Kornimate/medical-research-clean huggingface dataset:
effect of maternal heart sound on crying time and pain level in newborns during heel blood collection

Conditions: Pain; Infant, Newborn, Disease

Summary: this study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.

the randomized controlled and experimental study was conducted with 60 newborns applied to a public family health center for heel blood collection. the infants in the experimental group (n=30) were listened to the maternal heart sound before, during, and after the heel blood collection procedure, and routine blood collection was applied to the control group (n=30). newborn information form and newborn infant pain scale (nips) were used to collect data.

Eligibility criteria:
inclusion criteria: * gestational age of 38-41 weeks, * chronological age of 2-28 days, * without any physical, metabolic or genetic disease, * newborns who did not use any analgesic drugs before the procedure exclusion criteria: * newborns whose heel blood cannot be taken at once

Keywords: pain newborn non-drug pain management
interaction between st john's wort and metformin?

Conditions: Type 2 Diabetes; Depression

Summary: the goal of the study is to examine the difference of the pharmacokinetics of metformin with and without a 3 weeks pretreatment of st john's wort. furthermore secondary objectives include changes in glp-1, c-peptide, serum-insulin and plasma-glucose during an oral glucose tolerance test, changes in oct1 mrna in plasma and changes in leptin and lipid-profile following this possible interaction.


Eligibility criteria:
inclusion criteria: * men aged 18-64 years * homozygous for common genetic variants in the genes organic cation transporter 1/2 (oct1/oct2) * normal values of biomarkers accounting for: liver and kidney function, and normal blood glucose exclusion criteria: * chronic alcohol abuse * hypersensitivity to metformin or st john's wort * daily intake of drugs requiring prescription
biatain ag vs biatain in the treament of leg ulcers

Conditions: Leg Ulcers

Summary: the objective of this investigation is to demonstrate the effect of the foam dressing biatain ag, compared to biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy


Eligibility criteria:
inclusion criteria: * • patients over 18 who have given written informed consent * patients with a venous or predominantly venous leg ulcer (ankle-brachial index \> 0.8) that is between 2 cm and 13 cm in all directions * patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue * patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion * patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion * patients who are available for monitoring for at least 10 weeks exclusion criteria: * • patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment * patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion * patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion * patients who have been taking systemic antibiotics in the two weeks prior to inclusion * patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion * patients with unbalanced diabetes at the discretion of the investigator * patients with a known allergy to one of the components in biatain argent® or biatain * patients who are already taking part in another clinical study * patients who are pregnant or breastfeeding
capitalizing on a teachable moment to promote smoking cessation

Conditions: Smoking Cessation

Summary: the purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (ct) scan.

conduct formative research (months 1 - 4): identification of emergent themes and responses to existing booklets. adapt and refine booklets (months 5 - 8): advanced drafts of booklets. final reactions to draft booklets (months 9 - 12): series of smoking cessation booklets for spiral computed tomography (ct) patients.

Eligibility criteria:
inclusion criteria: study 1 * participants for study i will be drawn from a list of patients who have received a ct scan at the moffitt cancer center * smoked at least one cigarette per week prior to undergoing the ct scan * able to speak and read english study 2 * smoked at least one cigarette over the past week * able to read english

Keywords: lung cancer prevention
clinical study of the lrs thermosuit™ system in post arrest patients with intravenous infusion of magnesium sulfate

Conditions: Death, Sudden, Cardiac; Coma

Summary: this study will involve the use of therapeutic hypothermia. this prospective cohort pilot study will evaluate the clinical performance of a new device, the thermosuit™ system, to achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and hemodynamics in these patients. the study hypothesis is that magnesium sulfate will significantly increase the rate of cooling.

this study will involve the use of therapeutic hypothermia, an accepted medical treatment recommended for comatose post resuscitation patients by the international liaison committee on resuscitation (ilcor), the american heart association (aha), and the european resuscitation council. this prospective cohort pilot study will evaluate the clinical performance of a new device, the thermosuit™ system, to achieve therapeutic hypothermia in comatose patients following resuscitation from cardiac arrest, and the impact of the vasodilator, magnesium sulfate, on cooling performance and hemodynamics in these patients. 14 patients will be prospectively randomized to receive either magnesium sulfate or normal saline (placebo) in this study.

Eligibility criteria:
inclusion criteria: * cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (rosc). * estimated or known age \> 18 years. * intubation, ventilation and placement of esophageal temperature probe. * persistent neurologic dysfunction i.e. comatose upon enrollment \[gcs ≤ 8\]. exclusion criteria: * height greater than 188 cm. * elbow-to-elbow width greater than 60 cm (as measured above the supine patient). * core temperature less than 35°c after rosc (as measured in the esophagus). * comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system. * known pregnancy. * known terminal illness that preceded the arrest. * known enrollment in another study of a device, drug, or biologic. * major trauma or other co-morbidity requiring urgent surgery. * \> 4 hours since return of spontaneous circulation. * severe coagulopathy (with active bleeding). * hemodynamic instability despite vasopressors (sbp \ 30 minutes after rosc and before enrollment). * bradycardia (hr\<60/min) * allergy against mgso4 * av-block * myasthenia gravis * known terminal renal insufficiency (creatinine-clearance \< 20ml/min) * severe myocardial dysfunction (ef\<25%) * chronic digitalis therapy

Keywords: hypothermia, induced death, sudden, cardiac resuscitation coma
effort asthma: effects of diet and exercise in asthma

Conditions: Asthma

Summary: this project aims to study the effects of lifestyle changes on asthma and systemic inflammation in a randomized clinical trial of diet and exercise. the project is a multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred on improving asthma control in non-obese sedentary asthmatics via simple means.

after screening and enrollment, a total of 200 danish sedentary, non-obese asthma patients will be randomized to one of four groups: 1) control group (no intervention), 2) physical exercise intervention, 3) diet intervention (a diet with an overall high content of protein and a low glycemic index) or 4) exercise plus diet intervention. asthma is defined as respiratory symptoms and at least one positive asthma test. patients will continue their regular doses of anti-asthma treatment unchanged throughout the study period. type of anti-inflammatory medicine will be recorded and the adherence to the therapy will be assessed before the intervention period and at follow-up using questionnaires

Eligibility criteria:
inclusion criteria: * \>18 years old * uncontrolled or partly uncontrolled asthma * capable of exercising on bike * sedentary (currently do less than 60 min of structured/planned physical activity per week) exclusion criteria: bmi ≥ 30.0 or \<20.5 * chronic obstructive pulmonary disease (copd), pregnancy, other inflammatory or metabolic diseases * the use of oral anti-inflammatory medication or the use of antibiotic treatment during the last 8 weeks.
pelvic fractures in polytraumatized patients with hemodynamic instability: angioembolization vs preperitoneal packing

Conditions: Trauma; Pelvic Fracture; Hemodynamic Instability

Summary: pelvic fracture is a usual injury in trauma patients. an unstable trauma patient with a pelvic fracture has an elevated risk of death due to pelvic bleeding and the associated injuries. traditionally, it has been estimated that the main source of bleeding is venous and, consequently, the main treatment has been the preperitoneal pelvic packing. nevertheless, according to new data, arterial bleeding appears to be a more important source of pelvic bleeding than it was thought and angioembolization seems to be a good alternative in the treatment of these injuries. consequently, it is important to define better the management of these patients. this investigation project consists in a clinical trial study, performed by a multidisciplinary team of many hospitals around the country, in which angioembolization and preperitoneal pelvic packing are compared. unstable trauma patients with a pelvic fracture and no other injuries (negative fast / peritoneal aspiration, no evidence of bone fractures or thoracic injuries) will be submitted, in less than 60 minutes from hospital arrival, to angioembolization or preperitoneal pelvic packing, according to randomization. there will be a specific timing evaluation of different markers: hemodynamic (vital signs at arrival, immediately and 24 hours after treatment) and analytic (at arrival and upon entering to the intensive care unit). registered variables include: blood cell transfusions, vasoactive drug requirements, time elapsed between hospital admission and intervention, treatment duration, need of other strategies to stop pelvic bleeding, complications and mortality. the objective of this study is to determinate if angioembolization is superior to preperitoneal pelvic packing for pelvic bleeding control in unstable trauma patients due to pelvic bleeding.


Eligibility criteria:
inclusion criteria: * systolic blood pressure ≤ 90 mmhg * heart rate \> 100 bpm * shock index ≥ 0,8 * pelvic fracture * negative fast / peritoneal aspiration exclusion criteria: * other causes of bleeding that require treatment

Keywords: trauma pelvis fracture hypovolemic shock preperitoneal pelvic packing angioembolization hemodynamic instability
study of safety and efficacy of brolucizumab 6 mg dosed every 4 weeks compared to aflibercept 2 mg dosed every 4 weeks in patients with retinal fluid despite frequent anti-vegf injections

Conditions: Age-Related Macular Degeneration

Summary: this clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (namd) patients with retinal fluid despite frequent anti-vascular endothelial growth factor (vegf) injections.

this was a phase iii, multi-center, randomized, double-masked, parallel group study with 2 masked arms in which participants were randomized 2:1 to receive brolucizumab or aflibercept. all participants had study visits every 4 weeks through week 104. the study consisted of three study periods: screening period: the screening period lasted up to 2 weeks prior to administration of the first dose of study treatment, dependent upon confirmation of the patient meeting eligibility criteria. double-masked treatment period: participants meeting eligibility criteria entered the treatment period and were randomized in a 2:1 ratio into one of the following 2 masked treatment arms at the baseline visit: brolucizumab 6 mg injected every 4 weeks or aflibercept 2 mg injected every 4 weeks. treatment period lasted up to week 100. safety follow up period: participants were followed up for safety during 4 weeks after the last dose of study treatment. including the screening period, the total study duration for a participant was up to 106 weeks. some participants were eligible to continue into an extension study in order to receive treatment with brolucizumab (a) after completing the 104 -week double-masked treatment period, (b) upon meeting all inclusion/exclusion criteria for the extension study, and (c) based on investigator's judgment that the participant was expected to benefit from treatment with brolucizumab.

Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosis of wet age-related macular degeneration (amd) * currently receiving anti-vegf injections exclusion criteria: * active infection or inflammation in either eye * significant fibrosis in the study eye * recent ocular surgery * uncontrolled glaucoma * use of medications as specified in the protocol * pregnant, nursing * of child-bearing potential unless using highly effective method of contraception

Keywords: neovascular age-related macular degeneration namd intravitreal injection ivt anti-vegf brolucizumab aflibercept eylea double-masked merlin beovu
internal limiting membrane peeling in proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy Visually Threatening

Summary: subject/participant groups: study group: subjects undergo internal limiting membrane (ilm) peeling during vitrectomy for the indication of tractional retinal detachment control group: subjects do not undergo ilm peeling during vitrectomy for the indication of tractional retinal detachment

hypothesis: subjects undergoing ilm peeling during vitrectomy will have lower central macular thickness on oct, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects randomization: subjects will be randomized according to a coin toss during ppv, once grade 2 or grade 3 vitreoretinal adhesion has been determined: heads undergo ilm peeling, while tails do not. number of subjects: with study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.

Eligibility criteria:
inclusion: 1. subject age is 18-85 years. 2. subject consents to study participation and is capable of 6 months of follow-up. 3. the subject has type i or ii diabetes mellitus with active pdr in the study eye. 4. best-corrected spectacle visual acuity (bcsva) on the snellen eye chart ranges from 20/40 to hand motions in the study eye. 5. the subject is determined to need a ppv for the indication of trd (grades 2 and 3). exclusion: 1. subject is known to have a significant retinal/optic nerve disease otherwise unrelated to diabetes mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced bcsva (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye. 2. subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced bcsva in the study eye. 3. subject has a significant corneal or cataract opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced bcsva (corneal scar, ectasia, etc.) in the study eye. 4. subject has had a previous vitrectomy (anterior or ppv) in the study eye. 5. subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmhg despite medical/surgical treatment) in the study eye. 6. subject has uncontrolled hypertension (systolic \> 200 mmhg or diastolic \> 120 mmhg) despite adherence to a multiple anti-hypertensive medication regimen.
the impact of migraine on canadians' productivity: a real-world pharmacy-based study

Conditions: Migraine

Summary: this is a cross-sectional, real-world observational, community pharmacy-based study in which adults treated with a triptan for their migraine will self-report productivity and activity impairment using a web-based portal or paper-based questionnaire.

the primary objective of this study is to estimate the productivity and activity impairment associated with migraine in adults treated with a triptan. participant identification will be made using pharmacies member of the proxy network. eligible participants will be identified using the prescription of any formulation of triptans either when filling or refilling a prescription of a triptan or in the pharmacy electronic database (patients with a renewal in the last 3 months). the proxy network is a research network bringing together community pharmacies across quebec to facilitate the generation of real-world evidence. this network is designed to better understand a disease or a treatment using patient-reported outcomes (pros). the proxy network is an initiative of peripharm inc., a company specializing in pharmacoeconomics and outcomes research.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; * new or current prescription (renewal in the last 3 months) of any formulation of triptans medication (i.e., almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan and frovatriptan); * working full or part-time or going to school full or part-time; * ability to read and understand english or french; * signature of informed consent form (icf). exclusion criteria: * patients participating in a clinical trial. * patients filling a one-time vacation/emergency prescription (i.e. without a complete pharmacy file).
study on the learning curve for fundus first with ultrasonic tissue coagulation in elective cholecystectomy

Conditions: Cholecystolithiasis

Summary: the present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. all participating surgeons have experience of the traditional approach with electrocautery. the operation time as well as the surgeons own evaluation of difficulty and performance are noted. selected films are analyzed by independent surgeons with experience of the fundus first technique. the swedish registry of gallstone surgery and ercp (gallriks) are used to record the intra and postoperative complication rate.

the present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. all participating surgeons have experience of the traditional approach with electrocautery, but limited experience from gallstone surgery with ultrasonic tissue coagulation dissection. the operation time as well as the surgeons own evaluation of difficulty and performance are noted. selected video recordings are analyzed by independent surgeons with experience of the fundus first technique. the swedish registry of gallstone surgery and ercp (gallriks) are used to record the intra and postoperative complication rate. the study is intended to serve as a pilot study for a subsequent randomised controlled trial, comparing surgery with electrocautery and ultrasonic tissue coagulation dissection.

Eligibility criteria:
inclusion criteria: * preoperatively discovered choledocholithiasis exclusion criteria: * symptoms and signs of acute or chronic cholecystitis
treatment of metastatic vulvar carcinoma with carboplatin and paclitaxel chemotherapy

Conditions: Metastatic Squamous Cell Carcinoma of the Vulva

Summary: vulvar cancer is a rare malignancy. surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

vulvar cancer is a rare malignancy. surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Eligibility criteria:
inclusion criteria: * woman 18 years * signed and written informed consent. * histologically confirmed squamous cell vulvar carcinoma * world health organization performance status of 0-2 * adequate hematological function * adequate hepatic function * adequate renal function * negative pregnancy test for woman of childbearing potential * histologically or ct scan confirmed metastatic squamous cell vulvar carcinoma * measurable disease * lesion previously not irradiated * tnm stage any t any n m1 exclusion criteria: * vulvar cancer other than squamous cell carcinoma at biopsy * previous radiotherapy of the vulva, groins or pelvis * patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent * other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study
treatment outcomes in japanese rcc patients treated with avelumab plus axitinib as first-line therapy: retrospective study (j-dart2)

Conditions: Renal Cell Carcinoma

Summary: this study is a multicenter, non-interventional, retrospective, medical chart review of participants with metastatic renal cell cancer(mrcc) treated with avelumab plus axitinib as a first-line therapy in japan between 20 december 2019 and 17 october 2022. all decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. data will be collected if available per study site.


Eligibility criteria:
inclusion criteria: 1. diagnoses of mrcc based on the general rule for clinical and pathological studies on rcc (fifth edition) before receiving avelumab plus axitinib as first-line therapy. patients with mrcc who have unresectable disease, either unresectable locally advanced or metastatic disease. 2. age over 18 years at the time of the first administration of avelumab plus axitinib as firstline therapy for mrcc (baseline). 3. index date from 20 december 2019 to 17 october 2022. exclusion criteria: 1. patients participating in a prospective interventional clinical trial assessing an investigational product during the observation period. 2. patients (or a patient's legally representative) refusing to provide patient data during the consent process.

Keywords: retrospective multicenter non-interventional medical chart review japan metastatic renal cell cancer(mrcc) avelumab axitinib first-line therapy standard care in real-world clinical setting