bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Vehicle; Sham; Cyclosporine New Ophthalmic Formulation
Intervention description: Vehicle of cyclosporine administered as per protocol; Sham administered to non-study eye as per protocol on Day 1; Cyclosporine New Ophthalmic Formulation administered as per protocol
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in
      patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied
      in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will
      participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was
      cancelled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe dry eye disease in both eyes

          -  Best-corrected visual acuity (BCVA) of 20/100 or better in each eye

        Exclusion Criteria:

          -  Use of any cyclosporine preparations within 3 months

          -  Use of topical medications, other than artificial tears, in the eyes within 1 month

          -  Use of contact lenses in either eye within 1 month

          -  Stage 2 only: Participation in Stage 1 of this study
Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661; Ivacaftor; Placebo matched to VX-661; Placebo matched to Ivacaftor
Intervention description: Tablet, oral use; Film coated tablet, oral use; Tablet, oral use; Film coated tablet, oral use
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CF

Summary:

      The objective of this study was to evaluate the safety and efficacy of VX-661in combination
      with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del
      cystic fibrosis transmembrane conductance regulator (CFTR) mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del CFTR mutation

          -  FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height

          -  Stable CF disease as judged by the investigator

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant

          -  Pregnant and nursing females: Females of childbearing potential must have a negative
             pregnancy test at screening and Day 1 of the PC Phase and Day -7 or Day 1 of the OLE
             Phase (whichever was applicable)

          -  Sexually active participants of reproductive potential who are not willing to follow
             the contraception requirements

          -  The participant or a close relative of the participant is the investigator or sub
             investigator, research assistant, pharmacist, study coordinator, or other staff
             directly involved with the conduct of the study.
The Study of an Investigational Drug, Revusiran (ALN-TTRSC), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Whose Disease Has Continued to Worsen Following Liver Transplant
Condition: Transthyretin (TTR)-Mediated Amyloidosis; Familial Amyloidotic Polyneuropathy (FAP); ATTR Amyloidosis; Familial Amyloid Neuropathies
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Intervention: Revusiran
Intervention description: 500mg Revusiran by subcutaneous (sc) injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FAP; Familial Amyloidotic Polyneuropathy; ATTR Amyloidosis; Orthotopic Liver Transplant; RNAi therapeutic

Summary:

      The purpose of this study was to evaluate the safety and effectiveness of revusiran
      (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has
      continued to worsen after liver transplantation. Dosing has been discontinued; patients are
      being followed-up for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of FAP (familial amyloidotic polyneuropathy) with documented TTR mutation

          -  Received an orthotopic liver transplant ≥12 months before the date of informed consent

          -  An increase in polyneuropathy disability (PND) score post-transplant

          -  Polyneuropathy Disability score of ≤3b

        Exclusion Criteria:

          -  New York Heart Association (NYHA) classification of >2

          -  Other known causes of sensorimotor or autonomic neuropathy (eg, autoimmune disease)
The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries
Condition: Cardiac Output
Intervention: Ondansetron; Normal saline
Intervention description: 4mg of IV ondansetron; 10mL of IV normal saline
Intervention MeSH terms: Ondansetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Spinal anesthesia; Elective cesarean deliveries; Ondansetron

Summary:

      Ondansetron is a medication routinely given to mothers having cesarean deliveries to help
      prevent and treat nausea and vomiting. The investigators are studying the hemodynamic effects
      of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under
      spinal anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective CD under spinal anesthesia

          -  Fluency in English

        Exclusion Criteria:

          -  Contraindication to spinal anesthesiA

          -  Allergy to ondansetron
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Intervention: BMS-790052; BMS-790052; Placebo; peginterferon alfa-2a; ribavirin
Intervention description: Film coated tablet, Oral, 20 mg, once daily, 24 weeks; Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks; Film coated tablet, Oral, 0mg, Once daily, 24 weeks; Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks; Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 512.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a
      and ribavirin can result in higher cure rates in patients who previously failed therapy and
      may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects chronically infected with HCV genotype 1

          -  Non-responder to prior therapy with peginterferon alfa and ribavirin

          -  HCV RNA viral load of 100,00 IU/mL

          -  Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic
             HCV infection; for compensated cirrhotics can be any time prior to randomization
             (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study
             population)

          -  Ultrasound, CT scan or MRI results 12 months prior to randomization that do not
             demonstrate hepatocellular carcinoma

          -  Body Mass Index (BMI) of 18 to 35 kg/m2

        Exclusion Criteria:

          -  Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening

          -  Evidence of medical condition associated with chronic liver disease other than HCV

          -  Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib
Condition: Chemotherapeutic Agent Toxicity; Multiple Myeloma; Peripheral Neuropathy
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Peripheral Nervous System Diseases
Intervention: glutamine; quality-of-life assessment; placebo
Intervention description: Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.; Ancillary studies; Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies glutamine in preventing peripheral neuropathy in
      patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent
      peripheral neuropathy in patients receiving chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of multiple myeloma who received bortezomib at a dose of
             1.3mg/m2 SQ weekly

          -  No evidence of severe pre-existing peripheral neuropathy, NCI-CTCAE v4.03 =< 2

          -  Performance status =< 2 on the Eastern Cooperative Oncology Group (ECOG) performance
             scale

        Exclusion Criteria:

          -  Concurrent use of thalidomide, vincristine, platinum compound, or other agent known to
             cause significant neuropathy (concurrent lenalidomide will be allowed)

          -  Hospitalization with clinical evidence of active infections as manifested by recurrent
             fevers, positive blood culture results, or requiring intravenous antibiotic therapy

          -  Inadequate liver and renal function with liver transaminases 3x the upper limit of
             normal

          -  Glomerular filtration rate (GFR) according to Cockcroft-Gault < 30 mL/min

          -  Uncontrolled congestive heart failure

          -  Uncontrolled mood disorders

          -  Fasting blood glucose >150mg/dL or blood sugar (non-fasting) >200mg/dL if no history
             of diabetes. Uncontrolled diabetes with HgA1C greater 7% with last evaluation.

          -  Seizure disorder

          -  Monosodium glutamate (MSG) allergy or soy allergy

          -  Life expectancy of shorter than 3 months based on clinical laboratory parameters and
             the investigator's opinion

          -  Uncorrected Vitamin B12 or folate deficiency on last evaluation.

          -  Use of over the counter (OTC) supplements other than one multivitamin tablet a day

          -  Women who are pregnant or breastfeeding
Gulf War Illness: Evaluation of an Innovative Detoxification Program
Condition: Gulf War Illness
Intervention: plain crystalline niacin, exercise, sauna
Intervention description: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
Intervention MeSH terms: Niacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Healthy volunteers: No
Keywords: Hubbard detoxification; Exercise; Sauna therapy; Niacin; Gulf War illness

Summary:

      Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is
      characterized by persistent memory and concentration problems, headaches, fatigue and muscle
      and joint pain. It is not known what causes the illness, but exposure to chemicals is
      suspected. The Hubbard detoxification program consists of exercise and sauna therapy together
      with administration of several dietary supplements, particularly crystalline niacin used at
      increasing concentrations over a period of about four weeks. The investigators hypothesize
      that this program will reduce symptoms, as tested by administration of cognitive and quality
      of life tests and serum clinical chemistry tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case
             definition.

        Exclusion Criteria:

          -  Veterans who meet the inclusion criteria but have been diagnosed by a physician with
             (1) chronic conditions (eg., cancer, heart disease, diabetes, liver disease, multiple
             sclerosis, etc.) that are not associated with Gulf War service but can produce diverse
             symptoms similar to Gulf War Illness; (2) conditions that might interfere with
             respondents' ability to report symptoms (eg., psychiatric conditions or history of
             hospitalization for depression, alcohol or drug dependence; (3) pregnancy or
             unwillingness to use contraception.
N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis
Condition: Schizophrenic Psychoses
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Intervention: n-acetylcysteine; Placebo
Intervention description: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM; Placebo tablets are placed in water or juice in the AM and PM
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: schizophrenia; schizoaffective; schizophreniform; early schizophrenia spectrum psychosis

Summary:

      The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early
      phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and
      Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur
      during the pre-illness phase and around the transition to psychosis. Therefore, studying new
      treatments that could target changes occurring during this period is of critical importance.

      Aims:

      Does add-on NAC treatment in early psychosis influence:

        -  positive and negative symptoms

        -  extrapyramidal side-effects of other medication

        -  plasma concentration of glutathione

        -  Mismatch Negativity, a physiological marker
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capacity to provide informed consent

          -  DSM IV TR diagnosis of schizophrenia, schizophreniform, schizoaffective

          -  Psychiatric and medical stability

          -  Prescribing clinician's premission to participate, assurance of medical stability

          -  Having met threshold criteria for psychosis on CAARMS (Comprehensive Assessment of at
             Risk Mental States Scale) Psychosis subscale

          -  Up to 12 months of antipsychotic treatment

        Exclusion Criteria:

          -  Severe medical comorbidities

          -  Previous cerebral trauma

          -  Substance induced psychosis or organic psychosis

          -  Mental retardation

          -  NAC allergy

          -  Pregnancy, females and males planning pregnancy

          -  Treatment with antioxidants

          -  Insufficient command of English
This is a Study to Determine the Antidepressant Effects of AZD6765
Condition: Treatment Resistant Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: AZD6765; Placebo to AZD6765
Intervention description: Single IV infusion of 150 mg AZD6765.; Single IV infusion of Placebo to AZD6765
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Patients

Summary:

      The purpose of this study is to determine the antidepressant effects of AZD6765 compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of Major Depressive Disorder, currently depressed without
             psychotic features

          -  Females must be of non-childbearing potential.

        Exclusion Criteria:

          -  Treatment with Clozapine or ECT within 3 months prior to study

          -  Current or past history of psychotic features or a diagnosis of schizophrenia or any
             other psychotic disorder as defined in the DSM-IV
Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)
Condition: Neoplasm Metastasis; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Intervention: Cetuximab; Oxaliplatin
Intervention description: Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).
Until progression or unacceptable toxicity develops; Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).
Until progression or unacceptable toxicity develops
Intervention MeSH terms: Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FOLFOX-4; Cetuximab; First-line mCRC; EGFR positive; metastatic CRC

Summary:

      This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA +
      oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for
      epidermal growth factor receptor (EGFR)-expressing mCRC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First-line mCRC

          -  EGFR positive

          -  Bi-dimensional measurable index lesion

        Exclusion Criteria:

          -  Previous exposure to EGFR-targeting therapy

          -  Previous oxaliplatin-based therapy

          -  Previous chemotherapy for colorectal cancer except adjuvant treatment with progression
             of disease documented > 6 months after end of adjuvant treatment

          -  Radiotherapy

          -  Surgery

          -  Any other investigational drug in the 30 days before randomization

          -  Brain metastasis and/or leptomeningeal disease

          -  Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
The Randomized OPTIMAL-ACT Trial
Condition: Coronary Artery Disease; Ischemic Heart Disease; Anticoagulant-induced Bleeding; Coronary Syndrome
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Hemorrhage
Intervention: Unfractionated heparin
Intervention description: Administration of unfractionated heparin will be assessed using the activated clotting time
Intervention MeSH terms: Heparin; Calcium heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: activated clotting time; outcomes; bleeding

Summary:

      The purpose of this study is to find the ideal range of the activated clotting time (ACT)
      during percutaneous coronary intervention (PCI) that is associated with lowering the rate of
      undesirable medical outcomes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age>18

          -  Referred for coronary angiography with possible coronary revascularization or
             adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)

        Exclusion Criteria:

          -  Receipt of LMWH at treatment dose (not DVT prophylaxis dose) within 6 hours of
             coronary angiography

          -  Prior GP IIb/IIIa use within the previous 72 hours

          -  Use of warfarin (vitamin K antagonist) or direct oral anticoagulant

          -  Patients on LMWH bridging strategy

          -  PCI within prior 30 days

          -  Planned use of bivalirudin as the procedural anticoagulant

          -  Rotational atherectomy

          -  Excimer laser coronary angioplasty

          -  Chronic total occlusions

          -  Patients with active bleeding disorders or bleeding diathesis

          -  Patients with ST-segment elevation myocardial infarction

          -  Patient with clinical evidence of cardiogenic shock (defined as SBP<90 mmHg for ≥30
             min OR support to maintain SBP ≥90 mmHg AND evidence of end-organ hypoperfusion (urine
             output <30 mL/h or cool extremities)

          -  Chronic kidney disease stage 4/5 (GFR 30 mL/min)