bioihbjkbjnl/mcl2 huggingface dataset:
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: glycopyrrolate, 1.0%; glycopyrrolate, 2.0%; glycopyrrolate, 3.0%; glycopyrrolate, 4.0%; Vehicle
Intervention description: glycopyrrolate Topical Wipes, 1.0%; glycopyrrolate Topical Wipes, 2.0%; glycopyrrolate Topical Wipes, 3.0%; glycopyrrolate Topical Wipes, 4.0%; Vehicle Topical Wipes
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared
      to vehicle for the treatment of axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age or older.

          -  Primary, axillary hyperhidrosis of at least 6 months duration.

          -  A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.

          -  A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each
             axilla (total of 100 mg) while at rest at room temperature.

          -  Male or non-pregnant, non-lactating females.

        Exclusion Criteria:

          -  Prior surgical procedure for hyperhidrosis.

          -  Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or
             investigational)

          -  Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.

          -  Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists
             thought to relieve antidepressant-induced hyperhidrosis. Treatment with
             psychotherapeutic medications for less than 4 months prior to study enrollment. -
             Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine),
             or beta-blockers within 4 weeks prior to enrollment.

          -  Prior axillary treatment with axillary iontophoresis within 4 weeks.

          -  Axillary use of nonprescription or prescription antiperspirants within 2 weeks of
             study enrollment.

          -  Known history of a condition that may cause secondary hyperhidrosis.

          -  Known history of Sjögren's syndrome or Sicca syndrome.

          -  Abnormal findings on screening ECG deemed clinically significant by the Investigator.
Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Intervention: busulfan; cyclophosphamide; autologous hematopoietic stem cell transplantation
Intervention description: IV busulfan 0.8 mg/kg every 6 hours x 16 doses; IV cyclophosphamide 60 mg/kg over 4 hours x 2 days; infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0
Intervention MeSH terms: Cyclophosphamide; Busulfan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the
      growth of cancer cells by stopping them from dividing or killing them. An autologous stem
      cell transplant may be able to replace the blood-forming cells that were destroyed by the
      chemotherapy.

      PURPOSE: This phase II trial is studying how well giving busulfan together with
      cyclophosphamide followed by an autologous stem cell transplant works in treating patients
      with multiple myeloma.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Patients with a diagnosis of plasma cell myeloma

          -  Patients with cardiac ejection fraction >= 45% or clearance by Cleveland Clinic
             Faculty (CCF) cardiologist

          -  Patients with diffusion capacity of carbon monoxide (DLCO) >= 45% predicted or
             clearance by CCF pulmonologist

          -  Patient with previously harvested peripheral blood progenitor cells with a minimum of
             2 x 10^6 CD 34+ cells/kg harvested

        EXCLUSION CRITERIA:

          -  Patients receiving total body irradiation

          -  Non-myeloablative/reduced-intensity conditioning

          -  Pregnant and breast feeding patients

          -  Human immunodeficiency virus (HIV) positive

          -  Patients with serum creatinine > 2.0

          -  Prior Hematopoietic Stem Cell (HSC) transplant
Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
Condition: Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Intervention: Inotuzumab Ozogamicin
Intervention description: Part 1: Administered intravenously as 2 - 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total dose per cycle 0.8 mg/m^2 to 2.0 mg/m^2.
Part 2 Expansion and Part 3 Phase 2: Administered intravenously as 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total initial dose per cycle 1.8 mg/m^2.
Intervention MeSH terms: Inotuzumab Ozogamicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed/Refractory Acute Lymphocytic Leukemia (ALL)

Summary:

      The Phase 1 portion of this study will assess the safety, tolerability and efficacy at
      increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or
      refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2
      dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of
      inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in
      second or later salvage status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with CD22-positive ALL with either refractory disease (i.e. disease
             progression or no response while receiving their most recent prior anti-cancer
             therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer
             therapy with subsequent relapse). Subjects enrolled in the Phase 2 portion of the
             study must be due to receive salvage 2 or later therapy.

          -  Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard
             treatment with at least one tyrosine kinase inhibitor.

          -  Adequate renal and hepatic function, and negative pregnancy test for women of
             childbearing potential.

        Exclusion Criteria:

          -  Subjects with isolated extramedullary relapse or active central nervous system (CNS)
             leukemia.

          -  Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22
             immunotherapy within 4 months, or active graft versus host disease (GvHD) at study
             entry.

          -  Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome
             (SOS).
Study of BMN 110 in Pediatric Patients < 5 Years of Age With Mucopolysaccharidosis IVA (Morquio A Syndrome)
Condition: Mucopolysaccharidosis IVA; Morquio A Syndrome; MPS IVA
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis IV; Syndrome
Intervention: BMN 110
Intervention description: Patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/wk over a period of approximately 4 hours every week for up to 208 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Mucopolysaccharidosis IVA type A; MPS IVA Type A; Mucopolysaccharidosis IVA; MPS IVA; Morquio A Syndrome; Lysosomal Storage Disorder; LSD; N-acetylgalactosamine-6-sulfatase; N-acetylgalactosamine-6-sulfate; sulfatase; galactose-6-sulfatase; GALNS; enzyme replacement therapy; ERT

Summary:

      This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk
      infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of
      administration of the first dose of study drug, diagnosed with MPS IVA (Morquio A Syndrome)
      for up to 208 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Less than 5 years of age at the time of the first study drug infusion

          -  Documented clinical diagnosis of MPS IVA based on clinical signs and symptoms of MPS
             IVA and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic
             testing confirming diagnosis of MPS IVA

          -  Written informed consent provided by parent or legally authorized representative after
             the nature of the study has been explained and prior to any research-related
             procedures.

        Exclusion Criteria:

          -  Previous hematopoietic stem cell transplant (HSCT).

          -  Previous treatment with BMN 110.

          -  Known hypersensitivity to any of the components of BMN 110.

          -  Major surgery within 3 months prior to stuy entry or planned major surgery during the
             52-week treatment period.

          -  Use of any investigational product or investigational medical device within 30 days
             prior to Screening, or requirement for any investigational agent prior to completion
             of all scheduled study assessments.

          -  Concurrent disease or condition, including but not limited to symptomatic cervical
             spine instability, clinically significant spinal cord compression, or severe cardiac
             disease that would interfere with study participation or safety as determined by the
             Investigator.

          -  Any condition that, in the view of the Investigator, places the subject at high risk
             of poor treatment compliance or of not completing the study.
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Condition: Lip and Oral Cavity Cancer; Oral Leukoplakia; Oropharyngeal Cancer; Tongue Cancer
MeSH terms: Oropharyngeal Neoplasms; Mouth Neoplasms; Tongue Neoplasms; Leukoplakia; Leukoplakia, Oral
Intervention: Bowman-Birk inhibitor concentrate; placebo; laboratory biomarker analysis
Intervention description: Given orally; Given orally; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 325.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works
      in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain
      substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk
      inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients
      with oral leukoplakia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically and clinically confirmed oral leukoplakia and/or erythroplakia

          -  Bidimensionally measurable disease (≥ 100 mm^2 for total area of all lesions) after
             biopsy

          -  No presence of obvious head and neck aerodigestive tract cancer, carcinoma in situ, or
             previously treated head and neck cancer within the past 2 years

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of allergic reaction to soybeans, sorbitol, sucrose, artificial flavorings,
             aspartame, saccharin, or lidocaine

          -  At least 6 months since prior Bowman-Birk inhibitor concentrate

          -  At least 6 months since prior participation in another randomized clinical trail

          -  At least 3 months since prior systemic steroids or topical oral steroid preparations

               -  Topical nasal steroid sprays or cutaneous preparations with minimal systemic
                  absorption for nasal or dermatologic disorders allowed

          -  More than 6 months since prior beta carotene capsules

          -  At least 2 years since prior retinoid or other beta carotene therapy, including >
             25,000 IU of vitamin A for any reason

               -  Up to 2 multivitamins per day allowed
A Study of Muscle Strength Maintenance in Older Adults
Condition: Sarcopenia
MeSH terms: Sarcopenia
Intervention: Losartan; Placebo
Intervention description: Losartan will be given in increasing doses to those in the losartan arm.; Placebo will be given to those in placebo arm
Intervention MeSH terms: Losartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 70 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sarcopenia; frailty; losartan

Summary:

      This research study is being done to see whether losartan can prevent the decrease in
      strength associated with aging.

      Muscle loss is associated with aging and has multiple symptoms such as weakness, slowness,
      and fatigue (tiredness). Older adults with muscle weakness have a higher risk of falls and
      disability. In addition, the loss of independence for older adults can lead to a poorer
      quality of life.

      Recently, it was discovered that losartan, a medication commonly used to treat high blood
      pressure, had slowed the strength decline seen in older mice. In addition, it allowed injured
      mice skeletal muscle to heal faster. Therefore, we would like to see if losartan can do the
      same for older adults.

      Losartan is approved by the Food and Drug Administration (FDA) for the treatment of high
      blood pressure, heart failure, and to protect the kidneys in diabetic patients. Losartan is
      not FDA-approved to prevent the decrease in strength associated with aging.

      In this study, participants age 70 and older will be asked to take losartan or a placebo to
      see if losartan can help prevent loss of muscle strength. A placebo is a substance that looks
      like the study drug but that contains no active ingredients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 70 and over

          -  Pre-frail as determined by frailty criteria

        Exclusion Criteria:

          -  Under age 70

          -  Robust or frail by frailty criteria

          -  Have other indications for use of any angiotensin-receptor blockers (ARB) such as
             myocardial infarction in past year, history of congestive heart failure, uncontrolled
             hypertension

          -  Current use of ARBs or angiotensin-converting enzyme (ACE) inhibitors

          -  Prior allergic reaction to or hyperkalemia with losartan or any ARB

          -  Chronic renal failure with a glomerular filtration rate of < 30

          -  Current daily use of non-steroidal anti-inflammatory agents

          -  Current use of steroids

          -  Lower extremity disability that would prevent muscle strength testing

          -  Echocardiogram-diagnosed cardiac failure as evidenced by left ventricular ejection
             fraction less than 50%

          -  Cognitive impairment with a Mini-Mental State Examination < 24
Follow on Study From RE-ALIGN
Condition: Thromboembolism; Heart Valve Prosthesis
MeSH terms: Thromboembolism
Intervention: dabigatran etexilate low dose; warfarin 5mg; dabigatran etexilate intermediate dose; warfarin 1mg; dabigatran etexilate high dose; warfarin 3mg
Intervention description: active treatment (low); comparator warfarin; active treatment (medium); comparator warfarin; active treatment (high); comparator warfarin
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To collect additional data relating to safety and indicators of efficacy for patients who
      have participated in the 1160.113 study.
    

Eligibility criteria:

        Inclusion criteria:

          1. Completed study 1160.113 per protocol

          2. Continuing need for anticoagulation

        Exclusion criteria:

          1. uncontrolled hypertension

          2. severe renal impairment

          3. active liver disease

          4. increased risk of bleeding
Vitamin D3 for Aromatase Inhibitor Induced Arthralgias
Condition: Breast Cancer
Intervention: High Dose Vitamin D; Placebo; Standard Dose Vitamin D3; Letrozole 2.5mg
Intervention description: High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.; Placebo comparator; Standard Dose Vitamin D3 (600 IU of vitamin D3 daily); All subjects received letrozole as standard of care.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 160.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose is to determine if high dose vitamin D3 reduces the incidence of
      musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with
      early stage breast cancer and low serum vitamin D levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal women newly diagnosed with early stage breast cancer, who would be
             treated with an aromatase inhibitor

          -  Serum 25OHD levels < 40 ng/ml

        Exclusion Criteria:

          -  Severe or debilitating musculoskeletal pain

          -  Known metastatic disease

          -  History of renal stones

          -  History of hypercalcemia or hyperthyroidism

          -  Currently receiving adjuvant or neoadjuvant chemotherapy

          -  Currently receiving other investigational agents
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Intervention: TS022; Vehicle
Intervention description: Lotion; Lotion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Pruritus

Summary:

      The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and
      tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe
      pruritus (itching), following a 28-day regimen of twice-daily topical application.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults, males or females, 18 - 65 years of age at the time of obtaining the written
             Informed Consent

          2. Generally healthy subjects, who have no past or present history of any significant
             and/or newly-diagnosed disease or condition

          3. A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the
             Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale

          4. A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on
             the Five-Point Pruritus Scale

          5. Patient satisfies the diagnostic criteria for AD as determined by the criteria of
             Hanifin and Rajka

          6. Patient understands the study procedures and agrees to participate in the study by
             giving written Informed Consent

          7. Ability to read and understand English and to provide written informed consent and
             authorization for protected health information disclosure

        Exclusion Criteria:

          1. Concurrent skin pathology or recent history (within the past 5 years) of a chronic
             skin disease other than AD

          2. Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug
             application

          3. Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy
             within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within
             7 days) of Study Drug application

          4. Females who are planning a pregnancy, who are pregnant, or who are breastfeeding

          5. Inability or unwillingness to discontinue current AD treatment(s)

          6. Inability or unwillingness to comply with study visit schedule and/or other study
             activities as required by the study protocol
Phase IIa Vorinostat (MK0683, Suberoylanilide Hydroxamic Acid (SAHA)) Study in Lower Risk Myelodysplastic Syndromes (0683-064)
Condition: Myelodysplastic Syndromes; Blood Disease; Bone Marrow Disease
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Hematologic Diseases; Bone Marrow Diseases; Syndrome
Intervention: vorinostat; vorinostat
Intervention description: vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles.; vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients
      with lower risk Myelodysplastic Syndrome (MDS).
    

Eligibility criteria:

        Inclusion Criteria:

        Patient is a male or female, at least 18 years of age with low or intermediate-1 risk
        Myelodysplastic Syndrome (MDS) defined by the International Prognostic Scoring System

          -  Patient has previously untreated disease, or has received up to one prior treatment
             regimen for lower-risk Myelodysplastic Syndrome

          -  Patient has a performance status of equal to or less than 2 on the Eastern Cooperative
             Oncology Group Performance Scale

          -  Patient must have adequate organ function

        Exclusion Criteria:

          -  Patient has clinical evidence of Central Nervous System (CNS) leukemia

          -  Patient is pregnant or breastfeeding, or expecting to conceive within the projected
             duration of the study

          -  Patient had prior treatment with a histone deacetylase inhibitor