cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Surgery of Rectal Cancer and Ileostomy

Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.

From a prospective collected database, data regarding patients who underwent to laparoscopic TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 years and over)
* patients submitted to elective Anterior Rectal Resection

Exclusion Criteria:

* chronic use of immunosuppressant agents
* urgent surgery
UHCDS a-tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients

The purpose of this study is to assess the effects on fatigue and sleep of Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise in Fibromyalgia patients.

Fibromyalgia (FM) is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated.

Perhaps this is why its therapeutic approach is refractory to current treatments.

Apart from the widespread chronic pain characteristic of this syndrome, fatigue is a very disabling symptom in this pathology. It is a complicated, multifactorial, disconcerting and very persistent symptom that is highly frequent in FM. A vast majority of the published studies have focused the symptoms studied in FM on pain, while fatigue and sleep disturbances, despite not being minor symptoms, have not received the same attention.

Neuromodulation treatments with transcranial direct current stimulation (tDCS) have been shown to induce significant analgesia in FM through modification of sensory processing of pain by thalamic inhibitory circuits and improvement of sleep architecture. On the other hand, therapeutic exercise (TE) programs based on aerobic work and global muscle strengthening have been shown to have a beneficial effect in reducing the pain and severity of FM.

None of the four studies conducted so far combining tDCS and TE in fibromyalgia have evaluated the effect on fatigue or sleep. Currently, various studies conclude that Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation (UHCDS a-tDCS) on the dorsolateral prefrontal cortex (DLPFC) and M1 produces a 50% greater modulation of corticospinal excitability. To date, no RCT has studied its effect in subjects with FM.

The present study aims to investigate the effect of UHCDS a-tDCS combined with TE on fatigue and sleep quality in subjects with FM.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
* Able to participated in a therapeutic exercise program.
* Understanding of spoken and written Spanish.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Metallic implants in the head.
* Tumor, trauma or surgery in the brain.
* Epilepsy or stroke.
* History of substance abuse in the last 6 months.
* Use of carbamazepine in the last 6 months.
* Diagnosed psychiatric pathology.
* Rheumatic pathology not medically controlled.
* Coexisting autoimmune pathology.
* Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
Influence of Anesthesia Methods on CTCs in TURBT Patients

Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of anesthesia methods on the number of CTCs in patients receiving transurethral resection of bladder tumor (TURBT). The difference of anesthesia method is achieved by using general anesthesia in one group and spinal anesthesia in the other group.


Eligibility Criteria:
Inclusion Criteria:

1. .≤18 Age ≤85，ASAI-III.
2. .Patients with primary bladder cancer of Stage T1 to T4, who are scheduled for transurethral resection of bladder tumor.
3. .Written informed consent.

Exclusion Criteria:

1. History of surgery within 6 months.
2. Contraindications for spinal anesthesia.
3. With a history of any other malignancy.
4. Having received preoperative neoadjuvant therapy.
5. History of long-term opioid use.
6. Combined with autoimmune diseases or having a history of prolonged hormone use or immunosuppressant use within 1 year.
7. Combined with impaired liver function (Child - Pugh C) or renal insufficiency (serum creatinine level over 442μmol•L-1).
8. Known hypersensitivity or suspected allergy to intervention drugs.
9. Proposed postoperative admission to ICU.
Epidemiology and Prognostic of the Acute Heart Failure

EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological, observational, prospective and multicenter study. This study includes at first an exhaustive recording of the cases on a geographic area at East of France, then the recorded patients are followed up in a cohort at least 3 years. This study follows the experiences of the EPICAL study led by our team.

Main objective: To describe the characteristics of the patients affected by acute heart failure and to identify prognostic factors, in particular related to care. More exactly :

* To describe the sociodemographic, clinical, biological and therapeutic characteristics of the patients presenting an acute heart failure during hospitalisation and living at East of France ;
* To study the short and medium-term morbi-mortality of these patients, and identify the main factors determining the prognosis for survival ;
* To evaluate the prognostic impact of the intra and extra-hospital care ;
* To identify the evolution of the care's practices of the decompensated heart failure since the EPICAL study (15 years) and their influence on the prognosis of the disease.

Secondary objective: to constitute a biological collection of serum, plasma and urine of patients' sample presenting an acute heart failure.

Criteria of inclusion:

* Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year
* Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.

Acute heart failure includes decompensation of chronic heart failure, advanced stage of the heart failure, acute oedema of the lung and cardiogenic shock. According to the data of registers, the incidence of the acute heart failure in approximately 2,5 cases per 1000 adults per year, the expected sample size amounts to 2500 eligible patients over 1 year.

Data collection: the doctors declare the Acute Heart Failure of their departments. The technicians of clinical research collect the data concerning the sociodemographic, clinical, biological and therapeutic characteristics of the inclusive patients on arrival at the hospital, during the hospitalisation and at the exit. The biological takings are made for the patients having given their consent before the exit of the hospitalization. The patients are followed up during 3 years.

Eligibility Criteria:
Inclusion Criteria :

* Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year
* Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators

The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.

The investigators propose the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of the investigators ICD PtDAs. The Investigators will use a 6-site stepped-wedge design, with implementation guided by normalization process theory® and evaluation guided by the RE-AIM framework.

The investigators aim to evaluate reach and effectiveness of the ICD PtDAs using a pragmatic, stepped-wedge design on decision quality (knowledge and value-concordance) and psychosocial outcomes.

* Hypothesis 1a: PtDAs will reach over 50% of eligible patients.
* Hypothesis 1b: ICD PtDAs will be effective in improving decision quality in real-world practice.
* Hypothesis 1c: Better informed patients will have lower anxiety, higher rates of planning for the possibility of deactivation, and increased identification of a surrogate decision maker.

The investigators propose 3 a priori hypotheses:

* The decision aids will have a differential effect on the decisions of participants by age (\>= 70 years old vs \<70 years old);
* The decision aids will have a differential effect on the decisions of participants by heart failure type (non-ischemic vs ischemic);
* The decision aids will have a differential effect on the decisions of participants by the type of device they are considering (ICD vs ICD replacement vs CRT-D).

Along with these hypotheses, we recognize that other important covariates exist, such as health literacy and education level.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English-speaking (videos and surveys have only been validated in English)
* Patients have been offered a primary prevention ICD for initial implant, reimplantation, or CRT with defibrillation

Exclusion Criteria:

* Prisoners
Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome

Consecutive consenting patients over the age of 18 years diagnosed with Takotsubo syndrome according to the position statement of the European Journal of Heart Failure (2016) will be included in the study. The primary endpoint is to evaluate the incidence of coronary microcirculation dysfunction and its correlation with the clinical presentation and the prognosis in patients with TAKO-Tsubo syndrome. Secondary endpoints will be to assess the incidence of in-hospital mortality, the prevalence of cardiogenic shock, the correlation between the levels of biomarkers analyzed, microvascular dysfunction, perceived quality of life, and angina severity during hospitalization and at subsequent follow-ups, and the influence of knowledge of the level of microvascular dysfunction on clinical management and prescribed therapies. Enrolment: 2 years, follow-up: 1 month and 1 year. Total: 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Diagnosis of Takotsubo syndrome
* Signing of informed consent

Exclusion Criteria:

* Age \<18 years;
* Refusal to sign written informed consent.
Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure

The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.


Eligibility Criteria:
Inclusion Criteria:

1. Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States
2. Subject is \> 18 years old
3. Patients with known history of CSR. CSR symptoms may include the following:

   * sleep fragmentation as reported by patient or as witnessed by another person
   * night arousal after apneic episodes
   * reduced exercise capacity
   * daytime sleepiness
4. Expected to tolerate the ventilator therapy

Exclusion Criteria:

1. Baseline oxygen saturation \< 90% on a stable FIO2)
2. Patient is currently enrolled in another clinical study which may confound the results of this study
3. Patient for whom informed consent cannot be obtained
4. Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
5. Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)
6. Patients with severe COPD (per GOLD scale)
7. Patients with a history of myocardial infarction within the 6 months prior to the study
8. Patients with unstable angina
The Relationship Between Sleep Disorders and Cytokine Levels Among Hemodialysis and Peritoneal Dialysis Patients

Sleep disorders are common in patients with end-stage renal disease on both hemodialysis and peritoneal dialysis and are associated with significant medical, psychological and social disturbances. Numerous factors have been suggested as contributing to or associated with the high prevalence of sleep disturbance in this population.

Increasing evidence suggests that cytokines are involved in the regulation of sleep and wakefulness and that the communication between the sleep and the immune system is bi-directional. Blood-dialyzer or peritoneum-dialysate interaction during dialysis therapy has the potential to activate mononuclear cells leading to production of inflammatory cytokines. These cytokines are believed to play a significant role in dialysis-associated morbidity and mortality. Nevertheless, a cytokine overproduction may alter sleep pattern in chronic dialyzed patients, thus explaining the presence of sleep disorders in these patients. In the other way, sleep loss may have effects on immune process and secretion of cytokines in chronic dialyzed patients. The purpose of this study was to examine the relationship between quality of sleep and serum cytokine levels in hemodialysis and peritoneal dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* ESRD Patients with hemodialysis or peritoneal dialysis

Exclusion Criteria:

* Malignancy, hospitalization, infection, inflammation
Transfer of Fresh Versus Frozen/Thawed Embryos in IVF Cycles Where GnRH Agonist is Utilized for Oocyte Maturation.

It has been suggested that in IVF cycles where GNRH agonist is utilized for final oocyte maturation in patients at risk of ovarian hyperstimulation, pregnancy rates are reduced. We hypothesize that the use of GNRH antagonist reduces pregnancy rates through an effect on the endometrium and not oocyte quality, therefore better results may be obtained by not returning these embryos in a fresh cycle but rather cryopreserving them and returning them to the uterus and a later stage.


Eligibility Criteria:
Inclusion Criteria:

* Woman at risk of ovarian hyperstimulation syndrome in IVF cycles for whom GNRH agonist was utilized for final oocyte maturation

Exclusion Criteria:

* Patient's refusal to participate
Detection of Salivary Insulin Following Meals

In addition to its role as the major regulator of glucose uptake into peripheral tissues, the hormone insulin is also a primary regulator of fat storage and fat burning of the body. Mechanistic animal studies have shown that high insulin may be the initial trigger for weight gain and be the proximal cause of obesity. There is currently no quick or non-invasive way of measuring insulin as research and clinical techniques require collection of a blood sample followed by a complicated and costly biochemical assay. The investigators will test the hypothesis that insulin levels can be accurately measured in saliva in humans following meals that elicit high and low blood insulin responses. Findings will help determine if insulin can be use as a valid fluid to track insulin changes in humans.

Lean and obese healthy participants will consume both a high carbohydrate meal and a low carbohydrate meal designed to elicit different insulin responses on two separate occasions. Blood samples and saliva samples will be collected for 2 hours following each meal and insulin will be measured in both plasma and saliva. The relationship between plasma and saliva insulin following the two meals will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.5-24.9 or over 30.0 kg/m2

Exclusion Criteria:

* Diabetes or other medical conditions affecting glucose or insulin levels
* Smoker
* Competitive athlete
* Vegan or vegetarian
Safety and Bacteraemia Between Peripherally Inserted and Central Inserted Catheters.

Clinical, prospective, single-center, national trial. open and randomized at 1: 1 to compare the rate of bacteremia associated between non-tunneled Central venous catheter and peripheral inserted central catheter.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years.
* Patients hospitalized at our institution requiring at least 6 days of intravenous treatment in a conventional ward of our hospital.
* Signed informed consent by the patient and / or when necessary parent / legal guardian.

Exclusion Criteria:

* Patients with bacteremia at the time of catheter insertion.
* Patients admitted to hematology or intensive care units, for considered a type of patient characteristics very different from other patients.
* Patients with severe clinical situation.
* Patients in whom peripheral venous access is technically impossible, patients outpatient and express refusal of the patient.
* Pregnant patients.
Baseline Vitamin D Deficiency and COVID-19 Disease Severity

It is known that vitamin D has been found to decrease incidence of viral respiratory infections, as well as have effects on multiple cytokines involved in immunomodulation and the bradykinin/renin-angiotensin system.

Recently, data was released showing a correlation between baseline vitamin D deficiency status and increased risk of contracting COVID-19.

Separate analysis shows that many of the deleterious effects of COVID-19 may be due to the bradykinin/RAS system, and that vitamin D is one plausible treatment option to modulate these effects.

Studies are currently ongoing to determine if vitamin D supplementation of those hospitalized with COVID-19 has a beneficial effect on patient outcomes.

Healthcare resources have been strained during the pandemic in areas of heavy caseload. It is possible that those with concurrent vitamin D deficiency and COVID positivity have an increased need for escalation of care. A small study has been conducted in this area, but was limited by small number of subjects.

Abstract: It is known that vitamin D has been found to decrease incidence of viral respiratory infections, as well as have effects on multiple cytokines involved in immunomodulation and the bradykinin/renin-angiotensin system. Recently, data was released showing a correlation between baseline vitamin D deficiency status and increased risk of contracting COVID-19. Separate analysis shows that many of the deleterious effects of COVID-19 may be due to the bradykinin/RAS system, and that vitamin D is one plausible treatment option to modulate these effects. Studies are currently ongoing to determine if vitamin D supplementation of those hospitalized with COVID-19 has a beneficial effect on patient outcomes.

Objective: To determine if those hospitalized with COVID-19 with baseline vitamin D deficiency, have worse outcomes during their stay than those who are not vitamin D deficient at baseline.

Design, Setting, and Participants: This is a retrospective cohort study at an urban academic medical center which included patients with a 25-hydroxycholecalciferol level measured within one year before being tested for COVID-19 and hospitalized from March 9th to September 7th, 2020.

Exposures: Vitamin D deficiency was defined by the last measurement of 25-hydroxycholecalciferol less than 20 ng/mL before COVID testing (within one year).

Main Outcomes and Measures: The primary outcomes investigated include length of stay, need for supplemental oxygen, ICU admission, need for invasive life support (mechanical ventilation, vasopressors, dialysis), and discharge status (discharged alive vs. death).

Eligibility Criteria:
Inclusion Criteria:

* Covid 19 +
* Vitamin D level

Exclusion Criteria:

* Age \< 18
* no associated vitamin D level
Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital

Thyroid gland and its hormones play an important role in organ development and the homeostatic control of many physiological mechanisms such as body growth and energy expenditure. The two main thyroid hormones are triiodothyronine (T3) and thyroxine (T4) affect renal development and metabolism so any impairment in thyroid functions lead to or aggravate kidney diseases.

On the other hand, kidneys play an important role in the thyroid metabolism as it normally contributes to the clearance of iodide, primarily by glomerular filtration. Among patients with renal failure, there is diminished iodide excretion and an increase in plasma inorganic iodide, which results in increased uptake of the iodide by the thyroid gland. Increases in total body inorganic iodide can potentially block thyroid hormone production (the Wolff-Chaik off effect). Such a change may explain the slightly higher frequency of goiter and hypothyroidism in patients with chronic kidney diseases.

The kidneys affect the hypothalamic pituitary-thyroid axis, so any impairment in kidney functions leads to disturbed thyroid physiology. All levels of the hypothalamic-pituitary-thyroid axis may be involved, including alterations in hormone production, distribution, and excretion.

End stage renal disease (ESRD) and hemodialysis (HD) affect the levels of all thyroid hormones. The earliest and the most common thyroid function abnormality in patients with ESRD on HD is low T3 level (especially total T3 than free T3). This is called 'low T3 syndrome. The prevalence of subclinical hypothyroidism has been reported to be much higher in patients with ESRD on HD than in the general population.

Due to similarity of signs and symptoms, sometimes it is difficult to identify subjects with ESRD also has hypothyroidism; therefore, different studies have been carried out to establish the incidence of these conditions.


Eligibility Criteria:
Inclusion Criteria:

* Children started hemodialysis for end stage renal disease at age of 2 to 16 years will be included in the study.

Exclusion Criteria:

* Patients with known thyroid disease. Patients with a history of autoimmune disease .
AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies

The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics of a capsule of AZD6244 in participants with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* cancer which is refractory to standard therapies
* World Health Organization (WHO) performance status 0 to 2
* evidence of post-menopausal status or negative pregnancy test

Exclusion Criteria:

* Radiotherapy/chemotherapy within 21 days prior to entry
* brain metastases/spinal cord compression unless stable off steroids/anticonvulsants
* evidence of severe/uncontrolled systemic disease
* participated in an investigational drug study within 30 days