cyrilzakka/clinical-trials huggingface dataset:
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)

The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).


Eligibility Criteria:
Main Inclusion Criteria:

* Body mass index ≤32 kg/m2
* Patients who do not tolerate or do not accept positive airway pressure (PAP) treatments.
* Obstructive apnoea-hypopnea index (AHI) of 20-60 events/hour

Main Exclusion Criteria:

* Unable or incapable of providing informed written consent
* Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
* Significant co-morbidities making the patient unable or inappropriate to participate in the trial
Adolescent and Young Adult Cancer Survivors: Identity Development

The purpose of this study is to better understand how the illness has affected the identity and what needs the survivor may have. We hope that this information will help us provide better care to future adolescent and young adult cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Current age greater than and including 15 and up to and including 25 years of age at time of consent
* Diagnosis of a first cancer \> or = to 14 and up to and including 21 years of age
* At least 6 months post-treatment according to participant's self-report.
* Able to provide informed consent (or parent or legal guardian consent and participant assent for those participants under 18 years of age)
* Able to speak English. This inclusion criterion is included because study assessments were designed and validated in English and many of them are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the assessments.

Exclusion Criteria:

* Will exclude survivors with severe cognitive impairment that precludes them from being able to give information consent and/or complete the questionnaires.
A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

This is a parallel, Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of lunsekimig monotherapy in adult participants (aged 18 to 80 years, inclusive) with moderate-to-severe atopic dermatitis (AD).

This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD who have a documented history, within 6 months prior to baseline, of an inadequate response to topical treatments or for whom topical therapies are not advised. The study consists of 6 arms: 3 parallel dosing regimens and matching placebo arms. Additionally, participants have the option of engaging in a dense pharmacokinetic/pharmodynamic (PK/PD) sampling subgroup.

The study duration will be up to approximately 36 weeks, including up to 4 weeks of screening, 24 weeks of treatment period and an 8-week safety follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
* Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1)
* Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments
* Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1)
* Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline visit (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
* AD involvement of 10% or more of Body Surface Are (BSA) at baseline (Day 1)
* Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of ≥4 at baseline (Day 1)
* Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives \[eg, urea\]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment.
* Known history of, or suspected, significant current immunosuppression

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Brachial Artery t-PA Release in Heart Transplant Recipients

Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. This is because heart transplant recipients do not have nerves to their coronary arteries.

This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant recipients. The brachial artery has intact nerves.

Separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.


Eligibility Criteria:
Inclusion criteria:

1. Adults 18 years and greater who have undergone heart transplantation
2. Healthy

Exclusion criteria:

1. PVC \< 30
2. Hypertensive subjects on ACE inhibitors
3. Pregnant or nursing mothers
4. Diabetic with HbA1C \> 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
5. Cholesterol \> 30 mg/dL above NCEP accepted level based on cardiac risk.
6. Triglycerides \> 200
7. Previously diagnosed obstructive coronary artery disease
8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
9. History of cerebrovascular disease
10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
12. Angiotensin converting enzyme inhibitor use
13. Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
14. Peripheral Vascular Disease
15. Other chronic medical illnesses at the discretion of the investigators
Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease.

This study will compare smartphone usage data between three groups of patients diagnosed with either a memory complaint, mild cognitive decline, or Alzheimer's disease.

Alzheimer's disease (AD) is the leading cause of dementia in the world. The first cognitive function affected is memory and then other cognitive systems are affected leading to a progressive loss of autonomy of the patient. Currently, the diagnosis of AD is made at too late a stage. Patients with memory complaints or mild cognitive decline (MCI) are particularly at risk of developing AD.

However, there is no clinical or paraclinical evidence to predict precisely this risk of progression to AD. Investigator's hypothesis is that there is an association between the evolution of smartphone use and the conversion of cognitive status to AD.

The purpose of this pilot study is to identify existing differences between smartphone use data of patients with a memory complaint or of patients MCI or with an AD. It is a study of 90 patients (30 patients with memory complaint, 30 with MCI and 30 with AD) with a collection of smartphone usage data during three months.

Eligibility Criteria:
Inclusion Criteria:

* Patient consulting in routine care in one of the CMRR
* No sensory impairment that may compromise smartphone use

Exclusion Criteria:

* Inability to perform MMSE or MMSE \< 20 ;
* Other neurodegenerative condition (Parkinson's disease, Lewy body disease, frontotemporal lobar degeneration, amyotrophic lateral sclerosis)
* Severe anxiety or depressive disorder HADS score ≥ 17
* Terminal phase of a severe disease
* Evidence of a lesion on MRI that may be involved in cognitive impairment
Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)

Children with congenital heart defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years.

The study will be performed with a randomized crossover design. After the first assessment of coordinative capabilities children were randomized into two groups. One starts with exercised training for three months. After midterm assessment of the capabilities they will pause for another 3 months and reassessed. The second group will start without training for the first three months. After midterm assessment they will train for three months and have their final assessment.

Eligibility Criteria:
Inclusion Criteria:

* without significant residuals hemodynamically not significant
* without significant residuals after repair
* age 4-6 incl.

Exclusion Criteria:

* gradient at coarctation site \> 20 mmHg
* gradient RVOT, PV, LVOT, or AoV \> 30 mmHg
* right-left shunt (rest or exercise)
* left-right shunt with dilatation or failure of ana cardiac chamber
* pulmonary hypertension
* heart failure, necessitating therapy
* (suspected) myocarditis or cardiomyopathy
* significant arrhythmia
* ion channel defects, other arrhythmic diseases
* Fontan-like circulation
* repair by atrial switch
* oral anticoagulation
* other medical problems curtailing exercise capacity
The Baerveldt Versus ClearPath Comparison Study

This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.


Eligibility Criteria:
Inclusion Criteria:

* Men or women with age at screening ≥ 18 years and ≤ 90 years
* Inadequately controlled glaucoma
* Valve-less aqueous shunt as the planned surgical procedure
* Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.
* Primary tubes included
* Investigators to recruit consecutively all eligible patients from their clinics.
* Superotemporal or inferonasal placement of the tube
* Capable and willing to provide consent

Exclusion Criteria:

* NLP
* Unable/unwilling to provide informed consent
* Unavailable for regular follow up
* Previous cyclodestructive procedure
* Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation
* Presence of silicone oil
* Vitreous in the anterior chamber sufficient to require a vitrectomy
* Uveitic glaucoma
* Neovascular glaucoma
* Nanophthalmos
* Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
* Procedure combined with other surgery
* Any abnormality other than glaucoma in the study eye that could affect tonometry.
The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study

The present study will investigate the effect of artificially stiffening the aorta by means of an aortic stent on central aortic haemodynamics (CAH). This study will determine whether aortic stenting inadvertently adversely impacts on CAH, thereby providing the rational for subsequent therapeutic intervention to reduce the associated cardiovascular risk.

Increased pulse pressure and pulse-wave velocity are recognized indices of arterial stiffness (Laurent, Boutouyrie, Asmar et al., 2001; Qiu, Winblad, Viitanen et al., 2003). An increased pulse pressure (indicative of increased central aortic pressure) is independently associated with an increased incidence of postoperative neurological and cardiac complications (Fontes, Aronson, Matthew et al., 2008). Pulse pressure has been identified as an independent predictor of cerebrovascular events after cardiac surgery (Benjo, Thompson, Fine et al., 2007). Moreover, many studies have demonstrated that pulse-wave velocity is an independent predictor of morbidity and mortality in a range of study populations (for a review see Vlachopoulos, Aznaouridis, Stefanadis, 2010). An increasing body of evidence suggests that brachial artery pressure, although representative, is not an accurate reflection of central aortic pressure. The Conduit Artery Function Evaluation study, for example, revealed that certain drugs preferentially reduce central aortic pressure, whilst having similar effects on brachial artery pressure. Moreover, in this study central aortic pulse pressure was demonstrated to be an independent predictor of clinical outcomes (Williams, Lacy, Thom et al., 2006). Other studies support the finding that markers of CAP are more closely related to surrogate measures of cardiovascular risk such as left ventricular mass (Haider, Larson, Franklin et al., 2003) and carotid intima-media thickness (Kostis, Davis, Cutler et al., 1997).

One inadvertent effect of stenting is the introduction of a semi rigid conduit into the circulation. This could potentially increase pulse wave velocity and adversely affect central aortic pressures and haemodynamics. The investigators thus aim to investigate the effect of aortic aneurysm of surgery on central aortic pressures and haemodynamics

Eligibility Criteria:
Inclusion Criteria:

* All participants undergoing abdominal aortic aneurysm repair, with non-atheromatous common carotid arteries.

Exclusion Criteria:

* Atheromatous carotid arteries
Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke

The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.

The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvement in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions.

The findings from this study will help the researchers and clinicians decide how to help people with stroke better. Further, the findings will determine how depressive symptoms, health literacy, and other factors such as language and education affect attendance to therapy.

About 24 subjects will take part in this research.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English or Spanish speaking
* A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
* Referred to LVHN Outpatient Neurologic Rehab (hereafter referred to as outpatient PT)

Exclusion Criteria:

* Unable to follow 1-step commands
* \> 220 pounds (100 kg)
* Height \< 5'0" or \> 6'4"
* Unable to take a few steps with assistance
* A score of ≥ 50/56 on Berg Balance Scale (BBS)
* A score of ≥ 26/30 on Functional Gait Assessment (FGA)
* Resting blood pressure \>180/110 mmHg
* Resting heart rate \> 120 bpm
* Severe cardiac disease (New York Heart Association Classification IV)
* Severe spasticity (Modified Ashworth score \> 3)
* Unstable spine or unhealed pelvic/limb fractures
* Active heterotrophic ossification impacting lower extremity range of motion
* Significant lower or upper extremity contractures
* Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
* Pregnancy
* Colostomy
* Poor skin integrity
* Unresolved deep vein thrombosis
* Lower limb prosthesis or amputation
* Leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs
* ROM restrictions preventing normal, reciprocal gait
* Inability to stand for \> 3 minutes due to pain or orthostatic hypotension
* Pusher syndrome
* Cortical blindness
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.

Endovascular therapy to treat thoracic disease seems to provide a plausible benefit compared to surgery in terms of operative mortality and severe morbidity. The French National Health Authority (HAS) requires a 5-year follow-up as part of the renewal of reimbursement for these endoprostheses in order to collect long-term follow-up data under real-life conditions of use.

Eligibility Criteria:
Inclusion Criteria:

* Patient where a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis is implanted (successfully or not) for the treatment of disease of the descending thoracic aorta.
* Patient who had previously consented to the collection and processing of personal medical data.
* Patient older than 18 years at the time of treatment.

Exclusion Criteria:

* Patients who have already received treatment with a thoracic endoprosthesis other than the GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis and for whom 'revision' or reintervention is required.
* Patients whose clinical follow-up is not possible (i.e. patients who cannot return for control visits because they live abroad).
Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors

It is of clinical significance to better characterize the intrinsic defects harbored by mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow (BM) partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

Myelodysplastic syndromes (MDS) are a heterogeneous group of clonal malignancies that are characterized by ineffective hematopoiesis, progressive bone marrow failure, cytogenetic and molecular abnormalities, and increased risk for progression to acute myeloid leukemia (AML). It is a well-accepted theory that MDS and AML originate from primary alterations of hematopoietic stem cells (HSC) compartment, which confer a survival advantage to them at the expense of physiological hematopoiesis. More recently, there is growing evidences regarding the contribution of the bone marrow (BM) microenvironment to the pathogenesis of MDS and AML. Of particular interest, several studies have pointed towards a pivotal role of mesenchymal stromal cells (MSC), one of the main components of the BM niche, in the initiation and propagation of myeloid disorders. In this context, it is of clinical significance to better characterize the intrinsic defects harbored by MSC in MDS and AML context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant HSC and their BM partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of MDS and AML.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed myelodysplasia or acute myeloid leukemia (study place: ICLN) - Specific to the cases cohort
* Age-matched healthy donors undergoing a cardiovascular surgery - Specific to the control cohort
* Signed written informed consent form
* Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria:

* Medical history of hematological disorders
* Thrombocytopenia, anemia...
* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)
* Pregnant or breastfeeding women
* Refusing participation
Resveratrol for Pain Due to Endometriosis

This study aims to verify whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with placebo.

Endometriosis is a disease that affects 176 million women around the world, and it is present in about 60% of adolescent women with chronic pelvic pain and dysmenorrhea. Some researchers have investigated the antiproliferative effect of resveratrol in endometriosis using animal models and humans. The reduction in the size and activity of the endometriotic implants has been observed with the use of resveratrol. The reduction of pain in patients with endometriosis is an important aspect of the quality of life. The use of a medication with few side effects and the lack of clinical quality trials justify this study, which aims to verify whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with placebo. This study will be randomized, prospective, double blind with two arms of 22 patients; the CONSORT parameters will be followed. The degree of pain by visual analog scale, prolactin levels (ng / mL) and the carcinoembryonic antigen levels (CA125) (IU / L) will be measured at the begging and at the end of trial. These parameters will be the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Endometriosis diagnosed by laparoscopy

Exclusion Criteria:

* Known allergy to resveratrol
* Use of gonadotropin or danazol in the last month
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Provided signed, written informed consent.
* 18 years of age and older.
* Diagnosed with primary open-angle glaucoma or ocular hypertension.
* If a subject is a female of childbearing potential she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.