bioihbjkbjnl/mcl2 huggingface dataset:
Brain Glucose Metabolism During Transcranial Direct Current Stimulation
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      With this study we will be able to dose-dependently measure real-time glucose metabolism
      changes after non-invasively stimulating superficial parts of the dlPFC, a commonly used
      target in therapeutic tDCS applications. This will provide further insight if and how tDCS is
      capable to change one of most reliable parameters of brain metabolism.
    

Detailed description: 
      With this study, we will be able to substantiate if regional and whole brain glucose
      metabolism is affected by tDCS, assess the amount of signal change in relation to different
      currents and measure differences in glucose metabolism under stimulation reactivity between
      healthy subjects and depressive patients. The objective is to investigate the changes of
      regional cerebral metabolic rate of glucose (rCMRglu) in the brain after transcranial direct
      current stimulation in healthy subjects and depressive patients. The design is a
      cross-sectional proof of principle study in 20 healthy subjects and 20 depressed patients.
      During the PET scan tDCS will be applied with varying stimulus intensity. Furthermore,
      subjects will undergo a second PET scan with single-blind sham stimulation in order to
      validate the effects of tDCS. rCMRglu will be quantified using voxel-wise and ROI-based
      approaches. Changes in rCMRglu associated with tDCS-application will be calculated with a
      general linear model in a ramp function of the task-specific glucose uptake, according to
      previous work in our group. Exploratory statistical testing will be done using a paired
      samples t-test between task and rest conditions.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Other
Intervention description(s): 0.5 mA, 1mA, 2mA for 10 minutes each
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Transcranial direct current stimulation; Positron emission tomography
Endometrial Ablation With Non-hysteroscopic Methods
Condition: Dysfunctional Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Metrorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Endometrial ablation in women with dysfunctional uterine bleeding using second generation
      ablation devices is a common widespread therapeutic approach. This study aims to prove that
      amenorrhoea rates using Novasure are higher than those observed in microwave endometrial
      ablation, one year following intervention.
    


Intervention name(s): MEA; Novasure
Intervention type(s): Device; Device
Intervention description(s): Microwave endometrial ablation device; Bipolar impedence control system
Other intervention name(s): Microwaves (MEA®); Bipolar Impedance Control System (Novasure®)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of JNJ-70033093 (Milvexian) in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability and food effect of a
      single dose of milvexian administered as direct compression (DC) oral tablets and roller
      compacted (RC) oral tablets compared with milvexian administered as Phase 2 oral capsules
      (Part 1) and of new concept tablets consisting of a single dose of milvexian administered as
      oral Tablet 1 and Tablet 2 compared with milvexian administered as Phase 2 oral capsules
      (Part 3) in healthy participants under fasting and fed conditions; to characterize the
      pharmacokinetics (PK) of multiple twice daily (BID) doses for 5 days of milvexian
      administered as DC oral tablets and Phase 2 oral capsules in healthy participants (Part 2)
      and to assess the effects of dosing time and food timing on the PK of single-dose of
      milvexian Phase 3 oral tablet formulation in healthy participants (Part 4) and to evaluate
      the relative bioavailability of a single dose of milvexian administered as oral film-coated
      DC whole tablets, oral film-coated DC tablets dispersed in water and then mixed with apple
      sauce, and oral film-coated DC tablets dispersed in water and administered as a suspension
      using a nasogastric (NG) tube in healthy participants under fasting conditions (Part 5).
    


Intervention name(s): Milvexian
Intervention type(s): Drug
Intervention description(s): Milvexian will be administered orally or via nasogastric route as tablets or capsules.
Other intervention name(s): JNJ-70033093, BMS-986177
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Influence of Drug Transporter Expression on the Pharmacokinetics of the HIV Protease Inhibitor Kaletra
Condition: Healthy; Pharmacokinetics
Study type: Observational

Summary: 
      The aim of this study is to determine the pharmacokinetics of Kaletra™ (HIV protease
      inhibitors lopinavir and ritonavir) in different body compartments and to assess the role of
      four different drug transporters (MDR, MRP1, MRP2 and BCRP) in the tissue distribution of the
      two protease inhibitors. The latter will be studied by comparing intracellular concentrations
      of peripheral blood mononuclear cells (PBMCs) with total and free plasma concentrations in
      healthy individuals. These effects will be studied after single dose (day 1), during steady
      state (day 3), and during chronic treatment (day 14).
    

Detailed description: 
      Objective:

      Measurement of AUC, Cmax, tmax, t1/2 and clearance (Cl) of the protease inhibitor Kaletra™
      (lopinavir and ritonavir) each in the plasma of healthy individuals

        -  establish free and total plasma - blood cell concentration-relationship

        -  establish free and total plasma - saliva concentration-relationship

        -  establish blood cell concentration - drug transporter expression-relationship
    

Time perspective: Prospective
Keywords: ritonavir; lopinavir; HIV Infections
Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objectives:

      To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of
      age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.

      Secondary objectives:

      •Secondary immunogenicity objectives: To describe the immune responses 28 days after
      concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age
      and older To describe the immune response of VAXIGRIP according to European Medicines Agency
      criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)

      •Secondary safety objective: To describe the safety profile after vaccination in each group
    


Intervention name(s): Concomitant administration; Separate administration
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm); 1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis (acellular, component); Diphteria; Biological / vaccine
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Condition: Binge-Eating Disorder; Obesity
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will test the effectiveness and relative efficacy of naltrexone/bupropion
      medication as a maintenance therapy for the treatment of binge eating disorder (BED) in
      patients with obesity. This is a controlled test of whether, amongst responders to acute
      treatments, naltrexone/bupropion medication results in superior maintenance and longer-term
      outcomes compared with placebo.
    

Detailed description: 
      Binge eating disorder (BED), the most prevalent formal eating disorder, is associated
      strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with
      obesity and BED are needed that can produce sustained clinical outcomes and promote weight
      loss. This study (maintenance stage) RCT will provide new and novel findings from a
      controlled test, amongst responders to acute treatments, whether NB medication results in
      superior maintenance and longer-term outcomes than placebo. This is the first controlled test
      of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any
      medication with follow-up after medication discontinuation.
    

Intervention name(s): NB medication (Naltrexone Bupropion combination); Placebo
Intervention type(s): Drug; Other
Intervention description(s): NB medication; Placebo
Other intervention name(s): Contrave
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      To determine the effects of different intensities of Continuous Aerobic Exercises on Fatigue
      levels, Mental Well- Being & Mindfulness in Cardiac Rehab Phase 2.
    

Detailed description: 
      Physical activity has a strong association with health outcomes as it enhances physical and
      mental function by maximising cardio respiratory fitness and reduces the risk of multiple
      chronic diseases.

      Aerobic exercise is the type of physical activity that accelerates and maintain fitness, well
      being and quality of life of human being. Aerobic means in presence of oxygen and is based on
      the power generating process by the utilization of oxygen as a major fuel to cope up the
      energy demands during sustained physical activity. During Aerobic exercise lungs get more
      efficient by enhancing their breathing capacity which leads to the removal of carbon dioxide
      and maximal utilization of oxygen and improvement of its transport to lungs and muscles by
      circulating blood. Aerobic is the form of exercise which helps in oxygen transportation and
      absorption while enhancing the efficiency of cardiovascular system. Long term aerobic
      exercises significantly affect the structure of heart and improve stroke volume of heart.

      Fatigue is a feeling of tiredness and leads towards the inability of muscles to perform
      physically. It is mostly complained during cardiovascular disease and affects the functioning
      and quality of life in cardiac patients.

      Mental well-being is an important constituent of health. Good mental health proves to be
      beneficial for patients' recovery and independency in activities of daily living. Chronic
      diseases have a very strong association with mental disorder.

      Mindfulness is the ability to be fully alert and mental presence in the moment. Physical
      training boosts the mindfulness by enhancing the functioning of anterior cingulate cortex
      that has been linked to the improvement of self-regulation and attention. Aerobic exercises
      can improve the mood mindfulness.
    

Intervention name(s): Continuous Aerobic Moderate Intensity Exercise; Continuous Aerobic (Mild intensity Exercise)
Intervention type(s): Other; Other
Intervention description(s): Continuous Aerobic Moderate Intensity Exercise
5-10 min warm up
30 min moderate aerobic exercise (Treadmill walking exercise)
Constant intensity at 50% - 70% of max HR (3-6 METS)
5-10 min cool down; Continuous Aerobic (Mild intensity Exercise)
5-10 min warm up
30 min mild aerobic exercise (Treadmill walking exercise)
Constant intensity at 30-50 % of max HR (1-3 METS)
5-10 min cool down
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals
Condition: Prediabetic State; Diabetes Mellitus, Type 2; Cardiorespiratory Fitness; Inflammation; Exercise Test
MeSH terms: Diabetes Mellitus, Type 2; Prediabetic State; Inflammation
Study type: Observational

Summary: 
      The aim of this study to investigate and compare cardiorespiratory fitness (CRF) parameters
      of prediabetic, type 2 diabetic and healthy individuals. CRF assessed with cardiopulmonary
      exercise test (CPET) which is gold standard measure of CRF. Pulmonary functions,
      inflammation, disease specific parameters such as HbA1c, fasting plasma glucose etc affect
      CRF in prediabetic and type 2 diabetics.All parameters examine in this study.
    

Detailed description: 
      This study will be participated with Type 2 diabetic,prediabetic and healthy patients.
      Patients' laboratory values, pulmonary function test, respiratory muscle strength, exercise
      capacity, physical activity level, quality of life, cardiorespiratory fitness levels will
      assess and record. Pulmonary function test will be assesed with CPET system, respiratory
      muscle strength will be evaluated with mouth pressure. Exercise capacity will be evaluated
      using six minute walking test, incremental shuttle walk test. And cardiorespiratory fitness
      will assess CPET system. Physical activity level will be evaluated trial accelerometer and
      International Physical Activity Questionnaire.
    

Intervention name(s): Cardiorespiratory Fitness
Intervention type(s): Diagnostic Test
Intervention description(s): Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.
Other intervention name(s): Exercise capacity; Pulmonary function
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Type 2 diabetic patients -> Type 2 diabetes diagnosed population, Prediabetic -> According
        to ADA criteria persons in prediabetic condition Healthy
      
Keywords: prediabetes; type 2 diabetes; cardiorespiratory fitness; pulmonary functions; functional capacity; exercise capacity
Nutritional Intervention With Moderately High-protein, Low-glycemic Load Products in Type-2 Diabetes Patients
Condition: Type-2 Diabetes; Overweight
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate the effects on anthropometric, glucose
      metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index
      products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2
      diabetes patients following a chronologically scheduled pattern.
    

Detailed description: 
      Type 2 diabetes prevalence in adults has grown in the last years in many societies,
      accompanying the high incidence of obesity-related and other cardiovascular risk factors.
      Indeed, obesity is the most relevant overnutrition disease worldwide, being more dramatic
      than a self-esteem problem or an aesthetic issue, since it is associated to different
      metabolic disorders such as coronary diseases, hypertension, certain tumors, dislipidemia,
      biliary disorders, immunodeficiencies and insulin resistance. Different studies have shown
      the efficacy of low-fat diets on weight reduction, which has been associated to an
      improvement in overweight-related chronic pathological conditions. Additionally, a moderate
      increase of protein content (up to 30% of total caloric intake) in the diet and the inclusion
      of low-glycemic index products have been shown as a good tool for weight loss and
      maintenance. Recent studies have also shown the benefits of partial nutritional
      interventions, mainly on modifying breakfast intake, on anthropometrical and cardiovascular
      risk factors in overweight patients.

      The study has been designed as a longitudinal nutritional intervention with two consecutive
      4-week periods: from week 0 to 4, volunteers will follow their habitual diet. The second
      period (week 4 to 8), the volunteers' habitual breakfast, mid-morning and afternoon snacks
      will be substituted by 40-30-30 products, without changing any other parameter of their
      habitual diet or lifestyle.
    

Intervention name(s): Chronologically scheduled snacking with 40-30-30 products
Intervention type(s): Other
Intervention description(s): Short-term analysis of the effects of the substitution of the habitual breakfast, mid-morning and afternoon snack of type-2 diabetes patients by 40-30-30 products. Longitudinal 2-period study
Other intervention name(s): Enervit, Zone diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: chrononutrition; moderately high protein; glycemic index; type-2 diabetes; overweight; obesity; weight management
Effect of HABIT-ILE on Visuo-spatial Attention of Children With Unilateral CP
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study aims to investigate the changes induced by HABIT-ILE in impairments, activity and
      participation of children with unilateral CP, as well as neuroplastic changes induced by the
      treatment. Visuospatial deficits will be investigated and the effect of prismatic adaptation
      will be measured.
    

Detailed description: 
      This study aims to investigate the changes induced by HABIT-ILE at the 3 levels of the
      international classification of functioning and health (ICF) in children with unilateral CP,
      as well as neuroplastic changes induced by the treatment. Visuospatial deficits will be
      investigated and the effect of prismatic adaptation will be measured.
    

Intervention name(s): HABIT-ILE with prismatic adaptation; HABIT-ILE without prismatic adaptation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation; Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: motor skill learning, visuo-spatial attention
Effect of Tolvaptan on Cognitive Function in Cirrhosis
Condition: Cirrhosis; Hepatic Encephalopathy; Hyponatremia
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Hyponatremia; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality
      of life in cirrhotic patients with hyponatremia
    

Detailed description: 
      Baseline assessment will include a

        1. battery of eight cognitive tests

        2. Health related quality of life

        3. MRI head evaluating MR spectroscopy and diffusion tensor imaging

      Patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be
      repeated. During the first 3 days of tolvaptan administration, patients will be admitted and
      serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed.

      Between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in
      between.

      Participation will be terminated in case patients get transplanted or develop overt HE in
      between.
    

Intervention name(s): Tolvaptan
Intervention type(s): Drug
Intervention description(s): 15 to 30mg qd titrated to sodium concentration
Other intervention name(s): Samsca
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhosis; Hepatic Encephalopathy; Hyponatremia; Brain MRI; Health-related quality of life; cognitive function
Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment
      in elderly patients with advanced NSCLC.
    

Detailed description: 
      Docetaxel and vinorelbine are well known active agents in the treatment of NSCLC. The
      standard treatment of elderly patients with advanced NSCLC is monotherapy with a third
      generation agent. The role of comprehensive geriatric assessment in treatment efficacy and
      tolerance is an area of investigation.
    

Intervention name(s): Docetaxel; Vinorelbine
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles; Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Other intervention name(s): Taxotere; Navelbine
Intervention MeSH terms: Docetaxel; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Elderly; Chemotherapy; Docetaxel; Vinorelbine