cyrilzakka/clinical-trials huggingface dataset:
Handheld ECG Tracking of In-hOspital Atrial Fibrillation

This is a single center, open label, randomized control trial to assess the efficacy of a one-lead ECG handheld device (Zenicor) for the detection of previously unknown atrial fibrillation (AF) in hospitalized patients.

All patients admitted to the internal medicine department of the Hospital Fribourg throughout the study period will be screened for study enrollment. Patients \< 18 years, with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial. The study population will consist of approximately 800 patients in each group at the University of Fribourg Medical Center. Patients must meet all eligibility criteria for inclusion into the study.

Patients allocated to the treatment group will undergo twice daily monitoring with the handheld Zenicor ECG. Additional recordings will be obtained whenever patients notice palpitations. Recordings will be obtained in the presence of specially trained nurses. The recordings will then be validated through a web-based interface offered by Zenicor. The one-lead ECGs will be reviewed by the investigating physicians through the Web-based analysis service (Zenicor-ECG Doctor System) to assess the presence of atrial fibrillation.

The primary end point of the study is the percentage of newly detected atrial fibrillation at 6 months


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the internal medicine department of the University and Hospital Fribourg throughout the study period will be screened for study enrollment.

Exclusion Criteria:

* Patients with known or previously documented atrial fibrillation, patients with a cardiac pacemaker, and implantable cardioverter-defibrillator or intra-cardiac monitoring device will be excluded from the present trial.
Pharmacokinetics of Antiepileptics in Patients on CRRT

The purpose of the study is to measure levels of any of the following AEDs (levetiracetam, phenobarbital, phenytoin, ketamine, valproic acid, lacosamide) in blood and effluent on critically ill patients receiving CRRT in order to characterize drug pharmacokinetics and optimize dosing strategies in patients on CRRT.


Eligibility Criteria:
Inclusion Criteria:

* Expected to be on CRRT and receive any of the following for more than 24 hrs
* Expected to survive for more than 24 hrs
* Achievement of steady state drug concentrations prior to study enrollment

Exclusion Criteria:

* Pregnancy
* Age \< 18
* Prisoner
Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap

Comparing the changes of arterial anastomotic blood flow between general anesthesia alone and general anesthesia with epidural anesthesia in patients who undergoing free flap transposition using Duplex ultrasound.

Maintaining adequate blood flow is important on the success of free flap surgery. Epidural anesthesia can influence blood flow during surgery. Therefore, investigators aim to compare the effect of epidural anesthesia combined with general anesthesia and general anesthesia alone on blood flow in arterial anastomosis site of the free flap.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo free flap transfer under general anesthesia.
* 18 years of age or older, under 80 years of age
* Those who voluntarily agreed to participate in this clinical study

Exclusion Criteria:

* If the patient does not agree to participate in the study
* ASA physical status IV or higher
* If the patient was diagnosed with diabetes
* If the patient was diagnosed with chronic renal failure
* If the patient was diagnosed with peripheral vascular disease or hyperlipidemia
* If vasopressors or inotropics was used preoperatively.
* Contraindication of epidural anesthesia such as usage of anticoagulant or abnormalities of laboratory finding.
* If the researcher finds it to be inappropriate
Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis

Takayasu arteritis associated renal artery stenosis (TARAS) is the biggest cause of hypertension in young people \<40 years old. Hypertension caused by renal artery stenosis is usually hard to control in spite of two or more anti-hypertension drugs.

Percutaneous transluminal angioplasty (PTA) is recommended for hypertension caused by TARAS. In previous clinical practice, we observed relatively effects of PTA on controlling the blood pressure in patients with TARAS. But, high re-stenosis rate was also indicated. Drug coated balloon (DCB）is a new type of PTA, which could improve the re-stenosis rate significantly. In the clinical trials of peripheral vascular disease, it has been confirmed that DCB had lower re-stenosis rate than PTA. However, up to date, no studies was found about the use of DBC in TARAS.

Thus, this study was design as a random, double blind trial to evaluated the effects and safety of DCB in the treatment of hypertension caused by TARAS.


Eligibility Criteria:
Inclusion Criteria:

1. 18-60 years old;
2. diagnosed as Takayasu arteritis according to 1990 ACR classification
3. renal artery stenosis is confirmed by imaging results
4. had inactive disease, and the dose of glucocorticoids \<10mg/day
5. blood pressure \>160/90mmHg in spite of two or more antihypertensive drug
6. had no surgery of renal artery, including PTA, stent, or others.

Exclusion Criteria:

1. blood pressure \>200/120mmHg in spite of two or more antihypertensive drug
2. had severe disease conditions
3. allergy to contrast agent
4. had other autoimmune disease
5. had severe abnormal lab test result
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants

The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine in healthy participants.

This is a single-center study with 3 cohorts (groups). Approximately 58 participants will be enrolled in this study. In Cohort 1, approximately 16 participants will be enrolled for up to 78 days and they will receive 4 different single-dose regimens (Treatment A, B, C and D) of intranasal spray of esketamine solution in a crossover manner (participants will be switched from one single-dose regimen to another) and in an open label manner (both the investigator and the participant know the intervention received by the participant). In Cohort 2, approximately 14 participants will be enrolled for up to 35 days and they will receive 1 regimen of intranasal esketamine (Treatment D) in an open label manner. In Cohort 3, approximately 28 participants will be enrolled and they will be randomly assigned to receive either Treatment E (intranasal esketamine spray) or Treatment F (intranasal placebo spray) in a double blind manner (both the investigator and the participant do not know the intervention received by the participant). Safety evaluations will include assessment of adverse events, targeted nasal examinations, laboratory tests, electrocardiogram, physical examination, pulse oximetery, and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Blood pressure between 90 and 145 mmHg systolic and no higher than 90 mmHg diastolic
* A 12-lead electrocardiogram consistent with normal cardiac conduction and function
* Agree to protocol-defined method of contraception
* Comfortable with self-administration of intranasal medication

Exclusion Criteria:

* History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; renal or hepatic insufficiency; thyroid disease; neurologic or psychiatric disease, asthma
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center
* Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or at admission to the study center
* Known allergy to heparin or history of heparin-induced thrombocytopenia
ALS Phase II Study of NX210c

This study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple intravenous infusions of NX210c, at two dose levels, in patients with Amyotrophic lateral sclerosis (ALS).

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that predominantly affects motor neurons of both the brain and the spinal cord. This leads to muscular atrophy and paralysis, with the majority of patients succumbing to respiratory failure 3-4 years from symptom onset. To date, therapeutic options for ALS are limited and there is no curative treatment. Management of ALS is otherwise supportive and palliative.

There is strong evidence for blood-brain and blood-spinal cord barrier dysfunction in the early stages of ALS. Preclinical in vitro and in vivo data have shown that NX210c exhibits important properties that may be suitable for the treatment of neurological disorders in humans i.e., blood-brain barrier (BBB) integrity restoration, neurotransmission enhancement and neuroprotection.

Based on the safety data collected in a first-in-human single ascending dose study and a multiple ascending dose (MAD) study in healthy elderly subjects, NX210c has been demonstrated to be well tolerated and without safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years, inclusive at screening.
* Patients diagnosed as having possible, probable, probable laboratory-supported, or definite ALS according to El Escorial Revised criteria.
* King's Clinical Staging Stage ≤3, disease duration of ≤ 36 calendar months

Exclusion Criteria:

* Patients with any cognitive or psychological disorder, intellectual disability or other significant impairment that would result in an inability to understand and sign the informed consent.
* History of any clinically significant or unstable medical, neurological, psychiatric condition, disorder or disease (other than ALS) or social circumstances that, based on the investigator's judgment, would interfere with the conduct of the study or pose a risk to the patient if they were to participate.
Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium

This study evaluates the potentiation of muscle relaxation caused by rocuronium by inhalational agent sevoflurane. Half the patients will be ventilated with oxygen ,nitrous oxide and sevoflurane during induction of anaesthesia and half will be ventilated only with oxygen and nitrous oxide.

Rocuronium is a non depolarizing muscle relaxant. Inhalational general anaesthetic agents like Sevoflurane have some muscle relaxation effect by depressing the spinal motor neurons. Inhalational anaesthetics also alter the tonic input received from descending modulatory systems from the brain. Deep anaesthesia with inhalational agents may cause some degree of neuromuscular blockade.

Eligibility Criteria:
Inclusion Criteria:

* American society of anaesthesiologists physical status 1 and 2
* Age between 18-65
* Mallampatti classification 1 and 2

Exclusion Criteria:

* Patients refusal to participate
* American society of anaesthesiologists physical status 3 and 4
* Mallampatti classification 3 and 4
* Patients with neuromuscular disorder
* Patients on medications that affect neuromuscular block
* Pregnant and lactating patients
Analysis of the Genotype/Phenotype Relationship in the Fuchs' Corneal Endothelial Dystrophy in France.

The pathophysiology of the most common corneal endothelial dystrophies (Fuchs' Corneal Endothelial Dystrophy (FECD)) is beginning to be dismembered. One of the most common genetic anomalies is a triplet repetition in one of the introns of the Transcription Factor 4 (TCF4) gene located on chromosome 18. However, the number of repetitions varies greatly from one patient to another.

The intent of that study was to analyse if there is a relationship between the number of triplet repetitions and the rate of disease progression. This knowledge would make it possible to personalize the care.

Eligibility Criteria:
Inclusion Criteria:

For patient group:

* \>18 years old
* affiliated with or entitled to a social security scheme
* having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study
* with an Fuchs Endothelial Corneal Dystrophy (FECD) certified by slit lamp examination

For control group:

* \>18 years old
* affiliated with or entitled to a social security scheme
* having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

For patient group:

* Patients under guardianship or curatorship
* Patient planning to move within the year
* With no evidence of ophthalmological pathology requiring intraocular surgery within one year of the first visit
* Better initial corrected visual acuity \<1/10
* Not having had intraocular surgery in the 6 months prior to inclusion (after 6 months, the endothelium is considered stabilized)
* Not having any other progressive pathology responsible for a decrease in visual acuity (significant cataract Lens Opacities Classification System (LOCS) \>2 ; progressive retinal pathology, in particular age-related macular degeneration, unstabilized macular edema)

For control group:

* Patients under guardianship or curatorship
* with an Fuchs Endothelial Corneal Dystrophy (FECD) certified by slit lamp examination
Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients

Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.

An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.

The duration of the study will be of 6 months approximately, including 6 months of product intake.

Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 to 7 years old.
* Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification.
* Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).
* Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.

Exclusion Criteria:

* With intake of antibiotics in the last month.
* With intake of probiotics in the last two weeks.
* Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.
* Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).
* Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc.
* Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
* Congenital or acquired immunodeficiency.
* Immunocompromised (e.g., cancer and/or transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system).
* Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol.
* With oral hyper sensitivity impairments that prevent the uptake of the study product.
Comparison of FAUCS vs. Misgav Ladach

This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such comparison has not been done so far, and this study will examined if indeed the FAUCS techniques offers any advantages.

The FAUCS technique for performing a cesarean section has been described by a French group several years ago, and is claimed to reduce postoperative pain and increase ambulation. With this technique, after making the transverse skin incision, the fascia is opened vertically and to the left of the linea alba. The left rectus abdominis muscle is then pushed laterally, and the abdominal cavity is entered. The uterine incision in performed as usual. Due to the reduced incision size, a special spatula is used to facilitate extraction of the fetal head in some cases. No urinary catheter is used during or after the operation, and fluid administration is restricted during the procedure. The patient is encouraged to get out of bed 3-4 hours post surgery. This technique for performing a cesarean section will be compared with the traditional (Misgav Ladach technique) in terms of post-operative pain, need for analgesics, ambulation, neonatal outcome, and perioperative complications.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for a cesarean section
* term pregnancy: 37-42 weeks
* singleton pregnancy
* age 18 and above
* patients capable of signing an informed consent

Exclusion Criteria:

* multiple pregnancy
* emergency cesarean
* previous 3 cesareans and above
* placenta accreta
* uterine myomas in the lower segment
* fetal growth restriction
* fetal anemia
* preeclampsia
* women scheduled for general anesthesia
Assessing Perfusion of Osteotomized Scapula and Lat Flap

The gold standard for reconstruction of the jaw is the utilization of a bone free tissue transfer. Scapula reconstruction is an excellent option for elderly patients, those with significant comorbidities and for complex defects with large soft tissue reconstructive requirements. The scapula is supplied by the angular artery and circumflex scapula arteries. No studies have shown with objective measures, the viability of the lateral border of the scapula bone supplied by either the angular artery or circumflex scapula arteries. The aim of this observational study is to demonstrate with objective clinical measures, via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including with a single osteotomy giving two bone segments, in 30 patients who will undergo reconstructive head and neck surgery at LHSC.

The aim of this follow-up observational study is to demonstrate with objective clinical measures via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including a single distal osteotomy segment. 30 patients undergoing mandible or maxillary reconstruction with the scapular tip flap will be included. An osteotomy will be performed at up to 8cm from the scapular tip. The adequacy of blood supply to the scapula tip flap after a distal osteotomy and the latissimus dorsi muscle component of the flap will be measured intraoperatively, using SPY-Q software analysis.

Eligibility Criteria:
Inclusion Criteria:

* • Adult patients (18 years and older) seen at the head and neck clinic at London Health Sciences Centre (LHSC)

  * Planned to undergo a maxillary and/or mandibular reconstruction surgery with a scapular tip flap

Exclusion Criteria:

* • Younger than 18 years of age

  * History of failing microvascular flaps
  * Hypersensitivity toward ICG or related substances (e.g., imaging agents), defined as (based on ICG product monograph): possibly life-threatening dizziness, severe itching, hives, nausea, difficulty breathing, rash, low blood pressure)
  * Pregnant
  * Breastfeeding
  * Clinically apparent cognitive impairment
Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis

Psoriasis presents an independent cardiovascular risk factor characterized by chronic low-grade systemic inflammation and oxidative stress which altogether might lead to endothelial dysfunction. It has been reported that increased oxidative stress has a pivotal role in high dietary sodium-induced endothelial dysfunction. Previous studies on sodium accumulation in psoriatic skin lesions and the sodium-induced augmentation in Th17 immune response, raise the question on the complex interplay between sodium and psoriasis, especially in the context of cardiovascular morbidity.

This study aimed to investigate the effect of a 2-week low-salt diet on endothelium-dependent and endothelium-independent cutaneous microvascular vasodilation and Th17-Mediated Inflammation in patients with psoriasis vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosed psoriasis vulgaris
* subjects do not use topical corticosteroid therapy for at least 2 weeks before inclusion in the study and 2 weeks during the study
* subjects do not use systemic or biological therapy for at least 3 months before and 2 weeks during the study.

Exclusion Criteria:

* age \< 18 years
* existence of other immune-mediated diseases (with the exception of autoimmune thyroid diseases and psoriatic arthritis - people with these comorbidities can be included)
* malignant diseases
* current infectious diseases and allergic reactions within 6 weeks before the start of the study
ZD6474 Phase IIa Dose Finding Multicentre Study

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent.
* Life expectancy of 12 weeks or longer.

Exclusion Criteria:

* Pregnancy, breast feeding or female patients wishing to become pregnant.
* Treatment with a non-approved or investigational drug within 30 days before enrolment