bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: ABT-450/r/ABT-267; Ribavirin
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267; Capsule
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Japanese; Hepatitis C; Treatment naive; Treatment experienced; Genotype 2; Ombitasvir; Paritaprevir; Ritonavir; Ribavirin; VIEKIRAX Combination Tablets

Summary:

      This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and
      cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of
      ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic
      HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects
      with and without compensated cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HCV-infection prior to study enrollment

          -  Screening laboratory result indicating HCV genotype 2 infection

          -  Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at
             Screening

          -  Voluntarily sign an informed consent

        Exclusion Criteria:

          -  Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any
             HCV genotype other than genotype 2

          -  Prior therapy with direct acting antiviral agents for the treatment of HCV, including
             telaprevir, simeprevir and boceprevir

          -  Any cause of liver disease other than chronic HCV-infection, including but not limited
             to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease;
             autoimmune hepatitis; alcoholic liver disease; drug-related liver disease

          -  Clinically significant laboratory abnormalities

          -  Uncontrolled clinically significant disease, disorder or medical illness
Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions
Condition: Lumbar Spine Fusion; Pain; Back Pain
MeSH terms: Back Pain
Intervention: Epidural Catheter - Dilaudid; Dilaudid
Intervention description: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.; Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).
Intervention MeSH terms: Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar
           Spinal Fusion: A Prospective Randomized Study

        2. Purpose of the Study - This prospective randomized study will enroll 200 patients
           undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary
           objective is to determine the effect of epidural analgesia, as compared with standard
           care, on post-operative analgesia.

      Hypothesis:

      The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with
      epidural catheter placement will have superior post-operative analgesia compared to patients
      undergoing standard care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion
             surgery

        Exclusion Criteria:

          -  Baseline cognitive deficits sufficient to make objective pain self-assessments
             unreliable in the estimation of the Study Investigators.

          -  Inability to follow directions or comprehend the English language.

          -  Females who are pregnant as determined by positive pregnancy test on or before the day
             of surgery.

          -  Prisoners.

          -  Patient refusal to provide informed consent.

          -  Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).
Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
Condition: Moderate-to-severe Acute Pain
MeSH terms: Acute Pain
Intervention: sufentanil sublingual 30 mcg tablet
Intervention MeSH terms: Sufentanil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of
      moderate-to-severe acute pain in patients in an emergency room (ER) setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who present to the ER with moderate-to-severe pain due to obvious trauma or
             injury evident on physical examination.

          -  Patients classified as American Society of Anesthesiologists (ASA) class I-III

          -  Patients who are willing and capable of understanding and cooperating with the
             requirements of the study.

          -  Patients able to understand and communicate in English.

          -  Patients who have provided written informed consent and signed the IRB approved
             consent form.

        Exclusion Criteria:

          -  Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
             of more than 15 mg of morphine (or equivalent), within the past 3 months (e.g. more
             than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).

          -  Patients who have used any illicit drugs of abuse, abused prescription medication or
             alcohol (4 or more drinks per day) within one year before the start of the study.

          -  Patients with an allergy or hypersensitivity to opioids.

          -  Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken
             MAOIs within 14 days of the dose of study drug.

          -  Patients with current sleep apnea that has been documented by a sleep laboratory study
             or are on home continuous positive airway pressure (CPAP).

          -  Female patients who are pregnant (positive pregnancy test) or breastfeeding.

          -  Patients with a medical condition that, in the Investigator's opinion, could adversely
             impact the patient's participation or safety, conduct of the study, or interfere with
             the pain assessments, including chronic pain or active infection.

          -  Patients who present to the ER using supplemental oxygen.

          -  Patients who have participated in a clinical trial of an investigational drug or
             device within 30 days of enrollment.

          -  Patients who are active or reserve duty with the US military.
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Condition: Obesity; Overweight; Metabolism and Nutrition Disorder
MeSH terms: Obesity; Overweight; Nutrition Disorders
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have
      obesity or overweight.

      The main purpose is to learn more about how tirzepatide affects body weight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with
             at least one of the following comorbidities: hypertension, dyslipidemia, obstructive
             sleep apnea, cardiovascular disease

          -  Have a history of at least one self-reported unsuccessful dietary effort to lose body
             weight

        Exclusion Criteria:

          -  Have Diabetes Mellitus

          -  Have a self-reported change in body weight >5 kg within 3 months prior to screening

          -  Have obesity induced by other endocrinological disorders

          -  Have had a history of chronic or acute pancreatitis

          -  Have a history of significant active or unstable Major Depressive Disorder (MDD) or
             other severe psychiatric disorder within the last 2 years

          -  Have any lifetime history of a suicide attempt

          -  Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple
             endocrine neoplasia syndrome type 2 (MEN-2)
Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
Condition: Hydronephrosis; Neurogenic Bladder
MeSH terms: Urinary Bladder, Neurogenic; Hydronephrosis
Intervention: Alfuzosin
Intervention description: Dose: 0.2 mg/kg/day
Route: oral
Intervention MeSH terms: Alfuzosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: child; bladder; neuropathic; alpha blockers

Summary:

      Primary objective was to determine efficacy of Alfuzosin in the treatment of children and
      adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to
      elevated detrusor Leak Point Pressure [LPP] of neuropathic etiology.

      Secondary objectives were:

        -  To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and
           adolescents,

        -  To investigate the number of Urinary Tract Infection (UTI) episodes,

        -  To investigate the pharmacokinetics of Alfuzosin (population kinetics).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak
             Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive
             hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to
             neuropathic bladder dysfunction.

        Exclusion Criteria:

          -  Hydronephrosis of non-neuropathic etiology.

          -  Urological surgery in the last 4 months prior to the study.

          -  Urethral dilatation in the last 3 months prior to the baseline urodynamic assessment.

          -  α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment.

          -  Detrusor injections of botulinum toxin in the last 6 months.

          -  Urological diseases/conditions other than functional bladder obstruction of
             neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder
             anomalies, ureterocele).

          -  History of intolerance to α-blocker therapy.

          -  Orthostatic hypotension.

          -  History of risk factors for Torsade de pointes (e.g., family history of Long QT
             Syndrome).

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma; Open-Angle Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost SR; Sham Bimatoprost SR; Selective Laser Trabeculoplasty; Sham Selective Laser Trabeculoplasty
Intervention description: Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).; Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).; Selective Laser Trabeculoplasty administered on Day 1.; Sham Selective Laser Trabeculoplasty administered on Day 1.
Intervention MeSH terms: Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of
      Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle
      glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering
      medication for reasons other than medication efficacy (e.g., due to intolerance or
      nonadherence).
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require
        IOP lowering treatment.

        Exclusion Criteria:

          -  Eye surgery (including cataract surgery) and or eye laser surgery within the past 6
             months.

          -  Enrollment in other studies using Bimatoprost SR.
Comparative Efficacy of Different Mebendazole Polymorphs in the Treatment of Soil-transmitted Helminth Infections
Condition: Necator Americanus Infection
MeSH terms: Infections; Communicable Diseases; Helminthiasis
Intervention: Mebendazole polymorph A and C 500 mg; Mebendazole polymorph C; Placebo
Intervention description: Mebendazole tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg of mebendazole as a 50:50 mixture of Polymorphs A and C; Mebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone; Placebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 214.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No
Keywords: Hookworm; Necator americanus; Mebendazole

Summary:

      Mebendazole tablets which are produced by most pharmaceutical manufacturers, including the
      State Pharmaceutical Manufacturing Corporation (SPMC) of Sri Lanka, contain a mixture of
      polymorphs A and C. However, there is some evidence to show that mebendazole polymorph C is
      the only form effective against the soil-transmitted helminths. This protocol describes a
      stratified, randomized, placebo-controlled trial that examined the efficacy of different
      mebendazole polymorphs produced by the SPMC in the treatment of hookworm infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Necator americanus infection, as determined by examination of a single faecal smear,
             alone or with Ascaris lumbricoides or Trichuris trichiura

        Exclusion Criteria:

          -  Children below the age of 2 years

          -  Pregnant women

          -  Individuals with diarrhea on day of treatment
Safety Study of Lifitegrast to Treat Dry Eye
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Lifitegrast; Placebo
Intervention description: Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year; Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year
Intervention MeSH terms: Lifitegrast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 332.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution
      compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse
      events when administered BID for approximately 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to read, sign and date the informed consent and HIPAA documents

          -  Willing and able to comply with all study procedures

          -  Be at least 18 years of age

          -  Patient-reported history of dry eye in both eyes

          -  A negative urine pregnancy test if female of childbearing potential and must use
             adequate birth control throughout the study period

        Exclusion Criteria:

          -  Any ocular condition that, in the opinion of the Investigator, could affect study
             parameters including, but not limited to, active ocular infection, ocular
             inflammation, glaucoma, and/or diabetic retinopathy

          -  Unwilling to avoid wearing contact lenses for 24h prior to Visit 1 and for some
             duration during the study

          -  Any blood donation or significant loss of blood within 56 days of Visit 1

          -  Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of
             acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.

          -  Use of any prohibited medications during the appropriate pre-study washout period and
             at any time during the study unless otherwise specified

          -  Any significant illness that could interfere with study parameters

          -  History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal
             refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical
             procedure within 12 months prior to Visit 1; or any scheduled ocular surgical
             procedure during the study period.

          -  Known history of alcohol and/or drug abuse

          -  Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet
             cells (as with Vitamin A deficiency)
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: OPC-61815; Tolvaptan Tab 15 MG
Intervention description: Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg; Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 294.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using
      as the primary endpoint the change in body weight following 5-day intravenous administration
      of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF
      patients with volume overload despite having received diuretics other than vasopressin
      antagonists
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are currently on treatment with any of the following diuretics

               1. Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40
                  mg/day or higher

               2. Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide
                  analogs) at any dose

               3. Concomitant use of a loop diuretic and an aldosterone antagonist or
                  potassium-sparing diuretic agent at any dose

          -  Patients with congestive heart failure in whom lower limb edema, pulmonary congestion,
             and/or jugular venous distension due to volume overload is present

          -  Patients who are currently hospitalized or who are able to be hospitalized during the
             trial

        Exclusion Criteria:

          -  Patients with acute heart failure

          -  Patients who are on a ventricular assist device

          -  Patients who are unable to sense thirst or who have difficulty with fluid intake
Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
Condition: Restless Legs Syndrome; Restless Legs Syndrome (RLS)
MeSH terms: Dyssomnias; Parasomnias; Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: GSK1838262 Extended Release Tablets; Placebo
Intervention description: GSK1838262 extended release tablets; Placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PSG; Restless Legs Syndrome; gabapentin enacarbil; XP13512; GSK1838262; sleep disturbance; RLS; polysomnography

Summary:

      The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release
      tablets in the treatment of patients with Restless Legs Syndrome and associated sleep
      disturbance.
    

Eligibility criteria:

        Inclusion criteria:

          -  Provided written informed consent.

          -  Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria
             with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and
             significant sleep disturbance indicated on Item 4 of the IRLS rating scale.

          -  Have history of RLS symptoms at least 15 nights/month.

          -  Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using
             actigraphy).

        Exclusion criteria:

          -  Secondary RLS

          -  Primary sleep disorder

          -  Sleep apnea

          -  Have any medical conditions that may impact efficacy assessments or that may present a
             safety concern.

          -  Pregnant or lactating or women of child-bearing potential who are not practicing an
             acceptable method of birth control.

          -  Use of any prohibited medication.