bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy
Intervention: Xyrem (sodium oxybate) oral solution
Intervention description: Xyrem (sodium oxybate) oral solution
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Narcolepsy; Cataplexy

Summary:

      This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the
      OMC-SXB-7 open-label trial may be entered without any requirement as to length of
      participation in that trial.

      Approximately 70 patients are expected to participate at up to 6 investigative centers
      located in Canada. The trial will continue for up to 24 months or until marketing approval,
      whichever occurs sooner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial

          -  Signed and dated an informed consent
A Long-term Trial of OPC-34712 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: OPC-34712
Intervention description: orally administered once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To investigate the safety and efficacy of long-term administration of OPC-34712 in patients
      with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 years or older (at time of informed consent) diagnosed with
             schizophrenia based on DSM-IV-TR diagnostic criteria

          -  Outpatients who are receiving an oral antipsychotic treatment (other than clozapine),
             who are considered to require maintenance therapy using antipsychotics, and for whom
             monotherapy with OPC-34712 is considered feasible

        Exclusion Criteria:

          -  Female patients who are breastfeeding or who have a positive pregnancy test (urine)
             result prior to receiving investigational medicinal product

          -  Patients who are diagnosed with a disease other than schizophrenia (schizoaffective
             disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder,
             anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on
             current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder
             (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Diclofenac; Diclofenac; Placebo
Intervention description: 35 mg bid Capsules; 35 mg tid Capsules; Capsules
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and
      effective for the treatment of osteoarthritis pain of the hip or knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary diagnosis of Functional Class I-III OA of the hip or knee with documented
             osteoarthritis flare at baseline

          -  Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for
             OA pain

          -  Discontinued all analgesic therapy at Screening

          -  For women of child-bearing potential: a woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

        Exclusion Criteria:

          -  History of allergic reaction or clinically significant intolerance to acetaminophen,
             aspirin, or any NSAIDS, including diclofenac

          -  Requires continuous use of opioid or opioid combination products to control OA pain of
             the knee or hip

          -  Clinically significant unstable cardiac, respiratory, neurological, immunological,
             hematological, or renal disease

          -  Significant difficulties swallowing capsules or unable to tolerate oral medication

          -  Previous participation in another clinical study of Diclofenac Capsules or received
             any investigational drug or device or investigational therapy within 30 days before
             Screening.
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
Condition: Chronic Hepatitis C; HCV; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: glecaprevir/pibrentasvir
Intervention description: Tablet; glecaprevir coformulated with pibrentasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV Treatment Experienced; Hepatitis C; HCV Genotype 3; Without cirrhosis; Non-cirrhotic; HCV Genotype 2; Renal Transplant; HCV Treatment Naive; Post transplant; HCV Genotype 6; Liver Transplant; HCV Genotype 5; HCV Genotype 4; Kidney Transplant; HCV Genotype 1

Summary:

      The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of
      ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or
      renal transplant with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age at time of screening.

          -  Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6)
             infection.

          -  Subject is a recipient of a cadaveric or living donor liver transplant which was a
             consequence of HCV infection at least 3 months prior to screening Or subject received
             a cadaveric or living donor kidney at least 3 months before screening.

          -  Subjects must be documented as non-cirrhotic.

          -  Subject is currently taking a stable immunosuppression regimen based on tacrolimus,
             sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine,
             and/or cyclosporine.

        Exclusion Criteria:

          -  Female subject who is pregnant, breastfeeding or is considering becoming pregnant
             during the study or for approximately 30 days after the last dose of study drug.

          -  Clinical history of fibrosing cholestatic hepatitis post-transplant.

          -  Re-transplantation of the liver or kidney.

          -  Steroid resistant rejection of the transplanted liver or kidney, or a history of
             rejection treated with high dose steroid within 3 months of screening.

          -  History of post-transplant complications related to hepatic or renal vasculature.
A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
Condition: Human; Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Intervention: V501; Comparator: Placebo
Intervention description: 0.5 mL intramuscular injection of V501; 0.5 mL intramuscular injection of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1781.0
Sex: All
Minimum age: 9 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is to evaluate the safety, tolerability, and immune response of an investigational
      vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma
      Virus (HPV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adolescents and preadolescents with no prior sexual history

        Exclusion Criteria:

          -  Subjects with compromised immune system or have a history of severe allergic reaction
Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: NDL-PDT; c-PDT; placebo c-PDT
Intervention description: Metvix natural daylight photodynamic therapy; Metvix conventional photodynamic therapy; Metvix placebo conventional photodynamic therapy
Intervention MeSH terms: Methyl 5-aminolevulinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: 2 intra-individual groups:
Metvix NDL-PDT / Metvix c-PDT
Metvix NDL-PDT / Placebo c-PDT
Masking: Single (Investigator)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: actinic keratoses; photodynamic therapy; natural daylight

Summary:

      This study was to be conducted as a multi-centre, randomized, investigator-blinded, active
      and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding
      efficacy) and superiority (regarding pain) study.

      The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared
      to c-PDT in terms of lesion complete response rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the
             scalp on treated areas

          -  Subject with two symmetrical treated areas half scalps or two half faces excluding
             ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no
             more than a twofold difference in terms of total number of lesions between the two TAs

        Exclusion Criteria:

          -  Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas

          -  Subject with pigmented AK on the treated areas

          -  Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons

          -  Subject with porphyria,
Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus
Condition: Left Ventricular Thrombosis
MeSH terms: Thrombosis
Intervention: Apixaban 5 MG Oral Tablet [ELIQUIS]; Warfarin Sodium
Intervention description: Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.; as controlled arm since warfarin is the standard therapy for LV thrombus
Intervention MeSH terms: Warfarin; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the novel oral anticoagulant apixaban with the
      standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus
      over 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 - 80 years old

          2. Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG
             1996), with regional wall motion abnormalities

          3. HASBLED score less than 3

          4. No episodes of major bleeding in the past 6 months a) Major bleeding defined as i.
             episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL
             - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion
             (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and
             lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits

        Exclusion Criteria:

          1. Patient with unstable arrhythmias and/or recurrent cardiogenic shock

          2. Patient with large ischemic stroke on recruitment-defined as involving >1/3 of
             cerebral hemisphere or deemed to have high chance of haemorrhagic transformation

          3. Patient with permanent pacemaker

          4. Patient who is post valve replacement therapy

          5. Patient who is pregnant.

          6. Patient with advanced kidney disease at stage V and not on dialysis (CrCl <15 mL/min)

          7. Patient with advanced liver disease with coagulopathy

          8. Patient with organized and old left ventricular thrombus
Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD5789 (trifarotene) 50μg/g cream; Placebo cream
Intervention description: CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.; Placebo cream applied once daily for 12 weeks
Intervention MeSH terms: Trifarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1208.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: Efficacy; Safety; Acne vulgaris

Summary:

      Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily
      for 12 weeks in subjects with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is a male or female, 9 years of age or older, at Screening visit.

          -  The Subject has moderate acne at Screening and Baseline.

          -  The subject is a female of non childbearing potential

          -  The subject is a female of childbearing potential with a negative pregnancy test and
             who is strictly abstinent or who agrees to use an effective and approved contraceptive
             method for the duration of the study and at least 1 month after the last study drug
             application.

        Exclusion Criteria:

          -  The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or
             secondary acne form (e.g.,chloracne, drug-induced acne, etc.).

          -  The subject has any uncontrolled or serious disease or any medical or surgical
             condition that may either interfere with the interpretation of the trial results
             and/or put the subject at significant risk (according to the Investigator's judgment)
             if the subject takes part to the trial.

          -  The subject has been exposed to excessive ultraviolet (UV) radiation within one month
             prior to the Baseline visit or the subject is planning intense UV exposure during the
             study (i.e., occupational exposure to the sun, sunbathing, tanning salon use,
             phototherapy, etc.)

          -  The subject is unwilling to refrain from use of prohibited medication during the
             clinical trial
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
Condition: Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases
Intervention: Gadobutrol (Gadavist, Gadovist, BAY86-4875); Magnevist
Intervention description: 1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW); 0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Gadovist; Gadavist; Contrast agent; Brain; Spine disease; Magnetic Resonance Imaging

Summary:

      The purpose of this study is to determine if the contrast agent is effective and safe in the
      Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese origin, with known or suspected brain or spine diseases

        Exclusion Criteria:

          -  Pregnancy

          -  Lactation

          -  Conditions interfering with MRI

          -  Allergy to any contrast agent or any drugs

          -  Participation in other trial

          -  Require emergency treatment

          -  Severely impaired liver and kidney functions
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery
Condition: Arthroplasty, Replacement, Knee; Thromboembolism
MeSH terms: Thromboembolism
Intervention: enoxaparin; dabigatran etexilate; dabigatran etexilate
Intervention description: 40 mg once daily; 150 mg once daily; 220 mg once daily
Intervention MeSH terms: Enoxaparin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 2101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A phase III, randomised, parallel-group, double-blind, active controlled study to investigate
      the ef ficacy and safety of two different dose regimens of orally administered dabigatran
      etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on
      the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days,
      in prevention of venous thromboem bolism in patients with primary elective total knee
      replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)
    

Eligibility criteria:

        Inclusion criteria

        Inclusion criteria (selected):

          -  Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive
             total knee replacement

          -  Written Informed Consent

        Exclusion criteria

        Exclusion criteria (selected):

          -  Patients with an excessive risk of bleeding, for example because of history of
             bleeding diathesis major surgery or trauma within the last 3 months history of
             haemorrhagic stroke or any of the following intracranial pathologies: bleeding,
             neoplasm, arteriovenous (AV) malformation or aneurysm clinically relevant bleeding or
             gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within
             7 days prior to joint replacement surgery or anticipated need during the study
             treatment period thrombocytopenia.

          -  Active malignant disease or current cytostatic treatment

          -  Known severe renal insufficiency

          -  Liver disease expected to have any potential impact on survival, or elevated aspartate
             aminotransferase (AST) or alanine transaminase (ALT) > 2x upper limit of normal

          -  Recent unstable cardiovascular disease or history of myocardial infarction within the
             last 3 months

          -  Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial
             and are not practising or do not plan to continue practising acceptable me thods of
             birth control

          -  Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced
             thrombocytopenia) or dabigatran

          -  Contraindications to enoxaparin

          -  Participation in a clinical trial during the last 30 days
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV); Non-Influenza Comparator (Boostrix)
Intervention description: 1 dose approximately 0.5 mL of aQIV; 1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 6790.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate
      the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine
      Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ≥ 65 years old who are healthy or have co-morbidities

          2. Individuals who or whose legal guardian have voluntarily given written consent after
             the nature of the study has been explained according to local regulatory requirements,
             prior to study entry.

          3. Ability to attend all scheduled visits and to comply with study procedures

        Exclusion Criteria:

          1. Hypersensitivity, including allergy to any component of vaccines foreseen in this
             study

          2. Abnormal function of the immune system.

          3. Receipt of any influenza vaccine within 6 months prior to enrolment in this study or
             who plan to receive influenza vaccine while participating in the study.

          4. Additional eligibility criteria may be discussed by contacting the site
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; glibenclamide; placebo; placebo
Intervention description: 0.9 mg/day. Injected s.c. (under the skin) once daily.; 1.25-2.5 mg tablet. Given orally once or twice daily.; liraglutide placebo. Injected s.c. (under the skin) once daily.; glibenclamide placebo. Given orally once or twice daily.
Intervention MeSH terms: Liraglutide; Glyburide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 400.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic
      control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after
      24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24
      weeks followed by a 28 week extension period, in total 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight
             weeks

          -  HbA1c greater than or equal to 7.0% and less than 10.0%

          -  BMI (Body Mass Index) less than 35 kg/m2

        Exclusion Criteria:

          -  Treatment with insulin within the last 12 weeks

          -  Treatment with any drug that could interfere with the glucose level

          -  Any serious medical condition

          -  Females who are pregnant, have intention of becoming pregnant or are breastfeeding