bioihbjkbjnl/mcl2 huggingface dataset:
In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
Condition: Hemostasis
Intervention: Fibrinogen Concentrate (FC); Cryoprecipitate
Intervention description: The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.; Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 345mg/dL
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 1 Day
Maximum age: 30 Days
Healthy volunteers: No
Keywords: Fibrinogen Concentrate; FC; Cryoprecipitate; Transfusion; in vivo; Open-heart surgery; Cardiopulmonary Bypass; Fibrin Network Structure

Summary:

      This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate
      and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass
      to develop effective and safe strategies for managing coagulopathies in neonates.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Full term neonates (36-42 weeks gestational age)

          2. Infants =< 30 days of age at time of surgery

          3. APGAR score of 6 or greater at 5 minutes after delivery

          4. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of
             Atlanta

          5. Parents willing to participate and able to understand and sign the provided informed
             consent

        Exclusion Criteria:

          1. Preterm neonates (less than 36 weeks gestation)

          2. Patients undergoing an emergent procedure or surgery not requiring CPB

          3. Patients with personal or family history of a coagulation defect or coagulopathy

          4. Parents unwilling to participate or unable to understand and sign the provided
             informed consent
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.; Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIN457; psoriatic arthritis; chronic inflammatory disease; loading regimen; secukinumab; self-injection

Summary:

      The purpose of this study was to provide 16-week efficacy, safety and tolerability data
      versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.)
      self-administration with or without a loading regimen and maintenance dosing using pre-filled
      syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with
      active PsA despite current or previous NSAID or DMARD therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for
             Psoriatic ARthritis (CASPAR) criteria.

          -  Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

          -  Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

          -  Inadequate control of symptoms with NSAID.

          -  Other protocol-defined inclusion criteria do apply.

        Exclusion Criteria:

          -  Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
             infectious or malignant process.

          -  Subjects taking high potency opioid analgesics.

          -  Previous exposure to secukinumab or other biologic drug directly targeting
             interleukin-17 (IL-17) or IL-17 receptor.

          -  Ongoing use of prohibited psoriasis treatments / medications.

          -  Subjects who have ever received biologic immunomodulating agents except for those
             targeting TNFα.

          -  Previous treatment with any cell-depleting therapies.
Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin detemir; insulin NPH; insulin aspart
Intervention description: s.c. injection, once or twice daily.; s.c. injection, once or twice daily.; s.c. injection, at main meals.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 348.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe.

      The aim of this research is to compare the efficacy and safety of treatment with NPH insulin
      and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or
      twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Insulin detemir naive

          -  Type 1 diabetes for at least 12 months

          -  HbA1c lesser than or equal to 11.0%

        Exclusion Criteria:

          -  Significant concomitant diseases
PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
Intervention: PRC-063 oral capsules; Placebo oral capsules
Intervention description: Daily dose; Daily dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase
      3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in adults
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females 18 to 60 years of age

          2. Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or
             predominately inattentive type) by a psychiatrist, psychologist, or licensed allied
             healthcare professional

          3. Subject is willing and able to comply with all the protocol requirements.

        Exclusion Criteria:

          1. Primary and/or comorbid psychiatric diagnosis other than ADHD

          2. Has a current or recent history of hypertension, symptomatic cardiovascular disease,
             advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious
             heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
             that may place them at increased vulnerability to the sympathomimetic effects of a
             stimulant drug;

          3. Has used any investigational drug within 30 days of the screening visit;
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: Tocilizumab (TCZ); Placebo
Intervention description: Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.; Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of
      tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC)
      in hospitalized patients with severe COVID-19 pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive
             PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and
             evidenced by chest X-ray or CT scan

          -  SPO2 </=93% or PaO2/FiO2 <300 mmHg

        Exclusion Criteria:

          -  Known severe allergic reactions to TCZ or other monoclonal antibodies

          -  Active tuberculosis (TB) infection

          -  Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)

          -  In the opinion of the investigator, progression to death is imminent and inevitable
             within the next 24 hours, irrespective of the provision of treatments

          -  Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the
             past 3 months

          -  Participating in other drug clinical trials (participation in COVID-19 anti-viral
             trials may be permitted if approved by Medical Monitor)

          -  Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination

          -  Treatment with an investigational drug within 5 half-lives or 30 days (whichever is
             longer) of randomization (investigational COVID-19 antivirals may be permitted if
             approved by Medial Monitor)

          -  Any serious medical condition or abnormality of clinical laboratory tests that, in the
             investigator's judgment, precludes the patient's safe participation in and completion
             of the study

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit
             of normal (ULN) detected within 24 hours at screening (per local lab)

          -  Absolute neutrophil count (ANC) < 1000/mL at screening (per local lab)

          -  Platelet count < 50,000/mL at screening (per local lab)
Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Intervention: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301); Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
Intervention description: 0.5 mL, subcutaneous injection; 0.1 mL, subcutaneous injection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 446.0
Sex: All
Minimum age: 11 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; DTaP vaccine; Adolescents

Summary:

      This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a
      booster dose in adolescents.

      The purposes of this study are as follows:

        -  To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid
           (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and
           anti-tetanus toxoid (anti-T) antibodies

        -  To confirm that booster responses for anti-pertussis toxoid (anti-PT) and
           anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants
           received BK1301
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 11 or 12 years on the day of injection

          -  Received 3 or 4 doses of DTaP vaccine

        Exclusion Criteria:

          -  History of pertussis, diphtheria, tetanus

          -  History of anaphylaxis to vaccine components

          -  Serious conditions or diseases of the heart, vein, blood, respiratory, hepar, kidney,
             digestive system, psychiatric or nervous system

          -  Transfused or received gamma globulin within 3 months, or received high-dose gamma
             globulin within 6 months before the day of injection
Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate
Condition: Osteoporosis; Hypomagnesemia
MeSH terms: Osteoporosis
Intervention: EffCaMgCit; Placebo
Intervention description: Each sachet of EffCaMgCit will contain 19 meq or 380 mg calcium, 10 meq (122 mg) magnesium, and 50 meq total citrate.; Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate. Placebo will be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing. The placebo will contain 400 units of vitamin D.
Intervention MeSH terms: Magnesium citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: To provide adequate blinding, each medication sachet will be labelled with the study name, IRB number, principal investigator's name, expiration date and identification number of the study subject. Labels will be applied to the appropriate medication sachets once the subject has been randomized and assigned to a treatment group. Labelling of the sachets will be done by personnel who are not engaged in patient care.
Enrollment: 62.0
Sex: All
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bone mineral density

Summary:

      Proton pump inhibitors (PPIs) are widely used for the control of gastric ulcer-gastritis,
      erosive esophagitis (gastroesophageal reflux disease), peptic ulcer disease (duodenal ulcer),
      and heartburn. Despite their efficacy, their use has been implicated in possibly causing
      fragility fractures (osteoporosis), hypomagnesemia (magnesium deficiency) and increased risk
      of chronic kidney disease (CKD). The current trial represents the investigators' ongoing
      effort to discern whether these complications could be averted by effervescent calcium
      magnesium citrate (EffCaMgCit).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have taken PPI (omeprazole or equivalent ≥ 20 mg/day, ≥ three times per week, for
             at least 2 months)

          -  Expected to continue at a similar dosage

          -  Stage 1 hypertension (with systolic blood pressure <140 and diastolic <90)

          -  controlled diabetes mellitus Type II with HbA1C less than 7%

        Exclusion Criteria:

          -  end-stage renal failure on dialysis

          -  hypercalcemia

          -  hypophosphatemia (serum P < 2.5 mg/dL)

          -  hypertension stage 2 or higher

          -  diabetes Type II with HbA1C ≥ 7%

          -  treatment with adrenocorticosteroids, diuretics, non-steroidal anti-inflammatory
             agents

          -  regular dose of magnesium supplements, bisphosphonate, teriparatide, denosumab or
             selective estrogen receptor modulators.

        Inclusion/exclusion of other drugs or conditions will be considered on an individual basis.
Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Antimicrobial Barrier Dressing; Negative Pressure Wound Therapy (NPWT)
Intervention description: Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.; PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing
      or portable negative pressure wound dressing is superior in preventing wound complications
      and infection rates in obese patients undergoing total joint arthroplasty (TJA).
      Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip
      arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated
      dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and
      analyze the cost benefit of each.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Those identified at pre-operative testing to have an elevated BMI (> 35)

        Exclusion Criteria:

          -  Active infection

          -  previous scar or wound healing complication

          -  post traumatic degenerative joint disease (DJD) with hardware

          -  revision surgery

          -  inflammatory arthritis

          -  anticoagulation outside of the standard of care.
Effect of Ruboxistaurin on Clinically Significant Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Ruboxistaurin; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Ruboxistaurin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 309.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin
      will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with
      clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from
      baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity
      that is sustained for the patient's last 6 months of study participation. The SMVL data from
      this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of
      comparing ruboxistaurin to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or 2 diabetes

          -  18 years or older

          -  Hemoglobin A1c (HbA1c) less than or equal to 11%

          -  Mild to very severe non-proliferative diabetic retinopathy in the study eye

          -  Clinically significant macular edema in the study eye not within 100 microns of center
             of macula

        Exclusion Criteria:

          -  Previous surgery or laser treatment (or need for laser treatment within 3 months) in
             the study eye

          -  Glaucoma in the study eye

          -  Unstable cardiovascular disease

          -  Major surgery within past 3 months

          -  Significantly impaired kidney or liver function, or malignancy requiring chemotherapy
             or radiation therapy.
ORTHOVISC Shoulder Osteoarthritis Study
Condition: Glenohumeral Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Orthovisc; Control
Intervention description: Orthovisc injection; Celestone (betamethasone sodium phosphate and acetate) - 2 mL
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 274.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Orthovisc; Osteoarthritis; Shoulder; Randomized

Summary:

      A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to
      osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A candidate for unilateral treatment of osteoarthritis of the shoulder

          -  Have failed conservative treatment

        Exclusion Criteria:

          -  Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator
             cuff function

          -  No active instability or acute dislocation episodes within the previous 12 months

          -  Known allergy to hyaluronate preparations

          -  Pregnant or breast feeding

          -  Is receiving prescription pain medication for conditions unrelated to the index
             shoulder condition
A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: DCV; SOF; RBV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with
      Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients
      with liver cirrhosis.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation,
        please visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Genotype 3 HCV

          -  HCV RNA ≥10000 IU (International Unit)/mL

          -  Compensated Liver Cirrhosis

          -  BMI 18-40 kg/m2

          -  Previously treated for HCV or never treated for HCV

        Exclusion Criteria:

          -  Infection with HCV other than Genotype 3. Mixed infection of any genotype

          -  Evidence of decompensated liver disease

          -  Previous exposure to NS5A inhibitors

        Other protocol defined inclusion/exclusion criteria could apply