cyrilzakka/clinical-trials huggingface dataset:
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).

This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective interventional trial.

This is a prospective observational cohort sub-study of subjects enrolled in the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. All subjects will be followed for at least 48 weeks. Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study will be followed for an additional 48 weeks in the Extension Phase of ATN 110 (NCT01772823) or ATN 113 (NCT01769456) and ATN 117 (NCT01769469). The maximum duration of participation will be 96 weeks.

There is no therapeutic intervention specific to this sub-study, and there are no extra study visits required for participation in this sub-study. Questionnaires will be administered and blood and urine samples for laboratory evaluation of potential emtricitabine (FTC)/tenofovir (TDF) (Truvada®) toxicities will be obtained for this sub-study at visits that are required by the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. Measurement of bone mineral density (BMD) and bone mineral content (BMC) by dual-energy X-ray absorptiometry (DXA) scan are planned as a part of the ATN 110 (NCT01772823) and ATN 113 (NCT01769456) studies, and results will be utilized for the analysis in this study. This study does not require extra BMD or BMC measurements.

Eligibility Criteria:
Inclusion Criteria:

* Has been enrolled in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) , and
* Willing and able to provide written informed consent

Exclusion Criteria:

-Subjects exempted from undergoing DXA scans in ATN 110 (NCT01772823) or ATN 113 (NCT01769456) are not eligible to enroll in ATN 117 (NCT01769469).
Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer

This study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects.

Preclinical data suggest that radiation therapy may be uniquely suited to combine with immune checkpoint inhibitors, since radiation can disrupt a tumor's physical barriers to T-cell infiltration and augment antigen presentation, thus serving as an "in situ personalized vaccine" to activate the immune system and potentially enhance the systemic response.

The rationale for this study is to determine the safety and efficacy of combined immune checkpoint inhibitors and radiation therapy in metastatic non-small cell lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Stage IV metastatic Non Small Cell Lung Cancer
* Measurable disease of at least 1.5 cm in greatest dimension at least 2 non-irradiated sites (except for lymph nodes, in which the short-axis dimension must be at least 1.5cm). There must be at least 1 visceral organ metastasis outside of the brain.
* History of prior cytotoxic chemotherapy (with or without concomitant radiation therapy) with subsequent distant (metastatic) disease relapse, or progression of disease while on chemotherapy.
* Participant must be planned to receive (or actively receiving) standard of care checkpoint inhibitor immune therapy. For those patients actively receiving checkpoint inhibitor immune therapy the duration of immune therapy at the time of enrollment must be 4 months or less.
* Life expectancy greater than 3 months

Exclusion Criteria:

* Active autoimmune disease, primary immunodeficiency syndrome, HIV/AIDS, or hepatitis B or C
* Oral corticosteroid dependency
* Uncontrolled or untreated active brain metastases/CNS disease
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
Dystonia Treatment With Injections Supplemented By Transcranial Magnetic Stimulation

We applied 16 sessions of rTMS over 4 consecutive days for adult patients suffering from cervical dystonia who received botulinum toxin (BoNT) injections on a regular basis. The TMS protocol took place 9 weeks following their last BoNT injection. The primary outcome measure was improvement in cervical dystonia as measured by the TWSTRS scale. The secondary outcome measures included mood, cognition, and gait measures.

This was a crossover study design in which patients were randomized to active or sham stimulation during session 1 (S1) and then crossed over to the condition they were not randomized to at first during session 2 (S1). Patients who were receiving BoNT injections for cervical dystonia on a regular basis but only noted benefit from BoNT for 9 weeks or less were eligible to participate. The total study protocol took place over 24 weeks. During week 1, patients had their regularly scheduled botox injections. During week 9, patients underwent either active or sham rTMS, as detailed below. They had outcome measures obtained at week 9 (S1:T0; baseline/pre-TMS), week 10 (S1:T1; post-TMS), and week 12 (S1:T2; 2 weeks post-TMS). At week 12, they underwent their regularly scheduled BoNT injections. During week 21, patients underwent either active or sham rTMS, whichever condition they were not randomized into during the first session. They then had outcome measures obtained at week 21 (S2:T0; baseline/pre-TMS), week 22 (S2:T1; post-TMS), and week 24 (S2:T2; 2 weeks post-TMS).

The neurostimulation protocol was as follows: The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. Patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.

Eligibility Criteria:
Inclusion Criteria:

* patients 18-85 years of age who receive regular botulinum toxin (BoNT) scheduled every 12 weeks, on stable optimized doses but with reported benefits lasting ≤ 9 weeks for 2 consecutive cycles. Patents followed at our center routinely fill out a self-reported form to document the duration of benefits perceived with BoNT therapy. Participants will be allowed to continue oral medications that they are taking for dystonia concurrently but will not be allowed to change their concurrent medication regimen throughout the duration of the study.

Exclusion Criteria:

* Presence of metallic objects or neurostimulators in the brain
* Pregnancy
* History of active seizures or epilepsy
* Patients with severe scoliosis or other gait impairment that will preclude them from participating in gait evaluation.
Women's Opioid Treatment Follow-up Study

The goal of this study is to examine the feasibility of a gender-specific digital intervention for women with opioid use disorder. In this study, women with opioid use disorder will be randomized to receive treatment-as-usual plus a gender-specific digital intervention or treatment-as-usual only. Feasibility, satisfaction, and engagement with the intervention are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-up visits.

This study has two aims: (1) to demonstrate the feasibility of delivering a gender-specific digital intervention (GSDI) to women with opioid use disorder; (2) to collect preliminary estimates on the effect of the GSDI on engagement in medication treatment for opioid use disorder (MOUD). The investigators will conduct a pilot randomized controlled trial to achieve these aims. Women (N=40) who have recently initiated MOUD (within 30 days) will be enrolled and randomized to receive either the GSDI+TAU (gender-specific digital intervention + treatment as usual) or TAU-only. Feasibility, satisfaction, and engagement with the GSDI are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-ups. MOUD engagement will be assessed at two time-points: (1) 6-weeks and (2) 12-weeks post-enrollment to collect preliminary estimates on the effect of the GSDI on MOUD engagement.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years of age or older
* current opioid use disorder diagnosis
* have a smartphone
* initiated medication treatment for opioid use disorder in the past 30 days,
* able to provide informed consent

Exclusion Criteria:

* an acute psychiatric or medical condition, or cognitive impairment, that would impair the ability to complete study procedures
* admitted to their current treatment episode on an involuntary status
Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD

The aim of this study is to investigate if electroencephalogram (EEG) biofeedback incorporating the use of video games is effective in improving inattentive symptoms in children with ADHD.

This study will enroll 20 outpatient subjects aged 7 to 12 newly diagnosed with ADHD who have never received treatment with medication. These children should have inattentive symptoms, i.e. diagnosed with combined or inattentive subtype of ADHD, and should not have any of the exclusion criteria. Based on the gender ratios from other studies, we will enroll 8 boys and 2 girls into the intervention group, giving a male:female ratio of 4:1. 10 will be in the 'intervention' group and 10 in the 'control' group.

Informed consent will be obtained from the parents, and assent from the subjects, prior to any form of assessment or intervention as part of the study.

INTERVENTION

The 10 subjects in the intervention group will take part in a total of 20 sessions spread over a 10-week period. Each subject will first need to master a simple concentration task involving a fishing game. After this, the child will go on to play a second soccer game. Each game employs the BCI system, and is controlled by the child's concentration, which is fed to the computer via the EEG leads. The child watches the game on a computer screen. Each session may take approximately thirty minutes.

The other 10 children in the comparison group will act as controls. At the clinic visit at baseline assessment, they will play the fishing game. There will be no further intervention subsequently.

ASSESSMENT

The following questionnaires will be administered to all subjects in both study groups at week 5, week 10, and at 3 months post-intervention (week 22):

1. ADHD Rating Scale: parents and teachers
2. Child Behaviour Checklist (CBCL): parents
3. Teacher's Report Form (TRF): teachers

In addition, for those subjects in the intervention group, they will be given 2 worksheets (1 Maths and 1 short comprehension exercise) at the end of the intervention during visits 2, 4, 6, 8, 10, 12, 14, 16, 18 and 20 over the 10-week period. Their EEG activity will be recorded during the completion of these worksheets.

Eligibility Criteria:
Inclusion Criteria:

* Satisfy DSM-IV-TR criteria for ADHD (Combined OR Inattentive subtype)

Exclusion Criteria:

* Present or history of medical treatment with stimulant medication and/or Atomoxetine
* Co-morbid severe psychiatric condition or known sensori-neural deficit, e.g. complete blindness or deafness
* History of epileptic seizures
* Known mental retardation (i.e. IQ 70 and below)
* Predominantly hyperactive/impulsive subtype of ADHD
Oxytocin Dosage to Decrease Induction Duration

This is a randomized controlled trial in which women are allocated either 'high dose' or 'low dose' oxytocin infusions for induction of labour. The randomization is stratified by maternal body mass index.

Obesity is considered a major public health concerns and increases the risk of many comorbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and postpartum. In particular, obese pregnant women have more difficulty going into labor, a longer labor course, and even with pharmacologic treatment, have a higher chance of requiring cesarean delivery.

When pregnant women need help going into labor, they commonly receive a medication called Pitocin on the labor and delivery floor. Pitocin is the brand name and is a synthetic analog to the naturally produced oxytocin, a hormone secreted by mother when they naturally go into labor. This medication has been used widely around the world. There is emerging evidence that obese women need more oxytocin to go into labor compared to their lean cohorts. There are many studies to support the use of different oxytocin dosage protocols (both high and low dose infusion increments). Despite these evidences, a low dose oxytocin regimen is universally used in the United States, regardless of patient characteristics.

This study is a double blinded randomized controlled trial. Both lean and obese cohorts will be recruited for the study. The investigators will randomly place both cohorts into the low or the high dose oxytocin regimen treatment group. The investigators, patients and providers will be blinded and will not know the specific assignments. The purpose of this study is to evaluate the effect of high dose oxytocin in the obese cohort. The hypothesis is that obese patient will have shorter time to delivery with the high dose oxytocin regimen without incurring any additional risks or adverse outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy ≥ 37 weeks gestation
* Patient presented for induction of labor who is determined to be a candidate for oxytocin
* Cephalic presentation
* Reassuring fetal health assessment (no abnormal findings in fetal assessment, see below)
* Meeting one of the following BMI category:

Obese group: BMI ≥30 at \<20 weeks of pregnancy, or BMI ≥35 at a term gestation of pregnancy Lean group: BMI ≤25 at \<20 weeks of pregnancy, or BMI ≤28 at a term gestation of pregnancy

Exclusion Criteria:

* Non-reassuring fetal assessment at the time of recruitment
* Previous cervical ripening agents (cytotec, cervidil, cervical Foley Balloon)
* \<18 years of age
* Prisoners
* Any patients contraindicated for vaginal delivery
* Multiple gestations
* History of previous cesarean delivery
* Patients with history of significant cardiac disease
* Fetal demise
* Estimated fetal weight greater than 4500 grams in diabetic and 5000 grams in non-diabetic mother
* Ruptured membranes
* Spontaneous labor (latent or active phase)
* Augmentation of labor (latent or active phase)
Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease

Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that host genetic factor may play a role in determining disease progression. It is known that many cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms, this study aims to identify patients with high risk for progressive liver disease. These patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related liver disease.

Determination of the following fibrosis-relating gene polymorphisms in HCV-related chronic liver disease and HCC will be performed: TNF-α , TNF-β, Factor V Leiden, TGF-β1, PDGF-B gene, Angiotensinogen (AT),Angiotensin converting enzyme (ACE), microsomal epoxide hydrolase (mEH) and glutathione-S-transferase (GST).

Eligibility Criteria:
Inclusion Criteria:

* Patients with anti-HCV positive

Exclusion Criteria:

* Anti-HCV-negative patients
VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies

The Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. In order to plan the MRI on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). If patients agree to participate in the study, rMRI will be scheduled. During the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Diagnostic clinique de dystrophie rétinienne héréditaire ou maculopathie héréditaire, syndromique ou non syndromique
* Artificial vision treatment such as a retinal implant, or optogenetics scheduled in the next 6 months
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
* Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker).
* Other additional ocular pathology that can significantly affect vision
* Recent eye surgery less than 3 months old
Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)

This is a human inpatient clinical pharmacology study to assess potential interactions between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate (OROS-MPH). The primary objective of this study is to determine the safety of the OROS-MPH concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures include cardiovascular responses \[heart rate (HR), blood pressure (BP), and electrocardiograph (ECG) measurements\], oral temperature, adverse events (AEs), and clinical laboratory analyses.


Eligibility Criteria:
Inclusion Criteria:

* Be volunteers who meet DSM-IV criteria for methamphetamine abuse or dependence determined using a Mini-International Neuropsychiatric Interview (MINI) and be non-treatment seeking at time of study and have a positive urine test for methamphetamine (greater than or = to 500 ng/mL) during screening.
* Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
* Have a negative urine test for methamphetamine and other drugs of abuse (opiates, cocaine, and benzodiazepines) after clinic intake before the first infusion session.
* Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the site Principal Investigator
* Have vital signs as follows: resting heart rate between 45 and 100 bpm, systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg.
* Have electrolytes (Na, K, Cl, HCO3) and hematocrit that is clinically normal (+/- 10% of laboratory limits).
* Have liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) less than three times the upper limit of normal.
* Have kidney function tests (creatinine and BUN) less than twice the upper limit of normal.
* Have an ECG performed that demonstrates sinus rhythm between 45 and 100 beats per minute (bpm), normal conduction, and no clinically significant arrhythmias.
* Be able to swallow whole tablets of OROS-MPH due to the controlled release formulation.
* If female, have a negative pregnancy test and agree to use one of the following methods of birth control, or be postmenopausal, have had a hysterectomy or have been sterilized. Birth control must be in effect starting at least 7 days (14 days for hormone-based methods used alone) prior to clinic intake, and should extend at least until the last follow-up visit.

Exclusion Criteria:

* Please contact site for more information
Radiotherapy of Multiple Brain Metastases Using AGuIX®

This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT).

The main endpoint will be evaluated by a blinded endpoint committee.

The occurrence of brain metastases is a common event in the history of cancer and negatively affects the life expectancy of patients. Their incidence varies between 15 and 50% according to the histologic types. Surgery, stereotactic radiosurgery, radiotherapy and chemotherapy are the main treatments currently proposed.

For patients with multiple brain metastases, whole brain radiation therapy (WBRT) remains the standard of care. However, the median overall survival is less than 6 months and new approaches need to be developed to improve treatment of these patients.

In this context, the weak control of the disease comes from three main factors: the multiplicity of the brain lesions, the radioresistance of certain histologies and the poor distribution of cytotoxic agents in brain metastases.

The use of radiosensitizing agents is here of great interest. The radiosensitizing agent chosen in this study is AGuIX®. It is a Gadolinium-chelated polysiloxane based nanoparticle developed by NH TherAguix company for its theranostic properties (radiosensitization and diagnosis by multimodal imaging). Preclinical studies have demonstrated the radiosensitizing effect of AGuIX® in vivo in 8 tumor models xenografted in rodents, and particularly in brain tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with brain metastases, from a histologically confirmed solid tumor, eligible for WBRT
* At least 18 years old
* Signed informed consent after informing the patient
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Extracranial disease:

  * Complete or partial response or stability under systemic treatment
  * No extracranial disease
  * Or first line of treatment
* Life expectancy greater than 6 weeks
* Effective contraceptive method for all patient of childbearing potential
* Affiliated to a social security regimen

Exclusion Criteria:

* Leptomeningeal metastasis
* Evidence of metastasis with recent large hemorrhage
* Progressive and threatening extracranial disease under systemic treatment
* Previous cranial irradiation (except stereotactic irradiation)
* Known contra-indication, sensitivity or allergy to gadolinium
* Known contra-indication for Magnetic Resonance Imaging
* Renal insufficiency (glomerular filtration rate ≤ 50 mL/min/1.73m²)
* Pregnancy or breastfeeding
* Subject under administrative or judicial control