bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia
Condition: Spasmodic Torticollis
MeSH terms: Torticollis
Intervention: botulinum toxin type A; botulinum toxin type A
Intervention description: 200 Units at Visit 1 (Day 1); 750 Units at Visit 1 (Day 1)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare two types of botulinum toxin type A to treat the
      involuntary muscle contractions in the neck
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months

          -  Successfully treated previously with botulinum toxin type A

        Exclusion Criteria:

          -  Breast feeding, pregnant or could become pregnant

          -  Surgery or spinal cord stimulation for cervical dystonia

          -  Previous injections of phenol, alcohol for cervical dystonia
Artegraft Versus Propaten Dialysis Grafts
Condition: ESRD; Renal Failure
MeSH terms: Renal Insufficiency
Intervention: Artegraft; Propaten
Intervention description: Surgical placement of graft for hemodialysis access; Surgical placement of graft for hemodialysis access
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized to either
Combination product- device/biologic Artegraft® or Gore® Propaten®.
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs
      better than the other. How long each one lasts until a complication arises or until the graft
      is no longer used will be compared.

      The study hypothesis is that the Artegraft, being an actual blood vessel, will work better
      than the manufactured Propaten graft.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 18 years of age

          -  Candidate for hemodialysis

          -  Not a candidate for native AV fistula

          -  In need of a new AV graft in the upper arm location

          -  Artery and vein > 3mm.

          -  Medically stable and have a life expectancy of ≥ 12 months

          -  The patient or legal guardian understands the study and is willing to comply with the
             requirements.

        Exclusion Criteria:

          -  < 18 years of age

          -  Current history or within 6 months of IV drug abuse

          -  Chronic hypotension (<100 mm systolic pressure) not responsive to treatment

          -  Pregnant or lactating

          -  Known hypercoagulable state

          -  Requires only a revision of an existing graft

          -  Receiving artery or vein is less than 3 mm in diameter at the time of implantation

          -  Known axillary/subclavian occlusion or stenosis that has not been treated

          -  Known or suspected systemic infection

          -  Heparin sensitivity (known HIT)

          -  Enrolled in another investigational study.

          -  Subject has more than 1 graft in target limb.
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Intervention: abatacept
Intervention description: 125 mg subcutaneously each week for 24 weeks
Intervention MeSH terms: Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Biliary Cirrhosis; Ursodeoxycholic acid; Abatacept; Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4)

Summary:

      The purpose of this study is to determine if abatacept (Orencia) is effective in patients
      with primary biliary cirrhosis who do not respond adequately to standard treatment with
      ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed PBC diagnosis based upon at least 2 of 3 criteria

               1. Anti-mitochondrial antibody (AMA) titer > 1:40

               2. Alkaline phosphatase > 1.5 times the upper limit of normal for at least 6 months

               3. Liver biopsy findings consistent with PBC

          -  Incomplete response to UDCA defined by an alkaline phosphatase > 1.67 X the upper
             limit of normal after 6 months of UDCA at a minimum dose of 13 mg/kg/d

          -  Taking a stable dose of UDCA for at least 3 months prior to Day 0

          -  aspartate aminotransferase (AST) and alanine aminotransferase ALT < 5 times the upper
             limit of normal

        Exclusion Criteria:

          -  Presence of concomitant liver diseases including viral hepatitis, primary sclerosing
             cholangitis, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's
             syndrome.

          -  Prior liver transplantation

          -  Decompensated liver disease

          -  Use of immunosuppressants within 6 months of Day 0

          -  Use of biologic agents within 12 months of Day 0
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Placebo; Tobi Podhaler
Intervention description: One dose (4 capsules) of placebo; The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use
Intervention MeSH terms: Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: CF, Human Factors, TOBI® Podhaler™, user interface, IFU

Summary:

      The purpose of this study is to validate the user interface of TOBI Podhaler by establishing
      that the product can support safe and effective use for the intended users
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent or, parent/guardian consent and where applicable pediatric
             assent, must be obtained before any assessment is performed

          -  Male and female subjects aged 6 years and older

          -  Confirmed diagnosis of CF by one or more of the following tests for CF as documented
             in the patient's medical history : (1) quantitative pilocarpine iontophoresis sweat
             chloride test of > 60 mmol/L or 60 mEq/L, (2) genotype with identifiable CF-causing
             mutations on both chromosomes, (3) an abnormal nasal transepithelial potential
             difference characteristic of CF

          -  FEV1 value must be at least 25% of normal predicted values for age, sex, and height as
             documented in the patient's medical history (historical values within 3 months can be
             used for this criterion).

          -  Able to comply with all protocol requirements

          -  Clinically stable in the opinion of the investigator

        Exclusion Criteria:

          -  Subjects currently enrolled in studies that are not considered as observational
             non-investigational studies

          -  Subjects or caregivers who have used the Podhaler device previously

          -  Hemoptysis more than approximately 60 mL at any time within 30 days prior to
             enrollment

          -  History of hypersensitivity to the inhaled placebo dry powder (DSPC and/or calcium
             chloride powder)

          -  Signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax,
             bronchospasm, acute respiratory infection

          -  Clinically significant conditions or findings at enrollment that might interfere with
             the accurate and valid assessment of this study

          -  Subjects or caregivers who are considered potentially unreliable or considered
             unlikely to be compliant within the trial

          -  Pregnant women
Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing
Condition: Fluid Overload; Heart Failure Acute
MeSH terms: Heart Failure
Intervention: Metolazone 60 minutes prior to furosemide; Metolazone concurrently with furosemide
Intervention description: All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.; All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.
Intervention MeSH terms: Metolazone; Furosemide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, open-label, active control pilot study
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: diuretic; metolazone; furosemide

Summary:

      The purpose of this study is to examine whether administering metolazone 60 minutes prior to
      furosemide increases urine output compared with administering metolazone and furosemide
      concomitantly. Participants will have equal chance of being assigned to each group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission within 48 hours for acute decompensated heart failure with at least one
             symptom and one sign of volume overload

          -  Receipt of loop diuretic prior to admission

          -  Plan to administer furosemide 120 - 160 mg IV bolus twice daily over the next 24 hours
             with additional diuresis deemed necessary

          -  If patient is concurrently administered intravenous vasodilator or inotrope, the dose
             of vasodilator or inotrope must be stable for 6 hours prior to enrollment with a plan
             to continue the same dose for the 24 hour duration of this study

        Exclusion Criteria:

          -  Metolazone prescribed prior to admission

          -  Receipt of continuous intravenous infusion of furosemide

          -  Cirrhosis or end stage renal disease

          -  Non-English speaking patients
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Condition: Healthy
Intervention: Medline Pediatric Face Masks; KC Childs Mask
Intervention description: Medline Face Masks, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.; KC Childs Mask, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pediatric Face Masks; children

Summary:

      Compare the fit of two pediatric face masks in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  4 to 12 years of age

          -  conscious

        Exclusion Criteria:

          -  able to wear a mask

          -  no previous allergic reactions to face masks
Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa
Condition: Eating Disorders
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Intervention: Olanzapine; Aripiprazole
Intervention description: Participants will take olanzapine daily for 12 weeks.; Participants will take aripiprazole daily for 12 weeks.
Intervention MeSH terms: Olanzapine; Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Atypical Antipsychotics; Anorexia Nervosa

Summary:

      This study will compare the effectiveness of two atypical antipsychotic medications,
      olanzapine and aripiprazole, in treating people with anorexia nervosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for AN (DSM-IV criteria for amenorrhea will not be strictly
             applied, as these patients have been shown to be clinically indistinguishable from
             those with full criteria AN)

          -  Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2 (BMI of 19 is
             equivalent to approximately 85% of ideal body weight [IBW] according to Metropolitan
             Life standards, and BMI of 14 is equivalent to approximately 65% IBW)

          -  Unwilling to pursue inpatient treatment if BMI is less than 18 kg/m2

          -  Free of psychotropic (e.g., antidepressant, antianxiety, mood stabilizer,
             antipsychotic) medication for 2 weeks before study entry (free for 4 weeks before
             study entry if taking fluoxetine or antipsychotic medications)

          -  Prior treatment of AN

        Exclusion Criteria:

          -  Any medical or psychiatric problem requiring urgent clinical attention (e.g.,
             metabolic disturbance, acute suicidality) and/or significant comorbid illnesses that
             are not likely to benefit from proposed treatments

          -  Significant orthostatic high blood pressure (systolic change greater than 30 mmHg upon
             changing from supine to standing position)

          -  Allergy to olanzapine or aripiprazole

          -  Commencing psychotherapy in the community within 3 months of study entry

          -  Diabetes mellitus, with fasting serum glucose greater than 120 mg/dL or nonfasting
             serum glucose less than 140 mg/dL

          -  Known history of current or past jaundice

          -  Known history of narrow angle glaucoma

          -  Active substance abuse or dependence

          -  Schizophrenia, schizophreniform disorder, or bipolar illness

          -  Movement disorder or presence of tics

          -  History of tardive dyskinesia

          -  History of seizures

          -  Pregnant
Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Calcitriol
Intervention MeSH terms: Calcitriol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of
      treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat
      pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 2 to 16 years and 11 months of age

          -  Clinical diagnosis of stable mild to moderate plaque psoriasis

        Exclusion Criteria:

          -  Other forms of psoriasis

          -  Hypercalcemia

          -  Past history of kidney stones

          -  Vitamin D deficiency

          -  Other concomitant dermatological disease
The Effects of Potassium Citrate on Bone Metabolism
Condition: Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Bone Diseases; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Metabolic Diseases
Intervention: potassium citrate
Intervention description: 20 meq by mouth in capsule form twice daily
Intervention MeSH terms: Potassium Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind Placebo Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: Female
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postmenopausal osteopenia; treatment; bone loss

Summary:

      Skeletal buffering of chronic acid loads may contribute to a significant amount of bone loss
      over time. Evidence from a few small short-term studies suggests that basic compounds, namely
      potassium citrate and potassium bicarbonate may reduce bone loss and improve bone density.

      The purpose of this study is to evaluate the effects of potassium citrate on bone metabolism.
      We hypothesize that administration of potassium citrate to postmenopausal women with
      osteopenia will reduce bone resorption and improve bone mineral density.

      Postmenopausal women with osteopenia (T score between -1.0 and -2.5) and no history of
      fracture will be randomized to either daily potassium citrate or placebo for one year.
      Primary outcomes will be markers of bone turnover, which will be measured over 12 months.
      Secondary outcomes will be bone mineral density, compliance, and adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women, more than 2 years post menopause

          -  Osteopenia, defined as a T score at the lumbar spine or total hip between -1.0 and
             -2.5

          -  No history of prior fragility fracture

        Exclusion criteria:

          -  Renal insufficiency

          -  Use of potassium sparing diuretics

          -  Use of potassium supplements

          -  Hyperkalemia

          -  Secondary causes of osteoporosis or metabolic bone disease

          -  Delayed gastric emptying

          -  esophageal compression, intestinal obstruction or stricture

          -  use of anticholinergic medication

          -  active urinary tract infection.
Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: PEG-IFN alfa-2b; ribavirin
Intervention description: Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week; Ribavirin 200 mg capsules administered orally daily based on weight
Intervention MeSH terms: Ribavirin; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks)
      versus standard 48 week treatment in previously untreated adult participants with chronic
      hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as
      HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is ≥40 kg and ≤120 kg weight

          -  Participant and participant's partner(s) must each agree to use acceptable methods of
             contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months
             after last dose of study medication, or longer if dictated by local regulations.

          -  Previously documented CHC genotype 4 infection

          -  Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no
             other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

        Exclusion Criteria:

          -  Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus

          -  Treatment for hepatitis C with any investigational medication

          -  Treatment with any investigational drug within 30 days of the screening visit

          -  Evidence of decompensated liver disease including, but not limited to, a history or
             presence of clinical ascites, bleeding varices, or hepatic encephalopathy

          -  Autoimmune hepatitis or a history of autoimmune disease

          -  Hepatic fibrosis score F4

          -  Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac
             disease in the previous six months

          -  Autoimmune hepatitis or a history of autoimmune disease

          -  Thyroid disease uncontrolled with conventional treatment

          -  Epilepsy and/or compromised central nervous system (CNS) function