Kornimate/medical-research-clean huggingface dataset:
psycho-traumatic consequences of the covid-19 health crisis among professionals in emergency services

Conditions: Post Traumatic Stress Disorder

Summary: the covid-19 outbreak has been categorized as a pandemic and declared an international public health emergency by who. in this context, an exceptional mobilization and a complete reorganization of the organization of the healthcare offer was put in place.the investigators will study the psychological consequences among emergency department (ed) / samu (service d'aide médicale urgente) professionals exposed during the covid-19 pandemic to high psychological stress due to work overload, changes in practices and fears of contamination.they will evaluate at 9 and 12 months after the end of the second lockdown (july december 2020), post-traumatic stress disorder (ptsd), personal and professional stress, anxiety and depression, burn-out and consumption of anxiolytic products. this is a multi-center study and includes doctors, de interns and nurses, other paramedics and medical regulatory assistants working in one of the ed or samu working during phase 3 of the covid-19 pandemic. it should make it possible to know the psychological load of the months following the epidemic among health professionals who worked in emergencies during this period and to understand their risk of occurrence of ptsd. these elements are also essential to improve the management of health crises and to put in place preventive measures for health professionals, in particular in anticipation of recurrences, second wave or future new episode.


Eligibility criteria:
inclusion criteria: * adults * administrative and technical medical staff of the hospices civils de lyon * contractual or holder * having participated in the cover pro study * working in one of the hcl phase 3 departments of the covid-19 pandemic. * affiliated with a social security system * having signed an informed consent exclusion criteria: * refusal to participate * major under legal protection

Keywords: post traumatic stress disorder ptsd emergency services covid-19 burn-out
diagnostic value of 18f-choline pet/ct in patients with a thyroid nodule with an indeterminate cytology: pilot study

Conditions: Thyroid Gland

Summary: the purpose of the study is to investigate the contribution of pet-ct with f18-choline in the diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication of surgical resection.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient with thyroid nodule ≥15 mm with an indeterminate cytology according to the bethesda classification 2008 (vesicular lesion of undetermined significance (bethesda 3); follicular neoplasm or hürthle cells (bethesda 4); lesion suspicious for malignancy (bethesda 5)), and to be operated on * patient affiliated to a social security scheme * informed consent and signed exclusion criteria: * thyroid nodules \<15 mm * coalescing nodules preventing proper individualization of targeted nodule; * thyroid nodule with non-diagnostic cytology (bethesda 1), benign cytology (bethesda 2) or malignant cytology (bethesda 6) * hot thyroid nodule on the thyroid scan * major subject to a measure of legal protection or unable to consent * pregnant women / nursing * refusal to participate

Keywords: f18-choline surgery indeterminate thyroid node
open-label, single- and multiple-dose pharmacokinetic study of diazoxide choline

Conditions: Hypertriglyceridemia

Summary: this is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (pk) of diazoxide choline controlled-release tablet (dccr) administered orally under fed and fasting conditions at two dose levels.


Eligibility criteria:
inclusion criteria: * signed informed consent * healthy adults * fasting glucose ≤ 125 mg/dl and hba1c ≤ 6.5 * fasting triglyceride ≥150 mg/dl and ≤ 500 mg/dl exclusion criteria: * known cad, dm, uncontrolled htn * pregnancy or unable to complaint with the birth control method required
the effect of quercetin in sarcoidosis

Conditions: Sarcoidosis

Summary: the exact cause of the chronic lung disease sarcoidosis is still unknown. consequently, a complete efficacious treatment is still not available. earlier studies indicate an important key role for oxidative stress, i.e. an imbalance between the production of and the protection against ros, in the etiology of sarcoidosis. antioxidants, needed for protection against ros, are indeed lower in sarcoidosis. therefore, antioxidant therapy to strengthen the reduced antioxidant defense might be efficacious in sarcoidosis treatment. since ros are also capable of initiating and mediating inflammation, antioxidant therapy might also mitigate the elevated inflammation that occurs in sarcoidosis. the flavonoid quercetin possesses both anti-oxidative and anti-inflammatory capacities and might therefore serve as a good candidate for antioxidant therapy in sarcoidosis. therefore, the aim of the present study is to determine the effect of quercetin supplementation in sarcoidosis patients on markers of both oxidative stress and inflammation.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of sarcoidosis with emphasize on pulmonary sarcoidosis * no smoking * no treatment exclusion criteria: * clinical diagnosis (and treatment) of other diseases * symptoms of sarcoidosis in other organs besides the lung * use of food supplements or vitamins

Keywords: sarcoidosis quercetin supplementation oxidative stress inflammation
procalcitonin and endotoxin sequential levels to optimize the treatment of bloodstream infections

Conditions: Bloodstream Infection

Summary: bloodstream infections (bsi) are a major cause of morbidity and mortality. bloodstream infections are also costly and result in prolonged hospital stays. the duration of therapy necessary to clear blood stream infections is unknown and no study has systematically addressed this issue. however, the use of antimicrobials is not without consequence. these include financial cost, side-effects, promotion of superinfection (especially clostridium difficile-associated diarrhea), and the promotion of microbial resistance. this study hypothesizes that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker) guided treatment plan could significantly decrease unnecessary exposure to antibiotics in patients with bloodstream infections.

bloodstream infections (bsi) are a major cause of morbidity and mortality. community-onset bsi have an overall attributable mortality of 10-13% while nosocomial bsi mortality ranges are quite variable from 12-80%. bloodstream infections are also costly and result in prolonged hospital stays. nosocomial bsis have been shown to increase length of stay by 5-25 days and increase costs $23,000 - 40,000 above matched controls. the duration of therapy necessary to clear blood stream infections is unknown and no study has systematically addressed this issue. the use of antimicrobials is also not without consequence. these include financial cost, side-effects, promotion of superinfection (especially clostridium difficile-associated diarrhea), and the promotion of microbial resistance. this study hypothesizes that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker) guided treatment plan could significantly decrease unnecessary exposure to antibiotics in patients with bloodstream infections.

Eligibility criteria:
inclusion criteria: * hospitalized, adult patient, at least one positive blood culture reported within 24 hours of enrollment exclusion criteria: * previously enrolled in the study; discharged/deceased before first positive culture; receiving antibiotic for greater than or equal to 48 hours; endocarditis or osteomyelitis; antithymocyte globulin in the last 12 months; blood cultures positive for coagulase-negative staphylococcus only.
a crossover trial of chitosan oligosaccharide on post prandial glucose control in subjects with normal, ifg and igt

Conditions: Normal; Impaired Fasting Glucose; Impaired Glucose Tolerance

Summary: it is well known that chitosan oligosaccharide is low molecular weight and water soluble and chitosan oligosaccharide has been shown to reduce blood cholesterol and blood pressure, increase immunity, and enhance antitumor properties. the effect of chitosan oligosaccharide (go2ka1) supplementation on glucose control in subjects with normal blood glucose, impaired fasting glucose and impaired glucose tolerance.

a randomized, double-blinded, controlled, cross-over trial was conducted to verify the effects of chitosan oligosaccharide (go2ka1). forty healthy male and female subjects aged 20-75 years with normal blood glucose, impaired fasting glucose and impaired glucose tolerance were recruited. the subjects visited the research site twice over with a seven-day interval after an overnight fast at least 12 hr. on the screening visit, the participants were the 2-hr oral glucose tolerance test (ogtt) was conducted. and they were separated normal blood glucose, impaired fasting glucose and impaired glucose tolerance. on the first visit, the participants were randomly assigned to consume a test or placebo product \[test product: chitosan oligosaccharide powder 500mg (go2ka1); placebo product: white egg powder 500mg\] and ingested the assigned product. on the second visit, the participants consumed the other product that they did not eat on the first visit. on both visit day, the 2-hr oral sucrose tolerance test (ostt) was conducted and started at 8:00 in the morning; venous blood samples were collected before (0 hr) and after ingestion (0.5, 1 and 2 hr) of the products.

Eligibility criteria:
inclusion criteria: * normal blood glucose (fasting blood sugar below 100mg/dl, two hours after meals below 140mg/dl) * impaired fasting glucose (fasting blood sugar 100-125mg/dl) * impaired glucose tolerance (two hours after meals 140-199mg/dl) exclusion criteria: * history/presence of diabetes mellitus (including oral hypoglycaemic agent and insulin) * history of serious hypoglycemia * history of serious cardiovascular, cerebrovascular disease, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease * uncontrolled blood pressure (blood pressure level more than 140/90mmhg) * history/presence of alcoholism, drug addiction, etc. * taking a regulation of blood glucose medications within 1 month before study * participation other intervention studies within 1 months before study * history of diagnosed with cancer, cancer surgery and hospitalization * women who are pregnant or desire to become pregnant during the study period * having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study

Keywords: chitosan oligosaccharide diabetes mellitus blood glucose fasting blood sugar normal blood glucose impaired fasting glucose impaired glucose tolerance
car-nk cells (cl-nk-001) in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.

a dose-escalation study will evaluate the safety, tolerability and efficacy of car-nk cells (cl-nk-001) in patients with locally advanced, metastatic, or recurrent pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. aged 18-70 years; 2. locally advanced, metastatic, or recurrent pancreatic cancer, with immunohistochemical detection of egr1 (membrane positive tumor cell rate \>40% and expression intensity ≥2+), who have failed, been intolerant to or reject standard treatment; 3. at least 1 measurable lesion according to recist 1.1; 4. have not received anti-tumor treatment for at least 4 weeks; 5. ecog performance status of 0-2; 6. estimated life expectancy more than 12 weeks; 7. hematology: neutrophils ≥ 1.5×10\^9/l, lymphocytes ≥ 0.8×10\^9/l, hemoglobin ≥ 100 g/l, and platelets ≥ 75 × 10\^9/l; 8. blood biochemistry: total bilirubin ≤ 2×uln, alanine aminotransferase ≤ 3×uln, aspartate aminotransferase ≤ 3×uln, and creatinine clearance ≥ lln (cockcroft-gault formula); 9. volunteer to participate in this clinical study and willing to sign written informed consent. exclusion criteria: 1. evidence of central nervous system involvement; 2. have received adoptive cell therapy; 3. patients with any uncontrolled active infection, including but not limited to: hbv, hcv, hiv, or treponema pallidum serology positive; 4. vaccinated with a live attenuated vaccine within 3 months; 5. history of immunodeficiency; 6. active autoimmune disease; 7. have severe conditions, including but not limited to: (1) severe respiratory diseases; (2) severe cardiovascular diseases (previous history of cabg/pci; myocardial infarction/unstable angina pectoris, congestive heart failure of nyha iii-iv, left ventricular ejection fraction \ 480ms, long or short qt syndrome; previous history of ventrical arrhythmia, or ventrical arrhythmia under anti-arrhythmic drugs/icd); (3) poorly controlled diabetes and other metabolic diseases; (4) severe gastrointestinal diseases (severe gastrointestinal bleeding, severe diarrhea of ctcae ≥ 2, or severe gastrointestinal obstruction needing intervention); 8. possible severe adverse events, allergy or other contraindications to drugs or its component under study; 9. pregnant or lactating women; 10. history of neurological or psychological disorders; 11. not suitable to participate this clinical study judged by the investigator.

Keywords: pancreatic cancer car-nk
salpingectomy during cesarean section

Conditions: Healthy

Summary: based on the accumulated literature, salpingectomy may significantly reduce the risk for ovarian cancer. if investigators can prove that there is no increase in surgical complications and morbidity during salpingectomy in cs, compared to tubal ligation, investigators can recommend for women who are interested in sterilization- salpingectomy during cesarean section .

until recently, ovarian resection was considered the only option to prevent ovarian cancer. recently new evidence showing that the fallopian tube itself may be the source of certain types of ovarian cancer. so salpingectomy, may offer some protection. however, the extent of this protection has not been determined. therefore, and based on the foregoing, the investigators think there is an advantage in removal of fallopian tubes rather than tubal ligation cesarean sections. given the lack of evidence in the literature about the complications of this procedure, currently the investigators organize a study examines the rate of complications of salpingectomy compared to tubal ligation during cesarean section. therefore, the main objective of the study is to assess the incidence of intra-operative complications during cesarean section. the effect of the procedure will be examined on the following indicators: 1. the duration of the operation, 2. the rates of bleeding during the operation as estimated by the surgeon, 3. hemoglobin before and after the surgery, 4. rates of giving blood or after surgery 5. the technical difficulty in performing tubal resection according to surgeon assessment 6. the need for further surgical intervention a secondary objective of the study is evaluating the long-term complications: 1. assessment of pain intensity at three months after surgery 2. evaluation of menopausal symptoms, three months after surgery 3. test ovarian sonar and doppler three months after surgery 4. testing the value of amh three months after surgery

Eligibility criteria:
inclusion criteria: * women planned for cesarean section , according to medical or obstetric indication , and seek sterilization * women aged 30 and older * women who are capable to understand , read and sign an informed consent form exclusion criteria: * women aged less then 30 years * women who disagree to participate in the research

Keywords: salpingectomy cesarean section tubal ligation morbidity
a safety and efficacy study of oral dimebon in patients with mild-to-moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the connection study is a six-month confirmatory phase 3 study to determine the safety and efficacy of dimebon in the treatment of mild-to-moderate alzheimer's disease (ad).

this study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of dimebon in the treatment of patients with mild-to-moderate ad. dimebon is an investigational drug for alzheimer's disease. the target of dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).the connection study is the second of two pivotal studies evaluating the effect of dimebon. it is a 6-month study enrolling 525 patients in the united states, europe, and south america. all patients completing the 6-month study will be eligible to receive dimebon in an open-label extension trial. the patient population will be carefully selected to ensure inclusion of patients with ad, rather than other types of dementia. mild-to-moderate disease will be defined by the screening mini-mental state examination (mmse). patients will attend study visits with caregivers who will provide information about the patient's condition.

Eligibility criteria:
inclusion criteria: * mild-to-moderate alzheimer's disease * probable ad (national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda) and diagnostic and statistical manual of mental disorders-iv (dsm-iv) * mmse score 10-24 inclusive * computerized tomography (ct) san or magnetic resonance imaging (mri) consistent with ad * caregiver who cares for the patient at least 5 days per week exclusion criteria: * anti-dementia drugs including cholinesterase-inhibitors or n-methyl-d-aspartate receptor (nmda) receptor antagonists within 90 days * other causes of dementia * other primary psychiatric or neurological disorders * unstable medical illnesses or significant hepatic or renal disease

Keywords: alzheimer's disease, clinical trial, memory loss, mitochondria, investigational drug, neurodegenerative disease, dementia
performance of the hbv elispot in the detection of the t cellular immune response in patients infected by hbv or cured

Conditions: Hepatitis B

Summary: activation of the immune system against a pathogen can be considered one of the most effective interventions in the field of infectious diseases. transgene is developing a therapeutic vaccine "tg1050" for the treatment of patients with chronic and treated hepatitis b. this biotherapy compound is for the development of t cellular immune response in these patients in order to achieve the total elimination of infected cells. therefore it is necessary to have measures of ways to assess accurately and reliably the presence of such a response in the study subjects.


Eligibility criteria:
inclusion criteria: man or woman aged ≥18 years old. patients with chronic hepatitis b regardless of the genotype. * treated with nucleotide analogs approved for the treatment of hepatitis b. * or untreated. * with a positive or negative antigen hbe * regardless of the level of transaminases. patients with a history of hbv infection (recovered) with seroconversion of antigen hbs spontaneously or under treatment. patient with a general state ranging 0 or 1 on the ecog scale (eastern cooperative oncology group) patient who signed the informed consent patient with a social security affiliation exclusion criteria: patients co-infected with human immunodeficiency virus (hiv) or hepatitis c virus (hcv). patients treated with interferon, immunosuppressive, or experimental treatment consisting of an unapproved molecule for the treatment of hepatitis b. patient unable to meet the constraints of the study patient transplanted patient with a history of cancer or autoimmune disease within 5 years pregnant or lactating women

Keywords: hepatitis b virus elispot test t cellular immune response
safety and efficacy study of cells sheet-autologous chondrocyte implantation to treat articular cartilage defects

Conditions: Osteochondritis; Osteochondritis Dissecans; Joint Diseases

Summary: in this study,the autologous chondrocyte implantation (aci)technology and cell sheet technology are used to cells sheet-autologous chondrocyte implantation(cs-aci) for treating cartilage defects.the safety and efficacy study of cs-aci are evaluated.

all procedures are carried out after obtaining informed written consent from patients. cartilage tissue is acquired from the non-weight-bearing area of patients. chondrocyte are isolated and grown in culture for 6-8 weeks. after this time interval, the cells are reprocessed and the cell sheet is obtained. implantation of the chondrocyte sheet into the cartilage defect of the keen.the patients will be assessed clinically with scoring systems preoperatively as well as 24 months postoperatively to assess relief of symptoms and joint function. radiological assessment (mris)of the affected joints will be performed at the same time points aforementioned to assess integrity of the formed cartilage. second look arthroscopy and biopsy will also be performed to histologically assess the repair tissue and grade it via arthroscopic grading system according to the international cartilage repair society guidelines.

Eligibility criteria:
inclusion criteria: * male or female patients, age: between 18 and 50 years * defect: isolated icrs grade iii or iv single defect chondral lesions on articular cartilage * defect size: 2.5 to \< 5 cm2 after debridement to healthy cartilage up to 6 mm in depth. * nearly intact chondral structure surrounding the defect as well as an intact corresponding joint area * informed consent signed and dated by patient and patient understands the strict rehabilitation protocol and follow-up programme and is willing to follow it * no ligament damage or ligament damage after reconstruction exclusion criteria: * patients younger than 18 years and older than 50 years. * arthrofibrosis or ankylosis * arthritis * obesity * infectious diseases * the other cases of patients which doctors determine not participate in the trial

Keywords: cartilage repair cartilage defects cell sheet autologous chondrocyte implantation