bioihbjkbjnl/mcl2 huggingface dataset:
Secondary Prevention of Venous Thrombo Embolism (VTE).
Condition: Thromboembolism
MeSH terms: Thromboembolism
Intervention: Dabigatran; Warfarin
Intervention description: Dabigatran 150 mg BID (twice daily); Warfarin dosed individually to maintain INR 2.0-3.0
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 2867.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The general aim of this study is to determine the comparative safety and efficacy of
      dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR)
      of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous
      thromboembolism in patients who have been successfully treated with standard doses of an
      approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous
      Thrombo-embolism.
    

Eligibility criteria:

        Inclusion criteria:

        Inclusion_Criteria

          -  Acute symptomatic deep vein thrombosis (DVT)

          -  Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by
             objective testing

        Exclusion criteria:

        Exclusion_Criteria

          -  Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more
             weeks during the 3-12 months of treatment for the prior VTE.

          -  Patients who in the investigators judgement are perceived as having an excessive risk
             of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x
             ULN

          -  Severe renal impairment (estimated creatinine clearance <= 30 ml/min)
Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
Condition: Dysmenorrhea
MeSH terms: Endometriosis; Dysmenorrhea
Intervention: NPC-01
Intervention description: This study consist of the following steps.
Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.
Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):
After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this long-term study is to determine whether NPC-01 is effective in the
      treatment of dysmenorrhea associated with endometriosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dysmenorrhea associated with endometriosis

        Exclusion Criteria:

          -  Severe hepatopathy

          -  Pregnant woman
Motivational Interviewing to Improve Work Outcomes in Schizophrenia
Condition: Schizoaffective Disorder; Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: IPS; IE; VOMI
Intervention description: Individual Placement and Support Evidence based supported employment; Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search; Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: clinical trial; employment; schizoaffective disorder; schizophrenia

Summary:

      Many persons with schizophrenia have difficulty getting and keeping a job. This study is
      designed to compare the benefits of four sessions of motivational interviewing or illness
      education in increasing employment rates accruing from participation in supported employment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have schizophrenia or schizoaffective disease

          -  Currently unemployed but want to get at least a part time job

          -  Be on a stable medication regimen and compliant with treatment

          -  Live within one hour of the hospital

          -  Be willing to have care transferred to the Schizophrenia Outpatient Clinic at VA
             Greater Los Angeles Healthcare System

        Exclusion Criteria:

          -  Organic brain disease

          -  Physical illnesses that would preclude working
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Condition: Gout
MeSH terms: Gout
Intervention: pegloticase
Intervention description: 8 mg intravenous infusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gout; chronic gout

Summary:

      This is an open-label extension phase of two double-blind, placebo-controled Phase 3
      protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic
      gout. The purpose of this study is to provide a continuation of treatment to subjects
      completing the double-blind studies and obtain long-term safety and efficacy data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed treatment in one of two double-blind, placebo controlled studies of
             PEG-uricase in subjects with hyperuricemia and symptomatic gout

        Exclusion Criteria:

          -  unstable angina

          -  uncontrolled arrhythmia

          -  uncontrolled hypertension

          -  end stage renal disease requiring dialysis

          -  anemia
The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression
Condition: Depression; Major Depressive Disorder; Unipolar Depression
MeSH terms: Neurobehavioral Manifestations; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Wellbutrin; Placebo
Intervention MeSH terms: Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: depression; serotonin; norepinephrine; SSRI; Wellbutrin; bupropion; executive function; residual symptoms

Summary:

      Many people with depression are treated with a serotonin-specific reuptake inhibitor
      anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not
      feel completely 'well'. Often, individuals continue to complain of cognitive problems such as
      lack of attention, diminished motivation, and impaired problem-solving. This study looks at
      whether residual and cognitive symptoms of depression in individuals are affected by the
      addition of Wellbutrin (bupropion).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Depression

          -  SSRI-treated

        Exclusion Criteria:

          -  Bipolar disorder

          -  Serotonin-norepinephrine reuptake inhibitor (SNRI) or bupropion treatment

          -  Treatment-resistant depression

          -  Seizure disorder

          -  Bulimia or anorexia nervosa

          -  Pregnancy
Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
Condition: Menorrhagia
MeSH terms: Menorrhagia
Intervention: Levonorgestrel IUS (Mirena, BAY86-5028); Medroxyprogesterone acetate
Intervention description: Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.; Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Intervention MeSH terms: Medroxyprogesterone Acetate; Levonorgestrel; Medroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Idiopathic Menorrhagia

Summary:

      The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine
      system is effective in decreasing menstrual blood loss.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who have >/= 80 mL blood loss during their menstrual cycles and desire
             contraception

        Exclusion Criteria:

          -  Post menopausal menstrual cycle < 21 days or > 35 days

          -  Pregnancy
A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: oseltamivir; placebo
Intervention description: Dose ranging between 30 to 150 mg orally administered as syrup or capsules (depending on participant's age and weight) po twice daily for 10 days; Placebo matched to oseltamivir po twice daily for 10 days
Intervention MeSH terms: Oseltamivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      This 2-arm study will investigate the safety and tolerability of oseltamivir for the
      treatment of influenza in immunocompromised participants and characterize the effects of
      oseltamivir in immunocompromised participants on the development of resistant influenza
      virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be
      randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily
      orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po
      depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken,
      and safety evaluations made, at intervals during the study. The anticipated time on study
      medication is 10 days and the anticipated time on study is 40 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours
             prior to first dose

          -  Immunocompromised participants with primary or secondary immunodeficiency

          -  Symptoms suggestive of influenza-like illness

          -  Use of an effective contraceptive, as specified by protocol; women of childbearing
             potential cannot be pregnant or breastfeeding

        Exclusion Criteria:

          -  Influenza vaccination with live attenuated vaccine in the 2 weeks prior to
             randomization

          -  Antiviral treatment for influenza in 2 weeks prior to randomization

          -  Severe hepatic impairment

          -  Any current renal replacement therapy

          -  Any gastrointestinal disorders which may interfere with the absorption of oseltamivir

          -  Participation in a study with an investigational drug from 4 weeks prior to study
             start until study end
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
Condition: Complicated Urinary Tract Infection; Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: plazomicin; meropenem; levofloxacin (oral)
Intervention MeSH terms: Levofloxacin; Meropenem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 609.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cUTI; AP; ACHN-490; anti-infective; anti-bacterial; antibiotic; anti-microbial; UTI; bacterial infection; Gram-negative

Summary:

      This was a randomized, multicenter, multinational, double-blind study comparing the efficacy
      and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in
      the treatment of cUTI, including AP, in adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Pyuria

          -  Have a pretreatment baseline urine culture obtained within 36 hours before the start
             of administration of the first dose of study drug

          -  Clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract
             infection

          -  Normal renal function or moderate renal impairment

        Key Exclusion Criteria:

          -  Confirmed fungal urinary tract infection at the time of randomization

          -  Known urinary tract infection or colonization with Gram-positive pathogens

          -  Current cUTI or AP is known to be caused by a pathogen resistant to meropenem

          -  Female participants of childbearing potential if they are known to be pregnant or have
             a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a
             highly effective method of birth control during the study and for at least 30 days
             following the last dose of study medication

          -  Any rapidly progressing disease or immediately life-threatening illness

          -  Documented presence of immunodeficiency or an immunocompromised condition

          -  Documented or known history of otologic surgery or disease including use of hearing
             aid, head injury leading to otologic damage, Ménière's disease, tumor of the head,
             neck, or auditory system, perilymphatic fistula, or autoimmune disease of the inner
             ear, or family history of hearing loss (excluding age-related hearing loss [onset
             after age of 65 years])
Dapagliflozin DPPIV Inhibitor add-on Study
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: 10 mg tablet, oral, once daily, 48 weeks; Matching placebo tablet
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 833.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dapagliflozin DPP IV inhibitor add on study; Inadequate control

Summary:

      This study aims to investigate how dapagliflozin can control blood sugar in patients with
      type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with
      metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes

          -  Patients who are not receiving treatment , or those who currently receive metformin,
             sitagliptin or vildagliptin or the combination of these

          -  Patients will be screened by a blood test and only those who need additional therapy
             can be enrolled

        Exclusion Criteria:

          -  Patients with type 1 diabetes

          -  Patients with very poorly controlled diabetes

          -  Any clinically significant illness, which in the judgement of the investigator would
             compromise the patient's safety or successful participation in the clinical study
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: CM-AT; PLACEBO
Intervention description: Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days; Single unit dose powder of non-active substance administered 3 times per day for 90 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: All
Minimum age: 3 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Autism

Summary:

      The purpose of this study is to determine whether CM-AT is safe and effective in treating the
      core symptoms of autism in children with all levels of fecal chymotrypsin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets the current Diagnostic and Statistical Manual with Mental Disorders (DSM-IV-TR)
             for Autism (Autistic Disorder), screened by SCQ and confirmed by ADI-R;

        Exclusion Criteria:

          -  Patient weighing < 13kg (28.6 lbs)

          -  Previous allergy to porcine (pork) products

          -  Previous history of severe head trauma or stroke, loss of consciousness, seizure (or
             need for seizure medication either present or past) within one year of entering study
             or uncontrolled systemic disease

          -  Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease, muscular
             dystrophy, known genetic disorder, blood dyscrasia, ongoing GI disease

          -  Evidence of severe, moderate or uncontrolled systemic disease; and/or any co-morbid
             condition which in the Investigator's or Medical Director's opinion makes it
             undesirable for the subject to participate in the study or jeopardizes compliance with
             the protocol;

          -  Within 30 days of starting the study, certain supplementation, chelation or dietary
             restriction (a 30 day washout period would be required for inclusion);

          -  Ongoing dietary restriction for allergy or other reasons except nut allergies
             (lactose-free allowable);

          -  Use of of any stimulant medication must be discontinued 5 days prior to entering the
             study.

          -  Subject must have a stable dose of SSRI's for at least 30 days.

          -  Inability to ingest study drug and/or follow prescribed dosing schedule
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
Condition: Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Intervention: IV Vancomycin plus IV Aztreonam; Ceftaroline
Intervention description: vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.; 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
Intervention MeSH terms: Vancomycin; Ceftaroline fosamil; Aztreonam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 698.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abscess; Antibacterial; Antibiotic; Antimicrobial; Bacterial infection, skin; Ceftaroline; Ceftaroline acetate; Cellulitis; Cephalosporin; Complicated skin and skin structure infection; cSSSI; Intravenous; Methicillin-resistant Staphylococcus Aureus (MRSA); PPI-0903; Prodrug; Skin disease, bacterial; Skin infection; Staphylococcal skin infection; Staphylococcus aureus; Streptococcal skin infection; Surgical site infection; TAK-599

Summary:

      The purpose of this study is to determine whether ceftaroline is effective and safe in the
      treatment of complicated skin infections in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires
             significant surgical intervention, or cellulitis or abscess on lower extremity which
             occurs in subjects with diabetes mellitus or well-documented peripheral vascular
             disease.

        Exclusion Criteria:

          -  Prior treatment of current cSSSI with an antimicrobial.

          -  Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior
             isolation of an organism with in vitro resistance to vancomycin or aztreonam.
Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: etanercept
Intervention description: 50mg subcutaneous, once weekly, 24 weeks
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the
      high capacity process. Descriptive results will be provided however a formal hypothesis will
      not be tested in this trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe active disease with presence of at least 4 tender joints and 4
             swollen joints.

          -  Either the patient or a designee must be capable of administering the subcutaneous
             injection of study drug.

        Exclusion Criteria:

          -  Prior treatment with etanercept.

          -  Presence of active infection or active or untreated tuberculosis.