Kornimate/medical-research-clean huggingface dataset:
a trial of acetazolamide versus placebo in preventing mountain sickness during rapid ascent

Conditions: Acute Mountain Sickness

Summary: acute mountain sickness is a common ailment in people venturing over 2500 m altitude. pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. there are no randomized controlled trials that have studied protective effects of acetazolamide in rapid ascent, and there are few conflicting studies regarding this matter. this study is a randomized, double blinded, placebo controlled trial of acetazolamide versus placebo in 380 healthy individuals travelling to gosaikunda lake of nepal in rates of ascent that are faster than the recommendations. acetazolamide 125 mg twice daily and a placebo will be randomly assigned for 3 days and participants will be assessed at 3 stations. this study will undertake to establish the role of acetazolamide in rapid ascent and will be the first rct done in this issue. the investigators hypothesize that acetazolamide 125mg twice daily given before rapid ascent to high altitude in nepalese pilgrims will not be superior to placebo in decreasing both the incidence and severity of acute mountain sickness.


Eligibility criteria:
inclusion criteria: * nepalese national * aged 18 to 65 * travelling directly from dhunche to gosainkunda * rapid ascent as defined by ascent within 3 days exclusion criteria: * use of any drugs for the prevention of altitude sickness or headache * current illness * current altitude sickness (more than one mild symptom on the lake louise questionnaire (llq), or oxygen saturation less than 75% * known to be pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days * one night within the last 30 days spent at an altitude of 4500 metres or above * residents of altitude more than 2500m * a known drug allergy to sulfonamides. * treatment with any of the following in the last 2 days: acetazolamide (diamox®), steroids (dexamethasone/decadron, prednisone), theophylline or diuretics (lasix®), ibuprofen/motrin, naprosyn/naproxen, aspirin or acetaminophen. * any serious intracranial abnormalities such as history of brain tumours or pseudotumour cerebri * known severe uncontrolled headache syndrome * diagnosed renal function impairment, diabetes, cirrhosis of liver or liver dysfunction

Keywords: acute mountain sickness rapid ascent high altitude headache mountain medicine society nepal
changes in esophageal motility and swallowing symptoms after thyroid surgery

Conditions: Esophageal Motility Disorders

Summary: the pronounced effect of goiter on the esophagus needs further exploration, as the mechanisms by which goiter leads to swallowing difficulties are unknown. by investigating esophageal motility using high resolution esophageal manometry before and after thyroidectomy we seek to examine the impact of the goiter mass on the esophagus and swallowing with six months follow-up.


Eligibility criteria:
inclusion criteria: * patients with symptomatic benign nodular goiter referred for thyroidectomy exclusion criteria: * previous surgery to the neck; * suspicion of thyroid cancer * age below 20 years or above 80 years * neuromuscular disease.
trial with allergic rhinitis patients taking gsk256066 versus placebo in a pollen challenge chamber

Conditions: Rhinitis, Allergic, Seasonal; Seasonal Allergic Rhinitis

Summary: this study is in patients with seasonal allergic rhinitis (sar) and will compare the effect versus placebo of repeat doses of intranasal gsk256066 using the vienna challenge chamber. gsk256066 is a potent and highly selective phosphodiesterase-4 (pde4) inhibitor, currently in development by gsk for the treatment of allergic rhinitis, asthma and copd. subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used. this study aims to explore the actions of repeat doses of intranasal gsk256066 in patients with seasonal allergic rhinitis in the vienna challenge chamber compared to placebo. 12-lead ecg, vital signs and adverse event enquiries will be made throughout the study. nasal examination, symptom scores (tnss), nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.


Eligibility criteria:
inclusion criteria: * the subject is healthy. * they are aged 18 to 50 years inclusive. * body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive. * they have a history of seasonal allergic rhinitis * they exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the vienna challenge chamber, * they have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit. * they have a positive rast for grass pollen at or within the 12 months preceding the screening visit. * they are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit * they must have a baseline fev1\>80% predicted and a baseline fev1 (maximum recorded value)/ fvc (associated value)\>70% predicted. exclusion criteria: * pregnant or nursing females. * women of childbearing potential who are unwilling or unable to use an appropriate method of contraception. * any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2 weeks) or ongoing upper respiratory tract infection. * the subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge * the subject has a history of drug or other allergy * the subject is concurrently participating in another clinical study in the past 3 months * a supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmhg) at screening * a supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening. * the subject has donated a unit of blood within the previous 3 months.

Keywords: vienna challenge chamber seasonal allergic rhinitis inflammation
hepatitis c virus detection in oral squamous cell carcinoma

Conditions: Hepatitis C

Summary: compare hepatiis c virus (hcv) detection between oral squamous cell carcinoma (oscc) and normal tissues, to determine the possible relationship between hcv and oscc.

patient / population: paraffin embedded tissue samples of oscc. indicator: oscc patients control: normal patients formalin fixed paraffin embedded specimens from blocks retrieved from the archives of the oral and maxillofacial pathology department, faculty of dentistry, kasr alini hospital setting from january 2014 till february 2018. all clinical and histopathological data from medical reports, will be reviewed and data will be collected regarding age, sex, tumor location, history of smoking and alcohol consumption, nodal status, tumor recurrences and histological classification of the patients. the specimens will be obtained from 2 groups:- 1. oscc specimens. histological diagnosis of h\&e stained sections will be performed according to world health organisation (who) guidelines by 2 independent pathologists. 2. normal oral mucosa specimens (control). outcome: i) immunohistochemical detection of hepatitis c core antigen (hep c cag) : sc-58144, santa cruz biotechnology, usa) a mouse monoclonal antibody raised against hepatitis c virus will be purchased and used for immunohistochemical staining. staining procedure using an automated system ventana benchmark. the four µm thick paraffin embedded tissue sections will be deparaffinized in three changes of xylene then microwaved for antigen retrieval. the slides will be incubated with primary antibody overnight in the humidity chamber at room temperature. then, the slides will be incubated with secondary antibody. the peroxidase activity will be made visible with diaminobenzidine. finally, counterstaining will be obtained using mayer's hematoxylin. the immunostained sections will be examined using analyzer computer system (germany).

Eligibility criteria:
inclusion criteria: 1. presence of sufficient paraffin-embedded tumor material; 2. presence of oral cavity cancer (including oral tongue, floor of mouth, gingiva, lips, buccal mucosa) 3. absence of recurrent head and neck cancer 4. absence of previous oncologic therapy; 5. histological-proven squamous cell carcinoma. - exclusion criteria: subjects with missing information on age or sex will be excluded. -

Keywords: hepatitis c virus oral squamous cell carcinoma
influence of dm on artery blood flow and complications after radial artery cannulation

Conditions: End Stage Renal Disease

Summary: in atherosclerotic patients undergoing kidney transplantation, arterial cannulation is commonly performed for continuous monitoring of systemic blood pressure and intermittent assessment of arterial blood gases. the radial artery is the preferred artery, because of its well-documented low complication rate and easy access, but, radial artery cannulation is may associated with complications. atherosclerosis is a systemic phenomenon, and structural changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and reduction in distensibility occur frequently throughout the arterial tree. especially in patients with diabetes mellitus (dm), the radial artery is prone to atherosclerosis and perhaps calcification. in a recent study, it was found that the radial artery flow was decreased immediately after cannulation, but recovered to its pre-cannulation value after 5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately after cannulation, persisting until 5 min. this study enrolled the patients of asa physical status 1-2. in the patients scheduled for elective kidney transplantation, this compensatory increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis, particularly in patients with dm. in our study, we found whether there is appropriate compensatory increase of blood flow in the ulnar artery after the radial artery cannulation in two groups, patients with dm (group dm) or without dm (group nondm), both undergoing elective kidney transplantation.


Eligibility criteria:
inclusion criteria: * age \> 20yrs undergoing kidney transplantation * asa physical status ≥ 3 * patients with dm (dm group), patients without dm (nondm group) exclusion criteria: * coagulopathy * inflammation or infection at the puncture site for cannulation * a positive result on the modified allen's test * the cannulation failed twice * acute renal allograft rejection

Keywords: diabetes mellitus(dm) radial artery cannulation artery blood flow complication end stage renal disease undergoing kidney transplantation
"lank-2": activated and expanded nk cell immunotherapy together with salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia

Conditions: Relapsed/Refractory Paediatric Acute Leukaemia

Summary: to determine safety profile of immunotherapy with natural killer cells and activated expanded (nkaes) after salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia


Eligibility criteria:
inclusion criteria: 1. patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or 2. patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (patient must meet inclusion criteria 1 or 2) 3. lansky index \> 60% 4. mild (\<2) functional organs alteration (hepatic, renal, respiratory) according to national cancer institute criteria (nci ctcae v4). 5. left ventricular ejection fraction \> 39% 6. to grant informed consent in accordance with the current legal regulations. 7. presence of a compatible haploidentical donor (father or mother or brother). exclusion criteria: 1. patients with history of bad therapeutical compliance 2. patients not valid after psycho-social evaluation 3. positive hiv serology

Keywords: immunotherapy nkaes expanded haploidentical natural killer cells activated natural killer cells
sunrise® a new medical device to diagnose sleep apnea syndrome

Conditions: Sleep Apnea Syndrome, Obstructive

Summary: sleep apnea syndrome (sas) is a serious health issue that should be managed in order to limit its adverse health consequences. sas is known to induce cardiovascular diseases, diabetes and depression. the prevalence of sas is still growing with social and economic repercussion. today, polysomnography (psg) is the gold standard reference method for sas diagnosis. however, it is a constraining and expensive technology. in order to improve patients' life quality, many new technologies have been developed for the sas diagnosis. the aim of this study is to evaluate the sunrise®, a new medical integrated solution for sas diagnosis, in comparison with psg. this solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (eri) through an artificial intelligence algorithm analysis.

sunrise® is a type iia medical device with the ce label. it is a new home sleep technology, non-invasive, reliable and affordable by the patient. the objective of this study is to evaluate the efficiency of the device in comparison with psg for sleep apnea diagnosis. 40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the sunrise® device, recording their mandibular movements while sleeping. the sunrise® solution will provide the respiratory event index (rei) as well as the respiratory micro-arousals. inclusion visit will be executed at the university hospital grenoble alpes. however, psg and sunrise® will be set at the patient's home by ic@dom. the first night, the patient will be equipped by both psg and sunrise® and only by the sunrise® for the two following nights.

Eligibility criteria:
inclusion criteria: * patients suspected to have a sleep apnea syndrome (berlin score≥2) * able to use a smartphone application * be legally able to give consent * person affiliated to social security exclusion criteria: * patients already treated for sas * patients suffering from a chronic obstructive or restrictive pulmonary disease with or without oxygen. * patients suffering from a unstable cardiovascular disease or a severe heart failure requiring an hospitalzation in the previous three months or conform with the new york heart association criteria for class ii or iii diseases * patients treated with myorelaxant medicines * patients with a long beard disabling the setting of the mandibular sensor * subjects listed in articles l1121-5 à l1121-8: pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act. * person in exclusion period for another study or participating in a medical study testing drugs. * subjects not being cooperative or respecting the study instructions, according the investigator.

Keywords: new medical device mandibular movement respiratory event index polysomnography
a study of mrg002 in the treatment of patients with her2-expressed advanced malignant solid tumors.

Conditions: Advanced Malignant Solid Tumors

Summary: the objective of this study is to assess the safety and tolerability of mrg002 in combination with hx008 in patients with her2-expressed advanced malignant solid tumors; and to , explore the maximum tolerated dose (mtd), and to determine the recommended phase ii dose (rp2d) of combination therapy; , and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.


Eligibility criteria:
inclusion criteria: 1. willing to sign the informed consent form and follow the requirements specified in the protocol. 2. aged 18 to 75 (including 18 and 75), both genders. 3. life expectancy ≥ 12 weeks. 4. patients with histopathological or cytological confirmed her2-expressed advanced solid tumors, and with at least one measurable lesion according to the response criteria in solid tumors (recist v1.1). 5. the score of ecog for performance status is 0 or 1. 6. the toxicity of previous anti-tumor treatment has recovered to ≤ grade 1 as defined by nci-ctcaev5.0. 7. no severe cardiac dysfunction. 8. organ functions must meet the basic requirements. 9. cumulative dose of anthracycline ≤ 450 mg/m2 doxorubicin or its equivalent. exclusion criteria: 1. prior treatment with chemotherapy, biological therapy, immunotherapy, radiotherapy, investigational drugs, attenuated live vaccines, immunomodulators, cyp3a4 inhibitors/inducers, antibody-drug conjugates, etc. 2. treatment with immune checkpoint inhibitors or tumor vaccines within 60 days prior to the first dose. 3. treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to the first dose or during the study period. 4. history of severe cardiac disease. 5. poorly controlled hypertension and hyperglycemia. 6. presence of peripheral neuropathy ≥ grade 2. 7. history of moderate or severe dyspnea at rest due to advanced malignant tumor or its complications or severe primary pulmonary disease, or current need of continuous oxygen therapy, or current interstitial lung disease or pneumonia. 8. central nervous system metastasis. 9. received major surgery within 4 weeks prior to the first dose without complete recovery. 10. history of hypersensitivity to any component of mrg002 or hx008 or known history of hypersensitivity of ≥ grade 3 to macromolecular protein products/monoclonal antibodies. 11. evidence of active infection. 12. history of primary immunodeficiency or autoimmune disease. 13. female patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment. 14. previous history of other primary malignancies. 15. other conditions inappropriate for participation in this study, as deemed by the investigator.

Keywords: mrg002 hx008 antibody drug conjugate (adc) her2 pd-1 solid tumors
involvement of polymorphonuclear neutrophils and platelets in severe form of covid-19

Conditions: Covid19

Summary: the main objective is to quantify the population of reverse migrating neutrophils in patients with covid-19.

this is a non-interventional transversal research whose main objective is to quantify the population of reverse migrating neutrophils in patients with covid-19. design: a multicentric (3 sites) clinical trial sample size : 200 patients population concerned: patients hospitalized in intensive care with sars-cov-2 infection confirmed by rt-pcr from a nasopharyngeal swab. duration of participation (treatment + follow-up): until the patient is discharged from the icu and within 2 months top. no interim analysis is planned. analysis will be performed at the end of the study.

Eligibility criteria:
inclusion criteria: * patients admitted to the intensive care units of saint-antoine, tenon and pitié-salpêtrière hospitals (paris, france) * with moderate to severe respiratory distress syndrome and sars-cov-2 infection confirmed by rt-pcr from a nasopharyngeal swab * informed and not opposed to participation in research * included within 4 hours following the paatient's admission exclusion criteria: * patients under guardianship / curatorship * patients under ame

Keywords: covid19 neutrophils platelet aggregation activation clinical scores saps ii ("simplified acute physiology") sofa ("sequential organ failure assessment") global respiratory and non-respiratory scores
prevention of thromboembolism using apixaban vs enoxaparin following spinal cord injury

Conditions: Spinal Cord Injuries; Spinal Diseases

Summary: currently, enoxaparin is the usual prophylactic anticoagulant treatment at the acute and sub-acute phases of spinal cord injury (sci). patients at the sub-acute phase of sci (rehabilitation) will be given either enoxaparin 40 mg/day (control) or apixaban 2.5-5 mg twice a day. apixaban dose will be determined by the treating physician. treatment will be continued for either 6 or 12 weeks following injury (for ais grades c-d and a-b respectively). endpoints: venous thromboembolism will be evaluated by d-dimer test every 2 weeks and an ultrasound doppler at the beginning and the end of the treatment. bleeding events will be recorded and hematocrit will be monitored every two weeks.


Eligibility criteria:
inclusion criteria: * spinal cord injury (traumatic of not traumatic), hebrew speaker. exclusion criteria: * contra-indication for anticoagulant treatment * concomitant treatment with any other anticoagulant * anticoagulant treatment needed for indications other than vte prevention following spinal cord injury * active clinically significant bleeding * any lesion or condition considered a significant risk factor for major bleeding. * hepatic disease associated with coagulopathy and clinically relevant bleeding risk * pregnancy or breast-feeding * heart valve related issues * galactose intolerance * active cancer * patients who require thrombolysis or pulmonary embolectomy * patients with renal impairment * sensitivity to excipients of the medication * anti phospholipid syndrome * prosthetic heart valve * acute ischemic stroke
a trial on metacognitive training for depression (d-mct)

Conditions: Depression

Summary: the purpose of the present randomized-controlled trial is to investigate the efficacy of metacognitive training for depression (d-mct), a new low-threshold, modular group intervention.

despite the existence of evidence-based treatment methods, a significant treatment gap remains for major depression. while in acute psychiatric treatment of severely depressed patients a pharmacological treatment is usually applied, depression-specific psychotherapeutic (group) concepts are rarely part of the treatment, though recommended in clinical guidelines. a main reason is that present group concepts were designed primarily for outpatient settings and do not meet the structural requirements of inpatient care (i.e., short residence time, continuous admissions and dismissals). metacognitive training for depression (d-mct) is a new low-threshold, modular group intervention which was designed to fill this treatment gap by addressing contextual and structural shortcomings of existing concepts for the use in inpatient treatment. the training targets depressive symptoms by changing (meta-) cognitive biases identified in both cognitive models of depression and basic research. d-mct was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study. aim of the present randomized-controlled trial is to investigate the efficacy of d-mct as an add-on intervention in inpatient treatment of depressed patients compared with a standard add-on group therapy (positivity training, pt). based on a power analysis, the investigators target a sample size of 60 depressed patients, who will be randomized either to d-mct or pt. blind to diagnostic status, symptom level as well as cognitive biases will be assessed pre- and post-treatment (8 group sessions) as well as 3 months later (follow-up). primary outcome parameter is severity of depressive symptoms measured with the hdrs total score (17-item version). secondary outcome measures are self-assessed depression (bdi), dysfunctional beliefs (das), metacognitions (mcq), self-esteem (rse), and quality of life (whoqol-bref).

Eligibility criteria:
inclusion criteria: * diagnosis of major depression according to dsm-iv (mini interview) * diagnosis of dysthymia according to dsm-iv (mini interview) * dsm-iv = the diagnostic and statistical manual of mental disorders- fourth edition, text revision (american psychiatric association, 2000) exclusion criteria: * lifetime psychotic symptoms (i.e., hallucinations, delusions, or bipolar disorder) according to dsm-iv (mini interview) * current substance dependency according to dsm-iv (mini interview)

Keywords: psychotherapy, group metacognition cognitive bias