bioihbjkbjnl/mcl2 huggingface dataset:
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
Condition: Hereditary Angioedema Types I and II
MeSH terms: Angioedema; Angioedemas, Hereditary; Hereditary Angioedema Types I and II
Intervention: Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection
Intervention description: Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. Each attack that occurs in this time frame will be treated with 20 IU Berinert/kg body weight.
Intervention MeSH terms: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a prospective, international, multi-center, non-randomized, single arm, open-label,
      postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE
      subjects treated intravenously with Berinert. Individual treatment duration per subject is 9
      months, irrespective of the number of treated attacks. All subjects will receive 20 IU
      Berinert/kg body weight per attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of congenital C1-INH deficiency (HAE type I or II) and assessed by the
             investigator to likely require intravenous (IV) Berinert treatment during the study
             period.

          -  Male or female, ≥ 12 years of age at the time of signing informed consent.

          -  Written informed consent for study participation obtained before undergoing any study
             specific procedures.

        Exclusion Criteria:

          -  Incurable malignancies in the last 6 months prior to study entry.

          -  Acquired angioedema due to C1-INH deficiency.

          -  All other types of angioedema not associated with C1-INH deficiency.

          -  Use of any C1-INH products other than Berinert within 30 days before the study, or
             planned use during the study.

          -  Immunization within 30 days prior to study entry.

          -  Autoimmune conditions requiring use of immunosuppressants during the study.

          -  Known or suspected hypersensitivity to C1-INH.

          -  Participation in any of the previous Berinert studies from which anti-C1-INH antibody
             results were submitted to the Food and Drug Administration.
The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Breakthrough Pain
Intervention: Diclofenac Gel
Intervention description: Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Intervention MeSH terms: Diclofenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Knee osteoarthritis

Summary:

      The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA)
      patients using the diclofenac gel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 20-75

          -  Unilateral or bilateral knee osteoarthritis (OA), confirmed radiographically.

          -  Patients taking oral non-steroidal anti-inflammatory drugs (NSAIDs) in the amount and
             schedule prior to the breakthrough period will be permitted.

        Exclusion Criteria:

          -  Patients with clinical history of anterior cruciate ligament (ACL) involvement.

          -  Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)

          -  History of ulcers or gastrointestinal (GI) bleeding

          -  Coagulation disorders

          -  Hypersensitivity to Aspirin or NSAIDS

          -  Congestive Heart Failure and Edema

          -  Advanced renal disease

          -  Aspirin triad

          -  Pregnant women
Statin Therapy for Ischemic and Nonischemic Cardiomyopathy
Condition: Cardiovascular Disease; Cardiomyopathy; Heart Disease; Myocardial Disease; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Intervention: Atorvastatin Calcium
Intervention description: Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart.
Intervention MeSH terms: Atorvastatin; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Cardiovascular Disease; Cardiomyopathy; Heart Disease; Myocardial Disease; Myocardial Ischemia

Summary:

      The purpose of this study is to see if taking a cholesterol lowering drug Lipitor
      (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's)
      circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and
      if this will also show an improvement in the damaged areas of the patient's hearts as
      documented by MRI scans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ischemic Cardiomyopathy (as defined above) with ejection fraction < 35%

          -  Non-ischemic Cardiomyopathy with ejection fraction < 35%

          -  NCEP ATPIII indication for therapy with a statin drug

          -  No statin therapy within previous 6 months of study enrollment

          -  Prescribed stable doses of standard heart failure therapies including beta blocking
             agents, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, and
             diuretic agents as required

        Exclusion Criteria:

          -  Pregnant or lactating

          -  Myocardial infarction within 6 months preceding study enrollment

          -  Primary valvular heart disease

          -  Surgical or catheter based revascularization within the preceding 6 months

          -  Documented viral or inflammatory myocarditis or cardiomyopathy

          -  Peripartum cardiomyopathy

          -  Infiltrative cardiomyopathies

          -  Chemotherapy associated cardiomyopathy

          -  Without indication for statin therapy

          -  Contraindication to statin therapy including hepatic dysfunction, history of
             rhabdomyolysis or prior intolerance of statin therapy

          -  Contraindication to magnetic resonance imaging
Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
Condition: Mechanical Ventilation; Critical Illness
MeSH terms: Critical Illness
Intervention: Dexmedetomidine; Propofol; Fentanyl; Midazolam; Physical and Occupational Therapy
Intervention description: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS; continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS; 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale; 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2); Daily therapy sessions targeting range of motion, strength, and mobility
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypnotics and Sedatives; Respiration, Artificial; Ventilators, Mechanical; Critical care; Intensive care; Physical therapy; Occupational therapy; Sedative medications

Summary:

      This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged
      sedation (> 24 hours) in critically ill patients who require mechanical ventilation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years old

          -  mechanically ventilated through endotracheal tube

          -  anticipated need for ventilation > 48 hours

          -  requiring sedative/analgesic medication

        Exclusion Criteria:

          -  on mechanical ventilator > 96 hours

          -  primary neurologic disease

          -  post cardiac arrest

          -  do not speak English (assessment only English language validated)

          -  pregnancy or lactation

          -  active myocardial ischemia

          -  second or third degree heart block

          -  pancreatitis

          -  elevated serum triglycerides (> 400 mg/dL)
An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study
Condition: Bipolar Disorder, Mania
MeSH terms: Bipolar Disorder
Intervention: extended-release clonidine
Intervention description: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Subjects with Bipolar Disorder, mania will receive an extended-release from of clonidine on the second day of this 3-day study. Rating scale, record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: mania; clonidine; bipolar disorder

Summary:

      The investigators plan to to study an extended-release form of clonidine, which the
      investigators hope will be even better tolerated than the immediate-release form, as an
      antimanic agent. Subjects will receive an extended-release form of clonidine in addition to
      their usual medication regimen on the second day of this three-day study. Rating scales, a
      record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3
      days. Any medication changes made by the attending psychiatrist and prns administered will be
      recorded throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet SCID criteria for bipolar disorder, type I, Mania with YMRS > 15

          -  No significant improvement in symptoms after three or more days of hospitalization

          -  documented medical evaluation without identified acute or serious medical illness

          -  negative pregnancy test in women of child-bearing age

        Exclusion Criteria:

          -  involuntary commitment or lack of capacity to provide informed consent

          -  low blood pressure
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: FS-67 Patch; Placebo Patch
Intervention description: One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days); One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 252.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Ankle Sprain

Summary:

      The objective of this study is assess the efficacy and safety of single and multiple
      applications of the FS-67 patch in the treatment of ankle sprain in pediatric population
      (ages 13-17).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Grade 1 or Grade 2 ankle sprain

        Exclusion Criteria:

          -  Pregnancy or lactation
Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing
Condition: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Intervention: Rituximab
Intervention description: re-dosing dependent on interventional arm parameter.
Intervention MeSH terms: Rituximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Maximum age: 82 Years
Healthy volunteers: No
Keywords: rituximab; maintenance; remission

Summary:

      The purpose of this study is to determine the best management strategy to maintain remission
      in patients with ANCA vasculitis who have been treated with rituximab induced B cell
      depletion for at least two years. This study will compare intermittent B Cell depletion upon
      B cell return or intermittent B cell depletion upon serologic relapse.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients must be able and willing to give written informed consent and comply with
             the requirements of the study protocol.

          2. Diagnosis: ANCA vasculitis as defined by a positive MPO- and/or PR3-ANCA test together
             with clinical features characteristic of ANCA-positive diseases as detailed in the
             2012 Chapel Hill Consensus Conference Definitions(18).

          3. eGFR ≥ 73 cc/min/1.73m2

          4. Age: 18-82 years old

          5. Treated with rituximab-induced continuous B cell depletion at regularly scheduled
             interval with a goal of undetectable B cells for at least 24 months

          6. In sustained remission (defined by a modified BVAS-WG=0 AND a prednisone dose of ≤ 7.5
             mg) for at least 12 months.

          7. Undetectable (<10mm3) B cells (quantified by CD20+ number) on day 0

          8. Urine Hcg negative for women of child bearing potential and not planning to become
             pregnant for at least 12 months from enrollment and at least 12 months after any study
             related rituximab dose

          9. Judged to be otherwise healthy by the Investigator, based on medical history and
             physical examination (no known active disease process for which life expectancy is
             less than 36 months)

        Exclusion Criteria:

          1. Secondary Disease: disease suspected to be induced by levamisole-adulterated cocaine

          2. All transplanted patients

          3. Treatment: additional immunosuppressive agents other than rituximab and/or total daily
             prednisone dose ≥ 7.5 milligrams

          4. Hypogammaglobulinemia: IgG level < 300 mg/dL

          5. Terminal cancer or other primary illness with life expectancy of less than 36 months

          6. Active anti-GBM disease and other known autoimmune disease for which the need for
             additional immunosuppression is likely

          7. Pregnancy or breastfeeding
Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy
Condition: Hip Arthroscopy
Intervention: Acetaminophen; Percocet
Intervention description: acetaminophen 600 mg to be taken every 8 hours (TID); Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.
Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to
      analgesia for patient's pain after hip arthroscopy and to also assess if this new approach
      will result in a reduction in post-operative narcotic use.

      This study is a single-center, randomized prospective study comparing post-operative pain
      scores and narcotic consumption between individuals receiving acetaminophen along with a
      reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals
      receiving Percocet only. Both pain management options are considered to be standard of care.
      Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic
      ossification prophylaxis.

      The primary objective of the study are to compare patients' narcotic consumption and reported
      pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate
      pain relief compared to a narcotic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA class I-II

          -  Patients indicated and scheduled for arthroscopic hip surgery

        Exclusion Criteria:

          -  Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity,
             history of GI or bleeding disorder)

          -  Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia,
             etc.)

          -  Younger than 18 years of age or older than 65

          -  Any patient considered a vulnerable subject

          -  Patients on pain medication prior to surgery
A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients
Condition: Pruritis
MeSH terms: Pruritus
Intervention: 50,000 Units Ergocalciferol; Placebo
Intervention description: 50,000 Units oral ergocalciferol to be given once weekly; oral placebo once weekly
Intervention MeSH terms: Ergocalciferols; Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Pruritis in hemodialysis patients; 25-Vitamin D in chronic kidney disease

Summary:

      Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There
      may be many different reasons for the pruritis. Efforts to treat the problem have not been
      very effective.

      Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D
      plays an important role in the skin and is effective in treatment of certain skin conditions
      that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients.

      The objective of the investigators study is to determine the effect of supplementation with
      oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hemodialysis treatment for > 3 months

          2. Subjective complaint of excessive itching

        Exclusion Criteria:

          1. Age < 18 years

          2. Failure to provide informed consent

          3. Intact PTH < 70 pg/ml or > 1,000 pg/ml

          4. Serum phosphorus > 7.0

          5. Serum calcium (adjusted for albumin)> 11

          6. Active malignancy

          7. Likelihood of imminent renal transplantation

          8. Current ergocalciferol treatment
Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years
Condition: Constipation
MeSH terms: Constipation
Intervention: placebo; prucalopride
Intervention description: Placebo matching tablet 2 mg once daily before breakfast for 24 weeks; Prucalopride 2 mg daily before breakfast
1 mg for subjects >65 years; in case of insufficient response 2 mg at week 2 or week 4
Intervention MeSH terms: Prucalopride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 364.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Long term; Constipation; Digestive signs and symptoms

Summary:

      The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride
      versus placebo in subjects aged 18 years and older with chronic constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of
             age (no upper age limit).

          2. Subject has a history of constipation. The subject reports an average of ≤2 SBM/week
             that result in a feeling of complete evacuation (SCBM).

          3. Subject agrees to stop his/her current laxative treatment and is willing to use rescue
             medication according to the rescue rule [bisacodyl/enemas].

        Exclusion Criteria:

          1. Subjects in whom constipation is thought to be drug-induced

          2. Subjects using any disallowed medication.

          3. Subjects who previously used prucalopride.

          4. Subjects suffering from secondary causes of chronic constipation.
Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy
Condition: Disorder of Knee; Anesthesia
Intervention: Hyperbaric Levobupivacaine 0.75%
Intervention description: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
Intervention MeSH terms: Levobupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Knee Arthroscopy; Levobupivacaine; Spinal Anesthesia; Motor Block

Summary:

      The purpose of this study is to evaluate motor block probability throughout time and clinical
      profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a
      unilateral spinal block technique.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18-64 y.o. scheduled for knee arthroscopy (therapeutic or diagnostic)

        Exclusion Criteria:

          -  Cardiac or pulmonary disease

          -  Antiplatelet or anticoagulant drugs use during 7 days before surgery

          -  History of coagulative disorders

          -  Bilateral procedures