bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention description: three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis B, Vaccine; Randomized Controlled Trial; HIV; Immunogenicity

Summary:

      Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and
      their immune function and immune response to hepatitis B vaccination were also suboptimal,
      indicating that the current practice of hepatitis B vaccination can't protect HIV-infected
      adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination
      remains a challenge.

      This is a randomized, open-label trial, conducted among HIV-infected adults with drug
      rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of
      three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6
      among HIV-infected adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infected

          -  Aged between 18 and 70 years

          -  Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface
             antibody (anti-HBs) at enrollment

          -  Willing to adhere to the study protocol

        Exclusion Criteria:

          -  Being pregnant

          -  Acute cytolysis in the last three months before enrollment

          -  Any vaccination before or during the month preceding enrollment

          -  Any Intolerance or allergy to any component of the vaccine

          -  Ongoing opportunistic infection

          -  Hematological disorder

          -  Cancer

          -  Unexplained fever the week before enrollment

          -  Immunosuppressive or immunomodulating treatment in the last six months

          -  Liver disease
Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors
Condition: Skin Closure of Surgical Incisions by Tissue Glue vs Suture
MeSH terms: Surgical Wound
Intervention: Skin wound closure by tissue glue; Skin wound closure by conventional suture + dressing
Intervention description: The glue is used both as closure device and as wound dressing.; Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Tissue glue; Cyanoacrylate; Wound closure; Living donor nephrectomy; Surgical wound closure

Summary:

      By means of a prospective, randomised trial the investigators want to examine skin closure in
      living donors - subjected to laparoscopic, hand-assisted nephrectomy - by tissue glue
      (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1;
      30 + 30 donors).

      Study hypothesis: (i) Latest generation tissue glue (Cyanoacrylate (Liquiband)) is at least
      as good as conventional suture regarding wound healing/complications. (ii) Peroperatively,
      tissue glue is faster than conventional suture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Living kidney donor with informed consent

          -  Approved comprehensive work-up/evaluation at local hospital

        Exclusion Criteria:

          -  Allergy towards acrylate or similar chemicals

          -  Unable to communicate in norwegian language
PIEB vs CEI for Labor Analgesia: An MLAC Study
Condition: Pregnancy
Intervention: Bupivacaine; Sufentanil
Intervention description: Continuous or bolus administration; Continuous or bolus administration
Intervention MeSH terms: Sufentanil; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Utilizing a 'minimal local analgesic concentration (MLAC) study' design to first determine
      the relative potency of Programmed Intermittent Epidural Bolus (PIEB) compared to Continuous
      Epidural Infusion (CEI) and secondly to determine the mechanism to explain the potential PIEB
      efficacy advantage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I & II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early
             active labor (cervix <5 cm (if known)), Pain (VPS) > 3, 18-45 years of age

        Exclusion Criteria:

          -  <37 weeks gestation, H/o Cesarean Section, Multiple Gestation, Pre-eclampsia,
             Narcotics within 3 hours prior to labor epidural placement, Chronic Pain (as defined
             by chronic opiate consumption), Women who are participating in another study that will
             impact protocol
Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Self Mutilation; Personality Disorders; Borderline Personality Disorder
Intervention: Fluoxetine; Dialectical Behavior Therapy; Supportive psychotherapy
Intervention description: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated; Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.; Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
Intervention MeSH terms: Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: suicide; self-mutilation; fluoxetine; placebo; dialectical behavior therapy; supportive therapy

Summary:

      This study will determine whether dialectical behavior therapy and fluoxetine are more
      effective combined or alone in treating people with borderline personality disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets criteria for diagnosis of borderline personality disorder

          -  History of at least one suicide attempt or self-mutilation episode 12 months prior to
             study entry

          -  Experiences continued urges to self-mutilate or attempt suicide

          -  Stable living situation

          -  Use of effective birth control if sexually active

          -  Clinically stable enough to tolerate placebo condition

          -  Not participating in other forms of treatment during the study

        Exclusion Criteria:

          -  Any current organic mental syndromes, lifetime schizophrenic or bipolar disorders,
             psychotic disorders, or mental retardation

          -  Inability to complete psychiatric interview due to lack of cooperation or lack of
             comprehension

          -  Unable to tolerate fluoxetine or DBT

          -  Currently receiving treatment for an acute medical illness or other debilitating
             problem, including substance abuse or anorexia nervosa

          -  History of major depression lasting more than 3 months

          -  Current Hamilton depression score above 22 and not receiving treatment

          -  Pregnant or breastfeeding
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Tenofovir DF; DEXA Scan
Intervention description: 300 mg tablet administered orally once daily for up to 96 weeks; Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
Intervention MeSH terms: Tenofovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to characterize the long term (ie, 96 weeks of follow
      up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment
      in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone
      mineral density (BMD) change between CHB-infected adolescents 12 to < 18 years of age treated
      with tenofovir DF in European treatment centers who are assigned to one of two schedules for
      renal and bone laboratory monitoring and BMD measurement.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. 12 to <16 years of age

          2. Documented chronic hepatitis B virus (HBV) infection

          3. Weight ≥ 35 kg

          4. Able to swallow oral tablets

          5. Negative pregnancy test for females of childbearing potential

          6. Adequate kidney (renal) function

          7. Parent or legal guardian of potential study subjects able to provide written informed
             consent

        Key Exclusion Criteria:

          1. Previously received tenofovir DF

          2. Sexually-active males or females of reproductive potential who are not willing to use
             an effective method of contraception during the study

          3. Females who are pregnant or breastfeeding, or females who wish to become pregnant
             during the course of the study

          4. Known hypersensitivity to tenofovir DF, the metabolites or formulation excipients

          5. Any condition (including alcohol or substance abuse) or prior therapy that, in the
             opinion of the Investigator, would make the subject unsuitable for the study or unable
             to comply with treatment requirements

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
Condition: Heart Transplantation
Intervention: Everolimus (EVR); cyclosporine A (CyA); tacrolimus (TAC); Enteric coated mycophenolate sodium (EC-MPS); mycophenolate mofetil (MMF); Corticosteroids
Intervention description: Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL); 10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only; 0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only; 180 mg or 360 mg tablet dosed 1440-2280 mg per day; 250 mg or 500 mg tablets with a dose of 1500-3000 mg per day; according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Heart Transplantation; Cardiac Transplantation; CNI-sparing; renal function; CNI; Cyclosporine A; Everolimus; mycophenolic acid

Summary:

      This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and
      mycophenolic acid is associated with a better renal outcome as compared to the standard
      regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while
      both treatments are expected to be comparable with respect to efficacy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Heart transplantation, 3 months prior to enrollment

          -  Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral,
             Certican® and corticosteroids

          -  Sufficient graft function

          -  Sufficient renal function

          -  Females capable of becoming pregnant must have a negative serum pregnancy test within
             7 days prior to or at baseline, and are required to practice an approved method of
             birth control for the duration of the study and for a period of 6 weeks following
             discontinuation of study medication, even where there has been a history of
             infertility

        Exclusion criteria:

          -  Multi-organ recipients, re-transplantation, or previous transplant with any other
             organ.

          -  Patients who are recipients of A-B-O incompatible transplants

          -  Cold ischemia time >6 hours

          -  Historical or current peak PRA of > 25% at time of transplantation

          -  Already existing antibodies against the HLA-type of the receiving transplant Other
             protocol-defined inclusion/exclusion criteria may apply
Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Benzoyl Peroxide; Dermotivin® Soft Liquid cleanser; Cetaphil® Dermacontrol Moisturizer SPF30
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The aim of this study is to evaluate a complete acne regimen consisting of a medication
      (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil®
      Dermacontrol Moisturizer SPF30 in patients with acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject of any ethnic background of 12 years or older.

          -  Subject with mild or moderate facial acne vulgaris defined as an Investigator Global
             Assessment (IGA) score at 2 or 3 on a 0-4 scale.

          -  Subject with any skin phototype according to T.B. Fitzpatrick skin phototype
             definitions.

        Exclusion Criteria:

          -  Subject with severe acne (IGA>3) with nodules, cysts, scars or extra-facial lesions,

          -  Female subject who is pregnant, lactating or planning a pregnancy during the study,

          -  Subject susceptible to take a corticosteroid treatment during the study except inhaled
             or topic when needed to treat a condition outside the face,
Clopidogrel Versus Ticagrelor in Type-2 Diabetes
Condition: Coronary Artery Disease; Diabetes Mellitus
MeSH terms: Coronary Artery Disease
Intervention: Ticagrelor; Clopidogrel; Standard medical therapy
Intervention description: Ticagrelor 90 mg twice daily; Clopidogrel 150 mg once daily; Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Healthy volunteers: No

Summary:

      CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study
      evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and
      platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with
      percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes mellitus

          -  stable coronary disease

          -  coronary revascularization with PCI at least 1 month prior to recruitment

        Exclusion Criteria:

          -  acute coronary syndrome

          -  platelet count <70x109/l

          -  active bleeding or bleeding diathesis

          -  history of intracranial bleeding

          -  gastrointestinal bleeding <6 months

          -  cerebrovascular accident <3 months

          -  history of malignancy

          -  concomitant need for oral anticoagulant therapy

          -  severe liver disease or chronic renal failure (glomerular filtration rate <30 ml/min
             /1.73m2)
Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Ranibizumab 0.5 mg
Intervention description: Ranibizumab was supplied as a sterile solution in sealed glass vials.
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Macula degeneration; Ranibizumab; Choroidal neovascularisation; Treat and extend; Treat and observe

Summary:

      The purpose of the study was to compare 2 treatment regimens for patients suffering from
      choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first
      treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and
      than re-treatment of patients who have a visual loss of more than 5 letters with monthly
      control (Treat and Observe). The second treatment regimen was 1 injection each month for 3
      months and than extending the control period if the macula is dry during the monthly control
      (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the number
      of ranibizumab injections, the number of patient visits, the risk of adverse events due to
      the intravitreal injections, and policlinic occupation number could all be reduced.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients over the age of 50.

          -  Patients with primary, secondary, or recurrent subfoveal choroidal neovascularization
             (CNV) to AMD with classic, minimal classic, or occult lesions.

          -  Patients with CNV area ≥ %50 of the total lesion.

          -  Total lesion area ≤ 12 disc areas for minimal classic/occult lesions and ≤ 9 disc
             areas for the classic lesions.

          -  Best-corrected visual acuity (BCVA) score between 73 and 34 letters in the study eye.

        Exclusion Criteria:

          -  BCVA < 34 letters.

          -  Patients using anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate,
             corticosteroids, or protein kinase C inhibitors, etc) or inclusion in another trial
             (for any eye).

          -  Verteporphin, external radiational therapy, subfoveal focal laser photocoagulation,
             vitrectomy, or transpupillary thermotherapy application to the eye before the study.

        Other protocol-defined inclusion/exclusion criteria may apply.
Analgesia After Total Shoulder Arthroplasty
Condition: Total Shoulder Arthroplasty
Intervention: Interscalene Block (ISB) - 0.375% Ropivacaine + additives; Interscalene Block (ISB) - 0.2% Ropivacaine + additives; Interscalene Block (ISB) - 0.1% Ropivacaine + additives; Interscalene Block (ISB) - Systemic Control
Intervention description: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline; Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline; Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline; Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine which medication(s) should be included in the
      interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in
      the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The
      ideal nerve block would reduce pain after shoulder surgery without causing a great deal of
      muscle weakness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with osteoarthritis

          -  Primary total shoulder arthroplasty

          -  Age 18 to 80 years old

          -  Planned use of general anesthesia

          -  Planned use of a brachial plexus nerve block for postoperative analgesia

          -  Ability to follow study protocol

        Exclusion Criteria:

          -  Patients younger than 18 years old and older than 80

          -  Allergy or intolerance to one of the study medications

          -  Patients with an American Society of Anesthesiologists (ASA) physical status of IV

          -  Patients with insulin-dependent diabetes

          -  Patients with hepatic (liver) failure

          -  Patients with chronic renal (kidney) failure

          -  Bradycardia (heart rate < 50) or hypotension (systolic blood pressure < 90 mmHg)

          -  Chronic opioid use (taking opioids for longer than 3 months) (or active diagnosis of
             complex regional pain syndrome [CRPS]/reflex sympathetic dystrophy [RSD])

          -  Lack of English fluency