bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacokinetic Study to Evaluate the Dose-Proportionality of Tramadol (ULTRAM) Extended-Release (ER) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the dose proportionality of the pharmacokinetics
      (explores what the body does to the drug) of tramadol in healthy adult participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      randomized (study drug assigned by chance), and 3-way crossover (method used to switch
      participants from one study group to another in a clinical trial) study of tramadol
      extended-release (ER). All participants will be randomly assigned to 1 of 6 possible
      treatment sequences of tramadol. The study consists of 3 parts: Screening (within 20 days
      before study commences on Day -1); Open-label treatment (consisting of 3 single-dose
      treatment periods separated with washout period of 4-14 days, and dosing will be under
      fasting conditions on Day 1 in each treatment period); and Follow-up (up to 48-hour blood
      sample collection on Day 3 of Period 3). The duration of study is anticipated to be 6-8 weeks
      per participant. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Tramodol Extended-Release (ER)
Intervention type(s): Drug
Intervention description(s): Tramodol ER, will be administered orally as either 25, 50 or 100 milligram tablet, once daily on Day 1 of each treatment period (separated with washout period of 4-14 days).
Other intervention name(s): - Ultram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Tramodol; Ultram
The Care of Stroke in Ziekenhuis Oost-Limburg
Condition: Stroke
MeSH terms: Stroke
Study type: Observational [Patient Registry]

Summary: 
      A stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event.
      Previous, a stroke was treated only with anti-aggregation. Over time, multiple studies have
      showed a positive effect of intravenous thrombolysis with rt-PA (recombinant tissue
      plasminogen activator) in comparison with the standard treatment (anti-aggregation). Since
      2015, thrombectomy was proven to have an added value in combination with thrombolysis.
      Thrombectomy is an endovascular technique where the thrombus is removed or fragmented.

      Diagnosis and treatment of stroke will have a significant impact on the health-economic
      status of the patient. However, little data is known. Unfortunately, the outcome after
      diagnosis with a stroke is not well documented. Therefore, this follow-up study over a time
      period of one year, will give us a sufficient amount of data to evaluate patients diagnosed
      with a stroke in the hospital of Genk.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients (older than 18 years) diagnosed with stroke will be asked to parcipate. When
        the patient is not approachable for participation, the next of kin will be informed. An
        informed consent has to be obtained before study participation.
      
Keywords: thrombectomy; thrombolysis; Health-economic status; Outcome after stroke
An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients
Condition: Cardiac Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in
      patients after cardiac surgery who are mechanically ventilated leads to a significant
      decrease in the amount of fluid given to such patients in the first 24 hours after surgery
    

Detailed description: 
      1. The investigators will study patients after cardiac surgery

        2. The investigators will collect data on standard care in pre-intervention population

        3. The investigators will collect demographic and clinical data

        4. The investigators will collect biochemical data in the first 24 hours after surgery

        5. The investigators will collect biochemical, physiological and clinical outcome data

        6. The investigators will compare the standard care and intervention period data
    

Intervention name(s): IV fluid according to PPV; fluids according to standard care
Intervention type(s): Other; Other
Intervention description(s): intravenous fluids
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiac surgery; Pulse pressure variation; intravenous fluids
Interventional Touch Therapy in the Treatment of Children's Dental Clinics
Condition: Dental Fear; Nursing
Study type: Interventional

Summary: 
      This study mainly wants to discuss the anxiety and fear of children's dental visits. For
      preschool children, separation anxiety can be obvious at this time. The main research is 1.
      To explore the degree of fear of dental visits in preschool children;2. Children who are
      touched therapy, there differences in fear of children 's dental treatment? If parents or
      important others can provide touching care to increase children 's sense of safety, reduce
      children 's fear of dental visits, and improve the quality of dental care The main purpose of
      the study.
    

Detailed description: 
      In this study, a parallel randomized study design was adopted. The intervention of the
      experimental group was a "Touch Therapy " measure. The control group To provide dental health
      education in accordance with the routine procedures of children's dental visits, how to use
      toothbrushes, dental floss education, a total of 90 samples were collected. Children who meet
      the inclusion criteria of this study are randomly assigned to the experimental group and the
      control group. The main purpose is to provide "Touch Therapy " intervention measures, and the
      difference in fear of dental treatment for preschool children.

      Use the chip chip tool (PCT) to ask the children's degree of fear of dental treatment. The
      control group uses questionnaires to ask the caregiver's age, social and economic status,
      education, past dental experience, etc. In the intervention group, the questionnaire was used
      to ask the caregiver's age, socioeconomic status, education, past dental experience, etc.
      During the waiting process, first follow the touch flow chart and perform the touch in the
      waiting area for 10 minutes. When visiting the treatment chair, the companion will be asked
      to touch the child's unilateral hand for 5 minutes during the consultation process. A small
      chair is provided to accompany the child for a total of 15 minutes. The two groups will use
      the chip tool again after the consultation , Ask the children how scared they are after
      seeing a doctor, submit the collected data to a third party for analysis, and design a
      single-blind study.
    

Intervention name(s): Touch Therapy"
Intervention type(s): Other
Intervention description(s): During the waiting process, first follow the touch flow chart and perform the touch in the waiting area for 10 minutes. When visiting the treatment chair, the companion will be asked to touch the child's unilateral hand for 5 minutes during the consultation process. A small chair is provided to accompany the child for a total of 15 minutes. The two groups will use the chip tool again after the consultation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional research
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Touch therapy; Fear
SUMCO Metabolic Syndrome Project
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Physical activity is considered important in prevention and treatment of obesity and
      metabolic syndrome. Genotype of genes involved in metabolism is also known to be associated
      with the development of metabolic syndrome. However, scarce evidence exists regarding the
      influence of physical activity intensity and genotype on metabolic syndrome in people with
      obesity. The investigators examine physical activity using an uniaxial accelerometer, as well
      as aerobic fitness using an electric bicycle ergometer, several genotypes of genes related to
      glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal obesity who
      were employees in silicon wafer manufacture and participated in a health checkup.
    


Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): exercise class once a year
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Clinical Data Collection for the Closed Loop Development for the Type 2 Diabetes Treatment - DT2_1
Condition: Type 2 Diabetes Treated With Insulin
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this study is to collect the evolution of blood glucose levels in type 2
      diabetes (T2D) patients under different conditions of their daily life: physical activity,
      meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin
      delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
    

Detailed description: 
      T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D
      naturally progresses towards an increasingly pronounced insulin deficiency that leads to the
      need for pancreatic replacement, by administering insulin.

      Type 1 diabetes (T1D) requires a complete and immediate substitution of pancreatic insulin
      secretion. Currently, patients need to be involved in managing their disease by deciding how
      much insulin to administer based on the results of glucose monitoring. Artificial
      intelligence, thanks to a self-learning algorithm, enables the automation and customization
      of insulin administration. These devices, known as closed loops, bring real benefit to the
      patients included in the studies, by improving glycemic balance, by decreasing the number of
      hypo- and hyperglycemia but also by decreasing the mental load associated with the disease,
      improving their quality of life.

      These very significant benefits in the T1D treatment open the possibility of obtaining
      similar benefits in the T2D treated by the basal-bolus type insulin regimen. This study aims
      to develop a specific algorithm of T2D to meet its particular characteristics.

      The objective of this study is to collect the evolution of blood glucose levels in T2D
      patients under different conditions of their daily life: physical activity, meals, sleep,
      etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms
      to treat patients with insulin-resistant T2D using a closed loop.
    

Intervention name(s): Actimetry; Questionnaires; Glucose level and insulin administration
Intervention type(s): Device; Other; Other
Intervention description(s): Actimetry will be performed at home to measure physical activity, sleep duration and patient chronotype for 7 days.; Patients will complete food and medication intake questionnaires for 7 days.; Continuous subcutaneous glucose level (measured by continuous glucose monitor (CGM)) and the insulin doses delivered by the insulin pump will be collected for 7 days .
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Intervention model description: Actimetry is performed in all patients included.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type 2 diabetes; Insulin; Life conditions; Algorithm; Closed loop
Energy Expenditure & Activity During & After Exercise-Induced Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This project is aimed at determining whether an exercise-based weight loss intervention
      causes a compensation in some component of energy expenditure such that the increase in
      measured energy expenditure is less than the added exercise. The study will compare two
      separate exercise interventions to determine if this is influenced by exercise intensity.
    

Detailed description: 
      The primary aim of this proposed study is to determine how total daily activity thermogenesis
      (TDAT) and total daily energy expenditure (TDEE) are regulated in obese humans attempting to
      lose weight and maintain weight loss through exercise. Two exercise interventions will be
      compared; a structured aerobic exercise program and a walking program. exercise activity
      thermogenesis (EAT) will be verified, and non-exercise physical activity (NEAT), total daily
      activity thermogenesis (TDAT), and TDEE will be measured using state-of-the-art technologies.
      Subjects will be studied during a 6 month intervention period and then during a 6 month
      follow-up period. It is hypothesized that the walking program will have more favorable
      effects on TDAT and TDEE during both the intervention and follow-up periods. If the
      investigators hypotheses are correct, then data from the proposed study could be used to
      improve the effectiveness of exercise-based weight loss and weight loss maintenance programs.
    

Intervention name(s): Walking exercise
Intervention type(s): Behavioral
Intervention description(s): Subjects will be randomly assigned to either a structured, vigorous-intensity endurance exercise training program or an intermittent, low-intensity exercise program. Individualized exercise prescriptions will be designed to target an increase of 2500 kcal/wk, and the theoretical weight loss will be approximately 15 pounds (~6.8 kg) during the 6 month intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Alcohol and Cigarette Craving During Oxytocin Treatment
Condition: Alcohol Use Disorder; Smoking
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      This proposed research seeks to examine the behavioral and neural substrates of intranasal
      oxytocin compared to placebo on alcohol cue-induced alcohol and cigarette craving smokers
      with an alcohol use disorder (AUD). Non treatment-seeking smokers with an AUD will be
      recruited to participate in a between-subjects, placebo-controlled, randomized pilot
      functional magnetic resonance imaging (fMRI) study. Participants will undergo an fMRI scan in
      conjunction with an alcohol-olfactory cue-reactivity task. Secondary assessments will include
      alcohol and cigarette craving, alcohol and cigarette consumption, physiological measures
      (heart rate and blood pressure) and mood measures.
    


Intervention name(s): Oxytocin nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days; Participants administer the placebo (40 IU) twice a day for 5 - 7 days
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: oxytocin; craving; alcohol use disorder; smoking; cigarettes; drinking; functional magnetic resonance imaging; cue-reactivity
Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdrome Related to COVID-19
Condition: SARS-CoV Infection; Acute Respiratory Distress Syndrome; COVID-19; ARDS
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose,
      phase II study to evaluate the efficacy and safety of glenzocimab in ARDS.
    

Detailed description: 
      This randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose,
      phase II study evaluates the efficacy and safety of glenzocimab in ARDS.

      Patients will be screened for eligibility and all tests should have results prior to any
      randomization, so as to avoid screening failures to a maximum extent. The turn-around time
      for these tests should be comprised within 24hrs to allow for rapid inclusions if needed.
      Eligible patients (n=68) will be randomized in a 1:1 ratio to glenzocimab or placebo. Patient
      inclusions will be fractioned into sequential (3-day apart) cohorts of growing size (2, 4
      then 6 patients), each balanced between glenzocimab and placebo in order to check safety in a
      gradual manner. A Data Safety Monitoring Board (DSMB) will meet after 12 patients will have
      been accrued, and again after the first 30 patients.

      Glenzocimab will be administered by IV infusion. The dosing regimen will be 1000mg for 3
      days. All patients will receive in parallel the best medical care at the discretion of the
      investigating center, or per local guidelines. The allocation of each patient in any given
      center to an active treatment or placebo will strictly follow a central randomization scheme.
      The study period will be of a maximum of 40 days per patient. Patients will be closely
      monitored during the first 7 days following randomization with complete evaluations being
      performed at 24 hrs, 48 hrs, 72 hrs, then on Days 4 (96 hrs), 5 (120 hrs), 7 (+/-1 day), 14
      (+/-2 days), 20 (+/-2 days), 40 (+/-3 days). Should a patient being discharged before Day 40,
      distant consultations by telemedicine may be undertaken if it is not deemed desirable that
      the patient comes back to the institution.
    

Intervention name(s): glenzocimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV administration as a sterile product; IV administration
Other intervention name(s): ACT017
Intervention MeSH terms: Glenzocimab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double blind, multicenter, placebo-controlled, parallel group, fixed dose, phase II study. The study evaluates the efficacy and safety of glenzocimab.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Covid 19; ARDS; SARS-Cov; glenzocimab; Acute Respiratory Distress Syndrome; ACT017; glycoprotein VI; antiplatelet agent
Vitamin D, Steroids, and Asthma in African American Youth
Condition: Asthma; Allergy
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma has become considerably more prevalent and severe in the U.S. during the last 40
      years, particularly affecting youth in urban areas, yet the reasons for this are not clear.
      There is increasing evidence that vitamin D insufficiency contributes to more severe asthma
      through increased risk of respiratory infections and decreased sensitivity to
      glucocorticoids. Indeed, low vitamin D levels are linked with the need for exogenous
      glucocorticoids and increased asthma severity. Particularly relevant to health disparities,
      we showed a strong association between vitamin D insufficiency and asthma in urban African
      American (AA) youth. Importantly, AA youth in ours and other studies had lower vitamin D
      levels than non-AA participants.

      Because AA youth residing in urban Washington, DC have markedly worse asthma than other
      racial/ethnic groups (e.g. prevalence rate 20% higher than the national rate 15 and emergency
      department utilization rates up to 5 times the national rates and nearly 10 times the Healthy
      People 2010 target rate), we will utilize our access to this population at the extreme of
      asthma disparities to examine the contribution of vitamin D to disparities in the chronic
      control and acute severity of asthma. The overall goal of this study is to provide critical
      epidemiological/molecular information that will inform the interpretation of ongoing and
      impending randomized clinical trials of vitamin D supplementation in asthma, especially with
      regard to urban AA youth with asthma. We hypothesize that low serum 25-hydroxyvitamin D
      [25(OH)D] levels are associated with poor chronic asthma control, worse acute asthma
      severity, and glucocorticoid insensitivity. The knowledge generated by the experiments in
      this application will be crucial to translation of this inexpensive, easily-accessible, and
      thereby potentially disparity-reducing prospective therapy for asthma.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        AshMaP 2 subjects will be enrolled from all the sites in the Children's National Medical
        Center city-wide pediatric and adolescent health systems sites, including primary care
        offices (community and hospital-based), specialty clinics, Emergency Departments, and
        inpatient units.
      
Biospecimen description: 
      Blood, urine, tissue
    
Keywords: Obesity; Asthma; Vitamin D; Allergy; Genetic; Childhood; Pediatric; cohort; observational; prospective; molecular
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
Condition: Paraumbilical Hernia
MeSH terms: Hernia
Study type: Interventional

Summary: 
      It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with
      sublay mesh hernioplasty for paraumbilical hernia.
    


Intervention name(s): Onlay mesh Hernioplasty; Sublay Mesh Hernioplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath; Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment