bioihbjkbjnl/mcl2 huggingface dataset:
BOTOX® Economic Spasticity Trial (BEST)
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Intervention: Botulinum Toxin Type A 900kD; Placebo
Intervention description: The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.
First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.; The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.
First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
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: Double (Participant, Investigator)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a study to investigate if patients who have had a stroke and suffer from spasticity
      might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is
      characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and
      can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is
      a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to
      reduce spasticity significantly. Patients will be enrolled in this study at about 33
      locations in Europe and Canada. Study participation will last for about 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stroke due to a primary cerebral hemorrhage/infarction

          -  Subarachnoid hemorrhage producing an upper motor syndrome affecting one body side
             which results in a hemi-paralysis/plegia

        Exclusion Criteria:

          -  Patients with fixed contracture as a result of spasticity in the upper or lower limb
             planned to be treated and/or patients with other causes of spasticity (e.g. multiple
             sclerosis, spinal cord injury, etc.)
Comparison of Insulins Aspart and Lispro in Insulin Pumps
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Aspart; Insulin Lispro
Intervention description: Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.; Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 1 diabetes mellitus; Glycemic control; Continuous subcutaneous insulin infusion; Continuous glucose monitoring system

Summary:

      The purpose of the study is to compare the glycemic control between insulins aspart and
      lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes
      using an insulin pump.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 Diabetes treated with a pump for at least 3 months

        Exclusion Criteria:

          -  Pregnancy

          -  Plasma Creatinine > 1.2 mg/dl

          -  Inability to give informed consent

          -  HbA1c > 8%

          -  Known or suspected hypersensitivity to trial drugs or any of their components
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Renal Insufficiency; Kidney Failure, Chronic
Intervention: peginterferon alfa-2a [Pegasys]
Intervention description: 180 micrograms or 135 micrograms sc weekly for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic
      hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will
      receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular
      filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following
      48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-60 years of age;

          -  chronic hepatitis C;

          -  chronic renal failure, including patients on hemodialysis therapy;

          -  detectable HCV RNA levels (>500IU/mL).

        Exclusion Criteria:

          -  concurrent active hepatitis A or B;

          -  history or evidence of a medical condition associated with chronic liver disease other
             than HCV;

          -  history or other evidence of decompensated liver disease;

          -  therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment
             <=6 months prior to study;

          -  acute renal failure.
OASIS Wound Matrix (Oasis) Mechanism of Action
Condition: Diabetic Foot Ulcers (DFU); Venous Stasis Ulcers (VSU)
MeSH terms: Diabetic Foot; Varicose Ulcer; Foot Ulcer; Ulcer
Intervention: OASIS Wound Matrix
Intervention description: OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing
      wounds to explore the mechanism of action.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain
             restrictions on size, duration and underlying health

        Exclusion Criteria:

          -  Contraindications or hypersensitivity to the use of the study medications or their
             components
A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Inhaled Human Insulin (Exubera); Inhaled Human Insulin (Exubera)
Intervention description: Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID; Initial dose of 1mg TID of inhaled human insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess whether a simple initial dose prescription
      of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is
      non-inferior compared to the standard weight-based formula.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes mellitus Type 2

          -  Currently treated with at least 2 oral anti-diabetic agents

        Exclusion Criteria:

          -  Severe Asthma, severe COPD

          -  Smoking
The Feasibility of Florbetapir Quantitation
Condition: Alzheimers Disease
MeSH terms: Alzheimer Disease
Intervention: Florbetapir F18
Intervention description: No Florbetapir F 18 will be administered in this study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 96.0
Sex: All
Healthy volunteers: No

Summary:

      The overall objective of the study is to assess the feasibility of implementing a
      quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use
      of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Readers have undergone Amyvid reader training

          -  Readers have minimal experience with quantitation of amyloid PET scans

        Exclusion Criteria:

          -  Readers have previously been trained to quantitate amyloid PET scans
Subcuticular Suture for Cesarean Skin Incision Closure
Condition: Complications; Cesarean Section; Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Surgical Wound
Intervention: poliglecaprone 25 suture; polyglactin 910 suture
Intervention description: cesarean delivery incision closure with poliglecaprone 25 suture; cesarean delivery incision closure with polyglactin 910 suture
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 550.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: wound complications

Summary:

      A comparison of the type of suture used for cesarean skin incision approximation and the
      subsequent rate of wound complications has not been widely studied. Investigators seek to
      compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in
      Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication
      rates (SSI, hematoma, seroma, wound separation).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age of 37 completed weeks or greater based on their estimated due date
             calculated from last menstrual period or early ultrasound.

          -  Patients participating will be undergoing either:

               -  Scheduled cesarean delivery

               -  Non-emergent cesarean delivery

        Exclusion Criteria:

          -  Urogenital tract infection within 2 weeks prior to surgery

          -  Chronic oral or injectable steroid use (> 2 weeks)

          -  Emergency cesarean delivery (need to deliver immediately due to a maternal or fetal
             indication)

          -  Vertical skin incision

          -  Active participation in another research study
Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
Condition: Short Stature
MeSH terms: Dwarfism
Intervention: Letrozole; Anastrozole
Intervention MeSH terms: Letrozole; Anastrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: Male
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if there are differences in the final height or
      hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now
      routinely used to increase stature: Anastrozole and Letrozole. It also should determine if
      there are differences in the side effect profiles of the two drugs to be used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current height less than 5th percentile AND/OR

          -  Predicted adult height (based on bone age) more than 10 cm below target height (mid
             parental height)

          -  Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and
             testosterone > 15 ng/dl

        Exclusion Criteria:

          -  Bone age reading more than 14.0 years

          -  Follicle stimulating hormone > 20 IU/L
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
Condition: 13-valent Pneumococcal Vaccine; Premature Birth; Immunization; Safety
MeSH terms: Premature Birth
Intervention: 13-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: 13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.; 13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: No
Keywords: 13-valent pneumococcal conjugate vaccine; premature; immunization; safety.

Summary:

      The purpose of this study is to describe the safety, tolerability, and immunogenicity of a
      2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to
      preterm infants with concomitant vaccines, compared to infants born at term.There will be a
      follow-up phase to assess the persistence of the antibody response at 24 and 36 months of
      age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of
             enrollment.

        Exclusion Criteria:

          -  Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib)
             conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus,
             pertussis, or poliovirus vaccines.

          -  Previous anaphylactic reaction or allergy to any vaccine

          -  Contraindication to vaccination

          -  Known or suspected immune deficiency or immune suppression

          -  Major known congenital malformation or serious chronic disorder

          -  Significant neurological disorder

          -  Participation to another study
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Condition: Respiratory Failure; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis; Respiratory Insufficiency
Intervention: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
Intervention description: 8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)
Intervention MeSH terms: Antiviral Agents; Sofosbuvir-velpatasvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung disease; Lung Transplant; HCV; Hepatitis C

Summary:

      This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV
      negative recipient patients, with preemptive, interventional treatment with 8 weeks of
      commercially available DAA therapy to prevent HCV transmission upon transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Met MGH transplant center criteria, listed for lung transplant

          -  Able to sign informed consent

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  HIV positivity

          -  Any contra-indication to lung transplantation per center protocol

          -  For study patients in whom Epclusa® therapy is being considered, exclusion criteria
             includes patients on the following p-glycoprotein inducers or moderate to potent CYP
             inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital,
             oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.

          -  For study patients in whom MavyretTM therapy is being considered, exclusion criteria
             includes patients on the following medications who cannot stop therapy: carbamazepine,
             rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
Use of Bevacizumab in Trabeculectomy Surgery
Condition: Glaucoma; Optic Neuropathy; Fibrosis
MeSH terms: Optic Nerve Diseases; Glaucoma
Intervention: Bevacizumab; Control
Intervention description: Intrableb injection; intrableb BSS injection
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Elevated Intraocular Pressure (IOP); Optic Neuropathy; Bleb Failure; Avastin (Bevacizumab)

Summary:

      When a patient with glaucoma who has a pressure that is too high and causing damage to their
      vision, despite receiving the maximum amount of medication that can be tolerated, the
      decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma
      surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in
      the eye and partially covered with a flap of tissue. This new opening allows fluid to drain
      out of the eye bypassing the clogged drainage channels that are malfunctioning in patients
      with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and
      lowers eye pressure.

      However, many people need another trabeculectomy or other glaucoma surgery because the
      surgery may fail either early or much later because the body closes the drain created by the
      surgeon. The surgery is also less likely to work in patients with darker pigmentation,
      children who have congenital glaucoma, people with difficult to control glaucoma with new
      blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result,
      the investigators need to find ways to improve the longterm survival of trabeculectomy
      surgery in all patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age more than 18 years old

          -  Patients with glaucoma that is inadequately controlled on maximal tolerated medical
             therapy and scheduled for trabeculectomy surgery (with/without combined cataract
             extraction)

          -  Decision makers fluent in English

          -  Decision makers able to understand and read consent form

        Exclusion Criteria:

          -  Patients with active intraocular inflammation/uveitis or neovascular glaucoma

          -  History of previous trabeculectomy surgery or prior retinal detachment with scleral
             buckle placement in the surgical eye

          -  Aphakia in surgical eye

          -  Pregnant and nursing women

          -  Unable to fulfill inclusion criteria

          -  Refusal of consent
Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
Condition: Neoplasms
MeSH terms: Neoplasms
Intervention: Everolimus; Sandostatin LAR Depot
Intervention description: Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject's best interest.; Sandostatin LAR Depot was provided by Novartis or by the investigational site considering local regulations. The dose and frequency of Sandostatin LAR Intramuscular injections was the same as the last dose that was given in the parent study.
Intervention MeSH terms: Everolimus; Octreotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasms; Carcinoid tumor; Neuroendocrine tumor

Summary:

      Study to allow access to everolimus for patients who are on everolimus treatment in a
      Novartis-sponsored study and are benefiting from the treatment as judged by the investigator
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject enrolled in a Novartis-sponsored, CD&MA study receiving everolimus or
             everolimus plus Sandostatin LAR Depot and fulfilled all their requirements in the
             parent study

          -  Subject benefiting from treatment with everolimus, as determined by the guidelines of
             the parent protocol.

        Exclusion Criteria:

          -  Subject was permanently discontinued from everolimus study treatment in the parent
             study.

          -  Subject was receiving everolimus in combination with an unapproved or experimental
             treatment

        Other protocol-defined inclusion/exclusion criteria might apply