Kornimate/medical-research-clean huggingface dataset:
augmentation study of levetiracetam in obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to evaluate the effectiveness of levetiracetam augmentation relative to placebo in ssri non-remitters with obsessive compulsive disorder. the hypothesis is that anxiolytic effect of levetiracetam is more beneficial when adding with a ssri.

this is an investigator-initiated, single-site study, consisting of two phases: 8 weeks of open-label treatment with sertraline (50mg-150mg/day) in patients iwth ocd.at week 8, those who have failed to achieve remission will be continued on sertraline and will be randomized to receive levetiracetam (500mg-2000mg/day) or placebo for 8 weeks.

Eligibility criteria:
inclusion criteria: * ages 18-65 * primary diagnosis of ocd based on dsm-iv criteria and assessed by the mini international neuropsychiatric interview * yale-brown obsessive-compulsive scale (ybocs) score of at least 16 or greater on screening * ability to provide written consent form exclusion criteria: * any primary dsm-iv axis i disorder other than ocd * substance abuse during the last 6 months * a clinically unstable medical condition or clinically significant laboratory abnormalities * suicidal risk or serious suicidal attept during the last year * concurrent use of psychotropic medication including benzodiazepines, barbituates, antiepileptic drugs, antidepressants, buspirone, dietary supplements or herbal or homeopathic remedies with psychotropic effects * recent (within the last 3 months) initiation of cognitive behavioral therapy * failure of previous trial of levetiracetam at 2000 mg/day * pregnancy or lactation * women of childbearing potential who are unwilling to practice an acceptable method of contraception

Keywords: ocd anxiety pharmacotherapy sertraline levetiracetam
serum metal ion concentration after total knee arthroplasty (tka)

Conditions: Osteoarthritis; Metal Ion Levels

Summary: all metal implants release metal ions because of corrosion. total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. it is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.


Eligibility criteria:
inclusion criteria: * indication for tka in primary oder secondary osteoarthritis of the knee * patient's consent exclusion criteria: * additional implants present * allergy against constituents of implant or cement * any malignancies * renal insufficiency * any additional serious disease complicating the participation in this study

Keywords: metal ion concentration total knee arthroplasty metal hypersensitivity
an endoscopic barbed-clips suturing for colorectal esd

Conditions: Colorectal Neoplasms

Summary: endoscopic submucosal dissection (esd) was developed to allow en bloc resection of colorectal neoplasm. although colorectal esd has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-esd bleeding is one of the major adverse events. after esd procedure, endoscopists close the defects with devices to prevent complications. a novel endoscopic barbed-clips suturing has been developed to simplify endoscopic closure. in this study, the endoscopic barbed-clips will be evaluated when closing defects in the colon after esd.

endoscopic submucosal dissection (esd) has emerged as a new endoscopic technique that allows en-bloc resection of gi lesions, irrespective of size. the most common complications of the esd techniques are bleeding and perforation. several reports have shown that if prophylactic closure of a mucosal defect with clips would reduce the risk of bleeding following endoscopic intervention by esd. with the advancements in endoscopic therapy, various techniques for prevention of post-esd complications have been reported. however, there have some limitations including their inability to close large defects and the complexity of the approaches and the need for expensive equipment to complete the procedure. to address these issues, we have devised a novel endoscopic barbed-clips suturing method for mucosal defect closure after endoscopic submucosal dissection of colon. in this study, we assessed the technical feasibility of this novel technique.

Eligibility criteria:
inclusion criteria: * aged≥20 years with a single clinically or histologically diagnosed colorectal lesions of 20-50mm eligible for which fulfilled criteria for esd; exclusion criteria: * patients with coagulopathy (platelet count \ 2, * medical conditions requiring the continuous use of antithrombotic agents * prior abdominal surgery or radiation.
biomarkers for the diagnosis of transient ischemic attack

Conditions: Cerebrovascular Disorders; Ischemic Attack, Transient

Summary: a transient ischemic attack (tia) should be considered an emergency prevention opportunity in order to avoid recurrence as cerebral infarction (ci) serious (fatal or disabling). indeed, about 20% of patients who have ic had in previous days or weeks, a tia, which can be defined as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain damage and thus no sequelae. moreover, about 20% of ischemic events observed in practice are ait. despite the progress achieved in the treatment in the acute phase of an ic, prevention remains the most effective way to fight against this disease. this prevention can be put in place before the occurrence of a first ic, or after a first ic, especially when minor as a tia. however, the diagnosis of tia remains particularly difficult and it is necessary now to identify new tools for the diagnosis of transient ischemic attack. our study focused on the identification of one or more molecules (called biological markers or biomarkers) present in the bloodstream of patients, which will serve to facilitate the differential diagnosis of patients with tia.


Eligibility criteria:
inclusion criteria: * tia lasting 18h * nihss \< 0 * mri diffusion hypersignal less than 5 ml * follow up during 3 month * written informed consent prior to any study procedures exclusion criteria: * pregnant or breastfeeding women * major comorbidity (cancer, chronic infection) * recent trauma (less than 30 days) (cranial or extracranial) * surgical or endovascular recent surgery(within 30 days). * any old brain injury * any acute pathology likely to induce inflammation, hemostasis disorders ... * contraindications to mri: patients with a pacemaker, an implanted material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants, claustrophobic ... * patient under guardianship

Keywords: biological markers
low-cost sensor system for covid-19 patient monitoring: validation of braebon vital signs monitor (vts)

Conditions: COVID-19

Summary: the braebon vts is a low-cost, portable device that is being developed to take continuous and real-time vital sign measurements of covid-19 patients, both in the hospital and home setting. this study is being undertaken to test the braebon vts and validate against industry standards.

in response to the covid-19 pandemic, the braebon vital signs monitor (vts) has been developed with funding from the national research council of canada industrial research assistance program through the federal government's innovative solutions canada (isc) program. the vts will measure peripheral capillary oxygen saturation (spo2) and pulse via photoplethysmography (ppg), temperature, blood pressure (bp), heart and respiration rates, electrocardiogram (ecg), head position and movement over a continuous period. this monitor can be used remotely, and importantly will be low-cost so it can be accessed widely. data from the vts is transmitted wirelessly to a portable basestation which is a smartphone or tablet device via a customized application. this study will test the vts both within the clinical environment and in the remote home environment to see how well it monitors patients effected by covid-19 needing care, as well as satisfying an unmet need for remote monitoring across the healthcare system. this study will compare the newly developed vts with an industry gold standard of polysomnography (psg) in the sleep laboratory, or in the home with the medibyte jr (home sleep apnea test). approximately 150 patients will be recruited to the study across two different settings which includes a hospital setting and a remote setting, within the home environment.

Eligibility criteria:
inclusion criteria: * patients requiring a sleep evaluation using polysomnography * people referred to the sleep clinic * persons over the age of 18 exclusion criteria: * unable and/or unwilling to consent * no access to home wifi (applicable to participants local to kingston undertaking the study in the home setting)
a study of the effect of different doses of difluprednate eye drops on the intraocular pressure after phacoemulsification

Conditions: Uveitis, Anterior

Summary: the study aims at detecting the minimum effective daily dose and duration of difluprednate that can be used to treat postoperative inflammation after phacoemulsification without increasing the intraocular pressure, and whether it can be safely given within the first 24 hours after the operation.

conventional phacoemulsification will be performed by the same surgeon for all the cases using the stop and chop technique. anterior chamber examination for flare and cells using slit-lamp biomicroscopy according to the sun recommendations and intraocular pressure measurement using goldmann applanation tonometer will be done for all the cases before surgery and on the 1st, 3rd, 7th, 14th days as well as one month after the procedure. all cases will receive nepafenac 0.1% ( nevanac 0.1%) 3 times per day on the last preoperative day, one tablet of acetazolamide 250 mg (cidamex 250mg) within the first 3 hours after the procedure and moxifloxacin (vigamox 0.5%) 0.1 ml intracameral and post-operative drops 3 times per day for 10 days and will be divided into: in this pilot study: * group a : will receive difluprednate 4 times per day for 1 week, then twice per day for 1 week and then once per day for 5 days starting 24 hours after the operation * group b : will receive difluprednate 3 times per day for 4 days, then twice per day for 4 days and then once per day for 4 days starting 4 hours after the operation

Eligibility criteria:
inclusion criteria: * age 40-80 * grade 1 to 4 nuclear cataract locs ii * cumulative dissipated energy cde 1 to 10 * done by a single surgeon using the chopping technique exclusion criteria: * history of uveitis * the use of topical or systemic steroids on the last post-operative day * intraoperative or postoperative complications * intraoperative iris manipulations or phaco traume
study of the soliton rapid acoustic pulse (rap) device for the treatment of cellulite

Conditions: Cellulite

Summary: to evaluate the safety, and efficacy of soliton's rapid acoustic pulse (rap) device for the temporary improvement in the appearance of cellulite.

multi-site clinical study to evaluate the safety, efficacy and tolerability of soliton's rapid acoustic pulse (rap) device fo the temporary improvement in the appearance of cellulite.

Eligibility criteria:
inclusion criteria: * female ages 18-50 years * seeking treatment of cellulite in the thigh and/or buttock areas * area of severe cellulite on the thigh and/or buttock with an average simplified cellulite severity scale at baseline ≥ 4.0 (table 2) * having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater. * stable weight nominally +/- 5% for at least the past 6 months. * body mass index (b.m.i.) is ≤ 30 * participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, rf, laser, eswt, etc.) for the prior 12 months. * participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial. * will not undergo any other cellulite treatments for a period of 12 months following rap treatment. * participant is willing to participate in study and adhere to follow-up schedule * participant is able to read and comprehend english * participant has completed the informed consent form exclusion criteria: * participant is unwilling to have research photos taken of treatment areas in the presence of sponsor's researchers. * participant is unwilling to have rap treatment provided in the presence of sponsor's researchers. * participant is pregnant or planning to become pregnant during the duration of the study. * has atrophic scars, or has a history of atrophic scars or keloids. * tattoo or former tattoo at or near treatment area. * metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.). * active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc. * medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.). * history of coagulopathy(ies) and/or on anticoagulant medication. * skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. * current smoker. * any surgical procedure in the prior 3 months, or planned during the duration of the study.
application of cheek acupuncture in vaginal tightening surgery

Conditions: Pain Vulva

Summary: a large number of studies have shown that acupuncture can reduce perioperative pain in patients. cheek acupuncture therapy is a new acupuncture treatment, which belongs to the microneedle system, that is, acupuncture at specific acupoint on the face, which can relieve patients' pain. in this study, the efficacy and safety of cheek acupuncture in patients undergoing vaginal tightening surgery was verified by observing the consumption of opioid, intraoperative hemodynamics, dosage of oral remedial analgesics, postoperative quality of recovery, patient satisfaction, incidence of side effects, etc.


Eligibility criteria:
inclusion criteria: * patients aged 18-60 years, undergoing vaginal tightening surgery * american society of anesthesiologists (asa) physical status i to ii * voluntary participation and signed an informed consent form exclusion criteria: * acute and/or chronic pain before surgery * history of congenital heart disease, arrhythmia, or hypertension * history of severe mental or neurological diseases, drug or psychotropic drug abuse * cognitive dysfunction or inability to communicate. * the acupuncture acupoints are infected * coagulation disorders * patients with mandibular or zygomatic bone osteotomy

Keywords: acupuncture analgesia vaginal tighting surgery
use of dermabond in mitigation of spinal cord stimulation (scs) trial lead migration

Conditions: Chronic Pain

Summary: during the typical scs trial the leads remain outside of the skin and can be prone to migration. the leads are typically secured in place with suture, tape, or a combination of both. this study will evaluate the amount of movement based on the method of being secured at the time of placement

spinal cord stimulator trials require precise placement of leads to get appropriate distribution of pain.1 since the leads are not anchored into the tissue, migration of the leads can occur and result in suboptimal trial. migration (or movement in the epidural space after placement) of the leads can result in up to 2.49 mm to 3.24 mm migration in the leads depending on trial length . during the trial the leads remain outside of the skin and can be prone to migration. the leads are typically secured in place with suture, tape, or a combination of both. this study will evaluate the amount of movement based on the method of being secured at the time of placement

Eligibility criteria:
inclusion criteria: * age greater than 18 * having a spinal cord stimulator trial lead placement done * lead placement to be done in the thoracic spine area exclusion criteria: * dermabond allergy * inability to place 2 leads in subject * lead placement not in thoracic spine

Keywords: spinal cord stimulation (scs) chronic pain stimulator
use of ultrasonography for measuring achilles tendon thickness: a novel measurement method

Conditions: Achilles Tendon; Emergency Medicine; Ultrasonography

Summary: background: achilles tendon thickness has been associated with various diseases. among imaging modalities, ultrasonography stands out because of its advantages in assessing achilles tendon thickness. previous studies typically recommend performing achilles tendon ultrasonography with the patient in a prone position on an examination table. however, because it is not always possible or safe for each patient to assume the prone position, this study aimed to investigate the relationship between measurements obtained in the supine position and those obtained using the standard method. methods: a total of 180 healthy volunteers aged ≥18 years (70 female and 110 male; 360 achilles tendons), with no history of disease or medication use, were included in the study. achilles tendon measurements (thickness, width, and cross-sectional area) were obtained via ultrasonography in four different positions, including the standard method. the alternative methods included the supine position with the leg extended (method 2), the supine position with the ankle resting on the opposite knee (method 3), and the supine position with the leg held in the air at 90 degrees of hip and knee flexion (method 4). measurements were taken 2 cm distal from the achilles tendon insertion on the calcaneus.


Eligibility criteria:
inclusion criteria: * healthy volunteers aged \>18 years who agreed to participate in the study exclusion criteria: * individuals with tenosynovitis, tendinitis, bursitis, tuberculous arthritis, rheumatoid arthritis, a history of achilles tendon surgery, or tendon injuries.

Keywords: achilles tendon emergency medicine ultrasonography
develop and validate a self-administered instrument that will screen for eating disorder symptoms in persons aged 12 and older with type 1 diabetes.

Conditions: Type 1 Diabetes; Eating Disorder

Summary: the purpose of this study is to develop and validate a survey instrument to be used by persons with type 1 diabetes aged 12 and older to screen for an eating disorder.

phase 1 - develop an initial instrument and start to establish content validity. what do dually diagnosed patients believe are the most important, relevant, and significantly contributing constructs that we should measure in order to capture those individuals with type 1 diabetes who may exhibit symptoms of an eating disorder? what individual items will best measure these constructs? phase 2 - conduct individual interviews for cognitive testing of our instrument and further examine its content validity. how well do the individual items included in our instrument capture eating disorder symptoms in patients with type 1 diabetes? do these items accurately capture the information we seek to collect? what symptoms have we not considered? how readable and understandable are our questions? phase 3 - explore the internal consistency reliability and construct validity of our instrument. do the items in our instrument accurately capture the constructs we wish to measure? do similar items "hang together" in a manner that is clinically and theoretically meaningful? phase 4 - address convergent and discriminant validity as well as test-retest reliability. does our instrument demonstrate appropriate convergent and divergent validity as well as test-retest reliability? does our instrument capture eating disorder symptoms among persons with diabetes? is our instrument more specific to the population of individuals with diabetes than traditional eating disorder instruments (i.e., does our instrument capture more information and give a more accurate presentation than the other instruments)?

Eligibility criteria:
inclusion criteria: * eating disorder * type 1 diabetes exclusion criteria: * none
dose-finding study with lu aa24530 in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the primary purpose of this study is to assess the efficacy in treating patients with major depressive disorder of one or more doses of lu aa24530 relative to placebo

according to the world health organisation, major depressive disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. there are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. the overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. in the study, patients with depression are treated for 6 weeks. assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.

Eligibility criteria:
inclusion criteria: * major depressive episode that has lasted at least 3 months * moderate to severe depression exclusion criteria: * any current psychiatric disorder established as the principal diagnosis other than mdd as defined in the dsm-iv-tr and as assessed with the mini-international neuropsychiatric interview (mini) * current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the dsm-iv-tr * major depressive episode that has been unresponsive to two adequate courses of antidepressant treatment, each of at least 6 weeks duration * electroconvulsive therapy within 6 months prior to baseline * ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study * clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance * the patient is pregnant or breast-feeding

Keywords: drug therapy depressive disorder antidepressive agents depressive symptoms affective disorders randomized controlled trial placebo-controlled double-blind active reference multicenter study
influence of techniques of chest physiotherapy in the pediatric intensive care

Conditions: Atelectasis

Summary: the purpose of this study is to compare the effect of the autogenic drainage and the intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child with the ventilatory support.


Eligibility criteria:
inclusion criteria: * child \< 10 kg * hospitalization in the pediatric intensive care * presence of an atelectasis to the radiography and/or to the lung ultrasound * presence of an invasive ventilation or a non-invasive ventilation * criteria of cardio-respiratory stability met exclusion criteria: * absence of the physiotherapist and the radiologist referents (by ex: at night) * prematurity * neuromuscular disease * ventilation by high-frequency oscillation * extraphysical assistance * patient cardiac post-surgery with closure postponed from the thorax. in the closure of the thorax, the patient becomes eligible * intracranial pressure \> 20 mmhg or clinical signs of intracranial high blood pressure