cyrilzakka/clinical-trials huggingface dataset:
Nerve Stimulation During Esophagectomy

Esophagectomy is the cornerstone for treatment of esophageal cancer. However, it is associated with substantial morbidity and mortality. Studies suggest that systemic inflammation after surgery has a negative impact on surgical outcomes. Attenuation of an excessive inflammatory response within the perioperative period for high-risk surgical procedures may reduce morbidity and mortality. The inflammatory response may be important in the development of these complications and reduction of inflammatory cytokine may be associated with an improved outcome.

The current study will evaluate the feasibility and safety of neuromodulation during minimally invasive surgery for esophageal cancer (esophagectomy) to assess impact on the inflammatory response. During the esophagectomy, a stimulation lead will be placed on the exposed nerves, and energy applied to the lead to test whether the nerves can be activated. The study will also measure potential physiological responses to nerve activation.

Active dampening of the inflammatory response may be an important therapeutic target to decrease complications and improve recovery following esophagectomy. The current study is intended to evaluate the feasibility and safety of stimulating the exposed nerves in esophagectomy patients.

During minimally invasive esophagectomy, a neurovascular bundle (NVB) is exposed or partially exposed as part of the obligatory lymph node dissection. At the point in the esophagectomy when the NVB is being isolated, a lead will be applied laparoscopically to the NVB and connected to an external pulse generator. An ultrasound transducer will be introduced to the abdomen and placed on the NVB to visualize splenic arterial blood flow. The NVB will be stimulated while physiologic responses are observed. Blood samples will be taken before, and at certain pre-defined time points after, stimulation and recovery. The lead and ultrasound transducer will be removed after completion of stimulation, and the esophagectomy surgery will continue. Surgeon experience applying and removing the cuff electrode will be documented, in addition to the responses to NVB stimulation. Post-operative safety will be followed through 7-days (or day of discharge if earlier).

Eligibility Criteria:
Inclusion Criteria:

* Female of non-reproductive potential or male
* Undergoing minimally invasive esophagectomy
* Confirmed presence of splenic NVB loop via imaging prior to surgery
* Age equal or above 21 years at the screening visit
* Capable of giving signed informed consent (IC)
* Normal blood pressure, or hypertensive managed with medication such that they are deemed fit for surgery

Exclusion Criteria:

* Previous splenectomy
* Existing implantable device
* Active pancreatitis or history of severe pancreatitis with complications, hepatic or splenic disease
* Use of oral steroids 4 weeks prior to inclusion
* Current use immunosuppressive agents or biologicals. Previous use of biologicals is allowed, if a washout period of 2 months is applied
* Use of anticoagulants within 1 week of surgery
Effect of Heatwave Over Glycemic Control in Patients With T1D

Observational study about effect of the greatest Spanish heatwave over glycemic contro in adult patients with type 1 Diabetes mellitus.

Cross-sectional retrospective analysis of all patients with T1D in Castilla-La Mancha (south-central Spanish region) using intermittently scanned continuous glucose monitoring (isCGM). Glycometric data obtained through deidentified downloads from isCGM´s webpage. Primary outcome was time in range (TIR) 3.0-10 mmol/L (70-180 mg/d) change after the heatwave. Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant. The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Older than 18 years old
* Using intermittently scanned continuous glucose monitoring (isCGM)
* Paired active isCGM data from the heatwave period and two consecutive weeks

Exclusion Criteria:

* Younger than 18 years old
* Not using intermittently scanned continuous glucose monitoring
* Not having active paired isCGM data from the analyzed periods
Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients

Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental group who take convalescent plasma compared to 28 patients receive only conventional therapy without taking Convalescent plasma. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease are monitored in relation to monitoring through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) serological monitoring.

Objectives: The current COVID-19 pandemic needs unconventional therapies to tackle the resulted high morbidity and mortality. Convalescent plasma is one of the therapeutic approaches that might be of benefit. Methods: Forty nine early-stage critically-ill COVID-19 patients residing in respiratory care units (RCU) of three hospitals in Baghdad, Iraq were included, 21 received convalescent plasma while 28 did not receive, namely control group. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease were monitored clinically along with laboratory monitoring through SARS-CoV-2 RNA detection via PCR, and SARS-CoV-2 IgG and IgM serological monitoring.

Eligibility Criteria:
Inclusion Criteria:

* 49 critically-ill COVID-19 patients are included.
* All of the patients were with pneumonia and residing in RCU
* Age ≥ 18 y
* With dyspnea and oxygen saturation less than 90% in resting state.
* At their first 3 days in RCU either receiving O2 therapy, c-pap, or on ventilators.
* All of the patients were residing in infectious diseases wards before being transferred to RCU.

Exclusion Criteria:

* The exclusion criteria of the COVID-19 patients were:

  * Previous allergic history to plasma or its ingredients such as sodium citrate.
  * Cases with serious general conditions, such as severe organ dysfunction, that are not suitable for transfusion.
  * Very late stage of the acute respiratory distress (ARDS) where Convalescent plasma (CP) has proved to be of low therapeutic benefit
Association of Apolipoprotein B-48 Level and Large arterY Atherosclerotic iSchemic Stroke(ABYSS)

The purpose of this study is to evaluate whether the serum apoB48 level is associated with atherosclerotic ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

Large artery atherosclerotic ischemic stroke group(LAA group)

* Age over 20 years
* Patients with symptomatic stenosis in the eligible vessels(the middle cerebral artery, anterior cerebral artery, or internal carotid artery) as assessed by MRA or CTA corresponding to the acute ischemic stroke
* Patients without the occlusion of corresponding artery by MRA or CTA
* The fasting and postprandial serum Apo B-48 level can be assessed within 72 hours after the symptom onset of ischemic stroke

Small vessel occlusive ischemic stroke group (SVO group)

* Age over 20 years
* Patients with acute ischemic stroke of basal ganglia, internal capsule, or corona radiata
* Patients without both symptomatic and asymptomatic arterial occlusion or stenosis by MRA or CTA
* Patients without a history of systemic atherosclerosis(for example, acute myocardial infarction, angina, peripheral arterial disease, aortic aneurysm)
* The fasting and postprandial serum Apo B-48 level can be assessed within 72 hours after the symptom onset of ischemic stroke

Exclusion Criteria: both LAA group and SVO group

* Patients with cardioembolic ischemic stroke
* Patients treated with lipid lowering agents or steroid within the previous 30 dsys
* Patients with severe liver disease (AST \>100 or ALT \>100) at the time of randomization
* Patients with endocrine disease except diabetes mellitus at the time of randomization (for example, thyroid disease, adrenal disease)
* Patients with severe renal disease (serum creatinine \>2.0mg/dl)at the time of randomization
* chronic alcoholics or drug user
* Patients with infection at the time of randomization
* Patients, in the opinion of the investigator, unlikely to comply with the clinical study or unsuitable for the any other disease or reason
* Informed consent has not been obtained
Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia

Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.

Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required

Eligibility Criteria:
Inclusion Criteria:

* patients of both sexes, age \> 18 y-old
* cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t
* weight loss \>5% during the previous three months or \>10% during the previous six months

Exclusion Criteria:

* end-stage kidney disease
* life expectancy \< 2 weeks
ECCO2R - Mechanical Power Study

Although mechanical ventilation remains the cornerstone of ARDS treatment, several experimental and clinical studies have undoubtedly demonstrated that it can contribute to high mortality through the developing of ventilator induced lung injury even in patients with plateau pressure \<30 cmH2O. Since now there are no studies exploring the application of low flow extracorporeal CO2 removal and ultraprotective ventilation to reduce mechanical power, a composite index of VILI, independently from the value of plateau pressure or the severity of hypercapnia.


Eligibility Criteria:
Inclusion Criteria:

ARDS patients undergoing mechanical ventilation with:

* PaO2/FiO2 \<150 with a level of positive end expiratory pressure (PEEP) of 10 cmH2O or higher with a FiO2 \> 0.5
* Plateau pressure of 28 cmH2O or higher with tidal volume of 6 ml/Kg of ideal body weight
* Mechanical power of 18 J/min or higher.

Exclusion Criteria:

* \<18 years of age
* Pregnancy
* Obesity with BMI\> 30
* Platelets \<30 G/l
* Decompensated heart failure or acute coronary syndrome
* Acute brain injury
* Contraindication for systemic anticoagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder, recent major surgery)
* Patient moribund, decision to limit therapeutic interventions
* Catheter access to femoral vein or jugular vein impossible
* Pneumothorax.
Study on Application of Simulated Training in Ultrasound Guided Transversus Abdominis Plane Block

With the development of society and the enhancement of people's awareness of law and self-protection, it is necessary to use simulation technology to create a simulated human and clinical environment to replace the traditional teaching of clinical operation on real patients. So simulation teaching is more and more important in medical education. However, simulation teaching is in the ascendant in China, especially in the ultrasound-guided nerve block, limited by the lack of full simulation of puncture model, the simulation training of ultrasound-guided nerve block is not carried out much. Therefore, this study uses simulation training to carry out ultrasound-guided horizontal abdominal muscle block teaching, in order to explore an effective way of ultrasound-guided nerve block teaching.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old; ASA 1 \~ 2; patients under non-transvaginal gynecologic surgery, rectal surgery or descending colon surgery

Exclusion Criteria:

* Patients with communication disorder Central or peripheral nervous system diseases. Liver and kidney functions seriously damaged Coagulation function abnormality and local anesthetic allergy history Patients with serious heart disease, hypertension and diabetes. Patients who have used analgesic drugs or drugs that may affect cardiovascular function within 24 hours before operation.

Patients with infection at the puncture site.
Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study

The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal aortic aneurysm \> 5.0 cm or 2 times the normal aortic diameter
* Abdominal aortic aneurysm with history of growth \> 0.5 cm in 6 months
* Penetrating juxtarenal aortic ulcer \> 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

* Age \< 18 years
* Life expectancy \< 2 years
* Pregnant or breast feeding
* Inability or refusal to give informed consent
* Unwilling or unable to comply with the follow-up schedule
* Additional medical restrictions as specified in the Clinical Investigation Plan
* Additional anatomical restrictions as specified in the Clinical Investigation Plan
A Pilot Study for Optimizing Meropenem Administration in the ICU

Can antibiotic drugs be administered faster and make acceptable serum concentrations if we give short but multiple infusions compared to long and fewer infusions? In this study we will compare giving meropenem 1 gram 6 times daily in 15 minutes infusions to the recommended 2 gram 3 times daily in 3 hours infusions. In patients in the intensive care unit, the need for intravenous access is of essence. If 6 short infusions results in the same serum concentrations as 3 long infusions, we will increase intravenous access from 15 to 22.5 hours daily.

The primary aim of this pilot study is to examine if the dosing of the antibiotic meropenem given as 1 gram 6 times daily in 15 minutes infusions can be compared to 2 grams given 3 times daily in 3 hours infusion when measuring the serum concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l).

The secondary aims are

* That both administration forms will result in serum concentrations above MIC ≥ 100 % of the time (2 mg/l)
* Days in hospital
* 30 days mortality after admittance to the ICU
* Serious side-effects

Five extra blood samples will be performed 24, 48 and 72 hours between two dosing intervals. The dose will be adjusted according to renal function which will be monitored daily. The patients will be supervised for adverse effects until 2 days after treatment has stopped.

The study will be performed from 2021 to the end of 2024.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years admitted to the ICU at Oslo University Hospital, Rikshospitalet and
2. who shall be treated with meropenem because of proven or suspected serious infection and
3. who give their written informed consent either directly or through next of kin

Exclusion Criteria: Patients

1. with known hypersensistivity to betalactam antibiotics or
2. who use of valproat or
3. who are pregnant or
4. the lack of consent.
SpyGlass Direct Visualization System Clinical Registry in China

To document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice.

Prospective, Post market, Multi-center, Non-randomized Study

Patients who presenting with an indication for cholangioscopy or presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass procedure will join this study, totally 500 patients across 16 sites throughout China will participate in study. After SpyGlass operation, all patients will be followed for 72 hours to observe adverse events, and patients with indeterminate stricture or undefined filling defect indication with tissue sampling not yielding histopathology positive for malignancy and unresolved device and/or procedure related SAE at 72 Hours will continue to be followed up until 6 months. Finally, procedure success rate will be analyzed as primary endpoint, and SAEs and impact of patients management will be analyzed as secondary endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 and not above 85.
2. Willing and able to provide written informed consent to participate in the study.
3. Willing and able to comply with the study procedures.
4. Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.

Exclusion Criteria:

1. Endoscopic techniques are contraindicated.
2. ERCP is contraindicated
3. A medical condition that warrants the use of the device outside of the indication for use.
4. Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that \[18F\]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.

Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 \& 3 using hormone manipulation.

Eligibility Criteria:
Inclusion Criteria:

* Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes

Exclusion Criteria:

* Pregnancy
* Unable to do imaging
* Body weight greater than 400 lbs (181 Kg)
* Prisoners are not eligible
* Subjects unable to provide own consent are not eligible
* Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.
* Known adrenal pathology
Comparing Two Ways to Manage Head and Neck Lymphedema

This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.

Primary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on changes in the severity of lymphedema.

Secondary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on symptom burden and functional status.

Exploratory aim: To compare the healthcare utilization between patients receiving clinic-based versus home-based (a hybrid model) CDT

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* \<=24 months post-HNC treatment
* Diagnosis of head and neck lymphedema and referral by their oncology providers
* Able to perform self-manual lymphatic drainage
* Having an electronic device (a computer, tablet, iPad, laptop, or smartphone) and internet access at home

Exclusion Criteria:

* Active infection in soft tissues in the head and neck region
* History of moderate or severe carotid artery occlusion
* Significantly severe lymphedema (e.g., severe periorbital swelling)
* Conditions impacting the safe delivery of lymphedema therapy
The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease

The primary purpose of this study is to determine whether PCI added to OMT could be superior over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in elderly patients with coronary artery disease (CAD) during the additional 12 months.

Study Design

* Prospective, randomized, multi-center study of each 1600 subjects enrolled.
* Eligible subjects will be randomized 1:1 to a) PCI added to OMT (n=800) vs. b) OMT alone(n=800).

Subsequently, subjects in PCI added to OMT group will be randomly assigned to everolimus eluting stent(n=400) vs. zotarolimus eluting sten(n=400). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.

* Subjects with CAD who meet all inclusion and exclusion criteria will be included
* Clinical and laboratory follow-up should be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with CAD and those in whom initial CCS class I to III angina or Braunwald classification less than IIB
2. Patients with age 75 years or older
3. Patients receiving OMT (one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin)
4. Patients with stenosis of at least 70% in at least one proximal epicardial coronary artery or objective evidence of myocardial ischemia (substantial changes in ST-segment depression or T-wave inversion on the resting electrocardiogram or inducible ischemia with either exercise or pharmacologic vasodilator stress)
5. Patients with signed informed consent

Exclusion Criteria:

1. Patients with persistence of CCS IV angina
2. Resting chest pain (≥ Braunwald classification IIB)
3. Patients who experienced a markedly positive stress test (substantial ST- segment depression or hypotensive response during stage 1 of the Bruce protocol)
4. Patients with age 85 years or older
5. Patients with refractory CHF or cardiogenic shock
6. Patients with an EF of less than 30%
7. Patients who have received revascularization within the previous 6 months
8. Patients with coronary anatomy not suitable for PCI
9. Life expectancy ≤ 2 year
Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing

The purpose of this study is to evaluate the safety and efficacy of therapeutic anticoagulation with tinzaparin during pregnancy via weight-based dosing.

Physicians in the Calgary Health Region are using tinzaparin (predominantly) and other low molecular weight heparins (LMWHs) for the treatment venous thromboembolism (VTE) in pregnancy. The most recent anticoagulation guidelines from American College of Chest Physicians (ACCP) suggest that heparin levels (anti-Factor-Xa activity levels) may be done periodically through pregnancy to determine the need to adjust the dose of LMWH as pregnancy progresses. This monitoring is widely practiced. There is no clear consensus in the literature, however, with some experts suggesting that initial and subsequent dosing may be done based on weight alone (as is done in the non-pregnant population). Given the multiple physiologic changes which occur to drug metabolism during pregnancy, this bears further evaluation. To date, there is very limited data on weight-adjusted dosing of LMWH in pregnancy. This study is therefore designed to determine if dosing of tinzaparin during pregnancy based on weight, with periodic weight-based adjustments, will result in adequate therapeutic anticoagulation.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies in women over the age of 18 requiring anticoagulation for acute VTE (DVT/PE), or high-risk prophylaxis at a tinzaparin dose of 175 IU/kg.
* High-risk patients include those with multiple (two or more) episodes of VTE and/or women receiving long-term anticoagulants (e.g. single event with known thrombophilia; APLAs and history of venous thrombosis)

Exclusion Criteria:

* Multiple gestation\\
* Prosthetic valves
* Active bleeding or other contraindication to anticoagulation therapy
* Allergy to heparin, bisulfites, or fish, history of HIT (heparin induced thrombocytopenia), severe hypertension (diastolic \>130)
* Severe hepatic or renal failure
* Patients over 100kg.