bioihbjkbjnl/mcl2 huggingface dataset:
Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT
Condition: Chronic Pancreatitis; Insulin Dependent Diabetes
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Diabetes Mellitus, Type 1
Intervention: Hydroxychloroquine; Placebo
Intervention description: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.; Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open label, randomized, two-arm, single-blinded, placebo-controlled, parallel
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The study will be single-blinded. The PI, biostatistician who will analyze the data, consultants, and technicians running assays will be blinded to the study arm into which the subjects have been randomized. An alphanumeric identifier that refers to the study subject without any indicators of study arm allocation will be used. Only the surgeons and the research coordinator, but not the personnel conducting the metabolic studies, will be un-blinded as to the study arm randomization.
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pancreatectomy; Autologous Islet Transplantation; Pancreatitis; Diabetes; Hydroxychloroquine

Summary:

      This will be a pilot, 12-month phase II, open label, randomized, two-arm, single-blinded,
      placebo-controlled, parallel clinical trial of individuals undergoing TPAIT (Total
      Pancreatectomy and Autologous Islet Transplantation) for treatment of chronic pancreatitis
      (CP). The two study arms consist of HCQ-treated (Hydroxychloroquine) and placebo-treated
      individuals. The purpose of this study is to investigate the effects of HCQ administration
      compared to placebo on islet cell function post-autologous transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically confirmed diagnosis of chronic pancreatitis (CP)

          -  Intractable abdominal pain

          -  History of failed operation(s) for CP

          -  Recurrent acute pancreatitis

          -  HbA1c <8.0%

          -  Sustained alcohol remission

          -  Chronic narcotic use

        Exclusion Criteria:

          -  Insulin dependence

          -  Pancreatic carcinoma

          -  Pancreatic mass suspicious for carcinoma

          -  Cirrhosis

          -  Portal hypertension

          -  Continued alcohol abuse

          -  Manufacturer's product label-contraindicated use of HCQ

          -  History of retinopathy

          -  Actual weight at enrollment <40 Kg
Citrulline in Severe Sepsis
Condition: Severe Sepsis; Acute Lung Injury
MeSH terms: Sepsis; Toxemia; Lung Injury; Acute Lung Injury
Intervention: High Dose Citrulline; Placebo; Low Dose Citrulline
Intervention description: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days; D5W IV fluids at isovolumetric rate (about 15ml/hr); Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate
      biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to
      placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis
      is that intravenous L-citrulline will decreased the development or progression of acute lung
      injury in patients with severe sepsis compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe Sepsis

        Exclusion Criteria:

          -  No Consent

          -  Malignant or other irreversible condition

          -  Moribund and not expected to survive 48 hours

          -  End Stage Liver Disease

          -  Enrolled in another IND study

          -  Pregnant or breast feeding female

          -  Age<13 years old

          -  Allergy to citrulline or arginine
Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO)
Condition: Graves' Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Intervention: RVT-1401
Intervention description: RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label study
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IMVT-1401; Graves' Orbitopathy; Thyroid Eye Disease

Summary:

      The purpose of this study was to evaluate safety, tolerability, and pharmacodynamic
      parameters of RVT-1401 in graves' ophthalmopathy (GO) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥ 18 years of age.

          2. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active,
             moderate to severe GO with a Clinical Activity Score (CAS) ≥ 4 for the most severely
             affected eye at Screening (on the 7-item scale) and Baseline (on the 10-item scale).

          3. Onset of active GO within 9 months of screening.

          4. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on
             daily life), usually associated with one or more of the following: lid retraction ≥ 2
             mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race
             and gender, and/or inconstant or constant diplopia.

          5. Other, more specific inclusion criteria are defined in the protocol

        Exclusion Criteria:

          1. Use of any steroid (intravenous [IV] or oral) with a cumulative dose equivalent to ≥ 1
             g of methylprednisolone for the treatment of GO within 3 weeks prior to Screening.

          2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within
             the past 9 months prior to Baseline.

          3. Total IgG level < 6g/L at Screening.

          4. Absolute neutrophil count <1500 cells/mm3 at Screening.

          5. Participants with decreased best corrected visual acuity due to optic neuropathy as
             defined by a decrease in vision of 2 lines on the Snellen chart, new visual field
             defect, or color defect secondary to optic nerve involvement within the last 6 months
             at Screening.

          6. Previous orbital irradiation or surgery for GO.

          7. Other, more specific exclusion criteria are defined in the protocol
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: 0.5% SPL7013 Gel; 1.0% SPL7013 Gel; 3.0% SPL7013 Gel; Placebo Gel
Intervention description: Vaginal gel; Vaginal gel; Vaginal gel; Vaginal gel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: SPL7013; VivaGel; bacterial vaginosis; BV

Summary:

      The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of
      bacterial vaginosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a
             Nugent score of ≥4

          -  Otherwise healthy

        Exclusion Criteria:

          -  No active STIs
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
Condition: Influenza Caused by the Novel Influenza A (H1N1) Virus
MeSH terms: Influenza, Human
Intervention: CSL425; CSL425
Intervention description: CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume); CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for
      eliciting an immune response to H1N1 influenza in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged >= 18 to < 65 years at the time of providing informed consent.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to
             eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study
             Vaccine.
Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Intervention: Occiflex Robotic Intervention System
Intervention description: Occiflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Neck Pain, Occiflex, Computerized Mobilization

Summary:

      The study is intended to examine the safety and efficacy of computerized mobilization of the
      neck for the treatment of patients with chronic neck pain. This is a third continuation study
      aimed at examining the Occiflex Robotic System. This time we will be studying tailored or
      personalized three dimensional movement of the neck.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet
             joint disease and idiopathic chronic neck pain

        Exclusion Criteria:

          -  Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the
             neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders
             Cervical disc herniation
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
Condition: Multiple Myeloma; Solid Tumors
MeSH terms: Multiple Myeloma
Intervention: Carfilzomib
Intervention description: Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma; proteasome; Hematological; carfilzomib; PR-171

Summary:

      This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and
      efficacy of long-term or continuing carfilzomib therapy for patients who previously completed
      a primary carfilzomib treatment study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previous completion of a carfilzomib study within 90 days prior to first dose of
             maintenance study drug.

          2. Disease Assessments performed within 30 days prior to first dose of maintenance study
             drug.

          3. Written informed consent in accordance with federal, local, and institutional
             guidelines

          4. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of
             maintenance study drug.

          5. Subjects must agree to adhere to the study visit schedule and other study requirements
             and receive outpatient treatment and laboratory monitoring at the institution that
             administers the drug.

        Exclusion Criteria:

          1. Administration of an intervening chemotherapy between the time of previous carfilzomib
             study termination and first dose of maintenance study drug.

          2. Pregnant or lactating females

          3. Diagnosis of a new malignancy of a different tumor type.
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab [Avastin]; Docetaxel; Xeloda
Intervention description: 15mg/kg iv on day 1 of each 3 week cycle; 75mg/m2 iv on day 1 of each 3 week cycle; 2000mg/m2 po on days 1-15 of each 3 week cycle
Intervention MeSH terms: Bevacizumab; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of combination first-line treatment
      with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast
      cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each
      cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2
      p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional
      additional two cycles; after chemotherapy patients will be assessed for surgery. The
      anticipated time on study treatment is 3-12 months, and the target sample size is <100
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >=18 years of age;

          -  HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the
             breast;

          -  ECOG performance status 0-1.

        Exclusion Criteria:

          -  metastatic disease (stage IV);

          -  previous treatment for breast cancer;

          -  evidence of CNS metastasis;

          -  current or recent (within 10 days of first dose of Avastin) use of aspirin
             (>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;

          -  clinically significant cardiovascular disease.
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: capecitabine; Oxaliplatin; bevacizumab; capecitabine; Oxaliplatin; bevacizumab
Intervention description: 850 mg/m^2 po bid on Days 1-14 of each 3-week cycle; 130 mg/m^2 IV on Day 1 of each 3-week cycle; 7.5 mg/kg IV on Day 1 of each 3-week cycle; 1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle; 85 mg/m^2 IV on Day 1 of each 2-week cycle; 5 mg/kg IV on Day 1 of each 2-week cycle
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral
      Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a
      first-line treatment in patients with locally advanced or metastatic colorectal cancer.
      Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid)
      on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each
      3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1
      and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment
      was 1-2 years, and the target sample size was 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic or inoperable locally advanced colorectal cancer

          -  >=1 measurable target lesion

        Exclusion Criteria:

          -  Previous systemic therapy for advanced or metastatic disease

          -  Previous treatment with bevacizumab
Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
Condition: Lymphoma, Non-Hodgkin; Multiple Myeloma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin
Intervention: G-CSF and plerixafor
Intervention description: G-CSF and plerixafor were administered as described in the treatment arms.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's Lymphoma; Multiple Myeloma; Stem cell mobilization

Summary:

      Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with
      chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to
      determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if
      it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold
      before apheresis, and if transplantation with the apheresis product was successful, as
      measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
    

Eligibility criteria:

        Inclusion Criteria (Abbreviated List):

          -  MM in first partial response/complete response, first relapse, or second
             partial/complete response

          -  NHL in first or second partial or complete remission

          -  NHL patients who do not have bone marrow involvement and < 10% for follicular
             involvement

          -  MM patients who have stable disease with < 40% bone marrow involvement

          -  No more than three prior regimens of chemotherapy (thalidomide and Decadron are not
             considered chemotherapy)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  White blood cell count (WBC) >3.0 x 10^9/L

          -  Absolute neutrophil count >1.5 x 10^9/L

          -  Platelet count >100 x 10^9/L

        Exclusion Criteria (Abbreviated List):

          -  Brain metastases or carcinomatous meningitis

          -  Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]

          -  Cardiovascular disease that includes proven or predisposition to ventricular
             arrhythmias

          -  Acute Infection
A 24-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: migalastat HCl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Substrate

Summary:

      Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride
      (HCl) (migalastat) in participants with Fabry disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males between 18 and 65 years of age (inclusive)

          -  Hemizygous for Fabry disease

          -  Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation
             (individual or familial)

          -  Had enhanceable enzyme activity based on in vitro tests

          -  Had documented evidence of cardiac and/or renal dysfunction (for example, abnormal
             electrocardiogram (ECG), left ventricular hypertrophy, renal insufficiency)

          -  Were previously untreated by enzyme replacement therapy (ERT) or substrate depletion
             for Fabry disease, or if ERT or other specific treatment for Fabry disease was
             administered, were able to stop ERT for at least 30 weeks.

          -  Were willing to undergo 2 kidney and 3 skin biopsies

          -  Agreed to be sexually abstinent or use a condom with spermicide when engaging in
             sexual activity during the course of the study and for a period of 30 days following
             completion of the study

          -  Were willing and able to sign an informed consent form

        Exclusion Criteria:

          -  History of significant disease other than Fabry disease (for example, end-stage renal
             disease; Class III or IV heart disease [per the New York Heart Association
             classification]; current diagnosis of cancer, except for basal cell carcinoma of the
             skin; diabetes [unless hemoglobin A1c ≤8]; or neurological disease that would have
             impaired the participant's ability to participate in the study)

          -  History of organ transplant

          -  Serum creatinine >176 millimole per deciliter on Day -2

          -  Screening 12-lead ECG demonstrating corrected QT interval >450 milliseconds prior to
             dosing

          -  Taking a medication prohibited by the protocol: Fabrazyme® (agalsidase beta),
             Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any
             experimental therapy for any indication

          -  Participated in a previous clinical trial in the last 30 days

          -  Any other condition, which, in the opinion of the investigator, would jeopardize the
             safety of the participant or impact the validity of the study results