cyrilzakka/clinical-trials huggingface dataset:
Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest

Despite advances in post-resuscitation care of patients with cardiac arrest (CA), the majority of survivors who are treated after restoration of spontaneous circulation (ROSC) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state.

Early prognostication in comatose patients after ROSC remains challenging. Recent recommendations suggest carrying out clinical and paraclinical tests during the first 72 h after ROSC, to predict a poor neurological outcome with a specificity greater than 95% (no pupillary and corneal reflexes, bilaterally absent N20 somatosensory evoked potential wave, status myoclonus, highly malignant electroencephalography including suppressed background ± periodic discharges or burst-suppression, neuron-specific enolase (NSE) \> 60 µg/L, a diffuse and extensive anoxic injury on brain CT/MRI), but with a low sensitivity due to frequent confounding factors.

The heart rate variability (HRV) is a simple and non-invasive technique for assessing the autonomic nervous system function. In patients with a recent myocardial infarction, reduced HRV is associated with an increased risk for malignant arrhythmias or death. In neurology, reduced HRV is associated with a poor outcome in severe brain injury patients and allows to predict early neurological deterioration and recurrent ischemic stroke after acute ischemic stroke.

A reduced HRV could be a sensitive, specific and early indicator of diffuse anoxic brain injury after CA.

This multicenter prospective cohort study assesses the added value of early HRV (within 24h of ICU admission) for neuroprognostication after cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* Admitted in intensive care unit (ICU) after resuscitation from cardiac arrest (in-hospital or out-of-hospital)
* Coma (Glasgow score \< 8) after ROSC, requiring sedation and targeted temperature management for at least 24h

Exclusion Criteria:

* Dying patient (Limitation of life support techniques at admission to the ICU)
* Non-Sinus Rhythm
* Pregnant or breastfeeding women
* Patient under protection of the adults (guardianship, curators or safeguard of justice)
* Opposition by the trusted person or by the patient once he/she wakes up
Glucocorticoids and Skin Healing in Diabetes (GC-SHealD)

The study aims to investigate effects of inhibiting glucocorticoid activation on skin function and wound healing in patients with type 2 diabetes. Half of patients will be given a drug to inhibit glucocorticoid activation and the other half will be given a placebo.

Glucocorticoids are known to impair skin function and wound healing which are also compromised in patients with type 2 diabetes. The enzyme 11 beta-hydroxysteroid dehydrogenase type 1 (11β-HSD1) activates glucocorticoids in target tissues including skin. Pre-clinical data demonstrate that 11β-HSD1 inhibition improves skin function and wound healing but this has not been investigated in man.

Using the 11β-HSD1 inhibitor AZD4017, we will investigate if

1. Oral AZD4017 inhibits 11β-HSD1 activity in skin
2. AZD4017 is safe and well-tolerated in patient with T2DM
3. Oral AZD4017 regulates skin function
4. Systemic glucocorticoid levels and skin 11β-HSD1 activity, independently or in combination correlate with measures of skin function

Study feasibility will also be assessed; if successful, data from this pilot study will inform power calculations for a future trial to investigate the ability of 11β-HSD1 inhibition to promote foot ulcer healing in type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to consent
2. Type 2 diabetes with HbA1c ≤11% (≤97 mmol/mol) at screening while taking standard therapy at a stable dose for ≥10 weeks

Exclusion Criteria:

1. Women of child-bearing potential
2. Active leg/foot ulceration
3. Clinically relevant acute electrocardiogram anomalies
4. Uncontrolled hypertension
5. Endocrine disorder (other than type 2 diabetes ), including type 1 or secondary diabetes (except treated hypothyroidism)
6. Gilbert's disease
7. Alanine aminotransferase and/or aspartate aminotransferase and/or alkaline phosphatase \>1.5x upper limit of normal (ULN)
8. Bilirubin \>1.5x ULN
9. Estimated glomerular filtration rate \<45 ml/min/m2
10. Creatine kinase \>2x ULN
11. Drug abuse within the last year
12. Any glucocorticoid treatment within 3 months of screening
13. Anti-coagulant medication
14. Probenecid therapy
15. Medical/surgical procedure or trauma during drug administration or one week after drug cessation (excluding skin biopsies)
16. Involvement in trial planning and/or conduct
17. Participation in other clinical study within 1 month
18. Deemed inappropriate to participate by the trial team
A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

The purpose of this study is to test if a nerve block procedure called a stellate ganglion block can help decrease the chance of atrial fibrillation after surgery. Atrial fibrillation is the abnormal, fast beating of the upper chambers of the heart. Stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation.

The investigator hypothesizes that stellate ganglion blockade with local anesthetic performed prior to cardiac surgery will reduce the incidence and duration of postoperative atrial fibrillation (POAF).

Specific Aim 1: Determine the incidence of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week.

Specific Aim 2: Determine the duration of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week.

Specific Aim 3: Determine the success rate of the block as evaluated by ipsilateral hand temperature change and skin sympathetic nerve activity (SKNA).

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.
* Patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting.

Exclusion Criteria:

* Patients with a history of permanent atrial fibrillation, left or right ventricular assist device implantation or explantation.
* Patients with procedures not requiring cardiopulmonary bypass.
* Patients with procedures requiring deep hypothermic circulatory arrest.
* Patients with active infection or sepsis.
* Pre-operative immunosuppressive medication use (including steroid use).
* Pre-operative anti-arrhythmic medication use (aside from beta-blockers).
* Patients with Immunodeficiency syndrome.
* Patients with known neurologic disorder.
* Patients requiring left internal jugular central line placement.
* Performance of Maze procedures or left atrial appendage ligation procedures will not exclude patients from potential enrollment as atrial fibrillation still occurs postoperatively while the scarring from the Maze procedure forms.
Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes

This study examined the effect of a high protein or high carbohydrate breakfast on the glucose and insulin response following the breakfast meal, as well as the subsequent response following the lunch meal.

Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study. They completed two, 7-day conditions in random order with a minimum of a 7-day washout period between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO) breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at 0700 hours following a \~12 hour overnight fast and underwent forearm catheterization before a baseline blood draw. The participants consumed the respective breakfast at \~0730 hours. Four hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken continuously throughout the 8-hour test day.

Eligibility Criteria:
Inclusion Criteria:

* 21-55 y of age
* body mass index (BMI) between 30-40 kg/m2
* weight stable for the prior 6 months
* non-smokers
* minimal alcohol consumption (\< 2 drinks per day)
* type 2 diabetic (diagnosed ≥ 2 y)
* a fasting glucose level above 120 mg/dL
* HbA1c between 6.5-9.0%

Exclusion Criteria:

* insulin
* β-blockers
* GLP-1 agonists (e.g. exenatide)
* dipeptidyl peptidase (DPP) inhibitors
* weight loss
* using weight-loss medications
* pregnant or lactating
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy

The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps \<=3mm during colonoscopy.

The details of the proposed study are as follows:

1. Experimental group: using cold forceps for polyps \<=3mm of the colon
2. Control group: using cold snare for polyps \<=3mm of the colon
3. Methods:

   1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
   2. If polyps \<=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare.
   3. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
   4. The polyp as well as well as the two biopsies are reviewed by a pathologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Polyps \<=3mm

Exclusion Criteria:

* Pregnant
* Inflammatory bowel disease
* Polyposis syndromes
Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.


Eligibility Criteria:
Inclusion Criteria:

* Partial onset seizures, incompletely controlled on 1-3 medications
* At least 1 seizure per 28 days, on average

Exclusion Criteria:

* Primary generalized seizures
* Progressive CNS pathology
Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique

Cardiac output (CO) is an important hemodynamic variable in the management of critically ill patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential complications and there is increasing interest in less invasive methods of measuring CO. This study is designed to compare CO values from PAC thermodilution (COTD) and ultrasound dilution (COUD).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Presence of arterial catheter plus central venous pressure monitor and pulmonary artery catheter for hemodynamic monitoring.

Exclusion Criteria:

* Age \< 18 years of age
* Patients with structurally abnormal heart (e.g. shunt) (confirmed by history taking)
* Patients who have heparin allergy. (Confirmed by history taking)
Determination of the Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients

the study is to investigate the relationship of several parameters of complete blood count (CBC) including RDW with N-terminal pro-B-type natriuretic peptide (NT-proBNP) and cardiac troponin T (cTnT) in a cohort of acute myocardial infarction (AMI) patients.

Patients and methods:

* Type of study: Observational prospective study
* Place of study: Sohag cardiology and gastroenterology center, department of cardiology and cardiac care unit.
* Ethical considerations: This research will be revised by the Scientific Ethical Committee of Sohag University Hospital. Consents will be taken from all patients.
* Study Methods:

  * A prospective study on 30 patients diagnosed as acute myocardial infarction on which measurement of CBC, serum NT-proBNP, and cTnT levels will be performed at the time of admission and by the time of discharge.

    1. Full history:

       1. Personal history: e.g. age, sex and smoking.
       2. Family history of cardiac diseases
       3. Medical history of: Hypertension, Ischemic heart disease, prior coronary artery bypass grafting, Prior Percutaneous coronary intervention, Prior Stroke, Prior Atrial fibrillation, therapeutic history
    2. Detailed clinical examination
    3. Electrocardiogram
    4. Laboratory investigation:

       1. Routine investigation in the form of CBC including RDW
       2. Specific investigation which include NT-proBNP and cTnT

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as acute myocardial infarction

Exclusion Criteria:

Patient with

* Decompensated heart failure
* Pulmonary hypertention
* Acute pulmonary embolism
* Septic shock
Automated Respiration Rate to Improve Accuracy of the Electronic Cardiac Arrest Risk Triage Score (eCART) Algorithm

Currently, breathing rate and heart rate are checked by nursing staff manually every few hours and entered into a patient's medical record. The investigators are doing this study to see if a device that will automatically record breathing rate and heart rate every 15 minutes is as accurate as the manual measurement. The investigators will also see if these measurements, taken every 15 minutes, will help us predict adverse events more quickly and accurately than the measurements taken every few hours.

Both cardiac arrest and sepsis are primarily identified by vital sign abnormalities. However, the practice of nurses and their designees routinely checking hospitalized patients' vital signs every four to eight hours throughout the day and night has remained essentially unchanged for over one hundred years. While respiratory rate has been shown to be the most predictive vital sign for adverse events on the wards, it is often inaccurately measured and poorly documented. For example, a disproportionate amount of respiratory rates are recorded as either 18 or 20 breaths/min, which is often higher than actual rates.

We have previously statistically derived a physiology-based early warning score, called the electronic cardiac arrest risk triage score (eCART), using vital signs and lab values. The eCART was more accurate than scores commonly used in hospitals today. However, the vital sign values utilized for our score were manually collected by nursing staff every four hours. Recent technological advances have allowed for high-frequency measurement of pulse and respiratory rate using a cableless respiration monitor. These devices allow for more frequent and potentially more accurate measures of respiration, which may enhance the prediction ability for detecting adverse events on the wards. In addition, the increase in monitoring frequency may result in earlier detection of adverse events, which could translate into further improvements in patient outcomes.

A subset of patients may be continuously measured using a telemetry system. The alarms and ECGs from these patients are monitored by staff in a centralized station in the hospital. When a clinical event requiring action is observed, a call is made to the unit alerting the clinical staff that action is necessary. We will collect the continuous measurements collected from this system and compare these continuous measurements to the high frequency and manual measurements.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* able to provide written consent

Exclusion Criteria:

* none
Impact of a Self-hyPnOsis Practice on Chronic StresS Among Caregivers of Elderly People With Loss of Autonomy at Home

In France, stress particularly affects family caregivers because of the intensive help they provide on a permanent basis to people losing their autonomy at home. This care work is often considered as a "burden" and has all the characteristics of a chronic daily stress factor. The prevalence of stress among caregivers is high and the level of stress varies according to the type of care provided to seniors at home.

This chronic stress has harmful effects on the health of family caregivers (depression, fatigue, insomnia, onset of chronic diseases, early mortality). It can be detrimental to their well-being and quality of life.

However, ageing well at home for older people is based on this essential pillar: the caregivers. They must remain in good physical and psychological health. Reducing their daily stress is becoming a public health challenge and a national priority.

Currently, the management of caregiver stress is based on several measures and devices. Non-conventional care practices such as Mindfulness-Based Stress Reduction, meditation, relaxation and yoga are offered to family caregivers. Initial results of studies on the effect of these complementary medicines show an improvement in psychological stress. However, research in this field is relatively recent. The conclusions must therefore be approached with caution. Moreover, no medium or long-term evaluation has been found in the scientific literature.

Self-hypnosis is becoming a common practice in healthcare. It has demonstrated its effectiveness in reducing pain and anxiety in both adults and children. In addition, other recent scientific evidence supports the effectiveness of hypnosis in stress management. In France, no study on caregiver stress and its management by self-hypnosis has been identified in the literature. The hypothesis is that the stress level of caregivers of elderly people at home could be reduced through daily self-hypnosis practice at home.


Eligibility Criteria:
Inclusion Criteria:

* Stress \> or = 3 evaluated by the analogic visual scale of CHAMOUX
* Caregiver at home for a person uper than 60 years old with a loss of autonomy and followed in geriatrics or in polyvalent medicine
* Daily help in at least one of the 3 spheres of the elderly activity
* Person providing care services for more than 2 years with the elderly
* Person who can read and write
* Person affiliated to a social security scheme
* Person who gives his oral express consent
* Person who lives in Reunion Island

Exclusion Criteria:

* Person with serious chronic disorder (cancer for example)
* Person with a contraindication to hypnosis (cognitive and psychiatric disorders or alcohol dependence)
* Person under specific treatment preventing them from performing the intervention consistently
* Person who has already practiced hypnosis
Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals

Makers of ionic foot baths claim that their machines can eliminate heavy metals from the body. Researchers at the Canadian College of Naturopathic Medicine are evaluating the ability of an ionic foot bath to help eliminate heavy metals from the body by rigorously testing the machine under controlled conditions. The machine will first be tested without feet under normal operating conditions and again after operation under normal conditions with foot immersion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Adults

Exclusion Criteria:

* A wearer of a pacemaker or any other battery operated or electrical implant
* Pregnant or nursing women
* On heartbeat regulating medication
* On blood thinners (anticoagulants)
* On any drug known to have chelating properties
* Have had an organ transplant or a metal joint implant
* On a medication the absence of which would mentally or physically incapacitate them, e.g., psychotic episodes, seizures, etc.
A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers

This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine.


Eligibility Criteria:
Inclusion Criteria:

* Must give written and informed consent and any authorizations required by local law.
* Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2, inclusive

Exclusion Criteria:

* Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
* History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
* Positive drug or alcohol test at screening or prior to the first dose of study drug
Laboratory Assessment of the Concentration of Direct Oral Anticoagulants in Patients With Atrial Fibrillation

The incidence of thromboembolic and bleeding event associated with catheter ablation for atrial fibrillation(CAAF) varies from 0.9% to 5% during peri-operative period. Direct oral anticoagulants (DOAC) (such as Rivaroxaban, Dabigatran and Edoxaban) are gradually applied in clinical practice to prevent thrombosis events in patients with AF, but studies have shown that DOAC are also affected by surgery, an invasive procedure, sub-therapeutic, food, renal function and age. However, the pharmacokinetic and pharmacodynamic of DOAC during the peri-operative period of CAAF were lacking in China. The purpose of this study was to evaluate the pharmacokinetics and pharmacokinetics of DOAC in patients with peri-operative atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Non-valvular atrial fibrillation(NVAF) undergoing catheter ablation
* Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran)are administered peri-operatively during catheter ablation.

Exclusion Criteria:

* Patients who have taken direct oral anticoagulants or warfarin before admission.
* Cross-replacement of oral anticoagulants, such as taking dabigatran before surgery and replacing Rivaroxaban after surgery.
* Abnormal coagulation tests (prothrombin time, partial thrombin time, thrombin time, antithrombin activity).
* Pregnant and lactating women.
Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up

Two groups with retruded chin skeletal deformity. one treated with patient specific alloplastic implant and the other was treated with computer guided advancement genioplasty. soft tissue assessment was executed after one year


Eligibility Criteria:
Inclusion Criteria:

* Patients whose clinical features revealed possible correction of their facial deformity using chin surgery only
* No prior surgery involving the chin

Exclusion Criteria:

* Patients whose clinical features revealed possible correction of their facial deformity using mandibular surgeries.
* Patients with systemic diseases that carried high risk for general anesthesia.
A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.

Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);

Exclusion Criteria:

* Body mass index (BMI) of \>39 kg/m2;
* Pregnancy or intent to become pregnant
* Planned surgical procedure during the duration of the study
* History of clinically significant cardiovascular, central nervous system or psychiatric disease
* Previous exposure to exogenous NGF or to an anti NGF antibody;
* Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions