bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia
Condition: Keratoconus and Ectasia
MeSH terms: Keratoconus; Dilatation, Pathologic
Intervention: Riboflavin; VEGA UV-A Illumination System
Intervention description: Riboflavin is a solution that will be delivered to the treatment area; This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
Intervention MeSH terms: Riboflavin
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to evaluate the long tern safety and effectiveness of
      cross-linking in eyes with keratoconus and ectasia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older

          -  Diagnosis of Keratoconus or Ectasia

          -  Central or Inferior steepening on the Pentacam map

          -  Topography consistent with Keratoconus or Ectasia

          -  BSCVA 20/20 or worse

          -  Removal of contact lenses for required period of time

          -  Signed written informed consent

          -  Willingness and ability to comply with schedule for follow up visits

        Exclusion Criteria

          -  For Keratoconus, a history of previous corneal surgery

          -  Corneal pachymentry equal to or greater and 400

          -  Previous ocular condition in the eyes to be treated that may predispose the eye for
             future complications

          -  A history of chemical injury or delayed healing

          -  Pregnancy

          -  A known sensitivity to the study medications

          -  Nystagmus or any other condition that would prevent a steady gaze during treatment or
             other diagnostic tests

          -  Presence or history of any other condition or finding that makes the patient
             unsuitable as a candidate
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
Condition: Chronic HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: Sofosbuvir; RBV
Intervention description: 400 mg tablet administered orally once daily; 200 mg 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)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF)
      + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus
      (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV RNA ≥10^4 IU/mL at screening

          -  Confirmed chronic HCV genotype 1 or 3 infection

          -  HCV treatment naive

          -  Approximately 30% of individuals may have compensated cirrhosis at screening

        Exclusion Criteria:

          -  Any other chronic liver disease

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Current or prior history of clinical hepatic de-compensation

          -  Contraindication to RBV therapy, e.g., history of clinically significant
             hemoglobinopathy (sickle cell disease, thalassemia).

          -  Chronic use of systemically administered immunosuppressive agents

          -  History of solid organ transplantation
An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIIIFc
Intervention description: Administered as specified in arm description
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: Male
Maximum age: 5 Years
Healthy volunteers: No
Keywords: prophylaxis treatment; Hemophilia A; Hemophilia; episodic treatment

Summary:

      The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in
      previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives
      were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding
      episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of
      bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune
      tolerance induction (ITI) in participants with inhibitors.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability of the participant's legally authorized representative (e.g. their parent or
             legal guardian) to understand the purpose and risks of the study and provide signed
             and dated informed consent and authorization to use confidential health information in
             accordance with national and local participant privacy regulations.

          -  Weight >=3.5 kg at the time of screening.

          -  Severe hemophilia A defined as less than (<) 1 IU/dL (<1%) endogenous FVIII documented
             in the medical record or as tested during the Screening Period.

        Key Exclusion Criteria:

          -  Any exposure to blood components, factor VIII replacement products, including
             commercially available rFVIIIFc at any time prior to or during screening.

          -  History of positive inhibitor testing. A prior history of inhibitors was defined based
             on a patient's historical positive inhibitor test using the local laboratory Bethesda
             value for a positive inhibitor test (ie, equal to or above lower level of detection).

          -  History of hypersensitivity reactions associated with any rFVIIIFc administration.

          -  Other coagulation disorder(s) in addition to hemophilia A.

          -  Any concurrent clinically significant major disease that, in the opinion of the
             Investigator, would make the participant unsuitable for enrollment.

          -  Current systemic treatment with chemotherapy and/or other immunosuppressant drugs.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: AMDC-USR; Placebo
Intervention description: AMDC-USR Treatment; Placebo treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urinary Incontinence, Stress; Tissue Therapy (Cell Therapy); Transplantation, Autologous

Summary:

      This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived
      Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary
      incontinence (SUI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patient has primary symptoms of SUI, as confirmed by patient medical history
             and clinical symptoms, including a focused incontinence evaluation.

        Exclusion Criteria:

          -  Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of
             etiology from a patient medical history, including a focused incontinence history.

          -  Patient has symptoms of mixed urinary incontinence where urge incontinence is the
             predominant factor.

          -  Patient has had stress urinary incontinence symptoms less than 6 months prior to
             signing the informed consent.

          -  Patient has not previously attempted conservative treatment for at least 1 month prior
             to signing the informed consent. (Examples of conservative treatment include behavior
             modifications, bladder exercises, biofeedback, etc.)

          -  Patient has more than 2 episode of awakening to void during normal sleeping hours.

          -  Patient cannot be maintained on a stable dose and/or frequency of medication
             (including diuretics) known to affect lower urinary tract function, including but not
             limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers,
             for at least 2 weeks prior to randomization or is likely to change during the course
             of the study.

          -  Patient is pregnant, lactating, or plans to become pregnant during the course of the
             study.

          -  Patient refuses to provide written informed consent.

          -  Patient is not at least 18 years of age.

          -  Patient is not available for the follow-up evaluations as required by the protocol.
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
Condition: Candidiasis
MeSH terms: Candidiasis
Intervention: micafungin; amphotericin B deoxycholate
Intervention description: Administered by intravenous infusion; Administered by intravenous infusion
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Micafungin; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 48 Hours
Maximum age: 120 Days
Healthy volunteers: No
Keywords: candidiasis; candida; Neonate; candidemia; Micafungin; Mycamine; amphotericin B deoxycholate

Summary:

      The study will evaluate how effective and how safe the drug micafungin is when compared to
      the drug amphotericin B deoxycholate in treating neonates and young infants with certain
      fungal infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infant greater than 48 hours of life after birth up to day of life 120 at the time of
             culture acquisition

          -  Diagnosis of proven invasive candidiasis within 4 days prior to study start

          -  Subject's parent or legal guardian agrees not to allow subject to participate in
             another study with another investigational drug while on treatment.

        Exclusion Criteria:

          -  Infant with any history of a hypersensitivity or severe vasomotor reaction to any
             echinocandin or systemic amphotericin B product

          -  Infant who has received more than 48 hours of systemic antifungal therapy prior to the
             first dose of study drug

          -  Infant who has a breakthrough systemic fungal infection while receiving amphotericin B
             product or an echinocandin as prophylaxis

          -  Infant who has failed prior systemic antifungal therapy for this episode of invasive
             candidiasis

          -  Infant who is co-infected with a non-Candida fungal organism

          -  Infant whose positive yeast cultures are solely from an indwelling bladder catheter
             (unless obtained at the time the indwelling catheter was placed) or sputum.

          -  Infant previously enrolled in this study
Diabetic Gastroparesis Study 05
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Relamorelin 10 μg
Intervention description: Relamorelin 10 μg injected subcutaneously twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Gastroparesis

Summary:

      This open-label study is to assess the safety of continued treatment with relamorelin for
      participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146]
      study and to provide treatment for these participants until relamorelin becomes commercially
      available or the Sponsor terminates development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of either Study RLM-MD-03 or Study RLM-MD-04

          -  Ability to provide written informed consent (IC) prior to any study procedures and
             willingness and ability to comply with study procedures

          -  Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or
             RLM-MD-04, in the opinion of the investigator.

        Exclusion Criteria:

          -  Participant is planning to receive an investigational drug (other than study
             intervention) or investigational device at any time during Study 3071-305-020

          -  Participant has an unresolved adverse event (AE) from a lead-in study, ie, a
             clinically significant finding on physical examination, clinical laboratory test, or
             12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the
             participant's ability to participate in or complete the study

          -  Any other reason that, in the investigator's opinion, would confound proper
             interpretation of the study or expose a participant to unacceptable risk, including
             renal, hepatic, or cardiopulmonary disease

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: PGL4001 5 mg; PGL4001 10 mg
Intervention description: PGL4001 5 mg daily administration; PGL4001 10mg daily administration
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 451.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      Phase III, multicentre, randomized, double-blind, parallel group, long-term study
      investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment
      of uterine myoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a pre-menopausal woman between 18 and 50 years inclusive.

          -  Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

          -  Have FSH levels ≤ 20 mIU/mL

          -  Have excessive uterine bleeding due to myoma.

          -  Have regular menstrual cycles

          -  Have a myomatous uterus < 16 weeks with at least one myoma ≥ 3 cm in diameter.

          -  If of childbearing potential the subject must be practicing a non-hormonal method of
             contraception.

        Exclusion Criteria:

          -  Has a history of or current uterine, cervical, ovarian or breast cancer.

          -  Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.

          -  Has a known severe coagulation disorder.

          -  Has a history of or current treatment for myoma with a Selective Progesterone Receptor
             Modulator (SPRM).

          -  Has abnormal hepatic function at study entry.

          -  Has a positive pregnancy test, is nursing or planning a pregnancy during the course of
             the study.

          -  Has a current (within twelve months) problem with alcohol or drug abuse.

          -  Is currently enrolled in an investigational drug or device study or has participated
             in such a study within the last 30 days.
Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
Condition: Esophagitis, Reflux; Esophagitis, Peptic
MeSH terms: Esophagitis; Esophagitis, Peptic
Intervention: Dexlansoprazole MR; Dexlansoprazole MR; Placebo
Intervention description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.; Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.; Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erosive Esophagitis

Summary:

      The purpose of this study is to assess the ability of once-daily (QD) treatment with
      Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of
      erosive esophagitis (EE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693)
             or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy.
             Complete healing was assessed for change in LA Esophagitis Classification grades A, B,
             C, or D to healed (defined as anything less than the criterion for Grade A). The
             subject was counted as healed if endoscopy findings did not meet the Grade A
             criterion.

        Exclusion Criteria:

          -  Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2)
             receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study

          -  Use of antacids (except for study supplied) throughout the study.

          -  Subjects using drugs with significant anticholinergic effects such as tricyclics who
             cannot stay on a stable dose throughout the study.

          -  Need for continuous anticoagulant therapy.
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
Condition: Dravet Syndrome
MeSH terms: Epilepsies, Myoclonic; Syndrome
Intervention: Clobazam
Intervention MeSH terms: Clobazam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 1 Year
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      To investigate the long-term safety and tolerability of clobazam when administered for 1 year
      as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
    

Eligibility criteria:

        The inclusion and exclusion criteria for the patients who participated in lead-in Study
        14362A will be transferred from the 14362A study and for the patients who did not
        participate in lead-in Study 14362A the inclusion/exclusion is separately listed below.

        Inclusion Criteria:

          1. The patient has a diagnosis of Dravet Syndrome supported by:

               1. onset of seizures in the first year of life

               2. history of fever-induced prolonged seizures as determined by the Investigator

                    -  these may include prolonged (approximately 15 minutes or longer) hemi-clonic
                       seizures

               3. multiple seizure types which may include:

                    -  generalised tonic-clonic (required for inclusion)

                    -  clonic (required for inclusion)

                    -  myoclonic jerks/seizures

               4. history of normal development prior to seizure onset followed by development
                  delay or regression after seizure onset

               5. abnormal EEG consistent with Dravet Syndrome

          2. The patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day
             (maximum 20 mg/day) for at least 3 months

        Other protocol-defined inclusion and exclusion criteria may apply.
Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sorafenib; temsirolimus (Torisel)
Intervention description: Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).; Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.
Intervention MeSH terms: Sirolimus; Sorafenib; Temsirolimus; MTOR Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 512.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic or Advanced Renal Cell Carcinoma

Summary:

      This is an international, randomized, open-label, outpatient, multicenter study. Subjects
      will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by
      intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These
      investigational drugs will be administered in 6-week cycles for the duration of the study, up
      to 24 months. Subjects will be stratified by nephrectomy status, duration of response to
      sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC
      tumor histology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy
             status) with well-documented Radiological PD by RECIST criteria or clinical PD as
             judged by the investigator while receiving first-line sunitinib therapy. Subjects must
             have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).

          -  At time of randomization, at least 2 weeks since prior treatment with sunitinib,
             palliative radiation therapy, and/or surgery.

          -  At time of randomization, there must be at least 1 measurable lesion per RECIST.
             Lesions that have been previously irradiated or embolized cannot be selected as target
             lesions.

               -  More criteria apply

        Exclusion Criteria:

          -  Metastatic CNS from RCC.

          -  Subjects who discontinued Sutent therapy due specifically to intolerance.

          -  Prior systemic therapy for mRCC other than sunitinib.

          -  Active ketonuria, secondary to poorly controlled diabetes mellitus

               -  More criteria apply