bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Green Tea Consumption on Homocysteine Metabolism and Cognitive Dysfunction
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Green tea contains catechins and theanine as major ingredients and has been reported to have
      various beneficial influences on human health. It is reported that the drinking green tea is
      inversely associated with serum homocysteine level in elderly. However the effect of green
      tea consumption on cognitive dysfunction is not clinically clarified. The purpose of this
      study is to investigate the effects of green tea consumption on homocysteine metabolism and
      cognitive dysfunction in elderly with impaired cognitive function.
    

Detailed description: 
      Elderly people with impaired cognitive function go on increasing year by year with the coming
      aged society. Among them, the Alzheimer disease is a major cause of the illness, which is
      progressively worse, has no fundamental curable therapy, and induces the burdens of
      caregivers as well as the health insurance and national budget. Recently, homocysteine
      metabolism is reported to be related to atherosclerosis in aging, and draw attention as the
      etiology of cognitive dysfunction in elderly.

      Green tea contains catechins and theanine as main ingredients. These components are reported
      to have anti-atherogenic action and effect on improving cognitive dysfunction. However,
      clinical evidence for homocysteine metabolism and cognitive dysfunction has not been
      clarified. Therefore, in this study, the investigators attempted to investigate the effects
      of green tea consumption on homocysteine metabolism and cognitive dysfunction in elderly with
      impaired cognitive function.
    

Intervention name(s): green tea powder
Intervention type(s): Dietary Supplement
Intervention description(s): Consuming 2 g/day of green tea powder in three times divided for 3 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: green tea; aging; atherosclerosis; homocysteine; cognitive impairment
A Trial to Study BAY1753011 in Patients With Congestive Heart Failure
Condition: Heart Failure (HF)
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy of 30 mg of BAY1753011, with or without furosemide, versus furosemide
      alone in patients with heart failure and objective evidence of congestion.
    


Intervention name(s): BAY 1753011; Placebo BAY 1753011; Furosemide; Placebo Furosemide
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral; Tablet; Once daily in the morning; Oral; Tablet; 40mg unit; 80mg once daily in the morning; Oral; Tablet; Once daily in the morning; Oral
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic heart failure (CHF); Heart failure with reduced ejection fraction (HFrEF); Heart failure with preserved ejection fraction (HFpEF); Heart failure with mid-range ejection fraction (HFmrEF)
A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and
      multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This
      single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8
      cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9
      subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).
    


Intervention name(s): CRN01941 Oral Solution; CRN01941 Oral Capsule; Placebo Oral Solution; Placebo Oral Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Investigational drug; Investigational drug; Placebo; Placebo
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single and multiple-dose cohorts are placebo-controlled.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ear Electro-stimulation for Chronic Pelvic Pain
Condition: Endometriosis
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional

Summary: 
      The Brigham and Women's Pain Management Center is conducting a research study for chronic
      pelvic pain patients due to endometriosis. The study will assess the effect of
      electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have
      chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking
      opioid medication (such as morphine or oxycodone). The study will require two visits, each
      lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management Center,
      850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or
      ccahalan1@partners.org if interested.
    

Detailed description: 
      The Brigham and Women's Pain Management Center is conducting a research study for chronic
      pelvic pain patients due to endometriosis. The study will assess the effect of
      electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have
      chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking
      opioid medication (such as morphine or oxycodone). The study will require two visits, each
      lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management Center,
      850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or
      ccahalan1@partners.org if interested.

      Vitaly Napadow, Ph.D., Lic.Ac. Assistant Professor Dept. of Radiology, Massachusetts General
      Hospital, Harvard Medical School
    

Intervention name(s): Real stimulation VS Sham
Intervention type(s): Behavioral
Intervention description(s): Ear stimulation at specific points should work by stimulating a nerve called the vagus nerve. Previous research has shown that stimulating this nerve can help patients feel less pain. During any testing session, participants may receive either the real ear stimulation or a sham (placebo) treatment. The sham treatment will use the same equipment as the real treatment, but will not deliver any real stimulation to the ear. We use placebo/sham procedures in research to make sure that the study results are related to the study procedure, and not to other reasons.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Suicide Gene Therapy for Donor Lymphocytes Infusion After Allogeneic Hematopoietic Stem Cell Transplantation
Condition: Hematological Malignancy
MeSH terms: Neoplasms; Hematologic Neoplasms; Suicide
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main complications of allogeneic hematopoietic stem cell transplantation (HSCT) include
      graft-versus-host disease (GVHD) and poor immune reconstitution leading to severe infections
      and leukemia relapse. Mature donor T-cells present in the transplant facilitate T-cell
      reconstitution but also induce GVHD, which itself impairs immune reconstitution. We have
      developed a strategy of alloreactive T-cell depletion, using T-cells expressing the Herpes
      simplex thymidine kinase (TK) suicide gene combined with a ganciclovir (GCV) treatment. This
      system permits the selective elimination of dividing TK+ T-cells in vivo. To test this
      hypothesis in preclinical settings, we have previously developed several experimental models
      of GVHD using TK+ T-cells in mice. The demonstration that a preventive treatment with GCV
      administered close to the time of HSCT could control GVHD brought the proof of concept. We
      now propose a clinical trial to test whether donor lymphocytes infusion (DLI) using
      TK-transduced cells permits to induce a graft-versus-tumor (GVT) effect for treatment of
      relapse after HSCT, while GVHD can be controlled by GCV treatment.
    

Detailed description: 
      DLI-TK is administered either after failure of 1 or several previous standard (std-) DLI of,
      defined after a minimal follow-up of 2 months after the last injection. To prepare DLI-TK,
      donor T-cells are transduced with a retroviral vector encoding TK. Transduced cells are
      selected using a CliniMACS device (MYLTENYI). In case of previous std-DLI received, the
      DLI-TK cell dose is adjusted to be below or equal to the maximal cell dose previously
      received in std-DLI. No comparison is planned in the analysis.
    

Intervention name(s): donor lymphocyte infusion
Intervention type(s): Biological
Intervention description(s): Donor T-cell transduction
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hematological malignancy; allogeneic hematopoietic stem cell transplantation; donor lymphocyte infusion; antitumor immunotherapy; graft-versus-tumor effect; gene therapy; relapse; adult
Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease
Condition: Type 1 Diabetes Mellitus; End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney
      transplantation in patients of type 1 diabetes with end-stage renal disease using a
      glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Islet
      transplantation can result in insulin independence with excellent metabolic control when
      glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet
      mass. Alemtuzumab (Campath-1H ®) is a 150-kDa humanized IgG1 monoclonal antibody that targets
      the CD52 antigen. Prolonged lymphocyte depletion can be expected following alemtuzumab
      treatment.
    


Intervention name(s): simultaneous islet-kidney transplantation
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Islets of Langerhans Transplantation; Kidney Transplantation; Type 1 Diabetes Mellitus; alemtuzumab
Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ORADUR®-Methylphenidate
      in children and adolescents with ADHD.
    

Detailed description: 
      This Phase III, multi-center, randomized, double-blind, placebo controlled, two-way
      cross-over study aims to observe the efficacy and safety of ORADUR®-Methylphenidate in
      children and adolescents with ADHD age 6 to 18 years old.

      The study is comprised of four main phases: a screening period lasting about 14 days, an
      open-label titration period lasting 2 to 4 weeks, a double-blind and placebo controlled
      two-way cross-over study period of 4 weeks (2 weeks for Period 1 and 2 weeks for Period 2),
      then a follow-up phase of 2 weeks. Screening baseline is defined as Day 0 (Visit 2).

      At the last day of the titration period (Day 14 for 22 mg, Day 21 for 33 mg group, and Day 28
      for 44 mg group), subjects will be randomly assigned to receive ORADUR®-Methylphenidate at
      their optimal dose or placebo at a 1:1 ratio according to the randomization scheme during
      each study period (Period 1 and Period 2) at treatment phase; no washout period will be
      included between two treatment periods.
    

Intervention name(s): Placebo First, then ORADUR®; ORADUR® First, then Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).; ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).
Other intervention name(s): Placebo; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ORADUR®-Methylphenidate
Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the concentration of oxygen the study volunteer breathes. The accuracy of a
      noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation
      measurements from a laboratory blood gas analyzer.
    


Intervention name(s): Rainbow DCI Sensor
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Single Dosing Clinical Trial of HL151
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine
      after single oral administration of TALION tab, a IR formulation of bepotastine as reference
      drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults.
      Additionally the safety and tolerability of two drugs will be evaluated.
    


Intervention name(s): HL151; TALION tab.
Intervention type(s): Drug; Drug
Intervention description(s): Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal; Reference drug: TALION tab, 1T, every 12 hours, oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
Condition: Bronchial Asthma; Signs and Symptoms, Respiratory; Allergy
MeSH terms: Asthma; Signs and Symptoms, Respiratory
Study type: Interventional

Summary: 
      Haifa bay region is located close to a major industrial zone. The aim of the study is to
      evaluate the health status of school children living in Haifa bay region.The health status
      will be evaluated using health questionnaires and spirometry.
    

Detailed description: 
      Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate
      the health status of children living in Haifa bay region.

      The health status will be evaluated while using health questionnaires and spirometry.

      Objective: To evaluate the respiratory health of Haifa bay region children with comparatives,
      with respect to local air pollution levels.

      Material and Methods: Children from Haifa bay region from 10 different communities (1200
      children) will be included in the study, after both parents and the children (above 12 years
      of age) will sign an informed consent form.

      First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be
      filled in by the parents.

      Second step: Spirometry checking of the children. In parallel, air pollution levels will be
      measured and provided by a network of ground monitoring stations maintained by the Haifa
      District Municipality Association for the Environment (HDMAE). The station provides
      half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM
      10) pollutants over the entire investigation window. Additional meteorological data are also
      collected.

      Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which
      accounts for ambient concentrations of selected pollutants and the heterogenic spatial
      distribution of several demographic and socio-economic indexes in the region.

      The prevalence of pulmonary disease will be evaluated according to the risk maps The health
      status of the children will be documented from the children's primary clinic files as well.
    

Intervention name(s): Spirometry (Pony spirometer)
Intervention type(s): Device
Intervention description(s): Spirometry at rest
Other intervention name(s): Pony spirometer, Cosmed, Italy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Asthma; Allergy; Respiratory; Pollution; Children; Air pollution
Diabetes-Specific Nutritional Formulas Versus Oatmeal
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes-specific nutritional formulas (DSNFs) are frequently used as part of medical
      nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and
      enhance weight reduction. The mechanism through which DSNFs improve postprandial (PP) plasma
      glucose is not yet known.

      The aim of this study is to compare the effects of 2 DSNFs versus oatmeal on PP plasma
      glucose, serum insulin and serum active glucagon-like peptide-1 (GLP-1), serum free fatty
      acids (FFA) and serum triglycerides (TG).
    


Intervention name(s): Oatmeal breakfast; Glucerna formula; Ultra Glucose Control formula
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating
      the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated
      influenza.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed
      to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients
      aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment
      dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by 400
      mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1 day,
      followed by 800 mg favipiravir BID for 4 days).
    

Intervention name(s): Favipiravir; Favipiravir; Placebo comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days; High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days; Placebo BID x 1 day, and Placebo BID x 4 days
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza
Interval Training and Resting Metabolism
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      It has been reported that obese individuals are seated 2 ½ hour more than lean individuals
      and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between
      equal size people due to different occupational and leisure time activities. The primary aim
      of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary
      men.

      Subject will be randomized to three different training intervention, with 3 exercise session
      each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7
      day period both before and after training.
    


Intervention name(s): 1 x 4 minute interval; 4 x 4 minutes Intervals; Moderate continuous Training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 1 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate; 4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate separated by 3 minutes of active brakes in between at 70% of maximal heart rate.; 47 minutes of Moderate continuous Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: NEAT; maximal oxygen uptake; stroke volume
A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice
Condition: Head Lice
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group
      design study.
    

Detailed description: 
      This study is comprised of two phases: screening and treatment. The screening period is 24
      hours, followed by the treatment phase of 15 ± 3 days. During the treatment phase, subjects
      will be randomized to either test, reference of placebo treatments (3:3:1) in a double-blind
      manner in an outpatient setting. Once eligibility is confirmed, randomization will occur at
      visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 15
      ± 3 days in duration wherein subject will receive treatment with investigational product
      (either test, reference or placebo) on Day 1 or baseline (visit 2). Efficacy will be
      evaluated at Day 15. Safety and tolerability will be evaluated based upon AEs and patient
      self-assessments and self-assessments collected during follow-up visits.
    

Intervention name(s): Ivermectin 0.5% Topical Application Lotion; Ivermectin 0.5% Topical Application Lotion [SKLICE]; Placebo 0% Lotion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.; Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.; Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment