bioihbjkbjnl/mcl2 huggingface dataset:
Therapeutic Cocaine Vaccine: Human Laboratory Study
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Cocaine vaccine (TA-CD)
Intervention description: TA-CD (82,360 μg; IM) were administered at weeks 1, 3, 5 and 9.
Intervention MeSH terms: Cocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cocaine; immunotherapy; vaccination; antibody; addiction; dependence

Summary:

      Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces
      selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct
      effects is unknown. The objective of this human laboratory study was to measure the
      relationship between antibody titers and the effects of smoked cocaine on ratings of
      intoxication, craving and cardiovascular effects.

      Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks
      inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and
      at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria
             for other substance abuse, but not dependence (other than nicotine).

          2. Primary route of cocaine administration is smoking.

          3. Age 21-45.

          4. Females must be surgically sterilized or post- menopausal

          5. Able to give informed consent, and comply with study procedures.

        Exclusion Criteria:

          1. Dependence on substances other than cocaine or nicotine.

          2. Judged to be noncompliant with study protocol.

          3. History of autoimmune disease, immune deficiency or hypersensitivity to other
             vaccines. An HIV test must be negative.

          4. Currently uses drugs intravenously

          5. Currently taking any psychotropic medication

          6. Laboratory tests that are clinically unacceptable to the study physician (BP > 140/90;
             BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for women, < 36 for men)

          7. Blood or blood products given in the three months prior to vaccination

          8. Other vaccines, including flu vaccine, given within 30 days of screening.

          9. Ongoing active infection

         10. Currently taking immunosuppressives -
Aspirin Resistance and Percutaneous Coronary Intervention (PCI)
Condition: Stable Angina
MeSH terms: Angina, Stable
Intervention: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel; Antiplatelet Therapy (ASA, Clopidogrel)
Intervention description: IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally; Standard antiplatelet PCI treatment
Intervention MeSH terms: polysaccharide-K; Tirofiban; Ticlopidine; Abciximab; Clopidogrel; Prasugrel Hydrochloride; Cangrelor; Eptifibatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major Adverse Cardiovascular Event; MACE; Death; MI; CK MB greater 3x Normal; Urgent Revascularization; Stent Thrombosis; Bleeding

Summary:

      The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce
      ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention
      (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age older than 18 years

          -  Scheduled for elective or ad-hos PCI

          -  Aspirin use daily for greater or equal to one week

          -  Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA

        Exclusion Criteria:

          -  Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or
             Tnl greater or equal to 0.4ng/dl

          -  administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the
             previous 30 days

          -  Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or
             increased bleeding risk or history of bleeding in the last eight weeks

          -  Previous stroke or transient ischemic attack or any intracranial pathology in the last
             six months, major surgery or trauma within the previous six weeks

          -  Platelet count less than hundred thousand per cubic millimeter or hematocrit <33% or
             hemoglobin <11 g per deciliter

          -  Subjects who received full dose low molecular weight heparin within six hours prior to
             randomization

          -  Allergy or intolerance to any of the study drugs or the presence of any serious
             comorbidity with life expectancy of ≤1year

          -  Scheduled for saphenous vein graft intervention, chronic total occlusions or with
             impaired renal function (eGFR<60ml/min) or patients who were taking anticoagulants or
             antiplatelet agents other than aspirin and clopidogrel or nonsteroidal
             anti-inflammatory drugs within two weeks before the PCI procedure
Clinical Evaluation of Flortaucipir F 18
Condition: Alzheimer's Disease; Traumatic Brain Injury; Depression
MeSH terms: Alzheimer Disease; Brain Injuries; Brain Injuries, Traumatic
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: IV injection, 370 MBq (10 mCi), up to two doses; positron emission tomography (PET) scan of the brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to expand the database of flortaucipir F 18 safety and tau binding as
      measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data
      collection and analysis to facilitate companion studies including, but not limited to,
      longitudinal studies of aging, depression, and traumatic brain injury.
    

Eligibility criteria:

        Subjects should meet inclusion and exclusion criteria for the companion protocol in
        addition to the criteria below.

        Inclusion Criteria:

          -  Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of
             the companion study

        Exclusion Criteria:

          -  Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or
             endocrine disturbances

          -  Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if
             male or QTc > 470 msec if female

          -  Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking
             drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the
             setting of intraventricular conduction block may be enrolled with sponsor approval

          -  Have a history of drug or alcohol dependence within the last year, or prior prolonged
             history of dependence unless approved by the sponsor

          -  Are females of childbearing potential who are not surgically sterile, not refraining
             from sexual activity or not using reliable methods of contraception

          -  Have a history of relevant severe drug allergy or hypersensitivity

          -  Are patients who have received an investigational medication within 30 days prior to
             the planned imaging session for this study

          -  Are patients with current clinically significant unstable medical comorbidities

          -  Are patients who have received a radiopharmaceutical for imaging or therapy within the
             past 24 hours prior to the imaging session for this study
Stimulant Oxytocin Study
Condition: Stimulant Use & Co-occuring Opioid Use Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Intranasal oxytocin; Intranasal placebo
Intervention description: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40 International Units (IU) to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.; Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oxytocin; substance-related disorders; Opioid Replacement Therapy; Psychophysiology; Stress Biomarkers

Summary:

      This study will investigate the effects of intranasal administration of oxytocin, a social
      neuropeptide, on reducing stimulant use, enhancing therapeutic engagement, and susceptibility
      to stress-induced relapse in Veterans with stimulant use disorders and enrolled in opioid
      replacement therapy (ORT) program for co-occurring opioid use disorder (OUD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years old

          2. Enrolled as a patient who at the SFVAMC Opioid Treatment Program or the Oakland
             Behavioral Health Clinic Opioid Treatment Program

          3. Stable dose of opioid replacement therapy for at least 2 consecutive weeks

          4. Veteran

          5. One documented urine toxicology screen positive for stimulants in the past 12 months.

        Exclusion Criteria:

          1. Severe neuropsychological disorder

          2. Suicidal or homicidal ideation within the past 90 days or a suicide attempt in the
             past 6 months

          3. Hemodialysis, unless participant can produce urine samples weekly

          4. Sensitivity to methylparaben or propylparaben

          5. Positive urine pregnancy test or women of childbearing age not practicing effective
             means of non-hormonal birth control

          6. Chronic nasal obstruction, discharge, or bleeding
Autologous Cell Therapy for Female Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: Autologous Muscle Derived Cells
Intervention description: Urethral injection of autologous muscle-derived cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety
      and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle
      Derived Cells for treatment of Stress Urinary Incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  SUI with normal detrusor activity confirmed with urodynamics

          -  Bladder capacity >200 ml

          -  Incontinence has not shown any improvement for at least -6 months

          -  Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback,
             electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

        Exclusion Criteria:

          -  Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other
             significant pelvic floor abnormalities with high pressure instability

          -  Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)

          -  Uncontrolled diabetes

          -  Pregnant, lactating, or plans to become pregnant during course of the study

          -  Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and
             not expected to benefit from treatment

          -  Current or acute conditions involving cystitis or urethritis

          -  Scheduled to receive radiation treatment to the vicinity, or history of radiation
             treatment to the urethra or adjacent structures
Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Deferasirox; Placebo
Intervention description: Deferasirox provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use; Inactive ingredients used as a placebo comparator, provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use
Intervention MeSH terms: Deferasirox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Patients, investigator staff, persons performing the assessments, and data analysts remained blind to the identity of the study treatment from the time of randomization until database lock.
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TELESTO; MDS Study; Myelodysplastic Syndromes; Myelodysplastic Syndromes (low-int-1 risk)

Summary:

      This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with
      myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was
      conducted in 17 countries, started in 2010 and ended in 2018.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weigh between 35-135 kilograms

          -  Low or int-1 risk MDS

          -  Ferritin >1000 micrograms/liter at screening

          -  History of transfusion of 15 to 75 Packed Red Blood Cells (PRBC) units

          -  Anticipated to be transfused with at least 8 units of PRBCs annually during the study

          -  Women of child-bearing potential using effective methods of contraception during
             dosing of study treatment

        Exclusion Criteria:

          -  More than 6 months of cumulative ICT (such as daily deferasirox (Exjade®) or
             deferiprone or 5×/week deferoxamine)

          -  More than 3 years since patient began receiving regular transfusions (2 units per 8
             weeks or 4 units received in a 3 month period)

          -  Significant proteinuria

          -  History of hospitalization for congestive heart failure; other heart conditions as
             specified in the protocol

          -  Systemic diseases which would prevent study treatment

          -  Hepatitis B; Hepatitis C; HIV

          -  Liver cirrhosis

          -  Pregnant, or breast-feeding patients, or patients of child-bearing potential not
             employing an effective method of birth control

          -  History of drug or alcohol abuse within the 12 months prior to enrollment
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
Condition: Edematous; Synovitis; Foreign Body Reaction; Osteolysis
MeSH terms: Synovitis; Osteolysis; Foreign-Body Reaction; Foreign Bodies
Intervention: Placebo; Apatone®B
Intervention description: Two capsules taken twice daily with meals; Two capsules taken twice daily with meals
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: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: total joint arthroplasty; synovitis; ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion); osteolysis; periprosthetic metallosis

Summary:

      This research study is being conducted to determine if taking oral (by mouth in pill form)
      Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and
      improve function of non-infected symptomatic postoperative total joint replacements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postoperative Total joint replacement with osteoarthritis as the underlying pathology

          -  Proven non-infected symptomatic Total Joint Arthroplasty (TJA) (joint implanted for
             >12 months post-op)

          -  Age (50 to 85 years of age); based on a 10% trim of the age distribution for Summa
             Health System TJAs (7/1/08-6/30/2009).

        Exclusion Criteria:

          -  An infection of any kind (prior to, or during the study)

          -  Rheumatoid arthritis as the underlying pathology

          -  Cortisone injection received <6 months prior to study enrollment

          -  Insulin dependent diabetes

          -  Diagnosed immunodeficiency

          -  On dialysis or have poor kidney function

          -  Anti-coagulant medication (e.g., Coumadin or >100mg of Aspirin daily)

          -  Anti-seizure medication (e.g., Dilantin)

          -  Steroidal medication (e.g., Prednisone, Advair or Symbicort)

          -  NSAIDS (e.g., Celebrex or Toradol); a 14-day washout period will be allowed

          -  bisphosphonates (e.g., Fosamax, Actonel, Aredia, Didronel, Boniva or Reclast)

          -  hormonal therapy (e.g., Estrogen, Progesterone or Testosterone)

          -  Cancer (active or in remission)

          -  Planned concurrent vitamins exceeding a standard daily multivitamin or exceeding the
             Recommended Daily Allowance (RDA) for individual vitamins if used alone; a 72 hour
             wash out period will be allowed

          -  A glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  Pregnant or lactating; females who are in their reproductive years must have a
             negative serum pregnancy

          -  Lactose intolerant

          -  Citric acid intolerant
Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Abatacept; Placebo; Prednisone; Abatacept
Intervention description: Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months; Injectable, intravenous, 0 mg, every 28 days, 12 months; Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months; Injectable, intravenous, 10 mg/kg, every 28 days
Intervention MeSH terms: Prednisone; Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE

Summary:

      The purpose of this clinical research study is to learn whether Abatacept can treat and
      prevent lupus flares; specifically, in patients with active lupus flares in at least one of
      three organ systems: skin (discoid lesions); inflammation of the lining of the heart
      (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or
      inflammation of more than 4 joints (arthritis). All participants will receive prednisone or
      prednisone-equivalent treatment in combination with study medication. The safety of this
      treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  participants must be diagnosed with SLE and be experiencing an active lupus flare in
             at least one of three organ systems: skin (discoid lesions), inflammation of the
             lining of the heart (pericarditis), or inflammation of the lining of the lung
             (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a
             screening visit (arthritis)

          -  Stable dose of prednisone (<30mg) for at least one month

        Exclusion Criteria:

          -  participants experiencing an active lupus flare in the kidney or central nervous
             systems

          -  Treatment with a stable dose of azathioprine, mycophenolate mofetil,
             hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to
             the study

          -  participants with active viral or bacterial infections

          -  participants with any other autoimmune disease as a main diagnosis

          -  Prior treatment with rituximab