bioihbjkbjnl/mcl2 huggingface dataset:
TMS Modulation of Insula-related Brain Networks
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the modulatory effects of repetitive transcranial
      magnetic stimulation (rTMS) on functional connectivity with the insula. Functional
      connectivity (FC) measures the interaction between brain regions, and recent neuroimaging
      studies have used FC to investigate how addiction affects FC among pertinent brain regions.
      rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain
      connectivity and could be used therapeutically to treat addiction. However, investigators
      first need more information on brain FC and how it relates to behavior, in order to guide
      rTMS target selection.
    


Intervention name(s): repeated transcranial magnetic stimulation
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Measure of Cerebrovascular Dysfunction After TBI With fNIRS
Condition: Traumatic Brain Injury; Post-concussion Syndrome
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome
Study type: Observational

Summary: 
      The goal of this project is to determine if it is possible to assess Cerebrovascular
      Reactivity (CVR) to hypercapnia with functional Near Infrared Spectroscopy (fNIRS). Such a
      method would be particularly helpful in traumatic brain injury (TBI), where objective
      measures are needed, and would greatly expand the capacity to make such assessments in
      standard clinical practice.
    

Detailed description: 
      The prospective study design will consist of two study groups; the experimental group and the
      control group. In the Experimental Group (Group 1) we will enroll adult participants with TBI
      with persistent post-concussion symptoms or abnormalities on neuropsychological testing. In
      Group 2 we will enroll adult participants to serve as age and gender-matched healthy
      controls. Our goal is to recruit 100 subjects total in two groups of age and gender matched
      subjects, as follows: TBI (n = 50) and non-TBI (n = 50).

      Participants in both groups will undergo NIRS testing with hypercapnia challenge, to measure
      the increase in hemodynamic flow signal during hypercapnia challenge via 2 methods, the
      breath holding and the Douglas bag methods. We will test intersessional validity of the
      NIRS-hypercapnia challenge in the first 20 (10 TBI and 10 non-TBI) subjects who are willing
      to return for a second visit of repeat testing.

      The NIRS system is composed of 4 light sources and 10 detectors with a 16 point configuration
      system applied on the forehead of the subject. In our experiment, light intensity collected
      at each detector will be transformed into a signal related to the local concentrations of
      oxy- and de-oxyhemoglobin during the challenge. Each experiment will give a set of subject
      data, consisting of the peak amplitude and time-to-peak of the hemodynamic signals measured.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Males and females (military health care beneficiaries and non military health care
        beneficiaries) between 18 and 60 years who have a diagnosis of TBI and are symptomatic with
        DSM-IV Research Criteria for Post-Concussional Disorder (see below), gender matched non-TBI
        volunteers.
      
Keywords: TBI; fNIRS; hypercapnea; Cerebrovascular reactivity
Achieving Blood Pressure Control Through Enhanced Discharge
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The primary aim of the study is to determine if enhanced discharge from the emergency
      department will improve blood pressure control and self-care management. Enhanced discharge
      will include a hypertension intervention delivered by a touch-screen kiosk over a three month
      period.
    

Detailed description: 
      A targeted sample of patients with uncontrolled blood pressure at the time of their emergency
      department visit discharge will be randomized into either standard or enhanced discharge. To
      control for medication effects in achieving blood pressure control, both groups will receive
      similar blood pressure medication while actively participating in the study.
    

Intervention name(s): Patient education
Intervention type(s): Behavioral
Intervention description(s): Patient education on hypertension delivered through a touchscreen kiosk.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Patient education; Hypertension; Patient activation
Follistatin Levels in Metabolically Healthy and Unhealthy Obese Individuals
Condition: Obesity
Study type: Observational

Summary: 
      There is no clear boundary on which obese individuals should be considered metabolically
      healthy and which should be considered metabolically unhealthy. It is also not very clear
      whether the individuals who are considered metabolically healthy will remain healthy in the
      future. The objective of this study was to assess potential disparities in serum follistatin
      levels between these two distinct groups. Furthermore, the study sought to investigate
      whether this disparity could serve as a reliable indicator for distinguishing between
      metabolically healthy and unhealthy obese individuals.
    

Detailed description: 
      Individuals with similar body mass indexes may have different metabolic health and
      cardiovascular risks. Research shows that some individuals with comparable body mass index
      (BMI) are metabolically healthy and have a lower risk of cardiovascular issues, while others
      are metabolically unhealthy and have a higher risk. Studies indicate that the lifestyles of
      metabolically healthy and unhealthy obese individuals, such as diet, physical activity, and
      sleep patterns, do not differ significantly, even though the individuals have similar levels
      of total or subcutaneous adiposity. However, it has been shown that metabolically healthy
      obese individuals tend to have lower levels of visceral adiposity compared to unhealthy ones.

      Patients with BMI≥30, who applied to the internal medicine clinic, were included in the
      study. Among these patients, those without criteria of metabolic syndrome other than an
      increase in waist circumference (blood pressure ≥130/85 mmHg, fasting blood sugar ≥100 mg/dl,
      triglycerides ≥150 mg/dl, HDL-cholesterol <40 mg/dl in men and <50 mg/dl in women) and
      without prediabetes were defined as metabolically healthy obese individuals. Those with at
      least 1 metabolic syndrome criterion other than an increase in waist circumference were
      classified as metabolically unhealthy obese individuals. The participants' fasting blood
      sugar levels, HbA1c levels, insulin levels, lipid panel results, liver enzymes levels,urea
      levels, creatinine levels, whole blood count, and thyroid hormones were examined.
      Anthropometric measurements including height,weight and waist circumference were also taken
      for each individual.

      Participants were then invited back to repeat follistatin levels.
    

Intervention name(s): Serum follistatin levels
Intervention type(s): Diagnostic Test
Intervention description(s): blood samples are taken
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals between 18-60 years old, with a BMI of ≥ 30, who are not using any medication
        or have any disease that may effect their glycemia, lipid profiles or blood pressure.
      
Biospecimen description: 
      blood samples for follistatin
Comparing Land-based and Aquatic Reduced Exertion High Intensity Interval Training in Sedentary Young Adults
Condition: Physical Performance
Study type: Interventional

Summary: 
      Previous research has found improvements in performance (VO2max) and clinical (insulin
      resistance) with cycling REHIIT. In some populations (e.g. obese, arthritic) aquatic exercise
      is a safer, more enjoyable option. However, to date, no study has yet examined whether
      aquatic REHIIT confers the same benefits as land-based REHIIT. Therefore, the purpose of this
      study is to determine whether there are significant differences in clinical and performance
      outcomes between a land-based and comparable aquatics based Reduced Exertion High Intensity
      Interval Training (REHIIT) protocol.
    


Intervention name(s): Aquatic Based Exercise; Land Based Exercise
Intervention type(s): Other; Other
Intervention description(s): 10 minutes of exercise with two 20 second sprints three days per week for 8 consecutive weeks; 10 minutes of exercise with two 20 second sprints three days per week for 8 consecutive weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Study of High-protein Nutritional Support Impact on Postoperative Outcomes in Patients With Primary Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      The study was aimed to evaluate the impact of perioperative nutritional support with
      high-protein mixtures on the risk of postoperative complications, postoperative recovery of
      respiratory functions in patients with lung cancer, nutritional status and quality of life of
      patients. Possible adverse events were also studied and described.
    

Detailed description: 
      The study enrolled 114 patients with primary non-small cell lung cancer and nutritional
      deficiencies or at risk of developing them, admitted for surgical treatment and meeting other
      inclusion/exclusion criteria. Patients were randomly divided into two groups: the study group
      of 57 people and the control group of 57 people.

      Patients in the study group, in addition to the usual diet, received nutritional support.
      During the hospital stay, additional nutritional support was added to the patient's standard
      hospital diet. On an outpatient basis, patients received the required amount at their
      disposal and will take it as a supplement to his usual and habitual diet.

      Patients in the control group followed the standard hospital diet, and at discharge - the
      usual habitual diet.

      The study was conducted using Enrollme.ru electronic platform. In total, the study comprised
      screening and 5 visits.
    

Intervention name(s): Nutridrink Compact Protein
Intervention type(s): Dietary Supplement
Intervention description(s): Oral Nutritional Supplement, a liquid, ready-to-drink, high protein, high calorie blend. Intended for adult patients (from 18 years of age) with malnutrition or risk of its development. Produced by Nutricia
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary lung cancer patients were enrolled in the study with or at risk of nutritional
        malnutrition admitted for surgery and meeting the inclusion/non-inclusion
Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery
Condition: Digestive System Abnormalities
MeSH terms: Digestive System Abnormalities; Congenital Abnormalities
Study type: Observational

Summary: 
      The aim of this single center study is to measure the impact of standardized neonatal
      pediatric surgeries due to gastrointestinal malformations on the children's motor and
      cognitive development and psycho-emotional competence.

      To measure the neurodevelopment, the children will be tested with the Bayley Scales of Infant
      Development II Assessment.
    

Detailed description: 
      Objectives:

      The primary objective of this study is to compare differences in the score of Bayley Scales
      of Infant Development II Assessment (consisting of cognitive, verbal, nonverbal, motor
      development levels) between children with gastrointestinal malformations and early postnatal
      surgery at the age of 2 years and a control group.

      The secondary objective is to measure the growth of the patients compared to healthy children
      in the control group, to capture post-traumatic stress situations in families, and to capture
      the children's psycho-emotional competence.

      Study design:

      The study is designed as a cross-sectional single center study. The study patients are
      children of 2 years of age who underwent neonatal surgery in our clinic since June 2008 due
      to a gastrointestinal malformation.

      The control group consists of matched pairs concerning gestational age, weight and gender.

      The study consists of five parts:

        -  Introductory interview including the medical history

        -  Bayley Scales of Infant Development II Assessment

        -  Pediatric examination with anthropometry

        -  Questionnaire survey of post-traumatic stress situation

        -  Final conversation with the parents about the results

      The neurodevelopmental testing is performed by the child psychologist and the pediatric
      examination by the pediatrician.

      Study population:

      The study is purely exploratory and based on the number of patients born in our hospital with
      the malformations mentioned above (approximately 40).

      Each patient is compared against a healthy child of the same gestational age, weight class
      and gender (control group).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study is purely exploratory and based on the number of patients born in our hospital
        with the malformations mentioned above (approximately 40).

        Each patient is compared against a healthy child of the same gestational age, weight class
        and gender (control group).
      
Keywords: Congenital abnormalities; Digestive system abnormalities; Neonatal surgery; Neonatal anesthesia; Bayley Scales of Infant Development II
Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients
Condition: Diabetes
Study type: Interventional

Summary: 
      Food intake has a great influence on blood glucose of patients with diabetes. This study was
      designed to determine the glycemic index (GI) of a particular pomelo named Majia pomelo and
      its effects on postprandial glucose (PPG) excursions in both healthy subjects and patients
      with type 2 diabetes (T2DM).
    

Detailed description: 
      The purpose of this study was to evaluate the GI and effects on glucose excursion of Majia
      pomelo in both healthy and diabetic subjects. The results may help diabetic subjects and
      their health care providers in developing a diet that is both medically and culturally
      appropriate.
    

Intervention name(s): Pomelo; Glucose; Blank; Insulin; met or diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Drug; Drug
Intervention description(s): The sugar content of the pomelo was 5.86% of full weight, and we use 922g Majia pomelos which contained about 50g sugar equal to 50g glucose for GI measurement.; We dissolved 50 g of glucose in 200 ml water.; For the self-control period the diabetic patients underwent 3-day CSII treatment without change of insulin dose and we did not applied any intervention.; Patients who were included in the test of glycemic responses to postprandial pomelo consumption were hospitalized with the treatment of Continuous Subcutaneous Insulin Infusion(CSII), and the insulin for CSII was insulin aspart(NovoRapid).; In diabetic group, 20 diabetic patients were included for GI measurement , 18 of whom were on metformin treatment. Only 2 patients were on diet control due to the early stage of this disease.
Other intervention name(s): Majia pomelos; Citrus grandis cv. Majiayou; Anhydrous glucose; Insulin aspart; NovoRapid; metformin; diet control
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: glycemic index; glycemic response; diabetes; pomelo
Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
Condition: Diabetes Type 2; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This 5-week, double-blind, placebo-controlled, 2x2 crossover pilot study investigate the
      potential of collecting robust, real-time clinical study measures of glucose levels using
      Abbott Freestyle Libre Continuous Glucose Monitoring devices associated with a smartphone
      application
    

Detailed description: 
      The goal of this study is to characterize the performance of a Continuous Glucose Monitoring
      System in medical food studies. The Freestyle Libre Glucose Sensors will be used to follow
      subject's 8-day glucose trajectories over the course of a 5-week, double-blind,
      placebo-controlled, 2x2 crossover, medical-food experiment. The medical food has been
      designed to increase butyrate production and promote the health of the colonic mucin layer.
    

Intervention name(s): WB-011; Placebo; Continuous Glucose Monitor
Intervention type(s): Other; Other; Device
Intervention description(s): WB-011 medical food product.; Placebo Capsules identical to those containing WB-011.; Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial to Examine Individual Pain Tolerance in the Use of Two Anesthetic Techniques to Perform Saturation Prostate Biopsy
Condition: Prostatic Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effectiveness of two anesthetic techniques by measuring the pain through visual
      analog scale (VAS), to obtain saturation prostate biopsies.
    

Detailed description: 
      To assess the effectiveness of two anesthetic techniques by measuring the pain through visual
      analog scale (VAS), to obtain saturation prostate biopsies.

      Anesthetic technique (control) - Intravenous sedation with Midazolam, Fentanile and Ketamine.

      Anesthetic technique (intervention) - Regional Mepivacaine infiltration of periprostatic
      region.
    

Intervention name(s): MIDAZOLAM; MEPIVACAÍNE; FENTANILE; KETAMINE
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.; Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.; Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.; Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.
Other intervention name(s): MIDAZOLAM 15mg/3ml ATC N05CD08 MAN 65319; MEPIVACAINE 2% ATC N01BB03 MAN 62606; FENTANILE 0,05 mg/ml ATC N01AH01 MAN 41764; KETAMINE 50 mg/ml ATC N01AX03 Marketing Authorisation number 47034
Intervention MeSH terms: Midazolam; Ketamine; Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Biopsy; Local Anesthesia; Pain; Biopsy of prostate
A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Years Old, Inclusive
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of
      rabeprazole after single and multiple daily administration in children between the ages of 1
      and 11 years, inclusive, with GERD.
    

Detailed description: 
      This is an open-label (both the physician and the patient know the name of the study
      medication), multi-center, Phase 1 study, consisting of 2 parts. The first part of the study
      will be non-randomized, all patients will receive the same dose. In the second part of the
      study, patients will be randomized (study medication assigned by chance) into 2 dose groups.
      The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics (clinical
      global impressions and formulation palatability) and safety of rabrepazole after single and
      multiple daily administration at 2 dose levels in children between the ages of 1 and 11
      years, inclusive, with GERD. As this study is an exploratory assessment of the
      pharmacokinetics, pharmacodynamics and safety of rabeprazole in children, no formal
      hypothesis testing is applied. Safety and tolerability, including monitoring of adverse
      events, clinical laboratory results, physical examination, vital signs and ECG measurements,
      will be evaluated throughout the study. Patients will receive rabeprazole sodium as single
      daily oral doses for 5 successive days as a bead formulation. Patients in the first part of
      the study will receive single and multiple daily every 24 hours doses of 0.14 mg/kg, using
      increments of 1 mg dose. Safety and pk data from part 1 of the study will determine the 2
      dosages to be studied in part 2 of the study.
    

Intervention name(s): Rabeprazole sodium
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Pharmacokinetics; Pediatric Pharmacodynamics; Rabeprazole; Pediatric GERD; Aciphex