bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis; Fibrosis
Intervention: Simeprevir; Simeprevir; Sofosbuvir; Sofosbuvir
Intervention description: 150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.; 150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2; 150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.; 150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.
Intervention MeSH terms: Sofosbuvir; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus Infection; Simeprevir; Sofosbuvir; HCV; Cirrhosis

Summary:

      The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12
      weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus
      (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or
      treatment-experienced.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization

          -  Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a
             infected participants before randomization

          -  Documentation of the IL28B genotype before randomization

          -  HCV ribonucleic acid level greater than 10,000 IU/mL at screening

          -  Treatment-experienced participants must have at least 1 documented previous course of
             interferon-based regimen with or without ribavirin

          -  Absence of cirrhosis in participants

        Exclusion Criteria:

          -  Evidence of clinical hepatic decompensation (history or current evidence of ascites,
             bleeding varices or hepatic encephalopathy)

          -  Infection/co-infection with HCV non-genotype 1a or 1b

          -  Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2)
             (positive HIV-1 or HIV-2 antibodies test at screening)

          -  Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive)

          -  Previously been treated with any direct acting anti-HCV agent (approved or
             investigational) for chronic HCV infection
A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Intervention: Plant cell expressed recombinant glucocerebrosidase (prGCD); Plant cell expressed recombinant glucocerebrosidase (prGCD)
Intervention description: Intravenous infusion every two weeks for 9 months; Intravenous infusion every 2 weeks for 9 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the
      human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme
      glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in
      the cells of the monocyte-macrophage system.

      This is the second trial to utilize a recombinant active form of lysosomal enzyme,
      glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from
      transformed carrot plant root cell line.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 years or older

          -  Confirmed enzymatic diagnosis of Gaucher disease

          -  Splenomegaly defined as greater than eight times the expected volume (measured volume
             divided by estimated volume (0.2% of body weight)] as determined by MRI volumetric
             analysis

          -  Female patients of child-bearing potential who agree to use a medically acceptable
             method of contraception

          -  Thrombocytopenia (defined as platelet counts below the lower limit of normal) and/or
             anemia (defined by hemoglobin level at least 1 g/dL below normal range according to
             sex and age).

          -  Patients who have not received ERT in the past or patients whoc have not received ERT
             in the past 12 months and have a negative anti-glucocerebrosidase antibody test.

          -  Patients who have not received substrate reduction therapy (SRT) in the past 12
             months.

          -  Ability to provide a written informed consent.

        Exclusion Criteria:

          -  Currently taking another experimental drug for any condition

          -  Pregnant or nursing

          -  Presence of HIV and/or, HBsAg and/or hepatitis C infections

          -  Presence of severe neurological signs and symptoms, defined as complete ocular
             paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic
             Gaucher disease.

          -  Previous anaphylactoid reaction to Cerezyme® or Ceredase®.

          -  History of allergy to carrots.
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: Avatrombopag 60 mg
Intervention description: Oral avatrombopag administered once daily for 5 days prior to procedure.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: low platelet count; ITP

Summary:

      Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in
      subjects with thrombocytopenia scheduled for operations to critical sites or operations with
      a high risk of bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women greater than or equal to 18 years of age;

          -  A mean baseline platelet count between:

               -  50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants

               -  50 × 10^9/L and <75 × 10^9/L for participants with chronic liver disease;

          -  Participant is scheduled to undergo operations to critical sites (eg, eye surgery,
             neurosurgery) or operations with a high risk of bleeding (eg, major abdominal
             surgery), or, in the opinion of the Investigator, would otherwise require a
             pre-operative platelet transfusion to prevent bleeding

        Exclusion Criteria:

          -  Participant with a history of arterial or venous thrombosis within 6 months of
             baseline;

          -  Participant with known portal vein blood flow velocity rate <10 cm/second or previous
             portal vein thrombosis within 6 months of baseline;

          -  Participant plans to have a platelet transfusion or plans to receive blood products
             containing platelets within 7 days of the Baseline Visit;

          -  Use of erythropoietin-stimulating agents;

          -  Participant has a known medical history of genetic prothrombotic syndromes; or

          -  Participant has abnormal hemoglobin levels or prothrombin time/international
             normalized ratio
Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Intervention: catridecacog
Intervention description: Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg bodyweight
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 1 Year
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and United States of America (USA). The aim of this
      clinical trial is to investigate the pharmacokinetics (at which rate the substance is
      distributed and eliminated from the body) and the safety profile of catridecacog (recombinant
      factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children
      (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent by subject's parents or subject's legally acceptable
             representative before any trial related activities. Trial related activities are any
             procedures that would not have been performed during the normal management of the
             subject

          -  Age 1 to less than 6 years old at the time of enrolment

          -  Congenital FXIII subunit-A deficiency previously documented by genotyping or evaluated
             by genotyping through blood sampling at screening visit

          -  Body weight at least 10 kg

        Exclusion Criteria:

          -  Known antibodies to FXIII

          -  Hereditary or acquired coagulation disorder other than FXIII A-subunit congenital
             deficiency

          -  Platelet count (thrombocytes) of less than 50 × 10^9/L (at screening visit)

          -  Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus
             erythematosus

          -  Previous history of arterial or venous thromboembolic events e.g., cerebrovascular
             accident or deep vein thrombosis

          -  Known or suspected allergy to trial product or related products

          -  Any surgical procedure in the 30 days prior to enrolment and any planned surgery
             during the trial period

          -  Any disease or condition which, judged by the Investigator, could imply a potential
             hazard to the subject or interfere with the trial participation or trial outcome
             including renal and/or liver dysfunction
Safety and Efficacy of MultiHance in Pediatric Patients
Condition: Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases
Intervention: gadobenate dimeglumine
Intervention description: A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: disease of the central nervous system (brain or spine)

Summary:

      The purpose of this study was to assess the safety and enhancing properties of the magnetic
      resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having
      central nervous system (CNS) disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 2 and 17 years of age

          -  Informed consent from parents

          -  Assent from patient where required

          -  Known or highly suspected disease of the CNS and referred for either cranial or spinal
             MRI examination

        Exclusion Criteria:

          -  Contraindication to MRI

          -  Undergoing MRI in an emergency situation

          -  Known allergy to one or more of the ingredients in MultiHance

          -  Sickle cell anemia moderate to severe renal impairment

          -  Received another investigational compound within 30 days

          -  Pregnancy

          -  Lactating females

          -  Likely to undergo an invasive procedure within 72 hours of receiving MultiHance
Reflux Esophagitis Phase III Study (Maintenance Treatment)
Condition: Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Intervention: Esomeprazole; Esomeprazole; Omeprazole
Intervention description: 10mg once daily oral administration; 20mg once daily oral administration; 10mg once daily oral administration
Intervention MeSH terms: Esomeprazole; Omeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 540.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Reflux Esophagitis

Summary:

      The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once
      daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux
      esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily
      by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the
      treatment period (from the randomisation to the treatment completion) according to the Los
      Angeles classification.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with healed Reflux Esophagitis verified by EGD in the preceding study
             (D961HC00002)

          -  Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving
             general treatment with PPI

        Exclusion Criteria:

          -  Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.

          -  Use of any PPI from 14 days before EGD performed at the screening visit to the day of
             randomisation.
Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing
Condition: Inflammation; Burns; Ulcers
MeSH terms: Infections; Inflammation; Ulcer; Burns
Intervention: Mepilex Border Ag
Intervention description: Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: The change in signs of inflammation/local infection; To evaluate the comfort, conformability,; Pain during wear

Summary:

      The purpose of this study is to evaluate the change in signs of inflammation/local infection
      when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers
      (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of
      topical antimicrobial treatment according to the physician.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a
             partial thickness burn where an antimicrobial action is indicated* as judged by the
             investigator

          -  Male or female, 18 years and above, both in- and out-patients

          -  Signed Informed Consent Form

        Exclusion Criteria:

          -  Wound size equal to or above 9.5x15cm for the wound/burn to be included in the
             investigation

          -  Subject not expected to follow the investigation procedures

          -  TBSA > 10% (partial thickness burns only)

          -  HbA1C value > 7.2. (To be measured if BMI > 30)

          -  Pregnant and breastfeeding women

          -  Pressure ulcers deeper than stage 3

          -  Deep pressure ulcers in need of a filler

          -  Subjects with known sensitivity to silver or any other dressing materials

          -  Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound,
             diathermy or Magnetic Resonance Imaging

          -  Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide

          -  Subjects previously included in this investigation

          -  Subjects included in other ongoing clinical investigation at present or during the
             past 30 days
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
Condition: Idiopathic Short Stature
MeSH terms: Dwarfism
Intervention: Genotropin; Genotropin
Intervention description: Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.; Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 316.0
Sex: All
Minimum age: 3 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: ISS; human growth hormone

Summary:

      To demonstrate that an individualized, formula-based Genotropin regimen for children with
      Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th
      percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to
      explore treatment efficiency over four years of two formula-based dose regimens (sub-arms)
      compared to standard treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and
             9 years of age for females

          -  Naive to Growth Hormone treatment

        Exclusion Criteria:

          -  Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.
Safety Study of XP12B in Women With Menorrhagia
Condition: Menorrhagia; Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Intervention: Tranexamic acid tablets (XP12B)
Intervention description: Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 784.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Menorrhagia; Heavy Menstrual Bleeding

Summary:

      The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual
      bleeding associated with menorrhagia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with menorrhagia

          -  18-49 years of age

          -  Regularly occuring menstrual periods

        Exclusion Criteria:

          -  History or presence of clinically significant disease or abnormalities that might
             confound the study

          -  History of bilateral oophorectomy or hysterectomy
Meta-Iodobenzylguanidine Scintigraphy Imaging in Patients With Heart Failure and Control Subjects Without Cardiovascular Disease
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Intervention: 123I-mIBG (meta-iodobenzylguanidine)
Intervention description: Single dose
Intervention MeSH terms: 3-Iodobenzylguanidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 587.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Heart Failure; nuclear cardiology; sympathetic innervation; 123I-mIBG

Summary:

      The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to
      predict cardiac outcomes in subjects with heart failure and in comparison to subjects without
      cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study subjects must be adults with an established diagnosis of heart failure (New York
             Heart Association Class II or III) and reduced left ventricular ejection fraction
             (LVEF) (≤ 35%) or be healthy volunteers without heart disease.

        Exclusion Criteria:

          -  Healthy volunteers are not eligible if they have a history diabetes mellitus,
             signs/symptoms of neurological disease (eg, Parkinson's Disease, multiple system
             atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic
             nervous system.

          -  Subjects with New York Heart Association Class I or IV heart failure are not eligible.
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Oral Salmon Calcitonin; Oral Salmon Calcitonin (Placebo)
Intervention description: 0.8mg SMC021, twice daily; 0.8mg Placebo, twice daily
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1030.0
Sex: All
Minimum age: 51 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy,; tolerability

Summary:

      The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon
      Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical history and symptoms of knee osteoarthritis

        Exclusion Criteria:

          -  Any other disease or medication affecting the bone or cartilage.

          -  Any clinical signs or laboratory evidence diseases, which in the Investigator's
             opinion would preclude the participant from adhering to the Protocol or completing the
             trial.

        Other protocol defined inclusion/exclusion criteria may apply