Kornimate/medical-research-clean huggingface dataset:
comparisons of two different type heater in different inhalation anesthesia in terms of prevention of hypothermia

Conditions: Anesthesia; Hypothermia; Heat

Summary: unintentional perioperative hypothermia is a common occurrence. one of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. it is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. in this study, we aimed to compare the efficacy of using active air blown heater and resistive heater in preventing hypothermia in patients with low flow and high flow inhalation anesthesia

abstract prospective comparison of active air blown heater and resistive type heaters for prevention of hypothermia in high current and low current inhalation anesthesia aim: unintentional perioperative hypothermia is a common occurrence. one of the recommendations of the guidelines to prevent hypothermia is the use of active warmers. it is known that low-flow anesthesia protects from hypothermia compared to high-flow anesthesia. in this study, we aimed to compare the efficacy of using active air blown heater and resistive heater in preventing hypothermia in patients with low flow and high flow inhalation anesthesia. materials and methods: after ethics committee approval (date: 08.12.2022/23), 112 patients with american society of anesthesiologist (asa; american society of anesthesiologists) i-iii, who were to undergo rhinoplasty between june 01, 2023 and january 01, 2024, were included in the study after informed consent was obtained. group da was defined as low flow anesthesia and active air blast heater, group dr as low flow anesthesia and resistive heater, group ya as high flow anesthesia and active air blast heater, and group yr as high flow anesthesia and resistive heater. each group consisted of 28 patients. heart rate, systolic, diastolic and mean arterial pressure, peripheral oxygen saturation values and body temperature values were measured and recorded at certain time intervals during the perioperative period and in the recovery unit. body temperatures were also recorded in the ward. thermal comfort scores were evaluated on admission, in the recovery unit and in the ward, while shivering score and patient satisfaction score were evaluated only in the recovery unit.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18-65, who are included in the asa i-iii group, who will undergo rhinoplasty. exclusion criteria: * patients with bmi \> 35 kg/m² * patients with body temperature \>37.5°c, \<36°c degrees * those with cardiovascular system or central nervous system disease * patients with thyroid disorders * patients with autonomic dysfunction * patients not between the ages of 18-65 * patients with missing information in the information form * patients using steroids or vasoactive drugs. * patients whose operation time is less than 30 minutes

Keywords: high flow hypothermia low flow rhinoplasty
endoscopic ultrasound guided tissue sampling (the sharkbite study)

Conditions: Pancreas Cancer; Pancreas Neoplasm, Benign; Chronic Pancreatitis; Pancreas Adenocarcinoma

Summary: this study compares the diagnostic performance of endoscopic ultrasound (eus) guided fine needle aspiration and eus guided core biopsy (sharkcore) in patients with a solid pancreatic mass.

endoscopic ultrasound (eus) guided fine needle aspiration (fna) and fine needle biopsy (fnb) are the standard methods for obtaining tissue samples from tumours of the pancreas. the diagnostic accuracy by strict criteria is around 75-80%. a non diagnostic sample causes delay and the need for a repeat procedure. to date no significant difference has been found between standard fna and standard fnb needles. a novel opposing bevel design (sharkcore) needle for fnb may provide better diagnostic performance. the aim of this study is to compare the performance of a standard needle and the sharkcore needle. patients attending for routine biopsy of a suspected pancreatic tumour will be invited to participate. all participants will have 3 samples taken with each needle. the samples from each needle will be processed and reported separately with the pathologists blinded as to the report from the other needle. following the procedure participants will be observed as normal in the recovery area and allowed home later. further study participation is limited to 1 telephone call at 7 days. participants will be asked if they have developed any new symptoms since the procedure and whether they have had to seek medical attention for this.the risks of the study procedure are the same as those of a non study procedure. both needle types are in routine use in our unit. the study will be performed in the endoscopy unit of the freeman hospital. the study is funded by a grant from medtronic the company who make the sharkcore needle. the study is planned to recruit 108 participants over 10 months with a further 6 months of follow up. if the new needle is found to perform better its routine use will potentially reduce the delay experienced by patients as well as the cost incurred by repeat procedures.

Eligibility criteria:
inclusion criteria: * adult patients 18 years and above with a solid pancreatic mass of any size, needing to undergo the eus examination to collect sample for diagnosis will be recruited for the study. the definition of a solid pancreatic mass will be based on an ultrasound or a ct scan result or based on the findings of a eus examination done prior. * patients should have the ability and be willing to give informed consent exclusion criteria: * cysts that do not have a significant solid component will be excluded * any contraindication to pancreatic biopsy.
pulsed electromagnetic field treatment for painful periods

Conditions: Dysmenorrhea

Summary: a single-centre, randomised controlled, double blind study comparing use of the allay pulsed shortwave therapy treatment versus a placebo device or no treatment for management of primary dysmenorrhea.

women participating in the trial will be randomly allocated to any of the three arms of the study. * treatment for 2 menstrual cycles using the pswt allay device (bioelectronics corp, frederick usa) * treatment for 2 menstrual cycles using a placebo device * no treatment. if they are allocated to a device both the participant and the clinician will be blinded at to weather they are using the active device or the placebo. primary outcome measures are: * a reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale. * a reduction in average pain score on a 10cm visual analogue scale * a reduction in use of analgesia as recorded in a pain diary * improvement in quality of life as measured through a validated quality of life assessment tool (sf-36 questionnaire) - improvement in menstrual symptoms as recorded through a validated questionnaire (the modified menorrhagia multi-attribute scale (mmas)). * device acceptability as measured on a 5-point likert scale ranging from "unacceptable" to "totally acceptable". * impact upon associated cyclical symptoms as recorded in a patient symptom diary

Eligibility criteria:
inclusion criteria: * female with persistent (\>3months) cyclical period pain associated with menstruation (defined as 5 or more on vas). * able to give written, informed consent * able to wear device and keep up-to-date records of use * agrees to attend follow up * if currently using hormonal contraception agrees to continue on the same dose for the duration of the trial. exclusion criteria: * age under 16 years. * trying to conceive or \<6 weeks post partum * currently participating or planning to participate in another clinical trial
the covid-19 mobile health study (cmhs)

Conditions: COVID-19

Summary: this study evaluates a brand-new cell phone-based auto-diagnosis system, which is based on the clinical guidelines, clinical experience, and statistic training model. we will achieve secure and 1st hand data from physicians in wuhan, which including 150 cases in the training cohort and 300 cases in the validation cohort.


Eligibility criteria:
inclusion criteria: * high risk of covid-19 * rt-pcr test result of sar2-cov-19 exclusion criteria: * not available for rt-pcr test result of sar2-cov-19
effect of hepatic impairment on the pharmacokinetics of alectinib

Conditions: Hepatic Impairment

Summary: this is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.


Eligibility criteria:
inclusion criteria: all participants * body mass index between 18 to 35 kilograms per square meter (kg/m\^2) inclusive and weight greater than (\>) 50 kilograms (kg) * female participants must be surgically sterile or post-menopausal * male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method participants with hepatic impairment - documented chronic stable liver disease (child-pugh class a, b or c) exclusion criteria: all participants * pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential * positive test for drugs of abuse or alcohol * participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration * history of hypersensitivity to any of the additives in the alectinib formulation * participants under judicial supervision, guardianship, or curatorship * history of severe drug-related allergic reactions or drug-induced hepatotoxicity healthy participants * use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration * use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration participants with hepatic impairment * positive screening test for human immunodeficiency virus (hiv) * history of liver transplantation * hepatocellular carcinoma or acute liver disease * severe ascites at screening or admission to the clinic * recent history (past 2 years) or current severe hepatic encephalopathy (grade 3 or higher) * any evidence of progressive liver disease within the last 4 weeks * presence of surgically created or transjugular intrahepatic portal systemic shunts

Keywords: healthy volunteer alectinib hepatic impairment
fibromyalgia: somatic tracking and exercise program study

Conditions: Fibromyalgia (FM); Fibromyalgia; Fibromyalgia Syndrome

Summary: the goal of this clinical trial is to learn if the combination of two interventions is more effective in treating fibromyalgia symptoms than one intervention alone. the participant group will be people with fibromyalgia in age group 18-65 years. the two interventions to be tested over sixteen weeks are: * weekly exercise sessions in groups * weekly consultations with a therapist the main question it aims to answer is: is the combination of group exercising and somatic tracking work more efficient than physical activity alone in terms of managing fibromyalgia? participants will wear fitbit activity trackers, register pain intensity daily on a mobile app, and answer the fibromyalgia impact questionnaire (fiq). they will be divided into four groups: * one group receiving the exercise intervention * one group receiving the psychological intervention * one group receiving both intervention * one control group recieving general physical activity recommendations before the sixteen weeks intervention period, there will be a baseline period of eight weeks. durng the baseline period, participants will wear activity trackers and maintain their usual lifestyle. researchers will compare the combination of the interventions against only one intervention and the control group.

fibromyalgia is a chronic condition characterised by musculoskeletal pain, fatigue, poor sleep and an overall reduced quality of life. it is well known that physical activity improves symtpons of fibromyalgia, although not all people affected by the condition have positive experiences from exercising. people with fibromyalgia have also stated that physical activity alone is not enough for managing symptomes effectively. this is the background for the proposed randomized controlled trial with a 2\*2 factorial design, where two interventions are tested, alone and in combination. there will be a baseline period of 8 weeks and an intervention period of 16 weeks. evaluations will occur at the end of the baseline period (8 weeks) and at the end of the intervention period (24 weeks).

Eligibility criteria:
inclusion criteria: * diagnosed with fibromyalgia according to the criteria specified in wolfe et al (2016) * able to perform light physical activity * able to provide written informed consent * owning a smartphone * able to be followed for 24 weeks exclusion criteria: * pregnant * severe co-morbid psychiatric or neurological disorders * current participation in another clinical trial * recent surgery or other physical constraints preventing exercise

Keywords: fibromyalgia impact questionnaire randomized controlled trial clinical trial factorial design 2*2 factorial design physical activity somatic tracking activity fibromyalgia pain effect study musculoskeletal pain rheumatic diseases musculoskeletal diseases
a mass balance study of [14c] shr6508 in chinese hemodialysis subjects with secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: the study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of \[14c\] shr6508.


Eligibility criteria:
inclusion criteria: 1. be able and willing to provide a written informed consent form. 2. male subjects and postmenopausal women. 3. meet the body mass index (bmi) standard. exclusion criteria: 1. subjects with a history of cardiovascular diseases. 2. subjects with gastrointestinal diseases. 3. subjects with a history of surgery. 4. subjects with a history of blood loss. 5. abnormal blood pressure. 6. be allergic to a drug ingredient or component. 7. subject with a history of alcohol abuse and drug abuse 8. the investigators determined that other conditions were inappropriate for participation in this clinical trial.
chemotherapy-induced circadian rhythm disruption

Conditions: Breast Neoplasms

Summary: the purpose of this study is to investigate chemotherapy-induced circadian rhythm disruption through biomarkers, and the relationship between chemotherapy-induced circadian rhythm disruptions and side effects of chemotherapy.


Eligibility criteria:
inclusion criteria: 1. those who have undergone breast cancer surgery and are waiting for chemotherapy 2. premenopausal women 3. invasive adenocarcinoma of the breast stages i-iii exclusion criteria: 1. other cancer diagnosis within the last 5 years 2. other physical problems that can affect survival 3. other physical problems that can affect sleep or mood ex) pulmonary disease(copd, asthma), gi disorder(gerd), renal disorder(end stage renal disease), endocrine disorder(hypothyroidism, acromegaly), infectious disease(viral, bacterial infections, hiv infections), neurological disease(epilepsy, parkinson's disease, neuromuscular disorder, stroke, multiple sclerosis), cardiovascular disease(coronary heart disease), pain, etc. 4. ecog(eastern cooperative oncology group performance status) \>1 5. in the case of depression, anxiety disorder, sleep disorder, etc. 6. if you have worked night shifts or shifts within the past 6 months 7. weight 40kg or less, digestive diseases, history of gastrointestinal surgery, etc. 8. if you are currently taking psychiatric drugs (antipsychotics, antidepressant, mood stabilizer, benzodiazepine, psychostimulant, beta-blocker, etc.) 9. if you have traveled on a transmeridian plane in the 3rd zone or more within the past 6 months.

Keywords: breast neoplasms circadian rhythm chemotherapy biomarker core body temperature melatonin cortisol circadian gene
a prospective multi-center research on bowel dysfunction after sphincter preservative surgery

Conditions: Bowel Dysfunction; Rectal Cancer

Summary: this research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in china mainland, observe the incidence and risk factors about bowel dysfunction after operation.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. adenocarcinoma confirmed by pathology 3. distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by hard sigmoidoscope. 4. the tumor is estimated to be resectable and confirmed by multidisciplinary team (mdt). 5. the operation is estimated to be sphincter-preserving. 6. the eastern cooperative oncology group(ecog) performance status score of patient is ≤ 2. 7. the estimated life time is not less than one year. 8. the patient agree to sign the informed consent. exclusion criteria: 1. the patient refuse to follow research plan. 2. emergency case 3. pregnant and lactating female patient 4. the patient did not accept radical resection. 5. the patient did not accept first stage resection and anastomosis. 6. the patient has experienced anal-rectal surgery. 7. the patient has experienced left colon surgery. 8. the patient suffered long-existing bowel dysfunction before rectal cancer diagnosis. 9. the patient was diagnosed with cognitive or communicative obstacles. 10. the patient was diagnosed with serious repeated infection or other concomitance diseases. 11. the patient has participated other medical research which may affect his/her bowel function.

Keywords: rectal cancer anterior resection syndrome sphincter-preserving surgery
efficacy and safety comparison of tiotropium inhalation solution (respimat inhaler) and spiriva handihaler in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: non-inferiority of lung function response to tiotropium inhalation solution compared to spiriva handihaler


Eligibility criteria:
inclusion criteria: * all patients had to sign an informed consent consistent with international conference of harmonization-good clinical practice (ich-gcp) guidelines prior to participation in the trial, which includes medication washout and restrictions. * all patients had to have a diagnosis of chronic obstructive pulmonary disease. * patients had to have relatively stable, moderate to severe airway obstruction with an forced expiratory volume in one second (fev1) ≤ 60% of predicted normal and fev1 ≤ 70% of forced vital capacity fvc (visits 1 and 2). * male or female patients 40 years of age or older. * patients had to be current or ex-smokers with a smoking history of more than 10 pack-years. * patients had to be able to perform technically acceptable pulmonary function tests and peak expiratory flow rate (pefr) measurements, and had to be able to maintain records (patient daily diary card) during the study period as required in the protocol. * patients had to be able to inhale medication in a competent manner from the respimat inhaler, the handihaler and from a metered dose inhaler (mdi). exclusion criteria: * patients with significant diseases other than chronic obstructive pulmonary disease (copd) had to be excluded. a significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study. * patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion no. 1. * patients with a recent history (i.e., one year or less) of myocardial infarction. * patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years. * patients with a history of cancer within the last five years. patients with treated basal cell carcinoma were allowed. * patients with known symptomatic prostatic hypertrophy or bladder neck obstruction. * patients with known narrow-angle glaucoma. * patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥600 mm3. * further exclusion criteria apply
effects of craniosacral therapy on chronic neck pain

Conditions: Neck Pain

Summary: the purpose of this randomized controlled trial is to determinate the efficacy and safety of craniosacral therapy in the treatment of chronic unspecific neck pain.

craniosacral therapy (cst) is a variation of osteopathic manipulation with an integrative approach. by soft manual palpation of the craniosacral and fascia system sensory, motor, cognitive, and emotional processes can be influenced. in the prevention and treatment of chronic pain syndromes craniosacral therapy is demonstrated to be effective in clinical practice and quite a few scientific trials. but yet there are no randomized controlled studies concerning to chronic neck pain. so the aim of this study is to investigate whether a total of 8 cst units of 45 minutes will be effective in patients suffering from chronic nonspecific neck pain in contrast to sham therapy of the same extent. the prospective study design includes measurement points at baseline, post treatment, and 3 months follow-up.

Eligibility criteria:
inclusion criteria: * chronic unspecific neck pain for at least 3 months * mean neck pain of moderate intensity (\>/=45mm on vas) * therapy-naive subjects exclusion criteria: * specific neck pain due to severe deformity of the spine, prolapse, rheumatic or neurological disorder, trauma, operation or cancer * other severe somatic or psychiatric comorbidity * pregnancy * regular intake of opiates, corticosteroids (\>10mg prednisolon), muscle relaxants or antidepressants * recent invasive or manipulative treatment of the spine * participation in other clinical trials

Keywords: neck pain craniosacral manipulation complementary therapies randomized controlled trial sensory thresholds quality of life
efficacy and safety study of a medical device (kulist)to treat perianal fistulas

Conditions: Perianal Fistulas

Summary: the aim of this study is to evaluate the effects of rectally administered activated carbon (medical device kulist) in chronic, uncomplicated, perianal fistulas.

patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with kulist for 8 weeks. the efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography. also changes in patient assessment of symptoms and impact on daily function will be evaluated. safety will be evaluated by standard adverse event /adverse device effects reporting.

Eligibility criteria:
inclusion criteria: 1. patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open" 2. fistula classified as intersphincteric and transsphincteric according to parks´classification (parks 1976) 3. superficial fistula involving a part of the external sphincter muscle 4. age: ≥18 years and ≤ 75 years 5. informed consent and/or letter of authority (as applicable) obtained exclusion criteria 6. inflammatory bowel disease (ibd) 7. rectovaginal fistulas 8. rectourethral fistulas 9. rectovesical fistulas 10. extra-sphincteric and supra-sphincteric fistula according to parks´classification 11. complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator. 12. any surgical treatment for perianal fistulas 13. colorectal and/or anal malignancy 14. other malignancy requiring active treatment 15. subcutaneous fistulas not involving any part of the external sphincter 16. other diseases which as per the investigator's opinion should be contraindicated 17. subjects who are not able to complete study procedures as per the investigator's opinion