bioihbjkbjnl/mcl2 huggingface dataset:
Preliminary Study of Safety and Efficacy of Policosanol
Condition: Dyslipidemia; HIV Infections
MeSH terms: Dyslipidemias
Intervention: Policosanol; Placebo
Intervention description: 20 mg of policosanol in capsular form daily; Two capsules of 10 mg of microcrystalline cellulose daily
Intervention MeSH terms: Policosanol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV; lipids; dyslipidemia; policosanol; treatment experienced

Summary:

      Lay Language Summary: High cholesterol levels are common in persons with HIV infection.
      However, conventional cholesterol-lowering medications may have harmful side effects when
      given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of
      policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering
      properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that
      policosanol will lower levels of LDL cholesterol ("bad" cholesterol) and raise levels of HDL
      cholesterol ("good" cholesterol).
    

Eligibility criteria:

        Inclusion Criteria:

        CD4 count > 250 Plasma HIV RNA < 50,000 Currently receiving HAART age 18-60 total
        cholesterol between 200-240 or triglycerides between 150-400 or LDL cholesterol > 160

        Exclusion Criteria:

        kidney or liver disease current use of lipid-lowering drugs pregnancy lactation

        -
Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer
Condition: Carcinoma, Squamous Cell
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell
Intervention: FDG-PET/CT; Cetuximab
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: squamous cell carcinoma of the head and neck

Summary:

      The purpose of this study is to collect data and evaluate how the tumor is broken down in
      response to standard of care cetuximab treatment by evaluating the FDG-PET/CT scans,
      toxicity, see how well the FDG-PET/CT scans predict response to treatment and survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven diagnosis of squamous cell carcinoma of the head and neck
             (SCCHN).

          -  Have either locally recurrent, unresectable, previously irradiated SCCHN OR metastatic
             SCCHN, with at least one measurable tumor lesion (by CT scan) and at least one FDG
             avid (SUV >/= 3, >/= 1.5 cm) tumor lesion (by PET/CT).

          -  Age greater than 18 yrs.

          -  ECOG Performance Status of 0-3

          -  Signed IRB approved Informed Consent.

        Exclusion Criteria:

          -  Clinical history of severe interstitial lung disease (not COPD)-as defined by prior
             pulmonary function tests (PFTs) with residual volume, total lung capacity, or
             corrected diffuse lung capacity for carbon monoxide (DLCO) <30% of predicted. For this
             study, screening PFT's required only if clinically indicated.

          -  Prior therapy with an epidermal growth factor receptor (EGFR)-specific monoclonal
             antibody (MAB) for treatment of metastatic SCCHN. Prior therapy with an EGFR-specific
             MAB as part of the definitive treatment of non-metastatic SCCHN is acceptable if this
             occurred more than three months previously. Prior therapy with an EGFR specific TKI
             will not be an exclusion factor.

          -  Women of child bearing potential who are current pregnant or breast feeding.

          -  Prior severe (Grade 4) infusion reaction to cetuximab.

          -  A serious uncontrolled medical disorder that in the opinion of the Investigator would
             impair the ability of the subject to receive protocol therapy.

          -  Chemotherapy, radiation therapy, or investigational agents given with the last 14
             days.

          -  Uncontrolled diabetes mellitus. (Subjects with a fasting blood glucose > 200 at time
             of PET scanning may need to reschedule to another day after consulting with
             appropriate physicians.)
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Condition: Hepatic Cirrhosis; Hepatic Encephalopathy (HE)
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis
Intervention: MNK6106; Rifaximin
Intervention description: 1 gram tablet of MNK6106 for oral administration; 550 mg tablet of rifaximin for oral administration
Intervention MeSH terms: Rifaximin; Phenylacetic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The main reason for this study is to see how the study drug interacts with the body.

      It will compare different doses of the study drug with a drug already in use.

      Participants will be adults with liver disease that has affected the brain in the past.
    

Eligibility criteria:

        Key Inclusion Criteria:

        A potential participant may only be included if (at screening), he/she:

          1. Understands the study and has signed informed consent

          2. Is an adult, not pregnant or lactating

          3. Has cirrhosis of the liver

          4. Has had 1 instance of HE within 12 months

          5. Has hyperammonaemia defined as ≥37 μmol/L at screening

        Key Exclusion Criteria:

        A potential participant will be excluded if (at screening), he/she:

          1. Has contraindicated allergies

          2. Expects liver transplant within 1 month

          3. Has had a liver shunt within the last 3 months

          4. Has inadequate kidney, gastrointestinal, or cardiac function

          5. Has cancer, infection, lab abnormalities, or any other condition that, per protocol or
             in the opinion of the investigator might compromise:

               1. the safety and well-being of the participant or potential offspring

               2. the safety of study staff

               3. the analysis of results
D-serine and Cognitive Remediation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: D-serine
Intervention description: D-serine 60 mg/kg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: cognitive remediation

Summary:

      The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in
      a sensory based remediation (SBR) paradigm
    

Eligibility criteria:

        Inclusion criteria:

          -  18 to 64 years old,

          -  IQ≥85 and

          -  estimated Glomerular Filtration Rate (GFR) ≥60. All oral and depot antipsychotics
             (with the exception of clozapine) are allowable. Patients must be on their
             antipsychotic medication for 1 month and stable on dose of antipsychotic and
             adjunctive medications for 2 weeks prior to study entry.

        Exclusion criteria:

          -  history of neurological visual or hearing impairment,

          -  active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS),

          -  current alcohol or drug abuse (<1 month) or substance dependence (<4 months). All
             women of child-bearing potential must have a negative urine pregnancy test at the
             baseline visit. We require an IQ of ≥85 to ensure that subjects will have a capacity
             to learn. In our cross-sectional studies, we have observed an IQ≥85 in over 90% of
             candidates, suggesting that this is not an overly restrictive criterion.
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Budesonide plus Prevacid; placebo plus Prevacid
Intervention description: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.; Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Intervention MeSH terms: Budesonide; Lansoprazole; Dexlansoprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Eosinophils; Esophagitis; Microscopy

Summary:

      This study is designed to evaluate whether or not oral viscous budesonide is effective in
      treating children with Eosinophilic Esophagitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal
             biopsy

          -  Ages 1 yrs and older

          -  Ability to continue the same diet that the patient was on at the time of EGD with
             biopsy

        Exclusion Criteria:

          -  Adverse reaction or allergy to budesonide

          -  Pregnancy

          -  Chronic diseases requiring immunomodulatory therapy

          -  Use of swallowed topical corticosteroids for EE within the past 3 months

          -  Use of systemic steroids 2 months prior to study entry

          -  Upper gastrointestinal bleed within 4 months of study entry

          -  Chronic use of medications that predispose to upper gastrointestinal bleeding
             including non-steroidal anti-inflammatory medications or anticoagulants

          -  Evidence of adrenal suppression prior to study entry

          -  Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis

          -  Recent changes in asthma or allergic rhinitis therapy for 3 months
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: rebamipide
Intervention description: 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Intervention MeSH terms: Rebamipide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Rebamipide; Enema; Ulcerative Colitis

Summary:

      The purpose of this study is to examine the safety and efficacy of rebamipide by once daily
      intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with
      active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with active ulcerative colitis

          2. Patients having an insufficient response to ASA oral formulation: (1) Patients whose
             ongoing use of ASA oral formulation from ≥2 weeks prior to the day before registration
             is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/day, (2) Patients with
             continuous bloody stools from ≥2 weeks prior to the day before registration, (3)
             Patients whose DAI subscores are ≥2 points for "bloody stools" and ≥2 points for
             "endoscopic findings"

          3. Patients shown via colonoscopy to have major lesions between the sigmoid colon and
             rectum (with lesions not extending beyond the splenic flexure)

          4. Outpatients

        Exclusion Criteria:

          1. Patients who have a history of intestinal resection (other than appendiceal resection)

          2. Patients who have a complication of malignant tumor

          3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to
             become pregnant during the study period

          4. Patients who have complications of serious cardiac, hepatic or renal impairment
An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: Sunitinib
Intervention description: 50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2
      step design) after which Step 2 was opened and the total enrollment target for the study
      (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study
      did not open due to the final overall insufficiency of efficacy observed in 78 patients.
      Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a
      starting dose of 50 mg with provision for dose reduction based on tolerability. All patients
      received repeated cycles of sunitinib until disease progression, occurrence of unacceptable
      toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients
      were followed up in order to collect information on further antineoplastic therapy and
      survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented

          -  Disease progression/ recurrence after treatment with one prior single agent or
             combination chemotherapy regimen for advanced / metastatic disease (last dose at least
             4 wks before study entry). Patients may have also received prior adjuvant therapy if
             recurrence occurred > 6 months after adjuvant therapy completion

          -  Evidence of measurable disease by radiographic technique

          -  Adequate organ function.

        Exclusion Criteria:

          -  Clinically relevant ascites (i.e. requiring paracentesis)

          -  Severe weight loss

          -  NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment

          -  Diagnosis of second malignancy within last 3 years

          -  History of or known brain metastases, spinal cord compression, or carcinomatous
             meningitis

          -  Known HIV

          -  Serious acute or chronic illness

          -  Current treatment on another clinical trial

          -  Pregnant or breastfeeding
Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer
Condition: Head and Neck Cancer; Carcinoma, Squamous
MeSH terms: Carcinoma; Head and Neck Neoplasms; Carcinoma, Squamous Cell
Intervention: Oxaliplatin; Docetaxel; Cetuximab
Intervention description: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles; 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles; 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Intervention MeSH terms: Docetaxel; Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; head and neck cancer; squamous cell cancer

Summary:

      A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients
      to determine their effect on the control and reduction of tumor size
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed recurrent SCCHN

          -  18 years or older

          -  Tumor site accessible by biopsy

          -  Measurable disease

          -  Receiving no other therapy

          -  ECOG performance status 0-1

          -  Adequate bone marrow, renal function and hepatic function

        Exclusion Criteria:

          -  Active infection or fever within 3 days of treatment

          -  Active CNS metastases

          -  Prior malignancy within 5 years

          -  Hypersensitivity to study drugs

          -  Chemotherapy within 30 days of treatment

          -  Concurrent investigational therapy within 30 days

          -  Radiotherapy of more than 25% of bone marrow

          -  Peripheral neuropathy of grade 2 or greater

          -  Pregnant or lactating patients

          -  History of allogeneic transplant

          -  Active or previously treated HIV or Hepatitis B or C

          -  Patients with a tracheostomy
MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)
Condition: Paranoid Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction; Schizophrenia, Paranoid
Intervention: MK0249; Comparator: Placebo (unspecified)
Intervention description: MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.; MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Undifferentiated schizophrenia; residual schizophrenia

Summary:

      The purpose of this study is to determine the safety and effectiveness of an investigational
      drug MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is clinically stable, on current antipsychotic medication for at least 3
             months and current dose for 2 months

          -  Patient has a 6th grade reading level or better

          -  Females are not pregnant, and those who can have children agree to remain abstinent or
             use acceptable birth control throughout the study

          -  Patient has had a stable living arrangement for at least 3 months prior to study start

          -  Patient is in general good health based on screening assessments

          -  Patient has total Positive and Negative Syndrome Scale (PANSS) score between 36 and 75
             at screening and at the first baseline visit

          -  Patient has a Clinical Global Impressions - Severity (CGI-S) score less than or equal
             to 4 at screening and at the first baseline visit

        Exclusion Criteria:

          -  Patient has a major disease/disorder that may interfere with cognitive testing (such
             as mental retardation) and/or pose a risk upon study participation

          -  Patient has a history of head trauma with loss of consciousness greater than 15
             minutes

          -  Patient has had warfarin treatment, MAO inhibitors, clonazepam or clozapine within 1
             month of screening

          -  Patient has had ECT treatment within 6 months of screening

          -  Patient requires treatment with antihistamines or certain other medications listed in
             the protocol

          -  Patient has a history of liver disease that has been active within the last 2 years,
             or a history of cancer within the past 5 years

          -  Patient has a history of alcohol or drug dependence within the past year or alcohol or
             drug abuse within 3 months of screening
Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)
Condition: Vulvar High Grade Squamous Intraepithelial Lesion (HSIL); Vulvar Dysplasia; Vulvar Intraepithelial Neoplasia (VIN); VIN2; VIN3; Pre-cancerous Lesions of the Vulva; Human Papillomavirus (HPV)
MeSH terms: Squamous Intraepithelial Lesions of the Cervix; Carcinoma, Squamous Cell; Carcinoma in Situ
Intervention: VGX-3100; Imiquimod 5% Cream; CELLECTRA™ 2000
Intervention description: One milliliter (1 mL) VGX-3100 injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24.; Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.; IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.
Intervention MeSH terms: Imiquimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HPV-16; HPV-18

Summary:

      The purpose of this study is to test the safety and efficacy of an investigational
      immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar
      high-grade squamous intraepithelial lesion (HSIL) [vulval intraepithelial neoplasia 2 or 3
      (VIN 2 or VIN 3)] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is
      being assessed as an alternative to surgery with the potential to clear the underlying HPV
      infection. For more information visit our study website at: www.VINresearchstudy.com
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18 and above;

          -  Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3)
             caused by infection with HPV types 16 and/or 18 confirmed at screening visit;

        Exclusion Criteria:

          -  Biopsy-proven differentiated VIN;

          -  Any previous treatment for vulvar HSIL within 4 weeks prior to screening;

          -  Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;

          -  Pregnant, breastfeeding or considering becoming pregnant within 6 months following the
             last dose of investigational product;

          -  Immunosuppression as a result of underlying illness or treatment;

          -  Significant acute or chronic medical illness.