bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
Condition: Dyslipidemia
MeSH terms: Dyslipidemias; Hypertriglyceridemia
Intervention: ETC-1002; Placebo
Intervention description: ETC-1002 daily for 12 weeks; Placebo daily for 12 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of
      ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Provision of written informed consent prior to any study-specific procedure

          -  Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating
             medications and supplements

          -  Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications
             and supplements

          -  BMI between 18 and 35 mg/kg2

        Major Exclusion Criteria:

          -  Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension

          -  Females of child bearing potential (i.e., females who are not surgically sterile or
             post-menopausal)
Stem Cell Transplant w/Laronidase for Hurler
Condition: Mucopolysaccharidosis I; Hurler Syndrome
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis I; Syndrome
Intervention: Stem Cell Transplant; Laronidase ERT
Intervention description: enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following; Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Maximum age: 7 Years
Healthy volunteers: No
Keywords: Laronidase ERT; Stem cell transplant; storage disease; inborn errors of metabolism; hurler syndrome; glycosaminoglycans; enzyme replacement

Summary:

      The investigators hypothesize that weekly infusions of Laronidase ERT for 10-12 weeks prior
      to transplant and 8 weeks following transplant will result in a reduction of
      glycosaminoglycans (GAG) burden that is associated with decreased complications following
      transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with the diagnosis of mucopolysaccharidosis type IH (MPS I, Hurler syndrome)
             who are candidates for first hematopoietic stem cell transplant (HSCT) according to a
             University of Minnesota myeloablative HSCT protocol.

        Exclusion Criteria:

          -  Not being considered for University of Minnesota myeloablative HSCT protocol.

          -  Previous administration of laronidase enzyme

          -  Second or subsequent HSCT.
Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma
Condition: Sarcoma, Soft Tissue
MeSH terms: Sarcoma
Intervention: ifosfamide and doxorubicin vs gemcitabine and docetaxel
Intervention description: Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.
Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.
All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection.
Intervention MeSH terms: Gemcitabine; Docetaxel; Doxorubicin; Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore how a sarcoma is affected by and the side effects of
      a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard
      combination of chemotherapy drugs, ifosfamide and doxorubicin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  no evidence of metastasis

          -  soft tissue sarcoma

          -  intermediate or high histologic grade

          -  greater than 5 cm

          -  Zubrod performance status 1 or better

          -  age 10 or older

        Exclusion Criteria:

          -  clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or
             Kaposi's

          -  prior chemotherapy

          -  nephrectomy

          -  active unstable angina pectoris

          -  concurrent therapy
OTO-313 in Subjects With Unilateral Subjective Tinnitus
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Intervention: OTO-313; Placebo
Intervention description: Single intratympanic injection; Single intratympanic injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: intratympanic injection; IT injection; gacyclidine; tinnitus

Summary:

      The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral
      tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral
      tinnitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has early-onset subjective unilateral tinnitus that is persistent
             (consistently aware of their tinnitus throughout much of the waking day).

          -  Subject is able to use the diary to complete their daily tinnitus ratings.

          -  Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural
             hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear
             injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear
             barotrauma); age related hearing loss; resolved otitis media; ototoxic drug exposure.

          -  Subject is willing to comply with the protocol and attend all study visits.

        Exclusion Criteria:

          -  Subject has pulsatile tinnitus, temporomandibular joint disease (TMJ) associated with
             tinnitus perception, tinnitus resulting from traumatic head or neck injury, or
             tinnitus resulting from a tumor or stroke.

          -  Subject is pregnant, lactating, or undergoing fertility treatment.

          -  Subject has other clinically significant illness, medical condition or medical history
             at Screening or Baseline that, in the Investigator's opinion, would likely reduce the
             safety of study participation or compliance with study procedures.
Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Intervention: Phenytoin; placebo
Intervention description: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.; 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
Intervention MeSH terms: Phenytoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: participant , investigator
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it
      presents as subacute monocular visual loss that develops over several days.

      As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term
      beneficial effect on vision.

      There are a number of factors that contribute to nerve fibre damage including increased level
      of sodium, so blocking sodium entry could help to protect them against damage.

      The main objective of the study is determine whether phenytoin (which blocks sodium entry)
      can protect nerve fibre and improve final visual function after optic neuritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)

          -  willing to receive a steroidal regimen

          -  no pathologic finding in first oct

          -  no pathology and history of optic neuritis in contralateral eye

          -  <14 days since onset visual loss

        Exclusion Criteria:

          -  Contraindication or known allergy to Phenytoin

          -  Use of a calcium channel or sodium channel blocker in the past 2 months

          -  Corticosteroid use in the past 2 months

          -  Pregnancy

          -  Significant cardiac, renal or liver abnormalities

          -  Prior clinical episode of optic neuritis in either eye

          -  Bilateral acute optic neuritis

          -  Known ocular or neurological conditions or abnormalities other than refractive error
             that impair visual function

          -  Refractive error of greater than +5 or -5 diopters

          -  Any condition that may interfere with performance of Optical Coherence Tomography
             (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not
             related to optic neuritis as detected on the OCT reading
Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
Condition: Skin Ulcers; Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell; Skin Ulcer; Ulcer
Intervention: Arginine Butyrate; Standard local care dressing
Intervention description: To determine if Arginine Butyrate accelerates healing of refractory leg ulcers over Standard Local Care alone.; To heal leg ulcers.
Intervention MeSH terms: Arginine butyrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 16 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: dermatologic disorders; genetic diseases and dysmorphic syndromes; hematologic disorders; rare disease; sickle cell anemia; skin ulcers; thalassemia major

Summary:

      OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate
      in terms of healing rate in patients with refractory sickle cell ulcers.

      II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion
      or inhibition of wound healing in these patients.

      III. Determine whether the regimen used in this study is appropriate for testing in pivotal
      trials.
    

Eligibility criteria:

        PROTOCOL CRITERIA

        INCLUSION:

        --Disease Characteristics-- Significant sickle cell syndrome including Hemoglobin SS
        (HbSS), Hemoglobin S-beta thalassemia, and hemoglobin variants. Lower extremity or ankle
        ulcer (or ulcers) present for at least 6 months without healing --Patient Characteristics--
        Age: 16-60 yrs Performance status: Not specified Hematopoietic: Not specified Hepatic: No
        hepatic compromise Transaminases no greater than 250 IU Renal: No renal compromise
        Creatinine no greater than 1.2 mg/mL (adults) Creatinine no greater than 0.9 mg/mL
        (teenagers) Other: Not pregnant Fertile patients must use effective contraception No poorly
        controlled seizure disorders No other secondary conditions that might inhibit immune
        function

          -  Prior/Concurrent Therapy Other: Must be treated with antibiotics prior to entry for
             complicating cellulitis or secondary infections

        EXCLUSION :

        --Prior/Concurrent Therapy-- Biologic therapy: chronic transfusion therapy Chemotherapy:
        prior or concurrent cancer chemotherapy concurrent butyrate derivatives Endocrine therapy:
        concurrent corticosteroid therapy Radiotherapy: Not specified Surgery: Not specified
        --Patient Characteristics-- Hepatic: hepatic compromise Transaminases greater than 250 IU
        Renal: renal compromise Creatinine greater than 1.2 mg/mL (adults) Creatinine greater than
        0.9 mg/mL (teenagers) Other: pregnant; Fertile patients with no effective contraception
        Poorly controlled seizure disorders other secondary conditions that might inhibit immune
        function
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Condition: Chronic Kidney Diseases; Inflammation
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Inflammation
Intervention: Ziltivekimab
Intervention description: human IgG1k anti-human IL-6 monoclonal antibody
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Matching placebo
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IL-6; CRP; Chronic Kidney Disease; Cardiovascular Disease; Inflammation

Summary:

      Patients with chronic kidney disease, who have evidence of systemic inflammation with
      increased cardiovascular risk, will be enrolled into this trial. The purpose of this trial is
      to determine a dose to select for a potential cardiovascular outcome trial with Ziltivekimab.
      Doses to be tested will be 7.5 mg, 15 mg and 30 mg subcutaneous monthly compared to placebo
      for six months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

          -  Stage 3-5 CKD

          -  hs-CRP > 2.0 mg/L

          -  Comply with contraception

        Exclusion Criteria:

          -  Low neutrophil count

          -  Low platelet count

          -  Spot urine protein to creatinine ration > 4000 mg/g

          -  ALT/AST >2.5x ULN

          -  TSAT < 10%

          -  Positive TB test

          -  Evidence of HIV, hepatitis B

          -  Blind or illiterate

          -  Expected to require blood transfusion

          -  Thromboembolic event within 12-weeks

          -  Evidence of active infection

          -  Peptic ulcer disease, diverticulitis, inflammatory bowel disease

          -  Uncontrolled hypertension

          -  Planned coronary revascularization

          -  Major cardiac surgery, CHF

          -  Active malignancy, bone marrow or organ transplant

          -  Allergy to study drug

          -  Treatment with investigational drug, treatment with HIF stabilizer or ESA

          -  Use of immunosuppressive drugs, systemic antibiotics

          -  Breastfeeding, any other significant medical history
Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania
Condition: Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder
Intervention: Cariprazine (RGH-188); Placebo
Intervention description: Cariprazine 3 mg - 12 mg oral administration, once per day.; Dose-matched placebo oral administration, once per day.
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 238.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Mania; Bipolar I Disorder; Acute Mania Associated with Bipolar I Disorder

Summary:

      This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188
      monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks
      double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility
      criteria will be randomized to one of two treatment groups: RGH-188 or placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female inpatients 18 to 65 years of age

          -  Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
             Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode

          -  Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4
             on two of the following YMRS items:

               -  Irritability,

               -  Speech,

               -  Content, and

               -  Disruptive/Aggressive Behavior

        Exclusion Criteria:

          -  Patients who exhibit abnormalities on physical examination, have abnormal vital-signs,
             electrocardiogram (ECG), or clinical laboratory values [such as thyroid-stimulating
             hormone (TSH)].

          -  Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score >= 18 at
             Visit 2.

          -  Patients experiencing first manic episode.

          -  Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in
             the 3 months prior to Visit 1.
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Condition: T-cell Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell
Intervention: Lenalidomide
Intervention description: Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma

Summary:

      This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide
      monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study
      will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

      Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive
      single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles).
      Subjects may continue participation in the Treatment Phase of the study for a maximum
      duration of 24 months, or until disease progression or unacceptable adverse events develop.

      All subjects who discontinue the Treatment Phase for any reason will continue to be followed
      until progression of disease or until next lymphoma treatment is given, whichever comes
      first, during the Follow-up Phase.

      Objectives:

      Primary:

      • To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell
      Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor
      control rate, duration of response, time to progression and progression free survival.

      Secondary:

      • To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed
      or refractory T-cell NHL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must understand and voluntarily sign an informed consent form.

          -  Must be ≥ 18 years of age at the time of signing the informed consent form.

          -  Must be able to adhere to the study visit schedule and other protocol requirements.

          -  Biopsy-proven T-cell Non-Hodgkin's Lymphoma, either:

               -  Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or

               -  Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.

          -  Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.

          -  Must have received at least one prior combination chemotherapy regimen. There is no
             limit on the number of prior therapies.

        Exclusion Criteria:

          -  Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.
Sirolimus, Mycophenolate Mofetil and Bortezomib as Graft-Versus-Host Disease (GVHD) Prophylaxis After Reduced Intensity Conditioning (RIC) Hematopoietic Stem Cell Transplantation
Condition: Graft-vs-Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Sirolimus; Mycophenolate mofetil; Bortezomib
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GVHD; Stem cell transplantation; Sirolimus

Summary:

      This trial will test the hypothesis that the combination of sirolimus, mycophenolate mofetil,
      and bortezomib will be effective in preventing both acute and chronic GVHD after reduced
      intensity allogeneic stem cell transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with hematologic malignancies, who are at high risk of complications after
             conventional myeloablative transplantation

          2. Patients must have a 6/6 matched, related donor. Matching at HLA Class II will be
             based on PCR of sequence specific primers (SSP). Among family member transplants,
             serologic matching at Class I is sufficient

          3. Patient age greater than 18

          4. Performance status 0-2

          5. Life expectancy of > 100 days without transplantation

          6. Written informed consent must be obtained in all cases from the patient

        Exclusion Criteria:

          1. Pregnancy

          2. Prior Allogeneic Stem Cell Transplantation from any donor

          3. Evidence of HIV infection or active Hepatitis B or C infection

          4. Heart failure uncontrolled by medications

          5. Total bilirubin > 2.0 mg/dl that is due to hepatocellular dysfunction

          6. AST > 90

          7. Cholesterol > 300 mg/dl or Triglycerides > 400 mg/dl while adequately treated

          8. Uncontrolled bacterial, viral or fungal infection

          9. Requirement for voriconazole at the time of hospital admission