cyrilzakka/clinical-trials huggingface dataset:
Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are HIV infected . BIKTARVY improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. In addition, the use of TAF reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.

HIV-1-infected patients over 65 years old at risk of polymedication HIV-1-infected adults aged ≥ 65 years who are virologically-suppressed (HIV-1 RNA \<50 copies/mL) on a regimen containing a pharmacokinetic enhancer as ritonavir or cobicistat Evaluate the antiviral efficacy of 24 weeks treatment with the fixed dose combination(FDC) of TAF/FTC/BIC

Eligibility Criteria:
Inclusion Criteria:

* HIV-1-infected patient
* Age \> 65 years old
* Plasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the past 6 months before screening.
* Currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat
* No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. The reverse transcriptase resistant mutations M184V plus one TAM are allowed.
* If no genotype is available, DNA genotype will be performed at screening visit: no resistance mutation to integrase inhibitors, the reverse transcriptase resistant mutations M184V plus one TAM are allowed.
* Patient enrolled in or a beneficiary of a Social Security program (State Medical Aid or AME is not a Social Security program)
* Informed consent form signed by patient and investigator

Exclusion Criteria:

* HIV-2 infection
* Currently receiving one of the following drugs: Hypericum perforatum, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate, cyclosporine, primidone, ténofovir et adéfovir.
* Hemoglobin \< 10g/dL
* Platelets \< 100 000/mm3
* Hepatic transaminases AST and ALT \> 3x upper limit of normal (ULN)
* Severe hepatic insufficiency (Child Pugh Class C)
* Creatininemia clairance \< 30 mL/min (MDRD)
* History or presence of allergy to the trial drugs or their components
* Patients participating in another clinical trial including an exclusion period that is still ongoing during the screening phase
* Patients under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.
Detection of Plasmatic Cell-free BRAF and NRAS Mutations : a New Tool for Monitoring Patients with Metastatic Malignant Melanoma Treated with Targeted Therapies or Immunotherapy ( MALT )

The main objective of this project is to perform a longitudinal monitoring of BRAF and NRAS cell-free DNA in a large cohort of metastatic melanomas patients before treatment and during the follow-up. Results will be compared with clinical data as imaging (based on RECIST criteria) and the activity of lactate dehydrogenase in serum (LDH).

During a consultation of follow-up for an advanced malignant melanoma (stage IIIb or IIIC or IV), an investigator presents the study to the patient and give him the note of information and the informed consent.

The patient can benefit from a reflexion period of of 7 days.

In case of agreement, a first blood draw will take place before initiation of any treatment. Between D15 and D30 a second blood draw will be taken. Then a blood draw will be necessary every two months until recurrence or progression of the disease for a maximum of 22 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients in metastatic situation for a malignant melanoma inoperable stage IIIB or IIIC or stage IV
* In first line of treatment by a targeted therapy (only or in association) or immunotherapy
* Every histological types of cutaneous or mucous malignant melanoma (excepted choroid melanomas)
* The tumor must be mutates for BRAF or NRAS
* The mutation status must have been realized in the Laboratory Pathology Clinical and Experimental (LPCE) of the CHU de Nice analysis of the status on-site metastatic mutational and/or primitive tumor must
* Membership or beneficiary of the national insurance scheme

Exclusion Criteria:

* Histories of cancer or other synchronous cancer
* Pregnant, breast-feeding Women. A pregnancy test will be practiced to the women old enough to procreate.
* Vulnerable People: adults under guardianship, patients deprived of freedom, minor
Use of Motor Rehabilitation Courses in Children With Cerebral Palsy

In 2022, the prevalence of Cerebral Palsy (CP) is 2.5 cases per 1000 live births. In France, 125,000 persons are affected by CP. Many treatments and therapies exist to reduce CP-related disorders, but CP remains uncurable. Motor Rehabilitation Courses (MRC) are one of those therapies used with children with CP. Their uses has not been studied in France yet.

The aim of this survey is to find out about the use of motor rehabilitation courses for children with CP and, where appropriate, the content of these courses. This questionnaire will be used to determine the use and different types of MRS in which children participate.

In total, the questionnaire contains 131 items divided into 13 groups. The estimated filling time is 20 minutes.

The questionnaire is divided as follows:

1. INFORMATION DOCUMENT FOR THE RESEARCH PARTICIPANT
2. About the person with cerebral palsy
3. About the respondent
4. About the usual motor rehabilitation
5. About participation in motor rehabilitation courses
6. 7) 8) Information about MRS

9) Relationship of care or treatment received to participation in MRS 10) Information about the child 11) Information about the child's environment 12) Additional comments from the respondent regarding the MRS 13) Respondent's opinion on the questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Child with a diagnosis of cerebral palsy
* Aged between 6 and 18 years

Exclusion Criteria:

* Child diagnosed with CP after age 6
* Between 1 and 6 years of age
Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)

Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often performed under rapid right ventricular pacing (burst \>180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation aims at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects.

There is limited experience for the balloon expandable Edwards THV on the need for predilation (BAV). Experience so far has only been documented from smaller, uncontrolled case series.

The investigators aim to document the incidence of several kinds of complications in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.

Aortic valve predilation aims at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects, such as:

* Functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral, and renal ischemia.
* In patients with a reduced left ventricular ejection fraction (LVEF), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS). Both are associated with a high periprocedural mortality.
* BAV has been identified as a major source of thrombotic and valvular material, thus increasing the risk for coronary obstruction with subsequent myocardial infarction and/or stroke.
* The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture.

The investigators aim to document the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Males or females
* At least 18 years of age

Exclusion Criteria:

* Logistic EuroSCORE I \>40%
* Mitral or tricuspid valvular insufficiency (\> grade II)
* Previous aortic valve replacement
* Uncontrolled atrial fibrillation
* Left ventricular or atrial thrombus by echocardiography
* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
* Patients with mobile structures on the leaflets
* Need for a cerebral protection device
Inspire Singapore Study

Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.

Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st PSG, after therapy activation), titrate the therapy (2nd PSG, at 3 months post-activation) and confirm therapy performance (3rd PSG, at 6 months post-activation). Symptoms and quality of life (assessed by ESS and FOSQ), therapy adherence, and adverse events will also be collected and reported.

Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosis of moderate to severe OSA (AHI 15-65)
* Failure of, or intolerance to CPAP

Main Exclusion Criteria:

* Central + mixed apneas \> 25% of total AHI
* Presence of complete concentric collapse (CCC)
* Compromised neurological control of the upper airway.

Other eligibility criteria may apply.
Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults

Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.

The investigators objective in this proposal is to obtain imaging biomarker data in a group of individuals who are appropriate for establishing normative values for AD biomarkers. The investigators believe the most valid approach to establishing biomarker cut points is to base them on the upper bound of the range observed in young to early-middle-age subjects in whom the presence of occult AD pathology is extremely unlikely. Based on a large volume of community-based autopsy data, that upper age limit would be about 50 years old. The lower age bound for a group of subjects used to establish normative AD biomarker values would have to be based on considerations of brain maturation, which may continue into the middle- to late-20s. Thus, taking the above into consideration, the ideal age range for establishing normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages 30-49 years old.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively normal males or females aged 30 to 49 years old.

Exclusion Criteria:

1. Subjects unable to lie down without moving for up to 45 minutes.
2. Women who are pregnant or cannot stop breast feeding for 24 hours.
3. Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
4. Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
Occipital Nerve RF Between Occipital Nerve Block And Occipital Nerve Radiofrequency Ablation

This is a randomized, double blind, single-center, clinical trial. The study will be conducted over a period of 6 months. The study will be conducted at the Allevio Pain Clinic, Toronto, Canada.

During the first visit the investigator will assess potential subject's eligibility. Screening and recruitment, and randomization, and administer questionnaires will be performed by research coordinator. Study informed consent form (ICF) can be signed on the RF procedure day. If additional visits will be required to finalize the procedures related to the first visit they will be scheduled accordingly. After randomization the qualified participants will be scheduled for their bilateral Occipital RF or bilateral Occipital Block.

Participants will be asked to complete the follow-up questionnaires at baseline, 3 and 6 months. On their last study visit, participants will have an exit interview, in addition to completing study measures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Confirmed diagnosis of occipital headaches, patients with concurrent other types of headaches will not be excluded (except undiagnosed headaches)
* Duration of occipital headaches \> 3 months

Exclusion Criteria:

* Non-English speakers;
* Refusal to sign informed consent;
* Allergy to medications which will be used in the study;
* Concurrent undiagnosed headaches
* Current brain tumors
* Current known tumors with known metastasis in other organs
* Occipital blocks within the last 3 months
* Currently receiving treatment with Botox for migraine.
* Patient has RF of occipital nerve/s within the last year
A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants

The purpose of this study is to assess the effects of repeated daily administration of rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone following single-dose administration of abiraterone acetate tablets in healthy male participants.

This is an open-label (all people know the identity of the intervention), single-center (study conducted at one site), 2-period, sequential-design (studies that combine both longitudinal and cross sectional methods), to evaluate the effects of rifampicin on the pharmacokinetics of abiraterone acetate in healthy male participants. The study consists of a screening phase, an open-label treatment phase, and a follow up phase. The screening phase will be within 14 days before the first study medication administration. The treatment phase will consist of 2 treatment periods, Period 1: a single oral dose of abiraterone acetate tablets, and Period 2: a daily oral dose of rifampicin capsules alongwith a single oral dose of abiraterone acetate tablets. The 2 periods will be separated by a washout period of at least 7 days. Blood sample collection for pharmacokinetic assessments will be done for determination of abiraterone and rifampicin concentrations. The follow up phase will be of 14 days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examinations will be monitored throughout the study. The total study duration will be approximately 31 days.

Eligibility Criteria:
Inclusion Criteria:

* Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and function
* Must sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
* Must agree to use an adequate contraception method and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
* Have willingness to participate in the optional pharmacogenomic component of this study, participants (or their legally acceptable representative) must have signed the informed consent form

Exclusion Criteria:

* History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, and others
* Clinically significant abnormal values for hematology or clinical chemistry at screening or at admission to the study center
* Serum testosterone level of \< 200 ng/dL (at screening)
* Clinically significant renal laboratory findings including specifically, creatinine, and creatinine clearance
* Clinically significant hepatic laboratory findings or signs
Translation of District Sun Safe Policies to Schools

The purpose of the Translation of District Sun Safe Policies to Schools study was to test whether schools need assistance to facilitate the implementation of school district board-approved sun safety policies by individual elementary schools. The intervention is expected to produce a change in practices at the school level and to improve the sun safety behavior of children attending the intervention schools compared to control schools. A group of 40 school districts in Southern California that adopted board policy 5141.7 for sun safety provided 118 schools that were randomized to a intervention condition or to an attention control condition. The primary outcome is change in school-level sun safety practices based on 10 Centers for Disease Control and Prevention (CDC) categories for policy change (i.e., sunscreen use, UV protective clothing, hats, student education, teacher education, provision of shade, scheduling to avoid peak UV exposure, parent outreach, resource allocation for sun safety, and an accountability system). This primary outcome was assessed by a survey of the principal and one teacher at each school (N=118 principals and 113 teachers at pretest). Parents (N=1770 at pretest) of children attending the schools completed a self-report measure assessing the secondary outcomes of change in individual-level sun safety behavior of their elementary school aged children and number of communications received from the school regarding sun safety. Assessment of principals, teachers and parents occurred at pretest, just prior to randomization, and at a posttest 20-months after the pretest. One Parent Teacher Association (PTA) representative per school was contacted to assess PTA involvement in intervention activities related to sun safety.

The primary hypothesis was stated for the effectiveness of the intervention condition at increasing school-level sun safety practices consistent with the sun safety policies of the school districts and read, H1: At follow-up, a greater percentage of schools in the intervention condition will implement at least one component of the school district sun safety policy compared to schools randomized to the attention-control condition.


Eligibility Criteria:
Inclusion Criteria:

* School districts in California with school Board Policy 5141.7 available online, and with at least one elementary school.

Exclusion Criteria:

* Schools Districts that do not have school Board Policy 5141.7 online, or do not have any elementary schools
Comparative Study of the Link Between the Practice of Gambling and Money and Materialism Among Problem Gamblers and Non-problem Gamblers

The purpose of this study is to to explore the link between materialism and addiction to gambling and money


Eligibility Criteria:
Inclusion Criteria: ( specific to problem gamblers)

* subject having at least four diagnostic criteria in "Trouble linked to gambling and money" DSM-5 (APA 2013)
* subject who had written consent for participation in the EVALADD cohort
* Subject who has started treatment for a problem with the practice of gambling and money in the addictology and psychiatric department

( specific to non-problem gamblers)

* Subject playing games of chance and money at least once a year
* Subject playing games of chance and money less than once per week OR less than € 500 per year
* Subject having a score of 0-2 at ICJE questionnaire

Exclusion Criteria:

* Subject having difficulty reading or writing of the French language
* Subject having Parkinson's Disease
* Subject under guardianship
A Study of Apatinib Treatment in for Advanced Ovarian Cancer

The study is evaluated the effacy and safety of apatinib combined with chemotherapy in the advanced ovarian cancer

Ovarian cancer and fallopian tube cancer are common gynecological malignancies in our country. Ovarian cancer ranks the second in the incidence of gynecologic malignancies. The mortality rate is the highest. The following three major characteristics exist: First, 70% of the patients are advanced patients; 70% of the patients Easy to relapse after treatment; Third, 5-year survival rate of about 30%, a serious threat to women's health. Our hospital ovarian cancer, tubal cancer patients because of regional constraints, the economy is poor, the more the past, the use of simple chemotherapy, relapse rate and mortality were higher.

In the latest National Comprehensive Cancer Network (NCCN) guidelines, bevacizumab plus CP is recommended for patients with stage II, III, and IV ovarian cancer and fallopian tube cancer, and clinical trials of new drugs are recommended for recurrent / metastatic ovarian cancer. Apatinib mesylate is a small molecule VEGFR tyrosine kinase inhibitor authored by Jiangsu Hengrui Pharmaceutical Co., Ltd., whose chemical name is N- \[4- (Cyanocyclopentyl) phenylmethane sulfonate \] \[2 - \[(4-picolyl) amino\] (3-pyridyl)\] carboxamide of the formula C25H27N5O3S with a molecular weight of 493.58 (mesylate salt).Apatinib can effectively inhibit VEGFR-2 at a very low concentration, while higher concentrations can inhibit the action of apatinib, such as platelet-derived growth factor receptor (PDGFR), c-Kit and c- The site is the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamic studies show that apatinib can inhibit the VEGFR-2 tyrosine kinase activity, blocking VEGF signaling after binding, resulting in inhibition of tumor angiogenesis. Preclinical studies have shown that apatinib has a strong inhibitory effect on the growth of many human nude mice xenografts such as sarcoma, colorectal cancer, non-small cell lung cancer, gastric cancer and liver cancer and is a broad-spectrum anti-tumor drug.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, stage II-IV period, the expected survival of\> 6 months;
* ECOG \<2;
* Liver and kidney function is normal;
* No uncontrollable high blood pressure, bleeding, perforation, obstruction.

Exclusion Criteria:

* Serious cardiopulmonary insufficiency, can not tolerate chemotherapy;
* Pregnant or lactating women;
* 3 years have occurred in other tumors (cervical cancer in situ, has cured basal cell carcinoma, except for bladder epithelial tumors);
* Allergic to apatinib or its accessories.
Adult Tic Disorders Registry

The purpose of this study is to develop the adult tic disorders registry in order to characterize the relationship between tic severity and tic-related impairment in women compared to men with tic disorders.


Eligibility Criteria:
Inclusion criteria :

1. Age \>18 years
2. Patients with Tic disorders
3. Given the non-opposition

Non Inclusion criteria

1. No affiliation to a French health social insurance
2. Significant congenital disorders that may affect understanding of assessments
3. Patients under guardianship or curatorship