cyrilzakka/clinical-trials huggingface dataset:
Treatment Resistant Epilepsy and N-Acetyl Cysteine

This is a study to find out whether the dietary amino acid supplement, N-acetyl cysteine (NAC) is helpful in reducing the frequency of seizures in children with autism and comorbid epilepsy whose seizures are not responding well to usual medical treatment. The study is also looking to see if this supplement is helpful for immediate and ongoing treatment of symptoms of irritability. Additionally, this study will also look to see if certain substances in the blood that measure a specific type of stress on cells in the body can help tell us how NAC may be helping.

One third of patients with idiopathic autism have treatment resistant epilepsy, associated with earlier onset of seizures. In addition to insufficient response to medical treatment, they also have poorer responses to surgical and VNS approaches (Sansa et al 2011). Novel approaches to reduce seizure burden and improve quality of life for the children and their caregivers are needed.

There is a plethora of basic research documenting elevated oxidative stress in animal models of seizures. Several animal models have decreased oxidative stress through using compounds with antioxidant effects, but suprisingly, few human studies have been done to date.

This small open-label pilot study will examine the use of N-acetyl cysteine, an inexpensive but readily available over-the-counter nutritional supplement, to reduce seizure frequency in 10 youth with autism who have not responded completely to conventional anticonvulsant therapy

Eligibility Criteria:
Inclusion Criteria:

1. Children and adolescents/young adults ages 6-21, male or female, all races and ethnicities.
2. Autism
3. IQ less than 80
4. 10 subjects with treatment resistant generalized epilepsy as defined by trials of 3 or more anticonvulsants with continued seizure frequency of at least 1 per week, need to use a helmet, or vagal nerve stimulator placement.
5. Children with at least 1 grand mal/generalized seizure per week.

Exclusion Criteria:

1. Inability to swallow capsules
2. In females, pregnancy or sexual activity
3. Daily acetaminophen, glucocorticoid, or nonsteroidal anti-inflammatory drugs, or daily NAC or high-dose antioxidant vitamin supplements within 30 days of baseline.
4. History of acute or chronic liver, renal, endocrine, infectious, autoimmune, hematologic, metabolic, or other disorder in the judgement of the study physician.
Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing selective frontotemporal tumor resection.
* Age ≥18 years.
* Obtain written informed consent.

Exclusion Criteria:

* Refusal to provide written informed consent.
* Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
* Allergic to the study drug.
* History of psychotropic drugs within past 30 days.
* Pregnant or lactating women.
* History of traumatic brain injury or neurosurgery.
* Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
* Severe hepatic or renal dysfunction.
Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects

The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.

A lot of osseous substitution products were already used to fill osseous defects in order to prevent losses of osseous that are envisaged and so prejudicial.

Synthetic calcium phosphate ceramics (particularly granulated forms) already has shown their osteoconduction potential in human at different sites. But it is difficult to put these granules in very little place.

The injectable form of calcium phosphate granules "ready to use" is easier to be used and allow a diminution of the risk of infection during surgery, and permit homogeneity of the biomaterial.

Injectable form of calcium phosphate granules did already has shown his biocompatibility and biofunctionality in animals.

The purpose of this study is to study the biocompatibility and biofunctionality of this biomaterial in his injectable form in fillings of little losses of osseous substance from various origins were no charge will act to the biomaterial.

Eligibility Criteria:
Inclusion Criteria:

* Medium osseous defects (inferior to 20 cc) without articular communication
* Patients without a personal medical history of bone infection, cancer, diabetes, tuberculosis, and in general, any pathology which could interfere with the results of the study or expose the patient to additional risk
* Patients without drepanocytosis, or congenital or acquired immunizing deficit
* Patients who have the benefit of a social security system, a previous medical exam and who were informed and gave free consent about this study

Exclusion Criteria:

* Proven nicotinism and alcoholism
* Pregnant or nursing women
* Patients who received another study drug or another study device in the past 3 months or patients who will be included in another clinical study
* If postoperative follow-up for a patient is considered to be random by the investigator, he/she should not be included
Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia. This study is to assess the heart rhythm device accuracy of five cardiac wearable devices (Apple Watch, Kardia Mobile/Kardia Mobile 6L, Fitbit Sense, Samsung Galaxy Watch 3 and Withings Scanwatch, Withings SA, Model Number: HWA09) and its detection algorithms in identifying AF compared to a nearly simultaneously acquired physician-interpreted 12-lead ECG in a real world cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergoing electrophysiological study, pacemaker or implantable defibrillator (ICD) implantation or electric cardioversion at the University Hospital Basel are eligible for study participation and will be asked to participate

Exclusion Criteria:

* Use of a radial artery graft for coronary artery bypass grafting
* Tattoos located on the skin of the wrist or forearm where wearable device will be placed
* Patients receiving hemodialysis through arteriovenous fistula in the upper extremities
* Patients with inability to communicate and comply with all study requirements
* Patients who refused to participate in the trial
Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions

The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fasting conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Participation in a clinicl trial within 30 days prior to study initiation.
* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
Treadmill Training and Quality of Life in Parkinson's Disease

Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of life of the subjects. The purpose was to assess the effects of treadmill walking training with additional body load on the quality of life and motor symptoms of the subjects with PD.

Methods: Nine subjects with PD, Hoehn and Yahr stages 2 through 3, not demented and with capability to ambulate independently voluntarily participate in this study. The training program was divided into three phases (A1-B-A2): treadmill training with additional body load (A1), control condition (conventional physical therapy group) (B) and treadmill training with load again (A2). Each phase lasted six weeks. The quality of life and motor symptoms were assessed by PDQ-39 and UPDRS, respectively. Both evaluations and training were performed during on-phase of the medication cycle.


Eligibility Criteria:
Inclusion Criteria:

* Hoehn and Yahr (H-Y) stages 2 through 3
* Absence of dementia (Mini-Mental Status Examination - MMSE, defined according to educational level)
* Capacity to ambulate independently for at least 10 meters

Exclusion Criteria:

* Change medication (dopaminergic) during the study period
* Use treadmill for at least six months prior to the study
* Other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the accomplishment of the training
Volumetric Analysis of Bone Following Jaw Cysts Enucleation With and Without Alb-PRF

Cyst is the main cause for longstanding swelling in the mandible or the maxilla, its enlargement usually results in resorption and weakening of bone. Thus the treatment of the cysts is essential to preserve the bone and the adjacent vital structures. Healing of the bone defect and its surrounding soft tissues is a critical issue that needs concerns. Although the Platelet rich fibrin has promising effects in wound healing, it can resorb during 10-14 days. Thus a new autologous platelet concentrate is introduced by Kawasi et al that can remain stable for 4-6 months called albumin PRF.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from jaw cystic cavity volume greater than 1cm3
* Patients with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 6 months.
* Cystic lesion that requires removal under local or general anaesthesia.

Exclusion Criteria:

* Medically compromised patients contradicting operation.
* Patients with history of chemotherapy or radiotherapy.
* Patients with low level of platelet count.
* Patients with anticoagulant therapy.
* Patients who are unable to attend follow up appointments
Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM

Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)

Eligibility Criteria:
Inclusion Criteria:

* A signed written Informed Consent
* Presence of typical atrial flutter (cavotricuspid isthmus dependent)
* If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD)for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.
* One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
* In good physical health
* 18 years of age or older
* Agree to comply with follow-up visits and evaluation

Exclusion Criteria:

* Prior typical atrial flutter ablation treatment
* Pregnancy
* Atypical flutter or scar flutter(non-isthmus dependent)
* Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
* A recent myocardial infarction within 3 months of the intended procedure date
* Permanent coronary sinus pacing lead
* Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant)
* Evidence of intracardiac thrombus or a history of clotting disorders
* Participation in another investigational study
* Cardiac surgery within 1 month of the intended procedure date
* Allergy or contraindication to Heparin
the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension

cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment

patients diagnosed with pulmonary hypertension, including pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, will be evaluated by cardio pulmonary exercise test before and after medical or balloon pulmonary angioplasty treatment

Eligibility Criteria:
Inclusion Criteria:

* pulmonary arterial hypertension;( WHO1)
* chronic thromboembolic pulmonary hypertension;
* pulmonary arterial hypertension due to other cause;

Exclusion Criteria:

* massive hemoptysis;
* unable to accomplish cardiopulmonary exercise testing due to neuromuscular disorders;
* recent recurrent syncope;
* pulmonary hypertension due to hypoxia;
* pulmonary hypertension due to left heart diseases.
Chronic Wound Care of Lower Limb in M@diCICAT Center at CHU de Martinique

Chronic wound of lower limb. In developed countries, the prevalence of chronic wounds is linked to the ageing of the population and the increase in chronic diseases such as diabetes, obesity and cardiovascular disease. Consequence: amputations of lower limb. The prevalence of chronic wounds is also variable across the globe. In addition, chronic wounds are associated with psychosocial problems such as poor quality of life, loss of professional activity and progressive de-socialization of patients. To improve the quality of care we need in french wound assessment tools validated scientifically like the RESVECH 2.0 scale, validated in the Spanish language.

The VALRESCIC study aims to perform a cross-cultural and psychometric validation of the RESVECH 2.0 scale in order to be able to use it for monitoring wounds in both hospital and primary care settings in the French West Indies.

The RESVECH 2.0 scale is a heterogeneous scale to monitor the evolution of a chronic wound. This scale was created in 2010 and consists of 6 items with response modalities ranging from 5 to 14. The interpretation of the scale parameters may differ depending on the cultural context. The RESVECH 2.0 scale has been validated in the Spanish language (in Spain and Colombia) to assess the progress towards healing of pressure ulcers and chronic wounds of the lower limbs.

For the cross-cultural evaluation we will follow Beaton's methodology, which includes: translation, synthesis, retro-translation, expert committee review and pre-testing. For the psychometric validation, the following parameters will be measured: Feasibility and acceptability, validity, reliability, and sensitivity to change.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one chronic wound of the lower limbs admitted to the M@diCICAT® healing centre.
* Patients agreeing to participate in the study
* Patients affiliated to a social security scheme

Exclusion Criteria:

* Patients with critical ischemia of the lower limb concerned
* Patients under legal protection measures (guardianship, curatorship, safeguard of justice) and persons deprived of liberty
Study of OTO-104 in Subjects With Unilateral Meniere's Disease

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
* Subject has experienced active vertigo during the lead-in period.
* Subject has documented asymmetric sensorineural hearing loss.
* Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has a history of previous endolymphatic sac surgery.
* Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
* Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
* Subject has experienced an adverse reaction to IT injection of steroids.
* Subject has used an investigational drug or device in the 3 months prior to screening.
* Subject has previously been randomized to a trial of OTO-104.
Minimally Invasive Simultaneous Colorectal and Liver Surgery

Up to 25% of newly diagnosed patients with colorectal cancer (CRC) have liver metastases (LM). Simultaneous colorectal and hepatic resection has been proven to be a safe and effective approach in dealing with metastatic colorectal cancer.

The aim of this paper is to analyse perioperative and oncological outcomes of minimally invasive (laparoscopic and robotic) one-stage simultaneous resection of liver metastases and colorectal tumor in selected patients affected by colorectal cancer and synchronous liver metastases.

From October 2012 to March 2018 a minimally invasive one-stage resection was offered to selected patients referred to the investigator's institution with a diagnosis of CRC and synchronous LM, irrespective of the size and location of the primary and metastatic disease. When feasible, a fully-robotic colorectal and liver resection was performed. Prior consent was obtained and full treatment options where submitted to all patients treated. Data collected were prospectively analyzed.

Diagnosis and pre-operative staging were achieved with pancolonoscopy with biopsies and, where contraindicated or not feasible, with CT colonography.

Pelvic MRI with rectal cancer protocol was used for local staging of rectal cancer and total-body contrast-enhanced computed tomography (CT) and liver contrast-enhanced magnetic resonance imaging (MRI) for investigation of metastases. In selected cases a CEUS (contrast-enhanced ultrasound) or liver biopsy was performed in order to achieve a diagnostic definition.

All cases were discussed at multidisciplinary team meeting. Criteria for neoadjuvant chemotherapy were liver unresectability with a potential incomplete liver resection with anticipated positive surgical margins and an insufficient liver remnant.

Absolute contraindications for minimally invasive simultaneous surgery were considered unfitness for surgery due to comorbidities not allowing long operative time, the number of lesions in parenchymal sparing surgery (generally \>5), the pre-operative prediction of vascular resection.

Relative contraindications were considered the need for major hepatectomy and the finding of new intraoperative lesions, with consequent potential longer operative time.

Demographic, histopathological, surgical morbidity/mortality and short term peri-operative clinical outcome in all patients undergone simultaneous colorectal and liver resections were prospectively evaluated.

Morbidity evaluation included all intra-operative and early post-operative (within 30 days) complications and rated according to Clavien-Dindo classification.

All data are expressed as mean values ± range when appropriate

Eligibility Criteria:
Inclusion Criteria:

* colorectal primary tumor with synchronous liver metastases
* eligibility for minimally-invasive surgery

Exclusion Criteria:

* unfitness for prolonged operative time
* liver lesions \>5
* pre-operative prediction of vascular resection
International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.


Eligibility Criteria:
Inclusion Criteria:

* Patient receiving a comprehensive information about the study, and not opposed to participate
* Age ≥ 18 yo
* Classification of definite APS according to revised Sapporo-Sydney criteria
* Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months

Exclusion Criteria:

* Incomplete revised Sapporo-Sydney criteria
* No data regarding the recurrent thrombosis
* Pregnant woman
* Age \< 18 yo
Safety and Performance of a Fetal Monitoring System

The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent and follow study instructions
* 18 years of age or older
* Pregnant subjects ≥ 32 weeks' gestation
* Singleton pregnancy
* BMI ≥15, pre-pregnancy
* BMI ≤45, pre-pregnancy
* Belly circumference ≥80 cm and ≤ 130 cm

Exclusion Criteria:

* Known major fetal malformation or chromosome abnormality
* Abdominal medical skin conditions, including surgical incisions, open wounds with our without infections, edema, or irritation
* Participants with implanted electronic devices (pacemakers, defibrillator, etc.)
* Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study
* Medical or obstetric problem that in the investigator's opinion would make the participant incapable of taking part in the study
* In the investigator's opinion, the participant is not likely to be available for the minimum 60 minutes of the monitoring session
* History of skin allergies to cosmetics and lotions
* Known allergies to silver, nylon, or polyester