cyrilzakka/clinical-trials huggingface dataset:
Tunnel Access for Lateral Alveolar Ridge Augmentation

Minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of the flap. This approach preserves the blood circulation and does not damage the periosteum The purpose of this study is to evaluate the clinical outcome of a minimally invasive technique for maxillofacial horizontal bone augmentation .

performed by using a collagen dermal matrix, deproteinized bovine bone and hyaluronic acid.

Collagen matrix is inserted into a sub-periosteal tunnel using microsurgical instruments. Deproteinized bovine bone in a hyaluronic acid carrier are placed and inserted repeatedly into the pocket and absorbable suture is used to close the vertical incision.

Tunnel bone regeneration achieves treatment objectives using the least invasive surgical approach.The goal is to increase patient satisfaction, decrease post-operative discomfort and morbidity.Preservation of the integrity of the periosteum is a determining factor in reducing postoperative pain and improving wound vascularization.

The present study value the clinical results of a subperiosteal minimally invasive ridge horizontal augmentation technique.

The technique includes the use of a laparoscopic approach to deliver hyaluronic acid,xenograft and a dermal matrix into a subperiosteal pouch.

Eligibility Criteria:
Inclusion Criteria:

* • Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older

  * No general medical condition representing a contraindication to implant therapy
  * minimum 2 missing teeth in the maxilla or mandible from the canine to the second molar
  * No periodontal disease (periodontal probing depth \<4 mm) or treated periodontitis
  * Good oral hygiene (full mouth plaque index\<25%)
  * Adequate control of inflammation (full mouth bleeding on probing\<25%)

Exclusion Criteria:

* smoking of more than 15 cigarettes a day
* untreated periodontal disease
* pregnancy or breastfeeding at date of inclusion
* acute infections
* keratinized mucosal tissue less than 2 mm.
Mastering Diabetes Pilot Study

This is a pilot study looking at past results of the Mastering Diabetes program utilizing a survey.

Adult past and present participants of Mastering Diabetes will be sent an email asking for their participation in the survey. The email will contain a hot link to a REDCap survey which will begin with a description of the study followed by a consent form. Once the consent is agreed, the survey will ask for participants' demographics and information about the variables described below

No personal identifiable information is being collected.

The data from this study will help develop a prospective study to better evaluate the effectiveness of Mastering Diabetes in controlling diabetes.

Future comparative studies between programs are anticipated, which will help identify the strengths and weaknesses of different programs, as well as identify subpopulations that might benefit from one program as opposed to another.

Data will be shared via posters and papers among the lifestyle medicine community to help contribute to better lifestyle interventions.

Eligibility Criteria:
Inclusion Criteria:

* Adult past and present participants of Mastering Diabetes

Exclusion Criteria:

* None
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma

The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of azelaic acid iontophoresis (AAI) versus topical treatment with azelaic acid cream in female patients with melasma.

Patients will be randomized and allocated in concealed manner to one of the two treatment arms: AAI or topical azelaic acid cream.

Azelaic acid iontophoresis treatment schedule:

Patients randomized to the AAI group will receive iontophoresis with 15% azelaic acid twice weekly over a period of 12 weeks.

Azelaic acid topical treatment schedule:

Patients randomized to the topical treatment group will receive topical treatment with 20% azelaic acid cream twice daily over a period of 12 weeks.

Besides emollients no additional specific treatments will be allowed during the study.

The use of broad spectrum (UVA+UVB) sunscreen is recommended over the entire study period (9 month).

Follow-up period:

After completion of the active study period (3 month in both treatment groups), maintenance and efficacy of both treatment schedules will be followed up quarterly over 6 month

Eligibility Criteria:
Inclusion Criteria:

* Woman
* MASI - Score over 6
* Age: over 18 years
* Skin Type: III, IV, V

Exclusion Criteria:

* Skin Type: I, II, VI
* Pregnant or lactating women
* Local therapy of intent-to-treat area within the last 6 month
* Patient with a pacemaker or metal implant
* Epileptic
* Mental incompetence to understand the protocol
* Known allergic reactions to one of used substances
* Serious encroachment on physical condition
Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers

Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion.

We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets.

healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.

All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.

Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC), 0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin plus Omeprazole on day 21.

Platelet function tests will be determined by platelet-rich plasma aggregometry in response to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on day 0 as baseline and on day 7 and 21 of the study.


Eligibility Criteria:
Inclusion Criteria:

-healthy volunteers

Exclusion Criteria:

* pretreatment with aspirin
* pretreatment with non steroidal anti inflamatory drugs
* pretreatment with antacids
* history of peptic ulcer disease
* coagulation or aggregation disorder.
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test).

The duration of the treatment period is approximately 25 weeks and patients are followed until Death.

The total Duration of the study is expected to be 2.5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy.
* Aged from 60 to 80 years.
* Patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion).
* ECOG performance status 0 to 2.
* With a minimum of life expectancy \> 3 months.
* Negative HIV, HBV and HCV serological tests \< 4 weeks (except after vaccination).
* Having previously signed a written informed consent.

Exclusion Criteria:

* Any other histological type of T-cell lymphoma.
* Central nervous system or meningeal involvement by lymphoma.
* Contra-indication to any drug included in the R-CHOP regimen.
* Concurrent severe disease (according to the investigator's decision).
* Active bacterial, viral or fungal infection.
* Poor renal function (serum creatinine level \> 150 µmol/L) or impaired liver function tests (total bilirubin level \> 30 µmol/L, transaminases \> 2.5 upper normal limits) unless they are related to the lymphoma.
* Poor bone marrow reserve as defined by neutrophils \< 1.5 x 109/L or platelets \< 100 x 109/L, unless related to bone marrow infiltration.
* Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix.
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
* Patient under tutelage.
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout

This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.


Eligibility Criteria:
Inclusion Criteria:

* Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout

Exclusion Criteria:

* unstable angina
* uncontrolled arrhythmia
* uncontrolled hypertension
* end stage renal disease requiring dialysis
* anemia
CNKSR2 Natural History Study

This prospective natural history study is being conducted to define the electroclinical, neurodevelopmental, and behavioral characteristics of CNKSR2 epilepsy aphasia syndrome (EAS) and intellectual disability (ID) in children aged 6 to 21 years old with CNKSR2 mutations.

The data collected from this study will serve as an external control to eventual clinical trials examining precision medicine investigational therapeutics that aim to improve the seizure burden and neurodevelopmental outcomes in patients with CNKSR2 EAS/ID.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 6 and 21 years (inclusive) at time of consent.
2. Confirmed CNKSR2 mutation, as demonstrated by genetic testing and confirmed by the investigators.
3. Confirmed intellectual disability or developmental delays, as defined by the American Academy of Pediatrics (Moeschler, J, et al. 2014).

Exclusion Criteria:

1. Known pathogenic or clinically suspected mutation in a seizure-associated gene besides CNKSR2.
2. Confirmed mutation in a gene besides CNKSR2 that is known to increase the severity of the seizure phenotype.
3. Known central nervous system structural abnormality confirmed by imaging scan of the brain that is not consistent with the clinical phenotype of CNKSR2 EAS / ID.
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.


Eligibility Criteria:
Inclusion criteria:

* Tumor accessible for multiple biopsies
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Adequate bone marrow
* Renal and hepatic function
* LVEF (left ventricular ejection fraction) greater than 0% based on ECHO (echocardiogram) or MUGA (multigated acquisition).

Exclusion criteria:

* Females who are pregnant or nursing.
* Any unstable, pre-existing major medical condition.
* Received an investigational drug within the past 4 weeks.
* Had major surgery in the past 2 weeks.
* Currently receiving amiodarone or has received amiodarone in the past 6 months.
Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)

A phase IIR cmRCT trial companion to PERa registry, investigating the merit of SABR consolidation in men with metastatic prostate cancer. 80 patients will be randomly selected to be offered experimental SABR based on PSMA-PET detected disease after maximal systemic response. The primary endpoint is the rate of FFS at 1 year. Patients will be stratified according to hormone sensitive vs resistant disease prior to randomisation.


Eligibility Criteria:
Inclusion Criteria:

3.1.1 Enrolled in PERa (CHUM CER 17.032) and randomly selected for AnChoR-Prostate.

3.1.2 Diagnosis of metastatic prostate cancer having achieved maximum PSA response to SOC systemic therapy defined as two consecutive stable PSA within 6 months of regimen start. Stable PSA is defined as non- progressing (\<25% rise from nadir, per PCWG3 guidelines).

3.1.3 ECOG 0-2 3.1.4 PSA \> 0.2 ng/mL 3.1.5 1-5 sites of PSMA-PET avid disease amenable to SABR.

Exclusion Criteria:

* none
Evaluating Worksite Sleep Health Coaching in Firefighters: The Sleep Assistance for Firefighters Study

Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Cognitive Behavioral Therapy for Insomnia (CBTi) is a recommended and effective treatment, but access to such interventions remains low. This study will recruit 20 fire agencies in Arizona (400 firefighters) to test if a CBTi-informed intervention, including sleep health coaching and agency-wide promotion, improves sleep more effectively than usual care. The trial will also explore factors that influence successful implementation across agencies.

Insufficient sleep is a major public health crisis in the United States and worldwide, disproportionately affecting shift workers and other at-risk groups. Firefighters are one such group at heightened risk for disturbed sleep. Almost half of career firefighters report short sleep and poor sleep quality, and 35-40% of firefighters screen positive for a sleep disorder.

Evidence-based sleep health interventions are available and highly effective in eliciting behavioral change. The American College of Physicians recommends Cognitive Behavioral Therapy for Insomnia (CBTi) as the first-line treatment for Insomnia Disorder, and substantial evidence supports the efficacy of this therapy with comorbid conditions, including shiftwork and obstructive sleep apnea. Unfortunately, access to CBT-informed sleep health interventions remains low. Workplace wellness programs could be one way to help more firefighters receive sleep intervention.

This study will recruit 20 fire agencies in Arizona (n = 400 career firefighters) to examine whether a CBTi-informed intervention is more effective than usual care in reducing sleep disturbances or improving multidimensional sleep health. The intervention will last one year and will include telephone-administered sleep health coaching to firefighters, sleep health promotion to the agency and agency leaders, and external/internal facilitation strategies for implementation. The trial will also examine which combinations of factors are associated with successful agency implementation of the intervention. All participating agencies will receive the intervention; however, some agencies will wait longer to receive the intervention than others.

Eligibility Criteria:
Inclusion Criteria:

* Required to be employed as career (paid), uniformed fire service workers that must work in a participating fire agency.
* Must have moderate or more severe levels of sleep disturbances \[item-level calibrated T-score of 55 or higher on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) questionnaire\].
* Must have private access to a computer or phone for sleep health coaching.

Exclusion Criteria:

* Children younger than 18 years of age.
Innovative and Transdisciplinary Observation Program for the Quality of Life of Health Students

Scientific context: Students' quality of life reflects the general health of students, in connection with the studies themselves, but also with physical, biological, social, cultural, and psychological determinants. Indeed, students are young adults exposed to a complex period composed of transitions in different spheres of their life: housing, domestic tasks, social learning, lifestyle choices, etc. In addition to this, students in medical and health sciences have to face with stress due to a demanding training and exposure to the hospital world. According to the Haute Autorité de Santé (HAS), health professionals in activity or in training are identified as a "population at risk historically identified."

The studies on stress and psychological disorders, in medical students, are considerably documented on the international level and the incidence of various psychic problems (depressive state, suicidal ideas ...) and behavioural (food behaviours, addictive behaviours ...) has been shown to be predominant in this population. However, no studies have been conducted on aspects like self-esteem, self-efficacy and extracurricular activities. In this sense, it may be interesting to match quality of life of health students in Lyon compared to the results of the other studies carried out in France, and to have a global approach of the factors influencing quality of life, with identification of factors that are potentially harmful, but also beneficial to the global health. This study will also compare the results according to the different health sectors such as medicine, pharmacy, maieutic, odontology, and sciences of rehabilitation.

Research hypothesis: the study hypothesis is that description of the quality of life and, self-efficacy, self-esteem, nutrition, anxiety, physical activity, sleep quality, and addiction parameters in health student will better characterize student's issues in order to propose an appropriate intervention to improve their global health.

The study is an observational, cross sectional and monocentric study conducted among the population of students of the Lyon 1 University in the health science field on a 9 months period.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years)
* Enrolled in 3rd year of health study (Medicine, pharmacy, Institute of Rehabilitation Sciences and Techniques, odontology, maieutic) at the UCBL
* Participation at the required medical consultation at the college Health Department of UCBL

Exclusion Criteria:

* Lack of comprehension of the French language
* Implementation of protective measures
* Erasmus program
National Lymphangioleiomyomatosis Registry, France

RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic information and information concerning the timing and modalities of diagnosis.

Based on the registry, we will set up a prospective cohort of patients. The database will include detailed medical information, particularly regarding progression of the respiratory function.

Lymphangioleiomyomatosis is a rare pulmonary disease occuring preferentially in women. Few data are available regarding the epidemiology of this disease, the frequency of the various forms with mild to moderate or severe disease, and the rapid or slow progression.

Several sources of information will be used in order to increase completeness. The registry will also allow to estimate the proportion of patients with lymphangioleiomyomatosis who are managed by the Reference Center and Competence Centers for rare lung diseases in France.

Data will be collected by a research assistant, and the study will be coordinated by the Pole IMER - Department of Public health and Epidemiology of HCL (Lyon Hospitals).

This study will provide a better knowledge on the natural course of the disease and the variability in severity and progression of lymphangioleiomyomatosis, and the applicability of diagnostic criteria proposed in 2009. This study will provide the first detailed epidemiological information on Lymphangioleiomyomatosis, will assess the management of this rare disease within the French National Plan for rare diseases 2005 - 2009, and will provide valuable medical information prior to the establishment of clinical trials

Eligibility Criteria:
Inclusion Criteria:

* Patients with sporadic lymphangioleiomyomatosis or associated with Tuberous sclerosis.
* patients diagnosed or hospitalized or seen in consultation since 01/01/2008

Exclusion Criteria:

* None
Bone Graft in Aseptic Subtrochanteric Nonunion

This study aimed to compare the radiologic results between closed nailing without bone graft (BG) and open nailing with BG for subtrochanteric nonunion and to determine when open BG should be considered.

In this retrospective study, we investigated the patients who underwent surgical intervention for subtrochanteric nonunion between January 2008 and March 2018 in two institutions. The cases with infection, large bone defect, pathologic fracture, open fracture, previous surgery using plate, and follow-up less than 1 year were excluded. We compared the demographic details and radiologic results between patients who underwent the open procedure with BG (BG group) and the closed procedure without BG (non-BG group) as a historical control, and risk factors for the failure of revision surgery were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent surgical intervention using intramedullary nailing for aseptic subtrochanteric nonunion

Exclusion Criteria:

* The cases with infection, large bone defect, pathologic fracture, open fracture, previous and revision surgery using plate, and follow-up less than 1 year
The Association Between Time in Range With Markers of Endothelial and Cardiovascular Function

In this observaltional study, 90 patients aged \>12 years old with T1DM who are on MiniMed 780G system will be included.We aim to investigate the association between time in range (70-140mg/dl) and time in tight range (70-180mg/dl) with markers of endothelial and cardiovascular function.

In this observational study, 90 participants with T1D on MiniMed 780G system will be included. HbA1c, anthropometric measurements, CGM and Insulin Metrics will be assessed in all patients. Moreover, the investigators will assess:

1. the pulse wave velocity, the augmentation index and the central systolic blood pressure which are markers of arterial stiffness
2. the perfused boundary region of subglingulal vessels which is marker of endothelial function
3. the global longitudinal strain which is marker of myocardial function.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
2. HbA1c \< 12.5%
3. Age \>7years at the initiation of the system
4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
5. Clinically able to start the AHCL system
6. History of 3 clinic visits in the last year

Exclusion Criteria:

1. Diabetic Ketoacidosis in the 6 months prior to screening visits