bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Placebo; AbobotulinumtoxinA Treatment
Intervention description: Subjects will be randomization to receive either the study drug or the placebo group.; Subjects receive intervention injections with the study drug arbobotulinumtoxinA.
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Back; Pain; Muscle

Summary:

      The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA
      (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.

      The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A
      into erector spinae muscles (extensors of the spine) can relieve low back pain through
      anti-spasm and analgesic effect of botulinum toxin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-80, all ethnic groups, races, both sexes.

          -  Diagnosis of chronic low back pain (longer than 3 months).

          -  Pain of moderate to severe intensity (VAS 4 or higher).

          -  Subjects who are able to read, speak, and understand English.

        Exclusion Criteria:

        Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic,
        neoplastic, infectious, or autoimmune disorders).

          -  Hypersensitivity to any botulinum toxin product or is recipient

          -  Allergy to albumin. Lactose or cow milk protein

          -  Infection in the proposed injection site.

          -  Pregnancy or planned pregnancy (determined by urine pregnancy test). The women of
             childbearing age should use a reliable mode of contraception during the study period
             (abstinence, etc).

          -  Active breast feeding.

          -  Enrollment in any clinical trial (currently or within the past 3 months) in which
             treatments are imposed by a protocol.

          -  Patients taking high doses of aminoglycosides or other drugs affecting the function of
             neuromuscular junction (anticholinergics , muscle relaxants)

          -  Subjects who are younger than 18 years of age.

          -  Neuromuscular-junction disorders and motor neuron disease such as Amyotrophic Lateral
             Sclerosis.

          -  Evidence of acute pathology on neuro-imaging.

          -  Axis I diagnosis determined by a neurologist or psychiatrist.

          -  Anesthetic medications within two weeks and corticosteroid injections within 4 weeks
             of enrollment.

          -  Received botulinum toxin injections in the past 3 months.

          -  History of low back surgery , evidence of acute disc or severe lumbar stenosis in MRI
A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Intervention: pramlintide acetate 360 mcg; metreleptin; placebo-pramlintide 600 uL; placebo-metreleptin 1 mL; Pramlintide acetate 180 mcg
Intervention description: subcutaneous injection, twice a day, 360mcg; subcutaneous injection, twice a day, 5mg; twice a day; twice a day; subcutaneous injection twice a day, 180 mcg
Intervention MeSH terms: Pramlintide; Islet Amyloid Polypeptide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: overweight; obesity; pramlintide; leptin; Amylin

Summary:

      This study will evaluate the safety, tolerability, and effect on body weight of leptin,
      injected subcutaneously, in combination with pramlintide, injected subcutaneously.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is obese (Body Mass Index [BMI]>=30kg/m^2 and <=35kg/m^2); or overweight
             (BMI>=27kg/m^2 and <30kg/m^2) with abdominal obesity, based on the following: *waist
             circumference >102 cm if male, *waist circumference >88 cm if female

          -  Is a nonsmoker (has not smoked for at least 6 months prior to the study)

          -  Consumes a morning and evening meal each day

        Exclusion Criteria:

          -  Is diagnosed with type 2 diabetes

          -  Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program
             with the specific intent of losing weight (subjects who have been following an
             exercise regimen resulting in stable weight maintenance for at least 2 months prior to
             enrollment are eligible for study inclusion)

          -  Has been treated over the past 2 months, is currently treated, or is expected to
             require or undergo treatment with any of the following medications: *antiobesity
             agents (prescription or over-the-counter), *antipsychotic agents, *antiepileptic
             agents, *antidepressant agents, *drugs that directly affect gastrointestinal motility

          -  Has received any investigational drug within 30 days or within a period corresponding
             to 5 half-lives of that drug, whichever is greater, prior to this study starting

          -  Has previously received treatment with recombinant leptin or pramlintide
A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; atenolol; placebo
Intervention description: 5 mg daily or 10 mg daily; 25 mg daily or 50 mg daily; one tablet daily
Intervention MeSH terms: Atenolol; Nebivolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension; prevention; endothelial function

Summary:

      This is a randomized, double-blind, placebo-controlled study comparing the efficacy of
      nebivolol and atenolol at improving small artery elasticity and reducing cardiovascular
      disease risk in subjects with early vascular disease. Approximately 75 subjects with
      borderline/elevated blood pressures and impaired endothelial function, as measured by
      arterial elasticity scores, will be recruited and assigned to treatment groups using a block
      randomization scheme. Patients will be randomly allocated to nebivolol, atenolol or placebo,
      and then followed for 9 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  borderline blood pressure (120-145/80-90 mm Hg);

          -  borderline or abnormal small artery elasticity (C2) as measured by pulse contour
             analysis;

          -  treatment-naive for all blood pressure medications including diuretics for at least 30
             days prior to baseline visit;

          -  able to walk on a treadmill for 3 minutes;

          -  female patients with reproductive potential must use an approved contraceptive method
             if appropriate (for example, intrauterine device [IUD], birth control pills, or
             barrier device during and for 1 month after the last dose of study drug;

          -  voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

        Exclusion Criteria:

          -  history of intolerance to beta-blockers or clear contraindications to their use;
             current pharmaceutical treatment of blood pressure;

          -  known history of cardiovascular disease (myocardial infarction, coronary artery bypass
             graft, unstable angina, uncontrolled arrhythmias, stroke, etc.);

          -  known history of diabetes; known history of hepatic, renal or gastrointestinal
             disorder;

          -  known history of any illness that may cause additional risk (as determined by study
             investigator);

          -  pregnant or lactating women [when used during pregnancy, beta-blockers may cause fetal
             harm];

          -  participation in a concomitant clinical trial.
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Condition: Sickle Cell Disease; Priapism
MeSH terms: Priapism; Anemia, Sickle Cell
Intervention: sildenafil; placebo
Intervention description: sildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2); placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 13.0
Sex: Male
Minimum age: 14 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: priapism; sickle cell disease; sildenafil; phosphodiesterase type 5 inhibitor

Summary:

      This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor
      sildenafil has an effect on the frequency of recurrent priapism and the quality of life of
      males with sickle cell disease (SCD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 14 to 45, inclusive

          -  Episodes of prolonged penile erection in the absence of sexual interest or desire,
             with an average frequency of at least twice weekly, when averaged over the previous
             four weeks

          -  Able to provide informed consent or assent

        Exclusion Criteria:

          -  Use of chronic nitrates or recreational use of nitrate containing products

          -  Use of a PDE5 (phosphodiesterase type 5)inhibitor within the previous two weeks

          -  Alcohol use exceeding two standard drinks daily

          -  Hypersensitivity to sildenafil

          -  Estimated glomerular filtration rate <50ml/min

          -  Known cirrhosis

          -  Retinitis pigmentosa

          -  Necessary use of a P450 3A4 inhibitor (a drug which can increase plasma levels of
             sildenafil when taken together)
Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
Condition: Hemangioma of Infancy
MeSH terms: Hemangioma
Intervention: propranolol; Prednisolone
Intervention description: propranolol 0.5 mg/kg orally, 4 per day - 4-6 months; 1.0 mg/kg orally, 2 per day 4-6 months
Intervention MeSH terms: Prednisolone; Propranolol; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 2 Weeks
Maximum age: 6 Months
Healthy volunteers: No
Keywords: hemangioma

Summary:

      Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one
      year of life and do not need treatment. Others require treatment because they cause
      significant symptoms such as pain, or difficulty with breathing, eating or ambulating.
      Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3
      of patients. Unfortunately, steroids have many side effects in babies so physicians have
      sought other ways to treat them. Recently, the use of propranolol, a heart medication, was
      serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side
      effects than steroids but it is not yet known if it works as well as steroids. This study
      seeks to compare the effect and the side effects of propranolol versus steroids for treating
      hemangiomas that cause symptoms in infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  infants with symptomatic hemangiomas

        Exclusion Criteria:

          -  asthma

          -  diabetes

          -  hypertension

          -  hypotension

          -  hypoglycemia

          -  liver failure

          -  previous treatment for hemangiomas
Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: AVI-4658 (Eteplirsen)
Intervention description: Eteplirsen will be administered once weekly via an IV infusion. There are two treatment groups, 30 mg/kg and 50 mg/kg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 7 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51

Summary:

      The primary objective of this study is to assess the ongoing efficacy, safety, and
      tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne
      muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen
      study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers
      for DMD and the clinical status of participating DMD subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        A subject must meet all of the following criteria to be eligible for this study.

          1. The subject and/or their parent/legal guardian are willing and able to provide signed
             informed consent.

          2. The subject has successfully completed 28 weeks of treatment in Study 4658-US-201.

          3. The subject has a parent(s) or legal guardian(s) who is able to understand and comply
             with all of the study procedure requirements.

        Exclusion Criteria:

        A subject who meets any of the following criteria will be excluded from this study.

        1. The subject has a prior or ongoing medical condition that, in the Investigator's
        opinion, could adversely affect the safety of the subject or make it unlikely that the
        course of treatment or follow-up would be completed or impair the assessment of study
        results.
A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
Condition: Kidney Transplantation
Intervention: Alefacept; tacrolimus; basiliximab; mycophenolate mofetil; Corticosteroids
Intervention description: Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.; The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.; Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.; Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.; Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
Intervention MeSH terms: Mycophenolic Acid; Alefacept; Tacrolimus; Basiliximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: kidney transplant; alefacept

Summary:

      A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of
             transplant procedure

          -  Subject is a recipient of a de novo kidney transplant

          -  Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical
             related living donor, a non-related living donor, or a deceased donor

        Exclusion Criteria:

          -  Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+
             T-cell count of < 250 cells/µL

          -  Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30
             hours

          -  Recipient has a positive T or B-cell cross match by investigational site's standard
             method of determination

          -  Subject will receive a kidney from a 50-65 year old deceased donor with one of the
             following:

               -  History of hypertension and a terminal serum creatinine > 1.5 mg/dL

               -  Cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5
                  mg/dL

               -  History of hypertension and cerebrovascular accident as cause of death and a
                  terminal serum creatinine > 1.5 mg/dL
Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Fovista® (anti-PDGF BB) plus anti-VEGF
Intervention MeSH terms: Becaplermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; Choroidal neovascularization; Fovista®; E10030; Avastin®; Eylea®

Summary:

      The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered
      in combination with anti-VEGF therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  All fluorescein angiographic subtypes with presence of active choroidal
             neovascularization

        Exclusion Criteria:

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication

          -  Subjects with subfoveal scar or subfoveal atrophy

          -  Any ocular or periocular infection in the past twelve (12) weeks

          -  History of any of the following conditions or procedures in the study eye:
             Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
             trabeculectomy), glaucoma drainage device, corneal transplant
MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Condition: Malignant Neoplasm; Oral Pain; Stomatitis
MeSH terms: Neoplasms; Mucositis; Stomatitis
Intervention: Best Practice; Methylene Blue; Methylene Blue; Methylene Blue
Intervention description: Given standard of care therapy; Given lower dose PO; Given medium dose PO; Given higher dose PO
Intervention MeSH terms: Methylene Blue
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well methylene blue works in treating patients with cancer
      and pain associated with oral mucositis. Methylene blue may relieve pain associated with oral
      mucositis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a cancer diagnosis, receiving chemotherapy, radiation therapy or the
             combination

          -  Patients with a current diagnosis of oral mucositis

          -  Patients with pain and oral dysfunction associated with oral mucositis despite
             conventional therapy

          -  Voluntary written consent

          -  Patient must agree to use of contraception or abstinence from sex during the treatment
             period and for 30 days after patient's last dose

        Exclusion Criteria:

          -  Patients with known allergy to MB

          -  Patients taking medications with known significant drug interactions

          -  Pregnant or lactating patients

          -  Patients who are cognitively impaired and unable to consent for the study

          -  Patients with risk of broncho-aspiration based on documented swallowing test by a
             speech pathologist (if available)

          -  Patients with known history of G6PD deficiency

          -  Patients undergoing any other experimental intervention for oral mucositis

          -  Patients who have no pain or impairment in oral function, patients who are not
             symptomatic

          -  Patients with head and neck cancer

          -  Patients on serotonergic drugs