bioihbjkbjnl/mcl2 huggingface dataset:
Multifaceted Treatment of Catheter-related Urinary Tract Infection
Condition: Spinal Cord Injury; Neurogenic Bladder; Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Spinal Cord Injuries; Urinary Bladder, Neurogenic
Intervention: Shortened course of antibiotic therapy; Standard Therapy
Intervention description: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.; Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spinal Cord Injury; Urinary Tract Infection; Catheter Dependent

Summary:

      The specific objective of this clinical trial is to demonstrate that a multifaceted approach
      for treatment for catheter-related urinary tract infection (UTI) in patients with spinal cord
      injury is effective and feasible. We plan to test the following hypothesis: a multifaceted
      treatment approach that consists of immediate removal of the indwelling bladder catheter,
      selecting antibiotics based on the finding from a urine culture that is obtained through the
      newly inserted catheter, and a 5-day course of systemic antibiotics will effectively treat
      catheter-related infection that is limited to the lower urinary tract of patients with spinal
      cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with SCI who are hospitalized at the Michael E. Debakey VA Medical
             Center and suffer from lower UTI associate with an indwelling transurethral or
             suprapubic bladder catheter will be enrolled in the study

        Exclusion Criteria:

          -  Exclusion criteria will include septicemia, chronic antimicrobial therapy and
             inability, or unwillingness to give informed consent
Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH
Condition: Langerhans Cell Histiocytosis
MeSH terms: Histiocytosis, Langerhans-Cell; Histiocytosis
Intervention: Methotrexate; 6-Thioguanine; Leucovorin Calcium
Intervention description: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs; 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.; 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)
Intervention MeSH terms: Leucovorin; Methotrexate; Thioguanine; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Healthy volunteers: No
Keywords: Langerhans Cell Histiocytosis; LCH; 6-Thioguanine; 6-TG; Methotrexate; MTX; 94-132

Summary:

      The objective of this study is to determine the incidence of complete and partial response
      and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated
      with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologic proof of LCH who have multifocal or multisystem disease
             involvement.

          -  Patients must have a life expectancy of at least 8 weeks.

          -  All patients must have ECOG performance level rating of-< 2.

          -  Patients or their parents (guardian) must sign an informed consent indicating that
             they are aware of the investigational nature of the study, using commercially
             available drugs.

          -  Patients must have recovered from the toxic effects of prior therapy before entering
             this study or at least 2 weeks should have elapsed since the end of last course of
             chemotherapy.

          -  Patients must have adequate liver function (bilirubin _< 2.0 mg/dl, SGOT less than 1.5
             times normal (unless it is due to disease), adequate renal function (creatinine <_ 1.5
             mg/dl, creatinine clearance >_ 60 ml/min/1.73 m2) and normal electrolytes.

          -  Patients should have a granulocyte count > 500/uL and a platelet count >_ 100,000/uL
             (unless due to disease involvement of the bone marrow).

          -  Male and female patients of child-bearing age should use effective methods of
             contraception, if sexually active.

        Exclusion Criteria:

          -  Patients with active infections or significant medical conditions other than their
             disease (LCH) shall be excluded.
The SCCS Polypill Pilot Trial
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide; Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: combination pill; polypill; primary prevention

Summary:

      In this study the investigators will examine the effect of the polypill on medication
      adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrolled at the SCCS site in Mobile, Alabama, obtain care at Franklin Primary Health
             Center, or live in the surrounding area.

          -  Aged 45-75 years

          -  Baseline systolic blood pressure ≥120 mm Hg. In this open-label trial, the study
             physicians are permitted to prescribe any additional medication deemed appropriate to
             achieve blood pressure control.

        Exclusion Criteria:

          -  History of coronary heart disease or stroke

          -  History of cancer, except for basal cell skin cancer

          -  History of liver disease, not including chronic, clinically-stable hepatitis

          -  Laboratory evidence of hepatic dysfunction (an alanine aminotransferase level more
             than two times the upper limit of the normal range)

          -  Known renal disease, estimated creatinine clearance < 60

          -  Current use of more than 2 anti-hypertensive medications

          -  LDL cholesterol ≥190 mg/dl

          -  Insulin-dependent diabetes

          -  Known intolerance to any of the components of the polypill

          -  Potassium <3.4 or >5.5 mEq/L

          -  Use of medications that interact with statins, including those affecting the
             cytochrome P450 system

          -  Current use of diuretics for indications other than hypertension

          -  Comorbidities that might be expected to limit lifespan during the 12-month follow-up
             period

          -  Inability to provide consent.
Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Nivolumab; Ipilimumab; Placebo
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to
      evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed squamous cell head and neck cancer

          -  Widespread (metastatic) disease, or returned after previous treatment (recurrent)

          -  Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and
             HPV [Human Papilloma Virus (oropharynx only)]

          -  Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

        Exclusion Criteria:

          -  Previous treatment for metastatic or recurrent disease

          -  Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx,
             salivary gland, skin

          -  Any non-squamous subtype

          -  Active autoimmune disease

          -  Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus

          -  Previous treatment with checkpoint inhibitor drugs

          -  Active CNS metastases or carcinomatous meningitis

        Other protocol-defined inclusion/exclusion criteria apply
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-333; Placebo for ABT-333; Pegylated interferon; Ribavirin
Intervention description: 50 mg capsules; Capsule; Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly; 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the safety, tolerability, pharmacokinetics and
      antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus
      (HCV)-infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has provided written consent.

          -  If female, participant is postmenopausal or surgically sterile.

          -  If male, must be practicing two effective methods of birth control.

          -  Participant is hepatitis C virus (HCV) genotype 1 with HCV ribonucleic acid levels
             >50,000 IU/mL.

          -  Participants must demonstrate chronic hepatitis C infection for at least 6 months
             prior to study enrollment.

          -  Participants must have a liver biopsy with histology consistent with HCV-induced liver
             damage, and with no evidence of cirrhosis or liver pathology due to any cause other
             than chronic HCV.

          -  Condition of general good health other then HCV infection.

          -  Participants with a history of thyroid disease must have a thyroid stimulating hormone
             (TSH) value in the normal range.

        Exclusion Criteria:

          -  No prior history of receiving therapy for HCV infection.

          -  Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
             surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV Ab).

          -  Pregnant or breastfeeding females or male partners of women who are pregnant.

          -  History of seizures or cancer.

          -  History of major depressive disorder within 2 years.

          -  Any current or past history of cirrhosis.

          -  Any cause of liver disease other than chronic HCV infection.
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Condition: Herpes Simplex Type 2
MeSH terms: Herpes Simplex; Herpes Genitalis
Intervention: HerpV and QS-21; Placebo
Intervention description: HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) in combination with adjuvant QS-21; phosphate buffered saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: herpes simplex virus type 2,; genital herpes

Summary:

      The purpose of this study is to evaluate the effect of recombinant human heat shock protein
      70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital
      herpes by evaluating viral shedding before and after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seropositive for herpes simplex virus type 2 (HSV-2)

          -  Clinically active genital herpes defined as a history of 1-9 episodes per year for at
             least 1 year prior to screening or 1 year prior to beginning suppressive therapy.

          -  Willing to either use an effective method of contraception or abstain from sexual
             intercourse throughout the 48-week study period.

          -  If female of childbearing potential, have a negative serum pregnancy test.

          -  Agree to not receive any other investigational drugs while enrolled in this study.

          -  The above criteria must be met before participants are allowed to enter the 45-day
             swabbing period to be screen for the study.

          -  Completion and collection of greater than or equal to 80% (36 days) of the 45-day
             consecutive daily genital swabs.

        Exclusion Criteria:

          -  Severe active infection, compromised cardiopulmonary function, or other serious
             medical illness that, in the opinion of the principal investigator, would prevent
             study completion.

          -  A history of herpes simplex virus (HSV) infection of the eye (herpes simplex
             interstitial keratitis or uveitis), or herpes-associated erythema multiforme.

          -  A history of immune suppression or autoimmune disorder.

          -  Continued use of suppressive anti-viral therapy for HSV-2; a 1 week washout of any
             anti-viral therapy (suppressive and episodic) is required prior to initiating the
             swabbing period.

          -  Concomitant use of systemic corticosteroids or immune-suppressive medications. The use
             of nasal steroids is acceptable.

          -  Human immunodeficiency virus (HIV) positive.

          -  Presence of active Hepatitis B or C infection.

          -  Known hypersensitivity or allergies to acyclovir or valacyclovir.

          -  Pregnant or breast-feeding women.
Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
Condition: TBI; Major Depression; Other Psychiatric Disorders
MeSH terms: Depression; Depressive Disorder; Mental Disorders; Problem Behavior
Intervention: Escitalopram; Placebo
Intervention description: Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth; Sugar pill placebo
Intervention MeSH terms: Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TBI; Depression; Mood; Behavior

Summary:

      This research is being done to see if a drug called escitalopram (Lexapro) is helpful to
      people who are suffering from depression after traumatic brain injury (TBI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Closed head injury

          -  Fulfill Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) IV criteria
             "Major Depressive Disorder"

          -  18 years of age or older

          -  Able to provide informed consent

          -  Stable medical history

        Exclusion Criteria:

          -  History of Stroke, Encephalitis, Seizures, or any other pre-TBI neurological diseases

          -  History of mental retardation

          -  Alcohol or Substance dependence in the last 1 year

          -  Inability to undergo MRI scan

          -  Pregnancy

          -  Current use of any psychotropic medications including any antidepressants,
             antipsychotics, anxiolytics, or sedative hypnotics

          -  Poor response to escitalopram in the past

          -  Acutely suicidal or requiring inpatient psychiatric hospitalization, as determined by
             the study psychiatrist

          -  Good medication response to another antidepressant in the past
Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
Condition: Carotid Atherosclerosis
MeSH terms: Carotid Artery Diseases; Atherosclerosis
Intervention: Atorvastatin/niacin extended-release; Atorvastatin; Simvastatin; Simvastatin
Intervention description: 80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.; 10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.; (Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.; (Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Intervention MeSH terms: Niacin; Atorvastatin; Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is diagnosed with carotid stenosis AND is scheduled to undergo carotid
             endarterectomy

          -  Female patients of reproductive potential must abstain from sex or use an acceptable
             method of birth control through out the study

        Exclusion Criteria:

          -  Patient must undergo CEA less than 4 weeks after entering study

          -  Patient has recent history of acute coronary syndrome

          -  Patient has has coronary artery bypass graft surgery within 30 days of study start

          -  Patient has thyroid disease that has not been treated for more than 6 weeks

          -  Patient has donated blood within 8 weeks of study start

          -  Patient has poorly controlled diabetes mellitis

          -  Patient has human immunodeficiency virus (HIV) or Hepatitis B or C

          -  Patient is taking warfarin or other anticoagulants

          -  Patient is taking hormone replacement therapy
Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving
Condition: Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Intervention: lidocaine following cue-induced craving; lidocaine following neutral stimulus; saline
Intervention description: as described in Arm Description; as described in Arm Description; as described in Arm Description
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 25 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: cocaine; addiction; lidocaine; memory; drug abuse

Summary:

      We propose that the systemic administration of lidocaine following the induction of
      cue-induced craving, relative to saline plus cue-induced craving or lidocaine without
      cue-induced craving, will block the reconsolidation of cue memories. This will lead to a
      reduction in cue-induced craving upon repeated testing as well as subsequent cocaine use and
      basal craving.
    

Eligibility criteria:

        Inclusion Criteria:

          -  25-60 years old

          -  men or women

          -  any race or ethnicity

          -  cocaine addition is primary present and lifetime drug of abuse

          -  live locally

        Exclusion Criteria:

          -  Patients with active DSM (Diagnostic Statistical Manual)-IV other Substance Dependence
             (except nicotine) within the previous three months, Affective Disorder, Schizophrenic
             Disorders.

          -  significant cognitive impairment (WTAR<70) (Wechsler Test of Adult Reading <70)..

          -  use of tricyclic anti-depressants, benzodiazepines, cimetidine, mood stabilizers,
             opioids, lithium, sympathomimetics, anticonvulsants, sedative/hypnotics, β-blockers,
             or dopamine agonists will be excluded from the study.

          -  Medical conditions that might limit cooperation (e.g. dementia) or put the patient at
             medical risk (i.e. significant hematologic, hepatic, renal, or cardiovascular
             pathology - particularly arrhythmias) will be excluded.

          -  Patients with congenital or idiopathic methemoglobinemia or patients taking
             medications associated with increased risk of methemoglobinemia (including
             sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine,
             dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin,
             nitroprusside, pamaquine, paraaminosalicylic acid, phenacetin, phenobarbital,
             phenytoin, primaquine, quinine) will be excluded.

          -  Patients with past or present neurologic disorders (i.e. severe head trauma, transient
             ischemic attacks, stroke, tumor, etc.) will be excluded. - Active suicidal ideation,
             pregnant or nursing women, and prisoners will be excluded from the study.