bioihbjkbjnl/mcl2 huggingface dataset:
COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: Corox OTW Steroid Left Ventricular Lead
Intervention description: This is a registry: no study required interventions necessary.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Congestive Heart Failure; Cardiac Resynchronization Therapy; Left Ventricular Lead

Summary:

      The objective of this post approval registry is to confirm the long-term safety and
      effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in
      conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The
      Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left
      ventricle in a CRT-D system. The following are the specific objectives to be evaluated during
      this post-approval registry:

        -  Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing

        -  Safety of the COROX OTW Steroid LV pacing lead
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully implanted BIOTRONIK CRT-D system, including the Corox OTW Steroid LV
             Lead, from 1-30 days prior to enrollment

          -  Able to understand the nature of the registry and give informed consent

          -  Available for follow-up visits on a regular basis at the investigational site

          -  Age greater than or equal to 18 years

        Exclusion Criteria:

          -  Enrolled in another cardiovascular or pharmacological clinical investigation

          -  Planned cardiac surgical procedures or interventional measures within the next 6
             months

          -  Expected to receive a heart transplant within 6 months

          -  Life expectancy less than 6 months

          -  Presence of another life-threatening, underlying illness separate from their cardiac
             disorder

          -  Pregnancy
DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Intervention: Gadoterate meglumine
Intervention description: Gadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec.
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: DCE-MRI; Sorafenib response

Summary:

      The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance
      Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC)
      to treatment with Sorafenib assessed by mRECIST.
    

Eligibility criteria:

        1. Male and female adult patients (age ≥ 20 years old)

          2. Patients diagnosed with unresectable HCC [Child Pugh class A and major vascular
             invasion, extrahapatic metastasis, or progression after transarterial
             chemoembolization more than 2 times]

          3. Presence of mRECIST target lesion within liver [lesion which can be classified as a
             RECIST measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion
             suitable for repeated measure, lesion showing intraluminal arterial enhancement on
             contrast-enhanced CT or MRI]

          4. Patients planned to be treated with sorafenib

          5. Patient with liver CT performed or planned to be performed within 4 weeks before
             initiation of sorafenib treatment

          6. Patient with a life expectancy of 12 weeks or more

          7. No previous treatment with sorafenib

          8. Female patients who are surgically sterilized, or post-menopausal (minimum 12 months
             of amenorrhea) or who have a documented negative urine hCG test at screening
Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
Condition: Body Dysmorphic Disorder
MeSH terms: Body Dysmorphic Disorders
Intervention: Levetiracetam
Intervention description: The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
Intervention MeSH terms: Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: body dysmorphic disorder; levetiracetam

Summary:

      The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for
      people with body dysmorphic disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18-65;

          -  Current DSM-IV BDD or its delusional variant (delusional disorder, somatic type) for
             at least 3 months;

          -  A minimum total score of 20 on the Yale-Brown Obsessive Compulsive Scale Modified for
             BDD (BDD-YBOCS) (19);

          -  Suitable for treatment in an outpatient setting

        Exclusion Criteria:

          -  Unstable medical illness, including renal failure or dialysis;

          -  Myocardial infarction within 6 months;

          -  Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential;

          -  A need for prn benzodiazepines, another antiepileptic medication, or an anticipated
             change in the dose of any concomitant medications while receiving treatment with
             levetiracetam;

          -  Clinically significant suicidality, including a suicide attempt within the past two
             months;

          -  Lifetime history of DSM-IV dementia, schizophrenia, or any other DSM-IV psychotic
             disorder that is not attributable to BDD;

          -  Current or recent (past 3 months) DSM-IV substance abuse or dependence;

          -  Initiation of ongoing psychotherapy from a mental health professional within 3 months
             prior to study baseline;

          -  Ongoing cognitive-behavioral therapy from a mental health professional;

          -  Previous treatment with levetiracetam;

          -  Treatment with investigational medication, depot neuroleptics, or ECT within the past
             3 months.
Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?
Condition: Hip Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Intervention: tranexamic acid; placebo
Intervention description: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.; A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture; Orthopaedic Trauma Association (OTA) fracture

Summary:

      Does tranexamic acid improve the perioperative care of those patients treated surgically for
      hip fracture by decreasing the proportion of patients requiring transfusion and decreasing
      total perioperative bleeding.
    

Eligibility criteria:

        Inclusion criteria

          -  AO/OTA (Orthopedic Trauma Association) fracture classification 31B

          -  Surgically treated with either hemiarthroplasty or total hip arthroplasty

          -  Acute fracture treated within 72 hours of injury

          -  Low energy isolated injury

          -  Age greater than 18 years old

        Exclusion Criteria

          -  Transfusion received during admission, prior to surgery

          -  Creatinine clearance less than 30 mL/min

          -  History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE

          -  Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation,
             anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant

          -  Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of
             child-bearing potential)

          -  History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within
             the previous 30 days

          -  Coronary stent placement within the previous 6 months

          -  Disseminated intravascular coagulation

          -  Subarachnoid hemorrhage
A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.
Condition: Obesity
MeSH terms: Weight Loss
Intervention: Orlistat
Intervention description: 60mg capsule three times a day for up to 6 months
Intervention MeSH terms: Orlistat
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gastric bypass surgery

Summary:

      The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping
      patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication
      will be added to the usual standard of care which includes education regarding diet and
      exercise and monthly meetings with a registered dietician.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients preparing for gastric bypass surgery

        Exclusion Criteria:

          -  pregnancy
A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity; ER Morphine; hydrocodone plus acetaminophen; placebo
Intervention description: The first dose of the study medication was taken following collection of baseline measurements, and subsequent measurements were taken hourly thereafter. Respiration, heart rate, arterial oxygen saturation (pulse oximetry), and blood pressure were also monitored at these intervals to insure the safety of subjects.
Intervention MeSH terms: Acetaminophen; Morphine; Hydrocodone; Phenobarbital; Amphetamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic Pain; Opioids

Summary:

      Characterize the relative abuse liability of a short versus a long acting opioid in chronic
      pain patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with chronic pain for periods greater than 6 months

          -  Patients taking greater than 80 mg morphine equivalents of a short acting opioid (>8
             vicodin or 4 oxycodone/day)

          -  Referral to Pain or Substance Abuse Clinic for self-escalation of opioids

        Exclusion Criteria:

          -  Inability to understand and comprehend spoken English

          -  Patients with Munchausen's syndrome

          -  Patient has a history of Peripheral Vascular Disease

          -  Patient has a history of Raynaud's Phenomenon

          -  Liver Disease; Child's classification greater than 1 (liver cirrhosis) will be
             excluded

          -  Renal disease (BUN >25 or Cr >1.5)

          -  Congestive Heart Failure; Subjects with New York Heart Association (NYHA)Heart Failure
             Symptom Classification System Level of Impairment II, III and IV will be excluded

          -  Coronary artery disease; recent MI within the past six months or recent history of
             angina not controlled with NTG within the past six months

          -  Hypertension; 1)previously normotensive subject; systolic bp >140 mm Hg and diastolic
             bp > 90 mm Hg 2) Hx of active treatment with antihypertensive medications; systolic bp
             >150 mm Hg and diastolic bp > 100 mm Hg

          -  Cerebrovascular disease; recent history within the past year of a transient ischemic
             attack or recent history within the past year of a cerebrovascular event

          -  Malignancy requiring active treatment

          -  Patient is pregnant (as ascertained by a self-report and a mandatory commercial
             pregnancy test before any study medication is consumed)
Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Individual Placement and Support (Supported Employment); Social Skills Training; Olanzapine; Risperidone
Intervention MeSH terms: Olanzapine; Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Antipsychotic Agents; Employment

Summary:

      This study will compare employment support with behavioral skills training to employment
      support alone in schizophrenia patients taking either risperidone or olanzapine to determine
      which is more effective in helping the patients maintain a job.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia

          -  Candidate for maintenance schizophrenia treatment

          -  Willing to initiate and continue risperidone or olanzapine therapy for the duration of
             the study

        Exclusion Criteria:

          -  Any serious medical problems other than schizophrenia that would interfere with the
             study
Treatment of Bipolar Mania in Older Adults
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Intervention: Lithium (LI); Divalproex (DV)
Intervention description: The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L).; Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).
Intervention MeSH terms: Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This study will compare the benefits and side effects of lithium and divalproex in the
      treatment of older adults with bipolar mania.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic
             episodes

        Exclusion Criteria:

          -  Rapid cycling bipolar disorder

          -  History of substance abuse or dependence within last 3 months

          -  Diagnosis of schizophrenia or other chronic psychotic conditions

          -  Acute or unstable medical illness

          -  Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam

          -  Dementia

          -  Inability to communicate in English
The Role of Montelukast in Rhinitis and Sleep
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: montelukast; placebo
Intervention description: 10 mg po each day (compared to placebo for 2 weeks); placebo for 2 weeks
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: sleep; somnolence; allergies; rhinitis; fatigue

Summary:

      The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease
      nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep
      fragmentation in individuals with year round allergic rhinitis or perennial allergic rhinitis
      (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria will include:

          1. Age 16 to 65.

          2. History of allergic rhinitis.

          3. The ability to be placed on placebo without significant compromise in the quality of
             life.

          4. General good health.

          5. Ability to comply with the protocol and sign an informed consent.

          6. Have daytime sleepiness by history.

          7. Have poor sleep by history.

          8. Have fatigue by history.

          9. Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite)
             with correlating symptoms.

        Exclusion Criteria:

          1. Age fewer than 16 or over 65 years.

          2. A history of sleep apnea.

          3. Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma.

          4. Non-allergic rhinitis.

          5. Obesity.

          6. Inability to tolerate montelukast.

          7. Significant other diseases as determined by the investigator.

          8. Use of a research medication within 30 days.

          9. Use of a nasal steroid or topical antihistamine or decongestant within 30 days.

         10. Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or
             H2-blockers.

         11. Excessive use of alcohol or drug abuse.

         12. Inability to stop medication use during run-in period.

         13. Use of an oral antihistamine within 1 week of enrollment.

         14. Failed to have benefit when montelukast was used for rhinitis or asthma in the past
Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)
Condition: Tobacco Smoking
Intervention: Proactive telephone support; Reactive (standard) telephone support; Offer of voucher for cost-free Nicotine Replacement Therapy
Intervention description: Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls.; Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it.; Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Enrollment: 2591.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tobacco; Cigarette; Smoking; Counselling; Nicotine Replacement Therapy; Telephone; Quitline; Helpline

Summary:

      This study shall determine whether or not proactive telephone support for smoking cessation
      delivered to quitline callers is more effective than standard 'reactive' provision and
      whether or not the offer of a voucher for a cost free supply of nicotine replacement therapy
      (NRT) has any additional impact on smoking cessation rates achieved by behavioural
      interventions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are over 16 and will need to agree to i) receive counselling ii) to set a
             quit within two weeks and iii) consent to follow up processes.

        Exclusion Criteria:

          -  Telephonists will not enrol potential participants who are not capable of giving
             informed consent or who have not got access to a phone contact number to which calls
             can be made by Essentia staff.
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome
Intervention: Maxidex; No treatment
Intervention description: Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily; Healthy normal control group receiving no treatment
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ocular inflammation

Summary:

      The primary purpose of this study is to quantify the change in expression of biomarkers on
      the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.
    

Eligibility criteria:

        Inclusion Criteria of Sjorgren's Population:

        Inclusion Criteria:

          -  17 years or older

          -  LogMar visual acuity of 0.6 or better

          -  Ocular inflammation associated with Sjogren's Syndrome

        Exclusion Criteria:

          -  Has had an adverse reaction to either topical of systemic steroids in the past

          -  Has diabetes (type 1 or 2)

          -  Has glaucoma or evidence of ocular hypertension in either eye or treatment of either
             within six months of Visit 1

          -  Has worn contact lenses within one week prior to Visit 1

          -  Has received ocular prescription therapy in the last 30 days

          -  Has active ocular infections or inflammation not associated with Sjogren's Syndrome.

          -  Has any finding in the vitreous, macula, retina or choroid that show signs of
             inflammation and/or any structural change that in the opinion of the investigator is
             considered abnormal or unstable for that participant