Kornimate/medical-research-clean huggingface dataset:
thrombin in cardiac surgery

Conditions: Thrombin; Hemostatic Disorder; Surgical Blood Loss; Coagulation Disorder; Cardiovascular Surgical Procedures

Summary: coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. the investigators will measure thrombin generation using our novel device and compare it to standard methods, while examining the association of thrombin parameters with bleeding and other clinical outcomes.

this is a prospective observational cohort study of 200 cardiac surgical patients. thrombin generation via our novel point of care thrombin generation assay as well as calibrated automated thrombography (cat) will be measured at three time points: (1) before surgery; (2) post-cpb after heparin reversal with protamine; (3) at the time of chest closure or 60 minutes after heparin reversal with protamine. clinicians will remain blinded to the measures. recruitment will continue until the investigators enroll 50 patients with significant impaired thrombin generation capacity (\>50% drop from baseline) and 50 patients who receive hemostatic therapies. patients will be followed for 7 days postoperatively to assess individual products transfused.

Eligibility criteria:
inclusion criteria: -all adult patients (\> 18 years of age) undergoing cardiac surgery at toronto general hospital will be offered participation. exclusion criteria: -patients who are unable to consent to the study or who refuse participation will be excluded.
evaluation of efficacy and long-term safety for lucidis instant focus© - pmcf study protocol

Conditions: Cataract

Summary: the objectives of the study is to evaluate efficacy and long-term safety of the lucidis lens. through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a lucidis iol will be described.

refractory function in patients with a cataract is mainly restored by implanting intra-ocular lenses (iol) destined to replace the crystalline lens. while new surgical techniques for removing the crystalline lens have been developed, these lenses have been considerably perfected to resemble the natural crystalline lens as closely as possible. the objectives of the study is to evaluate efficacy and long-term safety of the lucidis lens. through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a lucidis iol will be described.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) * having agreed to take part in the study and complete post-operative follow-up requirements (by having signed the information leaflet-informed consent form); * with; * for whom the physician made the decision to implant a lucidis exclusion criteria: * patient included in an interventional therapeutic trial at the time of inclusion; * patient presenting contraindications for the implantation of an intraocular lens; * patient presenting an ophthalmic disorder liable to interfere with the study endpoints; * patient presenting with an astigmatism ≥1.0 d; * patient refusing or unable to comply with the follow-up procedures in the study (patient unable to be reached by telephone, liable to be lost to follow-up, etc.); * history of previous intraocular surgery in the study eye in the previous 6 months; * patient is pregnant, breast-feeding or unable to make the decision to participate in a clinical investigation (e.g. mentally ill or handicapped person)
tulip et masc : premiers usages

Conditions: Thoracic Outlet Syndrome

Summary: the aim of this work is to propose two new questionnaires (tulip and masc) which are simple to complete by the patient, quick to analyze and can be calculated directly by the physician, adapted to the general population, whether during an initial evaluation or for follow-up. the tulip questionnaire aims to characterize the symptoms suggestive of thoracic outlet syndrome (tos). the masc questionnaire aims to assess the functional maintenance of tos in a simpler way (fewer questions) than the disability of the arm, shoulder and hand (dash) questionnaire and in a lateralized way.

two questionnaires the tulip and the masc are submitted (self completion) to patients suspected of tos.

Eligibility criteria:
inclusion criteria: * suspicion of thoracic outlet syndrome exclusion criteria: non applicable

Keywords: suspicion of arterial tos and/or veinous tos dash questionnaire tulip and masc questionnaires
excimer light in psoriasis

Conditions: Psoriasis

Summary: the aim of this study is to determine the standard tissue levels of sp and its receptor in lesional skin of psoriasis patients in both developing and stationary stages before and after excimer light therapy.


Eligibility criteria:
inclusion criteria: * type of psoriasis: plaque psoriasis. * less than 10% surface area. exclusion criteria: * erythrodermic psoriasis * pustular psoriasis * topical treatment for psoriasis for the past 2 weeks. * systemic retinoids in the last 2 years. * systemic treatments (including any drugs that affect sp level as aprepitant) in the last 3 months. * contraindications to excimer light therapy (history of skin malignancy or precancerous conditions like xeroderma pigmentosum or photosensitivity)
vapocoolant (pain ease) use for venipuncture

Conditions: Pain

Summary: to determine the efficacy and safety of vapocoolant spray (pain ease medium stream) in decreasing the pain of venipuncture ("blood draw")

this is a prospective, randomized, blinded, comparator study. this study design is considered standard for establishing safety and efficacy data. active treatment vapocoolant spray (pain ease medium stream) spray) will be used. there will be a placebo (sterile water) in this study. the population selected for this study, adults (excluding the very old, \> 80 years old) represents a patient population that may benefit from vapocoolant spray. this is a patient population that according to the treating health care provider already requires venipuncture for "blood draw" but not intravenous cannulation. because venipuncture is a painful procedure, vapocoolant may confer benefit for the relief of pain.

Eligibility criteria:
inclusion criteria: * patient needing venipuncture ("blood draw') but not intravenous cannulation * adult 18 years and older up to and and including 80 years old * stable patient * mentally competent patient able to understand the consent form exclusion criteria: * patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane or 1,1,1,2, tetrafluoroethane ) * critically ill or unstable (e.g. sepsis or shock) * extremes of age: geriatric (\> 80 years) or pediatric ( \< 18 years old) * pregnant * venipuncture site located in area of compromised blood supply. examples include : patients with peripheral vascular disease, gangrene, raynaud's disease, buerger's disease. * venipuncture site located in area of insensitive skin; patients with a peripheral neuropathy including diabetic neuropathy. * patient intolerant of cold or with hypersensitivity to the cold. * patient unable or unwilling to give consent. * prior experience with vapocoolant spray * currently in another research trial

Keywords: vapocoolant
hyaluronic acid and uterine synechiae

Conditions: Uterine Synechiae After Scraping for Natural Miscarriage

Summary: the primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery. post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.

women patients coming for natural miscarriage will be compared according to whether a non-stick gel will be applicated or not after scraping surgery. 6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical hysteroscopy. proofreading of this exam will be made by 2 experts at the end of the study without knowing the randomization arm. long-term follow-up of the patients will be performed to evaluate the effect of the non-stick gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery using questionnaire asked by post, mail or phone.

Eligibility criteria:
inclusion criteria: * women patients aged between 18 and 46 years old * term ≥ 7 weeks amenorrhea and ≤ 14 weeks amenorrhea * blighted ovum or not completed miscarriage or haemorrhagic miscarriage or retention miscarriage * consent signature * social security coverage * women who wants to be pregnant exclusion criteria: * infected miscarriage * uncertain diagnosis between miscarriage and extra-uterine pregnancy * hydatiform mole * uterine synechiae history * surgical zone infection * hyalobarrier® gel endo hypersensitivity * clotting disorder * unstable diabetes * maternal malignant diseases * psychiatric disorder * incapacity in understanding the consent form and the questionnaires * law protected adult person

Keywords: uterine synechiae scraping surgery natural miscarriage
modulation of cortical brain activity during attentional control

Conditions: Rumination; Chronic Pain; Fibromyalgia

Summary: the goal of this study is to determine whether an open-loop sham neurofeedback system can effectively modulate eeg alpha rhythms, which are associated with attentional control. the main questions it aims to answer are: does positive sham neurofeedback lead to a decrease in relative eeg alpha power compared to a control condition without feedback? researchers will compare the effects of positive and negative sham-neurofeedback conditions to a control condition without feedback to assess the system's impact on alpha rhythm modulation. participants will: experience three conditions (positive sham-neurofeedback, negative sham-neurofeedback, and no feedback) within a virtual reality environment. undergo eeg recordings to measure changes in alpha power as a marker of attentional resource allocation. provide written informed consent and complete the study following ethical guidelines. this study seeks to explore the potential of open-loop feedback systems to enhance attentional control by modulating alpha rhythm.

attention is a vital cognitive process that enables selective focus on behaviourally relevant information. a perceived lack of attentional control has been linked to mental disorders such as depression and anxiety, often manifesting through maladaptive coping strategies like rumination. as a trainable cognitive skill, attentional control can be enhanced through learning processes, particularly when reinforced by positive feedback within a classical operant conditioning framework. eeg studies have demonstrated that decreases in alpha rhythm power are associated with increased attentional resource allocation. while neurofeedback systems, especially those targeting alpha rhythms, typically rely on closed-loop modulation during attentional tasks, the impact of open-loop feedback on eeg alpha modulation remains unexplored. this study aims to determine whether an open-loop feedback system can effectively modulate eeg alpha rhythms, as a marker correlate of attentional control. the investigators propose a within-subject experiment where participants will experience positive and negative sham neurofeedback conditions, as well as a control condition with no feedback, all within a virtual reality environment. the investigators hypothesize that relative eeg alpha power will decrease in the positive sham neurofeedback condition compared to the control condition, reflecting a meaningful increase in attentional resource allocation.

Eligibility criteria:
inclusion criteria: * adults aged between 18 and 60 years. * normal or corrected vision. * ability to provide written informed consent. exclusion criteria: * diagnosed with photosensitive epilepsy. * significant hearing loss or diagnosed hearing impairment. * current psychiatric illness or disorder. * history of migraines or chronic headaches. * history of substance or alcohol abuse. * currently pregnant. * discomfort with using a virtual reality headset, assessed during a pilot session.

Keywords: operant conditioning rumination metacognition neurofeedback selective attention
evaluation of biocleanse allografts for acl reconstruction

Conditions: Anterior Cruciate Ligament Tear

Summary: the purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the biocleanse™ process.

the purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the biocleanse™ process. you are being asked to volunteer in a research study. the purpose of this study is to compare the different ways of cleaning allograft tendons used to replace the main ligament in the knee. the anterior cruciate ligament (acl) is the main ligament in the knee that your doctor will replace in your surgery. the allograft tendons come from other people who have donated a tendon from the front of the knee after they died. the three ways of cleaning the tendons that will be used in this study are biocleanse, irradiation, and aseptic. aseptic uses clean conditions when preparing the tissue for surgery, sometimes with a chemical bath. biocleanse is a way of cleaning the tendon physically and chemically, while irradiation uses gamma rays. the goal is to clean the tendons to make them safer for the patients without weakening the tendon when put in the knee.

Eligibility criteria:
inclusion criteria: * acl reconstruction exclusion criteria: * none
alogliptin tablets special drug use surveillance type 2 diabetes mellitus: combination therapy with biguanides

Conditions: Surveillance

Summary: to examine the safety and efficacy of long-term combination therapy with alogliptin (nesina) and biguanides in participants with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy.

this is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and biguanides in participants with type 2 diabetes mellitus in the routine clinical setting. participants diagnosed with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy will be enrolled. the planned sample size is 1,000. the usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Eligibility criteria:
inclusion criteria: * participants who did not adequately respond to the following treatment • treatment with biguanides in addition to diet therapy and exercise therapy exclusion criteria: * participants contraindicated for nesina 1. participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus \[these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of nesina is not appropriate\]. 2. participants with severe infection, pre- or post-operative patients, or patients with serious traumatic injury \[blood glucose control by insulin injection is desirable for these participants, and hence use of nesina is not appropriate\]. 3. participants with a history of hypersensitivity to any ingredient of nesina.
inhaled molgramostim in pediatric participants with autoimmune pulmonary alveolar proteinosis (apap).

Conditions: Autoimmune Pulmonary Alveolar Proteinosis

Summary: the goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (apap) in pediatric patients between age 6 and 18. the main questions it aims to answer are: the effect of molgramostim on breathing tests and activity in pediatric patients with apap and the safety of molgramostim in pediatric patients with apap. this is an open-label study: all participants will receive treatment with molgramostim. patients will: * take molgramostim once daily via nebulizer every day for 12 months. * visit the clinic approximately every 12 weeks for checkups and tests. * keep a diary of any oxygen use.

this is an interventional open-label, single arm, multi-center study in pediatric subjects, age 6 through 18 years, who are diagnosed with autoimmune pulmonary alveolar proteinosis (apap). the diagnosis of apap should be confirmed by an anti-gm-csf antibody test and a history compatible with pap based on patient symptoms, high resolution computed tomography of the lung, lung biopsy or bronchoalveolar lavage cytology. the study consists of a 4-week screening period followed by a 48-week open-label treatment period. after completing the 48-week treatment or early withdrawal, subjects will enter a 4-week safety follow up period. the maximum treatment duration is 48-weeks, and the maximum study period will be 56 weeks. during the trial, lung lavage will be allowed as a rescue treatment in case of worsening of apap.

Eligibility criteria:
inclusion criteria: * be ≥6 and \<18 years of age, at the time of signing the informed consent and informed assent (if applicable). * have a history of pulmonary alveolar proteinosis, based on examination of a lung biopsy, bronchoalveolar lavage cytology, or a high-resolution computed tomogram of the chest. * have a positive serum anti-gm-csf autoantibody test result confirming apap. * have a hemoglobin (hb)-adjusted diffusing capacity of the lung for carbon monoxide (dlco) ≤70% predicted at screening. exclusion criteria: * have a diagnosis of hereditary (congenital) or secondary pap, or a metabolic disorder of surfactant production. * have undergone treatment with lung lavage (wll) within 1 month of baseline

Keywords: alveolar proteinosis autoimmune lung lavage gm-csf children
onsite vs. virtual group fitness in overweight/obese women

Conditions: Overweight and Obesity

Summary: the purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (hiit) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study of overweight and obese women.


Eligibility criteria:
inclusion criteria: * premenopausal adult females over the age of 18 and under the age of 45 with a bmi greater than or equal to 25 and a waist circumference greater than or equal to 35 inches. * no medical contraindications to participation in an exercise program including major medical illnesses (i.e. cardiovascular disease, stroke, cancer, etc.) * ability to provide informed consent * willingness and ability to participate in an interval training in-person group fitness exercise program 3x/week for 12 weeks exclusion criteria: * adults unable to consent or mini-mental score less than 18. * individuals who are not yet adults (infants, children, teenagers) * pregnant women * post-menopausal women * do not speak english * prisoners * subjects on medicines (serum glucose, insulin, weight loss medicines, beta-blockers) and having any medical pre-conditions that would interfere with one's capacity to exercise. * answer "yes" to any of the questions on the pre-activity screening questionnaire (pasq)

Keywords: exercise program
sleep and cognition after ambulatory hip and knee arthroplasty

Conditions: Sleep Disturbance; Delirium; Arthroplasty Complications

Summary: sleep and rest are key elements in postoperative rehabilitation and recovery. there are complex relations between major surgery, sleep disturbance and complications. major surgery leeds to severe postoperative sleep disturbances, initially reducing rem sleep time and disturbing the remaining sleep stages. major surgery is again a risk factor for postoperative delirium and other cognitive impairment. the underlying mechanisms includes pain, opioid medication, sleep disturbances and neuroinflammation, along with external factors as noise during hospitalisation. the physiologic stress from sleep disturbances and sleep deprivation is associated with blood-brain barrier impairment, inflammation, decreased restitution, altered nociceptive function. likewise, undiagnosed and untreated sleep apnea is a risk for postoperative complications and is itself affected by anesthesia and some analgesics (i.a. opioids). fast-track surgery development has led to restitution period shortening, optimized pain management reducing opioid use, postoperative inflammatory stress response reduction and less delirium. evolution of hip and knee arthroplasty(tha/tka), organisation, optimized pain management and pharmacologic modification of inflammatory response by high dose steroid has permitted to perform these surgeries in an outpatient setting. previous studies of fast-track tha/tka using multimodal opioid-sparring analgesia, however neither using high dose steroids nor in an out patient setting, have demonstrated rem sleep period reduction from a normal range of 18% preoperatively to 1% postoperatively. however, changes in sleep architecture after tha/tka in at setting attempting to minimise abnormal sleep by means of ambulatory surgery added to perioperative reduction of inflammatory response to surgery, pain and opioid use by high dose steroid, haven't been studied. the purpose of this study is to investigate how much an optimized ambulatory tha/tka , reducing pain and inflammatory response to surgery and opioid use by high doses steroid can conserve the preoperative sleep architecture.


Eligibility criteria:
inclusion criteria: * asa classification i or ii * scheduled hospital discharge same day after surgery * adult person following the patient 24 hours at the patients habitation * informed consent and signature. * patient speaks and understands danish exclusion criteria: * hospital discharge later than same day after surgery * no consent form patient * alcohol or drug abuse * anxiolytic og antipsychotic treatment * preoperative opioid treatment * soporific treatment