Kornimate/medical-research-clean huggingface dataset:
the effects of cold adaptation on skin blood flow, hand function, and comfort in healthy adults

Conditions: Cold Exposure

Summary: in cold weather environments, blood flow to the extremities is significantly reduced, which severely impairs hand function and induces thermal discomfort. prolonged or repeated cold exposure elicits an adaptive habituation response that is characterized by blunted skin vasoconstriction and thus may be an effective strategy to improve peripheral perfusion, reduce thermal discomfort, and maintain hand function during cold weather military operations. since mission conditions often involve low ambient temperatures, countermeasures that reduce cold-induced decrements in hand function and thermal comfort are important to enhance warfighter readiness in cold weather battlefield environments. the goals of this study are to 1) evaluate the effectiveness of cold habituation in improving skin blood flow, hand function, and thermal comfort during cold exposure and 2) identify the mechanisms that contribute to improvements in skin blood flow following habituation.

participants (n=15, 18-39 yrs) will complete a preliminary cold air exposure (baseline testing) followed by 8 days of repeated cold air exposures with minimal clothing. the cold exposures will be 2 hours in duration and will be conducted in 8°c (46°f) conditions. before and after the repeated cold exposures, participants will undergo hand function tests, assessments of thermal comfort, and skin blood flow testing.

Eligibility criteria:
inclusion criteria: * male or female, age 18-39 * in good health as determined by omso (office of medical support and oversight) * willing to refrain from exercise and caffeinated or alcoholic beverages for 12 hours before each testing session * willing to refrain from smoking or tobacco use 8 hours before each testing session exclusion criteria: * history of cold injuries of any severity (e.g., frostbite, trench foot, chilblains). * raynaud's syndrome. * cold-induced asthma/bronchospasm * previous hand/finger injuries that impair dexterity and hand function. * metal hardware (plates/screws) in the forearms and hands. * current use of medications or dietary supplements that could alter cardiovascular, thermoregulatory, or vascular control (e.g., anti-hypertensives, statins). * known allergies to medical adhesives. * heart, lung, kidney, muscle, or nerve disorder(s) * a planned mri during the study or within 2 days after completing a cold test. * women who are pregnant, planning to become pregnant, or breastfeeding. * not willing to have small areas of skin on the body shaved (if deemed necessary for attachment of study instrumentation)
multiple oral dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of pf-04878691

Conditions: Hepatitis C Virus

Summary: to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of pf-04878691.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18-55, inclusive. * body mass index (bmi) of 18-30 kg/m2; total body weight \>50kg (110lbs). exclusion criteria: * pregnant or nursing females. * females of child-bearing potential. * evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening. * smoking within the previous 6 months.

Keywords: hcv toll-like receptor 7 multiple oral dose escalation study of pf-04878691
chlorhexidine-impregnated sponge dressing: a clinical trial

Conditions: Catheter-Related Infections

Summary: the purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients.


Eligibility criteria:
inclusion criteria: critically ill patients hospitalized carrying a short-term central venous catheter exclusion criteria: * use of a central venous catheter with antimicrobial coating * suspected or confirmed bacterial infection at randomization * known allergic/hypersensitivity reaction to any compounds of the treatment * active lesions in the skin where the cvc is located and / or where the dressing of cvc is being conducted;

Keywords: bandages central venous catheters catheter-related infections
using dupilumab to improve circadian function, sleep and pruritus in children with moderate/severe atopic dermatitis

Conditions: Atopic Dermatitis; Sleep Disturbance

Summary: single center, prospective, open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old

subjects will complete two overnight sleep studies, before and after using dupilumab for 12 weeks, to assess the effect of dupilumab on sleep disturbance in eczema patients. these overnight visits will include psg, blood draws, skin sensors, urine collection, tape stripping, and photography. subjects will be given dupilumab to use for 12 weeks at home before returning for the second sleep study.

Eligibility criteria:
inclusion criteria: * participants, 6-17 years old at time of enrollment. * moderate to severe chronic ad inadequately controlled by topical treatment, diagnosed according to hanifin and rajka criteria by a pediatric dermatologist or allergist. * ad severity will be determined at baseline with validated investigator global assessment (viga) score of moderate (3) or severe (4). * patient assessed or parent-proxy (under 8 years old) promis sleep disturbance t-score ≥60. * willing and able to comply with visits and study-related procedures. * on stable regimens (consistent use 14 days before day 1 of study enrollment) of inhaled corticosteroids, topical steroids, and antihistamines. exclusion criteria: * poorly controlled asthma (asthma control test ≤19). * self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis. * use of concomitant medication that causes scratching. * major medical condition (such as cancer). * active condition that could affect sleep, such as obstructive sleep apnea, restless leg syndrome, insomnia, narcolepsy, severe sleep disordered breathing, severe depression, covid-19, or hives (urticaria). * having applied topical steroids within 7 days of first or second psg (important for biomarkers assessment). * use of systemic immunosuppressant within 30 days of first psg. * having showered or used moisturizers within 12 hours of first or second psg. * unable to communicate in english (some promis questionnaires not available in translation). * other contraindication to receiving dupilumab (such as history of allergic reaction to dupilumab or any of its components). * pregnancy. * clinical blindness (circadian disturbing).
visual performance with a trifocal intraocular lens

Conditions: Cataract

Summary: the purpose of this study is to evaluate the visual performance of a trifocal intraocular lens at distance, near and intermediate viewing, by way of visual acuity measurement, contrast sensitivity. patient satisfaction and quality of vision will also be assessed by way of a questionnaire.

monocular and binocular unaided (ucva) and best corrected visual acuity (bcva) will be measured at 6m in logmar units under photopic conditions (85cd/m2). subjective refraction will be performed to establish any residual refractive error will for distance, intermediate and near. defocus profiles (visual acuity over imposed defocus) are measured for each patient. the patient observes the 6m logmar chart through best distance correction, then defocusing is achieved by the addition of pairs of lenses from +2.00d to -4.00d in 0.50d steps.. the logmar acuity will be recorded and the data plotted. contrast sensitivity will be evaluated monocularly under photopic (85cd/m2) conditions and mesopic (4cd/m2) using the pelli-robson contrast sensitivity chart. near and intermediate performance will be evaluated using the radner reading charts to assess acuity (lograd units) and reading speed in photopic conditions 85cd/m2

Eligibility criteria:
inclusion criteria: * age 40-70yrs * bilateral implantation of a trifocal intraocular lens exclusion criteria: * existing ocular pathology * surgical complications * corneal astigmatism \> 1.50dc
intravenous versus peribulbar dexmedetomidine for strabismus surgery in adults

Conditions: Squint

Summary: using various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block

strabismus (misalignment of the eye) results from a difference in extraocular muscle function. consequently, two different images, one from each eye, are transmitted to the brain, resulting in a loss of visual depth. in adults, cosmetic appearance is the main issue but sudden occurrence of strabismus may cause diplopia because the brain cannot suppress the overlapping images. the goal of strabismus surgery is to align the eyes, reduce diplopia, and restore binocular vision ophthalmic regional block can be used as the primary anesthetic technique for strabismus surgery. the advantages of ophthalmic regional blockade include a reduced incidence of oculocardiac reflex (ocr) and emergence agitation, postoperative analgesia, and decreased postoperative nausea and vomiting (ponv). using various adjuvants has become a trend in regional anesthesia practice to improve the quality of anesthesia and prolong postoperative analgesia. dexmedetomidine, an alpha-2 agonist has been proposed as a safe and effective adjunct capable of extending the duration of the single-shot block. perineural dexmedetomidine, when added to bupivacaine, has been shown to potentiate its effects, providing a better quality of anesthesia and postoperative analgesia. intravenous (i.v.) dexmedetomidine, when used during regional anesthesia, has been shown to prolong sensory and motor blockade in addition to sedation and postoperative analgesia. no previous studies where different routes of dexmedetomidine have been compared in adult strabismus surgery.

Eligibility criteria:
inclusion criteria: 1. the patient planned to perform a unilateral strabismus surgery 2. age: 20-60 years 3. american society of anesthesiologists class i and ii exclusion criteria: 1. patients under the age of 20 2. uncooperative patients 3. patients with coagulopathy 4. patients who disincline to participate in the study will be excluded from the study
gait parameters of persons with down syndrome with and without orthotics using gaitrite

Conditions: Down Syndrome

Summary: this is a research study of persons with down syndrome between 2 and 80 years old who are independently walking. the purpose of this study is to see what effect orthotics have on how people with down syndrome walk.


Eligibility criteria:
inclusion criteria: * down syndrome, independent walkers exclusion criteria: * down syndrome, not independently walking

Keywords: down syndrome orthotics gait analysis
phthalates exposure in type 2 diabetic patients and diuretic therapy

Conditions: Renal Function Disorder; Glucose Metabolism Disorders

Summary: in this open clinical trial, 30 subjects with inadequately controlled t2d and eligible, as per good clinical practice, for therapy with sglt-2 inhibitor, will be randomized to receive a sglt-2 inhibitor vs other oral-antidiabetic drugs (oads) therapy for 3 months. measures will be performed at baseline, after 2 days, after one month and at the end of the study protocol, as per good clinical practice

* total concentrations of mehp, meohp and mehhp will be quantified, in the laboratories of the institute of clinical physiology, national research council, pisa, in a spot morning urine sample by ultra-hplc coupled with electrospray ionization/quadrupole time-of-flight mass spectrometry (agilent uhplc 1290 infinity coupled to an agilent 6540 ms-qtof, santa clara, ca) using stable isotope labeled substrates, i.e. mehp (ring-1,2-13c2, dicarboxyl-13c2), mehhp, mehhp 13c4, meohp and meohp 13c4 that will be purchased from cambridge isotope laboratories (tewksbury, ma). * urinary creatinine concentrations will be measured to adjust urinary concentrations of dehp metabolite (beckman coulter au400, brea, ca), thus minimizing the inﬂuence of urine volume. * serum and urinary inflammatory markers and adipocytokines will be quantitatively determined using sandwich enzyme-linked immunosorbent assays kits according to the manufacturer's instructions. optical density will be measured using a microplate reader. * serum and urinary markers of oxidative stress will be measured by gold standard techniques. in detail, mda will be quantified by tbars reactive substances measured by optical density; gsh-px by a specific assay kit according to the manufacturer's instruction; sod activity will be determined using a specific sod kit; urinary 8-isoprostane concentration will be measured by a specific affinity sorbent. (cayman chemical, ann harbor, mi, usa) according to the manufacturer's instructions. * to analyze mitochondrial dna we will apply a triplex design previously reported to amplify mitochondria loci located within the minorarc and majorarc, respectively. to assess nuclear dna, we will use rnase p copy number reference. * the phthalates-free diet will be self-administered by the individuals under intervention, following a set of instruction and rules provided by the physicians based on the current literature data.

Eligibility criteria:
inclusion criteria: * individuals of both sex; * age between 18 and 85 years; * t2d * t2d duration \> 6 months * bmi ≤ 40 kg/m2, * hba1c \> 48 mmol/mol * eligible for sglt-2i therapy exclusion criteria * age \>85 years, * egfr \<60 ml/min/1.73 m2, * occurring acute complications
zagal study: evaluating effectiveness and tolerability of zonisamide as adjunctive therapy in patients with partial onset seizures treated with two antiepileptic drugs

Conditions: Epilepsy

Summary: the purpose of this study is to acquire additional information about the appropriate level of dosing of zonisamide when it is prescribed for patients with partial onset epileptic crisis who are already being treated with two other antiepileptic drugs.

patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic crisis defined according to the international league against epilepsy (ilae) criteria, with a minimum of two seizures within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks, and capable and willing to give their informed consent, will be included in the study. to these patients, physicians will prescribe zonisamide in the following manner: titration period of 12 weeks, at the end of which all patients must be taking 300 mg. maintenance doses period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg. six weeks later within this period, a decision will be made to raise the 400 mg doses up to 500 mg if considered necessary and tolerable. drugs will be prescribed by the physician and purchased by the patient.

Eligibility criteria:
inclusion criteria: patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic seizures defined according to the international league against epilepsy (ilae) criteria, with a minimum of two crises within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks and capable and willing to give their informed consent, will be included. exclusion criteria: those who do not fulfill the inclusion requirements.

Keywords: zonisamide partial onset seizures effectiveness tolerability
purastat® vs standard therapy for haemostasis during endoscopic submucosal dissection

Conditions: Gastrointestinal Haemorrhage

Summary: endoscopic submucosal dissection (esd) is an endoscopic resection technique used to treat superficial neoplasia in the gastrointestinal tract. bleeding is a commonly encountered problem during submucosal dissection and is usually managed with electrocautery. however, this does carry a risk of deep thermal injury and perforation. purastat® is a novel extracellular scaffold matrix of amino acids that forms a transparent adherent barrier when applied to a bleeding point. the aim of this trial is to study the use of purastat® in reducing the need for thermal haemostasis during esd.

endoscopic submucosal dissection (esd) is an endoscopic technique that involves the use of an endoscopic knife to gently peel off a superficial neoplasia of any size in an en-bloc fashion. it meets the principles of onco-surgery and is associated with excellent outcomes. a difficulty however with the technique is control of bleeding during the procedure. the gi mucosa is a vascular territory and the current method of managing intraprocedural bleeding is electrocautery using either the endoscopic knife itself or the coag grasper. this introduces a thermal injury to the bowel wall and carries the risk of causing a perforation or causing pain. furthermore, it requires precise targeting of the bleeding vessel. practically this can be challenging, particularly if the coag grasper is needed which is a bulky device and can be difficult to apply precisely in some locations. purastat® (3-d matrix ltd, tokyo) is a liquid which is applied to a bleeding area which acts rapidly to form a gel coat which induces haemostasis. this transparent adherent barrier permits further endoscopic therapy to be performed. it can be applied in the general area of bleeding and does not require precise application to the exact point of bleeding. it is applied through a small catheter placed through the biopsy channel of the endoscope which can be used in very small spaces. purastat® is licensed as a ce marked device for use in exudative haemorrhage from vessels in solid organs and within the gi tract. given this indication, the role of purastat in esd needs to be explored as it could reduce the need for thermal haemostasis. this would be of significant clinical benefit during esd.

Eligibility criteria:
inclusion criteria: * male or female, aged 18 years or above. * an esd is attempted for clinical indications approved by mdt. * oesophageal or colonic lesion 2-5cm in size * participant is willing and able to give informed consent for participation in the study exclusion criteria: * known coagulopathy likely to affect risk of bleeding * submucosal tumour * anticoagulation or anti-platelet therapy (apart from single modality aspirin or clopidogrel) which cannot be stopped for clinical reasons * patient preference

Keywords: endoscopy, gastrointestinal endoscopic submucosal dissection bleeding
the impact of a moderate carbohydrate diet in children with type 1 diabetes on hybrid closed-loop therapy

Conditions: Diabetes Mellitus, Type 1

Summary: in the past, carbohydrate restriction was indicated as a treatment for people with type 1 diabetes when exogenous insulin was not available. now it is mainly used as an added treatment for people with type 1 diabetes on top of standard insulin administration and glucose monitoring. despite previous studies, the impact of carbohydrate restriction on glycemic control and quality of life is still not clear. furthermore, few studies exist on carbohydrate restriction in children with type 1 diabetes and combined with the use of hybrid closed-loop insulin delivery. therefore this study will determine the impact on glycemic control and the feasability of a moderate carbohydrate diet compared to a traditional diet in children (7-17 years) with type 1 diabetes on top of using a hybrid closed-loop system. in this randomized, crossover study, 28 children will follow a moderate carbohydrate diet (four weeks) and a traditional diet (four weeks) in randomized order. with a run-in period (two weeks) prior to the first diet and a wash-out period (six weeks) between the two diets, the children will participate in the study for a total of 16 weeks. the primary endpoint is the difference of time spent in target range (defined as a sensor glucose value between 70 and 180 mg/dl) between the four-week moderate carbohydrate diet and the four-week traditional diet.


Eligibility criteria:
inclusion criteria: * signed informed consent (icf) (both children/adolescents and parents) * ≥7 and ≤17 years old at moment of icf signature * ≥6 months type 1 diabetes diagnosis at moment of icf signature * ≥3 months use of the hybrid closed-loop system medtronic minimedtm 780g, tandem t:slim x2 control-iqtm or mylife ypsopump with camaps algorithm at moment of icf signature * ability to understand, read, write and speak dutch, french or english at moment of icf signature exclusion criteria: * \ 17 years old at moment of icf signature * \<6 months type 1 diabetes diagnosis at moment of icf signature * \<3 months use of the advanced hybrid closed-loop system medtronic minimedtm 780g, tandem t:slim x2 control-iqtm or mylife ypsopump with camaps algorithm at moment of icf signature * any other insulin therapy than advanced hybrid closed-loop system medtronic minimedtm 780g , tandem t:slim x2 control-iqtm or mylife ypsopump with camaps algorithm at moment of icf signature * failure to understand, read, write or speak dutch, french or english at moment of icf signature
dash-sodium trial in adolescents

Conditions: Blood High Pressure

Summary: the camp dash study trial will compare the effect of two dietary patterns and two levels of sodium intake on blood pressure and blood lipids in adolescents in the upper third of distribution for blood pressure. the two dietary patterns are based on the dietary approaches to stop hypertension (dash) trial in adults.

the camp dash study is a controlled trial. the aim of which is to compare the effect of two dietary patterns and two levels of sodium intake on blood pressure and blood lipids in adolescents in the upper third of distribution for blood pressure. the study also assesses whether influences on blood pressure and blood lipids of dietary interventions vary according to sex, race/ethnic groups, baseline levels, and other personal characteristics. the proposed dietary interventions of dash dietary patterns and sodium reduction have been shown to be effective in lowering blood pressure in adults. the two dietary patterns are based on the dietary approaches to stop hypertension (dash) trial in adults. they are a usual diet typical of what many american adolescents eat, and a dash-type diet. the dash diet is rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat compared to the usual diet. the two sodium levels are high reflecting current us consumption and low reflecting current recommended intake levels. weight will be held constant by adjusting energy intake. the study participants will live in a residence hall on the purdue campus where all food and beverages will be provided, and meals and snacks will be supervised.

Eligibility criteria:
inclusion criteria: * white, black, hispanic, and asian * sbp in the upper one-third of the distribution for their given sex, age, and height exclusion criteria: * pre-existing lipid disorders, abnormal liver or kidney function * taking medications that alter mineral absorption or metabolism, affect blood pressure or lipids * if subjects are taking dietary supplements and refuse to discontinue them 2 months prior to the study. * taking non-prescription illegal drugs, smoke, or drink alcohol * pregnancy * carry an epi pen for food-related allergies

Keywords: dietary patterns blood pressure adolescents dietary sodium