bioihbjkbjnl/mcl2 huggingface dataset:
Psychological Group Treatment in Adults With Attention Deficit Hyperactivity Disorder: Development of a Short Cognitive -Behavioral Program
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that begins
      in childhood and can persist throughout adolescence and adulthood. ADHD affects persistently
      about 5% of children and adolescents and about 2.5% of adults worldwide. The cognitive
      behavioral therapy (CBT) has proven to be effective in significantly reducing ADHD-symptoms,
      maintaining the effects during follow-up.

      The aim of this study is to develop and validate a psychological treatment program for adult
      ADHD-patients consisting of six sessions based on Cognitive Behavioural Therapy (CBT) and to
      study the effectiveness of the developed program in short and long term.

      A total of 90 patients will be randomized to two treatment groups (1:1). One group will
      receive 12 sessions of CBT and the other group six sessions of brief CBT.

      It is expected that the short-term effectiveness of a CBT psychological treatment program of
      six group sessions will be the same as the response to the CBT psychological treatment
      program of twelve group sessions in adult ADHD-patients with stable drug treatment.
    


Intervention name(s): cognitive behavioral therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): Cognitive behavioral therapy (CBT) is a psycho-social intervention that aims to improve mental health. CBT focuses on challenging and changing unhelpful cognitive distortions (e.g. thoughts, beliefs, and attitudes) and behaviors, improving emotional regulation, and the development of personal coping strategies that target solving current problems.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antibiotic Prophylaxis in Adult Heart Transplantation: a French National Survey
Condition: Antibiotic Prophylaxis; Adult Heart Transplantation
Study type: Observational

Summary: 
      The study focuses on the antibiotic prophylaxis use in adult heart transplantation in France.
    

Detailed description: 
      In adult heart transplantation, clinical situations differ between patients (elective,
      emergency, redux surgery, ventricular assisting device or extracorporeal live saving). At
      investigator's knowledge, there is not recommendations in France about antibiotic prophylaxis
      in adult heart transplantation. So, investigators aimed to study the antibiotic prophylaxis
      use in adult heart transplantation in France.

      Investigators conduct a French national survey about antibiotic prophylaxis used in adult
      heart transplantation center. Clinical situations such as elective, emergency, redux surgery,
      ventricular assisting device or extracorporeal live saving are investigated.

      Study was performed after Institutional approval was obtained from the local Ethics Committee
      (Comite de Protection des Personnes Nord Ouest III). An electronic survey was sent to all
      French adult heart transplantation centers (22) on march 1st, 2015. Reminders were planned on
      week 2 and 4 after initial sending. On june 2015, nonresponding centers were contacted by
      phone. Data were collected by a single investigator.
    

Intervention name(s): Antibiotic prophylaxis in adult heart transplantation
Intervention type(s): Procedure
Intervention MeSH terms: Anti-Bacterial Agents
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All French centers perfoming adult heart transplantation in 2015.
      
Keywords: antibiotic prophylaxis heart transplantation
An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a China registration study. A randomized, double-blind, placebo-controlled
      immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male
      participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1
      ratio to receive either vaccine or aluminum-containing placebo. Each participant received one
      injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a
      0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate
      immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At
      Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health
      concerns and Serious Adverse Experiences throughout the study. The primary objective is to
      evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose
      regimen of Gardasil® compared with placebo.
    


Intervention name(s): Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®); Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Human Papillomavirus (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6; aluminum-contained, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
Other intervention name(s): V501; Gardasil®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HPV infections
Mangrove-sword Bean-food Bar on the Weight and Weight for Age Z Score of Under-five Children
Condition: Nutrition Poor
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The goal of this clinical trial is to assess the effect of the food bar made from api-api
      mangrove (Avicennia marina) and sword bean (Canavalia ensiformis) blends on the weight and
      Weight-for-Age Z score affected by a landslide disaster.

      The main questions aimed to answer are:

        -  Food bar supplementation can effect the weight and WAZ score of under-five children
           affected by landslides disaster?

        -  Balanced nutrition education can increase the mothers' knowledge on the balanced
           nutrition of under-five children?

      Participants divided in to two group i.e.:

        -  Treatment/intervention group consumed 50 g mangrove sword bean food bar each day during
           15 days.

        -  Control group consumed 50 g sword bean food bar each day during 15 days.

        -  Each group received balanced nutrition for mothers once at the first week of study.
    

Detailed description: 
      Eligibility Criteria for Under-five children:

        -  Aged between 12 and 59 months

        -  Male and female

        -  Living in Cihanjuang Village of Sumedang District which affected by the landslide
           disaster

        -  Had malnutrition, normal, or over-nutrition status, and not suffering from infectious
           diseases.
    

Intervention name(s): Emergency Food Product
Intervention type(s): Dietary Supplement
Intervention description(s): Each subjects of treatment group consumed 50 g food bar during 15 days. Monitoring of compliance undertaken by home visit to recall daily food consumption three days a week and to record the food bar stocks at home during study, and also weekly weight measurement.
Other intervention name(s): Mangrove sword bean food bar
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.
Control group consumed 50 g sword bean food bar each day during 15 days. Mothers of two groups received balanced nutrition education once at the first week of study.
The compliance of subject consumed food bar undertaken by home visit of field enumerators to subjects' house.
They collected three days food recalls and monitored the distribution and stocks of food bar at the subjects' house.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Older people; under-five children; disaster; weight; mangrove-sword bean-food bar
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a Phase II, single center, randomized, open-label, placebo-controlled study in
      male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All
      subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream
      for up to 4 weeks.
    


Intervention name(s): PAC-14028 cream 1.0%; PAC-14028 cream vehicle; Elidel cream 1%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical application; Topical application; Topical application
Intervention MeSH terms: Pimecrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa
      2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV)
      ribonucleic acid (RNA) levels
    


Intervention name(s): Telaprevir; Ribavirin; Pegylated Interferon Alfa 2a; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): tablet; tablet; Solution for injection; matching placebo tablet
Other intervention name(s): VX-950; RBV; Peg-IFN-alfa-2a
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Theta-Burst-Stimulation in Early Rehabilitation of Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present prospective, randomized, controlled, double-blinded trial investigates the
      effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after
      stroke. Patients with hemipresis will receive either sham or real iTBS over their affected
      hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after
      the intervention phase and three months after enrollment.
    

Detailed description: 
      To date, rehabilitation of stroke with hemiparesis mainly includes physiotherapy and
      occupational therapy. Yet, the majority of patients retain movement impairment relevant for
      activities of daily living. One explanation for this deficit is the insufficient recovery of
      connectivity between brain regions after stroke. It is possible to modulate this process by
      repetitive transcranial magnetic stimulation (rTMS) using the protocol of intermittent
      theta-burst stimulation (iTBS). Previous data indicate that modulation of the motor cortex
      with iTBS enhances the effects of subsequent motor training. The present study aims at
      investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined
      with subsequent physiotherapy leads to better motor recovery, compared with physiotherapy
      after sham stimulation. In the first weeks and after three months, motor function, degree of
      disability and quality of life are examined in order to evaluate the effects of iTBS in the
      rehabilitation of stroke patients.

      Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of
      Cologne, 20/12/2016): Specification of exclusion criteria.

      Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of
      Cologne, 15/11/2018): Change of inclusion and exclusion criteria.
    

Intervention name(s): Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol; Magstim Super Rapid2 System, sham-stimulation (in iTBS)
Intervention type(s): Device; Device
Intervention description(s): iTBS applied over ipsilesional M1; iTBS applied with tilted coil over parieto-occipital vertex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer
      cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop
      tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy
      may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in
      treating patients who have malignant primary glioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of gefitinib when given in combination with
           temozolomide in patients with malignant primary glioma.

        -  Determine the toxic effects of this regimen in these patients.

        -  Determine the pharmacokinetics of this regimen in these patients.

      OUTLINE: This is a multicenter, dose-escalation study of gefitinib. Patients are stratified
      according to use of concurrent enzyme-inducing anti-epileptic drugs (yes vs no).

      Patients receive oral gefitinib once daily on days 1-35 and oral temozolomide once daily on
      days 8-12 for the first course only. For the second and subsequent courses, patients receive
      oral gefitinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Courses
      repeat every 28 days in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      Patients are followed every 2 months for 1 year and then every 3-6 months thereafter.

      PROJECTED ACCRUAL: Approximately 3-42 patients will be accrued for this study within 1-14
      months.
    

Intervention name(s): gefitinib; temozolomide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Temozolomide; Gefitinib
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma
Carcinoembryonic Antigen-loaded Dendritic Cells in Advanced Colorectal Cancer Patients
Condition: Colorectal Cancer; Liver Metastases
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As
      such they are currently used in clinical vaccination protocols in cancer patients. We
      evaluate the ability of mature DCs pulsed with carcinoembryonic antigen (CEA)-peptide (arm A)
      or electroporated with CEA-mRNA (arm B) to induce CEA-specific T cell responses in patients
      with resectable liver metastases from colorectal cancer. To evaluate immune responses,
      CEA-specific T cell reactivity is monitored in peripheral blood, resected abdominal lymph
      nodes, tumor tissue and biopsies of vaccination sites and post-treatment DTH skin tests.
      Patients are vaccinated intradermally and intravenously with CEA-peptide pulsed mature DCs
      three times prior to resection of liver metastases. In 2007 a side-study has been added (arm
      C), in which patients with stage III or high-risk stage II colorectal cancer that are
      amenable for standard adjuvant oxaliplatin/capecitabine therapy are vaccinated with
      CEApeptide-pulsed DCs. Also in this group, safety and immune responses in peripheral blood
      and the DTH-skin test are the primary endpoints. Results are compared with the results
      obtained in arm A.
    


Intervention name(s): CEA-loaded dendritic cell vaccine
Intervention type(s): Biological
Intervention description(s): Carcinoembryonic antigen (either peptide or mRNA) loaded dendritic cells.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dendritic cells; Colorectal cancer; Carcinoembryonic antigen; Vaccine; Immunotherapy
Pilot Study Of The Effects Of Resveratrol On Endothelial Function In Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Observational studies have shown that consumption of grapes and grape products such as red
      wine is associated with reduced cardiovascular risk. The mechanisms accounting for this
      benefit remain incompletely understood. Resveratrol is a component of grapes and red wine
      that has favorable effects on endothelial function in diabetic and obese animals. Resveratrol
      is available to people over-the-counter in health food stores and the internet as a dietary
      supplement.

      The endothelium plays a central role in the control of blood vessel function. When healthy,
      the endothelium prevents vasospasm, blood clot formation, and the development of
      atherosclerosis. Endothelial function is abnormal in patients with diabetes mellitus and this
      abnormality contributes to the development of cardiovascular disease.

      The present pilot study is designed to test the hypothesis that resveratrol (90 mg/day and
      270 mg/day for one week each) will have favorable effects on endothelial function in patients
      with diabetes mellitus.
    


Intervention name(s): Resveratrol
Intervention type(s): Dietary Supplement
Intervention description(s): Resveratrol
Other intervention name(s): ResVida
Intervention MeSH terms: Resveratrol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endothelium; resveratrol; diabetes mellitus
The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Systemic lidocaine administration may improve postoperative pain and recovery after
      laparoscopic inguinal hernia repair in pediatric patients
    


Intervention name(s): Systemic intravenous lidocaine infusion; Normal saline infusion
Intervention type(s): Drug; Drug
Intervention description(s): In group L, intravenous lidocaine infusion (0.1mg/kg) for 1minutes after induction of anesthesia. After 1 minutes, lidocaine infusion continued at rate of 1.5mg/kg/hr during operation, and discontinued before move the patients to PACU.; In group C, the patients receive same volume of normal saline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: systemic lidocaine; postoperative pain; recovery, pediatric; inguinal hernia; laparoscopy
Assessment of Iron Absorption From Aspergillus Oryzae
Condition: Iron Bioavailability
Study type: Interventional

Summary: 
      The objective of this study was to compare the absorption of a new iron product, iron
      enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope
      technique.
    

Detailed description: 
      Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive
      age women and children. Primarily, inorganic iron salts are being used as iron
      supplementation to treat IDA and are added to food to improve the nutritional value of the
      daily diet, however side effects and/or low absorption with diets are a result, limiting the
      impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with
      marginal lower iron status (ferritin cut-off value <30ug/L) were recruited in this study.
      Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in
      sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood
      samples were collected at baseline and two weeks to assess isotope enrichment and iron status
      indicators, such as hepcidin and ferritin were measured.
    

Intervention name(s): Ferrous Sulfate; Aspiron
Intervention type(s): Drug; Dietary Supplement
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Subjects were two meals on two consecutive days with the stable isotopes.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Iron Bioavailability; hepcidin; ferritin; iron absorption; iron status
Behavioral Indicators of Pain:Tool Development With Concurrent and Construct Validity
Condition: Pain
Study type: Observational

Summary: 
      The purpose of the pilot study is to validate an assesment tool to be used in the assessment
      of pain in the verbal, congitively intact patient. The ultimate goal is to be able to
      validate this tool in the non-verbal/cognitively impaired patient.
    

Detailed description: 
      Patinets will be observed for 2 six hour periods. Patients will be videotaped; every 10
      minutes: EMG reading will be obtained; hourly - vital signs, pain score and saliva cortisol
      from "spit" will be obtained.
    

Observational model: Defined Population
Time perspective: Prospective