cyrilzakka/clinical-trials huggingface dataset:
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients

The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.

For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

* \< 10% improvement in 6-minute hall walk, and
* no class improvement or worsening in New York Heart Association (NYHA) scale.

For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

* \> 1 heart failure (HF) related hospitalization, and
* no class improvement or worsening in NYHA scale.

Study Methods

* This is a prospective, randomized (simultaneous biventricular (BiV) pacing vs. sequential BiV pacing) study.
* Any patient that receives an FDA approved St. Jude Medical (SJM) CRT-D with V-V timing is eligible for enrollment.
* At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing. Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screening/randomization visit.
* Patients are followed for a period of 6 months post randomization:

  * Enrollment (1 week pre CRT-D implant to \< 2 weeks post CRT-D implant)
  * Screening/Randomization Visit (3 months post enrollment)
  * Follow-up Visit (6 months post randomization)
* Total # of centers - 80 centers
* Sample size - 800 patients screened for CRT non-responders

Eligibility Criteria:
Inclusion Criteria:

* Patient has a standard indication for a CRT-D.
* Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
* Patient is geographically stable and willing to comply with the required follow-up schedule.
* Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
* Patients requiring a CRT-D replacement must comply with BOTH of the following:

  * \> 1 HF related hospitalization
  * No class improvement or worsening in NYHA scale

Exclusion Criteria:

* Patient's life expectancy is less than 12 months.
* Patient has had cardiac surgery within 6 months of enrollment.
* Patient has an epicardial ventricular lead system.
* Patient is less than 18 years old.
* Patient is pregnant.
N6 Input Processing in Traditional CI Recipients

The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 12 years
* Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
* Minimum of 3 months experience with the N5 sound processor
* Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
* Native English speaker
* Willingness to participate in and comply with all requirements of the protocol

Exclusion Criteria:

* Unrealistic expectations
* Unwillingness to comply with investigational requirements of the protocol
* Additional handicaps that would prevent or restrict participation in the evaluations
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
* Age22-85
* Clinical signs consistent with acute ischemic stroke
* National Institutes of Health Stroke Scale (NIHSS) ≥8and\<30
* Thrombolysis in Myocardial Infarction (TIMI) 0 or TIMI 1 flow in the M1 or M2 of middle cerebral artery, internal carotid artery, basilar or vertebral arteries confirmed by angiography that is accessible to the SOLITAIRETM or MERCI® Device
* Patient is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the SOLITAIRETM or MERCI® Device.
* Patient who is ineligible or failed intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice.
* Patient is willing to conduct follow-up visits

Exclusion Criteria:

* NIHSS \> 30 or coma
* Neurological signs that are rapidly improving prior to or at time of treatment
* Females who are pregnant or lactating
* Known serious sensitivity to radiographic contrast agents
* Current participation in another investigation drug or device study
* Uncontrolled hypertension defined as systolic blood pressure \> 185 or diastolic blood pressure \> 110 that cannot be controlled except with continuous parenteral antihypertensive medication
* Use of warfarin anticoagulation with International Normalized Ratio (INR) \> 3.0
* Platelet count \< 30,000
* Glucose \< 50 mg/dL
* Arterial tortuosity that would prevent the device from reaching the target vessel
* Life expectancy of less than 90 days
* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
* CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, \>100 cc of tissue) on presentation
* CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
* Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis
Treatment for HBV-MN Patients in Chinese: An Open Parallel Controlled Trial

Lamivudine treatment for HBV-DNA negative HBV-GN patients.

lamivudine and predinisone treatment for HBV-DNA negative HBV-GN patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult HBV-GN patients with biopsy-proven MN, heavy protinuria, HBsAg or HBeAg positive, HBV-DNA negative

Exclusion Criteria:

* Primary MN patients, HBV-DNA positive
The Evaluation of Piezo and Endonasal Osteotomy Methods on Postoperative Healing Process in Septorhinoplasty

The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question\[s\] it aims to answer are:

* In which osteotomy technique the edema is lesser?
* Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?

Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.

Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements)

The goal of this observational study is to compare the effect of Piezo and endonasal osteotomy techniques on the healing process of patients undergoing septorhinoplasty surgery. The main question\[s\] it aims to answer are:

* In which osteotomy technique the edema is lesser?
* Which osteotomy technique is better for thick vs thin skinned patients ? In which osteotomy technique the healing process is faster?

18-65 years old males or females with nasal septum and/or nasal pyramid deviation and external nasal deformities who are willing to undergo open rhinoplasty procedure will be included in the study. Patients who have a history of previous rhinoplasty/septorhinoplasty procedure, abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time), use of anticoagulant drugs, chronic / inflammatory skin disease and/or chronic skin allergies, systemic diseases (hypertension, diabetes mellitus, bronchial asthma), nasal beautification procedures such as dermal fillings, using oral and/or topical (nasal skin) corticosteroids in three months preoperatively will be excluded.

Participants will be asked to have an ultrasonic measurement of the nasal dorsum preoperatively and at the first, third and tenth months postoperatively.

Researchers will compare the thick and thin skinned patients to detect which osteotomy technique is superior in the healing process ( lesser edema and faster healing due to skin thickness measurements).

Eligibility Criteria:
Inclusion Criteria:

* nasal respiratory dysfunction with the deviation of nasal septum and/or the nasal pyramid

Exclusion Criteria:

* previous rhinoplasty/septorhinoplasty procedure
* patients with abnormal coagulation parameters (prothrombin time, partial thromboplastin time, bleeding/coagulation time)
* use of anticoagulant drugs
* chronic / inflammatory skin disease and/or chronic skin allergies
* presence of systemic diseases (hypertension, diabetes mellitus, bronchial asthma)
* nasal beautification procedures such as dermal fillings
* use of oral and/or topical (nasal skin) corticosteroids in three months preoperatively
Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)

The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 250-500 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or sodium nitroprusside.

The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and sodium nitroprusside treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect and additional safety variables.

Eligibility Criteria:
Prerandomization Inclusion Criteria:

* Provide written informed consent before initiation of any study related procedures.
* Be at least 18 years of age
* Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery, and/or valve replacement/repair surgery

Prerandomization Exclusion Criteria:

* Women of child-bearing potential (unless they have a negative pregnancy test)
* Recent cerebrovascular accident (within 3 months before randomization)
* Known intolerance to calcium channel blockers
* Known or suspected hypersensitivity to sodium nitroprusside
* Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
* Pre-existing permanent ventricular pacing
* Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
* Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study

Postrandomization Inclusion Criteria:

* Determined to be hypertensive perioperatively as determined by the investigator
Observational Study Comparing Gastric Calibration Tubes

Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

A note is made of the problem encountered, how long it took to place it correctly ( time from insertion till first staple), what was done to solve the problem, if a new identical tube was used or another and what type was used. If another tube how log did it take to get first stapler done.

some demographic and procedure information is recorded: gender, age, BMI, procedure planned, first bariatric procedure or second after ...

Eligibility Criteria:
Inclusion Criteria:

* bariatric surgery being sleeve gastrectomy, gastric bypass or conversion procedure.

Exclusion Criteria:

* pre existing esophageal disease making use of gastric tube contra indicated, difficult or impossible.
Zuojin Wan Combined With Woonosan Fumarate for the Treatment of GRD Combined With Depression

To evaluate the improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by Zuojin Wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients between the two groups.

Gastroesophageal reflux disease (GERD) is a common digestive disorder, and in recent years studies have shown an increasing incidence of comorbid depression in patients with GERD. The treatment of gastric acid inhibition and mucosal protection alone is not effective for patients with reflux combined with depression, and the additional administration of neuromodulatory drugs will increase the incidence of adverse reactions, so the combination of traditional Chinese medicine may be one of the effective ways to solve the above problems. The aim of this study was to compare the efficacy of Zuojin Wan combined with vunorasan fumarate with that of vunorasan fumarate alone.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 65 years;
2. Fulfilment of western medical diagnostic criteria for GERD;
3. Meet the diagnostic criteria for mild depression;
4. Comply with the diagnostic criteria of Liver and Stomach Depression-Heat syndrome in Chinese medicine;
5. A score of 7-17 on the 17-item Hamilton Depression Scale (HAMD-17) (7-17 being mild depression);
6. Good compliance and autonomous behaviour;
7. No medications that may have an effect on the study, such as acid-suppressing agonists, were taken within 2 weeks prior to enrolment;

Exclusion Criteria:

1. HP positive patients;
2. Other organic diseases of the digestive system, such as peptic ulcer, peptic tumour, peptic haemorrhage, liver, gallbladder and pancreas disease, intestinal obstruction and inflammatory bowel disease;
3. Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological lesions, etc;
4. Pathological diagnosis of the esophageal mucosa suggestive of moderate-to-severe heterogeneous hyperplasia;
5. Previous surgery resulting in a decrease in gastric acid or a history of oesophageal or gastric surgery;
6. Varicose veins in the esophagus or fundus of the stomach;
7. Persons with severe primary heart, brain, liver, lung, kidney, blood or serious disease affecting their survival;
8. Those with depression, suicidal tendencies and mental disorders who cannot cooperate;
9. Pregnant or breastfeeding women, or patients who have a plan to have children in the near future;
10. Taking drugs that have an effect on the results of this study within 2 weeks before participating in this study;
11. Allergy or adverse reaction to the study drug.
Biomarker of Diabetic Retinopathy

Diabetic retinopathy (DR) is a complication of diabetes in which blood vessels supplying blood to the back of the eye (retina) are dysfunctional. This can lead to an improper supply of oxygen and nutrients to the retinal tissue, or it may trigger the formation of new blood vessels in response to the oxygen/nutrient deficiency. Ultimately affecting the normal vision. There is no known marker that will provide information on the health status of retinal blood vessels. Using highly specialized cells in the blood, this study will try to discover a marker of DR.


Eligibility Criteria:
Inclusion Criteria:

* Ability to cooperate with imaging procedures.
* Health status: established type 2 diabetes
* No history of panretinal photocoagulation (PRP)
* No history of treatment with intravitreal agents for past 12 months

Exclusion Criteria:

* Previous or current malignancy
* Acute or chronic infection (HIV, hepatitis B or C, tuberculosis)
* Cerebral vascular accident or cerebral vascular procedure
* Current pregnancy
* History of organ transplantation
* Presence of a graft (to avoid any effect of the graft)
* History of previous vitrectomy
* Subjects with a history of age-related macular degeneration age-related macular degeneration (AMD), glaucoma, uveitis, and branched or central vein occlusion.
Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications

Recommended by the KDOQI vascular access guidelines, antebrachial arteriovenous fistula is the best primary vascular access for hemodialysis in patients with end stage renal disease. The primary complications are common, of the order of 10-36 %, including lack of maturation and dominated by stenosis and thrombosis.

Local anesthesia associated with sedation is a validated method of anesthesia for made arteriovenous fistula but does not cause the motor block and not blocking vasospasm, deleterious to the surgery. Multiple injections necessary to cover the operating zone expose patient to pain and to intravascular injection of local anesthetics.

Regional anesthesia provides better conditions for realize more distal fistula. Sympathetic block provides arterial, venous vasodilation and decreases the incidence of vasospasm . It enables an increased flow rate at an early time fistula and faster maturation.

However, studies included low numbers of patient or are non-randomized. They cannot concluded a significant difference in the complication rate of arteriovenous fistula at an early time depending on the type of anesthesia .

This study aims to demonstrate that axillary block for surgical creation of arteriovenous fistula allows a reduction of complications at 6 weeks compared to local anesthesia


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stade 4 or 5
* First creation of arteriovenous fistula on the side of the surgery
* written consent
* Health care system adherent
* No decision of juridical protection

Exclusion Criteria:

* Pregnancy or breast-feeding
* Participation to an other research study that may interfere with this study
* Brachial arterio-venous fistula creation (upper elbow crease)
* Antecedent of homolateral arteriovenous fistula (controlateral fistula non excluded)
* Other surgery on arteriovenous fistula (superficialisation procedure, refection...)
* Contraindications to local anesthetics : Ropivacaine or Lidocaine allergy
* Contraindication to regional anesthesia : homolateral axillary lymphadenectomy
Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments

Preoperative fasting is defined as refraining from food for at least 6 hours and clear fluids for at least 2 hours prior to anaesthesia. On the one hand, it is a procedure that reduces the risk of aspiration of food content and the occurrence of Mendelson's syndrome, and on the other hand, it was considered to be the cause of disturbances in water management in patients undergoing general anaesthesia. However, reports from recent years have found that moderate preoperative fasting does not influence the risk of hypovolemia in anesthetized patients. It is also known that in fasting people the total body water is reduced. Thus, it can be assumed that there are mechanisms causing the movement of extravascular water into the lumen of blood vessels. For several years, the Body Composition Monitor (BCM) device for non-invasive measurement of the volume of individual water compartments of the human body has been available on the market. It allows to determine the volume of total body water, intracellular body water and extracellular body water. It is mainly used during dialysis, but it can also be used in other circumstances that require the determination of the body's hydration status. The principle of this method is based on non-invasive bioimpedance measurement with the use of 4 electrodes placed on two extremities.

The aim of the study is to determine whether there is a fluid shift between the intracellular and extracellular compartments in people undergoing preoperative fasting. Examination of this issue would allow for the development of hypothesis regarding the optimal perioperative fluid therapy. If there was a shift of fluid from the intracellular space, it seems more rational to supplement fluid deficiencies resulting from starvation with a 5% glucose solution. If, on the other hand, no fluid shift from the intracellular space was detected, which would suggest shifts within the extracellular space, it would be advisable to hydrate the patient with crystalloid solutions.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) general condition assessment 1 or 2

Exclusion Criteria:

* Chronic kidney disease
* Circulatory failure
* Phenylketonuria
* History of hypoglycaemic episodes or any carbohydrate metabolism disorders.