cyrilzakka/clinical-trials huggingface dataset:
French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)

This study is a registry including prospective and retrospective data on all patients who have been presented in a Multidisciplinary tumor board or RCP to be eligible for CAR-T cell treatment.


Eligibility Criteria:
Inclusion Criteria:

Retrospective inclusion :

* Patient treated with CAR-T from 1 July 2018 under temporary authorization (ATU) or covered by French health insurance system (under post-ATU or MA) in a qualified center before activation of this register in this center
* If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive

Prospective inclusion :

* Patient eligible for a treatment with CAR-T for an hematological malignancy which is covered by French health insurance (for ATUs / post-ATUs or MA), or as part of a clinical trial with the same indication, after the activation of this register in this center.
* Patient whose CAR-T indication has been validated during a multidisciplinary tumor board (RCP) of a qualified center, according to the ministerial order of 8 August 2019
* Patient deemed eligible for a treatment with CAR-T after a medical exam performed in a qualified center according to the ministerial order of 8 August 2019
* If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive.

Exclusion Criteria Patient not registered with the social security in France
An Open Study Comparing the Effects of Moxaverine on Ocular Blood Flow in Patients With Age- Related Macular Degeneration, Primary Open Angle Glaucoma and Healthy Control Subjects

A number of common eye diseases such as age-related macular degeneration and glaucoma are associated with ocular perfusion abnormalities. Although this is well recognized there is not much possibility to improve blood flow to the posterior pole of the eye in these diseases.

For many years, moxaverine has been used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the drug, but also on the rheological properties of red blood cells. In a recent study the investigators have shown that intravenous moxaverine increases choroidal blood flow in healthy young subjects. The present study aims to investigate, whether moxaverine also improves blood flow in the diseased eye after systemic administration.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 50 years
* Ametropia of less than 6 diopters and anisometropia of less than 2 diopters
* Clear non-lenticular ocular media

AMD patients:

* Patients with nonexudative AMD
* Visual acuity in the study eye \> 20/60

Glaucoma patients:

* Unilateral or bilateral primary open angle glaucoma
* At least 3 reliable visual field testings
* Treated intraocular pressure \< 21 mmHg,
* Visual field mean deviation MD \<10 (Humphrey 30-2)

Healthy control subjects:

* Age- , gender- and sex- matched to the two patient groups,
* Matched with regard to smoking habits of the two patient group
* No observable eye diseases

Exclusion Criteria:

* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug
* Blood donation during the previous 3 weeks
* Abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study
* Known diabetes mellitus
* Presence of any ocular pathology that interferes with the aims of the present study
* Intraocular surgery within the last 3 weeks
* Hypersensitivity to moxaverine
* Acute gastric bleeding, massive cerebral hemorrhage related to stroke
Probabilistic Targeting of the VIM

After having included the most improved patients by DBS among those implanted in Bordeaux Hospital University, and having defined the most active plots on tremor by its prospective grading on Fahn-Tolosa-Marin (FTM) scale and accelerometry, coordinates of active plots and landmarks will be calculated on post-operative imaging. Association between landmarks and active plots coordinates will be modelled with machine-learning algorithms. The aim is to retrieve the position of the VIM on the basis of the landmarks coordinates.

The intermedius ventralis nucleus of the thalamus (VIM), which represents the target for deep brain stimulation (DBS) in essential tremor, still remains invisible to imaging in spite of the development of new MR sequences. The coordinates currently used in the classical (ACPC) system are so imprecise that per-operative electrophysiology is mandatory to locate the exact position of this target. Micro-electrode recordings (MER) however improve hemorrhagic risk and may be poorly tolerated by patients operated on 7 to 8 hours under local anaesthesia. Based on litterature review, no one tried to retrieve the position of the VIM from anatomical landmarks coordinates in the era of MRI. The patients operated will be clinically tested to define those very well improved by the stimulation. Stimulation efficacy will be assessed by comparing the clinical evaluation (FTM scale) with and without stimulation, and the four contacts of each electrode will be tested clinically, with an accelerometer and an electromyography to determine which one is the most active on tremor. Coordinates of the anatomical landmarks will be calculated on the pre-operative MRI and those of the active plots on the fusion between post-operative CT-scan and pre-operative MRI. These coordinates will be analysed by machine-learning algorithms to create a model predicting the position of the active contacts from the coordinates of the landmarks.

Eligibility Criteria:
Inclusion Criteria:

* patient older than 18 years
* who underwent a DBS surgery targeting the VIM at Bordeaux University Hospital
* in the strict indication of the essential tremor
* with an excellent post-operative result defined by a complete withdrawal of medication, a stability of the stimulation effects without any setting adjustments since at least 3 months and an improvement of more than 66% on the FTM scale between OFF and ON-stimulation assessments.

Exclusion Criteria:

- patients who underwent a DBS surgery targeting the VIM for different indications (Parkinson's disease for instance), patients with a poor post-operative efficacy
Recovery After Sugammadex(Propofol vs Sevoflurane)

Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.


Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium

Exclusion Criteria:

* Known drug allergy,
* Contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex
* Difficulty to use Bispectral Index monitor
* Inability to obtain a proper monitoring of muscle relaxation.
Management and Outcomes of Perioperative Care Among European Diabetic Patients

The incidence of diabetes is increasing globally, including within Europe. There is an estimated 20million diabetic patients in Europe, which is likely to increase, thereby adding to societal demands on European health services. Diabetic patients are more likely to have surgical interventions than the general population. There are plausible pathophysiology and clinical mechanisms that diabetics are at increased risk of postoperative complications. When postoperative complications occur in the general population, they increase mortality or increase risk of major adverse cardiovascular events (Myocardial Infarction, Cerebrovascular Accident, Pulmonary embolism) at 30-days and up to one year later. In addition, diabetes is an independent risk factor for surgical site infections.

There is variation in practice guidelines in different countries in the perioperative management of diabetic patients undergoing major surgery, but this has not been documented on a large scale. Given the multiplicity of guidelines and differing recommendations, it is unsurprising that variability of 'real-world' clinical practice with regard to perioperative management of oral antihyperglycemic medications and insulin therapy has been noted in audits such as the National Confidential Enquiry into Patient Outcome and Death (NCEPOD).

Further, although it is recognised that diabetic patients are at increased risk of postoperative complications, this has not been recently evaluated, especially in light of ongoing developments in perioperative care, such as Enhanced Recovery Programmes. While a quality improvement intervention study has shown that maintaining tight preoperative glycaemic control improves postoperative glycaemic control, it is not known if this reduces postoperative morbidity overall. Further, whether certain anaesthetic techniques may be associated with better or worse outcomes after major non-cardiac surgery is unknown.

see brief summary

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients (all classes except gestational diabetes) undergoing surgery (defined as requiring any general anaesthesia technique or any specific regional anaesthetic technique or a combination)
* Ambulatory, elective or emergency surgery and patients who receive postoperative care in intensive care or high dependency units will be included.

Exclusion Criteria:

* Patients who are not diabetic
* Patients with gestational diabetes
* Patients undergoing minor surgery
Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale

Objective

To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries

Material and methods Case-control study nested in a cohort of pregnant patients in the first trimester. Inclusion criteria. : case is defined as spontaneous preterm births between 22 and 36 weeks in one of the 14 centers. The "control" patient will be considered as the following delivery over ≥ 37 weeks in the same center.

Multiple pregnancies, medical interruptions of pregnancy and deaths in utero will be excluded. Regarding the vaginal flora of cases and controls, the microorganisms will be researched and quantified by molecular methods.

Expected results

Patients and control patients will be compared for their demographic, obstetric, clinical and microbiological data. The parameters related to the risk of spontaneous prematurity at the p \<0.20 threshold will then be analyzed by multi-level logistic regression.

Implications At a time when the link between bacterial vaginosis and prematurity is controversial, the detection - or not - of microorganisms linked to the risk of prematurity will be a key issue.

Eligibility Criteria:
Inclusion Criteria:

* case: spontaneous preterm births between 22 and 36 weeks in one of the 14 centers
* controls : the following delivery over ≥ 37 weeks in the same center

Exclusion Criteria:

* Multiple pregnancies, medical interruptions of pregnancy and deaths in utero
Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section

In the past decades frequency of cesarean section was increasing. Bonding or early skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery bonding/early SSC is already well-established. After cesarean section this important process starts after termination of operation. A Cochran review analyzed randomized studies and shows positive effects of early SSC. Possible concerns to adopt bonding in the operating room are beside organizational ones (change of established processes) also a different ambiance in the operating room (temperature, light, noise). In a prospective randomized trial, early SSC after cesarean section should be analyzed.

Hypothesis

Mothers, who have the chance to bond immediately after birth in the operating room, have lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels. Adaptation of the newborn is within the normal range. Early bonding has a further positive effect on breast feeding, maternal pain processing and mental health.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* signed written informed consent
* single pregnancy
* elective cesarean section (between 7am and 15pm)
* Bleeding prophylaxis with Pabal® (carbetocin)

Exclusion Criteria:

* Age \< 18 years
* disabled to give signed written informed consent
* Disease of mother or unborn, which could influence the study or makes the study impossible (e.g. severe malformation)
* Non elective cesarean
* Desire to wean
* Desire to leave the hospital within 6 hours after birth
* Bleeding prophylaxis with Syntocinon® (oxytocin)
Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients

This study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS)
* Hamilton Anxiety Scale (HAM-A) score \> 14
* Aged between 18 and 65 years, with no gender restrictions
* Receiving stable doses of immunosuppressive therapy for at least one month
* Expanded Disability Status Scale (EDSS) score ≤ 6
* Right-handed
* Willing to participate and sign informed consent

Exclusion Criteria:

* Recorded relapse within the past month
* Recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month
* Participation in any other clinical study within the past month or currently
* Presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain
* Impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives
* History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections
* Pregnant or breastfeeding women, or those planning to conceive in the near future
* Hamilton Depression Scale suicide item score ≥ 3 or comorbid severe mental disorders
* Presence of severe or unstable organic diseases
* Poor compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection
* Any condition deemed unsuitable for study participation by the investigator
TipTraQ Home Sleep Test Validation Study, Duke

A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test.

This clinical study is designed to validate TipTraQ, a new sleep screening device developed by PranaQ, for the detection of Sleep Breathing Disorders (SBD), including obstructive sleep apnea-hypopnea syndrome (OSAHS). Given the high prevalence of undiagnosed OSAHS and the cumbersome nature of traditional polysomnography (PSG) - which involves multiple sensors and specialist interpretation - there is a pressing need for more accessible screening tools. TipTraQ aims to meet this need through a wearable device that utilizes photoplethysmography (PPG) and an accelerometer to monitor essential physiological parameters during sleep. This information is then analyzed by an interpretable artificial intelligence (AI) system to estimate key indicators of sleep health such as SpO2, total sleep time (TST), oxygen desaturation index (ODI), and apnea-hypopnea index (AHI).

The study is open-label and non-randomized, planning to recruit 125 subjects. Participants will use the TipTraQ device alongside a companion mobile app, with data analysis supported by AI technology hosted on a cloud server. The primary goal is to assess the accuracy of the TipTraQ system by comparing its output against the gold standard PSG annotations made by sleep experts.

This initiative represents a significant step towards simplifying and democratizing the screening process for sleep disorders, potentially enabling early detection and treatment for a larger segment of the population, thus mitigating personal health risks and broader societal impacts of undiagnosed SBD.

Eligibility Criteria:
Inclusion Criteria:

Subjects from the age of 20 and older that have an indication for an in-lab PSG study in the Duke University Hospital. The subject should be able to understand the study and sign the informed consent before being enrolled in the study. During the study period, the subject can withdraw from the study anytime.

Exclusion Criteria:

Subjects with the following medical conditions will be excluded from this study:

1. Heart transplant
2. Heart failure, New Youk Heart Association (NYHA) classification III or IV
3. Chronic Obstructive Lung Disease, Global Initiative for Chronic Obstructive Lung Disease (GOLD) categorization 3 or 4
4. Chronic opioid medication user Devastating Severe strokes, with the modified Rankin score (mRS)≥4
5. Tracheostomy
6. Incapable of comprehending and signing the informed consent and questionnaires, including but not limited to subjects with severe Alzheimer's, unconscious by head trauma, or of someone with limited mental capacity
7. Cannot correctly follow the order to use the TipTraQ device
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)

30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.


Eligibility Criteria:
Inclusion Criteria:

* Individuals age ≥18 years
* Diagnosis of Chronic Kidney Disease (CKD) stage 3-5 \[estimated glomerular filtration rate \&le;60 mL/min/1.73m2\]
* Receiving care at NYU Nephrology outpatient practice
* Able to provide informed consent

Exclusion Criteria:

* Primary ANS disorders (e.g., Parkinson's disease)
* Arrhythmias
* Implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) precluding assessment of HRV (e.g., chronic atrial fibrillation)
* On maintenance dialysis (HD)
* Epilepsy
* Symptomatic bradycardia
* Presence of an implantable defibrillators
* Presence of a permanent pacemaker
* Unable to consent
* Incarcerated individuals
* Pregnant individuals
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386

The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive naproxen as control.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
* Provision of signed informed consent.

Exclusion Criteria:

* History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
* Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
* A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
* Patients with a body temperature \>37.5°C at Visit 2, before start of surgical procedures
Shock Wave and Core Exercises for Postpartum Sacroiliac Pain

Despite the high popularity and novelty of shock wave therapy (SWT), it is surprising that just one study has examined the effect of SWT on patients with SIJD and their functional ability following treatment by using subjective assessment tools like numeric rating scale (NRS) and limited by its small sample size and lack of long-term follow-up. Therefore, the present study is expected to contribute to the body of knowledge by exploring the effect of adding SWT to core stability exercises in the management of postpartum sacroiliac joint pain.


Eligibility Criteria:
Inclusion Criteria:

* post-partum women diagnosed with SIJP with limitation of its movement referred from the orthopedist.
* Age is between 25-35 years old.
* Their body mass index will be ranged from 25-35 kg/m2.

Exclusion Criteria:

Patients who have one of the following criteria will be excluded from the study:

* Previous spinal surgery.
* Medical diagnosis other than SIJ dysfunction.
* Patients who had any other spine disorders.
* Patients who had leg length discrepancies.
* Patients with congenital postural deformities.
* Patients with spinal cord injury or acute or unstable neurological signs.
* Patients with cauda equina symptoms related to the spine including changes in bowel or bladder control and perineal sensation.
* Patients with lumber intervertebral disc, spondylosis, lumbar canal stenosis and spondylolysthesis.
A Study to Investigate the PK and Safety of CKD-393

A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults

Eligibility Criteria:
\[Inclusion Criteria\]

1. Between 19 aged and 50 aged healthy adult
2. Body weight more than 55kg for male, more than 50kg for female
3. Body Mass Index over 18.5kg/m2 and under 27.0kg/m2
4. if female, the subject must satisfy more than one of the following:

   * subject who have reached menopause (no natural menstruation for at least 2 years.)
   * subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method)

\[Exclusion Criteria\]

1. Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness
2. Subject with one of the following laboratory test results

   * AST, ALT \> UNLx1.5
   * eGRF \< 60 ml/min/1.73 m2 (MDRD formula)
   * immuno-serology test results in positive
   * Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg
3. Subject who has history of the following and the history may affect safety of the subject or result of this study

   * History of any prescription drug or herbal medicine within 14 days before first administration investigational products
   * History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
   * History of drug-metabolizing induction/inhibition enzyme such as barbital