Kornimate/medical-research-clean huggingface dataset:
biosensors for open and closed-loop glycemia control in t1d patients with insulin pump

Conditions: Diabetes Mellitus, Type 1

Summary: in t1d, the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex: even with recent technologies of continuous measurement and monitoring of blood glucose (cgm), current systems are electrochemical, insulin therapy algorithms do not are not optimal and cannot completely eliminate vital risks such as hypoglycemia. a new biosensor connected to the patient by microdialysis, will be tested in a clinical trial in chu-bdx on 10 t1d patients with an internal or external insulin pump. in various daily scenarios (meals, physical exercise) the biosensor diablo responses will be compared to the measurements of standard cgm systems.

continuous monitoring and linked drug delivery is a novel approach to the treatment of chronic diseases that provides powerful means to improve therapeutic outcomes and quality of patient's life. type 1 diabetes (t1d) concerns 5 to 10% of the estimated 415 million cases of diabetes worldwide in 2016, expected to rise to 642 million by 2040(1). continuous glucose monitoring systems (cgms) linked to insulin delivery has provided a major advance(2). t1d is a serious, currently chronic and costly disease in children or young adults. indeed, the destruction of pancreatic beta-cells leads to absolute insulin deficiency in t1d.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age * patient with type 1 diabetes (t1d) * patient being equipped and trained with an external or internan insulin pump linked to a cgm * affiliated person or beneficiary of a social security scheme * free, informed and written consent exclusion criteria: * patient under 18 years * patient not having t2d * pregnant or lactating patient * no consent signed by the patient

Keywords: continuous glucose monitoring biosensor
training in the fasted state, glucose metabolism and energy balance

Conditions: Glucose Metabolism Disorders

Summary: in healthy individuals, the body responds to glucose (sugar) ingestion by reducing the amount released from the liver. at the same time, skeletal muscles increase the rate at which they remove the glucose from the bloodstream, via the actions of the hormone insulin. this ensures that blood glucose levels remain in a controlled range. however, in developed countries, diseases such as metabolic syndrome and type 2 diabetes are becoming prevalent, due to dietary modifications and a reduction in physical activity. as one of the prominent barriers to regular physical activity is a lack of time, finding ways to maximize the health benefits of exercise is a priority for researchers. the investigators want to understand potential differences in the effects of six weeks of aerobic training, with the exercise performed either after breakfast or after a prolonged fast. specifically, this research aims to investigate whether there is a difference in the change in processes implicated in glucose regulation and secondly, in subsequent eating and physical activity behaviors. by investigating these changes this work will explore how exercise and nutrition can be optimized to benefit health and weight loss.


Eligibility criteria:
inclusion criteria: * male * aged 18-49 * body mass index (bmi) \> 25 kg/m2 * weight stable for \> 6 months * not currently engaging in any form of structured exercise * be able and willing to give informed oral and written consent * complete and meet the defined criteria of pre-study questionnaires and screen exclusion criteria: * have a history of metabolic, cardio-pulmonary or musculoskeletal disease * have plans to change diet and/or physical activity outside of the intervention * taking regular medication or food supplements from which it is not possible to refrain and which are known to influence any of the outcome measures. * failure to refrain from alcohol and/or caffeine containing drinks or strenuous exercise one day before or during the trial days * smokers * any reported condition or behavior deemed to pose a risk to the participant or introduce bias into the experiment

Keywords: exercise fasted glucose energy balance
contrast enhanced mammography or breast magnetic resonance: which choice for optimal diagnostic performance?

Conditions: Breast Cancer Prevention; Breast Cancer Diagnosis

Summary: this study compares the diagnostic performance of contrast-enhanced mammography (cem) and breast mri in evaluating breast lesions. it aims to assess sensitivity, specificity, and diagnostic accuracy to identify the optimal imaging modality for clinical scenarios such as dense breast tissue and high-risk populations.

search differences and performance of mri and cem

Eligibility criteria:
inclusion criteria: * age: women aged 18 years and older. * indication for advanced imaging: patients referred for contrast-enhanced mammography (cem) or breast mri due to suspicious findings or high-risk factors for breast cancer. * dense breast tissue or inconclusive findings: patients with dense breast tissue or inconclusive results from standard mammography. informed consent: ability to provide written informed consent for participation in the study. - presence of breast tissue: female or transgender women who have breast tissue suitable for imaging. exclusion criteria: * contraindications to mri: patients with contraindications to breast mri (e.g., implanted pacemakers, severe claustrophobia, or metallic implants that cannot be removed). * contraindications to contrast agents: patients who have allergies or contraindications to iodinated contrast agents used in cem. severe renal impairment: patients with severe renal impairment (egfr \< 30 ml/min/1.73 m²), as they may not safely undergo contrast-enhanced imaging. * pregnancy or breastfeeding: women who are pregnant or breastfeeding, as the use of contrast agents may pose risks to the fetus or infant. * already confirmed primary tumor: patients with a confirmed primary breast malignancy or another primary tumor site (e.g., gastrointestinal, lung) that has already been diagnosed. * other medical conditions: patients with serious medical conditions that may interfere with participation in the study or may affect the safety of the imaging procedures.

Keywords: contrast enhanced mammography breast mri breast cancer
nit-occlud pda post-approval study

Conditions: Patent Ductus Arteriosus (PDA)

Summary: the nit-occlud pda post-approval study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.


Eligibility criteria:
inclusion criteria: * angiographically confirmed pda with minimum diameter \< 4 mm. * weight is ≥ 5 kg. * age 6 months to 21 years. exclusion criteria: * cardiac anomalies requiring surgery. * known bleeding or coagulation disorder. * febrile illness within 7 days of planned procedure. * pregnancy. * pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 wood units). * hypersensitivity to contrast medium. * known nickel allergy.

Keywords: occluder
the effect of the ultrasound-guided serratus anterior plane block in combinaison with thoracic paravertebral cathéter versus thoracic paravertebral cather for perioperative analgesia in thoracic surgery

Conditions: Thoracic Surgery

Summary: introduction the paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. the objective of this study was to compare the efficacy of single-dose deep dentate block-level postoperative pain control in combination with a continuous perfusion paravertebral catheter versus continuous perfusion paravertebral catheter alone in controlled thoracic surgery. materials and methods we retrospectively included 159 asa i-iii major patients who underwent scheduled thoracic surgery in the operating theater of dijon university hospital, between march and november 2018. all patients benefited from the same anesthetic protocol routinely used in controlled thoracic surgery. they were included in two groups: deep serrate deep group (gs) with a deep serrated deep serrate block immediately after orotracheal intubation with 0.2% ropivacaine at 0.75 mg / kg and paravertebral catheter placed by the surgeon and put in charge at the fall of the surgical drapes versus control group (gc) benefiting from a paravertebral catheter alone. the primary endpoint was 24-hour morphine equivalent consumption. the criteria for secondary judgments were intraoperative remifentanil consumption, vas at 0h, 24h and 48h, morphine consumption at 0h, 48h and the profile of the various complications. the morphine equivalent was calculated according to an equivalence table with reference to oxycodone per os. quantitative data are presented in median and standard deviation and were compared by student's t-test or wilcoxon test.


Eligibility criteria:
inclusion criteria: * we included all patients over the age of 18 who met the classification criteria of the american society of anesthesiology (asa) and had thoracic surgery in the operating theater of dijon university hospital exclusion criteria: * exclusion criteria were asa 4 or higher, pregnant or breastfeeding women, minor patients, patients not able to use morphine pca, and patients with chronic algia.
a randomized, multiple dose, double blind, 5-way crossover study of the electrocardiographic (ecg) effects of bilastine

Conditions: Healthy

Summary: the purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg) compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and placebo. subjects will receive each of the five study treatments in a crossover fashion administered once daily for 4 days.

this is a single center, phase 1 study that utilizes a randomized, multiple-dose, double-blind, 5-way crossover design with a placebo control and two active controls. a minimum seven day washout period following four days of dosing for each of the five treatments.

Eligibility criteria:
inclusion criteria: * healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results exclusion criteria: * clinically significant medical condition * clinically significant history of ecg abnormalities or family history of qtc interval syndrome * use of tobacco and/or nicotine products \>3 months prior to screening * use of any prescription medications within 14 days prior to screening * use of over the counter medications (including herbal products) within 7 days prior to screening

Keywords: allergic rhinitis urticaria
pre-operative hypnosis to prevent side effects after surgery

Conditions: Breast Cancer Surgery

Summary: the aim of the pilot study is to translate and feasibility test a brief hypnosis intervention in 8-10 patients that are about to undergo thoracic surgery and in 4-5 patients about to undergo breast cancer surgery.

the hypnosis intervention will be based on a protocol from montgomery et al. they showed in a recent study that a brief 15-minute hypnosis intervention was effective in reducing a number of common side effects, including pain, fatigue and nausea. the scripted session includes a relaxation-based induction, suggestions for pleasant visual imagery, suggestions to experience relaxation and peace, and specific symptom-focused suggestions. the intervention will be professionally translated into norwegian, and adapted and modified as necessary to the specific context of this study. the pi, who is a an experienced clinical psychologist, will hold the session in the pilot study. patients will further be instructed to use hypnosis on their own following the intervention session. the patients will further be invited to participate in semi-structured interviews upon completion of the intervention, either by phone or in person, to discuss their experiences with the intervention, and share any advice for modifications or changes to the interventions or procedures. systematic text condensation will be applied in the analyses of the interviews.

Eligibility criteria:
inclusion criteria: * patients about to undergo either breast cancer surgery or thoracic surgery exclusion criteria: * insufficient norwegian speaking or writing skills to participate in the intervention * cognitive and psychiatric impairment * other serious malignancies
a 52-week study to assess the effects of mk0822 on knee osteoarthritis (mk-0822-011)

Conditions: Osteoarthritis

Summary: the purpose of this study is to test mk0822 on disease activity in patients with osteoarthritis in the knee. disease modifying activity of mk0822 will be assessed by measurements of knee cartilage using magnetic resonance imaging (mri) of the knee. this is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * patients with symptomatic knee osteoarthritis for at least 6 months based on clinical and radiographic criteria * patients should be in general good health and must have a certain level of knee pain or be taking pain medicines on most days * specific radiographic (x-ray) and mri features must also be satisfied exclusion criteria: * non-osteoarthritic causes of knee pain * ineligibility to undergo mri of the knee due to patient tolerability or safety reasons * previous septic arthritis, tibial osteotomy or knee replacement in both knees * acute injury of knee ligaments or meniscus in past 2 years * knee arthroscopy in past 12 months * anticipated arthroscopy or surgery in next 18 months * use of intra-articular injections of hyaluronan (e.g. hyalgan (tm), synvisc (tm), orthovisc (tm)) in past 6 months, or injections of glucocorticoids (e.g. kenalog (tm), aristospan (tm), depo-medrol (tm)) in past 3 months or anticipated knee injections during the study * glucosamine or chondroitin sulfate are allowable if they are at a stable dose for past 3 months and will continue at that dose during the study * other exclusion criteria apply-please ask the study doctor for details
efficacy of topical cyclosporine versus tears for improving visual outcomes following multifocal iol implantation

Conditions: Cataract; Dry Eye

Summary: the purpose of this study is to evaluate the efficacy on quality of vision and dry eye signs and symptoms in patients undergoing cataract surgery using the rezoom® multifocal iol.


Eligibility criteria:
inclusion criteria: * · males or females \> 50 years old * scheduled to undergo bilateral phacoemulsification with implantation of a multifocal iol. * likely to complete all study visits and able to provide informed consent * visual potential of 20/25 or better exclusion criteria: * · prior use of topical cyclosporine * known contraindications to any study medication or ingredients * active ocular diseases or uncontrolled systemic disease * active ocular allergies
holbæk obesity treatment (hot) versus conventional obesity treatment (cot) in children with overweight or obesity.

Conditions: Childhood Overweight and Obesity

Summary: the hot versus cot trial aims to compare the effectiveness of two different lifestyle interventions for treatment of childhood overweight and obesity with the purpose of informing future clinical practice guidelines within this field. the aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.

obesity is a chronic, progressive, and severe disease that compromises growth, development, and the general health and well-being of children, adolescents, and adults all around the globe. current treatment within this field varies considerably, but the prevailing concept is that treatment should be lifelong with a focus on implementing and maintaining changes regarding diet, physical activity, sedentary behavior, sleep, etc. the holbæk obesity treatment (hot) is built on the understanding that obesity is a complex chronic disease regulated by a neuroendocrine system, where weight-reducing actions initiate counteractive mechanisms to defend fat mass. conventional obesity treatment (cot) is based on a view that obesity results from energy imbalances and focuses on motivation, few changes at a time, and a narrative approach towards healthy energy intake and physical activity. these two approaches represent fundamentally different treatments of overweight and obesity.

Eligibility criteria:
inclusion criteria: * overweight or obesity defined as bmi corresponding to or above the 90th percentile for age and sex (international obesity task force cut-offs). * age six to \< 12 years at enrolment. * signed informed consent from both parents or legal guardians. exclusion criteria: * participation in multidisciplinary obesity treatment (i.e. treatment involving more than one type of healthcare profession) within the past 12 months. * having a sibling already enrolled in the hot versus cot trial. * both parents or legal guardians unable to communicate in danish (written or oral). * child unable to communicate in danish (oral). * current or previous clinical diagnosis of either anorexia or bulimia according to icd-10.
effectiveness of virtual reality- based rehabilitation program in individuals with adolescent idiopathic scoliosis after posterior fusion surgery

Conditions: Adolescent Idiopathic Scoliosis (AIS)

Summary: the aim of this clinical study is to investigate the effect of virtual reality based rehabilitation program on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life after posterior fusion surgery in individuals diagnosed with adolescent idiopathic scoliosis (ais). the main questions it aims to answer are: * does a virtual reality based rehabilitation program after posterior fusion surgery have an effect on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life in individuals diagnosed with ais? * is the virtual reality-based rehabilitation program after posterior fusion surgery more effective for individuals diagnosed with ais than the routine physiotherapy and rehabilitation program applied in the clinic? they will compare it with the \[routine physiotherapy and rehabilitation program\] to see if the virtual reality-based rehabilitation program is effective in individuals with ais after posterior fusion. participants : after being evaluated in terms of kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life, the virtual reality-based exercise group will be given an exercise program via the games in kinect sports ultimate for 30 minutes a day for a total of 6 weeks, 2 days . at the end of the 6 week, the participants will be re-evaluated and the results will be compared according to the control group.


Eligibility criteria:
inclusion criteria: * diagnosed with ais december 10-18 * underwent posterior spinal fusion surgery * post-operative (post-op) 6.during the week and after * absence of vision, speech and hearing problems * regular participation in the program to be implemented * volunteering of individuals exclusion criteria: * have a history of previous spinal surgery * have any contraindications to exercise * have a mental problem * have a neuromuscular, mesenchymal, rheumatic disease * have pulmonary and cardiac complications

Keywords: adolescent idiopathic scoliosis virtual reality based rehabilitation respiratory muscle strength posterior fusion surgery spinal mobility kinesiophobia spinopelvic parameter
a phase 2 study to evaluate biomarker change, efficacy, pharmacokinetics, safety and tolerability of telacebec (q203) in covid-19 patients

Conditions: COVID-19 Virus Infection

Summary: this is a phase 2, open-label, randomized controlled trial to determine the effects of telacebec (q203) on inhibition of leukotriene production, clinical change, pharmacokinetics, and safety in participants with moderate covid-19 disease


Eligibility criteria:
inclusion criteria: 1. provide written, informed consent prior to all study-related procedures. 2. provide written, informed consent to undergo human immunodeficiency virus (hiv) testing. 3. willingness and ability to attend scheduled visits and undergo study assessments. 4. able and willing to measure their oxygen saturation level and temperature, record their covid-19 symptoms and complete a patient diary. 5. male or female aged 18 years or older. 6. confirmed and documented sars-cov-2 infection, defined as rt-pcr laboratory confirmation. 7. clinical and/or radiological findings indicative of moderate covid-19 disease exclusion criteria: 1. severe or critical covid-19 disease at enrollment (day 1) (per nih treatment guideline categorization) as determined by the investigator. 2. inability to swallow oral medication. 3. concurrent known asthma, active tuberculosis or tuberculosis within the last 3 months, or any other condition that could compromise the well-being of the participant, or prevent, limit or confound protocol specified assessments, in the opinion of the investigator. 4. female participant who is pregnant, breast-feeding, or planning to conceive a child within the anticipated period of participating in the study or within 6 months after last dose of study medication. males planning to conceive a child during the study or within 6 months of cessation of treatment.
ketorolac in postoperative infants: pharmacokinetics and safety

Conditions: Postoperative Pain in Infants

Summary: infants handle ketorolac differently than adults. study of handling of this pain medication given to infants following surgery. detailed analysis of how the drug is eliminated from age 2 months to 18 months. compared morphine use in infants who received the drug to the group getting placebo. safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.

population kinetic analysis of ketorolac stereo-isomer concentrations after single dose given postoperatively in infants aged 2-18 months. safety assessments of renal and hepatic function tests by blood tests before and after drug administration, urinalysis pre- and post-drug, continuous oximetry before and for 12 hours after drug. morphine use between active drug groups and placebo group in the first 24 hours after surgery was assessed as a surrogate analgesic measure in these non-verbal infants. a modified infant pain scale was used to assure consistent pain management.

Eligibility criteria:
inclusion criteria: * non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, \< 6 months exclusion criteria: * bleeding history in infant or family * coagulopathy * gastrointestinal bleeding history * renal or hepatic disease assessed by history and by pre-drug blood tests * premature birth (\<36 weeks gestation)

Keywords: ketorolac pharmacokinetics ketorolac stereo-isomers infants postoperative analgesia safety