cyrilzakka/clinical-trials huggingface dataset:
Quality of Life and Autonomy in Health of Overweight or Obese People Receiving Reinforced Support

This mixed-methods prospective cohort study aims to evaluate a recently implemented reinforced support program named "X-ailes program".

The X-Ailes program is a face-to-face or telephone-based support program by health-system navigators/case-managers, funded by the French Ministry of Health (program for empowerment of care users). X-Ales is developed by an patients and public association to support overweight or obese care users facing difficulty to access to care or resources regarding the management of their health situation.

The subjects of the present study are the overweight or obese care-users followed-up by the X-Ailes program.

The aim of the study Eval-X-ailes is to assess the effect of the support program X-Ailes on quality of life, autonomy and literacy of overweight or obese care users at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* People aged 18 or more, male or female
* Body mass index equal or over 25
* Resident Living in one of the 2 territories covered by the X-ailes program (Lyon Metropolitan Area or Puy-de-Dôme County)
* Starting Included in the X-ailes program support (1st phone contact to initiate follow-up)
* Not objecting to participating in the evaluation of the X-ailes program

Exclusion Criteria:

* refusal to participate
Tele-epic (Telemedicine for Epilepsy Care)

Epilepsy is a chronic condition that requires consistent follow-up aimed at seizure control, surveillance of comorbidities, monitoring of antiepileptic drugs (AED) levels and side effects. Patients may encounter difficulties to be assessed adequately and the disease burden is increased by the need for travelling across the country for medical consultations. Driving restrictions are a further limit to access specialized Centers able to provide an integrated approach focused on patient needs. Telemedicine (TM) offers an invaluable support to patient follow-up, joining the sparse distribution of patients in the country with the prompt availability of a team of experts. The project assesses, through a randomized controlled trial, the non-inferiority of TM in monitoring seizure control compared to usual (face-to-face) care. This approach, coupled with a new self home-sampling method for the measurement of AED levels, will reduce health care costs and simplify patients management.


Eligibility Criteria:
Inclusion Criteria:

* adult (age\>18 yrs) and pediatric (age\<18yrs) outpatients with established diagnosis of epilepsy.
Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner

The purpose of this study is to measure and compare the difference of sound speed between pancreatic cancer and non-pancreatic cancer, and determine the critical value of sound speed for benign and malignant pancreatic cancer. The sensitivity, specificity, accuracy, positive predictive value and negative predictive value for the diagnosis of pancreatic cancer are calculated, so as to evaluate the clinical application value of local sound speed measurement in the diagnosis of pancreatic cancer.

The investigators include patients who are found to have solid pancreatic mass on continuous imaging. All subjects are scanned by Fuji film su-9000 ultrasonic system. After the lesions are found, local sound velocity measurement technology will be used to measure the sound velocity in the lesions. Pathology diagnosis or clinical follow-up results will be regard as diagnostic gold standard to divide the patients into pancreatic cancer and pancreatic cancer group. The investigators will compare the sound velocity value if there is statistically significant difference between the two groups, build the receiver operating characteristic curve, calculation of pancreatic benign and malignant lesions of sound velocity threshold, and and the investigators will calculate the sensitivity, specificity, accuracy, positive predictive value and negative predictive value, to evaluate local sound velocity measurement in the diagnosis of pancreatic cancer clinical application value.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 75, gender is not limited.
2. Evidence of solid pancreatic lesions have been found on imaging examination, including computed tomography, magnatic resonance imaging and endoscopic ultrasonography.
3. The lesion was greater 1cm.
4. The informed consent has been signed.

Exclusion Criteria:

1. Patients with serious cardiopulmonary diseases and poor general condition.
2. Patients with other contraindications to endoscopic ultrasonography.
3. Cannot or refuse to sign the informed consent.
Analysis of Treatment Outcomes in Patients Affected by Molar-Incisor Hypomineralization (MIH)

The aim is to long-term evaluate extraction or restoration therapy, of first permanent molars with extensive treatment needs as a result of severe MIH in a national multicenter study concerning dental fear and anxiety, oral health-related quality of life, jaw development, and health economics.

First permanent molars often show areas of porous and hypomineralized enamel. This manifests itself clinically as whitish-yellow to brownish well-defined spots and, in severe disorders, disintegration of enamel. One to all molars are affected and at the same time, the permanent incisors may show opacities. The condition is called Molar-Incisor Hypomineralization (MIH) and occurs in 14% of children globally.

Affected teeth create problems for the individual. The teeth are often painful, e.g. when brushing teeth, cold food/drink, or even when inhaling cold air. Dental treatment can be painful because it is difficult to get adequate anesthesia, probably due to subclinical pulp inflammation caused by the porosity of the enamel.

Molars with severely demineralized enamel need dental care shortly after they have erupted due to decay and subsequent caries. 9-year-old children with severe MIH had their PFM treated almost ten times as often as a healthy control group. In case of widespread decay and hypersensitivity, extraction may be a treatment option.

Two retrospective studies dealing with the extraction of first permanent molars due to MIH have been published: one study found that 87% showed acceptable gap closure and another study showed that 3 of 27 extraction cases had an objective need and only one case had a subjective need for orthodontic gap closure after the extraction. A review article discusses the scientific basis for treating severe first permanent molar due to severe MIH, and the author claims that both the profession and the public today believe in a more conservative restorative treatment. However, he states that there is a need for well-controlled long-term studies.

The aim is to long-term evaluate extraction or restoration therapy, of first permanent molars with extensive treatment needs as a result of severe MIH in a national multicenter study concerning dental fear and anxiety, oral health-related quality of life, jaw development, and health economics.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-9 years
* Diagnosed with at least one first permanent molar with MIH defree 4-6

Exclusion Criteria:

* Dental agenesis
* General disorders, including chronic diseases and functional limitations
Endoscopic Submucosal Dissection (ESD) and Endoscopic Mucosal Band Ligation (EMBL) for Early Cancer

To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with early neoplasm in the gastrointestinal tract

Exclusion Criteria:

* Patients who can not meet the surgery
Mesenchymal Stem Cell and Islet Co-transplantation

The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently, the investigators intend to test whether infusion of MSCs immediately after islet autograft can reduce onset of diabetes and improve glycemic control after total pancreatectomy and islet autotransplantation.

This is a Phase I study evaluating safety and tolerability of autologous BM-MSCs in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT). CCT-BMMSC will be infused at one of the following doses: (Tier 1), 20x10\^6 cell per patient, (Tier 2), 50x10\^6 cell per patient, and (Tier 3), 100x10\^6 cell per patient.

Primary objective: To describe and compare the safety and tolerability of infusion of fresh autologous bone marrow-derived Mesenchymal stromal cells after islet transplantation in chronic pancreatitis patients who undergo TP-IAT. The investigators plan to enroll 24 patients for the whole study. The duration of this study is 12 months. The investigators anticipate that this study will be completed within 2 years of commencement.

Secondary objective: Efficacy of infusion of fresh autologous bone marrow-derived Mesenchymal stromal cells together after islet transplantation in chronic pancreatitis patients who undergo TP-IAT as assessed through onset of diabetes, glycemic control, pain relief and quality of life index.

Safety variables: Adverse events (AEs), Laboratory parameters (hematology, biochemistry, urinalysis), Vital signs

Eligibility Criteria:
Inclusion Criteria:

* Chronic pancreatitis patients who undergo TP-IAT.
* \>18 years of age.
* Patients with BMI from 18.5 to 30.
* Renal function: \>90mls/min/1.73m squared
* Normal INR/PT/PTT values for MUSC clinical laboratory standards
* Diabetes free before surgery (fasting blood glucose\<125mg/dl).
* No prior pancreatic surgery with the exception of transduodenal sphincteroplasty or Whipple/Beger procedure.
* Patients with normal liver function as measured by serum levels of aminotransferase including alanine aminotransferase (ALT), and aspartate aminotransferase (AST), and total bilirubin levels.

Exclusion Criteria:

* Patients whose Hemoglobin, Hematocrit, and Platelet count are above or below normal values for MUSC clinical laboratory standards.
* Patients who has hematological malignancy.
* Patients who are under immunosuppression.
* Patients with marked calcification disease on CT scan.
* Patients with severe fibrosis and atrophy on pancreas MRI.
A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic Surgery

The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients aged from 3 to 12 years undergoing orthopedic mechanical correction surgery

Exclusion Criteria:

* coagulopathy, refusal (parents), current infection on the lumbar area, spinal tract pathology
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine

The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.


Eligibility Criteria:
Inclusion Criteria:

1. Must be diagnosed with migraine with aura or migraine without aura
2. Must have at least 10 headache days per month

Exclusion Criteria:

1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
2. Pregnant
3. Unwilling or unable in the judgment of the investigator to complete the study
4. Unavailable for any of the study visits
5. Light sensitive conditions: meningitis, iritis, blepharospasm, albinism
6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
8. Best corrected visual acuity less than 20/40 in either eye
Newborn Thermal Care Practices: A Community Based Program to Prevent Hypothermia

The purpose of this study is to train mothers/caretakers on how to prevent their babies from becoming too cold.

This study is designed to determine domiciliary care knowledge, attitudes and practices regarding essential newborn care, with a focus on newborn thermal control; develop behavior change communications to promote prevention, early recognition and effective management of newborn hypothermia, evaluate impact and cost-effectiveness of education/behavior change communications delivered by Community Health Workers and Community Health Promoters/Change Agents on essential newborn care practices, including care-seeking; prevalence, recognition and management of hypothermia, including adaptation, safety and utility of Kangaroo Mother Care; and neonatal morbidity and mortality; evaluate the feasibility and acceptability of using LCT ThermoSpot device in rural communities to enhance mothers' recognition and management of neonatal hypothermia; determine the influence of the neonatal hypothermia indicator (ThermoSpot) on recognition of and response to newborn hypothermia and health-seeking behavior of the caregivers; develop algorithms for recognition and management of hypothermia to inform neonatal IMCI and verbal autopsy protocols and gain insight into the potential roles of various cadres of workers in providing neonatal health services at the community level and inform the development of models of community-based essential newborn care.

Eligibility Criteria:
Inclusion Criteria:

* Uttar Pradesh
* Newborns at home

Exclusion Criteria:

* Hospitalized babies
Trident® Tritanium™ Acetabular Shell Revision Study

The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.

Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection.

Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation.

Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system.

It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events.

The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant females, 21-85 years of age at the time of surgery.
2. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
3. Patient has signed an IRB approved study consent form.
4. Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.

Exclusion Criteria:

1. Patient is morbidly obese, BMI \> 40.
2. Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.
3. Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (\> 30 days).
4. Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
5. Patient has an active or suspected latent infection on or about the hip joint.
6. Patient is a prisoner.
Examining Factors Influencing Thoracolumbar Mobility in Runners

The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running.

Context: The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running. Objective: To compare the TL mobility of individuals at different running levels and sedentary individuals. Design: Cross-sectional. Participants: The first group consisted of 35 runners who had been running for the last two years (RTY) while the second group had 35 runners who had been running for the last six months (RSM). The third group had 35 sedentary individuals. Main Outcomes Measures: Sports-related and sociodemographic information was recorded. The Myoton device was used over the Latissimus Dorsi (LD) muscle on both dominant and nondominant sides to measure muscle tone (Hz), elasticity, and stiffness (N/m) values. Trunk flexibility and flexibility of lumbar extensor muscles were measured with tape measurement (cm). The trunk range of motion (ROM, ˚) was measured using goniometer. Thoracolumbar Fascia Length Test and Modified Schober Test were used for thoracolumbar (TLF) fascia flexibility. Analysis of variance was used for statistical analysis. SPSS version 17.0 was used for all statistical analyses. The primary outcome was defined as lumbar extensor tightness. Numeric data obtained from the subjects were presented as mean, standard deviation (mean±SD) and percentage (%). The primary outcome was defined as lumbar extensor tightness. The sample size for each group was calculated to be 30 with a power of 80% and a significance level of 0.05. Considering potential dropouts, 35 participants were included in each group. The groups were not homogenous. As a nonparametric test, the 'Kruskal-Wallis test' was employed for the three-group comparison. The Mann-Whitney U test was used for the two-group comparison. Statistical significance was set at P \< .05.

Eligibility Criteria:
Inclusion Criteria:

* The participants were within the age range of 30 to 45.

Exclusion Criteria:

* The history of lower extremity or lumbar-related surgery within the last year and a body mass index (BMI) exceeding the normal threshold of 24.5 kg/m².
Effect of Exercise-Induced Weight Loss on Energy Metabolism

The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study. We aim to determine if changes in energy metabolism might explain why people don't lose the expected amount of weight in an exercise program.

This is an ancillary study to E-Mechanic, which is an National Institutes of Health study in 198 individuals with the objective to understand why certain people fail to lose weight in exercise programs. In E-Mechanic changes in body weight, body composition, energy intake and energy expenditure are measured before and after 3 different exercise programs of 24 weeks in duration. The 3 exercise programs being compared are self-directed exercise, low dose exercise and high dose exercise. The goal of this ancillary study is to undertake comprehensive assessments of energy metabolism in a metabolic chamber in a group of 60 obese individuals enrolled in the main study. We will compare differences in the changes in 24h energy expenditure and spontaneous physical activity between the 3 exercise programs. We will also test if changes in energy metabolism might explain why people don't lose the expected amount of weight after 24 weeks of exercise.

Eligibility Criteria:
Inclusion Criteria:

* Individuals enrolled in the E-MECHANIC main study (NCT#01264406) with a body mass index (BMI) greater than or equal to 30 kg/m2.

Exclusion Criteria:

* Not enrolled in the E-MECHANIC main study (NCT#01264406).
* Have a body mass index (BMI) less than 30 kg/m2.
Repeated Sweet Breakfasts and Subsequent Sweet Food Preferences and Intakes

This study will assess the impact of repeated sweet breakfast consumption versus repeated non-sweet breakfast consumption on subsequent sweet and non-sweet food preferences and intakes

Participants will be randomized to receive either sweet or non-sweet breakfasts for three consecutive weeks, and impacts on food preferences and intakes will be assessed at baseline (day 0), after 1 week (day 7), and after three weeks (day 21). Preferences for sweet and non-sweet foods will be assessed during two taste tests at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at two meals at each assessment time - breakfast and lunch. Identical buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast and lunch will be provided ad-libitum. Intervention breakfasts will only be consumed on the days between test days.

Eligibility Criteria:
Inclusion Criteria:

* No known food allergy
* No known taste or appetite abnormalities
* Non-smoker
* Habitually eats breakfast
* Able to provide consent and complete all study measures