bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia
Condition: Toxoplasmosis; Schizophrenia
MeSH terms: Toxoplasmosis; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an exploratory study in Egypt that will combine a treatment trial among early course
      schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically,
      the study will test the provocative results from animal studies indicating an impact of
      Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether
      exposure to TOX is associated with other cognitive and behavioral changes, as well as changes
      in overall social function. We will also explore the relative efficacy of Sodium Valproate
      (Depakote, DEP) in improving clinical and overall social function among TOX exposed and
      unexposed patients.

      Hypotheses

        1. At baseline, TOX exposure is associated with increased novelty seeking, clinical
           severity, and impaired cognitive and overall social function in patients with SZ.

        2. Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in
           SZ, particularly among TOX exposed SZ patients.

        3. Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection (VIP
           and TH levels).
    


Intervention name(s): Sodium Valproate treatment; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sodium Valproate treatment:During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either Sodium Valproate (Depakote, DEP) or placebo (PLA) group in a 1:1 proportion. For the Sodium Valproate treatment group, this will be followed by a two week period to adjust the dose of DEP and attain therapeutic levels (50-100 µg/mL). Then DEP treatment will continue for 16 more weeks, after which DEP will be discontinued. Subject will be followed up for four weeks post-DEP discontinuation to monitor delayed adverse side effects.; Placebo: During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either the experimental Sodium Valproate (Depakote, or DEP) or placebo (PLA) group in a 1:1 proportion. For the PLA group, this will be followed by a two week period of placebo during which members of the experimental Sodium Valproate (Depakote/DEP) will have DEP dose adjusted to attain therapeutic levels (50-100 µg/mL). Then PLA treatment will continue for 16 more weeks. Subjects will be followed up for four weeks post PLA-discontinuation to monitor for delayed adverse side effects.
Other intervention name(s): Depakote
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; toxoplasmosis
Role of Eosinophils in the Proliferation of Airway Smooth Muscle (ASM) Cells
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Being a key player in Asthma, eosinophils constitute a potential target to interfere with the
      series of biological events leading to Asthma pathogenesis. In this proposal, the
      investigators hypothesize that the interaction between eosinophils and airway smooth muscle
      cells (ASM) cells plays an important role in airway remodeling. Hence the investigators will
      investigate the role of eosinophils in enhancing ASM cells proliferation resulting in airways
      remodeling. The investigators will also investigate the mechanism behind this phenomenon.
      This will then pave the way for medical (drug) interference at one or several sites in order
      to prevent one of the main potential reasons behind airway remodeling, namely
      eosinophil-derived ASM proliferation.
    

Detailed description: 
      Rational and hypothesis Asthma is a chronic inflammatory disorder of the lung airways that is
      associated with airway remodeling and hyperresponsiveness (AHR). Its is well documented that
      the smooth muscle mass in asthmatic airways is increased due to hypertrophy and hyperplasia
      of the ASM cells. Moreover, eosinophils have been proposed in different studies to play a
      major role in airway remodeling. The association between increased eosinophil numbers and
      asthma severity has been well documented. Here, we hypothesized that the interaction between
      eosinophils and ASM cells plays an important role in airway remodeling and that eosinophils
      modulate the airways through enhancing ASM cell proliferation.

      Objectives of the study The aim of this study is to examine the effect of eosinophils on ASM
      cell proliferation using eosinophils isolated from asthmatic subjects.

      Specific aim 1. Effect of co-culture of ASM cells with eosinophils on ASM cell proliferation.

      In this specific aim, the effect of eosinophil on ASM cell proliferation will be studied by
      co-culturing eosinophils isolated from asthmatic and healthy patients with ASM cells in
      vitro. This will be done using non-stimulated eosinophils or eosinophils activated with
      Interleukin-5 (IL-5)and Interleukin-3 (IL-3). ASM proliferation will be monitored by
      determining the levels of the proliferation marker Ki-67 expression in ASM cells.

      Specific aim 2. Understanding the mechanism by which eosinophils enhance ASM proliferation.

      In this specific aim, we will study the mechanism by which eosinophils enhance the
      proliferation of ASM cells. To study if this effect of eosinophils is done through direct
      contact with ASM cells, we will co-culture ASM cells with eosinophils membrane fractions.
      Moreover, we will examine the effect of cytokines and extracellular matrix (ECM) proteins
      produced by eosinophils on smooth muscle cells
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        12 patients per group
Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children
Condition: Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Observational

Summary: 
      Pediatric research in the management of nausea has been limited by the absence of a reliable
      method to quantify the intensity of this subjective symptom. In adults, the visual analog
      scale (VAS) is an accurate tool, but this has not been shown to be reliable in young
      children. By default the most common objective outcome measure used in pediatric studies has
      been the incidence and number of emetic episodes. This measure, however, correlates poorly
      with the somatic subjective symptom of nausea.
    

Detailed description: 
      Pediatric research in the management of nausea has been limited by the absence of a reliable
      method to quantify the intensity of this subjective symptom. In adults, the visual analog
      scale (VAS) is an accurate tool, but this has not been shown to be reliable in young
      children. By default the most common objective outcome measure used in pediatric studies has
      been the incidence and number of emetic episodes. This measure, however, correlates poorly
      with the somatic subjective symptom of nausea.

      Apfel et al have shown that 30-40% of adult patients undergoing surgery have post discharge
      nausea and / or vomiting while 12% have vomiting. These data on nausea in adults were based
      on a visual analog scale for nausea. There are no data on the incidence of postoperative
      nausea in children since the severity of symptoms are difficult to measure as younger
      children are known to be unable to use the VAS reliably.

      Recently a pictorial scale for measuring nausea, the Baxter Animated Retching Faces (BARF)
      scale, has been developed and shown to have construct, content and convergent validity as an
      instrument to measure nausea in children. The clinical usefulness of this scale in
      determining the incidence of postoperative and post-discharge nausea in children has yet to
      be determined including the lowest age where it can be used reliably, the score associated
      with a patient's perception of a need for treatment, the minimum change in the scores of
      clinical relevance and the test-retest reliability when nausea is rated as not having
      changed.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Pre-operative patients at Texas Children's Hospital
Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when
      administered together.

      To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe
      , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.
    


Intervention name(s): low dose; normal dose; low dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): efavirenz single dosing once daily; efavirenz once daily; Efavirenz single dosing once daily
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electroacupuncture for Hypertension Patients With Chronic Kidney Disease
Condition: HYPERTENSION RENAL
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension, Renal; Hypertension
Study type: Observational

Summary: 
      1. To observe the Efficiency of Electroacupuncture for Hypertension Patients With Chronic
           Kidney Disease.

        2. To observe if different-time treatment having an impact on Hypertension Patients With
           Chronic Kidney Disease.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        in the ward of the department of nephrology
      
Biospecimen description: 
      serum
Interaction in Chronic Obstructive Pulmonary Disease Experiment
Condition: Chronic Obstructive Pulmonary Disease; Cardiovascular Disease; Smoking; Bronchodilation
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The final purpose of this study is to determine whether bronchodilation and cigarette smoking
      in Chronic Obstructive Pulmonary Disease (COPD) patients interact, resulting in an increase
      of cardiovascular disease. The aim of this part of the study is to demonstrate the basic
      mechanism: Does increased respiratory function after administration of a bronchodilator in
      patients with COPD lead to elevated pulmonary retention of the harmful compounds in inhaled
      cigarette smoke and to short-term biological effects associated with cardiovascular disease?
    

Detailed description: 
      COPD currently is one of the most frequent diseases. In more than 80% of COPD patients, the
      disease is caused by smoking. About half of the COPD patients are active smokers, although
      smoking is also the most important prognostic factor. Also, smoking is an important cause as
      well as an important prognostic factor in cardiovascular disease. The corner stone of medical
      treatment in COPD is bronchodilation; more than half of the patients use a long-acting
      bronchodilator. An increase of the pathogenic effect of smoking by an increased lung function
      after bronchodilation is likely though, since more pathogenic particles would penetrate the
      lung. We hypothesize that bronchodilators increase cardiovascular disease in COPD patients
      who smoke.

      In order to demonstrate the basic mechanism of our hypothesis, COPD patients receive a
      bronchodilator at one time and a placebo at another time, preceded and followed by cigarette
      smoking during one hour as by a strict time schedule. Smoke retention, lung function and
      blood biomarkers are repeatedly measured.
    

Intervention name(s): Tiotropium (Spiriva) + Salbutamol (Ventolin); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 time inhalation of 5 mcg of Tiotropium bromide by Respimat and 400 mcg of Salbutamol by Volume Spacer. cigarette smoking; 1 time inhalation of placebo with the amount of puffs similar to the active comparator. cigarette smoking
Other intervention name(s): Spiriva Respimat; Ventolin Aerosol; Ventolin placebo and Spiriva placebo
Intervention MeSH terms: Albuterol; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: intervention study; interaction; COPD
Preventing Behavior and Health Problems in Foster Teens
Condition: Parent Management Training
Study type: Interventional

Summary: 
      The primary goal of this study is to test the efficacy of two levels of the KEEP intervention
      with adolescents and their foster and kin parents in the San Diego Child Welfare System.
    

Detailed description: 
      The cost of child welfare services in the U.S. has been estimated at $20 billion per year.
      During the past decade, the number of teenagers in foster care has nearly doubled. Numerous
      studies have documented that these adolescents are at high-risk for developing serious
      problems, including substance use, participation in health-risking sexual behaviors,
      involvement in the juvenile justice system, serious educational problems and school drop-out,
      failed placements/foster care "drift" and homelessness. Yet, there is little research on the
      characteristics of interventions that can be used to guide the improvement of services for
      this vulnerable population of youngsters. The proposed study extends our previous research
      with adolescents referred for serious behavioral and emotional problems and research with
      elementary-aged children in foster care to a test of the efficacy of a preventive
      intervention for adolescents placed with foster and kin care providers in the San Diego
      County Child Welfare System. Two hundred and forty adolescents and their foster/kin care
      providers will participate (i.e., 60 in a foster/kin parent training only condition, 60 in a
      parent training plus youth skill training condition, and 120 in a casework "as usual" control
      condition). In addition to testing the efficacy of the two levels of intervention, the
      investigators propose to examine the effects of the intervention on a set of youth behavioral
      and health-related outcomes. Parenting mediators to be tested include positive parenting,
      parental supervision, and non-harsh discipline. Youth mediators are social competence,
      commitment to school, and knowledge about norms related to health-risking behaviors including
      substance use and high-risk sexual behavior. In addition, theoretical hypotheses about the
      effects of early risk/adversity factors to youth outcomes will be examined, and an economic
      analysis will be conducted to examine the relative benefits and costs associated with the two
      levels of intervention.
    

Intervention name(s): Parent Training; Youth Skills Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 16 weeks of parent training led by a trained group facilitator; 16 weeks of one-on-one sessions with a trained youth skills coach
Other intervention name(s): Parent Management Training; KEEP; Skills Coaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: behavior problems; foster care; parent training; youth skills training
15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7
      days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and
      cognition function tests.
    


Intervention name(s): SB-649868; Placebo; Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.; Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.; Subjects will receive Simvastatin 10 mg tablets orally.
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: SB-649868,; Simvastatin; Repeated dose,
MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective
      treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to
      detect breast cancer.

      PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who
      are at high risk for developing breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Estimate the diagnostic yield and positive predictive value of breast magnetic resonance
           imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime
           risk for developing breast cancer.

        -  Compare the diagnostic yield and positive predictive value of MRI with conventional
           breast cancer screening (mammography and physical examination) for the detection of
           breast cancer in women with a greater than 25% lifetime risk of developing breast
           cancer.

      OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients
      undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo
      an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical
      examination, mammography, or MRI undergo a core needle or excisional biopsy.

      PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 2 years.
    

Intervention name(s): motexafin gadolinium; biopsy; breast imaging study; comparison of screening methods; magnetic resonance imaging; study of high risk factors
Intervention type(s): Drug; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention MeSH terms: Motexafin gadolinium
Primary purpose: Screening
Keywords: breast cancer
Does Adding Spinal Anaesthesia to a General Anaesthetic Technique Influence Readiness for Discharge in Patients Having Hand Assisted Laparoscopic Live Donor Nephrectomy
Condition: Surgery
Study type: Interventional

Summary: 
      About 1100 living donor nephrectomies are performed in the UK every year contributing to
      almost 35% of all the kidney transplants. Laparoscopic surgical techniques are general
      employed for donor nephrectomy as they are associated with a shorter hospital stay and faster
      return to normal physical functioning. Local anaesthetic infiltration technique with or
      without spinal anaesthesia in combination with a general anaesthetic is increasingly being
      used as part of enhanced recovery programme across general surgery. The impact of combined
      spinal and general anaesthesia along with local infiltration and rectus sheath blocks on
      acute pain has not been studied in patients undergoing hand assisted laparoscopic live donor
      nephrectomy.

      The investigators plan to investigate whether adding a spinal anaesthetic to a conventional
      general anaesthetic technique actually influences clinical outcomes of length of hospital
      stay and acute pain in patients undergoing hand assisted laparoscopic live donor nephrectomy.

      The investigators plan to randomise 90 patients undergoing hand assisted laparoscopic live
      donor nephrectomy over 24 month period at Central Manchester University hospitals and divide
      them in two groups of 45 each. Group A will receive a general anaesthetic (GA) with spinal
      anaesthesia (Spinal group) and Group B will receive a GA with a rectus sheath block (Rectus
      sheath group) and local anaesthetic infiltration
    


Intervention name(s): Bupivacaine and Diamorphine; Remifentanil, Propofol and Cistracurium; Bupivacaine and Rectus Sheath injection
Intervention type(s): Procedure; Procedure; Procedure
Intervention MeSH terms: Remifentanil; Heroin; Bupivacaine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Donor Nephrectomy
Study Evaluating DVS-233 for Treatment of Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the long-term safety of desvenlafaxine sustained release (DVS-233SR) during
      open-label treatment of outpatients with major depressive disorder (MDD).
    


Intervention name(s): DVS-233 SR (desvenlafaxine sustained release )
Intervention type(s): Drug
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Follow-up Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators purpose is to follow remitted patients from their previous study using
      transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents
      relapse.
    

Detailed description: 
      Our first ongoing study (Efficacy Study of Transcranial Direct Current Stimulation (tDCS) to
      Treat Major Depressive Disorder) addresses whether tDCS is an effective treatment for
      depression treatment. The purpose of the present study is to determine whether tDCS is also
      an effective strategy for sustaining remission.

      We will enroll patients who presented remission using tDCS from our previous study and offer
      them to tDCS every other week for three months, than once a month for another three months.
      We will address whether tDCS prevents relapse by assessing depression scores once a month,
      using a time-to-event analysis.

      The importance of the present study is to determine whether tDCS is able to sustain remission
      during long-term follow-up of depressed patients.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): tDCS will be applied at 2mA/30 minutes, every other week during the first three months than once a month during the next three months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depressive disorder; follow-up; relapse; remission; transcranial direct current stimulation