bioihbjkbjnl/mcl2 huggingface dataset:
Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia (WM)
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: Bortezomib; Rituximab
Intervention description: Once weekly for 3 weeks; Intravenously once a week for the first and fourth weeks of a cycle
Intervention MeSH terms: Rituximab; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: relapsed Waldenstrom's macroglobulinemia; refractory Waldenstrom's macroglobulinemia; Velcade; WM

Summary:

      In this study, we are trying to find out if the combination of these two drugs is effective
      in treating Waldenstrom's macroglobulinemia (WM). The combination of these two drugs has not
      been studied for patients with relapsed or refractory macroglobulinemia. The U.S. Food and
      Drug Administration (FDA) has approved bortezomib for the treatment of multiple myeloma, a
      cancer that is closely related to Waldenstrom's macroglobulinemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Patients with previously untreated WM and those who have received prior therapy are
             eligible

          -  Must have received prior therapy for their WM and have relapsed or refractory WM.

          -  CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow
             cytometric analysis performed up to 3 months prior to enrollment.

          -  Measurable disease

          -  ECOG Performance Status 0,1, or 2

          -  Total bilirubin < 2.0 mg/dl

          -  AST < 3 x ULN

          -  Life expectancy of greater than 12 weeks

        Exclusion Criteria:

          -  Uncontrolled infection

          -  Other active malignancies

          -  Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or
             corticosteroids less than 2 weeks, prior to registration.

          -  Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
             considered investigational

          -  Known to be HIV positive or HEP B positive

          -  Radiation therapy less than 2 weeks prior to registration

          -  Grade 2 or greater peripheral neuropathy

          -  Myocardial infarction within 6 months rior to enrollment or has NYHA Class III or IV
             heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
             electrocardiographic evidence of acute ischemia or active conduction system
             abnormalities.

          -  Hypersensitivity to bortezomib, boron, or mannitol

          -  Pregnant or breast feeding women

          -  Other investigational drugs within 14 days of enrollment

          -  Serious medical or psychiatric illness likely to interfere with participation
Beta-blockers in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Carvedilol; Placebo
Intervention description: Beta-adrenergic receptor blocker; Placebo
Intervention MeSH terms: Carvedilol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators will conduct a, randomized, phase 2, placebo-controlled, double-blinded,
      crossover trial of carvedilol in 26 PAH patients with World Health Organization functional
      class II or III symptoms and RV ejection fraction (EF) < 45% for 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  WHO category 1 pulmonary arterial hypertension (Nice 2013)

          -  WHO functional class II-III

          -  RVEF by cardiac MRI < 45%

          -  Stable on PAH-specific therapy as defined by no change in PAH-specific treatment and
             functional class in the past 3 months. Patient can be on either mono or combination
             PAH-specific therapy

        Exclusion Criteria:

          -  Subjects will be excluded from participation in the study if any of the following
             conditions exist:

          -  Significant persistent bradycardia (resting heart rate < 60 bpm) without a permanent
             pacemaker

          -  Second or third degree AV block without a permanent pacemaker

          -  Significant sinus tachycardia (resting heart rate > 110 bpm)

          -  Use of anti-arrhythmic drugs

          -  Hypotension defined as systolic blood pressure < 100 mmHg at the time of enrollment

          -  Significant illness in the past 30 days requiring hospitalization

          -  Acute decompensated right heart failure within past 30 days

          -  Known allergy or intolerance to carvedilol or other β blockers

          -  Cardiac index < 2 l/min/m2 or right atrial pressure > 15 mm Hg by right heart
             catheterization within last 3 months

          -  Asthma

          -  Positive pregnancy test in patients of child bearing-potential
Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Condition: Nicotine Dependence; Alcohol Dependence
MeSH terms: Alcoholism; Tobacco Use Disorder
Intervention: Topiramate; Placebo
Intervention description: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).; Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.
Intervention MeSH terms: Topiramate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: tobacco use disorders; alcoholism

Summary:

      The purpose of this study is to determine whether topiramate is effective as an aid to
      smoking cessation for recovering alcohol dependent men.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects will be included if they:

          -  are 18-70 years of age, inclusive;

          -  are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol
             dependence in early full remission (1-36 months abstinence);

          -  are current tobacco smokers who smoke an average of 10 or more cigarettes per day in
             the two months prior to the screening visit;

          -  are motivated to try to quit smoking and maintain abstinence from alcohol and other
             illicit drugs;

        Exclusion Criteria:

        Subjects will be excluded if they:

          -  have any clinically significant laboratory evidence of hematologic, hepatic,
             cardiovascular, renal, pulmonary, or thyroid disease;

          -  have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary,
             metabolic, cardiovascular, infectious, or endocrine disease;

          -  have a history of known hypersensitivity to topiramate;

          -  in the investigator's judgment, pose a current suicidal or homicidal risk;

          -  have taken any investigational drug within 30 days of baseline; and

          -  have a current seizure disorder or a history of severe alcohol withdrawal (alcohol
             withdrawal seizures, hallucinations / illusions, delirium tremens).
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Condition: Extremely Low Gestational Age Newborn; Premature Infant
Intervention: oropharyngeal administration of own mother's colostrum; oropharyngeal administration of sterile water
Intervention description: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.; application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 48 Hours
Maximum age: 96 Hours
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory
      protection against nosocomial infection in extremely premature infants. However, most of them
      could not proceed enteral feedings due to clinical instability in the first few days. Recent
      studies supports oropharyngeal administration as a potentially safe and effective delivery
      method for immunologic benefits and only small amount of colostrum could be administrated for
      immune therapy for extremely premature babies. The purpose of this study is to determine the
      beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in
      extremely low gestational age infants and evaluated the safety of this method to extremely
      premature infants in the first few days of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  premature infant with a gestational age less than 28 weeks born at Seoul National
             University Hospital and admit to the Seoul National University Children's Hospital
             NICU immediately after birth

          -  parents of the infant signed to the informed consent form with voluntary agreement

        Exclusion Criteria:

          -  infants with major congenital anomalies or chromosomal syndromes

          -  infants of mothers not willing to provide colostrum in the first week of life

          -  infants of mothers with known infectious diseases that may be transmitted through the
             breast milk such as HIV, hepatitis C or active TB
Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
Condition: Nasal Polyps
MeSH terms: Nasal Polyps
Intervention: Furosemide; Placebo
Intervention description: furosemide; placebo
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal
      polyposis following sinus surgery. This project aims to further investigate that claim
      through a blinded randomized controlled clinical trial following patients who undergo
      functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly
      assigning participants to receive topical furosemide versus placebo nasal spray for 2 months
      post operatively. Outcomes would be compared at 6 months through endoscopic grading scores
      using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to
      measure the rate and degree of recurrence and impact on symptoms in the treatment group
      versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with chronic rhinosinusitis and sinonasal polyposis who are candidates for
             functional endoscopic sinus surgery

        Exclusion Criteria:

          -  Hypersensitivity to furosemide or sulfonamides

          -  pregnancy

          -  history of tinnitus

          -  history of sensorineural hearing loss

          -  poorly controlled diabetes

          -  current diuretic therapy

          -  known electrolyte disorder

          -  currently taking aminoglycosides

          -  BUN and creatinine levels out of the normal range

          -  history of renal disease

          -  allergy to sulfonamides
MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial
Condition: Dental Caries; Dental Pulp Exposure
MeSH terms: Dental Caries; Dental Pulp Exposure
Intervention: RCT Group; MTA/FS pulpotomy Group
Intervention description: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.; After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Healthy volunteers: No
Keywords: pediatrics; dental caries; dental pulp exposure; incisor

Summary:

      To compare radiographic and clinical outcomes and survival of mineral trioxide
      aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital
      primary maxillary incisors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children with one or more carious primary maxillary incisors where removal of dental
             caries will likely to produce a vital pulp exposure

          -  reside in the GTA at time of inclusion

          -  English-speaking

        Exclusion Criteria:

          -  history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract,
             tenderness to percussion and pathological mobility

          -  incisors with preoperative radiographic evidence of periapical or periradicular
             radiolucency, a widened periodontal ligament space, physiological resorption,
             incomplete root formation, internal or external root resorption, pulp canal
             obliteration or pulp calcifications

          -  non-restorable tooth
Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia
Condition: Severe Thalassemia
MeSH terms: Thalassemia
Intervention: Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan
Intervention description: Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion
Intervention MeSH terms: Fludarabine; Melphalan; Alemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 1 Year
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Thalassemia; Alemtuzumab; Hematopoietic cell transplant; non-myeloablative

Summary:

      This study is being done to determine if blood cell transplants, with either bone marrow or
      cord blood from unrelated donors, are effective in children with severe thalassemia and if
      this treatment approach has acceptable risks and side effects.

      This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine,
      Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation.
      The primary hypothesis is that this regimen will promote stable engraftment of unrelated
      donor hematopoietic cells, support normal erythropoiesis, and result in an event free
      survival of > 75% of children with thalassemia major.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1-16.00 years old

          -  Have transfusion dependent thalassemia major

          -  Shall not have an HLA-matched family donor

          -  Must have a suitably matched unrelated marrow donor or UCB product

          -  Lansky score >/= 70

          -  Adequate pulmonary, renal, liver, and other organ function as defined in protocol

          -  Negative pregnancy test

          -  Adequate total nucleated cell or CD34+ dose of product as defined in protocol

          -  Iron chelation must be discontinued >/= 48 hours prior to conditioning regimen

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  HIV positive

          -  Prior allogeneic marrow or stem cell transplantation
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
Condition: Hypophosphatasia
MeSH terms: Hypophosphatasia
Intervention: asfotase alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 24 Weeks
Maximum age: 42 Months
Healthy volunteers: No
Keywords: Hypophosphatasia; HPP; Bone disease; Soft bones; Low alkaline phosphatase; Genetic metabolic disorder; Alkaline phosphatase; Tissue non-specific alkaline phosphatase; Rickets; Osteomalacia

Summary:

      This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and
      young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).

      Partial funding for this study was provided by the Office of Orphan Product Development
      (OOPD).
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient completed participation in ENB-002-08 (NCT00744042)

          -  Written informed consent by parent or other legal guardian prior to any study
             procedures being performed

          -  Parent or other legal guardian willing to comply with study requirements

        Exclusion Criteria

          -  History of sensitivity to any of the constituents of the study drug

          -  Clinically significant disease that precludes study participation

          -  Enrollment in any study (other than ENB-002-08) involving an investigational drug,
             device, or treatment for HPP (e.g., bone marrow transplantation)
Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)
Condition: Obesity; Overweight; Body Weight
MeSH terms: Overweight; Body Weight
Intervention: SCH 497079; Placebo
Intervention description: 100 mg capsule administered orally; Placebo capsules matching SCH 497079 administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and
      overweight participants. The primary measure of effectiveness is the change in body weight
      during treatment. Additional measures include waist circumference and body mass index (BMI).
      In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated.
      The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that
      with placebo with respect to the primary efficacy variable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= 18 years of age, of either sex, and of any race.

          -  Obese or overweight participants.

        Exclusion Criteria:

          -  Participants who have a history of major eating disorders, gastrointestinal (GI)
             surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectious,
             GI, hepatic, renal, hematologic, immunologic or psychiatric disease or diabetes.
A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399; Placebo
Intervention description: 30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.; IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of
      treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for
      participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of
      LY2127399 or placebo. Participants will participate in 10 or more visits to the study site,
      over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of 18 and 75 years

          -  Have given written informed consent approval

          -  Women must not be at risk to become pregnant during study participation

          -  Diagnosis of Rheumatoid Arthritis according to the 1987 revised American Rheumatism
             Association (ARA) criteria for the classification of RA

          -  Serum C-reactive protein (CRP) measurement greater than the upper limit of normal
             (ULN, 0.574 mg/dL), or erythrocyte sedimentation rate (ESR) ≥28 mm/hr

          -  Current, regular use of Methotrexate, at a stable dose

          -  Biologic DMARD naïve, and have had an insufficient response (in the opinion of the
             investigator) to an adequate therapeutic dose of at least 1 oral DMARD

        Exclusion Criteria:

          -  Use of excluded medications (reviewed by study doctor)

          -  Surgical treatment of a joint with 2 months of study enrollment that is to be assessed
             in the study

          -  Are unable to ambulate; that is, confined to bed or wheelchair bound

          -  Have medical findings which, in the opinion of the study doctor, put participant at an
             unacceptable risk for participation in the study

          -  Have had recent or ongoing infection which, in the opinion of the study doctor put
             participant at an unacceptable risk for participation.