cyrilzakka/clinical-trials huggingface dataset:
The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate

This is a randomized, placebo-controlled trail, the objective of this study is observation the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by hemabate during spinal anesthesia for elective cesarean section. The primary outcome is the presence of post-delivery intra-operative nausea and vomiting in parturients. The patients demographic characteristics, blood pressure, sensory block level, and the medications will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-40 years;
* American Standards Association status I-II.

Exclusion Criteria:

* Patients with allergy or hypersensitivity to propofol, lipid emulsion, or granisetron;
* History of nausea or vomiting within 24h before cesarean delivery;
* History of gastrointestinal or psychiatric disease, motion sickness, smoking, postoperative nausea and vomiting;
* Morbid obesity;
* Consumption of drugs such as opioids, antiemetics , H2 antagonists, phenothiazines and/or corticosteroids within 24h before the study period;
* Any chronic medical or surgical disorders complicating the pregnancy;
* Conditions contraindicating regional anesthesia.
Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)

The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.


Eligibility Criteria:
Inclusion Criteria:

* Referred for contrast enhanced MDCT
* Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
* Diagnosed as having diabetes mellitus

Exclusion Criteria:

* Unstable renal function
* Unstable diabetes
* Concurrent administration of nephrotoxic drugs
* Undergoing dialysis
How Well Ethiopian Parents Assess and Manage Their Children's Postoperative Pain: Descriptive Correlational Study

This study aims to evaluate the practice of mothers towards the evaluation and management of postoperative children's pain.According to this study, Parents displayed low to moderate levels of knowledge adequacy towards the use of pain relief methods in relation to their children's postoperative pain and pain management, which indicates the need to provide parents with more information regarding their children's postoperative pain management.

Introduction: Acute postoperative pain in children is common. Although mothers care for their children's pain in most cases, it has been noted that mothers have limited knowledge about pain assessment and management of children.

Objectives: This study aims to evaluate the practice of parents towards evaluating and managing postoperative children's pain.

Method: This descriptive correlational study was conducted among 102 parents with children aged between 2 and 12 undergoing elective surgical procedures. Parental use of pain relief strategies (PURPS) and parental postoperative pain management (PPPM) tools were used to collect data on the adequacy of knowledge of using different pain relief strategies and the skill of parental pain assessment, respectively. Investigators used Spearman's rank correlation coefficient to determine the relationships between pain scores given by parents and nurses. The statistical tests were performed at a 95% confidence interval and a 5% significance level.

Eligibility Criteria:
Inclusion Criteria:

* Parents whose children are receiving elective surgical procedures
* age between the ages of two and twelve in year
* The legal parents' fluency in the local language in speaking, writing, and reading,
* lack of a diagnosis of any visual, auditory, sensory, or other illness

Exclusion Criteria:

Children with

* ASA classifications III or IV,
* significant developmental delays,
* chronic illnesses
* premature births,
* underlying chronic pain conditions (e.g., diabetes)
* a medical history of multiple painful experiences (e.g., malignancies)
Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.

Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring.

Extracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft.

The mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated.

The hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.


Eligibility Criteria:
Inclusion Criteria:

* ECP treatment decision based on transplant team habits (care management)
* Age ≥ 18 years
* Affiliation to a French social security scheme
* Kidney transplant at least 6 months prior to inclusion
* cABMR proven by a renal graft biopsy less than 3 months and meeting the following histological criteria:

  * allograft glomerulopathy (cg\>0, and maximum score cg2) or intimal fibrosis
  * C4d positive or ptc+g greater than or equal to 2
  * Presence of Donor Specific Antibody (DSA)
  * Interstitial Fibrosis and Tubular Atrophy (IFTA) less than or equal to 2
* Glomerular filtration rate \> 30 mL/min/1.73 m2
* Signed informed consent to participate in the study

Exclusion Criteria:

* Active infection or infection with hepatitis B, C or HIV virus
* Pregnant, breastfeeding or parturient woman
* Person deprived of liberty by judicial or administrative decision
* Person receiving psychiatric care under duress
* Person subject to legal protection
* Person out of state to express consent
Brain Stimulation for Traumatic Brain Injury

The purpose of this study is to determine whether repetitive Transcranial Magnetic Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI).


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of traumatic brain injury.
* Between one to two years after traumatic brain injuri
* Must be able to sign the Informed Consent Form

Exclusion Criteria:

* Drug addiction
* Uncontrolled epilepsy
* Extensive Cranial vault defects
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes

The investigators aim to determine, using a point-of-care randomized controlled trial design, if hemodialysis patients, who are randomized to metoprolol succinate (a dialyzable, beta-1 selective beta blocker), have an improved cardiovascular outcome compared to those randomized to carvedilol (a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties). The investigators will also examine intervention practices to identify components that best support engagement and sustainability.

Approximately 35,000 Veterans have end stage kidney disease (ESKD) with an incidence of 13,000 annually. These numbers are increasing because of the epidemic of diabetes, the most common cause of ESKD, among the Veteran population. Patients with ESKD on hemodialysis have substantial cardiovascular morbidity. Veterans annual mortality is in excess of 15% and more than half the deaths are due to cardiovascular disease. Beta blockers have been shown to prevent cardiovascular events in randomized clinical trials in patients without chronic kidney disease, particularly those with heart failure and after myocardial infarction. Beta blockers are a mainstay of therapy in dialysis patients, with two-thirds of Veterans on dialysis receiving a beta blocker. There are no head-to-head randomized studies comparing the two most commonly used beta blockers in ESKD patients in the United States, metoprolol and carvedilol, but observational studies suggest superior outcomes for patients treated with metoprolol. The identification of the superior beta blocker may significantly improve the morbidity and mortality of the VA dialysis population.

The investigators aim to compare two beta blockers with similar indications, usage and availability within the VA but with major differences in patients dialysis clearance and adrenergic effects. The investigators aim to determine if patients undergoing dialysis have improved survival when using metoprolol succinate, a beta blocker that is removed by dialysis and is beta-1 selective, compared to carvedilol, a beta blocker that is not removed by dialysis and is not beta-selective and is also an alpha-blocker.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are those (including men, women and minorities)
* On hemodialysis
* Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol

Exclusion Criteria:

* Impaired decision-making capacity
* Patients not receiving carvedilol who have a history of asthma
* known hypersensitivity to any component of either drug
* Provider unwilling to sign a new medication order for a randomized patient
* No surrogate consent will be allowed
Evaluation of Staple Watson Wrist Arthrodesis

When the wrist is damaged, for traumatic or degenerative reasons, the cartilage is worn out and the bones rub together: this is osteoarthritis. In order to stop this pain, it may be necessary to block these bones from each other, sacrificing mobility to achieve indolence.

Multiple techniques are described according to the type of osteoarthritis and for each type of osteoarthritis itself, but the principle remains the same. The methods currently commonly proposed are the staple and the screwed plate.

The aim of the study is to evaluate the surgical practice of the Orthopaedics and Traumatology department of the University Hospital of Rennes, and its long-term results, as this type of surgery is intended to be definitive.

The surgery performed in the Orthopaedics and Traumatology department of the University Hospital of Rennes, has 2 notable points: its technique and its equipment.

* The procedure is based on the staples 4Fusion1 (Stryker/Memometal), which is still poorly assessed in the literature.
* The surgical procedure has several technical specificities: intra osseous cartilage freshening and preservation of the lunotriquetral ligament if intact.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients
* All patients operated on for a 4-bones arthrodesis performed by stapling at the CHU RENNES between 1 January 2008 and 31 December 2017 with 4fusion stapling
* Patients who gave consent after full information

Exclusion Criteria:

* Refusal to participate after information
* Protected adults
* Person deprived of liberty
Validation of the French Version of the Pain Sensitivity Questionnaire

The Pain Sensitivity Questionnaire (PSQ) is a tool created in 2009 by Dr. R. Ruscheweyh in Germany. It aims at identifying the natural sensitivity to pain, through a set of 17 simple questions. These questions simulate daily life situations likely to induce pain of various intensities. The internal validity of the tool had been demonstrated both for the original version in German, and then for its English version. The external validity had also been demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers (German version), and to patients before surgery (English version). A French validation of the questionnaire is needed, in order to integrate it in pain research programs in French-speaking countries.

The aim is to validate the French version of the PSQ in a 2-step plan : (i) validity of internal structure, convergent validity and reproducibility, in a sample of patients before scheduled surgery, and (ii) structure and convergent validity against external criterion, in healthy volunteers. A secondary objective is to study the relationship of scores of the PSQ with a scale assessing sensitivity to natural smells, noise and light sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 to 65, currently French-speaking and able to answer questionnaires, undergoing a pre-anesthetic mandatory visit, either for scheduled surgery, or as a follow-up of pregnancy
* healthy volunteers aged 18 to 60, currently French-speaking and able to answer questionnaires, BMI 19 to 30 kg/m2, free from any medication since 7 days before each study session, covered by the French welfare health system. Exclusion criteria are : risk of pregnancy, any medical history or condition likely to impair participation or quality of outcome measurement, any ongoing relevant disease, any cutaneous lesion at nondominant forearm, any ocular, neurological or acoustic contra-indication to the tests, spontaneous tinnitus or disease with hyperacusia, anxiety or depression with score \>11 on HAD, addiction to drugs or alcohol abuse, inclusion in a concomitant trial, French legal protection

Exclusion Criteria:

-
Analysis of Cytokine Expression Pattern in Systemic Sclerosis

By contrast to other proinflammatory cytokines which are found up-regulated in the skin of patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine that undergoes down-regulation. This finding is interesting regarding the description of IL-34 as an immunosuppressive cytokine. In this study, the expression and the role of interleukin-34 (IL-34) will be investigated in the physiopathology of systemic sclerosis.

The mechanisms involved in the physiopathology of systemic sclerosis (SSc) are not fully understood, particularly the pattern of cytokine expression in the skin of SSc patients. These cytokines are known to play a central role in the regulation of numerous inflammatory diseases and, among them, IL-34 is the only cytokine which has been found to be down-regulated in other skin inflammatory disorders such psoriasis or atopic dermatitis. IL-34 has been described as an immunosuppressive cytokine, and our preliminary results show that IL-34 is active on fibroblasts, a key cell that undergoes dysfunction in SSc. Thus, we are willing to explore its expression profile in the skin of SSc patients and its potential role in the physiopathology of the disease. For this study, we will analyze IL-34 mRNA levels in the skin and the plasma of SSc patients by comparison to healthy patients. Thirty patients will be included in the Internal Medicine Unit of the CHU de Poitiers during a single visit, in the frame of their medical follow-up, to collect two skin biopsies and 5 ml of blood after obtaining their informed consent. The expression of IL-34 will also be investigated at the protein level by immunostaining on skin sections and by ELISA (skin protein lysates and plasma). Moreover, the expression of other proinflammatory cytokines will be investigated both at the mRNA and protein levels.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year-old
* Diagnosis of systemic sclerosis according to ACR/EURAL 2013 criteria.
* Skin sclerosis reaching an area over finger bases of hands and feet
* Free subject, without neither guardianship, wardship nor subordination
* Patient with Social Security
* Informed and signed consent by the patient after clear and loyal information on the study

Exclusion Criteria:

* Age \< 18 year-old
* Patients that do not fit the ACR/EURAL 2013 criteria
* Patients under immunosuppressive treatment
* Sclerosis limited to fingers of hands and feets.
* Patient without Social Security
* Pregnant and nursing women
Aceto-whitening in the Assessment of Gastrointestinal Neoplasia

Acetic acid chromoendoscopy is an established standard technique used to detect dysplasia within the gastrointestinal tract. Acetic acid spray helps to identify neoplasia by highlighting the surface pattern, highlighting the vascular pattern and by a process known as the aceto-whitening reaction, where tissues take acetic acid and turn white for a brief period and then slowly revert back to a normal colour. The neoplastic surface and vascular pattern are all very well described, and have played a big role in the recognition of early cancer. The aceto-whitening reaction is well described but the differential in timing between neoplastic and non-neoplastic areas is not well understood.

The investigators aim to establish the differential in the timing of the disappearance of the aceto-whitening reaction between healthy tissue, dysplastic tissue, intramucosal cancer and invasive cancer after acetic acid dye spray in the oesophagus and colon. By understanding this better, the investigators may be able to predict with greater accuracy whether a highlighted abnormal area is cancer or high grade dysplasia, or whether it is low grade dysplasia or inflammation, which has significant prognostic implications for the patient.

The investigators hypothesize that the differential in the timing of the disappearance of the aceto-whitening reaction between normal and abnormal tissue could help in the detection of gastrointestinal neoplasia.

This is a prospective pilot study. It is standard practice within our unit to use acetic acid for the detection of neoplasia. No patient would receive any additional intervention that would not normally be performed.

We will record the surface and vascular patterns before and after acetic acid spray. As usual we will then apply acetic acid spray to the Barrett's epithelium and time how long it takes for the aceto whitening to disappear. It is the timing of the disappearance that is the key study intervention. We will biopsy these areas to confirm the diagnosis. Again this is standard practice and no patient will be denied an intervention that is normally performed, and no extra interventions will be performed over and above the standard clinical practice.

We will correlate the histology to the aceto-whitening disappearance time to identify a threshold time which can serve as a cut off between neoplastic and non-neoplastic tissue.

We hypothesise that the aceto-whitening reaction lasts much longer in the normal epithelium of Barrett's oesophagus and colon. This reaction will be much shorter in areas with abnormal pathology like dysplasia or cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known Barrett's metaplasia under surveillance
* Patients with Barrett's metaplasia who had undergone endoscopic treatment for neoplasia previously and were under surveillance for metachronous neoplasia
* Patients suspected of neoplasia referred for endoscopic mucosal resection or other targeted endoscopic treatment of the lesion

Exclusion Criteria:

* Oesophagitis
* Contact bleeding
* Acute mucosal trauma
Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions one year after randomisation.

The aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of of the AJCC TNM classification.
* Technically resectable disease according to the local multidisciplinary team conference (MDT)/tumor board.
* Performance status ECOG 0-1.
* Adequate organ function.
* Women of childbearing potential (WOCBP\*) must have a negative serum or urine pregnancy test.
* Patients of childbearing/reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least five months after the last study treatment.
* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
* Before patient registration/randomization, written informed consent must be given according to ICH/GCP/GDPR and national/local regulations.

Exclusion Criteria:

* M1 according to current (8th) version of of the AJCC TNM classification.
* cT4b according to current (8th) version of of the AJCC TNM classification.
* Primary tumor not resectable without laryngectomy.
* Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy.
* Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.
* Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.
* Prior or concomitant treatment with radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields.
* Known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens.
* Inability to fully understand and digest study patient information or to comply with study instructions due to language difficulty or cognitive failure such as dementia or severe psychiatric disorder.

(Criteria slightly shortened)
Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy

The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years, able to give written informed consent
* Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
* Renal replacement therapy (continuous or intermittent)

Exclusion Criteria:

* Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
* An expected survival of less than two days.
* Known pregnancy
* Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
* Ceftaroline as monotherapy for resistent species or fungal infections.
* Other reasons oposing the study participation on the discretion of the investigators