bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Ombitasvir/Paritaprevir/Ritonavir; Dasabuvir; Ribavirin (RBV)
Intervention description: Tablet; paritaprevir co-formulated with ritonavir and ombitasvir; Tablet; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Hepatitis C; Hepatitis C Virus; Hepatitis C Genotype 1b; Interferon-Free

Summary:

      This was a multicenter study evaluating the efficacy and safety of
      ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12
      weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV
      treatment-experienced, cirrhotic HCV genotype 1b-infected adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at
             Screening)

          -  Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh
             score less than or equal to 6 at Screening

          -  Participant had never received antiviral treatment (including pegIFN/RBV) for
             hepatitis C infection (treatment-naïve participant) or had documentation of meeting
             one of the defined categories of a treatment-experienced participants

          -  Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound,
             computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3
             months prior to screening or a negative ultrasound at screening.

          -  Females must be post-menopausal, of non-child bearing potential or practicing specific
             forms of birth control

          -  Males must have been surgically sterile, or agreed to practice 2 effective methods of
             birth control throughout the course of the study.

        Exclusion Criteria:

          -  Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus
             antibody

          -  Evidence of current or past Child-Pugh B or C classification

          -  Confirmed presence of hepatocellular carcinoma

          -  Abnormal laboratory tests

          -  Participant who self-reported on average drinking more than 2 drinks per day for
             current drinkers

          -  Previous treatment with a direct acting antiviral agent (DAA) containing regimen

          -  History of solid organ transplant.
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL261
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epilepsy; seizure clusters; acute repetitive seizures; rescue treatment

Summary:

      The purpose of this study is to examine the long-term safety and tolerability of USL261 in
      the treatment of seizure clusters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a competent, adult caregiver who can recognize and observe the subject's seizure
             cluster episodes

          -  Has successfully completed study P261-401, and the subject and caregiver have
             demonstrated adequate compliance with P261-401 study procedures as determined by the
             investigator

        Exclusion Criteria:

          -  Has experienced status epilepticus during or since the P261-401 study

          -  In the opinion of the investigator, is experiencing an ongoing, uncontrolled,
             clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a
             clinically significant adverse event in study P261-401 that might prevent the subject
             from safely participating in the study

          -  Has a neurological disorder that is likely to progress in the next year

          -  Has a history of acute narrow-angle glaucoma

          -  Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or
             gastrointestinal disease that could interfere with the study, subject safety/safety
             monitoring, or is not stable despite current therapy

          -  Subject has severe chronic cardio-respiratory disease or the need for ambulatory
             oxygen

          -  Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study

          -  Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical
             history

          -  Subject has had vagus nerve stimulator (VNS) implanted since the completion of study
             P261-401
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
Condition: Hyperparathyroidism; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: sevelamer carbonate; placebo
Intervention description: 2400 mg with each meal for 4 weeks; 3 tablets with each meal
Intervention MeSH terms: Sevelamer
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: 18 Years
Maximum age: 120 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: secondary hyperparathyroidism; phosphate; calcium; chronic kidney disease

Summary:

      The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium
      reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain
      normocalcemia in chronic kidney disease. This study will examine the hypothesis with measures
      of phosphate homeostasis and calcium reabsorption. A double-blind trial of the intestinal
      phosphate binder sevelamer carbonate will be employed to examine whether reductions in
      phosphate influx alter distal nephron phosphate concentration and the [PTH] required for
      calcium reabsorption in the expected manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  eGFR < 60 ml/min

          -  age at least 18 years

        Exclusion Criteria:

          -  any primary parathyroid disease
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
Condition: Spinal Surgery; Vascular Surgery
Intervention: rThrombin
Intervention description: 1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 3b; rThrombin; spine surgery; vascular surgery; hemostasis; immunogenicity; safety

Summary:

      The purpose of this study is to evaluate the safety and immune system response to recombinant
      thrombin when used to control bleeding in spinal and vascular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently undergoing cervical, thoracic, or lumbar discectomy; corpectomy,
             laminectomy, lateral or interbody fusion, including both anterior and posterior
             approaches (not including minimally invasive procedures; arterial reconstruction;
             peripheral artery bypass (PAB) grafting; or arteriovenous (AV) vascular access
             procedures

          -  History of surgery with high likelihood of exposure to bovine thrombin within the past
             3 years. Prior surgery must have been 1 of the following open procedures: open
             procedures involving the spine or cranium, PAB grafting, AV vascular access
             procedures, autologous skin grafting, or other surgical procedure accompanied by
             documented treatment with bovine thrombin

          -  Age of 18 years or younger at time of informed consent

          -  If female and of child-bearing potential: Negative pregnancy test result within 14
             days prior to treatment

          -  Use of a medically accepted form of contraception from the time of informed consent to
             completion of all follow-up study visits, if sexually active male or a sexually active
             female of childbearing potential

          -  Signed IRB/independent ethics committee-approved informed consent document

        Exclusion Criteria:

          -  Currently undergoing procedures requiring cardiopulmonary bypass or involving the
             aortic arch

          -  Known hypersensitivity to rThrombin or any of its components

          -  Presence of medical, social, or psychosocial factors that, in the opinion of the
             investigator, could impact safety or compliance with study procedures

          -  Breastfeeding

          -  Receipt of treatment with any experimental agent within 30 days of study enrollment or
             treatment
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
Condition: Eyelash Hypotrichosis
MeSH terms: Hypotrichosis
Intervention: bimatoprost solution 0.03%; bimatoprost vehicle solution
Intervention description: One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.; One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with
      vehicle in Japanese adults with hypotrichosis of the eyelashes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have inadequate eyelashes

        Exclusion Criteria:

          -  Any disease/infection/abnormality of the eye or area around the eye

          -  Any ocular surgery within 3 months or anticipated need for ocular surgery during the
             study

          -  Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes

          -  Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3
             months

          -  Use of any over-the-counter eyelash growth product within 6 months or any use of
             prescription eyelash growth products

          -  Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6
             months
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa carbidopa intestinal gel (LCIG); Placebo Gel; Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets; Placebo (PBO) oral capsules; CADD-Legacy® 1400 ambulatory infusion pump; PEG tube; J-tube
Intervention description: infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour); percutaneous endoscopic gastrostomy tube; jejunal tube
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: levodopa-carbidopa; Carbidopa; levodopa; dyskinesia; Duodopa; levodopa-carbidopa intestinal gel; Severe Motor Fluctuations; levodopa/carbidopa suspension; DUOPA

Summary:

      The primary objective of this study was to demonstrate the superiority of levodopa -
      carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease
             Society (UKPDS) Brain Bank Criteria

          -  Levodopa-responsive participants who demonstrate some identifiable 'on response,'
             established by Investigator observation

          -  Demonstrate severe motor fluctuations in spite of individually optimized treatment and
             where therapy options are indicated

        Exclusion Criteria:

          -  Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as
             secondary parkinsonism

          -  Undergone surgery for the treatment of PD

          -  Contraindications to levodopa

          -  Subjects with any neurological deficit that may interfere with the study assessments
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in
      combination with insulin glargine or insulin degludec, is safe and effective in participants
      with type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have T1D for at least 1 year prior to screening and continuously
             using insulin for at least 1 year.

          -  Participants must have HbA1c of ≥7.0 and ≤10.0%.

          -  Participants must have been treated for at least 90 days prior to screening with
             either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at
             least twice daily.

          -  Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter
             (kg/m2).

        Exclusion Criteria:

          -  Participants must not have used other anti-hyperglycemic medications or therapies
             (inhaled, oral or injectable) except for metformin within 90-days prior to screening.

          -  Participants must not have had more than 1 severe hypoglycemic episode within 6 months
             prior to screening.

          -  Participants must not have had more than 1 hospitalization related to hyperglycemia or
             diabetic ketoacidosis within 6 months prior to screening.
Study of Immunotherapy to Treat Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ipilimumab; Placebo
Intervention description: 5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, Up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure; Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
Intervention MeSH terms: Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 988.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if advanced prostate cancer patients that are
      treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Advanced prostate cancer

          -  At least 1 bone metastasis

          -  Testosterone < 50 ng/dl

          -  Prior treatment with docetaxel

        Exclusion Criteria:

          -  Brain metastasis

          -  Autoimmune disease

          -  Known HIV, Hep B, or Hep C infection

          -  More than 2 prior systemic anticancer regimens for prostate cancer

          -  Prior treatment on BMS CA180227 for prostate cancer
Ibuprofen Sodium Tension Headache Study
Condition: Pain
MeSH terms: Tension-Type Headache; Headache
Intervention: Ibuprofen Sodium; Standard Ibuprofen; Placebo
Intervention description: Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen); Single-dose of standard ibuprofen tablets (400mg); Single-dose of placebo
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Headache

Summary:

      This study will compare the ability of a single-dose of a novel ibuprofen formulation to
      relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type
      headache
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females at least 18 years to 65 years of age

          -  A diagnosis of an episodic tension-type headache, as defined by the International
             Headache Society

        Exclusion Criteria:

          -  Pregnancy or breast-feeding

          -  Alcohol or substance abuse

          -  Any serious medical or psychiatric disorder
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Intervention: Testosterone Transdermal System; Placebo patch
Intervention description: Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks; placebo patch, changed twice a week for 52 weeks
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1271.0
Sex: Female
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Natural Menopause

Summary:

      This study is designed to evaluate the endometrial safety of a testosterone patch as
      treatment for low libido in naturally postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women will be screened for study participation and must be at least one year post
             menopausal, 45-70 years old, in general good health, and may or may not be on hormone
             therapy, and must have low sexual desire which causes distress.

        Exclusion Criteria:

          -  Women will be screened for study participation and must not be using androgen therapy
             or have any medical, physical, psychological, or pharmacological condition that could
             make participation unsafe or confound the safety evaluation.
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: T2750; Vismed
Intervention description: 1 drop in each eye 3 to 6 times daily during 84 days; 1 drop in each eye 3 to 6 times daily during 84 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to
      severe Dry Eye Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Male or female aged from ≥ 18 years old.

          -  Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to
             study selection.

        Exclusion Criteria:

          -  Best far corrected visual acuity < 1/10

          -  Severe blepharitis

          -  Severe Dry Eye

          -  Eyelid malposition

          -  Known hypersensitivity to one of the components of the study medications or test
             products.

          -  Pregnant or breast-feeding woman.

          -  Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized)
             not using effective contraception (oral contraceptives, intra-uterine device,
             contraceptive implant or condoms).

          -  Inability of patient to understand the study procedures and thus inability to give
             informed consent.

          -  Non compliant patient (e.g. not willing to attend the follow-up visits, way of life
             interfering with compliance).

          -  Already included once in this study.

          -  Patient under guardianship.