bioihbjkbjnl/mcl2 huggingface dataset:
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.
Effects of Biktarvy on CFR in Stable HIV Patients
Condition: HIV
Intervention: Biktarvy
Intervention description: Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was
      approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is
      Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was
      found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes.
      B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result,
      B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on
      coronary flow reserve.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with HIV on abacavir/lamivudine/dolutegravir STR regimens for at least 1 year
        fulfilling the following inclusion criteria:

          1. age ≥ 45 years for men and ≥ 55 years for women;

          2. at least one coronary risk factor including smoking, dyslipidemia, hypertension,
             obesity (BMI >30) or diabetes, or a calculated 10-year risk of heart attack of 7.5% or
             higher;

          3. HIV RNA < 200 copies/mL at last clinical measurement, done within the past 12 months
             prior to screening, with no intervening HIV RNA > 200;

          4. Screening HIV RNA < 50 copies/mL, CBC, and chemistries that, in the judgment of the
             investigator, do not preclude the use of Biktarvy.

        Exclusion Criteria:

          1. patients not fulfilling inclusion criteria;

          2. unstable HIV disease or other medical condition that, in the opinion of the
             investigator, would interfere with the conduct of the study;

          3. history of cardiomyopathy (LVEF <40%) or significant valvular heart disease;

          4. cirrhosis;

          5. end stage renal disease on dialysis;

          6. uncontrolled hypertension (defined as SBP >200 or DBP >110);

          7. pregnancy;

          8. Patients requiring medications contraindicated with the components of B/F/TAF;

          9. Patients on active treatment for severe asthma or severe COPD.
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: DCV/ASV/BMS-791325
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Healthy volunteers: No

Summary:

      To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed
      dose combination in Genotype 1 Chronic Hepatitis C subjects.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subject chronically infected with HCV genotype 1 (GT-1)

          -  Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)

          -  HCV RNA ≥ 10,000 IU/mL at screening

          -  Treatment-naïve subject with no previous exposure to an interferon formulation (ie,
             IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)

          -  Interferon (IFN) experienced subject who have received previous treatment with IFNα,
             with or without RBV

        Exclusion Criteria:

          -  Liver or any other transplant (including hematopoietic stem cell transplants) other
             than cornea and hair;

          -  Current or known history of cancer (except in situ carcinoma of the cervix or
             adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
             to screening;

          -  Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously
             obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy
             if this was performed);

          -  Evidence of decompensated liver disease including, but not limited to, radiologic
             criteria, a history or presence of ascites, bleeding varices, or hepatic
             encephalopathy
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1258.0
Sex: All
Minimum age: 42 Days
Maximum age: 112 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series
      in Healthy Infants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants born at >36 weeks of gestation and 2 months of age at the time
             of consent.

          -  Healthy infants determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis).

          -  Major known congenital malformation or serious chronic disorder.

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Condition: Pelvic Organ Prolapse; Urinary Incontinence; Pelvic Floor Disorders; Gynecologic Disease; Post-Op Infection; Surgical Site Infection; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Surgical Wound Infection; Urinary Incontinence; Pelvic Floor Disorders; Genital Diseases, Female; Prolapse; Pelvic Organ Prolapse
Intervention: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Intervention description: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Urogynecology; Surgery; Antiseptic Preparation

Summary:

      This is a randomized controlled trial to determine if there is a difference between
      chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery
      post operative infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female Subjects >18 years of age

          -  English or Spanish speaking/reading

          -  Must be able to provide informed consent

          -  Undergoing urogynecologic procedures or surgery

        Exclusion Criteria:

          -  Pregnant - all patients are verified regarding pregnancy status prior to gynecologic
             surgical intervention at all sites of surgery - for patients who are premenopausal and
             have a uterus, a urine pregnancy test is administered in the preoperative setting.
             Pregnancy status is also determined prior to this in the office setting by interview
             and patient provided history prior to offering surgery to the patient.

          -  Inability to return for follow-up visits

          -  No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation

          -  Lack of telephone

          -  Known allergy to either antiseptic agent

          -  Prisoners will not be eligible to participate in this study
Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache
Condition: Postdural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Intervention: Epidural Blood Patch; Sphenopalatine Ganglion Block
Intervention description: A device: 17 gauge Tuohy needle will be placed to the epidural space using the loss of resistance technique. Once positioned a sterile stylet will be replaced within the needle to maintain the sterility of the epidural space. A tourniquet may be used to identify a peripheral venous site, which will be sterilely prepped with betadine x3 and then chloraprep. Venipuncture will be performed with a device: 20gauge or larger needle. 20mL of blood will be aspirated in a sterile system into an appropriately sized syringe. After sterile transfer, this autologous blood will be slowly injected into the epidural space.; The drug: 5% lidocaine ointment, a local anesthetic, will be applied to the end of a device: long channeled cotton tipped applicator inserted into both nares and placed over the mucosa in the area of posterior aspect of the middle ethmoid, toward the presumed anatomic location of the sphenopalatine ganglion, evidenced by a slight resistance at the appropriate depth. 5mL of drug: 1% lidocaine solution will then be injected into the hollow shaft of the device: applicator and allowed to topically anesthetize the ganglion by gravity flow for 30 minutes.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 13 Years
Maximum age: 92 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare a pain block in the midface, versus the traditional,
      more invasive, therapeutic epidural patch for the treatment of headaches
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ages 13-92

          -  Subjects have medical diagnosis of PDPH and require treatment

          -  Subjects who signed consent/assent

        Exclusion Criteria:

          -  <13 years of age

          -  Pregnancy

          -  Subjects with heart failure

          -  Subjects already being treated with lidocaine patch or other vehicle for chronic pain

          -  Non-english speaking subjects

          -  Subjects with platelets <100,000

          -  Subjects that are septic

          -  Subjects with an allergy to lidocaine

          -  Subjects with known nasal polyps

          -  Subjects with recent neurological event

          -  Subjects on anticoagulant therapy

          -  Subjects that received prior therapy with SPG block or EBP
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: aflibercept; laser photocoagulation
Intervention description: Administered IVT; Transpupillary conventional laser will be administered according to standard local procedures.
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open-Label
Enrollment: 127.0
Sex: All
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the efficacy of aflibercept compared to laser
      in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the
      study are to assess the need for a second treatment modality, to assess the recurrence of ROP
      in the study and to assess the safety and tolerability of aflibercept.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Gestational age at birth ≤ 32 weeks or birth weight ≤1500 g

          -  Patients with treatment-naïve retinopathy of prematurity (ROP) classified according to
             the International Classification for ROP in at least one eye as:

               -  Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or

               -  Zone II Stage 2 plus or 3 plus, or

               -  Aggressive posterior retinopathy of prematurity (AP-ROP)

        Key Exclusion Criteria:

          -  Known or suspected chromosomal abnormality, genetic disorder, or syndrome

          -  Previous exposure to any Intravitreal (IVT) or systemic anti-vascular endothelial
             growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during
             breastfeeding

          -  Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3
             or higher, periventricular leukomalacia, congenital brain lesions significantly
             impairing optic nerve function, severe hydrocephalus with significantly increased
             intracranial pressure)

          -  Pediatric conditions rendering the infant ineligible for study intervention at
             baseline or for repeated blood draws as evaluated by a neonatal intensive care unit
             specialist and a study ophthalmologist

          -  Presence of active ocular infection within 5 days of the first treatment

          -  Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and
             stage 5)

          -  ROP involving only Zone III

        NOTE: Other protocol defined inclusion/exclusion criteria apply.
A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Rotigotine 1 mg/24 h; Rotigotine 2 mg/24 h; Rotigotine 3 mg/24 h
Intervention description: Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 mg/24 h (5 cm^2 patch size).; Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 mg/24 h (10 cm^2 patch size).; Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 3 mg/24 h (15 cm^2 patch size).
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: RLS; Neupro; Rotigotine

Summary:

      The purpose of this study is to assess the long-term safety, tolerability and the long-term
      efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject weighs >=40 kg

          -  Subject has completed at least one dose step in SP1006, a previous study of rotigotine
             in adolescents with Restless Legs Syndrome (RLS), without meeting withdrawal criteria

          -  Female subjects must be surgically incapable of childbearing, or effectively
             practicing an acceptable method of contraception (oral/parenteral/implantable hormonal
             contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an
             acceptable method. Subjects must agree to use adequate contraception during the study
             and for 4 weeks after their final dose of study drug

          -  Subject is expected to benefit from participation, in the opinion of the investigator

        Exclusion Criteria:

          -  Subject is experiencing an ongoing serious Adverse Event (SAE) that is assessed to be
             related to rotigotine by the investigator or Sponsor

          -  Subject has active suicidal ideation as indicated by a positive response ("Yes") to
             either Question 4 or Question 5 of the "Since Last Visit" version of the electronic
             Columbia Suicide Severity Rating Scale (eC-SSRS) at the final evaluation visit of the
             previous rotigotine study (ie, Visit 10 of SP1006)
Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)
Condition: Refractory Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: Eculizumab; Placebo
Intervention description: Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26; Placebo
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myasthenia Gravis; Eculizumab; safety; efficacy

Summary:

      The purpose of this study is to determine if eculizumab is safe and effective for the
      treatment of refractory generalized Myasthenia Gravis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female patients ≥18 years old

          -  Diagnosis of MG made by the following tests:

               1. Positive serologic test for anti-AChR Abs as confirmed at screening, and

               2. One of the following:

                    1. History of abnormal neuromuscular transmission test demonstrated by
                       single-fiber electromyography (SFEMG) or repetitive nerve stimulation, or

                    2. History of positive anticholinesterase test, e.g. edrophonium chloride test,
                       or

                    3. Subject has demonstrated improvement in MG signs on oral cholinesterase
                       inhibitors, as assessed by the treating physician.

          -  MGFA Clinical Classification Class II to IV at screening.

          -  MG-ADL total score must be ≥6 at screening and Randomization (Day 1).

          -  Subjects who have:

               1. Failed treatment with at least two immunosuppressive agents. Or,

               2. Failed treatment with at least one immunosuppressive agent and require chronic
                  plasma exchange or IVIg

        Key Exclusion Criteria:

          -  History of thymoma or other neoplasms of the thymus

          -  History of thymectomy within 12 months prior to screening

          -  MGFA Class I or MG crisis at screening (MGFA Class V)

          -  Use of rituximab within 6 months prior to screening

          -  Use of IVIg or PE within 4 weeks prior to Randomization (Day 1)