cyrilzakka/clinical-trials huggingface dataset:
Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV

Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood exposure to HIV.

At baseline, participants are prescribed TAF/FTC/RPV and a blood test. At W6, all participants are contacted by phone to evaluate completeness and tolerability of the TAF/FTC/RPV regimen.

At baseline, participants seek care in one of the centers of " Pays de la Loire " area after a potential HIV exposure. They receive TAF/FTC/RPV, one pill taken with food once daily for 28 days according to national guidelines. They have to start this post-exposure prophylaxis within 48 hours after the HIV exposure.

At inclusion, participants give their written consent to have their data recorded in an electronic medical record Nadis® and their oral consent after reading the study information letter. A blood test is prescribed to examine biological variables (HIV, HBV, HCV serologies, TPHA VDRL, ALT/AST, hemogram and serum creatinine). Characteristics of participants and context of the risk are collected in the electronic medical record Nadis®. A blood test is prescribed at W2, W6 and W12 to evaluate tolerability and efficacy of the treatment.

At W6, all participants are contacted by phone call to evaluate completeness and tolerability of the TAF/FTC/RPV regimen. They are reminded to have a blood test done at W6 and W12.

Eligibility Criteria:
Inclusion Criteria:

* Subject seeking care in one of the French CEGIDD or in one of the French centers of " Pays de la Loire " area (CHU Nantes, CHU Angers, CHD La Roche sur Yon, CH Le Mans, CH Saint Nazaire, CH Laval) after a potential sexual or non-sexual HIV exposure
* Adult ≥18 years old
* Oral informed consent
* Written informed consent to have their data recorded in an electronic medical record ("Nadis" software).
* Indication of HIV post-exposure prophylaxis according to the French guidelines

Exclusion Criteria:

* Subject not willing or refusing to participate
* Subject on legal protection
* HIV positive status
* Pregnancy or breastfeeding
* Already treated by pre exposure prophylaxis
* Already included in the study
Assessment of VZV-specific ELISPOT Assay for Predicting VZV Infection in Kidney Transplant Recipients (AVE-KT)

VZV is one of the important opportunistic infection in transplant recipients.Until now, there is no laboratory method to stratify the risk of VZV reactivation after solid organ transplantation. Theoretically, VZV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of VZV development after solid organ transplantation. The investigators thus evaluate the usefulness of VZV-specific ELISPOT assay in kidney transplant candidates to predict the development of VZV infection after kidney transplantation.

We will develop VZV-specific ELISPOT assay, then perform this assay before transplantation. We will evaluate whether this assay will predict zoster reactivation after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* age 16 years or more
* agree with written informed consent
* WBC count 2000/uL or more

Exclusion Criteria:

* no exclusion criteria
Peripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees

Older adults who use cochlear implants to address hearing loss show wide variation in benefit. This research investigates the role of normal aging, the health of peripheral and central auditory pathways, and positioning of the cochlear implant electrode array in contributing to this variability. A range of input types from simple auditory signals to spoken sentences is used to examine these questions.

This research aims to understand age-related temporal processing in older cochlear-implant (CI) users. The overall objective is to disentangle the peripheral and central contributions to age-related temporal processing deficits in this population. The central hypothesis is that age-related speech perception deficits are explained by unique contributions from peripheral and central auditory functions, significantly affecting outcomes in older CI users.

The central hypothesis will be tested by determining (1) the extent to which temporal processing of simple signals from single-electrode stimulation can be explained by aging and the peripheral electrode-to-neural interface; (2) the extent to which speech perception can be explained by aging and the peripheral electrode-to-neural interface; (3) the extent and manner in which central auditory compensation overcomes peripheral processing deficits that contribute to age-related performance declines in CI subjects.

Outcome measures collected in this project include behavioral measures of speech and auditory perception and electrophysiological responses.

Also collected are questionnaire-based reports of history of CI device use, cognitive screening measures, and imaging-based information regarding electrode placement in the cochlea.

Better understanding of the locus of age-related temporal processing deficits in this population will aid in developing age-specific guidance regarding CI candidacy, programming, and rehabilitation, thereby improving expected benefit and quality of life.

Eligibility Criteria:
For Cochlear Implant arm:

Inclusion Criteria:

* cochlear implant in one or both ears
* post-lingual onset of deafness
* 1+ years cochlear implant experience
* use of Cochlear-brand implants
* implanted after 2004

Exclusion Criteria:

* use of non-Cochlear-brand cochlear implants
* no use of oral language
* pregnant women are not eligible for the imaging portion of the study.
* residual acoustic hearing with unaided thresholds \<90 dB HL at more than two standard audiometric frequencies
* other known disability or neurological disorder

For Typical Hearing arm:

Inclusion Criteria:

* audiometrically normal hearing, near-normal hearing, or mild/moderate hearing loss.

Exclusion Criteria:

* severe hearing loss
* history of neurological disorders
* history of middle-ear disorders
Complications of Cholecystostomy in ACC

Acute cholecystitis (AC) is the second most frequent pathology in Surgical Emergencies; laparoscopic cholecystectomy (LC) is the gold standard treatment, but not all patients are fit for surgery at the diagnostic. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity.

This study aims to analyse the complications of PC and review its indications in the literature.

It is a single-centre retrospective study of 2000 acute cholecystitis in adults from January 2011 to december 2023, including demographyc characteristics, comorbidy severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification,the indicatioons for a PC and local complications of PC.

Eligibility Criteria:
Inclusion Criteria:

* All patients admited in the Hospital del Mar with the diagnostic of an Acute Cholecystitis

Exclusion Criteria:

* Acute cholangitis
* Acute Pancreatitis
* Neoplasia
* Chronic Cholecystitis
* Patients under 18 yearls old
* Pregnancy
Breast Health Education for Underserved Latino Women

Subjects will be recruited from the participants in the Union and Mecklenburg County Living Room Visits. Participants in the Living Room Visit will have been recruited using community event flyers. During the Living Room Visits, the Health Educator will provide a general overview of the study. Individuals who are interested in participating in the study will then be generally screened for eligibility by the Protocol Coordinator who will then proceed to provide informed consent to potential subjects.

In an effort to increase early detection of breast cancer our program is designed to remove some of the most common barriers faced by uninsured Latino women including lack of breast health knowledge and inability to pay for screening. The Levine Cancer Institute offers breast cancer education and screening in the growing Latino populations of both Mecklenburg and Union Counties through educational programs known as "Living Room Visits." Living Room Visits are educational sessions hosted at a participant's house that will be led by a Carolinas Healthcare System (CHS) certified bilingual health educator. At least 250 women will participant in the educational sessions between both counties with each session hosting 12-15 participants. Of those women participating in Living Room Visits, those interested will be individually informed of the research opportunity and provided informed consent before being asked to take a pre-test survey. After the educational session, subjects who consented to the study will also complete a post-test survey. Three months after each Living Room Visit, subjects will also be called to complete another post-test survey to assess educational retention. Phone calls and post-test surveys will be administered by Collaborative Institutional Training Initiative (CITI) trained CHS certified bilingual employees only. Analysis of the pre and post-intervention surveys will be administered by a CHS statistician using de-identified data.

Eligibility Criteria:
Inclusion Criteria:

* Latino
* Female
* At least 18 years old
* Resident of Union County or Mecklenburg County, North Carolina

Exclusion Criteria:

* Non-Latino
* Male
* Less than 18 years old
* Not a resident of Union County or Mecklenburg County, North Carolina
Long Term Follow up After 1 Year Initial Lifestyle Intervention

The effect of non-surgical methods for obesity treatment are not fully documented. This study focus on the long term effect of an intensiv follow up (the "Evje Model") compared to a regular follow up.

The "Evje Model" is a combined model, consisting of repeated stays at a specialist centre, telephone follow up at home, home groups, self monitoring and close contact with the patients' local physician.

200 patients will undergo a 1 year intensive lifestyle intervention.This group will be randomised into an intervention group (n=100) and a control group (n=100). The intervention group will undergo four years of further follow up in accordance with the intervention model, which means two one weeks stays each year at the Evje Clinic, telephone follow up, self monitoring and collaboration with the patients' local physician.

The control group will be followed up by the patients local physician and a yearly control at the Center for Morbid Obesity at Vestfold Hospital (Sykehuset i Vestfold HF).

The purpose is to measure the effect of these two follow up models in regard to weight loss maintanance, Quality of Life and comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* Patients, referred from Public Hospitals, with morbid obesity that have undergone one year intensive life style intervention in accordance with the Evje Model.

Exclusion Criteria:

* Pregnancy, major and active psychiatric disease, active and serious eating disorder
Evaluation of the Effectiveness of Arthrocentesis Using Catheter in the Treatment of Temporamandibular Joint Disorders

The aim of the study was to measure the changes in perceived pain and mouth opening values after branule arthrocentesis procedure in joints with TMJ disease. To investigate the effect of branule application on perceived pain and mouth opening in TMJ disease cases.

Two groups will be formed consisting of patients who present with complaints of TMJ pain, limited mouth opening and hearing sounds in the joint and are diagnosed with TMJ disorder. After explaining the i-PRF protocol obtained by taking blood to both groups and obtaining the necessary consents, arthrocentesis will be performed on the relevant joint area using a branul for the patients in the first group and a single needle for the patients in the second group. Patients will be called for check-ups on the 1st day, 1st week and 1st month after the protocols and the current perceived pain level before and after the treatment will be determined by scoring with Visual Analog Scala (VAS) and measuring the mouth opening with a ruler ( mm).

Eligibility Criteria:
Inclusion Criteria:

* Patients who complain from signs and symptoms of internal derangements and were diagnosed by the RDC/TMD as having disc displacement with/ without reduction with / without limitation associated with arthralgia or as having disc displacement with reduction associated with arthralgia in a presence or absence of joint sounds.
* Patients who did not responded to conservative treatment for a minimum of 3 months.
* Obtaining written informed consents signed by the patients.

Exclusion Criteria:

* Patients with myofascial pain or related limitations
* Patients who have had any previous intra-articular injections or other invasive procedures of the masticatory joint (TMJ)
* Patients with connective tissue diseases or neurological disorders such as rheumatoid arthritis
* Patients with a history of major jaw trauma
* Patients with a history of psychiatric disorders or substance abuse
High Volume Injection or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy

The aim of the study is to examine patients with chronic Achilles Tendinopathy (AT) and to compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment combined with eccentric exercises).

Healthy males with AT will be randomly assigned to either 1) HVI (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (\~ 4 mls) or 3) Placebo (Plc) treatment. All subjects will perform a 12-wk eccentric training program and examinations will be done at baseline (before treatment) with follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and differences between groups (HVI, ACP and Plc)

Chronic Achilles tendinopathy (AT) is a common and impairing disorder. Only sparse scientific evidence exists for the present used treatments and no golden standard treatment exists so far.

Aim: The aim of the study is in AT patients to examine and compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment and eccentric exercises).

Materials and methods: Healthy males (21-59 years; n=60) with AT is randomly assigned to either 1) HVI (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (\~ 4 mls) or 3) placebo (Plc) treatment. Participants will treated on 4 successive occasions with 2 weeks (wks) interval (HVI will only be injected once at baseline, the 3 following injections will be placebo). The injections will be performed under ultrasound guidance. All subjects will undergo a 12-wk eccentric training program. Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score), tendon ultrasound thickness and muscle function (one-legged heel-rise test). All outcome measures will be recorded at baseline and again at 6 weeks, 12 week and 6 month follow-up.

Results: Will se the changes and differences between groups (HVI, ACP and Placebo) in VISA-A scores, VAS scores, ultrasound (tendon thickness) and muscle function.

Statistics: All data will be analyzed in SigmaPlot v11 using two-way repeated measures ANOVA with Student-Newman-Keuls Post-hoc test. This is used to see changes over time in all groups (time effect) and differences between groups within time-points (group effect). All data will be presented as mean ± SEM time.

Eligibility Criteria:
Inclusion Criteria:

* Clinically and ultrasound diagnosed unilateral midt-tendinous achilles tendinopathy
* Symptoms \> 3 month
* No steroid injections \< 6 month
* 60 males with BMI \<30 between 18-60 years.

Exclusion Criteria:

* Bilateral achilles tendinopathy
* Insertional tendinopathy
* Steroid injections \< 6 month
* Diabetes or cardiovascular disease
* Smoking
* Treatment with fluoroquinolones \< 6 month
Implementation of a Biological Sample Collection in Systemic Sclerosis Patients

Systemic sclerosis (SSc) is the most severe of the systemic autoimmune diseases. It is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). There are currently no validated prognostic biomarkers for the progression of SSc, yet it is crucial to better predict the progression of SSc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). Furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. The internal medicine department of the Lille University Hospital is a national and European reference center for the management of patients with SSc. Nearly 500 patients are followed annually in the internal medicine department. As part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the Lille University Hospital for a complete assessment of their SSc. This assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. The purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. The main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of SSc patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital
* Fulfilling the ACR/EULAR and/or VEDOSS criteria for SSc
* Being insured by the French social security system
* Having the ability to understand the requirements of the study and provide informed consent

Exclusion Criteria:

* Administrative reasons: unable to receive informed information, lack of social security coverage
* Pregnant or lactating women
* Persons deprived of liberty
* Minors or protected adults
* Persons who have refused or are unable to give informed consent
* Persons in emergency situations
Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty

The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.


Eligibility Criteria:
Inclusion Criteria:

* A subject must meet all of the following inclusion criteria in order to enter the study:

  * Adult subject 18 years or older,
  * Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
  * Scapula and proximal humerus must have reached skeletal maturity,
  * Willing and able to comply with the protocol,
  * Willing and able to personally sign the informed consent form,
  * Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.

Exclusion Criteria:

* A subject will not be eligible to participate in the study if any of the following conditions is present:

  * lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
  * Severe Walch grade B2 glenoid defined as \>60% posterior head displacement and \>20% posterior glenoid bone loss,
  * metal allergies or sensitivity,
  * infection at or near the site of implantation,
  * distant or systemic infection.
Randomized Clinical Trial of Standard FMT Treatments

This is a single center, randomized, parallel assignment, double-blinded, efficacy and safety study to be conducted in subjects with recurrent C. difficile Infection (RCDI). Approximately 200 subjects will be enrolled in the study and randomized at 1:1 ratio to receive lyophilized intestinal bacteria obtained from either single or three donors (group 1 receiving healthy microbiota collected from single donor 90g stool for 2 consecutive days; group 2 receiving healthy microbiota collected from three donors 90g stool for 2 consecutive days). All subjects will be followed for approximately 180 days following FMT treatment for safety.

The endpoints of the study are to evaluate the efficacy and safety of lyophilized product by capsules obtained either from single or three donors and the prevention of subsequent bouts of CDI in 60 days post FMT.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects 18 years of age or older.
2. Sexually active male and female subjects of childbearing potential agree to use an effective method of birth control during the study.
3. Female subjects of childbearing potential will be asked if they could be pregnant. If the subject is unsure a pregnancy test will be completed
4. Subject/LAR willing and able to provide informed consent.
5. Able to follow study procedures and complete the follow-up questionnaire for safety.
6. Subject must have an attending physician who will provide non-transplant care (Either PI of this study or referring physician).
7. Medical history of ≥ 3 bouts of CDI in outpatient or ≥ 2 bouts of CDI in inpatient with either group having ≥ 2 positive fecal tests for C. difficile toxin and at least one bout of CDI within 6 months of enrollment.
8. Received at least two courses of standard-of-care antibiotic therapy for CDI.

Exclusion Criteria:

1. Unable to take capsules orally.
2. Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT.
3. Unwilling to stop taking non-dietary probiotics 24-96 hours prior to FMT.
4. Unable to stop taking bile acid sequestrants (e.g. cholestyramine) 24-96 hours prior to FMT.
5. Unable to stop use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide 24-96 hours prior to FMT and after FMT.
6. Receipt of CDI monoclonal antibodies as treatment for the most recent bout of CDI.
7. Life expectancy of \< 6 months.
8. In the opinion of investigator, subject for any reason, should be excluded from the study.