Kornimate/medical-research-clean huggingface dataset:
safety and tolerability, pharmacokinetic and pharmacodynamic study with izd334

Conditions: Healthy Volunteers; Cryopyrin Associated Periodic Syndrome

Summary: this is a first in human (fih), single-centre, double -blind, randomised, cross-over, sad followed by a mad study of izd334 conducted in healthy adult participants as well as an open-label cohort in adult patients with caps. the study is designed to evaluate the safety, tolerability, pk, pd, and food effect of izd334 in healthy adult participants, and to evaluate the safety, tolerability, pk, pd, and preliminary clinical efficacy of izd334 in adult patients with caps.


Eligibility criteria:
inclusion criteria: (healthy volunteers) * healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent) * participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening and/or before administration of the initial dose of study drug * participants must have a body mass index (bmi) between ≥18.0 and ≤32.0 kg/m2 at screening * participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the investigator or delegate inclusion criteria: (caps patients) \*patients with a confirmed diagnosis of caps (fcas or mws) aged 18 to 65 years (inclusive at the time of informed consent) exclusion criteria: (healthy volunteer) * pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period * prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the investigator's (or delegate's) opinion, could adversely affect the safety of the participant * presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol * blood donation or significant blood loss within 60 days prior to the first study drug administration exclusion criteria: (caps patients) * live vaccinations within 3 months prior to screening, for the duration of the study and for up to 3 months following the last dose of study drug; * positive quantiferon test at the screening visit or within 2 months prior to screening.
intraoperative iv iron on postoperative red blood cell recovery

Conditions: Osteoarthritis, Hip

Summary: the objective of the present study is to determine the impact of intraoperative iv-iron supplementation on postoperative recovery of rbc mass by retrospectively analyzing and comparing the changes of postoperative hematocrit values after the surgery in patients underwent elective uni-limb total knee arthroplasty surgery with or without iv-iron supplementation during surgery


Eligibility criteria:
inclusion criteria * patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery * patients provided a written informed consent. * patients with s-ferritin \< 300 mg/dl (male) or 200 mg/dl (female) * patients with preoperative serum hemoglobin concentration \>10 g/dl exclusion criteria * patients with history of anaphylaxis, iron overload, active infection. * patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Keywords: iron arthroplasty red blood cell
sleep duration in women with previous gestational diabetes

Conditions: Gestational Diabetes

Summary: women with a history of gestational diabetes (gdm) are at high risk of developing diabetes in the future. sleep disturbances are emerging as risk factors for incident diabetes. the purpose of this study is to test the effects of 6-week sleep extension in women with a history of gdm and short sleep on glucose metabolism by randomized controlled study.

the primary aim of this study is to evaluate the effects of a sleep extension intervention in non-diabetic women with a prior history of gdm and habitual short sleep duration on the outcomes of glucose metabolism. the participants will be randomized to a 6-week sleep extension intervention group, using technology-assisted sleep intervention, or a healthy living information control group. glucose metabolism parameters will be assessed by an oral glucose tolerant test.

Eligibility criteria:
inclusion criteria: * premenopausal women, age 18-45, with a history of gdm who currently do not have diabetes * at least one year post-partum * reported habitual sleep duration \<7h/night during work- or weekdays with a desire to sleep longer * reported time spent in bed =\<8 hours * own a smartphone compatible with fitbit. * no need to provide care at night for her child(ren), defined as \>3 times a week and \>30 minutes at a time * no history of obstructive sleep apnea, insomnia, or restless leg syndrome exclusion criteria: * a1c ≥6.5% * currently pregnant or planning pregnancy or breast feeding * insomnia symptoms defined as severe as assessed by the insomnia severity index (score ≥15) * rotating shift or night shift work * high risk for obstructive sleep apnea screened by stop bang questionnaire. * significant medical morbidities, such as congestive heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer or psychiatric problem, history of stroke with neurological deficits, cognitive impairment, kidney failure requiring dialysis, illicit drug use.

Keywords: sleep duration glucose metabolism
the research of analgesia and sedation effect of remifentanil on icu short operation

Conditions: Critical Illness

Summary: remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset and short lasting duration. remifentanil usually is used to help reducing the pain of patients with mechanical ventilation in icu. maybe it can also be used to ease the pain in icu small short time operation.the purpose of this study is to determine (1) whether remifentanil is effective in small short time operations in icu or not, (2) the save range of remifentanil in small short time operations in icu, (3) and the adverse reaction that happens in these operations.


Eligibility criteria:
inclusion criteria: * critically ill patients need endotracheal intubation * tracheotomy * central venous puncture * pleural puncture * abdominal puncture * lumbar puncture * bone marrow puncture * fiber bronchoscopic examination * other small short-time operations exclusion criteria: * patients allergic to opioids * in pregnancy or in feeding * with myasthenia gravis * with hypovolemia, * take monoamine oxidase inhibitor(maoi) in 14days * in coma and gcs\<8 * with bradycardia or hypotension

Keywords: remifentanil analgesia intensive care units
safety study of erythropoietin (epo) in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to determine whether recombinant human erythropoietin (eporh) is safe in the treatment of patients with parkinson's disease.

after onset of parkinson's disease (pd)- in spite of the use of medications that constitute the symptomatic treatment- the disease is worsens with an inevitable progression, thus causing complications that lead to the loss of patient´s manual skills and independent gait. at present, the treatment of pd with the use of medications is based on dopamine precursors and dopaminergic agonists but as the disease advances, other symptoms that do not respond to dopaminergic stimulation do appear. for this reason, it is a priority to find a way to focus on neuroprotection during the course of the disease. there are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (epo). positive results on the neuroprotective/neurotrophic efficacy of epo in neurological and psychiatric diseases have been obtained from treatment trials, but nevertheless, it is indispensable demonstrate that with the proposed medication doses it's well tolerated by pd patients.

Eligibility criteria:
inclusion criteria: * hohen and yahr´s scale between i and iii * one or more years of evolution of pd, * good response to levodopa (more that 30 % of change)valued in motor updrs * an acceptable general health status, exclusion criteria: * chronic psychiatric or other neurological diseases. * previous polyglobulin * hematocryte, same or inferior to 50

Keywords: neuroprotection parkinson disease erythropoietin
fear, gastrointestinal distress, and interoception: physiological and psychological mechanisms in eating disorders

Conditions: Feeding and Eating Disorders

Summary: the proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.


Eligibility criteria:
inclusion criteria: * female * dsm-5 eating disorder * score 16 or higher on the clinical impairment assessment * experience nausea or stomachache after eating at least "sometimes" * 18 to 40 years old * body mass index between 18.5 and 26.5 kg/m2 exclusion criteria: * medical conditions affect appetite or weight * recent pregnancy or current breastfeeding * dairy, strawberry or honey food allergy * specific phobia, blood-injection-injury type
safety and immunogenicity of covid-19 vaccine booster in patients with liver diseases

Conditions: COVID-19; Vaccine Reaction; Liver Diseases

Summary: previous studies should that patients with chronic liver diseases, cirrhosis, hepatocellular carcinoma and post-liver-trasplant status had lower immunological response to sars-cov-2 vaccines than healthy population. along with the waning of antibody and emerging sars-cov-2 variants, a third dose sars-cov-2 booster vaccination is now considered as an effective strategy. previous studies showed good safety and immunogenicity of the sars-cov-2 booster vaccination in healthy population. however, the relevant information in patients with liver diseases need further research. this study (nmcid-chess 2201) aimed to investigate the safety and immunogenicity of the sars-cov-2 booster vaccination in population with chronic liver diseases


Eligibility criteria:
inclusion criteria: * previously vaccinated with two doses of sars-cov-2 vaccines and planning to get booster vaccination. * clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver diseases, cirrhosis, liver cancer, liver transplant subjects, etc. * understanding and willing to comply with the study procedures and provides written informed consent. exclusion criteria: * pregnancy or lactation. * active or known history of sars-cov-2 infection. * diseases causing immunosuppressive or immunodeficient status or autoimmune diseases. * a history of discontinuing anti-hbv agents in recent three months.

Keywords: sars-cov-2 vaccine booster liver diseases safety immunogenicity
effect of isometric and aerobic physical exercise on blood pressure levels in hypertensive elderly people

Conditions: Hypertension,Essential; Hypertension

Summary: introduction: adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. the effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. objective: to verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals.

introduction: adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. the effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. objective: to verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals. methods: thirty-six controlled hypertensive volunteers, aged ≥ 60 years, of both sexes, will be randomly selected based on their medical records. volunteers will be randomized to perform an isometric wall squat exercise session (n=12 - 4 repetitions of 2 minutes of execution and 2 minutes of rest, performed at a specific angle of the volunteer\&#39;s knee joint - borg scale of 11 to 13 points - moderate intensity) or an aerobic exercise session on a stationary bike (n=12 - 40 minutes and at moderate intensity stipulated between the range of 50% to 60% of hr reserve and borg scale of 11 to 13 points - moderate intensity) or a control session without exercise, 40 minutes per session (n=12). 24-hour ambulatory blood pressure monitoring will be performed pre- and post-session. statistical analyzes will be performed using the anova test (one way), power of 80% and alpha 95%, spss-26.0.

Eligibility criteria:
inclusion criteria: * hypertensive elderly; * both genders; * aged ≥ 60 years; * hypertensive patients on continuous use of antihypertensive medication; * hypertensive who did not practice physical exercise regularly (≥ 2 sessions per week). exclusion criteria: * those who presented one of the following issues will be excluded: * diabetes mellitus; * chronic renal failure; * body mass index (bmi) ≥ 35 kg/m2; * coronary artery disease; * heart failure; * any injury to the lower limbs; * smokers.

Keywords: hypertension isometric exercise aerobic exercise
efficacy of local anesthesic on diaphragmatic function after upper abdominal surgery

Conditions: Hepatectomy

Summary: upper abdominal surgery is known to induce such pulmonary complications as pneumonia, atelectasis, pleural effusion. the post operative diaphragmatic dysfunction participates to these complications and lasts for 7 days after upper abdominal surgery. the sniff-test is a recognized tool for measuring the diaphragmatic function.the purpose of this study is to evaluate the effectiveness of parietal analgesia with continuous infiltration of local anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal incision. our main outcome is to measure the diaphragmatic function with the sniff test in 44 patients with parietal infiltration of ropivacaine and in 44 patients with placebo. our secondary outcomes are the evaluation of the effect of continuous parietal analgesia with ropivacaine on ipmax and epmax, oxygen saturation, post operative pulmonary complications and post operative recovery. this prospective study will determine if the pre peritoneal local infiltration of ropivacaine is useful to decrease post operative diaphragmatic dysfunction.


Eligibility criteria:
inclusion criteria: * surgical indication for upper abdominal surgery through subcostal incision * more than 18 years old , less than 80 years old * asa score between 1 and 3 * effective contraception for more than 3 months in women of childbearing age * patients signed an informed consent * affiliation to a social security regimen exclusion criteria: * bmi more than 30 kg/m2 * nasal obstruction during inclusion * preoperative treatment with morphine * need for a postoperative nasogastric tube * difficulty to understand the use of the pca and/or the sniff-test * impossibility to place the catheter in preperitoneal position * pregnant women or breasting women * patients under guardianship * contraindication to use of ropivacaine * inclusion in another clinical trial

Keywords: diaphragmatic function sniff-test pulmonary complications upper abdominal surgery
intensive monitoring scheme of lidocaine cataplasms

Conditions: Adverse Reaction to Drug

Summary: in this center, retrospective research methods are used to collect data. patients who had used lidocaine cataplasms at least once were included consecutively. taking the time when the patient first used lidocaine cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of lidocaine cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).


Eligibility criteria:
inclusion criteria: * all patients receiving lidocaine cataplasms from january 1, 2021 to april 1, 2022. exclusion criteria: * unable to obtain complete medication information.
better adherence with new oral anticoagulant in atrial fibrillation : effectiveness of a personalized education program

Conditions: Non-valvular Atrial Fibrillation

Summary: this study is multicentric, single-blind, and interventional with a randomization into two parallel arm, between a standard of care information and an additional information of the patient, with a 12 month follow up. the aim of this study is to evaluate the effectiveness of a personalized information program versus information provided from standard of care in patients taking xarelto for stroke prevention in atrial fibrillation.


Eligibility criteria:
inclusion criteria: * all patients treated with rivaroxaban chronically, (atrial fibrillation non-valvular under current amm) for less than one year whatever anti vitamin k treatment history * affiliate or beneficiary of a social security system. * patient who formulated its "does not oppose" to participate in this research * age higher than or equal to 18 years exclusion criteria: * opposition to participation * patient don't understand french language * patient does not have responsibility for the management of treatment (treatment administered by a nurse at home, or by caregivers) * tutorship or curatoship * law-protected patient * pregnant women or breast-feeding

Keywords: patients treated by rivaroxaban
recurrent respiratory papillomatosis and extraesophageal reflux

Conditions: Recurrent Respiratory Papillomatosis; Extra Oesophageal Reflux; Laryngeal Cyst

Summary: the purpose of the study was to determine, whether patients with recurrent respiratory papillomatosis (rrp) suffer from extra oesophageal reflux more often than patients with laryngeal cyst (control group).

recurrent respiratory papillomatosis (rrp) is a chronic viral disease, which affects children and adults as well. it is characterised by grow of squamous cell tumours on mucosa of aerodigestive tract, with predilection for the larynx. the disease is caused by the human papillomavirus (hpv). however, in contrast to the low incidence of rrp, hpv prevalence is common. it is indicated that other factors may contribute to the pathogenesis of rrp. one such factor might be extraesophageal reflux (eer). we investigated whether patients with rrp suffer more often from eer.

Eligibility criteria:
inclusion criteria: * age 1-75 years * cooperating patients with laryngeal papillomatosis * patients tolerating impedance probe * signed informed consent, consent with the examinations * control group of patients with a cyst or vocal cord polyp (reflux finding score 0-2) and/or patients indicated to augmentation, medialization or lateralization of the vocal cords exclusion criteria: * patients non-tolerating impedance catheter * patients who do not understand czech language * patients who do not proclaim consent with enrolment into the study * patients who do not proclaim consent with the planned examinations * patients after surgical treatment of tumour of the swallowing or respiratory tract

Keywords: recurrent respiratory papillomatosis extra oesophageal reflux laryngeal cyst phonosurgery oesophageal impedance
a study to investigate the safety and efficacy of cp- 690,550 in patients with moderate and severe ulcerative colitis.

Conditions: Ulcerative Colitis

Summary: the hypothesis of the study is that at least one dose of cp 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.


Eligibility criteria:
inclusion criteria: * patients must be at least 18 years of age at screening * males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study. * male and female patients with active currently moderate to severe ulcerative colitis defined by mayo score of ≥6 * patients with endoscopic sub-score of ≥2 on the mayo score determined within 7 days of baseline. exclusion criteria: * diagnosis of crohn's disease or diagnosis of indeterminate colitis * treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis * patients that are currently receiving immunosuppressants, anti-tnfα therapy or interferon

Keywords: treatment of ulcerative colitis; cp 690 550
pulmonary artery involvement in takayasu's arteritis

Conditions: Takayasu Arteritis; Pulmonary Artery Hypertension

Summary: the purpose of this study is to analyze the clinical manifestations, imaging features, and prognosis-related factors of pulmonary artery (pa) involvement in takayasu's arteritis (ta), and to explore the early clinical features of pa involvement in ta patients.

takayasu's arteritis patients with pulmonary artery involvement were enrolled into this study. the demographic information of the patients (age, sex, course of disease), symptoms at their admissions (cough, hemoptysis, dyspnea, palpitations, fever), laboratory examinations (blood lab routines, erythrocyte sedimentation rate, c-reactive protein), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest ct, ctpa, pulmonary perfusion imaging, pulmonary angiography, pet/ct) were collected by reviewing the cases. the prognostic information was collected by telephone follow-up. the follow-up end point was december 2015.

Eligibility criteria:
inclusion criteria: * 1.meet the diagnostic criteria of ta as defined by the american college of rheumatology (acr). * 2.pa involvement: meet at least one of three items: (1) at least one of computed tomographic pulmonary angiography (ctpa), pulmonary perfusion imaging, or pulmonary arteriography suggests thickening of vessel wall, stenosis, aneurysm, or occlusion; (2) 18f-fluorodeoxyglucose positron emission tomography/computed tomography (pet/ct) suggests high intake of local radioactive material in pulmonary artery wall; (3) pulmonary artery systolic blood pressure is higher than 50 mmhg assessed by transthoracic echocardiography (defined as pah), without left ventricular disease. exclusion criteria: -

Keywords: takayasu arteritis pulmonary artery hypertension