bioihbjkbjnl/mcl2 huggingface dataset:
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
Condition: Graft Versus Host Disease; Hematopoietic/Lymphoid Cancer
MeSH terms: Graft vs Host Disease
Intervention: fludarabine phosphate; busulfan; cyclophosphamide; allogeneic hematopoietic stem cell transplantation; tacrolimus; mycophenolate mofetil
Intervention description: Given IV; Given IV; Given IV; Undergo myeloablative or reduced intensity allogeneic stem cell transplant
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Busulfan; Fludarabine; Fludarabine phosphate; Tacrolimus
Phase: Phase 2
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: 69 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in
      treating patients with hematological diseases. Giving chemotherapy before a donor stem cell
      transplant helps stop the growth of cells in the bone marrow, including normal blood-forming
      cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused
      into the patient they may help the patient's bone marrow make stem cells, red blood cells,
      white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an
      immune response against the body's normal cells (called graft-versus-host disease). Giving
      cyclophosphamide after the transplant may stop this from happening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a hematological malignancy requiring an allogeneic stem cell transplant
             consistent with the standard of care

          -  Remission of any acute hematologic malignancy or adequate disease control for chronic
             malignancies.

          -  Ages 18-69 years old.

          -  Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor

        Exclusion Criteria:

          -  Significant organ dysfunction defined as: LV EF < 50% (evaluated by echocardiogram or
             MRI), DLCO or FEV1 < 65% predicted, AST/ALT > 2.5 x ULN, Bilirubin > 1.5 x ULN, Serum
             creatinine > 2mg/dL, dialysis, or prior renal transplant

          -  HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or
             human T-cell lymphotropic virus (HTLV-I/II) are not excluded from participation)

          -  Positive pregnancy test for women of childbearing age.

          -  Major anticipated illness or organ failure incompatible with survival form transplant.

          -  Severe psychiatric illness or mental deficiency sufficiently severe as to make
             compliance with the transplant treatment unlikely and informed consent impossible.
Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
Condition: Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: Momelotinib
Intervention description: Momelotinib tablets administered orally once daily
Intervention MeSH terms: N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Myelofibrosis; Post Polycythemia Vera Myelofibrosis; Post Essential Thrombocythemia Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia; blood disorders

Summary:

      This open-label study is to determine the long-term safety and tolerability of momelotinib in
      previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia
      vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF),
      polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved
      stable disease or better with momelotinib treatment while enrolled in a previous clinical
      trial.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently enrolled in study CCL09101E, or YM387-II-02, or successfully completed 24
             weeks of study GS-US-352-1672

          -  Able to comprehend and willing to sign informed consent form

        Key Exclusion Criteria:

          -  Known hypersensitivity to momelotinib, its metabolites, or formulation excipients

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg
Condition: Pancreatic Tumours; Midgut Neuroendocrine Tumours
MeSH terms: Neoplasms; Neuroendocrine Tumors; Pancreatic Neoplasms
Intervention: Lanreotide autogel 120 mg
Intervention MeSH terms: Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered
      every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable
      pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the
      standard dose of lanreotide Autogel® 120 mg every 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced,
             unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone
             related syndromes, with a proliferation index (Ki67) ≤20%.

          -  Positive somatostatin receptors type 2

          -  Progression as assessed by an independent central reviewer according to RECIST v1.0
             while receiving first line treatment with lanreotide Autogel® at a standard dose of
             120 mg every 28 days for at least 24 weeks

        Exclusion Criteria:

          -  Grade 3 or rapidly progressive (within 12 weeks) NET

          -  Any NET other than pancreatic and midgut

          -  Previous treatment with any antitumour agent for NET other than lanreotide Autogel®
             120 mg every 28 days. Exception made of prior treatment with Octreotide at standard
             dose stopped for other reason than disease progression.

          -  Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis
             with no cholecystectomy since then.
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
Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: INTRAVENOUS GSK679586; INTRAVENOUS PLACEBO; FLUTICASONE PROPIONATE
Intervention description: GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump; Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump; Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.
Intervention MeSH terms: Fluticasone; Xhance
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
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Asthma control questionnaire

Summary:

      Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of asthma for ≥ 6 months

          -  taking inhaled corticosteroids

          -  non-smoking

          -  Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening.

          -  Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline
             after nebulised salbutamol or albuterol.

          -  symptomatic according to the ACQ-7

        Exclusion Criteria:

          -  Unstable severe asthma

          -  Recent respiratory illness

          -  Presence of other respiratory disease or chronic pulmonary condition other than asthma

          -  Treatment with omalizumab within 4 months of study

          -  Recent gastrointestinal or respiratory parasitic infestation

          -  History of severe allergy to food or drugs

        Other protocol-defined inclusion/exclusion criteria may apply
Ketamine in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Intervention: Ketamine; Midazolam
Intervention description: 1 single dose of IV ketamine; 1 single dose of IV midazolam
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Borderline Personality Disorder; Ketamine; Suicide; Social Cognition

Summary:

      The purpose of this study is to test the potential of the rapid-acting anti-depressant
      ketamine to decrease suicidality in Borderline Personality Disorder (BPD).

      The rate of completed suicide in BPD is similar to that of depression or schizophrenia. There
      is currently no specific medication treatment for BPD.

      Ketamine is an FDA-approved anesthetic agent that has been shown to rapidly decrease
      suicidality and improve mood in people with Major Depressive Disorder (MDD). Though symptoms
      overlap, effective treatments for MDD and BPD differ. This clinical trial tests if ketamine
      also decreases suicidality and improves mood in BPD.

      This trial will also measure several other outcomes after ketamine versus placebo in BPD:
      adverse events, BPD symptoms, pain, social cognition, and neuroplasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21-60

          -  Clinical diagnosis of Borderline Personality Disorder

          -  Has suicidal ideation.

          -  Fluent in English

          -  Has a current mental health treater, and agrees for study to communicate with treater

        Exclusion Criteria:

          -  Current suicidal intent

          -  Med changes in last 4 weeks

          -  Any ketamine in any context in the last one year.

          -  Current prescription for topiramate, lamotrigine, or lithium.

          -  Psychotic disorder in self or first-degree relative

          -  Current substance dependence including alcohol dependence

          -  Any history of NMDA (N-methyl-D-aspartate )-antagonist abuse

          -  Any history of opiate abuse

          -  History of major medical illness especially neurologic or cardiovascular condition, or
             any other medical contra-indication to ketamine administration at the discretion of
             the study MD.

          -  Positive urine test for drugs of abuse screening on day of ketamine administration

          -  Positive pregnancy test on day of ketamine administration

          -  At the discretion of study staff
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Liposomal Doxorubicin; Cyclophosphamide; Trastuzumab
Intervention MeSH terms: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HER2 positive breast cancer; Metastatic breast cancer

Summary:

      Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that
      will be administered every 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must sign an informed consent before of specific procedures of clinical
             trial.

          -  Patients with histologically confirmed breast cancer and overexpression of Her2neu.

          -  Age> 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) equal or < 2.

          -  Patients have not been treated previously with chemotherapy for metastatic disease.

          -  Patients must have at least one measurable lesion according to RECIST criteria.

          -  Patients should have an adequate organ function to tolerate chemotherapy.

        Exclusion Criteria:

          -  Patients with hypersensitivity reactions to any of the medications of the clinical
             trial.

          -  Patients who are pregnant or lactating are not eligible.

          -  Hepatic disease.

          -  Not controlled active infection

          -  Symptomatic metastatic brain cancer

          -  Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300
             mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)
Regimen Optimization Study
Condition: Kidney Transplantation
Intervention: Thymoglobulin; Belatacept; mycophenolate mofetil(MMF); Corticosteroids; Everolimus(EVL); Tacrolimus(TAC)
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Everolimus; Abatacept; Tacrolimus; Thymoglobulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress
      the immune system (called immunosuppressive regimens) to stop the immune system from
      attacking the transplanted kidney in order to limit damage to or the possibility of rejecting
      the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two
      immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate
      mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women, aged 18 to 75

          -  Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+)

          -  Diagnosed with end stage renal disease (ESRD) and scheduled to undergo transplantation
             of a non-HLA identical, living or standard criteria deceased donor kidney

        Exclusion Criteria:

          -  Primary cause of ESRD is: primary focal segmental glomerulosclerosis; or Type I or II
             membranoproliferative glomerulonephritis; or Hemolytic Uremic Syndrome / Thrombotic
             Thrombocytopenic Purpura

          -  Had a previous graft loss due to acute rejection

          -  At increased immunologic risk of graft loss due to panel reactive antibodies (PRA)
             >20% or need for desensitization therapy

          -  Scheduled to receive a: kidney from identical twin; or paired kidney; or kidney from a
             Cytomegalovirus(CMV) positive donor when recipient is CMV negative; or kidney from an
             extended criteria donor

          -  Have a body mass index (BMI) of > 35 kg/m2 for nondiabetics or > 30 kg/m2 for
             diabetics

          -  Diagnosed as Hepatitis B positive; or Hepatitis C positive; or HIV positive; or
             currently or previously active or inadequately treated latent
Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients
Condition: Epidermolysis Bullosa; Pruritus
MeSH terms: Epidermolysis Bullosa; Pruritus
Intervention: VPD-737; Placebo
Intervention description: VPD-737 inhibits the receptor neurokinin-1.; Matching tablets to VPD-737 tablets without active drug
Intervention MeSH terms: Serlopitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2 investigator-initiated, randomized, double-blind, placebo-controlled, parallel-arm trial evaluating the comparative effect of serlopitant 5 mg by mouth daily versus placebo in treatment of chronic pruritus in pediatric and adult EB patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Research personnel not involved in this study was responsible for blinding. This was the only personnel with access to the code linking study drug bottle numbers to treatment (i.e. active or placebo). The code was broken when all data was captured and locked on an electronic data capture system.
Enrollment: 14.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      Our goal is to determine whether daily oral administration of VPD-737 (5 mg) is effective and
      safe in treating moderate to severe pruritus in patients with Epidermolysis Bullosa (EB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Epidermolysis Bullosa (EB) and pruritus

        Exclusion Criteria:

          -  Chronic liver or renal disease