Kornimate/medical-research-clean huggingface dataset:
study of arrhythmia and ecg abnormalities in patients with covid-19

Conditions: Arrhythmia; SARS-CoV-2 Infection

Summary: cardiac involvement has been described in severe acute respiratory syndrome - coronavirus-2 (sars-cov-2) infection. although there are no approved drugs to prevent or treat sars-cov-2 infection at present time, several medications used have the potential to increase qt interval and eventually provoke torsades de pointe. the investigators therefore create a study that include all patients with sars-cov-2 infection having an electrocardiogram (ecg). the investigators evaluate the percentage of patients with ecg abnormalities, describe the abnormalities and evaluate the occurrence of syncope, ventricular arrhythmia and corrected qt (cqt) interval modification in patients receiving treatment.

in patients with sars-cov-2 infection, the investigators analyze baseline ecg as well as follow-up ecg. patients followed by bordeaux university hospital for covid-19 can be included. ecg are digitized in the computerized patient file (dxcare) for further analysis.

Eligibility criteria:
inclusion criteria: * patients over 18 years of both gender, * followed by bordeaux university hospital for sars-cov-2 infection with a cardiac monitoring or ecg realized. * non opposition expressed. exclusion criteria: * minor, * inability to understand the study

Keywords: covid-19 ecg torsade de pointe qt interval
telemedical examination of a three-component oculomotor testing battery

Conditions: Stroke; Vertigo; Dizziness

Summary: the study investigates the feasibility and safety of the telemedical implementation of three diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing system. the testing battery comprises halmagyi's head impulse test, test for nystagmus and test of skew (vertical misalignment) known as the hints protocol. previously published data have shown high sensitivity and specificity of the protocol for the discrimination of central and peripheral causes of acute vestibular syndrome. in this study the three tests will be executed on 30 healthy subjects using video goggles (eyeseecam, interacoustics gmbh, germany) connected to a mobile wireless-workstation for bidirectional audiovisual communication in a clinical environment (meytec gmbh, germany). a newly developed remote control and video conferencing solution allows the execution and evaluation of the hints protocol in a telemedical setup. the examination is guided by a remote physician using the help of a trained assistant attending to the subject. corresponding clinical bedside tests will be executed for comparison. primary endpoint is feasibility of the three diagnostic tests in a telemedical setting. safety as well as accuracy of the telemedical versus bedside examination will be analyzed as secondary outcome measures. aim of the study is to improve diagnostic accuracy for patients with acute vestibular syndrome in remote areas where specialists are rare.


Eligibility criteria:
inclusion criteria: * consenting adults exclusion criteria: * acute vertigo or dizziness, acute neck pain, history of stroke, history of acute vestibular syndrome, strong unilateral or bilateral visual impairment, complete movement restriction of cervical spine

Keywords: telestroke hints diagnosis telemedicine acute vestibular syndrome
can transcranial direct current stimulation improve ambulation and fatigue resistance in people with ms?

Conditions: Multiple Sclerosis

Summary: in this project the investigators will be using non-invasive brain stimulation on people with multiple sclerosis (pwms) to improve leg muscle function. two groups of participants will be recruited. one group will perform strength testing with and without the brain stimulation. the second group of participants will perform a fatigue task, pulling against a wire at a low level of force, with and without the brain stimulation. this type of brain stimulation has been shown to transiently improve strength and fatigue measures in other populations, e.g. aged, parkinson's, and improve cognitive abilities in people with multiple sclerosis. it is the investigator's hope that the increases in performance seen in other patient groups will also occur in people with multiple sclerosis. future investigations will look to apply the non-invasive brain stimulation technique during physical rehabilitation to improve short and long term outcomes related to physical function.


Eligibility criteria:
inclusion criteria: * medically diagnosed with ms * moderate disability (patient determined disease steps score 2-6) * self-reported differences in function between the legs (2-5 on a 1-5 scale) * people with ms with physician clearance exclusion criteria: * a relapse of disease symptoms in the last 60 days * a condition unrelated to ms that would exacerbate fatigue, such as anemia, hypothyroidism, shiftwork-related fatigue, b12 deficiency, major sleep disorder, or major depressive disorder * medical diagnosis or condition that makes participating in exercise training dangerous, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, hiv, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy * history of heart attack or current diagnosis of cardiovascular disease * history of seizure disorders (or on medications known to lower seizure threshold), hydrocephalus (buildup of fluid in the brain), or diabetes * alcohol dependence or abuse (\>2 drinks/day), or present history (last six months) of drug abuse * history of significant traumatic brain injury or hydrocephalus * pregnancy * recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state. * presence of metal is present or implanted device or metal object that is not safe for tms.
visanne post-approval observational study (vipos)

Conditions: Endometriosis

Summary: the study assesses safety aspects of dienogest (dng) 2mg/day (visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.

endometriosis is a common, chronic, gynecological disease characterized by pain and impaired fertility. it causes chronic inflammation, ovarian cyst formation, fibrosis and adhesions. symptoms seem to respond to decreased circulating estrogen. the mainstay of medical treatment is hormonal induced anovulation and a reduction in endogenous estrogen production. medications for endometriosis such as danazol and gnrh agonists have clinically relevant side-effects limiting treatment duration with these medications to 6-12 months. dienogest (dng) is a 19-nortestosterone derivative progestogen. dng 2mg/day is a reliable and effective treatment for dysmenorrhea, premenstrual pain, dyspareunia and diffuse pelvic pain associated with endometriosis. two important class effects of progestogens are the induction of bleeding disturbances and their influence on mood disturbance. it is not known what influence dng will have on bleeding disturbances associated with endometriosis, particularly over a longer time frame. in addition, women who suffer from endometriosis are at high risk of developing depressive symptoms. it is difficult to differentiate if depressive symptoms are causally associated with progestogen use or sequela of the disease process. this study investigates the safety of dng for endometriosis with regard to medical interventions for anemia and worsening of depressive symptoms associated with the disease. it is a prospective, controlled, non-interventional cohort study with two cohorts: users of dng and users of other medications for the treatment of endometriosis. the study will be implemented in several european countries.

Eligibility criteria:
inclusion criteria: * women using a newly prescribed regimen for endometriosis (first-time users or switchers or re-starters) * women who are willing to participate in this long-term follow-up study exclusion criteria: * women who are not cooperative/available for follow-up * women with a language barrier

Keywords: dng anemia depression
effects of fsh on endothelial function (fend)

Conditions: Change in Flow Mediated Dilation

Summary: purpose of the study will be to evaluate the effects of the s.c. administration of 300 iu of fsh in 16 healthy males. the endothelial function will be evaluated by the measurement with ecographic approach of the flow mediated dilation (fmd) of the brachial artery. the fmd will be measured before and 6, 12, 24 or 48 hours after fsh or placebo adiministration in the same subjects studied 2 weeks apart. the results will help to clarify whether perturbation of fsh, similar to the one observed in women after the menopause, affect endothelial function.

the effects of follicle-stimulating hormone (fsh) have been poorly studied. in women, fsh is involved in estrogen production, while in men regulates spermatogenesis. on the other hand, in women, menopause is associated with an increase in the risk of cardiovascular disease and the concentration of fsh rises. it is unclear whether such an increase has any effect on the development of atherosclerosis. endothelial dysfunction represents an early trigger of atherosclerosis. since estrogens can directly stimulate endothelial function and increase in response to fsh administration, males might represent a potential model to study the effcts of fsh independent from estrogens.purpose of the study will be to evaluate the effects of the s.c. administration of 300 iu of fsh in 16 healthy males. the endothelial function will be evaluated by the measurement with ecographic approach of the flow mediated dilation (fmd) of the brachial artery. the fmd will be measured before and 6, 12, 24 or 48 hours after fsh or placebo adiministration in the same subjects studied 2 weeks apart. the results will help to clarify whether perturbation of fsh, similar to the one observed in women after the menopause, affects endothelial function.

Eligibility criteria:
inclusion criteria: healthy volunteers - exclusion criteria: -

Keywords: endothelial function, atherosclerosis, fsh, fmd
quality of life in patients undergone vulvar reconstruction after vulvar cancer resection (3233)

Conditions: Vulvar Neoplasms

Summary: this study aims to evaluate the patients'quality of life before and after surgery for vulvar cancer and reconstruction, employing different questionnaires and investigating different items.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery for vulvar cancer * patients providing consent to be enrolled in the study exclusion criteria: * cognitive impairment * psychiatric disorder * neurodegenerative disorder

Keywords: vulvar neoplasms vulvar cancer vulvar reconstruction vulvoperineal reconstruction gynecological cancer quality of life
s9427, suramin in treating patients with stage iii or stage iv adrenocortical cancer incurable by surgery

Conditions: Adrenocortical Carcinoma

Summary: rationale: some tumors need growth factors produced by the body to keep growing. suramin may interfere with the growth factor and stop the tumor from growing. purpose: phase ii trial to study the effectiveness of suramin in treating patients with stage iii or stage iv adrenocortical cancer.

objectives: i. assess the response of patients with adrenocortical carcinoma treated with suramin. ii. evaluate the qualitative and quantitative toxic effects of this therapy. outline: patients are described according to stage, performance status, prior radiotherapy, prior surgery, and prior mitotane therapy. patients receive suramin iv for 5 days in the first week, then twice a week for 2 weeks, and then weekly for a total of 12 weeks. hydrocortisone is taken po twice daily. following a 12 week rest, patients receive a second course; those with stable or responding disease continue treatment for a maximum of four courses. projected accrual: a maximum of 40 patients will be accrued at a rate of 6-7 per year.

Eligibility criteria:
disease characteristics: histologically confirmed adrenocortical carcinoma in stage iii or iv and incurable by surgery bidimensionally measurable disease patient characteristics: age: 18 and over performance status: swog 0-2 hematopoietic: wbc at least 4,000/mm3 absolute granulocyte count at least 2,000/mm3 platelet count at least 150,000/mm3 prothrombin time and partial thromboplastin time no greater than upper limit of normal (uln) hepatic: sgot and alkaline phosphatase no greater than 2 times uln renal: creatinine clearance at least 50 ml/min serum creatinine no greater than uln other: no second malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma of the skin,in situ carcinoma of the cervix, or other cancer for which patient has been disease free for 5 years not pregnant or nursing effective contraception required of fertile patients prior concurrent therapy: biologic therapy: no concurrent biologic therapy at least 4 weeks since prior biologic therapy (one regimen only) chemotherapy: no concurrent chemotherapy at least 4 weeks since prior mitotane no other prior chemotherapy allowed endocrine therapy: at least 6 weeks since prior hormonal therapy no concurrent hormonal therapy radiotherapy: at least 4 weeks since prior radiation therapy (to less than 25% of bone marrow) no concurrent radiation therapy surgery: prior surgery allowed in relapsed patients with no other prior treatment

Keywords: stage iii adrenocortical carcinoma stage iv adrenocortical carcinoma
nbi-1065845-mdd3026: study to assess the efficacy and safety of nbi-1065845 as an adjunctive treatment in participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the study will evaluate the efficacy of nbi-1065845 compared with placebo as an adjunctive treatment in participants with mdd on improving symptoms of depression.


Eligibility criteria:
key inclusion criteria: * participant has a primary diagnosis of recurrent mdd (moderate or severe) or persistent depressive disorder. * participant has had an inadequate response to oral antidepressant treatments in the current episode of depression. * participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study. * total hamilton depression rating scale-17 item (ham-d17) score ≥22 at screening and at study baseline (day 1). * willing and able to comply with all study procedures and restrictions in the opinion of the investigator. key exclusion criteria: * a current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than mdd. * are considered by the investigator to be at imminent risk of suicide or injury to self or others. * participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ect) in the current major depressive episode.

Keywords: mdd depression major depressive disorder nbi-1065845 tak-653 madrs
the effect of deferasirox on response rate of acute leukemia patients not treated by standard chemotherapy regimens

Conditions: Acute Myeloid Leukemia; Acute Lymphoid Leukemia

Summary: the purpose of this study is to determine whether deferasirox is effective in the treatment of acute lymphatic leukemia (all) and acute myeloid leukemia (aml).

many studies have demonstrated that iron is essential for the metabolism, cell cycle regulation and metastasis in different cancer cell lines. it is also believed that iron concentration will increase in cancer cells by enhancing expression of tfr-1 receptors and in case of receptor saturation, non-receptor-mediated pinocytosis would be a significant pathway for more iron intake. iron deficiency may lead to increase p 53 which consequently will stop cell mitosis in g1-s state. it also increases expression of n-myc down-regulated gene 1 which can suppress metastasis in cancer. it has been suggested that iron chelators may decrease leukemic tumor growth in animal models of acute myeloid leukemia (aml). some other case studies demonstrated the role of iron chelators in relapse and/or refractory aml. finally a phase 1 clinical study is undertaken for evaluate the role of tiapine and cytarabine for adult aml and high-risk myelodysplastic syndrome. so in this study the investigators try to evaluate the role of iron chelating agent (deferasirox) for patients with acute lymphatic leukemia (all) and aml patients who cannot be treated with standard chemotherapy regimes .

Eligibility criteria:
inclusion criteria: 1. patients with acute leukemia (myeloid or lymphoblastic) who do not receive the standard chemotherapy regimens for treatment; because of the following reasons: 1. age \> 65 2. existence of another illness, such as heart failure (ef\> 40) 2. ferritin \< 500 μg / l 3. not existence of other co morbidity 4. gfr \> 40 exclusion criteria: 1. gfr \< 40 2. control group become iron overloaded (ferritin \> 500 μg /l) 3. incidence of any severe gastrointestinal symptoms (mucositis, enterocolitis, typhlitis, nausea, diarrhea) 4. not willing to continue treatment.

Keywords: acute myeloid leukemia acute lymphoid leukemia deferasirox
pneumothorax drainage with vacuum bottle

Conditions: Iatrogenic Pneumothorax; Vacuum Bottle Assisted Needle Aspiration

Summary: the use of vacuum bottle in drainage of pneumothorax was seldom reported. this study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

for aspiration or drainage of pneumothorax, a 16-gauge or 18-gauge over-the-needle non-tunneled catheter, a pigtail, or chest tube are frequently used to penetrate the pleural space. a 50-ml or 60-ml syringe may be connected to the over-the-needle catheter or a pigtail for simple aspiration, while underwater-sealed bottle or suction drainage connected to chest tube for drainage of pneumothorax. vacuum bottle for removing pleural effusion are frequently reported in literature and common in daily practice. however, the use of vacuum bottle in drainage of pneumothorax was seldom reported. this study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.

Eligibility criteria:
1. inclusion criteria: · clinical diagnosis of pneumothorax 2. exclusion criteria * bleeding tendency * tension pneumothorax * shock

Keywords: pneumothorax/therapy drainage
study of physiopathological mechanisms and results of treatment with bronchial thermoplasty in severe asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.

bronchial thermoplasty is a new therapeutic tool for severe and uncontrolled asthma patients. clinical trials have demonstrated clinical benefits regarding quality of life and exacerbations. animal models suggested the reduction of bronchial smooth muscle as the principal responsible for the clinical benefits observed in asthma patients treated in the clinical trials, although there is little information about its mechanism of action, and limited to a very small number of case reports. given that the mechanism of action of bronchial thermoplasty is still not well understood, we proposed a biological study in asthma patients treated with bronchial thermoplasty with the purpose to analyze changes in inflammatory markers and histological samples, as well as its correlation with clinical outcomes in real practice.

Eligibility criteria:
inclusion criteria: * patients under 18 years old. * severe persistent asthma according to gina. * inhaled corticosteroids and long-acting ß2 agonist (laba). * other medications for asthma, as oral corticosteroids, anti-ige, theofiline, etc. are also acceptable. * asthma quality of life questionnaire (aqlq) \< 7 * asthma control test (act) \< 19 * ≥ 2 exacerbations in last year exclusion criteria: * history of cigarette smoking with \> 15 pack/years. * other respiratory diseases. * comorbidity that can justify the symptoms of the patients. * life-threating unstable asthma. * any contraindication to perform a bronchoscopy (respiratory insufficiency, coagulation abnormalities, allergy to sedative drugs, etc.)

Keywords: asthma bronchial thermoplasty bronchial smooth muscle
treatment of hyperlactatemia in acute circulatory failure based on analysis of co2: a prospective randomized superiority study (the lactel study)

Conditions: Hyperlactatemia; Actue Circulatory Failure

Summary: the management of a patient with shock is based on improving tissue oxygenation through hemodynamic optimization. lactate is a marker of tissue hypoperfusion commonly used in the icu. in principle, hyperlactatemia can be caused by either increased tissue production (tissue hypoperfusion: type a), decreased lactate uptake (type b), or a combination of both mechanisms. it is important to correctly determine the cause(s) of hyperlactatemia, as this determines the treatment (expanders, inotrope, vasopressor, blood derivative transfusion), and the patient's morbidity and mortality. a classic example of this concept is volume expanders, which are frequently used to correct hyperlactatemia secondary to tissue hypoperfusion, but are associated with mortality if used excessively (fluid overload). in clinical practice, it is difficult to differentiate the exact causes of hyperlactatemia (type a and type b). from work carried out over the last 20 years in septic shock and then in other states of shock and in the operating theatre, it has been shown that the arteriovenous co2 gradient (pco2gap) measured from arterial and venous blood gases is a marker of tissue hypoperfusion with better predictive ability than the usual markers (clinical examination, svo2....). furthermore, when we relate pco2gap to the arteriovenous o2 difference (pco2gap /c(a-v)o2), this ratio allows us to distinguish with greater accuracy between states of acute circulatory failure associated with anaerobiosis (tissue hypoperfusion, type a) and those related to the underlying disease. also, several studies have demonstrated a strong ability of the pco2gap and the pco2gap/cavo2 ratio to predict the severity of shock, mortality of the shock patient, hyperlactatemia, and correction of hyperlactatemia with hemodynamic treatment. as a result, many authors have proposed algorithms for the management of shock patients based on the measurement of these co2-derived indexes. the hypothesis of this study is that the use of an algorithm based on co2gap and the co2gap/cavo2 ratio is superior in terms of correction of hyperlactatemia to usual practice based on clinical and macro-hemodynamics.


Eligibility criteria:
inclusion criteria: * oral, free and informed consent obtained from a trusted person (health care proxy) or a close relative or consent in an emergency situation * adult patient managed in intensive care for whom the physician has decided on hemodynamic management because of signs of acute circulatory failure (systolic blood pressure \ 3 sec * arterial lactate level ≥ 3 mmol l-1 exclusion criteria: * person not affiliated to national health insurance * person subject to a measure of legal protection (curatorship, guardianship) * person subject to limited judicial protection * pregnancy or breastfeeding