bioihbjkbjnl/mcl2 huggingface dataset:
BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Intervention: botulinum toxin Type A; Normal Saline
Intervention description: Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.; Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 468.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult
      post-stroke lower limb spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of post-stroke lower limb spasticity for at least 3 months

          -  Minimum body weight of 50 kg

          -  Never treated with botulinum toxin of any serotype for any reason, or if previously
             treated with botulinum toxin of any serotype, if previously treated for spasticity in
             the affected lower limb, must have been administered

               -  20 weeks before Day 1, or if previously treated for any other indication must
                  have been administered ≥12 weeks prior to Day 1

        Exclusion Criteria:

          -  Spasticity in the opposite leg that requires treatment

          -  Casting of the study limb within 6 months or planned casting during the first 12 weeks
             of the study

          -  Treatment modalities in the study limb including ultrasound, electrical nerve
             stimulation, electrical stimulation, acupuncture within 1 month of Day 1 or treatments
             planned during the study

          -  Not able to perform 10 meter walking test independently with or without assistive
             device

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral
             sclerosis
Brain Imaging and Treatment Studies of the Night Eating Syndrome
Condition: Night Eating Syndrome
MeSH terms: Syndrome; Night Eating Syndrome
Intervention: escitalopram oxalate
Intervention description: The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding will be conducted which will compare SERT binding in 31 night eaters with that of 10 control subjects. The first procedure will be to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls. Medication will be administered starting at 10 mg daily, with increase up to 20 mg, as indicated and tolerated, for up to three months. Visits will occur at baseline and weeks 1, 2, 4, 6, 8, 10, and 12.
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in
      the treatment of the Night Eating Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men and women suffering from NES

          -  ages 18 to 70 years

          -  BMI greater than 18.5 kg/m2

        Exclusion Criteria:

          -  Children or adolescents <18 years

          -  persons older than 70

          -  patients with diabetes mellitus

          -  thyroid disease and other endocrine and metabolic disorders

          -  use within the past month of any psychotropic medication, oral steroids, diuretics or
             hypnotics

          -  current anorexia nervosa or bulimia nervosa

          -  participation in an organized weight reduction program

          -  use of antiobesity medication

          -  an occupation that involves night shifts or other unusual time requirements -Major
             Depressive Disorder (judged severe)

          -  Bipolar Disorder

          -  suicidal risk

          -  current or past psychosis

          -  substance use or abuse disorder within the past 6 months
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
Condition: Kidney Transplantation; Chronic Kidney Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: Cyclosporine (CsA); Belatacept LI (less intensive); Belatacept MI (more intensive)
Intervention description: tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT); solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT); solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Intervention MeSH terms: Cyclosporine; Abatacept; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to learn if Belatacept can provide protection from organ
      rejection following kidney transplantation while avoiding some of the toxic effects of
      standard immunosuppressive medications such as kidney damage. Effects on kidney function and
      patient survival as well as drug safety will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is a recipient of a living donor or deceased donor kidney transplant.

          -  Male or Female, 18 or older

        Exclusion Criteria:

          -  First time recipient, PRA >- 50% or for retransplantation PRA >- 30%.

          -  If retransplantation, previous graft loss cannot be due to acute rejection.

          -  Positive cross match.

          -  Subject receiving extended criteria donor (ECD) organ

          -  For Long-term extension study-Subjects who have completed three years of study
             treatment (through Week 156)
A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Solanezumab; Placebo
Intervention description: Administered IV; Administered IV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: anti-amyloid; monoclonal antibody

Summary:

      The main purpose of this study is to investigate the safety and efficacy of the study drug
      solanezumab in participants with prodromal Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis by the study investigator of a clinical syndrome of cognitive
             impairment consistent with prodromal AD per International Working Group (IWG)
             diagnostic criteria or mild cognitive impairment (MCI) due to AD per National
             Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.

          -  Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.

          -  Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test
             (FCSRT) (Picture version) at screening.

          -  Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).

          -  Scores >0 on the Functional Activities Questionnaire (FAQ).

          -  Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF)
             result at screening consistent with the presence of amyloid pathology.

        Exclusion Criteria:

          -  Has had MRI or computerized tomography (CT) of brain within previous 2 years showing
             pathology that would be inconsistent with a diagnosis of AD.

          -  Has known allergy to humanized monoclonal antibodies.

          -  Has an ongoing clinically significant laboratory abnormality, as determined by the
             investigator.

          -  Has screening MRI with results showing >4 amyloid related imaging abnormalities H
             (ARIA-H) micro-hemorrhages or presence of ARIA-E.

          -  Has any contraindications for MRI studies, including claustrophobia, the presence of
             metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with
             MRI.

          -  Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor
             or memantine for less than 2 months before randomization. (If a participant has
             recently stopped AChEIs and/or memantine, he or she must have discontinued treatment
             at least 2 months before randomization.)
A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Cardiovascular Diseases
Intervention: Degarelix; Leuprolide
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 545.0
Sex: Male
Healthy volunteers: No

Summary:

      The purpose of this trial is to test if a marketed drug for advanced prostate cancer
      (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another
      marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer
      and cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced prostate cancer

          -  Indication to initiate androgen deprivation therapy (ADT)

          -  Predefined cardiovascular disease

        Exclusion Criteria:

          -  Previous or current hormonal management of prostate cancer (unless terminated at least
             12 months prior to trial)

          -  Acute cardiovascular disease in the previous 30 days
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease
Condition: Iron Deficiency Anemia; Nondialysis-dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol; Oral Iron
Intervention description: Experimental: Ferumoxytol; Active Comparator: Oral iron
Intervention MeSH terms: Ferrous fumarate; Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; ferumoxytol; CKD; pediatric; nondialysis-dependent

Summary:

      Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral
      iron for the treatment of pediatric participants with chronic kidney disease (CKD).
    

Eligibility criteria:

        Key Inclusion Criteria for this study include:

          1. Males or females 6 months to <18 years of age

          2. Nondialysis dependent CKD, including kidney transplant recipients

          3. Has iron deficiency anemia defined as: a) hemoglobin level <11.0 grams (g)/deciliter
             (dL) and b) transferrin saturation level <20%

          4. Female participants of childbearing potential who are sexually active must be on an
             effective method of birth control for at least 1 month prior to Screening and agree to
             remain on birth control until completion of participation in the study

        Key Exclusion Criteria for this study include:

          1. History of allergy to either oral or IV iron

          2. Allergy to two or more classes of drugs

          3. Female participants who are pregnant, intend to become pregnant, are breastfeeding,
             within 3 months postpartum, or have a positive serum/urine pregnancy test

          4. Hemoglobin level ≤7.0 g/dL

          5. Serum ferritin level >600 nanograms/milliliter
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
Condition: ESRD; Diabetes
Intervention: Dianeal; Physioneal; Extraneal; Nutrineal
Intervention description: Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose); Physioneal 40 or Physioneal 35; Extraneal - 7.5% Icodextrin; Nutrineal - 1.1% Amino Acids
Intervention MeSH terms: Icodextrin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ESRD; Diabetes; CAPD; APD

Summary:

      Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal)
      in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated
      Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the
      magnitude of change from the baseline value in the HbA1c levels.

      Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs
      Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower
      glycemic-control medication requirements, decreased incidence of severe hypoglycemic events
      requiring medical intervention, improved metabolic control, nutritional status, and Quality
      of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs
      Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be
      assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. M/F patients 18 years of age or older

          2. Diagnosis of ESRD (GFR ≤ 15 mL/min)

          3. CAPD or APD using only Dianeal and/or Physioneal, at least 1 exchange of 2.5% or 4.25%
             dextrose/day, no prescribed dry time

          4. DM (Type 1 and 2) on glycemic-control medication, for 90 days

          5. HbA1c > 6.0% but ≤ 12.0%

          6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

        Exclusion Criteria:

          1. Cardiovascular event within the last 90 days

          2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)

          3. Allergy to starch-based polymers

          4. Glycogen storage disease

          5. Glycogen storage disease

          6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30
             days

          7. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77) at Screening.

          8. Serum urea > 30 mmol/L

          9. Receiving rosiglitazone maleate
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MP-424; Ribavirin; Peginterferon Alfa-2b
Intervention description: 750 mg every 8 hours for 12 weeks; 600 - 1000 mg/day based on body weight for 24 weeks; 1.5 mcg/kg/week for 24 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV
      in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 1, chronic hepatitis C

          -  Non-responders (patient who did not respond to previous treatment)

          -  Able and willing to follow contraception requirements

        Exclusion Criteria:

          -  Cirrhosis of the liver or hepatic failure

          -  Hepatitis B surface antigen-positive or HIV antibodies-positive

          -  History of, or concurrent hepatocellular carcinoma

          -  History of, or concurrent depression, schizophrenia; or suicide attempt in the past

          -  Pregnant, lactating, or suspected pregnant patients, or male patients whose female
             partner is pregnant
Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
Condition: Avascular Necrosis of Femoral Head
MeSH terms: Femur Head Necrosis; Necrosis; Shock
Intervention: zoledronic acid (aclasta)
Intervention description: Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: avascular necrosis of femoral head; bisphosphonate; collapse

Summary:

      The purpose of this study is to test the effect of zoledronic acid over 2 years in preventing
      early collapse and progression of joint dome depression (≥ 2 mm by X-ray) of the femoral head
      in patients with large (> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who agree to clinical trial

          -  Patient who are more than 18 years of age

          -  Osteonecrosis of the femoral head

          -  Steinberg stage I, II non traumatic osteonecrosis of femoral head

          -  Necrotic area of > 30% (HJ Kim et al )

          -  JIC (Japanese Investigation Committee): C1 or C2 lateral lesion (by X-ray or MRI)

        Exclusion Criteria:

          -  Patients who are pregnant (patients who are of child bearing potential who are not
             practicing a reliable contraceptive method (oral, subcutaneous, mechanical, or
             surgical contraception)

          -  Patients who have contraindicated condition to zoledronic acid such as chronic renal
             failure (calculated creatinine clearance less than 35.0 ml/min), severe heart disease
             such as atrial fibrillation, sensitive to bisphosphonates and hypocalcemia (serum
             calcium less than 8 mg/dl or 2.0 mmol/L)

          -  Patients who have collapsed lesion including subchonral fracture

          -  Patients who have multiple lesion of osteonecrosis of femoral head

          -  Patients who received other kinds of bisphophonates or anabolic agents before
             zoledronic acid use

          -  Patients with any medical or psychiatric condition which, in the Investigator's
             opinion would preclude the participant from adhering to the Protocol or completing the
             trial per protocol

          -  Patients who are considered potentially unreliable and patients who may not reliably
             attend study visits
Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Intervention: oral levofloxacin; nebulized levofloxacin
Intervention MeSH terms: Levofloxacin; Ofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis
      (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms
      and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral
      antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily
      intranasal antibiotic irrigations. The two treatments will be compared to see if there is any
      difference in patient outcomes. This will help guide treatment strategies for patients with
      CRS in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults (age ≥ 18).

          2. Diagnosis of CRS.

          3. Worsening sinonasal symptoms.

          4. Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and
             anterior ethmoidectomy).

          5. English speaking.

          6. Open sinuses (open middle meatus bilaterally; determined on endoscopy).

          7. Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen
             antibiotic regimens.

        Exclusion Criteria:

          1. Patients < 18 years of age.

          2. Treatment with systemic or topical antibiotics within the last 1 month.

          3. Pregnant women.

          4. Non-English speaking persons.

          5. Systemically ill at initial visit necessitating treatment prior to culture data.

          6. Allergies to chosen susceptible antibiotics.

          7. Sinonasal culture with less than 1+ growth.

          8. Multiple organisms grown on culture that are not sensitive to a single antibiotic.

          9. Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome,
             ciliary dyskinesia).

         10. Patients with immunodeficiencies.