bioihbjkbjnl/mcl2 huggingface dataset:
Asenapine in the Treatment of Older Adults With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Asenapine
Intervention description: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist.
Intervention MeSH terms: Asenapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      Objectives: The investigators propose a first-ever, prospective trial of asenapine in older
      adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and
      functional/general health status. Given the dearth of treatment data on older adults with BD,
      findings are likely to be of substantial clinical interest, may inform larger future studies
      and will assist in refining bipolar treatment recommendations.

      Hypotheses:

      Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive
      symptoms in older adults with BD.

      Secondary: Asenapine therapy will be associated with improved functional and general health
      status, improved global psychopathology, and good tolerability in older adults with BD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have type I Bipolar disorder by DSM-IV criteria confirmed on the Mini
             Neuropsychiatric Interview (MINI)

          -  Subjects must be age 60 or older

          -  Subjects must have sub-optimal response to current psychotropic management including
             at least one of the following:

               1. Behaviors and symptoms of irritability, agitation, mood lability or diminished
                  ability to interact with others in their place of residence

               2. Diminished ability to take care of basic personal needs in their place of
                  residence due to symptoms of BD

        Exclusion Criteria:

          -  History of intolerance or resistance to asenapine

          -  Clinical diagnosis of dementia or Mini-mental state (MMSE) < 24

          -  History of TIA, stroke or MI within the past 12 months

          -  Medical illness that is the clear, underlying etiology of BD

          -  Unstable medical illness or condition including prolonged QT interval, which in the
             opinion of the study investigators, is likely to affect the outcome of the study or
             the subject's safety

          -  DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months.

          -  Rapid cycling BD defined as 4 or more discrete mood episodes within the previous 12
             months.

          -  At high risk for self-harm or suicide
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia
Condition: ADHD With Sleep Onset Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Ramelteon; Placebo
Intervention description: 8 mg tablets every night for 2 weeks; placebo tablets for every night for 2 weeks
Phase: Phase 4
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: 19 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset
      and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to
      placebo. Secondary:We expect that Ramelteon will show statistically significant improvements
      vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning,
      including such specific items as focus and social and occupational functioning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ADHD and insomnia-

          -  19-65 years of age

          -  In good general health

          -  Negative pregnancy test

        Exclusion Criteria:

          -  Current primary psychiatric diagnosis other than ADHD

          -  Positive urine drug screen for any sedative hypnotic or drugs of abuse

          -  Unstable medical condition

          -  HIV positive

          -  Seizure disorder

          -  Known hypersensitivity to Ramelteon
Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty
Condition: Rhinoplasty; Non-steroidal Ant Inflammatory Drugs; Opioid Use
Intervention: Norco; NSAID
Intervention description: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco); Ibuprofen 400mg for post-operative pain
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of oral opiate pain
      medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative
      rhinoplasty pain. This study will also evaluate potential contributing factors affecting the
      efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs
      in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used
      for post-operative pain. The study will then compare which is more effective in controlling
      post operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either
             obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical
             techniques utilized will be included. This will include patients that undergo
             additional procedures during the rhinoplasty including osteotomies, turbinate
             reduction, septoplasty, nasal valve repair and ear cartilage graft.

        Exclusion Criteria:

          -  Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure
             as this is known to cause significant pleuritic chest pain.

          -  Patients receiving functional endoscopic sinus surgery concurrently with the
             rhinoplasty will be excluded.

          -  Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who
             have other comorbidities that prevent them from taking NSAIDs.

          -  Patients with a history of radiation, active head and neck malignancy or other pain
             disorders such as various rheumatologic diseases will be excluded to decrease
             confounding factors in the control of pain.
Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
Condition: Bone Infection; Joint Infection
MeSH terms: Infections; Communicable Diseases; Arthritis, Infectious
Intervention: Antibiotics
Intervention description: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.
Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines.
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1054.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oral; intravenous; antibiotics; bone; joint; infection

Summary:

      The study will compare the outcomes of treating bone and joint infections with 6 weeks of
      intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic
      "strategy" rather than of individual antibiotics. The study will be open label, but the
      primary outcome will be proven failure of infection treatment, determined by pre-established
      objective criteria for treatment failure. The null hypothesis tested is that there will be no
      difference in treatment failure rates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is willing and able to give informed consent for participation in the study. Has a
             bone and joint infection one of the following categories;

               1. Native osteomyelitis.

               2. Native joint septic arthritis.

               3. Diabetic foot infection with osteomyelitis.

               4. Prosthetic joint associated infection.

               5. Discitis/ spinal osteomyelitis/ epidural abscess

          -  Has had at least 48 hours, but not more than 7 days, of IV antibiotic therapy already
             given after definitive surgical management.

          -  Has a clinical diagnosis of bacterial infection (caused by any organism excepting
             mycobacteria).

          -  Is clinically stable in the opinion of the study clinicians, has no further
             interventions to treat acute infection required or planned.

        Exclusion Criteria:

          -  Has Staph aureus bacteraemia.

          -  Has suspected bacterial endocarditis.

          -  Has suspected mediastinal infection.

          -  Has suspected central nervous system infection.
Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease; Bronchitis; Emphysema
MeSH terms: Bronchitis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Intervention: Arformoterol Tartrate Inhalation Solution; Tiotropium; Arformoterol and Tiotropium; Placebo
Intervention description: Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.; Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.; Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.; Placebo inhalation solution and placebo inhalation powder
Intervention MeSH terms: Tiotropium Bromide; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 235.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: COPD including chronic bronchitis and emphysema

Summary:

      The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day
      and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects
      with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects must be at least 45 years old at the time of consent.

          -  Subjects must have a pre-established primary clinical diagnosis of COPD.

          -  Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1.

          -  Subjects must have a FEV1 ≥ 0.70L at Visit 1.

        Exclusion Criteria:

          -  Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.

          -  Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness
             severity grade of ³2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at
             Visit 1.
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Condition: Pleural Infection; Empyema; Pleural Diseases; Parapneumonic Effusion
MeSH terms: Infections; Communicable Diseases; Empyema; Pleural Diseases
Intervention: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase); Medical Thoracoscopy
Intervention description: Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose; Medical thoracoscopy will be performed as per standard protocols.
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this prospective randomized clinical trial is to compare two currently
      accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to
      instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant
      Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion
      (CPPE) in adults.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects >18 years old with:

        Evidence of empyema or complex parapneumonic effusion

        Exclusion Criteria:

        Age <18 years Pregnancy Inability to give informed written consent Previous thoracic
        surgery or thrombolytic therapy for pleural infection Medical thoracoscopy cannot be
        performed within 48 hours Hemodynamic instability or severe hypoxemia Non corrected
        coagulopathy Homogeneously echogenic effusion on pleural ultrasonography
A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis
Condition: Anemia, Kidney Disease, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Methoxy polyethylene glycol-epoetin beta
Intervention description: Participants received 50-250 mcg SC according to local label
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This comparative, open-label, multicenter, parallel-group study evaluated the effect of
      altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to
      achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants
      with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea
      level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis,
      received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local
      prescribing label.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >/= 18 years of age

          -  Chronic kidney disease stage III-IV or V

          -  Probable start of dialysis within 18 months (pre-dialysis group)

          -  Hemodialysis or peritoneal dialysis in a stable regimen for at least 3 months
             (dialysis group)

          -  Adequate iron status

          -  Females of childbearing potential must agree to use two effective methods of
             contraception during the study and for at least 2 months following the last dose of
             study drug

        Exclusion Criteria:

          -  Failing renal allograft in place

          -  Acute or chronic bleeding within 8 weeks prior to screening

          -  Transfusion of red blood cells within 8 weeks prior to screening

          -  Poorly controlled hypertension, defined as hypertension that needs hospitalization to
             obtain control

          -  History of seizures, hemoglobinopathies and/or severe liver disease

          -  Active malignant disease, except for non-melanoma skin cancer

          -  Immunosuppressive therapy in the 12 weeks prior to screening

          -  Treatment with any other investigational agent or participation in a clinical trial
             within 28 days prior to enrolment

          -  Known hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of
             its excipients

          -  Pregnant or lactating women
Fluoxetine in Pediatric Body Dysmorphic Disorder
Condition: Body Dysmorphic Disorder
MeSH terms: Body Dysmorphic Disorders
Intervention: Fluoxetine; Placebo
Intervention description: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.; Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.
Intervention MeSH terms: Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Body Dysmorphic Disorder; BDD; BDD treatment; delusionality variant; OCD

Summary:

      This trial will study the effectiveness of the medication fluoxetine for children and
      adolescents ages 16 and younger with BDD who qualify.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female children and adolescents aged 16 and younger

          -  BDD or its delusional variant present currently and for at least 6 months prior to the
             study

          -  Ability to communicate meaningfully with the investigators and competent to provide
             written assent

        Exclusion Criteria:

          -  Presence of Schizophrenia or Bipolar Disorder

          -  Recent suicide attempt or suicidal ideations that warrant hospitalizations

          -  Previous allergic reaction to fluoxetine

          -  History of a seizure disorder
Methylphenidate for Attention Problems After Pediatric TBI
Condition: Traumatic Brain Injury; TBI; ADHD
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Intervention: Methylphenidate; Placebo
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: TBI; traumatic brain injury; ADHD; methylphenidate; Concerta; attention problems

Summary:

      Traumatic Brain Injury (TBI) - methylphenidate treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between ages of 6-17

          -  Sustained Moderate to Severe TBI

          -  TBI occurred at least 6 months prior to beginning the study

          -  TBI occurred no earlier than 5 years of age

          -  Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or
             hyperactivity scale

        Exclusion Criteria:

          -  History of developmental disability or mental retardation

          -  Current active participation in ADHD-related behavioral intervention

          -  History of psychiatric condition requiring an inpatient admission in past 12 months

          -  Actively taking medications with a contraindication to Concerta that cannot be
             discontinued

          -  Current use of stimulant medication or ADHD specific medications that cannot be
             discontinued

          -  Non-blunt head injury

          -  Family history of arrhythmia

          -  Pregnancy
Kidney Damage in Patients With Normal eGFR
Condition: Coronary Artery Stenosis
MeSH terms: Coronary Stenosis
Intervention: Non ionic contrast media comparator; Non ionic contrast media comparator
Intervention description: One time administration for PCI; one time administration for PCI
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated
      contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled
      must have normal eGFR. Statistical summaries will be presented to analyse the various
      laboratory tests for the two groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provides written Informed Consent and is willing to comply with protocol requirements;

          -  Is at least 18 years of age;

          -  Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic
             coronary angiography.

          -  Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2
             calculated with the MDRD formula within 72 hours prior to enrollment.

        Exclusion Criteria:

          -  Is a pregnant or lactating female.

          -  Has a history of severe congestive heart failure

          -  Has a history of hyperthyroidism

          -  Has a history of hypersensitivity to iodinated contrast agents

          -  Has unstable renal function