptorelin 11.25 mg.
    

Eligibility criteria:

        Inclusion Criteria in the screening phase:

          -  Onset of sex characteristics (Tanner method) breast development in girls or testicular
             enlargement in boys before the age of 8 years in girls and 9 years in boys.

          -  Weight ≥ 20 kg.

        Inclusion Criteria in the treatment phase:

          -  Proven central precocious puberty defined as onset of sex characteristics development
             (according to Tanner method) diagnosed before the age of 8 years in girls and 9 years
             in boys.

          -  Age at evaluation less than 9 years for girls and 10 years for boys.

          -  A pubertal response of LH to GnRH test in both sexes (stimulated LH ≥ 5 IU/l).

          -  Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age
             (CA) > 1 year.

          -  Testosterone level ≥ 0.5 ng/ml in boys.

        Exclusion Criteria:

          -  Patient with a peripheral precocious puberty: extrapituitary secretion of
             gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.

          -  Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.

          -  Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth
             curves).

          -  The patient has received a previous treatment with a GnRH analogue, or
             medroxyprogesterone or cyproterone acetate.
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
Condition: Hepatitis C Infection; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: ombitasvir/paritaprevir/ritonavir; dasabuvir
Intervention description: Tablet; Tablet
Intervention MeSH terms: Ritonavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus; Interferon-Free; Ribavirin-Free; Hepatitis C; Hepatitis C Genotype 1b

Summary:

      This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and
      dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b)
      hepatitis C virus (HCV).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic HCV infection at Screening.

          2. Screening laboratory result indicating HCV genotype 1b infection.

          3. Treatment-naïve and non-cirrhotic.

        Exclusion Criteria:

          1. HCV genotype or subtype other than GT1b.

          2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive
             anti-HIV antibody (HIV Ab) test.

          3. Any current or past clinical evidence of cirrhosis.

          4. Screening laboratory analyses that shows abnormal results.

          5. Clinically significant abnormalities or co-morbidities, other than HCV infection that
             make the participant an unsuitable candidate for this study.
Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
Condition: Branch Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Intervention: Ranibizumab; Laser
Intervention description: laser photocoagulation
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 455.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular Edema, Branch Retinal Vein Occlusion, visual impairment

Summary:

      This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing
      administered with or without adjunctive laser treatment versus laser photocoagulation (the
      current standard of care) up to Month 6 in patients with visual impairment due to ME
      secondary to BRVO. Additionally the results of this study will provide long-term (24-month)
      safety and efficacy data for ranibizumab, administered with or without adjunctive laser
      treatment in this indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any study assessment is performed

          -  Diagnosis of visual impairment exclusively due to ME secondary to BRVO

          -  BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Stroke or myocardial infarction less than 3 months before Screening

          -  Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value
             of >100 mm Hg at Screening or Baseline.

          -  Any active periocular or ocular infection or inflammation at Screening or Baseline in
             either eye

          -  Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before
             Baseline in either eye

          -  Neovascularization of the iris or neovascular glaucoma in the study eye

          -  Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6
             months before Baseline

          -  Panretinal laser photocoagulation within 3 months before Baseline or anticipated or
             scheduled within the next 3 months following Baseline in the study eye

          -  Focal or grid laser photocoagulation within 4 months before Baseline in the study eye

          -  Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months
             before Screening in the study eye

          -  Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®],
             fluocinolone acetonide [Iluvien®]) in the study eye
Establishing the Vitamin D Requirements During Lactation
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: 400 IU Vitamin D3 (cholecalciferol); 2400 IU Vitamin D3 (cholecalciferol); 6400 IU Vitamin D3 (cholecalciferol)
Intervention description: 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant; 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant; 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 460.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Breastfeeding; Vitamin D; Vitamin D deficiency

Summary:

      The purpose of this study is to determine the effectiveness and safety of maternal and infant
      vitamin D supplementation as a function of ethnicity and latitude in the prevention of
      vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will
      generate important new information for health care professionals and policy makers with
      regard to vitamin D requirements and the potential benefit to both mother and infant
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mother plans to breastfeed exclusively for at least six months

          -  Mother is in good health

          -  Infant is 35 weeks' gestation or greater

          -  Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not
             requiring oxygen therapy or parenteral nutrition beyond first 72 hours).

        Exclusion Criteria:

          -  Mother does not plan to breastfeed exclusively for the first six months (plans to use
             formula for infant's feedings during the first six months

          -  Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or
             parental nutrition beyond the first 72 hours

          -  Infant is less than 35 weeks' gestation

          -  Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern

          -  Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes,
             or calcium abnormalities related to renal disease such that calcium parameters are
             abnormal

          -  Mother has history of hypercalciuria
Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: Ciclopirox Olamine Cream; Loprox Cream 0.77%; Placebo
Intervention description: topical cream; topical cream; topical cream
Intervention MeSH terms: Ciclopirox
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 561.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Tinea Pedis; Ciclopirox Olamine

Summary:

      The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox
      Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment
      of subjects with tinea pedis, and to show the superiority of the active treatments over that
      of the vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 10 years of age, and otherwise healthy

          -  Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis

          -  In good health with no clinically significant disease that might have interfered with
             study evaluations

          -  Study participant or legal guardian was willing and able to read and sign an IRB
             approved ICF, which included agreement to comply with all study requirements as
             indicated in the protocol. For subjects 10 to 17 years of age, an assent form for
             minors was completed.

        Exclusion Criteria:

          -  History of hypersensitivity or allergy to ciclopirox

          -  Had any skin condition that would interfere with the diagnosis or assessment of tinea
             pedis

          -  Had a history of dermatophyte infecton unresponsive to antifungal treatment

          -  Had a history of alcoholism, drug abuse, or problems that would likely have made the
             subject unreliable for the study

          -  Had any condition or used any medication that, in the opinion of the Investigator,
             might have interfered with the conduct or results of the study or placed the
             prospective subject at increased risk

          -  Was unwilling to sign the informed consent

          -  Female who was pregnant or lactating
A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor; Tezacaftor/Ivacaftor
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group,
      multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and
      older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele
      with a gating defect that is clinically demonstrated to be ivacaftor responsive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect
             that is clinically demonstrated to be ivacaftor responsive

          -  FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening

          -  Stable CF disease as judged by the investigator.

        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
             subject.

          -  Pregnant and nursing females (females of childbearing potential must have a negative
             pregnancy test at Screening and Week -4 Visits).

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements