cyrilzakka/clinical-trials huggingface dataset:
Effects of Electrical Baroreflex Stimulation on Sympathetic Activity, Renal Hemodynamics, and Insulin Sensitivity

Electrical stimulation of carotid baroreceptors (baropacing) acutely decreases arterial pressure in patients with refractory hypertension. The reduction in blood pressure seems to be mediated through sympathetic inhibition with concomitant reduction in the activity of the renin-angiotensin system. Indeed, switching on and off the stimulation is accompanied by decreases and increases in central sympathetic vasoconstrictor outflow, respectively. Plasma renin concentration also decreases with acute electrical baroreflex stimulation.

In some patients chronic baropacing is associated with long-term blood pressure reduction.

However, there is sparse information as to the relative contribution of blood pressure regulating systems to account for the acute and chronic effects of baropacing. Sympathetic, renal, and vascular mechanisms are of special interest. Furthermore, technical aspects of electrical baroreflex stimulation may play a role, e.g. worsening of the electrical contact between the stimulating electrodes and the baroreceptor afferents.

This study is designed to answer the following primary questions:

1. Does chronic electrical stimulation of carotid baroreceptors inhibit sympathetic vasoconstrictor tone also in the long-term?
2. Does sympathetic vasoconstrictor tone increase on switching off chronic baropacing? Such an increase would confirm electrical integrity of the system and proper contact to the baroreceptor afferents.
3. Does acute electrical baroreflex stimulation decrease renal vascular resistance?
4. Does acute electrical baroreflex stimulation influence glucose delivery to skeletal muscle and change insulin sensitivity? The study follows an open-label observational design and it is planned to recruit up to 30 patients over 3 years.


Eligibility Criteria:
Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for enrollment in the study:

* Adult patients having an implanted device for electrical baroreflex stimulation.
* Signed written informed consent.

Exclusion Criteria:

Subjects meeting all of the following criteria will be excluded from the study:

ReSy Study - Protocol version: December 20, 2010 8

* Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
* Subject unlikely to comply with protocol, e. g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
* Pregnancy. Breast-feeding.
* History of hypersensitivity to inulin or paraaminohippurate or to drugs with a similar chemical structure have to be excluded from the constant-infusion procedure.
* History of drug or alcohol abuse.
* Blood donation of more than 500 mL during the previous 3 months (men) or 6 months (women).
Laser Cataract Surgery With the Femtosecond Laser Technology

The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
* Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.
* The surgeon may use the Mento Potential Acuity Meter (PAM)laser interferometer, McIntyre Pinhole, or his/her judgement to estimate the patient's potential acuity.

Exclusion Criteria:

* Concurrent participation or participation in the last 30 days in other clinical trials.
* Known steroid IOP responder.
* Taking medications that may affect vision, IOP, or ease of cataract surgery (e.g. Flomax, Glaucoma medications, etc.).
* Acute or chronic disease or illness that would increase risk or confound study results(e.g. uncontrolled diabetes mellitus, immunocompromised, etc.).
* Uncontrolled systemic or ocular disease.
* Corneal abnormalities (e.g. stromal, epithelial, or endothelial dystrophies)
* Pseudoexfoliation.
* Ocular hypertension (\>or =20hg) or glaucomatous changes in the optic nerve.
Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program

In this randomized controlled trial; differences in overall stress, burnout and wellbeing will be assessed for employees of a company participating in Inner Engineering Online, an online mind-body course that incorporates both meditation and yoga.

The study will be conducted in two phases, where in participants will be advised to practice meditation or read books.

The benign behavioral intervention involved is Inner Engineering Online (IEO), a mind-body course that incorporates meditation and yoga, as well as reading a book or journal of their choice.The subjects will be randomized into two groups after they agree to the participate in the study. The study will be conducted in 2 phases.

Phase 1: If they are in group 1, they will participate in IEO which includes practice of meditation \& yoga daily for a minimum of 30 minutes and complete a IEO activity log for 30 days.They will be asked to complete a set of questionnaires at baseline and after 30 days.If they are in group 2, they are asked to read a book or journal of their choice for 30 minutes each day for the first 30 days and complete a reading log.

Phase 2: After they complete reading for 30 days, group 2 participants will now participate in IEO which includes practice of meditation \& yoga daily for a minimum of 30 minutes and complete an IEO activity log for the next 30 days. They are asked to complete a set of questionnaires at baseline, 30 days, and at 60 days.

These questionnaires aim to assess for burnout, stress, and well-being. These include:

* Maslach Burnout Inventory - Human Services Survey - 16 item questionnaire measuring burnout
* Perceived Stress Scale - 10 item questionnaire measuring stress
* Center for Epidemiology Studies depression Scale (CES-D) - 20 item questionnaire measuring depression
* Emotional Distress and Anxiety Short Form - 7 item questionnaire measuring anxiety
* Joy subscale of the Dispositional Positive Emotion Scale - 6 item questionnaire measuring happiness
* Mindful Attention Awareness Scale - 15 item questionnaire measuring mindfulness

Finally, participants of both the groups will be subjected to a 30 day follow-up surveys after a month of IEO completion. They will receive a set of previously administered questionnaire and a compliance survey at this point. Group 1 participants receive this survey at the 60 day time point while Group 2 participants receive it at 90 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age\>=18 years
2. Interest in Inner Engineering Online Program

Exclusion Criteria:

1. Low English Proficiency
2. Not currently residing in United States
A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Communicating Hydrocephalus Undergoing Lumboperitoneal Shunt Surgery

Target population: patients 18 years of age or older who require surgical treatment with lumboperitoneal shunt surgery for traffic hydrocephalus Estimated sample size: 30 cases. Study design: this study is a multicenter prospective observational study, with lumbar puncture pressure measurement before and during surgery, and shunt valve setting pressure set according to the requirements of clinical practice in the hospital where it is performed, and the collection of relevant data, including preoperative lumbar puncture pressure, intraoperative lumbar puncture pressure after anesthesia, shunt valve initial pressure, shunt valve pressure at 6 months pressure, length of the intravertebral shunt, and length of the intraperitoneal shunt. Complications, shunt effects, and the number of shunt valve adjustments during the 6-month period were also observed and recorded.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 years or older;
2. Confirmed diagnosis of communicating hydrocephalus;
3. Signed informed consent for surgery and informed consent for research.

Exclusion Criteria:

1. Pregnant women;
2. Inappropriate for lumboperitoneal shunt surgery despite the diagnosis of communicating hydrocephalus.
Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes.

The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity.

The prevalence rate of stroke increased by 106.0% (93.7-118.8) from 1990 to 2019 in China, and stroke burden is still severe. Community ambulation is an important factor that influences health-related quality of life after a stroke.In daily living, effective community ambulation requires the ability to maintain balance and walking function while engaging in other tasks that demand attentional resources simultaneously (i.e., dual-tasking). Increasing evidence has shown that stroke patients have more problems with dual-task balance and walking function than their age-matched able-bodied peers. stroke individuals were found to have more reduction in both the walking speed and cognitive recall than control group during walking with remembering a shopping list. Hence, since stroke victims must reintegrate into community, this kind of cognitive-motor interference needs to be thoroughly studied.

Eligibility Criteria:
Inclusion Criteria

Clinical diagnosis of stroke, Stroke onset of more than 6 months Aged 50 or more Capable of following verbal instructions Having a Montreal Cognitive Assessment score≥22, Able to walk for 1 minute without physical assistance Not receiving any formal rehabilitation training Having a Fugl-Meyer Ankle dorsiflexion-standing position score≥1

Exclusion Criteria

Contraindications to exercise (e.g., unstable angina) Contraindications to MRI (e.g., pacemaker) Color blindness Neurological disorders Gait-precluding pain Comorbidity
Hypoglycemia in Hospitalized Patients

Patients with diabetes who develop low blood sugars (hypoglycemia) in the hospital are at risk for losing the ability to develop symptoms that warn them that they are having a low blood sugar. There is almost no available information investigating how the inability to feel symptoms of a low blood sugar contributes to the risk of this happening when people with diabetes are hospitalized. The purpose of this study is to develop a symptom score model that will help to identify patients at risk for low blood sugars in the hospital and to examine what happens to patients who do experience a low blood sugar in the hospital.

Patients who develop recurrent hypoglycemia are predisposed to developing hypoglycemia-associated autonomic failure (HAAF, impaired awareness). There is almost no information investigating the contribution of HAAF as a risk factor for hypoglycemia in hospitalized patients. Our central aim is to develop a validated inpatient hypoglycemic symptom score model to examine HAAF and its correlation with cognitive dysfunction, re-hospitalization rates, inpatient morbidity and mortality.

This will be a prospective non-blinded study performed in a tertiary care center that will include non-critically insulin treated patients with Type 1 and 2 Diabetes. We will identify patients who have experienced moderate hypoglycemia (40-70 mg/dl) or severe hypoglycemia (\< 40 mg/dl) within the prior 24 hours by daily generated computerized reports. Participants will be asked to complete a Hypoglycemia Symptom Scores Questionnaire and cognitive testing within 24-36 hours post event. Participants will be contacted at 6 and 12 months following the index hospitalization to obtain information regarding recurrent episodes of hypoglycemia, need for re-hospitalization, and occurrence of any new diabetes related complications.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes
* Non-critically ill hospitalized surgical and medical patients
* Anticipated length of stay (LOS) \>3 days
* Anticipated life expectancy \> 1 year
* Mentally competent individuals

Exclusion Criteria:

* Patients who are admitted for hypoglycemia or Diabetic Ketoacidosis
* Anticipated LOS \<3 days
* Mentally incompetent individuals defined as any patient with evidence of dementia or delirium recorded in their medical history or progress note
* Patients receiving Total Parenteral Nutrition
* Treatment with high dose narcotic medications
* Patients who would not be able to follow up at 3 to 6 and 9-12 months by telephone call
* Patients with expected life expectancy \< 1 year
Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation

This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment

Exclusion Criteria:

* Age less than 18 years
* Treatment with UDCA within one month before operation
* Inability to provide written informed consent prior to study entry
* Non-liver organ(s) failure prior to entry
ECG Vector Determination

This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.

This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data and determine the process for proper generator and lead placement. The study will be conducted in two phases: Phase I includes ECG data collection from human subjects; Phase II, the Implant Instructions for Use will be evaluated by Cyberonics' Clinical Engineers based on the activities of five to eight experienced VNS surgeons.

Eligibility Criteria:
Inclusion Criteria:

1. At least 12 years old and in general good health for Phase I. At least 18 years old and in general good health for Phase II.
2. Patients or their guardians must be willing to provide signed informed consent/assent and HIPAA authorization. Note: Patients diagnosed with epilepsy and taking at least 1 antiepileptic medication are desired but not required for the study.

Exclusion Criteria:

1. History of pathologically significant cardiac arrhythmias including but not limited to atrial fibrillation or flutter, chronotropic incompetence, supraventricular tachycardia, ventricular flutter or fibrillation, or implantation of a permanent cardiac pacemaker or defibrillator.
2. Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI.
3. History of physical adverse reaction to adhesive electrodes.
Comparison Between Two Different Distention Medium in Diagnostic Hysteroscopy

The investigators aim to enroll 2000 patients to undergo diagnostic hysteroscopy for suspected uterine pathologies. Women will be randomized into two groups on the basis of distension medium : group A CO2; group B physiological solution. Pain discomfort will be evaluated after the examination.


Eligibility Criteria:
Inclusion Criteria:

* suspected uterine pathologies
* infertility

Exclusion Criteria:

* pregnancy
* severe hypertension, cardiovascular disease or respiratory disease
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy

The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic prostatectomy.

The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia with propofol and remifentanil and the optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

Patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate cancer and who are 20 years of age or older and under 80 years of age and who agree to participate in this study.

Exclusion Criteria:

Patients with a history of cerebral hemorrhage or cerebral infarction, Patients \< 20 years of age, Patients ≥ 80 years of age, Patients with unexpected hemodynamic instability during surgery, Failure to measure optic nerve sheath diameter.
The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Elderly patients, including those who have had a stroke, are more at risk of undernutrition than other groups because of reduced nutritional reserves, prolonged hospital stay and increased demands of repeated ill-health. Stroke may compound these problems because of physical and mental incapacity, problems with perception and communication, and swallowing disorders. The full extent of undernutrition and its independent contribution to stroke outcome is not presently known. It is also not known whether it can be corrected, and whether doing so would improve the outcome. The aim of this study is therefore to describe the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Eligibility Criteria:
Inclusion Criteria:

* 1 st onset stroke patient
* MRI confirms his/her stroke
* more than 2.5% weight los within 2 weeks
* initial serum albumin \< 35 g/l
* BMI \< 18.5
* more than MMSE 10
* medically stable

Exclusion Criteria:

* recurrent stroke patient
* malabsorption patient
* terminal cancer
MALE Mamm Organoids

It is believed that the use of organoids derived from male breast tumors can be of fundamental support for the definition of the molecular mechanisms underlying the onset of the tumor. Furthermore, the development of such preclinical models could be of significant support for the identification of specific personalized and ad hoc therapeutic treatments for male pathology.

The main objective of the project is to set up at least 5 organoid cultures of male breast cancer derived from patients who have undergone surgery. This study will allow to define the success rate in the generation of organoids.

A secondary objective is to verify the correspondence between the organoids generated and the tumor tissue of origin.

In this regard, broad-spectrum molecular investigations will be carried out, such as mutational analysis of DNA through Whole Exome Sequencing (WES), gene expression profiles through RNA sequencing (RNAseq) and small RNA sequencing, proteomic and metabolomic analysis of both the tumors of origin and the cultures of derived organoids (PDO).

Furthermore, to verify the functional correspondence of the organoids with the tumor of origin, in vitro viability tests will be carried out by treating the PDOs with the same drugs administered to the patients.

Eligibility Criteria:
Inclusion Criteria:

* Men aged \>18 years
* Patients with histologically confirmed breast cancer with or without synchronous metastases, who will undergo the relevant surgical intervention
* Adequate biological material to be able to carry out the analyses described above
* Signing of the relevant informed consent form

Exclusion Criteria:

not present
Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis

Children with burns often require repeated reconstructive surgeries. These children tend to develop high levels of anxiety before coming to the operating room. Preoperative sedation, while somewhat effective in relieving this anxiety, has a number of side effects. The researchers hypothesized that preoperative anxiety could be effectively reduced by the utilization of a device which induces a relaxing hypnotic state through emmersion in a virtual reality environment.

The virtual reality environment is created by a Virtual Reality Hypnosis (VRH) device. The patient wears a headset which contains video and audio display. A twenty minute program is viewed, which guides the patient into a relaxed state via soothing audio and video input.

Eligibility Criteria:
Inclusion Criteria:

* Child presenting for reconstructive burn surgery

Exclusion Criteria:

* Visual or auditory difficulties
ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals

Bilateral stenting by Endoscopic Retrograde Cholangiopancreatography in malignant hilar biliary obstructions (MHBO) is challenging and technically difficult. EUS hepaticogastrostomy (EUS-HGS) has been increasingly used as an alternative method to achieve internal biliary drainage in MHBO. Because of the difficulty of ERCP in such scenario, the combination of EUS-HGS and ERCP provides a possible chance of longer stent patency with less event of stent clogging Aim of the work: to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced MHBO.

The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 1:1 ratio to: ERCP biliary drainage (ERCP-BD) group: bilateral metallic stents insertion will be attempted by transpapilary approach. Combined ERCP and EUS-HGS group: unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS.

technical success, clinical success, procedural duration, and re-interventions and adverse events will be assesed

Eligibility Criteria:
Inclusion Criteria:

* Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III \&amp; IV only.
* Histologically confirmed malignant hilar biliary obstruction.
* Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
* Absence of duodenal narrowing/obstruction.
* Accept sharing in the study

Exclusion Criteria:

* Pregnancy.
* Distal biliary obstruction as the main lesion.
* Benign biliary stenosis.
* Malignant hilar biliary obstruction bismuth type I and II.
* Presence of duodenal obstruction.
* Surgically altered anatomy or inability to access the major duodenal papilla.
* Patients underwent previous intervention for biliary drainage.
* Previously failed biliary cannulation at ERCP.
* Large volume ascites.
* Patients unfit for anesthesia.
* Patients having uncorrectable coagulopathy or thrombocytopenia.
* History of allergy to radiocontrast agents.
* Refuse sharing in the study.