cyrilzakka/clinical-trials huggingface dataset:
Biological Aging of Skeletal Muscles in Humans

Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.

However, strong inter-individual variations of this prevalence of sarcopenia exists. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.

In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.

Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.

However, strong inter-individual variations of this prevalence of sarcopenia exists. Some elderly (60 years old) reveal a biological aging of 80 years old, whereas 60 years old people reveal a biological aging of 60 years old. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.

Previous sarcopenia studies in Humans did not really focus on chronological aging, they were all based on a comparison between young and old people. No study considered inter-individual modifications (biological aging) in sarcopenia. Furthermore, few studies were associated in the same study to "omic", histological, and epigenetic data, to obtain integrated point of view of Human Sarcopenia.

In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.

Eligibility Criteria:
Inclusion Criteria:

* Belonging to the Proof cohort
* Between 80 and 83 years old
* Informed consent signed
* Genetic analyses consent signed
* Subject affiliated or entitled to a social security scheme

Exclusion Criteria:

* Anti coagulative treatment
* Severe obesity (\>35)
* All chronic pathology requiring a treatment
* Severe renal insufficiency (discovery less than 6 months)
* Abnormal coagulation appraisal
* Allergy to local anesthetics
* Installation of a prosthetic hip and / or knee in the last six months
* Senile dementia
* Refusal of genetic study
Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly

This study was designed to determine whether elderly residents of long term care facilitated who had been taking proton pump inhibitors (PPI) for more than 12 months were more likely to have vitamin B12 deficiency than residents not taking PPI, and whether cyanocobalamin nasal spray improved these subjects' vitamin B12 status.

Subjects had serum creatinine \<1.8 mg/dL, no diagnosis of severe megaloblastic or pernicious anemia, and had not been taking vitamin B12 supplements. At baseline, serum vitamin B12 and methylmalonic acid (MMA) concentrations of 34 subjects from the PPI group were compared with those of the non-PPI group. The PPI group (n=13) was treated with cyanocobalamin nasal spray for eight weeks, and post-treatment vitamin B12 and MMA concentrations were compared with baseline concentrations.

Eligibility Criteria:
Inclusion Criteria:

* age 60-89 years
* PPI use for \>12 months (PPI group)
* no PPI use for 30 days prior to arm 1
* long term care resident

Exclusion Criteria:

* pernicious anemia
* severe megaloblastic anemia
* free-living
* serum creatinine \> 1.8 mg/dL
Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Data will be collected on the safety and effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular office visits up to 3-years. Patients enrolled in this registry will be asked to complete a questionnaire (Functional Assessment of Cancer Therapy-Brain \[FACT-Br\]) about their well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office visits.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, by the patient or a legally acceptable representative, obtained before any registry-related activities are undertaken. The informed consent must be signed within 14 calendar days after surgery.
2. Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence.
3. Patients planning to receive Gliadel Wafer, or having already received Gliadel Wafer and having signed consent to enroll in the registry within 14 calendar days after surgery for treatment of central nervous system (CNS) tumor(s), or are currently enrolled in another study where they received Gliadel Wafer.
4. Signed release form, by the patient or a legally acceptable representative, permitting abstraction of the patient's medical records at Baseline and during participation in the registry.

Exclusion Criteria:

1. The patient is enrolled in an interventional clinical trial, in which treatment for CNS tumor(s) is managed through a protocol that excludes Gliadel Wafer treatment.
2. Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry.
3. Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.
The Longevity Genes in Founder Populations Project

We believe extreme longevity is due to specific genes which function to delay aging and prevent disease. The purpose of our research is to identify the genes/mutations associated with healthier aging; to understand the biological functions of these genes/mutations; and to develop therapies to replicate these preservative genetic activities in individuals who do not have the genetic profile for longevity.


Eligibility Criteria:
Inclusion Criteria:

* Ashkenazi Jewish, age 95+,
* Offspring of person age 95+,
* Offspring of parents who died age 70 or younger.

Exclusion Criteria:

* Non-Ashkenazis
Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings

The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac Output Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those with blood cancers). Additionally, the researchers will learn if the USCOM gives additional information about patients' conditions when their blood pressures drop and they are treated with intravenous fluids.


Eligibility Criteria:
Inclusion Criteria:

-≥ 18 years of age

* English speaker
* Diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires HSCT

Exclusion Criteria:

* Obstruction of the suprasternal notch that prevents placing the USCOM probe in the correct location
* Tracheostomy or endotracheal tube that prevents placing USCOM probe in the correct location
* Inability to lie flat, on left or right side, or with the head of bed at a 30 degree angle for the USCOM exam (ex. due to respiratory distress or physiologic reasons)
* Impairment by a psychiatric, cognitive, or physiologic disorder that limits ability to understand explanation of study and give consent
Polygraphic Evaluation of the Effects of Different Rapid Maxillary Expansion Appliances on Sleep Quality

Rapid maxillary expansion (RME) is a commonly used orthodontic treatment in patients with maxillary constriction to provide skeletal expansion, correct posterior crossbite and resolve naso-respiratory problems by reducing oral respiration.The aim of this randomized controlled trial was to evaluate the effects of tooth-borne, tooth tissue-borne and bone-borne RME appliances on sleep quality with polygraphy. The null hypothesis was that there is no difference for the sleep quality between the appliances.

Introduction. The aim of this 3-arm randomized controlled trial (RCT) was to evaluate the effects of tooth tissue-borne (KBME), tooth-borne (Hyrax), and bone-borne (MIDME) rapid maxillary expansion (RME) appliances on sleep quality with polygraphy.

Methods. This study was designed in parallel with an allocation ratio of 1:1:1. 46 patients with narrow maxilla and OSAS were included in this study and randomly assigned to three groups: tooth tissue-borne, tooth-borne and bone-borne expanders. Participants were congregated from the Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University, Turkey. In all groups, the expansion appliance was activated one-quarter turn twice a day until the desired suture opening was achieved. The primary outcome of this study was the correction of posterior crossbite. Secondary outcomes included polygraphic assessment of sleep parameters. Each subject participated in 1 overnight sleep test with polygraphy before the expansion (T0) and after a 3-month retention phase of treatment (T1). According to the results of polygraphy, 7 parameters; (apnea hypopnea index (AHI), number of apnea and hypopnea, desaturation index, lowest desaturation, average saturation, supin AHI) were examined to evaluate the changes in sleep scores. Kruskal-Wallis analysis and Dunn-Bonferroni test were used for inter-group comparisons and Wilcoxon analysis was used for intra-group evalaution. P\<0.05 was accepted statistically significant. Computer-generated randomization was used with group allocation concealed using opaque, sealed envelopes. The outcome assessor was blinded to group assignment. The outcome assessor was blinded; however, it was not feasible to blind either operator or patients.

Eligibility Criteria:
Inclusion Criteria:

1. No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
2. Bilateral crossbite and need for RME,
3. Maxillary and mandibular permanent teeth fully erupted,
4. Willingness to participate in the study

Exclusion Criteria:

1. the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
2. having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
3. history of previous orthodontic treatment.
To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension

To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension

This is a 16-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod, naproxen, and ibuprofen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to naproxcinod 375mg, naproxcinod 750mg, naproxen 250mg, naproxen 500mg, or ibuprofen 600mg in a 1:1:1:1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Men/Women, 40 or older, diagnosed with hip or knee osteoarthritis.
* Hypertensive Patient with treated and controlled essential hypertension.
* Must receive at least one antihypertensive treatment from the following drug classes: Diuretic, Angiotensin-Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blockers (ARB) or Beta-Blocker (BB).
* Must be current chronic user of NSAIDS or acetaminophen.
* Must discontinue all analgesic therapy at Screening.

Exclusion Criteria:

* More than two different classes of antihypertensive drugs.
* Uncontrolled diabetes.
* Hepatic or renal impairment.
* A history of alcohol/drug abuse.
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
* History of congestive heart failure.
* Clinically relevant abnormal ECG.
* Current or history of a medical disease that could interfere with the study objectives or put the patient's safety at risk.
* Current or expected use of anticoagulants.
* Participation within 30 days prior to pre-screening in another investigational study.
Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan

The primary objective is to determine if the use of losartan, an angiotensin II receptor blocker, can attenuate left ventricular hypertrophy, independent of its antihypertensive effects, in patients with near end stage chronic kidney disease (CKD) who have an arteriovenous fistula created.

Secondary outcomes include the impact of the medication on BNP and hyperkalaemia

Study Design: This is a prospective double blind placebo control 2 arm, randomized (1:1) parallel group study in patients with near end stage renal failure who require creation of an arteriovenous fistula for future haemodialysis. Enrolment will be over a period of 12 months. The blinded phase will be for 3 months. The study design is summarized in Appendix 1. The study consists of a screening phase, a randomization phase and a treatment phase.

Patients will be randomized into 2 groups:

* Group 1 Losartan (50mg daily blinded) and 25 mg of atenolol
* Group 2 Placebo (blinded) and 25 mg of atenolol

Patients: Patients must comply with specified inclusion and exclusion criteria. The number of patients used will be sufficient to show a 15% difference in the left ventricular mass (LVM) between the two groups

Study Endpoints: The primary endpoint is the between group difference in LVM from baseline to 1 month.

Statistical Considerations: The analysis will be based upon an 'ANCOVA'-type linear regression model that includes baseline LVM and treatment group as explanatory variables, and final LVM as the outcome variable.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of CKD at near-end stage renal failure (CKD Stage IV) ( eGFR = 15-30 mls/min).
2. Age \>18 years of age and \<85 years of age.
3. Males and post-menopausal, sterile women. Non-pregnant pre-menopausal women should be on adequate contraception and have no intention of becoming pregnant during the duration of the study.
4. At baseline TTE LVEF\>45%
5. Willing and able to give informed consent.

Exclusion Criteria:

1. Serum potassium level of more than 5.5 mmol/L
2. Acute myocardial infarction or cerebrovascular accident in the previous 6 months.
3. Severe uncontrolled hypertension (diastolic BP \>100mmHg or systolic BP \>160 mmHg)
4. Evidence or suspicion of renovascular disease.
5. Atrial fibrillation
6. Evidence or suspicion of collagen disease, cancer, psychiatric disorder that interferes with patient compliance, drug or alcohol abuse, pregnancy, breast feeding and ineffective contraception.
Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.

This is a randomized, open-label, Phase I/II study of intravitreally administered ranibizumab for the treatment of tube patency in glaucoma patients.

Thirty (30) patients with severe glaucoma requiring tubes will be randomized (2:1) to either ranibizumab or observation.

Consented, enrolled subjects assigned to the treatment group will receive open-label intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections Sham intravitreal injections for the observation group will NOT be performed.

Study periods:

Study start date: May 1st, 2007 (estimated) Enrollment period: 6-8 months (estimated) Follow-up period: 6 months Study end Date: December 1st, 2010 (estimated)

Eligibility Criteria:
Inclusion Criteria:

1. ability to provide written informed consent and comply with study assessment for the full duration of the study.
2. age ≥ 21
3. diagnosis of glaucoma and determined to be candidate for therapy with tube insertion.

Exclusion Criteria:

1. pregnant or lactating females
2. Persons on oral contraceptives and women of child-bearing age
3. prior enrollment in the study
4. any conditions the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
5. participation in another simultaneous medical investigation or trial
6. history of active inflammatory, infectious, or idiopathic keratitis precluding view of anterior segment structures
7. previous injections of ranibizumab in either eye.
8. Persons on Plavix (clopidogrel bisulfate) and coumadin
9. Persons with uncontrolled high blood pressure
10. Persons with renal or liver disease
Nitrous Oxyde Misuse Among Teenagers Consulting in an Addictology Center Dedicated to Young Drug Users in Montpellier

Nitrous oxide gas is used in several application areas : medical as an anesthetic drug ; in food industry as a foaming and a mixing agent ; industrial to speed combustion. It is also misused for its hilarant, euphoric and hallucinogenic effect. For this purpose the gas is transfered in a balloon to be inhaled.

As its effects are briefs, its consumption is often perseived as safe. However, some risks exist and are majorated by the way of use and for some groups of people.

Since 2016, the French observatory of drug and substances addiction (OFDT) describes an increasing misuse of nitrous oxide amoung teenagers and young adults. In november 2019, a french press release alerts on the recent increasing of neurologic side effects related to the misuse of nitrous oxide.

That's why, it seems to be interesting to improve the screening of nitrous oxide abuse, in particular amoung adolescents and young adults.

In our study, the investigators would like to determine the characteristics (social, medical, any drug abuse) of teenagers and young adults who misuse nitrous oxide. Through a questionnaire, the investigators plan to select teenagers and young adults who consult in an addictology center dedicated to young drug consumers in Montpellier. This questionnaire is anonymous. The data will be collected only after obtaining the patient's agreement.

The final goal is to create a tool to help general practitioners in screening young people at risk of nitrous oxyde misuse.


Eligibility Criteria:
Inclusion criteria:

- teenagers and young adults consulting in an addictology center dedicated to young abusers in Montpellier and who agree with being included in the study

Exclusion criteria:

- to refuse to participate to the study
Phase II Study of TPA Plus Dexamethasone & CMT in Hematologic Malignancies

This phase II trial is studying the side effects and how well giving tetradecanoylphorbol acetate together with dexamethasone and choline magnesium trisalicylate works in treating patients with relapsed or refractory acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria

* Must have a histologically documented relapsed/refractory AML for which there is no standard therapy that has been demonstrated to have curative or palliative potential.
* ECOG performance status of 0-2.
* Must be 18 years or older.
* Estimated life expectancy \> 1 month.
* Laboratory data:

  * total bilirubin ≤ 1.5 x upper limit of normal unless due to Gilbert's syndrome
  * serum creatinine ≤ 2.0 mg/dl
  * AST ≤ 3.0 x upper limit of normal
  * Cardiac ejection fraction \> 40%
  * FEV1.0 \> 50% predicted
* Prior therapy: \> 3 weeks since chemotherapy, biological therapy or radiation; anticipated maximum hematological improvement since last dose of chemotherapy. (Concurrent hydroxyurea administration will be allowed to control WBC count, platelet count, or symptoms).
* No active infections.
* Negative pregnancy test for women of childbearing potential.
* No uncontrolled psychiatric illness or medical illness that the principal investigator feels will compromise the patient's tolerance of the study medication.
* Must provide informed consent.

Exclusion Criteria

* Patients with an allergy to proton pump inhibitors, required for GI prophylaxis; or salicylates are excluded.
* Pregnant or lactating women
* Age \<18 years. Because no dosing or adverse event data are currently available on the use of TPA alone or in combination with dexamethasone in patients \< 18 years of age, children are excluded from this study but will be eligible for future pediatric Phase II combination trials.
* The effects of TPA on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 10 weeks after. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Should the female partner of a participant in this study become pregnant or suspect she is pregnant during this study, the PI of this study will be available to provide advice about further medical/obstetric care/referral for the female partner.
* Patients with active CNS involvement (documented by radiographic lesions and/or malignant cells in the CSF) will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Patients with treatment of any other investigational drug within the last 30 days prior to entering the study.
Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery.

The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months.

The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patient ( ≥18 years)
* Patient who has agreed to the use of his medical data for the purposes of this research,
* Patient having been operated between May 2016 and September 2018 in a programmed or urgent surgery, as part of clean / contaminated to dirty surgery at mVHWG grade 3 in the centers participating in the study,
* Patient who benefited between May 2016 and September 2018 from a biosynthetic mesh

Exclusion Criteria:

* Patient who has not consented to the use of her medical data for the purposes of this research,
* Patients who have benefited from the placement of a Phasix® ST biosynthetic mesh in intraperitoneal or Phasix® in retro-muscular prophylaxis,
* Patient under safeguard of justice,
* Patient under guardianship or curatorship.