Kornimate/medical-research-clean huggingface dataset:
comparison of tocilizumab plus dexamethasone vs. dexamethasone for patients with covid-19

Conditions: Coronavirus Infection; SARS (Severe Acute Respiratory Syndrome); Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Disease

Summary: the overall objective of the study is to determine the therapeutic effect and tolerance of tocilizumab combined with dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with coronavirus disease 2019 (covid-19). tocilizumab (tcz) is an anti-human il-6 receptor monoclonal antibody that inhibits signal transduction by binding sil-6r and mil-6r. the study has a cohort multiple randomized controlled trials (cmrct) design. randomization will occur prior to offering dexamethasone alone or dexamethasone +tocilizumab administration to patients enrolled in the corimuno-19 cohort. tocilizumab will be administered to consenting adult patients hospitalized with covid-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. patients who will chose not to receive tocilizumab will receive standard of cares. outcomes of tocilizumab-treated patients will be compared with outcomes of standard of care (including dexamethasone) treated patients


Eligibility criteria:
inclusion criteria: 1. patients included in the corimuno-19 cohort 2. patients belonging to the following group: * requiring ≥ 3l/min of oxygen * who progression scale = 5 * no niv or high flow exclusion criteria: * patients with exclusion criteria to the corimuno-19 cohort. * known hypersensitivity to tocilizumab or dxm or to any of their excipients. * pregnancy * current documented bacterial infection not controlled by antibiotics. * certain evolving viral diseases (especially active herpes, chickenpox, shingles), * psychotic states still not controlled by treatment, * live vaccines in the previous 4 weeks, * active tuberculosis or disseminated strongyloidiasis * patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication: * absolute neutrophil count (anc) ≤ 1.0 x 109/l * haemoglobin level: no limitation * platelets (plt) \< 50 g /l * sgot or sgpt \> 5n
endotracheal tube with polyurethane cuff and subglottic secretion drainage

Conditions: Mechanical Ventilation

Summary: patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube

subglottic secretions accumulated above the endotracheal cuff may progress, descending along the channels within folds of the cuff wall, to the lower respiratory tract causing vap. subglottic secretion drainage (ssd) appears to be effective in preventing vap, primarily by reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. we set out the hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from the subglottic area) it should be also possible to reduce the incidence of late-onset vap.

Eligibility criteria:
inclusion criteria: * patients expected to require mechanical ventilation for more than 24 hours exclusion criteria: * age \<18 years, * pregnancy, * hiv, * blood leukocytes counts \<1000 cells/mm3, * solid or haematological tumour, * immunosuppressive therapy

Keywords: ventilator-associated pneumonia endotracheal tube polyurethane cuff polyvinyl cuff subglottic secretion drainage
to evaluate the impact of treatment interruption on re-initiation of bifeprunox

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. the study duration is approximately 7 to 10 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * 18-55 years exclusion criteria: * subjects who are acutely psychotic * subjects with current axis i primary psychiatric diagnosis other than schizophrenia * subjects at significant risk of suicide * subjects with a seizure disorder

Keywords: treatment interruption on reinitiation schizophrenia schizoaffective disorder
end to end versus side to end anastomosis after anterior resection of cancer rectum

Conditions: Rectum Cancer

Summary: comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. the main outcomes were bowel functional outcomes and qol. bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. the secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality.

during the past two decades, remarkable progress has been made in the treatment of rectal cancer. the main goal of rectal surgery for malignancy is oncologic radicality in an effort to achieve the preservation of sphincters and sexual-urinary function.the introduction of circular stapling devices is largely responsible for their increasing popularity and utilization. sphincter-saving procedures associated to partial or total mesorectal excision (tme) for the treatment of mid and distal rectal cancer have become increasingly prevalent as their safety and efficacy have been proved. total mesorectal excision (tme) is the best available treatment for rectal cancer. with the advancement of surgical techniques, the majority of patients with mid and upper rectal cancer can undergo a sphincter-saving tme procedure. after tme, the most widely used reconstructive technique is straight coloanal anastomosis. with the advancement of surgical technique, the local recurrence rate after rectal cancer surgery has been decreased from 25-50% to 3-8%. naturally, it is time to focus on how to improve bowel functional outcomes and quality of life (qol) for rectal cancer patients. however, because the sigmoid colon is usually excised during surgery which decreases the storage volume of stool, there is a common problem seriously influencing the life quality of patients, including increased tool frequency, urgency and incontinence, which is termed as anterior resection syndrome (ars). about 19-56% of patients would suffer from ars. thus, the demand for a technique with better functional outcomes made surgeons modify the straight anastomotic technique. thus, another modified anastomotic technique, side-to-end anastomosis, which has been used since 1966, has gained attention. side-to-end anastomosis usually needs a 3-5 cm-long colonic segment. multiple studies on the literature have shown that compared with straight anastomosis, side-to-end anastomosis has advantages in bowel functional and operative outcomes.

Eligibility criteria:
inclusion criteria: * 18 years of age to 80 years. * laparoscopic or open anterior resection of cancer rectum. exclusion criteria: * synchronous colorectal carcinoma * emergency surgery * history of colon or rectal segmental resections * fixed rectal carcinoma who received preoperative radiotherapy

Keywords: cancer rectum anastomosis end to end side to end
early protected full weight-bearing vs. partial weight-bearing after surgical fixation of unstable ankle fractures, monitored with bio-feedback insoles.

Conditions: Post Operative Treatment After Unstable Malleolar Fractures

Summary: the purpose of this study is to compare the postoperative results after orif (open reduction inner fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. but in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

this study aims to compare the postoperative results after pwb (partial weight bearing) and early fwb (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to pwb. it also aims to show, that an early fwb is safe in terms of complication rate.

Eligibility criteria:
inclusion criteria: * patients with surgically stabilized unstable ankle fractures * signed informed consent * closed tibial and fibular epiphysis * age 18 or older exclusion criteria: * dementia and other known cognitive impairment or incapacity of judgement * polytrauma * bilateral injury of the lower extremities * additional injury of the ipsilateral lower extremity which prevents full weight bearing * associated injury of one or both upper extremities * open fractures grade ii° and iii° * chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy * open epiphysis * pregnancy

Keywords: malleolar fractures postoperative treatment protocol full weight bearing partial weight bearing bio-feedback insoles
trial of proton versus carbon ion radiation therapy in patients with chordoma of the skull base

Conditions: Chordoma; Tumor; Treatment

Summary: this study is a prospective randomised clinical phase iii trial. the primary objective of this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is superior to the standard proton treatment with respect to the local-progression free survival (lpfs).

the study is a prospective randomised clinical phase iii trial. the trial will be carried out at heidelberger ionenstrahl-therapie (hit) centre as monocentric trial. proton therapy is the gold standard in the treatment of skull base chordomas. however, high-let beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. the aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed. patients with skull base chordoma will be randomised to either proton or carbon ion radiation therapy. as a standard, patients will undergo non-invasive, rigid immobilization and target volume delineation will be carried out based on ct and mri data. the biologically isoeffective target dose to the ptv in carbon ion treatment (accelerated dose) will be 63 gy e ± 5% and 72 gy e ± 5% (standard dose) in proton therapy respectively. local-progression free survival (lpfs) will be analysed as primary end point. toxicity and survival are the secondary end points. also matters of interest are patterns of recurrence, prognostic factors and plan quality.

Eligibility criteria:
inclusion criteria: * karnofsky performance score ≥60% * age \>18 years and \<80 years * informed consent signed by the patient * histological confirmation of chordoma with infiltration of the skull base. exclusion criteria: * inability to understand the aims of the study, no informed consent * prior rt of skull base region * other malignancies with disease-free interval \< 5 years (excepting pre- cancerous lesions) * participation in another trial * pregnancy * simultaneous cht or immunotherapy.

Keywords: base of skull chordoma radiation carbon ions protons
high-cutoff hemodialyzer to reduce chronic inflammation in hemodialysis patients

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to test whether a dialyzer with a higher than usual permeability for proteins can eliminate proinflammatory proteins from the blood of patients on regular maintenance hemodialysis who have chronically elevated levels of inflammation markers such as c-reactive protein (crp) in their blood.

patients with esrd on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g. serum crp values). hemodialysis may clear the blood from low molecular weight toxins and retention products such as creatinine, potassium, or urea. the dialyzer clearance of middle to high molecular weight substances such as cytokines and cytokine receptors is low. nearly 50% of chronic dialysis patients have persistent subclinical inflammation which is strongly associated with cardiovascular disease and mortality. the study tests the hypothesis that removal of proteins in the weight range of 10.000-30.000 d via a more permeable dialyzer membrane reduces chronic inflammation in these patients.

Eligibility criteria:
inclusion criteria: * regular hemodialysis for at least 3 months * treatment thrice weekly * high-flux hemodialyzer for at least 4 weeks * age \> 18 years and \< 80 years * at least one crp value \> 5mg/l within 8 weeks before inclusion * able to understand and consent the study * written informed consent exclusion criteria: * no consent * clinically apparent acute infection * crp \> 50 mg/l * serum albumin \< 3,5 mg/l * central venous line as dialysis access * immunosuppressive medication * pregnancy or lactation * inclusion into any other interventional trial

Keywords: kidney failure chronic renal dialysis inflammation monocytes end stage renal disease on regular thrice weekly hemodialysis
comparing fitbit® quality of measured sleep to sleep measured by polysomnography in the sleep lab

Conditions: Obstructive Sleep Apnea

Summary: this study is to evaluate a commercial tool on the market (fitbit®) that also quantifies sleep. no one has studied how pediatric patients perform with it and how accurate it is in measuring their quality of sleep. this study will use the obstructive sleep apnea (osa) questionnaire completed by parents and fitbit® together and evaluate how they perform against the polysomnography (psg).


Eligibility criteria:
inclusion criteria: * patients who consent/assent to wearing fitbit® band over wrist overnight during sleep study and parents who consent to answering questionnaire. exclusion criteria: * none
face-to-face versus online hypnotherapy for the treatment of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: psychological therapies are effective in reducing irritable bowel syndrome (ibs) symptom severity and increasing quality of life and are recommended for the management of ibs by guidelines. evidence appears strongest for the efficacy of hypnotherapy as psychological treatment. however, therapist-led interventions are time consuming and relatively costly. approaches based on e-health are cost saving and appear more attractive to patients as no visits to a therapist are necessary. therefore, the investigators plan to conduct a multicentre randomised controlled trial to examine whether the effectiveness of online hypnotherapy is non-inferior compared to individual face-to-face hypnotherapy delivered by a therapist, according to current fda guidelines. online psychoeducation will be used as control condition. in addition, the investigators hypothesize that treatment with online hypnotherapy is a more cost-effective therapy than face-to-face hypnotherapy in ibs patients.


Eligibility criteria:
inclusion criteria: * age 16-65 years * a diagnosis of ibs according to the rome iv criteria * in the presence of alarm symptoms, such as rectal blood loss, weight loss, anemia, first onset of symptoms above 50 years of age, patients will be first referred for further investigation by their treating physician to exclude organic disorders, conform current dutch guidelines for ibs. * women in fertile age must use contraception or be postmenopausal for at least two years. exclusion criteria: * insufficient command of the dutch language * no access to internet * evidence of current anxiety and/or depression disorder as defined by a score ≥10 on the gad-7 and/or phq-9 questionnaire. in this case it is conceivable that the ibs symptoms are strongly related to psychopathology for which different treatment might be more appropriate. * history of ulcerative colitis, crohn's disease, coeliac disease or significant liver disease * major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy * past or present radiotherapy to the abdomen * current pregnancy or lactation * using of psychoactive medication in case there's no stable dose for at least 3 months prior to inclusion * use of over-the-counter or prescription antidiarrheals, analgesics and laxatives (only be allowed as specific rescue medication) * hypnotherapy treatment received in the last 3 months prior to inclusion * using more than 20 units of alcohol per week * using drugs of abuse
effect of high-intensity focused ultrasound on abdominal skin laxity post sleeve gastrectomy

Conditions: Skin Laxity; Gastrostomy

Summary: the purpose of the study is to evaluate the therapeutic effect of high intensity focused ultrasound in treatment of abdominal skin laxity post sleeve gastrectomy.

lax skin is a common consequence of bariatric weight loss, and it may require one or more plastic interventions. this study carried out to investigate the effectiveness of high-intensity focused ultrasound (hifu) in treatment of abdominal skin laxity post sleeve gastrectomy.

Eligibility criteria:
inclusion criteria: the subject selection will be according to the following criteria: * age range between 30-45 years. * female patients will participate in the study. * all patients will have post sleeve gastrectomy abdominal skin laxity mild to moderate degree according to skin laxity scale randomized images were evaluated by three clinical specialists for the degree of skin laxity (0-3 scale; 0 = no laxity, 1 = mild, 2 = moderate, 3 = severe). * all patients enrolled to the study will have their informed consent. exclusion criteria: the potential participants will be excluded if they meet one of the following criteria: * age more than 45 years or less than 30 years. * patients have acute viral diseases, acute tuberculosis, mental disorders * older people with more extensive photo-aging, severe skin laxity. * open skin lesions at the target area. * severe or cystic acne. * metallic implants in the treatment area. * genetic disease * skin infectious diseases. * sociological diseases. * pregnant.
serendem : md1003 in patients suffering from demyelinating neuropathies, an open label pilot study

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; Peripheral Neuropathy; Charcot-Marie-Tooth Disease; Charcot-Marie-Tooth Disease Type 1A; Charcot-Marie-Tooth Disease, Type 1B; Anti-MAG Neuropathy

Summary: the single-center, open-label phase ii study has the objective of assess the effect of md1003 on motor and sensory conduction in patients suffering from demyelinating polyneuropathies in 15 subjects.


Eligibility criteria:
inclusion criteria: * male and female aged between 20 and 85 years. * patients fulfilling one of the following diagnosis: * five patients with chronic inflammatory demyelinating polyneuropathy on both clinical and neurophysiological grounds. * five patients with proven genetic diagnosis of cmt1a or cmt1b * five patients with anti-mag polyneuropathy. * electrophysiological parameters worsening for the past 3 years * available emg record, performed during the past 6 months to assess variability of ncv parameters * signed and dated written informed consent to participate in the study in accordance with local regulations * likely to be able to participate in all scheduled evaluation and complete all required study procedures, * in the opinion of the investigator, the patient will be compliant and have a high probability of completing the study. * both male and female subjects who are not either surgically sterile (tubal ligation/obstruction or removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least one year confirmed by a negative hormone panel) must commit to using two highly effective method of birth control for the duration of the study and for two months after the treatment termination. exclusion criteria: * any general chronic handicapping disease other than peripheral neuropathy * impossibility to perform the 10 meters walking test * impossibility to assess electrophysiological parameters * patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer, * patients with hypersensitivity to md1003 excipients (lactose) * laboratory tests out of normal range according to the reference laboratory values. deviations may be accepted if considered by the investigator as not clinically significant with regards to the study continuation, * patients with history or presence of alcohol abuse or drug addiction, * patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve. * any new medication for neuropathy initiated less than 3 months prior to inclusion. for cidp patients, relapse in the past 3 months before inclusion. * not easily contactable by the investigator in case of emergency or not capable to call the investigator * subjects without effective contraception

Keywords: neuropathy demyelinating polyradiculoneuropathy
computed tomography (ct) based lymphatic mapping and localization of sentinel lymph node in breast cancer patients

Conditions: Breast Cancer

Summary: breast cancer patients who diagnosed by core needle biopsy or excisional biopsy underwent ct scan to locate the sentinel lymph node (sln) before sln biopsy (slnb) at the same day of surgery. when ct examination performed, those patients were in supine position, with the arms stretched upward but bent at the elbow with the hands at the side of the cranium which similar to the surgical position. after local anesthesia, 2ml of iopamidol was injected subcutaneously to the peritumoral and peri-areolar areas followed by gentle massage for about 1 minute. contiguous 2-mm-thick ct images that included the breast and axilla were obtained prior to administration of the contrast agent. after 3d ct reconstruction, the sln was identified as the most inferiorly visible nodule in the axilla connected to the lymphatic vessel on the ct imaging monitor. a professional intervention doctor punctured the defined lymph node guided by the ct monitor using the breast lesion localization needles (interv). the needle would stay in the patient's axilla until the surgery. all the lymph nodes including the ct defined one and which marked by methylene blue dye or 99mtc-sulfur colloid tracers were removed, which then would be tested by touch imprint cytology for the intraoperative diagnosis. patients who had positive sln would receive axillary dissection. the investigators evaluated the new method by comparing lymph nodes defined by ct and traditional ways.


Eligibility criteria:
inclusion criteria: * breast cancer patients（t1-t2n0） * age 18-70 * accept of slnb * accept our protocol in the informed consent exclusion criteria: * labc patients * age \< 18 * history of epilepsy * history of thyrotoxicosis * pregnant women

Keywords: the investigators evaluated the new method by comparing lymph nodes defined by ct and traditional ways.
relative bioavailability study of ribavirin 200 capsules and rebetol 200 mg capsules in females under fasting conditions

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to demonstrate the relative bioavailability of ribavirin 200 capsules and rebetol 200 mg capsules in females under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.