bioihbjkbjnl/mcl2 huggingface dataset:
Electro Flo 5000 and Vest Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Intervention: Electro Flo 5000; Incourage Vest System
Intervention description: Airway clearance device; Airway Clearance Device
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum
      weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway
      clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health
      and perform AC at home as part of their routine therapeutic regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of CF established by standard criteria (sweat chloride > 60 mmol/L and/or
             two alleles affected by gene mutations know to be associated with CF).

          2. Age older than 12 years.

          3. Known to consistently produce sputum.

          4. Currently on a home therapeutic regimen that includes some form of AC performed at
             least 2 times daily.

          5. FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10%
             variation in lung function parameters over the preceding 3 months).

        Exclusion Criteria:

          1. Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.

          2. Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.

          3. Chronic chest pain.

          4. Participation in another interventional clinical trial in the previous 30 days. -
Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal
Condition: Alcohol Withdrawal
Intervention: Chlordiazepoxide; Gabapentin
Intervention description: 25mg four times daily x 3 days then tapered over 3 days; 300mg four times daily x 3 days then tapered over 3 days
Intervention MeSH terms: Chlordiazepoxide; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind controlled trial comparing treatment outcomes between
      chlordiazepoxide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent
      veteran subjects. The objective of this trial is to compare the safety and effectiveness of
      these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin
      over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence,
      withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and
      alcohol craving.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Alcohol dependent at risk for withdrawal symptoms

        Exclusion Criteria:

          -  Benzodiazepine dependent
The Use of Iron Therapy for Patients With Anemia After Caesarean Section
Condition: Postoperative Anaemia
MeSH terms: Anemia
Intervention: Ferinject; Ferrous fumarate; Placebo for ferrous fumarate; Placebo for ferinject
Intervention MeSH terms: Iron; Ferrous fumarate; Ferric Compounds
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postoperative; anemia; gynaecologic; surgery

Summary:

      The purpose of this study is to determine whether oral or intravenous iron is effective in
      the treatment of anaemia (iron-poor blood) after caesarean section.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gynecological surgery

          -  Hb 5-7 mmol/L

        Exclusion Criteria:

          -  Pregnancy

          -  Oncological operations

          -  Infections (PID)

          -  Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal
             testing; Hysteroscopies

          -  Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ),
             Conization,

          -  Small vulvar / vaginal operations such as (cysts, labia correction)

          -  Endometrial ablation

          -  Legal incapacity

          -  The patient has used pre-operatively an iron preparation and / or blood transfusion or
             during the surgery

          -  Hematologic disorders

          -  Erythropoiesis-stimulating agents &lt; 3months ago

          -  Myelosuppressive therapy in history

          -  Hepatitis

          -  HIV

          -  Alcohol abuses

          -  Not understanding Dutch

          -  Allergic reaction to iron therapy in past
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
Condition: Blood Loss
MeSH terms: Hemorrhage
Intervention: Hemostatic Matrix
Intervention description: FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
Intervention MeSH terms: Hemostatics; Thrombin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Healthy volunteers: No
Keywords: To decrease blood loss during knee surgery

Summary:

      The purpose of this study is to determine if the agent, Floseal, can decrease the amount of
      blood patients lose after total knee replacement (TKR) surgery. If this product can be found
      to have an effect on bleeding, it may potentially reduce the problems associated with
      bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood
      transfusion. The subject's overall participation will be over a period of 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Single Knee replacement for arthritis of the knee

        Exclusion Criteria:

          -  No inflammatory arthritis (ie. Rheumatoid arthritis)

          -  No allergies to cow meat (bovine allergies

          -  No history of bleeding disorders
ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Levocetirizine
Intervention description: Pharmaceutical form: Tablet
Concentration: 5 mg
Route of administration: Oral use
Intervention MeSH terms: Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Persistent Allergic Rhinitis; HDM; Parietaria; sneezing; rhinorrhea; ocular pruritus; Rhinasthma; inflammatory cells; ICAM-1; ATAREAL; Xyzal; Levocetirizine

Summary:

      Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on
      demand, measured by evolution of individual symptom scores during 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical history of Persistent allergic Rhinitis (PER) requiring treatment known at
             least since 2 years.

          -  Positive skin prick test (wheal > 3 mm larger than the diluent control) or Radio
             Allergo Sorbent Assay (RAST) (>= 3.5 IU/ml) to House Dust Mite (HDM) and Parietaria
             (less than 1 year).

          -  Minimum mean Total 4 Symptom Score (T4SS) of 6 over baseline period.

        Exclusion Criteria:

          -  Subjects currently treated by specific parietaria pollen immunotherapy

          -  Subjects suffering from non-allergic asthma

          -  Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids
             dependent asthma (severe asthma)

          -  Atopic dermatitis or urticaria requiring antihistamine treatment or the administration
             of oral or topical corticosteroids
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Condition: Smoking Cessation
MeSH terms: Mental Disorders; Problem Behavior
Intervention: placebo; varenicline tartrate; bupropion hydrochloride; Nicotine Replacement Therapy Patch
Intervention description: All dosing to have taken place per study A3051123; All dosing to have taken place per study A3051123; All dosing to have taken place per study A3051123; All dosing to have taken place per study A3051123
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4595.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking cessation; psychiatric disease; cardiovascular events

Summary:

      Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety
      for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total
      of 52 weeks of cardiovascular safety data collection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be eligible if they were randomized to study A3051123.

        Exclusion Criteria:

          -  Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc)
             prior to final visit of study A3051123.
Effect of Nafamostat on Postreperfusion Syndrome (PRS)
Condition: Liver Transplantation; Postreperfusion Syndrome
MeSH terms: Syndrome
Intervention: Nafamostat; Normal saline
Intervention description: 0.2 mg/kg as bolus 1 minute before reperfusion; 10 ml of normal saline
Intervention MeSH terms: Nafamostat
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study intends to see the effect of nafamostat on the attenuation of postreperfusion
      syndrome (PRS) that frequently occurs during liver transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= 18 year old scheduled to undergo liver transplantation

        Exclusion Criteria:

          -  Previous history of pulmonary, cardiovascular, or renal disease

          -  Previous history of allergic reactions to nafamostat
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Intervention: Coenzyme Q10; Placebo
Intervention description: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance; dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Coenzyme O10; Children; Idiopathic Dilated Cardiomyopathy

Summary:

      This study aims to determine the effect of Coenzyme Q10 supplementation on conventional
      therapy of children with heart failure due to idiopathic dilated cardiomyopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known cases of Idiopathic Dilated Cardiomyopathy (IDC)

          -  Those patients in whom heart failure medications were stable for at least 1 month

          -  More than 6 months aged

        Exclusion Criteria:

          -  Recent modification in medications

          -  Hemodynamic instability

          -  Congenital heart disease

          -  Metabolic heart disease

          -  Cardiac dysfunction resulting from abnormalities in other organs and those with an
             acquired cardiomyopathy
Oral Nutrition After Regular Radical Cystectomy
Condition: Post Cystostomy
Intervention: Oral Nutrition Protocol (ONP) group; Control group
Intervention description: For the experimental group, an oral nutrition protocol (ONP) with restrictive instructions for parenteral nutrition is implemented. Oral intake is increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used are Fortimel Jucy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.; Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cystectomy; parenteral nutrition; discharge; outcome

Summary:

      After radical cystectomy, postoperative ileus (POI) is a common complication resulting in a
      delayed oral nutritional intake with prolonged recovery and hospital stay. However, it is
      questionable if nutritional support by routine use of parenteral nutrition (PN) is
      justifiable.

      A non-randomized before-after trial was conducted. Patients treated with an elective regular
      radical cystectomy and without preoperative contra-indications for enteral nutrition were
      eligible. In the control group, PN was initiated immediately after the procedure and
      continued until resumption of diet. In the interventional group, an ONP was implemented. PN
      could be initiated if oral intake was still insufficient after five days. The primary end
      point was the postoperative length of stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  regular radical cystectomy

        Exclusion Criteria:

          -  preoperative contra-indications for enteral nutrition (EN): intestinal obstruction,
             malabsorption, multiple high-output fistula and intestinal ischemia
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: etanercept; sulphasalazine (SSZ)
Intervention description: 50 mg; Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.
Intervention MeSH terms: Sulfasalazine; Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 566.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Spondylitis (AS)

Summary:

      The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the
      treatment of Ankylosing Spondylitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of ankylosing spondylitis

          -  Active ankylosing spondylitis

        Exclusion Criteria:

          -  Complete ankylosis of spine

          -  Previous treatment with etanercept
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, open label, multicenter study will evaluate the safety and change in
      hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients
      with chronic renal anemia who are not on dialysis. Patients will receive as a recommended
      starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is
      dependent on the patient's weight. Dose adjustment may be required due to inadequate or
      excessive treatment response. The anticipated time on study treatment is 28 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, age >/=18 years

          -  Diagnosis of chronic renal anemia

          -  Not on dialysis

          -  Hemoglobin concentration <10 g/dl

          -  No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study
             start

          -  Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min

          -  Adequate iron status

        Exclusion Criteria:

          -  Transfusion of red blood cells during the previous 2 months

          -  Poorly controlled hypertension

          -  Significant acute or chronic bleeding, e.g. gastrointestinal bleeding

          -  Active malignant disease (except non-melanoma skin cancer)

          -  Hemolysis

          -  Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
Condition: Tachycardia, Atrioventricular Nodal Reentry
MeSH terms: Tachycardia; Tachycardia, Atrioventricular Nodal Reentry
Intervention: Freezor® Cardiac Cryoablation Catheter CryoConsole System
Intervention description: cryoablation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrioventricular nodal reentrant tachycardia; AVNRT

Summary:

      The purpose of this post approval study of heart block is to gather additional information
      regarding how often patients develop heart block (atrioventricular block) after having
      standard ablation procedure using cryotherapy with the Freezor™ catheter.
    

Eligibility criteria:

        Inclusion Criteria:

        Some inclusion criteria can only be established during the electrophysiologic study (EPS);
        thus there are two groups of inclusion criteria.

        For inclusion in the study subjects must fulfill ALL of the following criteria:

        Pre-EPS inclusion criteria:

          1. Patients with a clinical history of AVNRT who are referred for ablation.

          2. Patients willing to provide written informed consent.

        Post-EPS inclusion criteria:

        1. Patients with EPS-documented AVNRT

        Exclusion Criteria:

        ANY of the following is regarded as a criterion for excluding a subject from the study:

          1. Patients with any pre-existing AV block.

          2. Patients with known cryoglobulinemia
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Enfuvirtide
Intervention description: All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.
Intervention MeSH terms: Enfuvirtide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This study assessed the safety and tolerability of enfuvirtide in participants with advanced
      HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens
      containing at least one product from each anti-retroviral class, or had experienced
      intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg)
      subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment
      limiting toxicities and participants benefited from study treatment as per investigator's
      discretion. The anticipated time on study treatment was based on the commercial availability
      of enfuvirtide in Thailand, and the target sample size was 30 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals at least 16 years of age infected with HIV-1

          -  CD4 lymphocyte count less than equal to (<=) 100 cells per cubic millimeter
             (cells/mm^3) and HIV-1 ribonucleic acid (RNA) viral load greater than equal to (>=)
             10,000 copies/mL while on highly active antiretroviral therapy (HAART)

          -  Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous
             antiretroviral regimens

        Exclusion Criteria:

          -  Evidence of ongoing alcohol and/or drug or substance abuse

          -  Prior non-adherence to antiretroviral treatment regimens

          -  Evidence of active, untreated opportunistic infection, intercurrent illness, drug
             toxicity or any other condition.