bioihbjkbjnl/mcl2 huggingface dataset:
Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Alcoholism
Condition: Alcohol Dependence; Executive Dysfunction; Abnormal Craving for Drugs
MeSH terms: Alcoholism
Intervention: transcranial Direct Current Stimulation
Intervention description: transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 1 mA, during 10 min) will be applied over the left dorsolateral prefrontal cortex once a week for 5 consecutive weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcoholism; Lesch's typology; tDCS; ERP; P300; FAB; MMSE; Cognitive tasks

Summary:

      Alcohol dependency is the most frequent addiction leading to a massive burden of both,
      patients health, and economy. Present therapeutic concepts suffer from limited efficacy, and
      thus new innovative therapies are needed. Neuroscientific studies have shown that prefrontal
      function in alcohol-dependent patients is impaired, leading to cognitive disturbances, and
      continuation of dependent behaviour. The results of pilot studies demonstrate that activation
      of prefrontal cortices via non-invasive brain stimulation improves cognitive performance in
      healthy subjects, and diminishes dependency-related behaviour in patients. The investigators
      aim to develop a stimulation protocol suited to induce a clinically relevant improvement of
      prefrontal functions in patients suffering from alcohol dependency. Therefore, the
      investigators will develop stimulation protocols which are able to modulate prefrontal
      activation for a much longer time course than those currently available, and will explore if
      the induced physiological alterations translate to respective cognitive improvements and
      reduction of addictive behaviour.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with diagnosis confirmed by Diagnostic and Statistical Manual of Mental
             Disorders in its Fourth Edition (DSM-IV);

          -  Alcoholics classified as type IV according to Lesch's Typology.

          -  18-65 years old from both genders;

          -  clinically stable and not requiring hospitalization;

          -  with significant history of consumption of at least 35 weekly doses of alcohol on
             average last year;

          -  and an active intake of at least 35 weekly doses of alcohol in the last 90 days before
             starting the study;

          -  being in a minimum of seven days of abstinence until beginning of the study protocol;

          -  able to read, write and speak Portuguese.

        Exclusion Criteria:

          -  Diagnosis of other drug dependence, except nicotine and caffeine use;

          -  Diagnosis of other mental disorder
Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Marijuana blunt; marijuana cigarette
Intervention description: Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg).; Marijuana cigarettes were provided by the National Institute on Drug Abuse.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Marijuana; Comparison between joints and blunts; Pharmacokinetic effects

Summary:

      The purpose of this study is to investigate whether or not marijuana blunts will produce
      comparable plasma THC levels as marijuana joints and if blunts will produce larger
      cardiovascular and subjective effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current blunt marijuana use (minimum of twice/week) drug screen

          -  21-45 years of age

          -  Practicing an effective form of birth control (condoms, diaphragm, birth control pill,
             IUD)

        Exclusion Criteria:

          -  Current, repeated illicit drug use(excluding marijuana)

          -  Heavy cigarette use (> 10 cigarettes/day)

          -  Presence of significant medical illness (e.g., diabetes, cardiovascular disease,
             hypertension)

          -  Laboratory tests outside normal limits that are clinically unacceptable to the study
             physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)

          -  Significant adverse reaction to marijuana

          -  Current parole or probation

          -  Pregnancy or current lactation

          -  History of significant violent behavior

          -  Major current Axis I psychopathology(e.g., mood disorder with functional impairment or
             suicide risk, anxiety disorder, schizophrenia)

          -  History of heart disease

          -  Current use of any over-the-counter or prescription
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
Condition: Pouchitis; Ulcerative Colitis
MeSH terms: Pouchitis
Intervention: Fecal microbiota transplantation; Placebo
Intervention description: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.; Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: FMT

Summary:

      The aim of our study is to investigate the efficacy and safety of fecal microbiota
      transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a
      double-blinded randomized placebo controlled study. 13 patients receive a fecal
      transplantation from the healthy tested donor and 13 patients in the control group receive
      their own feces.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Status post of restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA)
             for ulcerative colitis

          -  Pouchitis diagnosed by the symptoms and by endoscopy including histology within 6
             months prior to FMT

          -  Need of frequent or continuous use of antibiotics or probiotics because of the chronic
             pouchitis

          -  Availability of consecutive fecal samples during one year

          -  Compliance to attend FMT and control pouchoscopy after 52 weeks

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  Use of immunosuppressive or biological medication

          -  Use of corticosteroids

          -  Acute pouchitis

          -  Pregnancy
Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
Condition: Pleural Neoplasms
MeSH terms: Mesothelioma; Pleural Neoplasms
Intervention: pemetrexed; cisplatin
Intervention description: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles; 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus
      cisplatin before surgery is at killing all the tumor so that none is left at the time of
      surgery. Following surgery, all eligible patients will receive radiation to the chest. How
      patients respond, whether the cancer returns and if so, where, will also be monitored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible
             stages:

               1. Patients must be M0

               2. Patients with T1, T2, and T3 disease (without cardiac involvement) are eligible
                  (T status can be established clinically and radiologically or at exploratory
                  thoracotomy without surgical resection

               3. Patients with N0, N1,or N2 disease are eligible

          -  Performance status of 0 to 1 on the ECOG performance status schedule.

          -  No prior systemic chemotherapy and no prior intracavitary cytotoxic drugs or
             immunomodulators, unless given for the purpose of chemical pleurodesis

          -  No previous radiation therapy

          -  Estimated life expectancy of at least 12 weeks

        Exclusion Criteria:

        Patients will be excluded if they meet ANY of the following criteria:

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry

          -  Have previously completed or withdrawn from this study or any other study
             investigating pemetrexed

          -  Pregnancy or breast-feeding

          -  Serious concomitant systemic disorders (i.e. active infection) that, in the opinion of
             the investigator, would compromise the safety of the patient or compromise the
             patient's ability to complete the study

          -  Second active primary malignancy (except in situ carcinoma of the cervix, adequately
             treated non-melanomatous carcinoma of the skin, low grade (Gleason score less than or
             equal to 6), localized adenocarcinoma of the prostate or other malignancy treated at
             least 2 years previously with no evidence of recurrence
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: Sotrovimab (Gen1); Sotrovimab (Gen2); Sotrovimab (Gen2)
Intervention description: Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material; Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection; Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion
Intervention MeSH terms: Sotrovimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Part A is double-blinded. Parts B and C are open label.
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; coronavirus; coronavirus disease 2019; COVID-19

Summary:

      This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will
      receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2
      (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Part A, participants must be aged 18 years or older at the time of obtaining
             informed consent

          -  For Parts B and C, participants must be aged between 18 years and 69 years old at the
             time of obtaining informed consent

          -  Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment
             and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 days from
             onset of symptoms

        Exclusion Criteria:

          -  Currently hospitalized or judged by the investigator as likely to require
             hospitalization in the next 24 hours

          -  Symptoms consistent with severe COVID-19

          -  Participants who, in the judgement of the investigator are likely to die in the next 7
             days.

          -  Severely immunocompromised participants

          -  For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to
             enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be
             allowed for 90 days after dosing)

          -  For Parts B and C, conditions that would prohibit receipt of IM injections in the
             investigator's opinion

          -  For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment
             (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for
             90 days after dosing)
Study of Capecitabine to Treat Recurrent High Grade Gliomas
Condition: Malignant Glioma
MeSH terms: Glioma
Intervention: Capecitabine
Intervention description: 1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HGG; anaplastic astrocytoma; anaplastic oligodendroglioma; anaplastic mixed glioma; glioblastoma multiforme; GBM; Xeloda; capecitabine

Summary:

      The purpose of this study is to determine if capecitabine is effective in the treatment of
      high grade gliomas that have returned after completing treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of high grade glioma (WHO grade III or IV: anaplastic
             astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma
             multiforme)

          -  Male or female 18 years of age or older

          -  Negative pregnancy test (if of childbearing potential)

          -  Any number of previous recurrences will be allowed

          -  Karnofsky Performance Status > 60

          -  Hematocrit > 30,000

          -  White blood cell count > 1,500

          -  Platelet > 100,000

          -  Absolute Neutrophil Count > 1,000

          -  Bilirubin < 1.5 x upper limits of normal

          -  Transaminases (ALT and AST) < 1.5 x upper limits of normal

          -  Creatinine < 1.5 x upper limits of normal

          -  Adequate medical health to participate in this study

          -  Adequate documentation of menopause (natural/surgical) or patient commitment to
             routine use of reliable birth control (barrier/hormonal)

          -  Ability to read and understand the informed consent document

          -  Ability and willingness to follow all requirements of the study including following
             all directions, taking medication as prescribed and completing all diaries and forms

        Exclusion Criteria:

          -  Karnofsky Performance Status < 60

          -  Hematocrit < 30,000

          -  White blood cell count < 1,500

          -  Platelet < 100,000

          -  Absolute Neutrophil Count < 1,000

          -  Bilirubin >1.5 x upper limits of normal

          -  Transaminases (ALT and AST) > 1.5 x upper limits of normal

          -  Creatinine > 1.5 x upper limits of normal

          -  Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or
             insufficient allergy prophylaxis
IL-11 in Adults With Von Willebrand Disease Undergoing Surgery
Condition: Von Willebrand Disease
MeSH terms: Von Willebrand Diseases
Intervention: Neumega (Oprelvekin, Interleukin 11, IL-11)
Intervention description: 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
Intervention MeSH terms: Oprelvekin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IL-11; von Willebrand disease; von Willebrand factor; VWFmRNA; surgery

Summary:

      The purpose of this study is to determine the efficacy and safety of rhIL-11 when given
      subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or
      major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and
      severity of bleeding and transfusion requirement during and after surgery. Safety will be
      measured by the frequency of adverse events, including fever, headache, fatigue, myalgias,
      arthralgias, fluid retention, or edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 years of age and older

          -  Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively
             normal VWF multimers

          -  A past bleeding history

          -  Responsive to DDAVP

          -  Scheduled elective major surgery or major dental surgery at MUH or PUH

          -  Willingness to have blood drawn

        Exclusion Criteria:

          -  Presence of other bleeding disorders, acquired Von Willebrand disease, primary
             thrombocytopenia

          -  Use of immunomodulatory or experimental drugs, or diuretics

          -  Pregnant or lactating women or those unwilling to use contraception during study

          -  Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation,
             atrial flutter), hypertension, MI, stroke, or thrombosis

          -  Past allergic reaction to Neumega or DDAVP

          -  Surgery within the past 8 weeks

          -  Inability to comply with study protocol requirements

          -  Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs

          -  Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
             containing substantial quantities of FVIII and/or VWF within five days of study

          -  Past allergic reaction to Neumega or DDAVP

          -  Surgery within the past 8 weeks

          -  Inability to comply with study protocol requirements

          -  Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs

          -  Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
             containing substantial quantities of FVIII and/or VWF within five days of study
Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Intervention: Erlotinib
Intervention description: Erlotinib supplied as tablets; oral dose of erlotinib of 150 mg daily to be continued for 16 weeks. Responders will continue for up to 12 months, non-responders will cease taking erlotinib
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the overall response rate to erlotinib in
      patients with polycythemia vera (PV). Response rate will be assessed by improvement in the
      complete blood count, ultrasound of the spleen, and JAK2 molecular status. It is purposed in
      this study to explore a possible molecular targeting of the driving mechanism of PV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  WHO 2008 diagnosis of Polycythemia Vera Hemoglobin > 18.5 g/dl for men (16.5 g/dl for
             women) and presence of JAK2V617F mutation and either bone marrow trilineage
             myeloproliferation or subnormal serum erythropoietin level Patients may be on active
             treatment (phlebotomy, aspirin) ECOG performance status 0,1,2,or 3 Adequate hepatic
             function, adequate renal function

        Exclusion Criteria:

          -  Patient with active malignancy Patients with clinically significant cardiac disease
             within 1 year Opthalmologic or gastrointestinal abnormalities Concurrent cytoreductive
             therapy is not allowed
ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: Zoster Vaccine, Live; Comparator: Placebo
Intervention description: A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1; A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 309.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of the study was to assess the safety, tolerability, and immunogenicity of
      ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Varicella-history positive, herpes zoster (HZ)-history negative patients

          -  60 years of age and older receiving chronic/maintenance systemic corticosteroid
             therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2
             weeks immediately prior to enrollment and expected to continue to receive a daily dose
             of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up
             period (dose may vary within this range during the 6-week postvaccination period)

          -  All females enrolling must be postmenopausal

        Exclusion Criteria:

          -  Patients with a history of hypersensitivity reaction to gelatin or neomycin

          -  Prior receipt of varicella or zoster vaccine; prior history of herpes zoster

          -  Immune globulin and/or blood products given within 5 months prior to or expected
             within the 6-week postvaccination period

          -  Receipt of any live virus vaccinations within 1 month or receipt of any inactivated
             vaccinations within 7 days prior to enrollment

          -  Known immune deficiency that is caused by a medical condition

          -  Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other
             medications which may suppress the immune system including methotrexate,
             corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents
             used to treat cancer, or medications which alter the level of the immune response used
             to treat arthritis or other illnesses

          -  Concomitant use of antiviral therapy

          -  A history of alcohol abuse or recreational drug use