Kornimate/medical-research-clean huggingface dataset:
hot and cold applications on pvc insertion

Conditions: Peripheral Venous Catheterization

Summary: background: this study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting pvc. methods: this randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. pvc was inserted, the researcher applied a hot or cold application to the catheter insertion site for one minute.

background: this study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting pvc. methods: this randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. the sample was comprised of 90 individuals, including 30 in the cold application group, 30 in the hot application group, and 30 in the control group receiving treatment in the cardiology clinic between november and december 2018.

Eligibility criteria:
inclusion criteria: * being able to speak and understand turkish, * being over 18 years of age, * having unimpaired sense of time or place orientation, * having no psychiatric disorders, * having no visual or hearing problem, * having indication of iv catheter application, * having no administration of analgesic or anaesthetic agents prior to iv catheter insertion, * having catheter inserted in one attempt, * having no allergy to hot and cold applications, * being voluntary to participate in the study. exclusion criteria: * infection * previous history of surgery, * scarring in the catheter insertion site, * psoriasis in the catheter insertion site, * active dermatitis in the catheter insertion site, * peripheral nerve disease, * diabetes, * peripheral neuropathy in the catheter insertion site

Keywords: peripheral venous catheter hot application cold application pain anxiety
p16+ oropharyngeal cancer radiation optimization trial reducing elective treatment volumes (protect)

Conditions: Squamous Cell Carcinoma of the Oropharynx

Summary: volume and dose de-intensified radiotherapy for p16+ squamous cell carcinoma of the oropharynx: a multi-centre, single arm prospective cohort study

de-intensified radiotherapy to a dose of 60 gy to the primary tumour and involved lymph nodes and 54 gy to subclinical regions at risk in 30 fractions. omission of level ib lymph node regions from the elective nodal volumes. chemotherapy will be administered as per standard of care, consisting of concurrent cisplatin (high-dose: 100mg/m2 iv every 3 weeks or low-dose: 40mg/m2 iv every week) or cetuximab (at the discretion of medical oncologist).

Eligibility criteria:
inclusion criteria: * age 18 or older * provide informed consent * ecog performance status 0-2 * histologically confirmed squamous cell carcinoma * p16-positive tumor, as determined by immunohistochemistry at local hospital * primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx) * eligible for curative intent treatment. * smokers and non-smokers are included * tumor stage (ajcc 8th edition): t1 to t3 * nodal stage (ajcc 8th edition): n1 to n2 * adequate bone marrow function, hepatic, and renal function for chemotherapy (hemoglobin \> 80 g/l; absolute neutrophil count \>1.5x109 /l, platelets \> 100 x109/l; bilirubin \< 35 umol/l; ast or alt \< 3 x the upper limit of normal; serum creatinine \< 130 umol/l or creatinine clearance ≥ 50 ml/min) exclusion criteria: * - clinical, radiologic or pathologic ib nodal involvement (including invasion into submandibular gland) * primary cancer with extension and involvement of the oral cavity * metastatic disease * contraindications to radiotherapy or chemotherapy * prior history of head and neck cancer within 5 years * prior head and neck radiation at any time * inability to attend full course of radiotherapy or follow-up visits * pregnant or lactating women
genetic epidemiology of blood lipids and obesity - ancillary to nghs

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Obesity

Summary: to conduct a genetic epidemiologic study of the coronary heart disease (chd) risk factors of blood lipids and obesity in black and white girls who participated in the nhlbi-supported national growth and health study (nghs). the study was ancillary to nghs.

background: the national growth and health study, nghs, was an epidemiologic study of 2,379 black and white girls, ages 9-10 years at entry, who were followed annually. the ancillary study had the potential for identifying those genes involved in determining black/white differences in lipid metabolism and obesity. this was an exciting area in which there was virtually no available information. finally, the study permitted an examination of the effects of gene variation on changes in quantitative levels of blood lipids as well as in body fat during different stages of pubescence since the nghs protocol included annual anthropometric and maturation assessments and biannual blood lipid determinations along with extensive environmental measures which included dietary, household, and psychosocial information. the study was unique because of the rare opportunity to do genetic analyses in a large cohort of two ethnic groups of children on whom a very rich data base was available. design narrative: the study was an independent research project ancillary to the nghs and utilized the extensive biological and environmental information available from the nghs core data base. blood samples were obtained from 1,133 girls seen at their followup examinations in year 7 in order to determine genotypes at those loci known to be implicated in lipid metabolism and obesity. both protein \[apolipoproteins c-ii, d, and e and lp(a)\] and dna \[apolipoprotein b, lipoprotein lipase (lpl), and ldl receptor\] were analyzed. the distribution of genetic variation within each ethnic group was determined. at each candidate gene locus, the genotype effects were estimated on quantitative level of apolipoproteins and lipoproteins, and also on the degree and distribution of body fat after adjusting for concomitant variables (such as age, biologic maturation stage adiposity) within each ethnic group. by comparing the frequencies of genotypes at candidate loci, their allelic effects were assessed as well as their impact on blood lipids and obesity development in black and white females. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
safinamide as add-on therapy in patients with early idiopathic parkinson's disease treated with a stable dose of a single dopamine agonist

Conditions: Idiopathic Parkinson's Disease

Summary: to evaluate the safety and efficacy of two dose ranges of safinamide (high dose: 150 to 200 mg/day and low dose: 50 to 100 mg/day) orally, as compared to placebo, as add-on therapy in patients with early idiopathic parkinson's disease who are currently receiving a stable dose of a single dopamine agonist. it is hypothesized that, over a 24-week period, add-on treatment with safinamide will result in greater improvement of motor symptoms in these patients, compared to treatment with a dopamine agonist alone.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of idiopathic parkinson's disease of less than 5 years duration, and a hoehn and yahr stage of i to iii, * who were receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to visit 1 (screening). exclusion criteria: * patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study; * patients with a diagnosis or recent history of substance abuse, * a history of psychosis, * who were depressed, * had evidence of dementia or cognitive dysfunction, * or who were experiencing end of dose wearing-off; * female patients of childbearing potential; * patients who have previously received safinamide.

Keywords: parkinson disease
telerehabilitation in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: patients with multiple sclerosis will be randomized into two groups. one group will receive live telerehabilitation sessions 3 times a week over a course of three months. the other group will receive video instructions for aerobic and strengthening exercises. patients fatigue, sleep quality and quality of life will be measured.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple scleroisis exclusion criteria: * any musculoskeletal condition preventing patients to actively participate in exercise sessions
amikacin penetration into the cerebrospinal fluid

Conditions: Gram Negative Meningitis; Post Traumatic Bacterial Meningitis

Summary: the limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding understanding the disposition of amikacin administered intrathecally will enable to propose rational treatment of these patients.

the limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding understanding the disposition of amikacin administered intrathecally will enable to propose rational treatment of these patients.

Eligibility criteria:
inclusion criteria: 1. culture proved bacterial meningitis where the prescribed therapy includes the use of systemic and intraventricular amikacin therapy. 2. the included patient should have an intraventricular catheter placed for intraventricular pressure measurement and admitted to an intensive care unit. 3. blood creatinine concentration up to 1.49 mg/dl measured at the inclusion day. exclusion criteria: 1. patients or legal guardians who refuse to participate in the study. 2. known allergy to amikacin. 3. blood creatinine concentration of 1.5 mg/dl or higher. 4. subjects without intraventricular catheter who will need repeated lumbar punctures for csf amikacin determinations. 5. patients suffering from known chronic liver disease.

Keywords: amikacin pharmacokinetics pharmacodynamics intra-thecal injection
delayed recompression for decompression sickness

Conditions: Recompression Treatment After Decompression Sickness

Summary: decompression sickness syndrome (dcs) is caused by microbubbles forming in blood vessels or tissues during a reduction in environmental pressure (decompression). bubbles have mechanical, embolic and biochemical effects with manifestations ranging from none to fatal. by reducing bubble volume and hastening inert gas elimination, recompression therapy with hyperbaric treatment remains the main therapy for dcs. the most common hyperbaric protocol used, is based on us navy treatment table 6, started as early as possible after surfacing. the outcome of hyperbaric therapy varies with reported complete resolution in 13%-63% of the patients suffering from severe dcs, and in 73%-100% of the patients with mild-moderate dcs. the significance of time to recompression is controversial. it has been suggested that early hyperbaric treatment improves the outcome by decreasing bubble size and avoiding further tissue injury. however, in recent studies time to recompression had very little effect on clinical recovery. moreover, the time beyond which hyperbaric treatment isn't effective has not been determined yet. the aim of this study was to evaluate the clinical outcome of delayed hyperbaric treatment to divers who referred to tertiary care hospital hyperbaric unit, more than 48 hours after surfacing. the clinical outcome of the delayed hyperbaric treatments was compared to early treatments given at the same hyperbaric unit.

from january 2000 to february 2014, 204 divers were treated for dcs in the institute of hyperbaric medicine, assaf harofeh medical center, israel. the data will be collected retrospectively from medical records and include age, sex, diving experience, maximal depth, dcs possible cause, dcs type, symptoms, time from surfacing to symptoms onset, time from surfacing to recompression, recompression table, additional treatment after the first recompression and treatment outcome. statistical analysis will be done using univariant analysis was performed using spearman's correlation and chi-square in categoric variabales, independent t-test in numeric variables. this will be performed in spss v.21 software.

Eligibility criteria:
inclusion criteria: * decompression sickness after diving * recompression treatment between 2000-2014 in assaf harofe medical center hyperbaric institute exclusion criteria: * decompression sickness excluded

Keywords: decompression recompression delayed late
safety and efficacy of using a novel full visual access platform system in transvaginal hysterectomy

Conditions: Uterine Myoma; Surgery, Laparoscopic

Summary: the modified vnotes hysterectomy was accomplished and validated for efficacy and safety using a multi-access vaginal confinement instrument with a fully visualised vaginal access platform.

a multi-center prospective randomized controlled trial was conducted to evaluate the efficacy and safety of the vnotes technique in patients with uterine fibroids who were scheduled for total hysterectomy. the patients were randomly assigned to the vnotes group (experimental group) and the traditional vnotes group (control group). the access platform was established using a visualization method or the traditional laparoscopic method, and the surgical operation was completed. the time required to establish the platform, the amount of bleeding, the total surgical time, the anesthesia indicators, complications, and follow-up indicators were recorded, and the effectiveness and safety of the technique were evaluated.

Eligibility criteria:
inclusion criteria: 1. female patients ≤ 60years old 2. patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids 3. bmi ranges from 18.5 to 27.9kg/m2; 4. informed consent signed by the subject himself or his legal representative. exclusion criteria: 1. pregnant and lactating women; 2. asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis; 3. preoperative examination for malignant possibility 4. uterine volume ≥20 weeks, history of pelvic inflammatory disease, severe endometriosis, degree iii or iv uterine prolapse; previous surgical history of intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, and pelvic abdominal tumor; gynecological examination of the uterine and rectal fossa is completely closed; 5. patients known to have severe hepatic or renal dysfunction; 6. patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity; 7. complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, cushing\&#39;s syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders; 8. patients with acute infection; 9. known to have participated in any other clinical trial or taken hormone therapy within 3 months; 10. who cannot sign the informed consent; 11. for those with known or suspected poor compliance who could not complete the trial.
evaluation of sonelokimab for the treatment of patients with active psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: this is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. the study includes adalimumab treatment as an active reference arm.

patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. primary efficacy evaluation will take place at week 12. patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. in certain countries, treatment will end at week 12.

Eligibility criteria:
inclusion criteria: 1. participant is ≥18 years of age; 2. participant has a confirmed diagnosis of psa per the 2006 classification criteria for psoriatic arthritis (caspar) with symptoms for ≥6 months prior to the screening visit; 3. participant has active disease (defined by a tjc68 of ≥3 and a sjc66 of ≥3); 4. participant has either current active pso or a dermatologist confirmed history of pso; 5. participant tests negative for rheumatoid factor (rf) at the screening visit; 6. participant tests negative for anti-cyclic citrullinated peptide (ccp) antibodies at the screening visit; 7. participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information. exclusion criteria: 1. participant with known hypersensitivity to sonelokimab or any of its excipients; 2. participant with known hypersensitivity to adalimumab or any of its excipients; 3. participant who has previously failed on anti-interleukin (il)-17 therapy; 4. participant who has previously failed on anti-tumor necrosis factor alpha (tnfα) therapy; 5. participant who has had previous exposure to more than 2 biologic agents of any type to treat psa prior to the screening visit; 6. participant who has a diagnosis of chronic inflammatory conditions other than pso or psa; 7. participant who has a diagnosis of arthritis mutilans

Keywords: arthritis, psoriatic skin diseases joint diseases arthritis psoriasis
effect of exercise and education after pneumonia

Conditions: Pneumonia

Summary: the mortality rate and quality of life is effected in patients with pneumonia, especially in the older population. the end point of this study is to improve quality of life by and interventional exercise and education. patients will be randomized at admission and enrolled into the study. they will be assessed with various performance and quality of life indicators before, during and after the study, and exercise tolerance will be assessed throughout and after.

the purpose of this research study is to assess improvement in functional status and quality of life of patients 40 years of age and older patients hospitalized for community acquired pneumonia and healthcare associated pneumonia with a multi-disciplinary program of exercise, education and psychological support. this study will use a randomized, controlled clinical trial design. the total number of patients enrolled will be 120, divided into two groups of 60 patients each. one group will have patients age 40 to 60 and second group will have patients age 60 and above. stratified randomization will be done to divide these into two (control group and intervention group) equal groups with 30 patients each. the primary endpoint is improvement in quality of life indices. secondary endpoints are improvement in functional status, change in 6 minute walk test, exercise intolerance, immunization, occult desaturation and change in body weight of patients hospitalized for community acquired pneumonia with a multi-disciplinary program of exercise, education and, psychological support. eligibility includes age 40 and above at the time of admission, diagnosis of cap and hcap via radiographic and pna symptoms, discharge to home, ability to read and sign informed consent to participate, ability to perform procedures/exercises involved in the study and ability to comprehend educational component of program.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cap or hcap via radiographic imaging and symptoms of pneumonia age 40 and above. 2. discharge to home. 3. ability to read and sign consent. 4. ability to perform in procedures/exercise. 5. ability to understand educational component of the program. 6. antibiotic administration for pneumonia within 12 hours of admission. exclusion criteria: 1. severe lung diseases like ild(interstitial lung disease), ards (adult respiratory distress syndrome.) 2. ventilator dependent patients. 3. discharge to nursing home. 4. comorbidity that could limit exercise training. 5. dementia, schizophrenia or any active severe psychiatric disorder. 6. any active malignancy or diagnosis of lung malignancy. 7. inability to attend program two times per week. 8. recent myocardial infarction within two months. 9. unstable angina, heart failure (nyha class iii and iv.) 10. patients with pneumonia who did not receive antibiotics within 12 hours of admission.
effect of remote ischaemic preconditioning on clinical outcomes in cabg surgery

Conditions: Coronary Heart Disease

Summary: coronary heart disease (chd) is the leading cause of death in the uk, accounting for 124,000 deaths (2006) and costing the uk economy over £7.9 billion a year. patients with severe chd are usually treated by coronary artery bypass graft (cabg) surgery, the risks of which are increasing due to older and sicker patients being operated on. new treatment strategies are therefore required to improve health outcomes in these high-risk patients undergoing cabg with or without valve (cabg±valve) surgery. the hypothesis tested in this research proposal is that remote ischaemic preconditioning (ric), a virtually cost-free, non-pharmacological and simple non-invasive strategy for reducing the damage to the heart muscle at the time of surgery, improves health outcomes in high-risk patients undergoing cabg±valve surgery. in this research project, 1610 high-risk patients undergoing cabg±valve surgery will be recruited via 28 uk hospitals performing heart surgery. patients will be randomly allocated to receive either ric or control. for ric, a blood pressure cuff will be placed on the upper arm to temporarily deprive it of oxygen and nutrients, an intervention which has been shown in the investigators pilot studies to reduce damage to the heart muscle by up to 40% during cabg±valve surgery. the investigators will determine whether ric can improve health outcomes in terms of better patient survival, less heart attacks and strokes, shorter hospital stay; less damage to the heart, kidney and brain during surgery; better heart function post-surgery and less chance of developing heart failure; better exercise tolerance and quality of life.


Eligibility criteria:
inclusion criteria: 1. patients undergoing cabg with or without valve surgery using blood cardioplegia 2. patients aged 18 years and above 3. patients with an additive euroscore greater than or equal to 5 exclusion criteria: 1. cardiogenic shock 2. cardiac arrest on current admission 3. pregnancy 4. significant peripheral arterial disease affecting the upper limbs 5. patients with significant hepatic dysfunction (prothrombin\>2.0 ratio) 6. patients with significant pulmonary disease (fev1\<40% predicted) 7. patients with known renal failure with a gfr\<30 ml/min/1.73 m2 8. patients on glibenclamide or nicorandil, as these medications may interfere with ric 9. patients recruited into another study which may impact on the ericca study

Keywords: remote ischemic preconditioning coronary artery bypass graft surgery cardioprotection clinical outcomes