bioihbjkbjnl/mcl2 huggingface dataset:
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
Condition: Hypofibrinogenemia; Afibrinogenemia; Bleeding Disorders
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Afibrinogenemia
Intervention: RiaStAP; Saline
Intervention description: To decrease post-operative bleeding volume.; Placebo consisting of normal saline 0.9%
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 1 Day
Maximum age: 1 Year
Healthy volunteers: No
Keywords: CBP, congenital heart defects, cardiopulmonary bypass

Summary:

      The goal of the study is to determine whether the use of Human Fibrinogen Concentrate
      (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and
      infants undergoing cardiopulmonary bypass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus
             Children's Hospital will be eligible for enrollment in the study.

        Exclusion Criteria:

          -  Patients who fall outside of the age range for the study will be excluded. Patients
             known to have had an anaphylactic or severe reaction to the drug or its components
             will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM
             MCF > 15mm, will be excluded.
Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China
Condition: HEMOPHILIA B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Benefix
Intervention description: Subjects will be treated by the investigator according to usual care in China and in accord with the China BeneFIX Package Insert.
The treatment duration is approximately 6 months (±7 days) or approximately 50 Exposure Days (EDs) (±5 EDs) (see protocol definition on EDs) whichever occurs first.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this post-approval study is to evaluate the safety and efficacy of Benefix in
      subjects with hemophilia B in usual care settings in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and/or female subjects with hemophilia B.

          -  Subjects/parents/legal representatives must be able to comply with study procedures
             (informed consent/assent process, clinical visits, reporting of infusion and bleed
             data, reporting of adverse events, etc)

        Exclusion Criteria:

          -  Presence of any other bleeding disorder in addition to hemophilia B. Subjects with a
             past history of, or current factor IX inhibitor. For laboratory-based assessments, any
             Bethesda inhibitor titer greater than the laboratory's normal range or ≥0.6 Bethesda
             Unit (BU)/mL.

          -  Subjects with known hypersensitivity to the active substance or to any of the
             excipients of BeneFIX.

          -  Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; biphasic insulin aspart 30; metformin
Intervention description: Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.; Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin.; Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic
      control of biphasic insulin aspart 30 twice daily with two different dosage split regimens
      for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a
      glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in
             combination with metformin and glimepiride in trial BIAsp-3756

          -  HbA1c above or equal to 7.0%

          -  Body Mass Index (BMI) below or equal to 40.0 kg/m2

        Exclusion Criteria:

          -  Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial
             BIAsp-3756

          -  Known proliferative retinopathy or maculopathy requiring acute treatment

          -  Any disease or condition which the Investigator (trial physician) feels would
             interfere with the trial
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: Bimatoprost 0.01%
Intervention description: 1 drop in the affected eye(s), administered in the evening for 12 weeks.
Intervention MeSH terms: Bimatoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 800.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with
      elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular
      hypertension (OH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

        Exclusion Criteria:

          -  None
Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Clonidine; Placebo
Intervention description: clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine; Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 36 Weeks
Maximum age: 45 Weeks
Healthy volunteers: No

Summary:

      This is a prospective randomized double blinded study comparing the effect on duration of
      pharmacologic treatment and duration of hospital stay when using clonidine at 12
      µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the
      management of term and near term infants with neonatal abstinence syndrome (NAS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requiring neonatal intensive care unit (NICU) admission for management of neonatal
             abstinence syndrome

          -  Gestational age greater than or equal to 36 weeks

          -  Less than or equal to 48 hours of treatment with morphine for NAS

        Exclusion Criteria:

          -  Presence of seizures

          -  Congenital malformations, genetic syndromes or the presence of TORCH infections

          -  Major medical problems

          -  Heart rate and/or blood pressure instability
Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: clindamycin phosphate 1.2% and tretinoin 0.025%; clindamycin 1% gel; tretinoin 0.025% cream
Intervention description: applied once daily for 12 weeks; Topical clindamycin applied each morning for 12 weeks; Tretinoin 0.025% cream each evening for 12 weeks
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Mild to moderate acne vulgaris

Summary:

      The purpose of this research study is to evaluate the effectiveness of two different types of
      topical acne medication. This study will help to determine if one combined medication results
      in better acne improvement than two separate medications for acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or Females 12 years of age or older with a diagnosis of mild to moderate acne
             vulgaris.

          -  Subjects must sign written informed consent and agree to come for all study visits.

        Exclusion Criteria:

          -  Use of experimental drugs within 1 month prior to initiation of study therapy.

          -  Pregnant and nursing females will not be allowed in the study, and females of
             childbearing potential will have a pregnancy test at baseline. Females of childbearing
             potential must agree to use approved birth control methods for the duration of the
             study.

          -  Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids,
             systemic antibiotics, nicotinamide, systemic steroids or any other medication that may
             confound the results of the study within 1 month prior to start of the study

          -  Use of any other topical medications for acne, including cosmetics containing retinol,
             within 2 weeks prior to study entry.

          -  Any skin condition or disease that may require concurrent therapy or may confound the
             evaluation;

          -  History of hypersensitivity to any of the formulation components;

          -  Facial skin cancer or facial actinic keratosis;

          -  Use of any photosensitizing agents.

          -  Use of isotretinoin within the last 6 months.

          -  Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.

          -  Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic
             use.
Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Duloxetine
Intervention description: Participants received increasing amounts of Duloxetine for 7 weeks.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OCD; Obsessive Compulsive Disorder; Obsessions; Compulsions; Duloxetine; Cymbalta

Summary:

      The purpose of this study is to assess the efficacy of Duloxetine in the treatment of
      obsessive compulsive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of OCD by DSM-IV

          -  Age 18-65

          -  Y-BOCS greater than 20

          -  Written informed consent

          -  Females of childbearing potential must have a negative serum or urinary beta-HCG test.

        Exclusion Criteria:

          -  Pregnant women or women of childbearing potential who are not using a medically
             accepted means of contraception.

          -  Patients who, in the investigator's judgment, pose a serious suicidal or homicidal
             risk.

          -  Serious or unstable medical illness including cardiovascular (including hypertension),
             hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients
             on anticoagulant therapy.

          -  History of seizure disorder

          -  Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental
             disorder

          -  If there is a history of substance abuse, patients in remission at least 6 months.

          -  Currently being treated with behavioral therapy, specifically exposure and response
             prevention, for OCD.

          -  Other medications for medical disorders that may interfere with duloxetine

          -  Current major depression or prescribed an antidepressant for major depression within
             the past 12 months. We will assess depressive symptoms with the BDI throughout the
             course of the study in order to assess subsyndromal depressive symptoms and to assess
             for the emergence of depressive symptoms.

          -  Taken other psychotropic medication within 2 weeks of beginning the study (4 weeks for
             fluoxetine).

          -  More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with
             another SSRI in the past.

          -  Known hypersensitivity to duloxetine or any of the inactive ingredients.

          -  Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or
             potential need to use an MAOI drug during the study or within 5 days of
             discontinuation of study drug.

          -  Patients with uncontrolled narrow-angle glaucoma.
A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Triptorelin 11.25 mg
Intervention description: Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the benefit of immediate hormonal treatment after
      Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To
      reach this target, the trial will compare a group of patients treated with triptorelin at 8
      weeks after the surgery and for a duration of 9 months (3 injections) versus another group
      (called "active surveillance group") who will be not receiving triptorelin. Both groups will
      be followed every 3 months to monitor any sign of disease progression during a minimum of 36
      months
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically confirmed adenocarcinoma of the prostate

          -  Radical Prostatectomy with curative intent performed no more than 8 weeks before
             randomisation

          -  High risk criteria of disease progression, defined as follows:

        Gleason score ≥8 on prostatectomy specimen, and/or Pre RP PSA level ≥20 ng/mL, and/or
        Primary tumour stage 3a (pT3a) (with any PSA level and any Gleason score)

          -  Post-RP PSA levels ≤0.2 ng/mL at 6 weeks

        Exclusion Criteria:

          -  Evidence of lymph nodes or distant metastasis

          -  Positive margins

          -  Evidence of any other malignant disease, not treated with a curative intent

          -  Had surgical castration
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Olopatadine HCl Nasal Spray, 0.6%; Azelastine HCl Nasal Spray, 0.1%
Intervention description: 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days; 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days
Intervention MeSH terms: Azelastine; Olopatadine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Rhinitis; Allergy; Nasal Spray; Antihistamine; Intranasal Corticosteroid

Summary:

      The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with
      Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal
      Spray for the treatment of seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide consent/assent

          -  History of spring/summer allergic rhinitis

          -  Positive skin prick and/or intradermal test

          -  Absence of significant anatomic abnormalities, infection, bleeding, and mucosal
             ulcerations

          -  Non-pregnant (where applicable)

          -  Able to complete daily diary

        Exclusion Criteria:

          -  Smoker

          -  Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps

          -  History of current chronic sinusitis

          -  Asthma

          -  Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting
             antihistamines

          -  History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or
             other diseases/illnesses

          -  History or evidence of nasolacrimal drainage system malfunction
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Condition: Smoking Cessation
MeSH terms: Mental Disorders; Problem Behavior
Intervention: Placebo; varenicline tartrate; bupropion hydrochloride; Nicotine Replacement Therapy Patch
Intervention description: Triple dummy placebo for each treatment arm; Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks; Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).; Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8144.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking cessation; psychiatric disease

Summary:

      This study is being conducted to assess varenicline and bupropion as aids to smoking
      cessation treatment in subjects with and without an established diagnosis of major
      psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified
      adverse events (AEs) in both of these populations).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and
             considered suitable for a smoking cessation attempt.

          -  Smoked an average of at least 10 cigarettes per day during past year and during the
             month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at
             screening.

          -  For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in
             protocol.

        Exclusion Criteria:

          -  Subjects with a past or current diagnosis of one of the following disorders:

             a. Psychotic Disorders:

          -  Schizophreniform

          -  Delusional Disorder

          -  Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive
             Disorders c. All Substance Induced Disorders (Other than nicotine)
Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Dalteparin (Fragmin); Unfractionated heparin
Intervention description: Dalteparin 5000 IU once daily subcutaneously for 6-14 days.; Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.
Intervention MeSH terms: Heparin; Calcium heparin; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica

Summary:

      The purpose of this study is to compare the efficacy and safety of dalteparin vs
      unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized
      acutely ill medical patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged greater than or equal to 18 years

          -  Acute medical condition with a projected hospitalization of greater than or equal to 4
             days and had less than or equal to 3 days of prior immobilization for more than two
             thirds of the day

          -  Acute congestive heart failure Class III-IV per NHYA/ Acute respiratory failure not
             requiring mechanical ventilation or Both

          -  Acute infection without septic shock/ Acute episode of inflammatory bowel disease/
             Acute rheumatologic disorders/ Acute lumbar pain or sciatica or vertebral compression
             with at least one risk factor for VTE

        Exclusion Criteria:

          -  Contraindications to use of anticoagulants

          -  Active bleeding or abnormal coagulation tests

          -  Recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or
             intracranial aneurysm or ischemic stroke within the last month.

          -  Major surgical or invasive procedure within the last month resulting in ongoing
             convalescence

          -  Lumbar or spinal puncture within last 48 hours

          -  S creatinine levels more than 2

          -  On inotropic agents