Kornimate/medical-research-clean huggingface dataset:
glysure acute care settings study

Conditions: Adult Intensive Care Patients

Summary: the company who have developed the glysure product have previously carried out a study to be able to show that the glysure system is accurate in measuring blood sugar (glucose) levels. this was done with patients in the intensive care unit (icu) after heart surgery. the company now want to confirm that the glysure product is accurate at measuring blood glucose levels on all patients who stay in the icu. this clinical study requires 40 patients and is to check the safety of a continuous glucose monitoring system (glysure) and it's performance in comparison to separate individual blood glucose testing using a hand held blood tester called i-stat. each patient must be in the study for at least 36 hours. the main benefit of continuous blood glucose monitoring is that it gives a true picture of the glucose status of a patient and this can potentially help avoid the glucose level dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can intervene based on 'real-time' data on the glucose levels. in this study patient treatment is not dictated by the data measured during the study. clinicians are blind to the results on the glysure monitor.


Eligibility criteria:
inclusion criteria: 1. patient or legal representative must be willing to sign an informed consent document 2. patient is male or female aged 18 years or above 3. patient requires a central venous catheter (cvc) to be inserted as part of disease management and treatment 4. patient is expected to remain in the intensive care unit for at least 36 hours post enrolment to the study exclusion criteria: 1. patient or legal representative is unable to provide written informed consent 2. patient who is pregnant 3. patient who is currently being administered mannitol and/or may require the administration of mannitol whilst in the icu 4. patient with history of pulmonary embolism (pe) 5. patient with history of thrombosis 6. patient with known hyper-coagulation 7. patient with known history of heparin hypersensitivity 8. patient with history of heparin induced thrombocytopenia 9. participation in a clinical study involving an unlicensed pharmaceutical product or device within the 3 months prior to enrolment in this study 10. patient with known hypersensitivity/allergy to adhesive i.v. dressings such as 3m tegaderm film or statlock® devices 11. patient who is being managed in a cardiac icu setting after cardiac surgery
health, functioning, work, and experiences of social and health services of persons with stroke

Conditions: Stroke; Health, Subjective; Cardiovascular Diseases; Central Nervous System Diseases

Summary: the purpose of the health, functioning, work, and experiences of social and health services of persons with stroke study (finpoststroke) is to identify factors related to self-reported health, functioning, work, inclusion, and accessibility of social and health services, and how such factors are interconnected in finnish adults one or more years after stroke. participants will be targeted from two tertiary hospitals' registries and recruited via mail. this cross-sectional explorative observational study is based on register data and postal survey. the survey questionnaire includes several valid patient-reported outcome measures. the study will add knowledge to be utilized in developing health care and rehabilitation services for people with stroke, as well as provide information for various parties involved.

the purpose of the health, functioning, work, and experiences of social and health services of persons with stroke (finpoststroke) study is to identify factors related to self-reported health, functioning, work, inclusion, and accessibility of social and health services, and how such factors are interconnected in finnish adults one or more years after stroke. the international classification of functioning, disability and health (icf) is used as a structured framework. adults with cerebral infarction, subarachnoid hemorrhage, or intracerebral hemorrhage will be targeted from kuopio and hus helsinki university hospitals' patient registries. the survey data is planned to be collected with postal questionnaire by may 2025. the questionnaire includes several valid patient-reported outcome measures to assess health and functioning, work and income, inclusion, and social and health services. participants will be recruited via mail with an invitation letter and study information attached to the questionnaire. all participants are expected to give written informed consent prior to the study. this study will add knowledge to be utilized in developing health care and rehabilitation services for people with stroke, as well as provide information for various parties involved. we plan to publish at least four peer-reviewed articles along with common articles and texts concerning self-reported health, functioning, work, inclusion, and accessibility of social and health services among finnish adults with stroke.

Eligibility criteria:
inclusion criteria: * treated for a stroke (icd-10 codes i60-61, i63-64) in hus helsinki university hospital or in kuopio university hospital between january 2018 and december 2022 * stroke is primary diagnose for the treatment * 18 years or older at the time of survey exclusion criteria: * stroke is secondary diagnose for the treatment * treated for a stroke only as outpatient in other than emergency room * lives abroad * missing address

Keywords: icf survey stroke health functioning work inclusion health and social services
study to assess breast sensation before and after breast cancer treatment

Conditions: Breast Reconstruction; Ductal Carcinoma In-situ

Summary: the purpose of this study is to establish techniques for evaluating breast cutaneous sensation at baseline and following either lumpectomy or mastectomy for breast cancer.

measuring nerve recovery and breast sensibility has been reported in a limited fashion in the past. a number of studies have assessed patients before and after breast reduction surgery using semmes-weinstein monofilaments and found this to be an effective technique. a limited number of studies have been done in patients undergoing mastectomy for breast cancer using these techniques. the main limitation of these existing studies is the lack of prospective measurements before surgery and through time, thus restricting the findings to isolated long-term outcomes. additionally, no studies have compared patients undergoing mastectomy versus lumpectomy to determine the impact that surgical approach has on breast sensibility.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ductal carcinoma in-situ (dcis) or invasive breast cancer * patients that have been offered lumpectomy or mastectomy for surgical treatment * patients with a high risk of breast cancer and are pursuing prophylactic mastectomies exclusion criteria: * metastatic malignancy of any kind * subjects will not have breast surgery as a portion of their breast cancer care * between 25 and 65 years old * subjects with breast implants or a history of prior breast implants * subjects that have had prior breast reduction surgery * subjects who have had radiation to one of both breasts in the past * subjects who cannot give informed consent

Keywords: sensation
efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract infection (uuti)

Conditions: UTI - Lower Urinary Tract Infection; Antibiotic Resistant Infection

Summary: this is a prospective, phase 4, open label, multi-center study of the clinical and microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract infections in adult women.


Eligibility criteria:
inclusion criteria: 1. female patients ≥18 years of age with more than 24 hours of urinary symptoms attributable to a uti 2. two of the following signs and symptoms of uuti: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain, gross hematuria 3. a mid-stream urine specimen with: 1. a dipstick analysis positive for nitrite and 2. a dipstick analysis positive for leukocyte esterase 4. has given written informed consent to participate in the study. exclusion criteria: 1. presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature \> 38°celsius), chills, costovertebral angle tenderness, flank pain, nausea and/or vomiting 2. receipt of prior effective antibacterial drug therapy for uuti for the presenting illness unless the recovered pathogen demonstrates resistance to initial antibiotic and clinical symptoms persist 3. concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with uuti 4. patients with ileal loops or urinary stoma 5. patients with an indwelling urinary catheter in the previous 30 days 6. patients with paraplegia 7. patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uuti (e.g., patients with vesico-ureteral reflux) 8. any history of trauma to the pelvis or urinary tract 9. patient's urine culture results, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a potential fungal pathogen 10. patient's urine culture results, if available at study entry, identifies the causative uropathogen for the presenting illness to be resistant to ciprofloxacin 11. patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal dialysis or had a renal transplant 12. patient is known to have severe neutropenia 13. patient is known to be pregnant 14. patients with uncontrolled diabetes mellitus 15. patients with a known history of myasthenia gravis 16. patients who require concomitant administration of tizanidine 17. patients with a history of allergy to quinolones 18. patient is considered unlikely to survive the study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
registry of coronary lithotripsy in spain.

Conditions: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Artery Disease

Summary: the replica trial tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.

the replica trial tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age. * patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who, at the operator's discretion and according to the hospital routine clinical practice, require an icl with the shockwave catheter. * the patients have been informed of the study characteristics and have given their written informed consent. exclusion criteria: * refusal to participate in this study. * patients whose life expectancy is \< 1 year. * patients with hemodynamic instability with killip class iii or iv.

Keywords: intracoronary lithotripsy calcified lesions percutaneous coronary intervention
microfracture with platelet rich plasma gel injection for osteochondral lesion of the talus

Conditions: Osteochondral Lesion of Talus; Microfractures; Platelet Rich Plasma

Summary: the goal of this clinical trial is to learn if combined local injection of platelet rich plasma (prp) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (olt). the interface integration of the injured area will also be assessed via radiographic follow-up. the main questions it aims to answer are: * does arthroscopic microfracture combined with prp gel injection improve ankle function of participants based on american orthopedic foot and ankle society (aofas) score? * does arthroscopic microfracture combined with prp gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (mri)? researchers will compare arthroscopic microfracture with concomitant local injection of prp gel to isolated microfracture to see if intraoperative prp gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of olt. participants will: * undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of prp gel * receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment * take mri preoperatively and 6, 12 and 24 months after surgery


Eligibility criteria:
inclusion criteria: * chronic ankle pain, diagnosed as osteochondral lesion of the talus; * lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm; * conservative treatment of at least 3 months fails to relieve symptoms; * willingness to voluntarily participate in the trial and to sign informed consent. exclusion criteria: * varus or valgus deformity of the ankle of more than 5 degrees; * grade iii injury of the lateral collateral ligament of ankle; * chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.); * joint fibrosis, stiffness, and significantly restricted range of motion; * evidence of moderate to severe knee osteoarthritis on plain radiographs; * failure to complete the rehabilitation protocol as required; * patient medically not fit for surgery, radiographs or mri; * for women, pregnant, planning to be pregnant or lactating.

Keywords: osteochondral lesion of talus microfractures platelet rich plasma arthroscopic techniques clinical efficacy
comparison of chitosan and carboxymethylcellulose silver dressings on burn wounds in pediatric and adult subjects

Conditions: Bandages

Summary: the purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.


Eligibility criteria:
inclusion criteria: * inpatient status at the site * written consent obtained from the subject * burn injury must have been incurred within 36 hours prior to enrollment. * burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths * burn injury must exceed 3% total body surface area. exclusion criteria: * subject is pregnant. * bone fractures. * inhalation-related trauma. * sensitive and/or allergic to materials containing silver. * burn injury exceeds 40% total body surface area. * burn injury diagnosis indicates deep partial or full thickness wounds. * burn a result of electrical/chemical injury or frostbite. * an active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.
ad109 dose finding in mild to moderate osa

Conditions: Obstructive Sleep Apnea

Summary: this is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of ad109 vs placebo in patients with mild obstructive sleep apnea.

participants underwent initial pre-screening to determine potential study eligibility. participants selected for further screening had either a previous history of osa of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by stop-bang questionnaire score). only participants who met all non polysomnography (psg) enrollment criteria at visit 1 were eligible for a screening psg.

Eligibility criteria:
inclusion criteria: * ahi between 5 and 20 events/h * pgi-s equal to or higher than 1, or one or more of the following symptoms: * snoring or nightime gasping/choking * daytime sleepiness, fatigue or decreased concentration * nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache * irritability, decreased mood or libido exclusion criteria: * history of narcolepsy. * clinically significant craniofacial malformation. * clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control). * cpap should not be used for at least 2 weeks prior to the study * history of using oral or nasal devices for the treatment of osa may enroll as long as the devices are not used during participation in the study.
evaluating the effects of tasimelteon in individuals with autism spectrum disorder (asd) and sleep disturbances

Conditions: Autism Spectrum Disorder; Sleep Disorder; Neurological Disorder; Sleep Disturbance

Summary: this is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with asd.


Eligibility criteria:
inclusion criteria: * ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required). * a confirmed clinical diagnosis of autism spectrum disorder (asd) and a recent history of sleep disturbances. * the sleep disturbance must not be a result of another diagnosable disorder or medication. * male or female between 2 and 65 years of age, inclusive. * willing and able to comply with study requirements and restrictions. exclusion criteria: * inability to dose daily with tasimelteon or previous intolerance to tasimelteon. * indication of impaired liver function. * evidence of increased risk of self-harm. * pregnant or lactating females. * a positive test for drugs of abuse. * other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.
contribution of the meopa in the physiotherapy care of painful articular steepness among elderly

Conditions: Pain Management and Care

Summary: the meopa is used to obtain an analgesia of the short-term painful acts. to the population of elderly patients, the therapeutic resources to control the passing pain require in their manipulation a certain caution and are not divested of side effects badly tolerated at this age. an alternative in the opioid presents all its interest. the meopa is here an alternative of choice in the care of these pains, in particular in case of pre-existent cognitive achievement, of polypathologies or of polymédication. the gas meopa administered to the mask could thus be an effective additive in the physiotherapy treatment of the elderly person. the main objective is to assess the efficacy , in terms of recovery of the hip and knee joint articular amplitude, of 3 sessions of reeducation using meopa versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment.


Eligibility criteria:
inclusion criteria: * male or female aged 65 years old or more * patients having a prescription for physiotherapy * absence of contraindication to meopa * patients whose initial assessment show a passive articular deficit of at least a joint of hip or the knee and whose painful assessment is ≥ 5 or ≥ 2 during mobilisation on the validated scale algoplus * patients whose reeducation project established by the physiotherapist * patients having agreed to participate in the study and having signed the consent * subjects affiliated to the social security system exclusion criteria: * patient requiring a ventilation in pure oxygen * patient with a consciousness deterioration preventing his cooperation * care under meopa during the period of the protocol and during the month which precedes * increase of the dosage of morphine of less than 48 hours patient under guardianship
a study evaluating the efficacy and safety on moderate to severe dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to compare the efficacy and safety of hbm9036 ophthalmic solution versus placebo in the treatment of dry eye

hbm9036 is a molecularly engineered tumor necrosis factor receptor 1 (tnfr1) fragment. a total of 100 subjects are expected to be randomized. subjects will be randomized 1:1 at visit 2 to hbm9036 ophthalmic solution or placebo group, bilaterally bid for eight weeks. the primary efficacy endpoint is sign changes from baseline in change from pre- to post-cae inferior corneal staining score (icss) of the study eye evaluated at week 8 .

Eligibility criteria:
inclusion criteria 1. have a history of use eye drops for dry eye symptoms within 6 months of visit 1 or desire to use eye drops; 2. have in the study eye a schirmer's test score of ≤ 10 mm and ≥ 1 mm at visits 1 and 2; 3. be willing and can adjust current treatment for dry eye according to the protocol, judged by the investigator; 4. must be willing to complete all study assessments required by the protocol. exclusion criteria: 1. be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; 2. have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months, or had femtosecond small incision lenticule extraction (smile) within the last 12 months, or had phacoemulsification within the last 3 months, or had dry eye or aggravation of dry eye caused by other ocular operations has not been stable; 3. have used ophthalmic cyclosporine a, tacrolimus or xiidra® within 60 days prior to visit 1;
effectiveness of ultrasound guided pecs block on opioid consumption and patient satisfaction through adequate pain control following breast cancer surgery.

Conditions: Breast Neoplasm Female; Pain, Postoperative; Pain; Analgesia; Anaesthesia; Breast Cancer

Summary: breast cancer is the most common and leading cause of cancer deaths among females worldwide. patients undergoing modified radical mastectomy (mrm) are associated with moderate to severe acute postoperative pain and shoulder mobility restriction. this study aims to determine the effectiveness of ultrasound-guided pecs block for reducing opioid consumption, providing adequate postoperative pain management and improving patient satisfaction following breast cancer surgery.

the traditional pain management for patients undergoing mrm has relied heavily on opioids but a number of multimodal pain control strategies also exist including combining opioids with nsaids, cyclooxygenase-2 inhibitors, acetaminophen and regional blocks. recently, literature underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery. pecs (pectoral nerve block) block provides analgesia for breast surgeries with few adverse effects. objectives to evaluate the effect of ultrasound guided pectoral block in reducing intraoperative and postoperative opioid consumption following modified radical mastectomy. the secondary objective is to determine patient satisfaction levels associated with adequate pain control. hypothesis pectoral nerve blocks provides superior analgesia with less opioid consumption and improves patient satisfaction in postoperative period compared to conventional pain management for modified radical mastectomy patients

Eligibility criteria:
inclusion criteria: * patients undergoing elective modified radical mastectomy (mrm) * all adults aged between 18 and 65 years * asa (american society of anesthesiologists ) i \& ii exclusion criteria: * patient refusal * hypersensitivity to local anaesthetics * coagulopathy or bleeding diathesis * local infection at the site of block * bmi more than 35 kg/m2 * chest wall deformity or previous breast surgery * mrm with latissimus dorsi or deep inferior epigastric perforator flap reconstruction