Kornimate/medical-research-clean huggingface dataset:
standard vs high prophylactic doses or anticoagulation in patients with high risk of thrombosis admitted with covid-19 pneumonia (prothromcovid)

Conditions: Covid19; Thrombosis

Summary: the main objective is to evaluate the efficacy and safety of three doses of tinzaparin (prophylactic, intermediate and therapeutic) in hospitalized patients with covid-19 pneumonia.


Eligibility criteria:
inclusion criteria: 1. patients admitted to hospital with covid-19, pcr and/or antigens test + sars-cov-2 infection or (presence of infiltrate compatible with chest x-ray or tc) 2. patients with, at least, one of the following evolution disease risk criteria: * sat 02\<94% * need for oxygen therapy or pao2/fio2\<300mmhg or estimated pao2/fio2 based on spo2/fio2\<300 mmhg. * dd\>1000µg/l * pcr \>150mg/l * il6 \>40pg/ml 3. age \> 18 years 4. weight 50-100 kg 5. after receiving oral and written information about the study, patient must give informed consent duly signed and dated before performing any activity related to the study. exclusion criteria: 1. patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to icu at the moment of randomization. 2. current diagnosis of acute bronchial asthma attack. 3. history or clinical suspicion of pulmonary fibrosis. 4. current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis. 5. patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation. 6. patients with pneumonectomy or lobectomy. 7. renal failure with glomerular filtration \<30 ml/min/1.73m2 8. patients with contraindication for anticoagulant treatment. 9. congenital bleeding disorders. 10. hypersensitivity to tinzaparin or ufh or some of its excipients. 11. history of heparin-induced thrombocytopenia. 12. active bleeding or situation that predispose to bleeding. 13. moderate or severe anaemia (hb\<10 g/dl) 14. low platelet count \< 80000/µl 15. patients with life expectancy less than 3 months due to primary disease evaluated by the physician. 16. patients currently intubated or intubated between the screening and the randomization. 17. pregnancy.
oral side effects of covid-19 vaccine

Conditions: Oral Manifestations; Covid19; Vaccine Adverse Reaction

Summary: this study is a multicenter cross-sectional survey-based study conducted in four european countries (czech republic, germany, slovak republic, and turkey). an online questionnaire will be utilized to collect data from volunteer subjects following the strobe reporting guidelines of cross-sectional studies.

the primary objective of this multicentre cross-sectional survey-based study is to estimate the prevalence of oral side effects of covid-19 vaccine in the short term. the secondary objectives are: * to identify the risk factors of covid-19 vaccine oral side effects in the short term. * to evaluate the relationship between oral side effects and other inflammatory side effects of covid-19 vaccine in the short term. the target population is healthcare workers as they are identified among the priority groups of covid-19 vaccine deployment plans in the eu/eea and the uk. one more reason to select the healthcare workers among different groups of the population, their higher awareness about the possible vaccine-related oral side-effects so that more accurate and reliable results can be obtained. a self-administered questionnaire will be developed, and its content validity will be tested using a panel of experts. the test re-test reliability of the questionnaire will be tested by 30 volunteers (10 czech, 10 turkish, 10 german) to achieve at least a cronbach's alpha of 0.70. the questionnaire will be available in five languages; czech, english, german, slovak and turkish. dual forward translation and expert panels will produce equivalent czech, german, slovak and turkish versions of the questionnaire. the questionnaire will be composed of multiple-choice items divided into four main categories; a) demographic data including gender, age, location of practice, profession, and experience, b) medical anamnesis including medical comorbidities, medications, and recent oral symptoms, c) covid-19 related anamnesis including vaccination date, previous infection, and exposure to infected cases, and d) vaccine side effects including inflammatory symptoms, cutaneous symptoms, and oral symptoms. (annex 1)

Eligibility criteria:
inclusion criteria: * healthcare workers who received covid-19 vaccine during the last 30 days. * participating subjects should be at least 18-year-old and able to give their informed consent independently. exclusion criteria: * the healthcare workers who did not receive the covid-19 vaccine recently. * non-healthcare workers who received the covid-19 vaccine recently.

Keywords: covid19 oral manifestations vaccine adverse reaction
physiological response and visual attention to visual food images in healthy subjects and in functional dyspepsia patients

Conditions: Functional Dyspepsia

Summary: in functional dyspepsia (fd), abnormal cognitive and emotional changes such increased sensitization, anxiety, and depression scores have been reported in addition to the peripheral changes in gastrointestinal tract functions. in this study, investigators will evaluate the activity of autonomic nervous system, emotional response, and visual attention to food and non-food images in 30 male and female fd patients and 30 age/gender-matched healthy volunteers. these data will provide a new finding of the influence of impaired cognitive processing of food on symptom generation in functional gastrointestinal disorder patients.


Eligibility criteria:
inclusion criteria: * male and female, volunteering adults bmi: 18-25 kg/m² right-handed age: 18-65 years capacity to give informed consent for fd patients, diagnosis of functional dyspepsia over the last 12 months certified by a medical record inconspicuous gastroscopy during the last 6 months certified by a medical record exclusion criteria: * visual impairment severe psychiatric illness (e.g. schizophrenia, severe depression (bdi-ii:29-63)), substance dependence and abuse intake of antidepressants / antipsychotics

Keywords: skin conductance response facial muscle activity heart rate variability eyetracking
relationship between stop bang score and airway management

Conditions: Airway Obstruction; Obstructive Sleep Apnea; Hypoxia

Summary: nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive sleep apnea syndrome (osas) to undergo elective surgery. recognition of these patients by anesthesiologists and taking necessary precautions will significantly reduce perioperative complications and mortality. stop-bang is a questionnaire used to predict high risk of osas. the aim of our study is to evaluate the clinical use of the oxygen reserve index as an early warning of possible desaturation in patients with low and high risk of osas according to the stop bang score.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i-iii * between 18-65 years old * volunteered to participate in the study exclusion criteria: * diagnosed with asthma, copd, heart failure or coronary artery disease, osas * morbidly obese (bmi\>45 kg/m2), * patients with a history of alcohol or drug addiction * women in pregnancy or lactation * allergic to the drugs used in the study

Keywords: oxygen reserve index stop bang score difficult airway
emergency preservation and resuscitation (epr) for cardiac arrest from trauma

Conditions: Cardiac Arrest From Trauma

Summary: the goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary bypass.

the intent of the technique to be studied is to induce a state of hypothermic preservation in trauma victims who have exsanguinated to the point of cardiac arrest. in appropriately selected subjects, after an initial emergency attempt at resuscitation with standard techniques, an arterial catheter will be inserted into the descending thoracic aorta. using appropriate tubing, pump, and heat exchanger,a large quantity of ice-cold saline (0.9% sodium chloride for injection usp) will be pumped as rapidly as possible into the aorta with the goal of cooling the brain (tympanic membrane temperature, tty) to \<10 c. if possible, a large venous catheter will be placed and recirculation of fluid established. once the subject has been sufficiently cooled, bleeding will be controlled surgically. the subject will then be resuscitated and rewarmed with full cardiopulmonary bypass. the goal is to improve neurologically-intact survival in these patients.

Eligibility criteria:
inclusion criteria: * penetrating trauma with clinical suspicion of exsanguinating hemorrhage * at least 1 sign of life at the scene (pulse, respiratory efforts, spontaneous movements, reactive pupils) * loss of pulse \<5 min prior to emergency department (ed) arrival or in ed or operating room * ed thoracotomy performed without immediate return of a palpable pulse in the carotid arteries after clamping the descending thoracic aorta exclusion criteria: * no signs of life for \>5 min prior to the decision to initiate epr * obvious non-survivable injury * suggestion of traumatic brain injury, such as significant facial or cranial distortion * electrical asystole * rapid external assessment of the injuries suggests massive tissue trauma or blunt trauma involving multiple body regions * pregnancy * prisoners

Keywords: trauma cardiac arrest hemorrhagic shock
the vanderbilt atrial fibrillation ablation registry

Conditions: Atrial Fibrillation

Summary: the vanderbilt atrial fibrillation ablation registry (vafar) is a prospective clinical and genetic biorepository that systematically enrolls patients undergoing atrial fibrillation (af) ablation. the registry was started in 2011 and has greater than 1000 af ablation records with stored blood and dna samples. the goals of vafar are to: 1) identify clinical, genetic, and serological predictors of response to af ablation in order to improve patient selection, and 2) to provide a resource for translational research investigating the electrophysiologic mechanisms of af pathogenesis.

the study population consists of patients at least 18 years of age who are scheduled for af ablation at vanderbilt university. data recorded at enrollment includes a detailed past medical history and measurements from pre-ablation imaging (cardiac mri or ct). at the time of ablation, a blood sample is collected for storage of plasma/serum and extraction of dna, and details of the ablation procedure are recorded. post-ablation monitoring for arrhythmia recurrence is performed according to a standard clinical follow-up schedule at 3, 6, and 12-months. ecg's are performed at each follow-up visit along with placement of an ambulatory ecg-monitor. at 6-months post-ablation, cardiac imaging with a repeat cardiac mri or ct is performed.

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. able to give written, informed consent 3. scheduled for an ablation procedure to treat atrial fibrillation exclusion criteria: 1. none

Keywords: catheter ablation genomics
effect of noninvasive brain stimulation on hypokinetic dysarthria in parkinson's disease

Conditions: Parkinson Disease

Summary: hypokinetic dysarthria (hd) is common in parkinson's disease (pd) patients and responds only partially to pharmacotherapy and surgery. the investigators will explore long-term effects of repetitive transcranial magnetic stimulation (rtms) applied over right superior temporal gyrus, brain area known to be engaged in the feedback control of voiced speech. the project results will allow for the identification of potential therapeutic effects of rtms as a tool that could contribute to the speech therapy of hd in pd patients. the results will also enhance our understanding of brain mechanisms underlying specific long-term effects of rtms.

a two parallel group, randomized, placebo controlled design will be used. twenty pd patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). other twenty pd patients will be stimulated with the same protocol using sham stimulation. an mri protocol consisting of t1, epi bold, and dti (diffusion tensor imaging) sequences and speech evaluation (acoustic signal processing and 3f test) will be performed prior to and after 10 days of rtms and then repeated after 4, 8 and 12 weeks.

Eligibility criteria:
inclusion criteria: * patients with clinically established pd (postuma et al. 2016) exclusion criteria: * psychiatric disorders, including major depression, hallucinations * any mri-incompatible metal in the body * epilepsy * lack of cooperation * presence of dementia
clinical evaluation following use of systane® ultra in the management of dry eye

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to evaluate the clinical benefits of systane® ultra lubricant eye drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

this study consists of a 14-day run-in phase (between the screening visit and baseline/visit 1) and a treatment phase. during the run-in phase, subjects will discontinue current artificial tears and will be dispensed systane® ultra to be administered 1 drop in each eye as needed (prn). subjects who meet the re-evaluation criteria after the run-in phase will be randomized in a 1:2 manner to receive treatment with systane® ultra 4 times per day (qid) or prn, respectively, for 28 days.

Eligibility criteria:
inclusion criteria: * willing and able to attend all study visits. * use of bak-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to screening visit (maximum use of 4 drops a day). * at least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear. * use provided artificial tear at least once a week during run-in phase. * willing to take study treatment as directed for the entire study and able to complete the study diaries as required. * other protocol-specified inclusion criteria may apply. exclusion criteria: * use of artificial tears, as specified in the protocol. * use of topical ocular medications, as specified in the protocol. * women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study. * any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations. * ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol. * ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to screening visit. * any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study. * contact lens use within 2 weeks prior to screening visit, and unwilling to avoid contact lens use during the course of the study. * other protocol-specified exclusion criteria may apply.
complications associated with promontofixation for pelvic organ prolapse: comparing robot assisted laparoscopic and non-robot assisted laparoscopic surgical procedures

Conditions: Pelvic Organ Prolapse

Summary: the primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques. the patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. access to data from the national health data system (sdns), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. we propose, therefore, to extract data from the sniiram via the snds (matching of patients' nir to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.


Eligibility criteria:
inclusion criteria: * patient has a first,(primo-event), symptomatic, genito-urinary prolapse of at least stage ii (pop-q classification) requiring surgery * the patient must have given her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 60 months of follow-up exclusion criteria: * the patient is participating in another study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant * patient has a stage-1 prolapse (pop-q classification) * patient has asymptomatic prolapse * the patient has a prolapse recurrence (i.e. this is not the first case of prolapse) * the patient is not available for 60 months of follow-up * patient has a vaginal or urinary infection * patient has poorly-adjusted diabetes * patient on long-term corticotherapy * patient has previously had pelvic radiotherapy * patient has contraindication for anesthesia * patient has an intestinal inflammatory disease

Keywords: da vinci robot uterine prolapse vaginal prolapse sacrohysteropexy
acu-tens for pain relief during colonoscopy

Conditions: Pain

Summary: background: colonoscopy is often regarded as a painful and unpleasant procedure. transcutaneous electric nerve stimulation on acupoints (acu-tens) is a non-invasive modality that has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy. objective: to investigate the efficacy of acu-tens in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy. design: prospective, randomized, placebo-controlled study. subjects: one hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture/acu-tens will be recruited. interventions: patients will be randomized to receive either 45 minutes of acu-tens or placebo-tens before colonoscopy. the acupoints relevant to the treatment of abdominal pain and distension, including zusanli, hegu, neiguan, tianshu, and dachangshu will be used. for the placebo-tens group, a non-conductive plastic film will be placed between the acupoint and the electrode so that no current will be transmitted. acu-tens and placebo-tens will be continued throughout colonoscopy. a mixture of propofol and alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups. outcome measures: primary outcome: doses of patient-controlled sedation/analgesia consumed. secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.


Eligibility criteria:
inclusion criteria: * consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy * patients with american society of anesthesiologists (asa) grading i-ii * informed consent available exclusion criteria: * patients with previous experience of acupuncture or acu-tens * patients with previous history of colorectal surgery * patients who are diagnosed with irritable bowel syndrome according to rome iii criteria * patients with chronic pain syndrome * patients with psychiatric disorder * patients with poor cognitive function * patients with renal impairment * patients with obstructive sleep apnea syndrome * patients with cardiac arrhythmias * patients with cardiac pacemaker * patients who are pregnant * patients who are allergic to the acu-tens electrodes or propofol/alfentanil
oral fluid vs iv fluid after primary tka

Conditions: Osteoarthritis, Knee; Total Knee Arthroplasty; Oral Fluid Replacement

Summary: the goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty. the main question it aims to answer is: does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement?


Eligibility criteria:
inclusion criteria: * age 40-85 years old * asa i, ii * primary osteoarthritis exclusion criteria: * diuretics use * morbid obesity * previous knee surgery * cannot undergo spinal anesthesia
randomized trial comparing lenalidomide with low dose dexamethasone versus lenalidomide in second line multiple myeloma

Conditions: Multiple Myeloma

Summary: this is: * a prospective, randomized, open, phase ii, multi-centre, interventional study. patients who are in at least pr and have received lenalidomide as 2nd line treatment for mm will be recruited. * the patients will be randomized into two groups. group r will receive lenalidomide 25 mg/day p.o. continuously for 21 days and group rb will receive a similar dose of lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22 of every 28 day treatment cycle. study includes a maximum of 24 cycles including two consolidating cycles per patients.


Eligibility criteria:
inclusion criteria: inclusion criteria - all subjects must: 1. be at least 18 years of age 2. subjects must have a documented diagnosis of mm and have either refractory or relapsed and refractory after first line treatment disease defined as: * primary refractory * refractory * relapsed and refractory 3. subjects must have undergone prior treatment with one treatment line of anti-myeloma therapy. induction therapy followed by asct and consolidation/maintenance will be considered as one line.have a confirmed diagnosis of mm 4. have received lenalidomide after one prior treatment for mm and have reached at least a partial response (pr), according to imwg criteria, including two consolidating cycles. subjects have experienced a response at least pr after starting treatment with lenalidomide and cortisone cycles. 5. have personally signed and dated a legally effective written informed consent form prior to admission to the study. 6. must be willing and able to understand and comply with the study requirements. 7. females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception. 8. male must agree to practice contraception exclusion criteria: 1. any of the following laboratory abnormalities: * absolute neutrophil count (anc) \< 1,000/µl * platelet count \< 75,000/ µl * creatinine clearance \< 45 ml/min according to cockcroft-gault formula * serum sgot/ast or sgpt/alt \> 3.0 x upper limit of normal (uln) * serum total bilirubin \> 2.0 mg/dl 2. ecog performance status \<4. 3. individuals who have had a stem-cell transplant as a 2nd line treatment for mm 4. individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening. 5. individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them. 6. pregnant or lactating females. 7. any other clinically significant medical disease or condition that, in the investigator´s opinion, may interfere with protocol adherence or a subject´s ability to give informed consent.

Keywords: relapsed and refractory multiple myeloma