cyrilzakka/clinical-trials huggingface dataset:
Multicentric Evaluation of Two Telematics Systems in Type 2 Diabetic Patients in Failure of Oral Treatment and Having to Start Treatment by Basal Insulin

TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.

Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.

Secondary objectives :

1. - To compare the 2 methods of telemonitoring employed.
2. - To evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed.
3. - To evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (DQOL).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes since more than 3 years and claiming a strict balance glycemic;
* Patients treated since at least 3 months, by metformin and secreting insulinic (KNOWN or glinide);
* Patients uncontrolled with HbA1c ≥ 7.5% and \< 10% at the inclusion.
* BMI \< 40 ;
* Patients requiring a insulin treatment
* Patients agree to start a slow insulin treatment
* Patients already practising the glycemic self-monitoring or agree to learn it and practise it;
* Patients able to include/understand operation and to use the PDA-phone and/or the SVI;
* Patient not taking part in another biomedical research study
* Patients agree to carry out at least 2 finger sticks per day;
* More than 18 years, there is no higher age limit.

Exclusion Criteria:

* Patients introducing any evolutionary pathology associated and not stabilized, exhibitor with an uncontrolled diabetes during the year to come;
* Patients in a situation which justifies of a clinical follow-up diabetologic more frequent than that (quarterly) envisaged by the study
* Patients requiring a transitory passage to insulin;
* Patients needing a hospitalization for the adaptation of insulin doses;
* Patients presenting a cardiologic event
* Patients presenting a hemoglobinopathy interfering with the proportioning of HbA1c;
* Patients suffering from drug-addiction, alcoholism or psychological troubles
* Type 1 or secondary diabetes
* Patients who don't need strict metabolic objectives;
* Pregnant or parturient patients
* person with no freedom.
Prevalence of Anterior Open Bite in a Group of Egyptian Children Aged Eight Years and Above

This study aims to determine the prevalence of anterior open bite and its etiological factors in a group of Egyptian children aged 8 years and above. patients who met the eligibility criteria will be given a questionnaire to fill followed by obtaining casts stabilized into occlusion to obtain the vertical and horizontal relationships.


Eligibility Criteria:
Inclusion Criteria:

* Medically free children aged 8 years and above, both genders and cooperative parents and children

Exclusion Criteria:

* Presence of orthodontic appliance and parents refuse to participate
An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA

The immediate goal of the proposed research is to test the value of a new low-cost, low-dose standing CT system for efficient early detection of both joint degeneration and elevated contact stress. The standing CT scanner holds promise for detecting arthritic changes earlier than other imaging modalities because of the combination of its 3D nature and ability to image joints in a weight-bearing pose. A secondary goal of the proposed research is to enable predictive models for osteoarthritis risk based on measures of post treatment contact stress, both to inform treatment and so that new interventions can be tested in a manner incorporating risk stratification.

Individuals who present with an intra-articular of the tibial plafond will be consented to participate in this study. We will obtain pedCAT scans at 6, 12, and 18 months post-injury, as well as several questionnaires that will be administered during the clinical visits. We will also review the subjects' electronic medical record for data related to the injury, including the timing and mechanism of injury, time from injury to surgery, length of hospital stay, any complications and/or subsequent ankle surgeries, as well as any clinic notes, imaging, and/or outcomes scores related to the calcaneus fracture.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 to 70 years old Sustained an intra-articular fracture of the tibial plafond Indicated for operative treatment Present for treatment within 4 weeks of injury

Exclusion Criteria:

* Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70
The Effects of Cricket- and Beef-derived Protein on Plasma Amino Acid Concentrations and Appetite Responses

Dietary protein plays an important role in appetite regulation. Source of ingested dietary protein may have different effects on appetite, satiety, and/or food intake in humans. Insects are a rich source of protein consumed by many people around the world; however, the capacity of insect-derived protein to regulate appetite and food intake is unclear. The purpose of this study was to compare postprandial plasma glucose, insulin, amino acid, and appetite regulatory hormone concentrations, subjective appetite sensations, and food intake following the ingestion of 25 g of cricket- and beef-derived protein in healthy young males.

With the rapid increase in the global population, the production of sufficient amounts of conventional animal-based protein to meet global dietary demands may no longer be desired nor feasible. Insects may represent an environmentally sustainable additional source of dietary protein that has the potential to help ensure global food security in the future. However, the functional characteristics of insect-derived proteins when fed to humans is unclear. Further, how insect-derived proteins compare to other animal-derived proteins (e.g. from beef) have not been explored.

The purpose of this study was to compare postprandial plasma glucose, insulin, and amino acid concentrations, gut-derived appetite regulatory hormones, subjective appetite sensations, and ad libitum energy intake following the ingestion of 25 g insect- or beef-derived protein in healthy young men. It was hypothesized that hyperaminoacidaemia would be more rapid following the ingestion of beef-derived protein compared to cricket-derived protein, although total amino acid availability would be similar between protein sources over a 300-minute postprandial period. It was further hypothesized there would be no difference between protein sources on postprandial subjective appetite sensations or subsequent ad libitum energy intake.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged between 18-35 years inclusive
* Healthy, moderately active
* BMI \< 30 kg/m2 and \> 18.5 kg/m2
* Having given informed consent

Exclusion Criteria:

* Presence of any identified metabolic or intestinal disorders
* Use of tobacco products
* Adherence to a strict vegetarian or vegan diet
* Use of medications known to affect protein metabolism
* Allergy to shellfish or crustaceans
* Allergy to beef protein
* Engagement in physical exercise training more than 6 days per week
Pulmonary Disease in a Psychiatric Inpatient Population

Purpose: Patients with mental health disorders have a reduced life expectancy, compared to the general population. The shorter life expectancy is caused by natural and unnatural death. In general, patients with a mental disorder tend to have a more unhealthy lifestyle, than the general population, characterized by e.g. lack of exercise and smoking.

Hypothesis

Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients There is a higher prevalence of COPD in psychiatric inpatients compared to the general population Screening of patients with one respiratory symptom and a smoking history, has the same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking history

Method:

80 psychiatric inpatients will undergo spirometry with reversibility test and COPD Assessment Test (CATest). Furthermore, patient history regarding respiratory symptoms and smoking will be taken into account.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients in Psykiatrien Syd, Region Zealand, ward S1,S2,S3,S4,S5,S6
* Admission time over 48 hours

Exclusion Criteria:

* Patients who is not able to perform spirometry due to their psychiatric condition
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated.
* Both eyes with diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* History of trauma, infection, clinically significant inflammation within the 3 previous months.
* Uncontrolled diabetic patient.
* Pregnancy or breast feeding.
The Utility of Regional Bioimpedance in Chronically Ventilated Patients

Chronically ventilated patients will be hemodynamically measured by bioimpedance (NiCAS by NI medical ltd.) for cardiac output, Total peripheral resistance and other NICAS derived parameters.

Patients fluid balance will be planned according to these parameters and the rate of liberation from ventilator and rate of worsening renal function will be measured

Patients will be divided into two groups , the study group and the control group randomly assigned by a computer program .

After obtaining written informed consent , cardiac monitoring will be carried out by means of a NiCAS patients in both groups.The physician will not be exposed to the measurement data of the patients in the control group. For the research group : Monitoring will be carried out once a day , preferably at the same time the first three days . An increase in time interval is possible in accordance with an improvement in the patient . Patients will be treated according to the protocol described in Figure 1. Also , a graphic description of the various treatment zones and the exclusion zone is presented in Figure 2 .

For the control group patients will be treated according to the usual ward protocols.

The basic rules are:

Avoiding over- drying by using parameter TBW .

* Avoidance of renal dysfunction by maintaining the cardiac output above 2.3 , and avoiding the use of beta-blocker overdose in cases of low cardiac output and bradycardia as a result of maintaining an average blood pressure over 70 .
* In cases of high peripheral resistance - Reduction of resistance while maintaining normal blood pressure .

Eligibility Criteria:
Inclusion Criteria:

* All chronically ventilated patients (ventilated for more than 14 days)
* Age between 18-90

Exclusion Criteria:

* Non ventilated patient
* Total body water \>80%
Continuous Noninvasive Method for Estimating and Predicting Maternal and Fetal Hemodynamic Changes During Regional Anesthesia

Machine learning techniques and algorithms originally developed for use in the field of robotics can be applied to continuous, noninvasive physiological waveform data to discover hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) predict cardiovascular collapse well ahead of any clinically significant changes in standard vital signs, 2) monitor and estimate fluid resuscitation needs, 3) estimate acute blood loss volume, and 4) estimate intracranial pressure. The investigators hypothesize that these same methods can be used to predict functional hypovolemia during regional anesthesia for labor or fetal intervention.

Specific aims:

1. Collect noninvasive physiological waveform data from patients undergoing regional anesthesia for labor or fetal intervention at the University of Colorado Hospital and Children's Hospital Colorado.
2. Combine the physiological data from patient monitors with clinical and demographic data, including maternal problem list, medications, volume infused, use of vasopressors, arterial and venous pressures, fetal heart rate, fetal umbilical artery Doppler velocimetry, maternal uterine artery Doppler waveform, fetal and neonatal outcomes etc. for use in developing mathematical model for early detection of maternal functional hypovolemia.
3. Develop robust, real-time, computational models for:

   * estimating maternal volume status prior to administration of epidural anesthesia
   * estimating effective intravascular volume loss during maternal regional anesthesia
   * predicting an optimal, individual specific requirement for IV resuscitation and/or need for vasopressor agents while providing adequate analgesia using regional techniques and optimizing the fetal outcomes
   * identifying mothers susceptible to epidural induced hypotension

Eligibility Criteria:
Inclusion Criteria:

* 1. Age: 14 - 44 years
* 2. Pregnant
* 3. Undergoing regional anesthesia for labor or fetal intervention at the University of Colorado Hospital and Children's Hospital Colorado

Exclusion Criteria:

* 1. Severe pre-eclampsia/eclampsia
* 2. Pre-procedural maternal hypertension requiring treatment
* 3. Significant fetal heart rate abnormalities prior to regional anesthesia
* 4. Incarcerated
* 5. Decisionally challenged
* 6. Limited access to or compromised monitoring sites for non-invasive finger and ear or forehead sensors
Improving Participation of Autistic Children and Adolescents in the Habilitation Process

This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre.

The increasing number of children diagnosed with autism spectrum disorder (ASD) presents significant challenges for healthcare providers. Research emphasizes the importance of involving children in their healthcare decisions. However, due to the complex nature of ASD, characterized by differences in communication and social interaction, healthcare professionals struggle to adapt their services for these children.

To address this issue, the present study compares two assessment methods for children with ASD: one based on surveys and another based on meetings with healthcare professionals. In addition, supplementary information from the children's parents or guardians and healthcare providers will be gathered .

Data collection methods will include questionnaires, interviews, and analysis of individual habilitation plans. The goal is to recruit 120 children aged 7-17 diagnosed with ASD but without intellectual disabilities, with half undergoing the survey-based assessment and the other half undergoing the meeting-based assessment.

Eligibility Criteria:
Inclusion Criteria:

* autism spectrum disorder

Exclusion Criteria:

* intellectual disability
Profiling the Dynamic of Binge Eating Disorder (PRODY-BED)

The goal of this observational study is to explore if different and specific profiles can be identified in adults with binge eating disorder (BED) depending on their additional eating pathology, emotion regulation and executive functions. The main questions it aims to answer are:

* Is there different and specific subgroups of patients with BED according to baseline profiles in emotion regulation, executive function and additional eating pathology (including restriction, chaotic eating, grazing and eating on external cues)?
* Are subgroups of individuals with BED (based on identified profiles) associated with outcome at end of treatment and follow-up?
* What is the trajectories in remission rates of specific symptom dimensions (eating disorder pathology, emotion regulation, executive function, and depressive symptoms) in individuals with BED and is there specific trajectory profiles in these dimensions?
* Is early changes in specific symptom dimensions (eating pathology, emotion regulation, executive function, or depression) associated with outcome of BED? Participants will be asked to fill in questionnaires before treatment as usual, 10 weeks into treatment, at end of treatment and at 6- and 12-month follow-up.

Binge eating disorder (BED) is a severe eating disorder characterized by recurrent episodes of binge eating, where control over eating is lost and huge amounts of food are eaten within a short period of time. Hence, weight issues are often inevitable and overweight is common, as are social, mental as well as physical problems.

The etiology of binge eating disorder is an interplay of neurobiological and environmental factors. Overall pathological eating, including grazing, external, emotional or restrictive eating, is associated with binge eating, and so is dysregulation in the reward center, impairment of executive functions and emotion regulation. The investigators suggest that it is possible to identify specific profiles driving binge eating, depending on the severity of these dimensions, and that these profiles might predict the outcome of treatment. The investigators also suggest that early change in general eating pattern, emotion regulation, and depressive symptoms is associated with binge eating outcome. These assumptions will be tested in a sample of adults in treatment for BED at one of three sites using questionnaires before, during and after treatment, incl. 6- and 12-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+,
* diagnosed with Binge eating Disorder,
* and offered treatment at on of the inclusion sites.

Exclusion Criteria:

* Severe psychiatric comorbidity (e.g. psychosis, severe developmental disorder, severe cogntive impairement)
A Randomized Trial of NSAID Dosing Strategies

This study will compare the efficacy of two different non-steroidal anti-inflammatory drugs (NSAIDs) ketorolac and ibuprofen for people with acute moderate or severe musculoskeletal pain. The investigators will also determine whether taking acetaminophen prior to the NSAID impacts efficacy


Eligibility Criteria:
Inclusion Criteria:

* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion Criteria:

* Contraindication to NSAIDs (allergy to NSAID or allergy to aspirin without history of tolerating NSAIDs, history of gastrointestinal bleeding, daily medication for gastritis or PUD, chronic kidney disease 2-5, heart failure)
* Contraindication to acetaminophen (hepatitis or cirrhosis)
* Use of an NSAID within the previous eight hours
* Use of acetaminophen within the previous eight hours
* Chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain
* Recurrent pain in the same body part as the presenting complaint
Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta

The purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. WThe present study will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic DI or AI treated in seven national competence or reference centers in rare oral diseases.


Eligibility Criteria:
Inclusion Criteria:

* be between 10 and 18 years of age,
* consult for a care or follow-up consultation
* having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta
* having access to a cell phone and/or tablet and/or personal or family computer
* covered by the social security of one of his parents
* understand French and one of whose parents (or legal representative) understands French
* have declared his or her non-opposition and one of whose parents (or legal representative) has declared his or her non-opposition to participate in the study.

Exclusion Criteria:

* Child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read
Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities

The purpose of this study is to prove a reduction of postoperative wound infections after direct preoperative use of a microbial sealant in the form of Integuseal for vascular procedures on lower extremities.


Eligibility Criteria:
Inclusion Criteria:

* planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft

Exclusion Criteria:

* secondary procedures and suprainguinal procedures
Oral Colostrum and Its Effect on Immune System

The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo

Prematurity is a public health problem because premature newborns have an immature immune system. Breast milk (colostrum) contains bioactive components that provide antimicrobial, anti-inflammatory, antioxidant, and immunomodulatory functions. These bioactive components are in higher concentrations in mothers' colostrum of premature babies. Because of the morbidities presented by premature infants, they remain fasting and lack the potential benefit provided by colostrum. When the colostrum is placed in the oropharyngeal mucosa, the immunocompetent cells stimulate the immune system, increasing the serum concentrations of immunoglobulins.

Objectives: To determine the efficacy of early administration of colostrum in the oropharyngeal mucosa in preterm infants less than 32 weeks of gestation and its effect on the immune system by quantifying immunoglobulins in preterm infants born at the National Institute of Perinatology. .

Methods / Design: 1 year, double blind randomized controlled clinical trial. The newborns included will be randomly assigned to one of the 2 groups: Group 1:, newborns receiving colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.

Newborns from Block B will receive orally sterile water (placebo) 0.3 mL following the same protocol. Serum immunoglobulin A, M and G concentrations will be determined before the start of the study on day 0 of life and after 7 and 28 days of life. They will continue in time until 36 SDG or at discharge, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* NEWBORN 32 Gestational weeks
* Hospitalized in neonatal intensive care Unit
* Agreement signed by the legal representative

Exclusion Criteria:

* Intraventricular haemorrhage II/IV grade
* Congenital sepsis (early sepsis)
* Congenital malformations
* Early transfusions