cyrilzakka/clinical-trials huggingface dataset:
Robotic Rehabilitation of the Upper Limb After a Stroke

Hemiparesis is the most common motor disorder after a stroke. Most patients do not recover functional use of their paretic upper limb.

The use of robotic assistance provides intensive motor training through a large number of repetitive movements, usually oriented and interactive tasks (pointing tasks, tracking paths tasks...). These feature have been demonstrated to be critical to stimulate brain plasticity after a brain damage. The InMotion Arm 2.0 manipulator works with an adaptive algorithm that provide patients with real-time Assistance-as-Needed™ desgned to enhance motor performance.

Hypothesis: In the sub-acute phase of stroke, the structured practice of a large number of repeated movements will increase motor function of the upper limb compared to conventional rehabilitation. Secondly, this practice will be more effective in a free active mode (without assistance) than an active assisted mode (Assistance-as-Needed™).

Expected secondary benefits: Subjective impression of improved use of the upper limb in activities of daily living and reduction of spastic cocontractions affecting the agonist and antagonist muscles during movements of the upper limb.

Objectives: This randomized controlled trial will evaluate the effects of structured repetition programs of arm movements, on the function of the hemiparetic upper limb and motor control, between 4 and 10 weeks after the stroke, using a robotic device with or without assistance in partial substitution of conventional rehabilitation care, compared to a program with conventional care alone.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline;
* Active flexion of the paretic shoulder ≥15 °;
* Average score on the modified scale of Frenchay \<5;
* Patient having agreed to sign an informed consent.

Exclusion Criteria:

* Passive extension of the paretic elbow \<120 °;
* Passive extension of the paretic wrist \<10 °;
* Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible;
* Infection, inflammation or complex regional pain syndrome of the paretic upper extremity;
* Injection of botulinum toxin to the upper limb less than 3 months old;
* Patient under safeguard of justice;
* Patient include in an other clinical trial.
Human Milk Oligossaccharide and Acetate Production in Vivo

The study investigators hypothesize (1) that the SCFA/acetate metabolism differs between metabolic phenotypes and (2) that using a mixture of fibres that differ in degree of polymerization and branching namely a resistant starch and a human-like milk oligosaccharide enhance the acetate availability in the distal colon and systemic circulation, consequently leading to its metabolic effects.

To study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese, prediabetic men with the fibre mixture the day before the clinical investigation day (CID) and study during the CID its effects on fasting and postprandial substrate and energy metabolism.


Eligibility Criteria:
Inclusion criteria:

Lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2) healthy men aged 30 - 65 years

as well as

overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) prediabetic men aged between 30 - 65 years

Exclusion criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L and 2h glucose ≥ 11.1 mmol/L)
* Gastroenterological diseases or abdominal surgery;
* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
* Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day;
* Plans to lose weight or following of a hypocaloric diet;
* Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
* Intensive exercise training more than three hours a week;
* Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
* Regular use of laxation products;
* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
* Follow a vegan diet.
EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan

The purpose of this study is to determine if INCORPorATe IP3 is feasible prior to a larger trial focused on determining efficacy. Feasibility will be measured using the RE-AIM framework4: Reach or Participation (Primary Outcome): (a) percent of eligible participants who are successfully recruited and attend at least one group session; Effectiveness: retention rate in the intervention; Implementation: fidelity to the intervention protocol; Maintenance: intervention sustainability based on continued engagement from the participants.

Non-Hispanic black (NHB) women are 49% more likely to experience a preterm birth (PTB), delivery before 37 weeks. PTB is associated with increased risk of poor short and long-term neonatal outcomes. PTB can occur in multiple clinical scenarios including spontaneous PTB (e.g. preterm labor, preterm pre-labor rupture of membranes) and medically induced preterm labor (e.g. preeclampsia). Women with a history of PTB are at 1.5 - 2 fold increased risk for future PTB. There are medical therapies than can reduce the risk of recurrent PTB specific to the presumed etiology of the prior PTB. Thus, women with a history of a prior PTB who receive care with Duke Maternal Fetal Medicine (MFM) receive and Individualized Prematurity Prevention Plan (IP3) to reduce their risk of recurrent PTB. The IP3 plans are often labor intensive with requirements ranging from daily medications, weekly clinic visits, painful injections or invasive ultrasounds.

Given the increased rate so of PTB among NHB women and some suggestion of decreased adherence in this population1, we previously conducted qualitative studies with NHB women to uncover patient perceived barriers to IP3 adherence2,3. These studies revealed that NHB women with prior preterm birth felt that stress and lack of support were key barriers to preterm birth prevention adherence. Stress and limited support made women feel isolated from their peers and community. Based on these data we worked with a stakeholder group to develop a patient-centered, community-involved intervention that will increased adherence to an individualized prematurity prevention plan using community-level social supports. The resulting invention titled, EngagINg the COmmunity to Reduce Preterm Birth via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3) includes community doula led group social support.

Eligibility Criteria:
Inclusion Criteria:

* self describe race as Non-hispanic black
* history of prior singleton preterm delivery (before 37 weeks gestation
* current singleton gestation, with Individualized Prematurity Prevention (IP3) plan.

Exclusion Criteria:

* women with anomalous fetuses
* age below 18 years
* non-English speaking
Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

one year extension study following a previous double-blind study to evaluate safety of the drug

A one year extension study for patients who completed E2020-A001-319. Patients will receive 5my donepezil daily for the first 8 weeks and will be assessed by the incidence of advere events, changes in physical exams, ECG and clinical lab determinations. The results will be assessed 6 timues during the year. After 8 week, the investigator may increase the dose to 10mg/day if the patient if the patients show satisfactory tolerability. Six psychometric scales will also be evaluatd.

Eligibility Criteria:
Inclusion Criteria:

* must have completed previous study E2020-A001-319

Exclusion Criteria:

* absence of a reliable caregiver
* clinically significant medical condition
* recent TIA
Association Between RVT and Prognosis After Neoadjuvant Targeted Therapy in EGFR NSCLC

EGFR-mutated NSCLC is a distinct subtype that responds well to targeted therapies. Neoadjuvant targeted therapy aims to downstage tumors and improve surgical outcomes, but the prognostic role of residual viable tumor (RVT) remains unclear. This retrospective study examines the association between RVT and survival outcomes. The findings will further validate the importance of RVT as a surrogate.

Non-small cell lung cancer (NSCLC) with EGFR mutations represents a molecularly distinct subset of lung cancer that benefits from targeted therapies. Neoadjuvant targeted therapy has emerged as a promising approach for locally advanced NSCLC, aiming to achieve tumor downstaging and improve surgical outcomes. However, the prognostic significance of residual viable tumor (RVT) after neoadjuvant targeted therapy remains poorly understood. This retrospective study investigates the association between the percentage of RVT and survival outcomes in EGFR-mutated NSCLC patients following neoadjuvant targeted therapy. Specific survival outcomes were disease-free survival (DFS) and event-free survival (EFS). By highlighting RVT as a critical prognostic biomarker, the findings provide actionable insights for optimizing postoperative management and stratifying high-risk patients. This work underscores the need for pathological evaluation of RVT to refine prognosis and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old;
* Pathologically diagnosed EGFR-mutated non-small cell lung cancer (NSCLC);
* Treated with neoadjuvant targeted therapy;
* Undergoing definitive surgery.

Exclusion Criteria:

* A history of prior chemotherapy, immunotherapy, or radiotherapy.
* A history of malignancy or lung surgery;
* Missing key data.
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions

The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications. The Composite Interference Scres are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the CIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:

1. Objective IKDC score (clinical evaluation)
2. Subjective IKDS score (functional evaluation)
3. Safety (report of any adverse event)
4. Follow-up of the patient's recovery


Eligibility Criteria:
Inclusion Criteria:

* Acute or chronic ACL deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons
* Males or females aged froù 18 to 60 years
* No history of surgery on the affected knee
* Patients not under guardianship or judicial protection
* Signature of non opposition form (consent of the patient

Exclusion Criteria:

* History of ligament, meniscal surgery or fracture of the affected knee
* Pregnancy of breastfeeding women
The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine

The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.

cage: MC+® cage plate: atlantis® plate

Eligibility Criteria:
Inclusion Criteria:

* Single level degenerative cervical spine disease
* aged 30 - 70
* no improvement of symptom for 8 weeks of non-surgical treatment.
* degeneration in other levels without stenosis, accepted

Exclusion Criteria:

* osteoporosis
* disease with poor bone quality
* Cancer
* Previous cervical spine surgery
* Multiple levels disease
* Ossification of posterior longitudinal ligament
* Kyphosis at the index level
* Developmental stenosis (diameter of C7 spinal canal \< 10mm)
Strabismus Measurements Using Automated 3D Video Oculography

Measuring ocular motility and alignment is important for diagnosing different causes of strabismus, following patients recovering from cranial nerve palsies, preparing patients for strabismus surgery and follow-up post surgery. The current clinical gold standards for measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are accurate, but require patient cooperation, and are not objective because the patient has to indicate the position of the light he sees on the screen. Our objective is to develop an accurate and easy to use goggles system to measure ocular alignment and motility using 3D video oculography.


Eligibility Criteria:
Inclusion Criteria:

* Patients 11 years or older
* congenital strabismus
* acquired strabismus
* paretic strabismus (oculomotor, abducens and trochlear nerves)
* before and after strabismus surgery
* normal controls

Exclusion Criteria:

* Patients unable to sign informed consent
* Patients with significantly impaired vision
* Patients unable to cooperate with standard strabismus workup (including Hess and Harms tests)
* For sub-study: intolerance to scleral search coils
Gene-Environment Interaction in Prostate Cancer

The purpose of this study is to determine whether certain environmental factors, namely occupational exposures and diet, have a greater effect on prostate cancer risk in the presence of selected inherited genetic factors.


Eligibility Criteria:
men diagnosed with prostate cancer before age 70 and race/age frequency matched healthy controls
Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents

In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Patients often have injections for many years, sometimes monthly or every 2 months.

The discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the COVID-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.


Eligibility Criteria:
Inclusion Criteria:

* Ocular pathology requiring repeated IVT treatment of anti-angiogenic drugs (exudative AMD, diabetic macular edema or secondary to retinal venous occlusion ...)
* Beginning of IVT treatment repeated before 10/01/2019 (6 months before the start of French confinement)

Exclusion Criteria:

* Refusal to participate
Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

Transjugular intrahepatic portosystemic shunt (TIPS) dysfunction is defined as a loss of decompression of the portal venous system due to occlusion or stenosis of the TIPS. Occlusion of the TIPS can either be due to thrombosis or hyperplasia of the intima. Thrombosis of the TIPS usually occurs early and can happen within 24 hours of TIPS creation. The frequency of this complication is on the order of 10%-15% when bare stents are used. Post-TIPS short-term low molecular weight heparin (LMWH) was used to prevent the early thrombosis formation. Weather post-TIPS LMWH was necessary when polytetrafluoroethylene-covered stent was used during TIPS creation was not answered. The present study was designed to evaluate the effect of short-term use of LMWH on early TIPS dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of liver cirrhosis
2. Technical success of TIPS was achieved.

Exclusion Criteria:

1. Non-cirrhotic portal hypertension
2. Portal vein thrombosis
3. Budd-Chiari syndrome
4. Pregnancy
5. Contradictions to anticoagulation therapy
CADASIL Registry Study

The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) and related disorders in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CADASIL , to optimize clinical management.


Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent.
2. Age\>18
3. Clinical diagnosis of patients with CADASIL,and confirmed by genetic test or skin biopsy
4. Asymptomatic NOTCH3 mutation carriers
5. Relatives of CADASIL patients or carriers
6. Unrelated healthy controls

Exclusion Criteria:

1. Unable to cooperate with inspectors
2. Serious systemic illness, such as heart, liver, kidney disease or major mental illness
3. Contraindications for imaging examination
The Effect of the Game on Students' Intramuscular Injection Skills

Today, error rates increase in intramuscular (IM) drug administrations, which are frequently applied in clinical settings, due to many factors such as the increase in the number of students in nursing education, the low number of educators, insufficient clinical space and insufficient laboratory environments. This situation makes it inevitable to use different teaching methods in nursing education, especially in the acquisition and development of psychomotor skills. Games, which are a type of virtual simulation methods; It is defined as a pedagogical tool that offers the student the widest possible learning opportunity, interesting, interactive media, and a teaching beyond entertainment. It is very important to acquire the necessary knowledge and skills in the management of intramuscular drug administration, which will constitute the majority of postgraduate applications of nursing students, by using today's technologies during their student life. Another factor that is effective in psychomotor skill learning is; students' anxiety level. Nursing students may experience anxiety while using the new technique, which negatively affects the learning process of the student. One of the reasons for the anxiety experienced by the students is that they have not reached enough professional knowledge and skills. It is observed that this level of anxiety increases especially in psychomotor skills. In the exams conducted for the evaluation of laboratory practices in nursing education, the student demonstrates the skills learned during the term. The level of anxiety he feels during this practice may also affect his performance. The general result of studies examining the relationship between test anxiety and academic performance is that there is a negative relationship between test anxiety and academic success. For this reason, it is very important to control students' anxiety. Although the level of state anxiety increases from time to time, especially in the trainings carried out with simulation, it is one of the training methods that increases the self-confidence of the students by reducing their anxiety in the future. Based on these reasons, this research; The aim of this study was to evaluate the effect of computer-assisted game on success and anxiety level in the development of intramuscular injection application skills in nursing education.


Eligibility Criteria:
Inclusion Criteria:

* Being a first year nursing student
* To be taking the basics of nursing course for the first time
* To have at least 50 points from the IM Injection Information Form

Exclusion Criteria:

* Graduated from Health Vocational High School
* Having a communication problem related to vision and hearing
Comparison of Rotational Angiography/Electroanatomical Mapping Fusion Versus CT/Electroanatomical Mapping Fusion to Guide AF Ablation

The purpose of this study is to compare rotational angiography (3DATG technology)intra-procedure (during the ablation procedure) with CT (x-ray) pre-procedure (before the ablation procedure) fusion to create an anatomical picture of a heart to help adequately guide an ablation procedure for patients with arrhythmias.

Rotational angiography (or three dimensional arteriography or "3DATG") is a new tool used to guide atrial fibrillation (AF) ablation. The current approach to imaging for AF ablation involves obtaining a computer tomography (CT) angiogram of the atrium pre-procedure and combining it with an electro-anatomical map, a process called merging or overlay. The investigators propose to investigate the quality of the 3DATG as a replacement for the CT in obtaining a left atrial angiogram (to guide AF ablation).

All imaging modalities to be evaluated in this study are currently used in clinical practice. They are not experimental methods. The goal is to compare two modalities that have never been directly compared before. The CT angiography utilizes a standard CT scanner and intravenously injected contrast agent to visualize the left atrium. While the 3DATG is a method that achieves similar results to a CT scanner, the difference is that the 3DATG images are acquired by rotating the X-ray source around the patient on a C-arm instead of a dedicated CT scanner.

60 participants will be consented and randomized to either pre-procedure CT or intra-procedure 3DATG. Scheduled participants will undergo sedation and catheter instrumentation as appropriate. CT anatomy data will then be merged with the live X-ray via the EP Navigator system in standard fashion or the patient will be prepped for appropriate 3DATG anatomy data acquisition and merged with the EP Navigator system. The EP Navigator system will then be used to send either data to NavX or CARTO to create the intended electro-anatomical map.

Using the CT or 3DATG acquired electro-anatomical map, the ablation procedure will be conducted in the same way as would the local practice and standard of care for any patient not participating in the study.

The ablation procedure and the sites of ablation lesions will be tagged on the 3D overlaid anatomy in the same fashion as previously published and all participants will be followed as routine at a 1 month and 3 month follow up.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing a clinically indicated left-sided ablation procedure for atrial fibrillation

Exclusion Criteria:

* Patients not willing or able to provide consent to participate or already involved in another clinical trial.