Kornimate/medical-research-clean huggingface dataset:
vehicle-controlled study of skq1 as treatment for dry-eye syndrome

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to evaluate whether skq1 ophthalmic solution is safe and effective compared to vehicle for the treatment of the signs and symptoms of dry eye syndrome.

multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. qualified subjects are randomized 1:1 to receive either skq1 ophthalmic solution, or placebo (vehicle of skq1 ophthalmic solution). the primary endpoints are: change from baseline (visit 2) to visit 5 of ocular discomfort; change from baseline (visit 2) to visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions)

Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a subject reported history of dry eye; * have a history of use of eye drops for dry eye symptoms; * ocular discomfort; * schirmer's test score; * have corneal fluorescein staining ; * have lissamine green conjunctival staining; * have a conjunctival redness; exclusion criteria: * have been previously exposed to previous skq1 ophthalmic solution treatment; * have any clinically significant slit lamp findings at visit 1; * be diagnosed with an ongoing ocular infection or active ocular inflammation at visit 1; * have had any ocular and/or lid surgeries within 6 months of visit 1 or any planned over the study period; * have an uncontrolled systemic disease; * be a woman who is pregnant, nursing or planning a pregnancy; * be a woman of childbearing potential who is not using an acceptable means of birth control; * have a known allergy and/or sensitivity to the study drug or its components; * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of visit 1;

Keywords: dry eye dry eye syndrome skq1 kcs keratoconjunctivitis
exploratory study of the interest of mri susceptibility weighted imaging for the pre-operative assessment of pelvic endometriosis extent

Conditions: Endometriosis

Summary: knowledge of the precise location of endometriosis is essential for a successful surgical treatment. mri susceptibility-weighted imaging (swi-mri) yields high sensitivity for blood by-products detection. since endometriosis lesions are haemorrhagic, and therefore rich in blood by-products such as hemosiderin, swi-mri could be useful in the pre-operative assessment of endometriosis, especially in superficial peritoneal lesion detection. the purpose of our study is to evaluate the performance of swi-mri for the preoperative work-up of endometriosis

pelvic endometriosis is a cause of pelvic pain, dysmenorrhea, urinary symptoms and infertility. mri is considered as the best imaging technique to detect and to predict the extent of the disease. susceptibility weighted imaging is routinely performed to identify haemorrhagic lesions in brain mri protocols and has proven to be a sensitive technique to detect blood by-products. a pelvic mri protocol including swi will be performed in all women addressed for diagnostic assessment or pre-operative work-up of endometriosis.

Eligibility criteria:
inclusion criteria: * adult woman (over 18yrs old) addressed for diagnostic assessment or pre-operative work-up of endometriosis; * informed signed consent * affiliated or beneficiary of a social security system exclusion criteria: * patient \<18yrs old * pregnant or nursing woman * patient under legal protection * contraindication to mri

Keywords: endometriosis magnetic resonance imaging (mri) susceptibility-weighted imaging (swi)
yield of colonoscopy in children with rectal bleeding

Conditions: Colonic Diseases

Summary: description study of colonscopy in children with bleeding per rectum attending gastrointestinal endoscopic unit in assiut university children hospital from 2014-2019

rectal bleeding is a source of anxiety for both children and parents and is frequently encountered clinical complaint in routine practice in pediatric patient . lower gastrointestinal bleeding means bleeding from sites distal to the ligament of treitz and presents as rectal bleeding while passage of bright red blood from the rectum is called hematochezia. the etiology of rectal bleeding is different in children than in adult according to age group which enables physicians to make appropriate differential diagnosis. there are several etiologies for rectal bleeding in pediatric practice ranging from mild condition requiring little or no treatment to severe and life-threating ones requiring immediate intervention. the etiologies include anal fissure, food allergy, infectious enterocolitis, meckel'sdiverticulum, intussusceptions, volvulus, lymphonodular hyperplasia, inflammatory bowel disease, angiodysplasia, hemorrhoids, and hemolytic -uremic syndrome. common causes of bleeding per rectum in children vary between studies . once the bleeding is suspected to be coming from lower gastrointestinal tract it warrant an evaluation in all cases by proctosigmoidoscopy followed by colonoscopy . colonoscopy is the examination of choice for diagnosis and management of bleeding per rectum in children . the benefits of colonoscopy include identification of the site of bleeding regardless of the rate or presence of bleeding through visualization the entire length of the colon often include the distal ileum by possibility of endoscpic intervention and biopsy taking to make and confirm the diagnosis and follow up evaluation, so gastrointestinal endoscopy with biopsy is an essential tool for diagnosis of crohns disease and ulcerative colitis in children, as well as therapeutical intervention of colonoscopy by hemostasis, removing polyps, dilating stricture or decompressing the obstructed bowel . colonoscopy is considered a safe and low risk procedure. complications of colonoscopy are rare and usually minor, as adverse effects of sedative medicine as (nausea,vomiting or allergies) can ocurr. bleeding after colonoscopy is usually minimal but may follow mucous biopsy or polypectomy, perforation is very rare but it is the most serious complication of colonoscopy in children, it is usually related to polypectomy and can be successfully managed with surgical intervention. in case of infection in which cause the child will be given antibiotics.

Eligibility criteria:
inclusion criteria: * all children with rectal bleeding underwent colonoscopy exclusion criteria: * children underwent colonoscopy rather than rectal bleeding
xience v® everolimus eluting coronary stent system usa post-approval study (xience v® usa-phase 1)

Conditions: Coronary Artery Disease

Summary: xience v usa is a prospective, multi-center, multi-cohort post-approval study. the objectives of this study are * to evaluate xience v eecss continued safety and effectiveness during commercial use in real world settings, and * to support the food and drug administration (fda) dual antiplatelet therapy (dapt) initiative. this initiative is designed to evaluate the composite of all death, myocardial infarction (mi) and stroke (macce) and the survival of patients that are free from academic research consortium (arc) definite or probable stent thrombosis (st) and that have been treated with drug eluting stents (des) and extended dual antiplatelet therapy.

study phase i is from index procedure to 1 year. this prospective, open-label, multi-center, observational, single-arm study is designed to evaluate xience v eecss safety and effectiveness in real world settings up to 1 year after implantation. the primary endpoint is the stent thrombosis (definite and probable) rate up to 1 year as arc. the co-primary endpoint is the composite rate of cardiac death and any mi at 1 year. up to 8,000 patients are planned to be consecutively enrolled at up to 275 sites in the u.s. clinical follow-up will occur at 14, 30, 180 days and 1 year. all patients enrolled in the xience v usa who have completed study phase i will be evaluated at 1 year to determine whether they are eligible to participate in one of the following cohorts in study phase ii: xience v usa long term follow-up (ltf) cohort, harvard clinical research institute (hcri) dapt cohort, or abbott vascular (av) dapt cohort.

Eligibility criteria:
inclusion criteria: * the patient agrees to participate in this study by signing the institutional review board approved informed consent form. exclusion criteria: * the inability to obtain an informed consent. age limit is determined by investigator. there are no angiographic inclusion or exclusion criteria for this study.

Keywords: angioplasty coronary restenosis coronary artery disease coronary artery restenosis coronary artery stenosis total artery occlusion stents stent thrombosis total coronary occlusion vascular disease myocardial ischemia
lllt effects on inferior alveolar nerve (ian) recovery post-orthognathic surgery

Conditions: Mandible; Deformity; Surgical Healing; Orthognathic Surgery; Nerve Injury

Summary: low-level laser therapy (lllt) is a well-studied technique that has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. this study will use two groups with patients randomly assigned to either the study group, receiving lllt, or one receiving a placebo treatment, after they have lower jaw surgery. measurements will be taken at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams to check pain, swelling and nerve function, and the two groups will be compared to see if the lllt group has any difference

low-level laser therapy (lllt) is a well-studied technique to induce biomodulation of pain and wound healing. the technique has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. previous studies have used split-mouth designs, short follow-up periods or, often, both. this study aims to have two groups, one receiving lllt and one receiving a dummy treatment, at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams. at each visit, pain (via vas), swelling (measured from the midpoint of the chin to the base of the ear, bilaterally), and nerve function (using a soft and hard sensory test, in 8 regions of the mandible and lower lip) will be performed, with additional measurements at 8 weeks and 20 weeks. the measurements will be analyzed for statistical differences between the lllt intervention group and non-intervention group.

Eligibility criteria:
inclusion criteria: * patients undergoing mandibular surgery with bilateral sagittal split osteotomies exclusion criteria: * patients must be free from pre-operative inferior alveolar neurosensory deficiencies * intra-operative accidental fracture or rupture of the inferior alveolar nerve

Keywords: orthognathic lllt
reliability study of a motor function measure digitalized playful completion modules

Conditions: Neuromuscular Diseases

Summary: neuromuscular diseases include more than 200 rare disorders affecting muscles or the nervous system. functional scales assessing motor function are tools allowing to measure the evolution of motor impairment of patients with a neuromuscular disease. they are frequently used as main outcome measures in clinical trials which are currently in full development thanks to advances in genetic and drug researches. among the available scales, the motor function measure (mfm), a scale consisting of 32 items, had shown good metrological properties in terms of validity, reliability and sensitivity to change, regardless of the diagnosis and extent of motor impairment. by exploring the potential of digital technologies applied to mfm, investigators created a completion module composed of animations with different playful and informative scenarios displayed on a digital tablet. the main purpose of this project is to conduct a multicentre study to assess reliabilities of the mfm completed using the mfm-play. expected benefits of this project are to improve the experience and the participation of the children to who is often imposed multiple assessments during the numerous follow-up visits of clinical trials, while maintaining good metrological properties of the mfm.


Eligibility criteria:
inclusion criteria: * patients with a neuromuscular disease confirmed by the clinic, electroneuromyography (enmg), biology, muscular biopsy, or genetic * aged ≥ 2 yo and ≤ 60 yo * having been informed and not objecting to participating in the study (information and non-opposition of parents/holders of parental authority for minor patients) exclusion criteria: * participating in other interventional research with an exclusion period that is still ongoing or that may interfere with the results of this study * having had surgery or illness impacting their motor function within the last 6 months * having understanding and/or behavioral deficiencies preventing rigorous assessment * patient placed under legal protection (this includes guardianship, curatorship and safeguard of justice)

Keywords: motor function assessment reliability study patient participation
airway closure during extracorporeal membrane oxygenation: the aiclose study

Conditions: Acute Hypoxemic Respiratory Failure

Summary: about 65,000 canadians develop acute respiratory failure requiring breathing machines (ventilators) to give oxygen to their lungs. unfortunately, up to 50% of these individuals will not survive their illness. mechanical ventilation through breathing machines, though potentially lifesaving, may further injure the lungs and the respiratory muscles. in the patients with the most severe and life threatening forms of respiratory failure a breathing machine alone may not be able to provide enough oxygen to the lungs and vital organs. in these critical situations, patients may require an artificial lung machine, which is referred to as extracorporeal membrane oxygenation (ecmo) to temporarily replace the function of the patient's own lung and supply critical oxygen to the body, while protecting the damaged lungs. how to use the breathing machine safely while a patient is on ecmo is still unknown. using conventional breathing machine settings while on ecmo can lead to large portions of the lungs or airway to remain collapsed, which can contribute to further lung damage. the investigators have recently discovered a way of detecting if patients on a breathing machine suffer from collapsed airways. knowing if the most severe patients on ecmo have airway collapse is a pivotal question that the investigators plan to answer in our study. the investigators will use our technique to determine how many patients on ecmo have airway closure and determine if this contributes to a longer time on ecmo and a longer time on a breathing machine, and if this impacts a patient's survival in the intensive care unit.


Eligibility criteria:
inclusion criteria: * acute hypoxemic respiratory failure * vv-ecmo * less than 24 hours from ecmo cannulation exclusion criteria: * air leak * vv-ecmo as bridge to lung transplantation * status asthmaticus
ciprofol vs propofol for reducing hypoxia incidence in ercp

Conditions: Anesthesia; Adverse Effect; Biliary Tract Diseases

Summary: intravenous anesthesia has been widely used in endoscopic retrograde cholangiopancreatography (ercp). in the past decade, many practices have been carried out under the propofol-based monitored anesthesia care without endotracheal intubation in patients undergoing ercp. ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of propofol. ciprofol seems a promising anesthetic agent for intravenous anesthesia but the evidence supported its application in ercp is still limited.

this is a prospective, randomized, double-blind trial comparing the incidence of hypoxia in the propofol versus ciprofol intravenous anesthesia. a total 136 patients will be recruited and randomly assigned to either the propofol or the ciprofol group. the primary outcome is the proportion of patients experiencing hypoxia. the secondary outcomes include: the incidence of hypotension in perioperative period; the incidence of conversion from intravenous anesthesia to general anesthesia; sedation-related procedure interruption; carbon dioxide( co2) accumulation during operation; patients' satisfaction with anesthesia and postoperative recovery / vas score / incidence of nausea and vomiting; the incidence of intraoperative and postoperative adverse events, such as adverse excretion, severe hypoxemia, severe circulatory dysfunction; length of stay and mortality within 30 days after operation.

Eligibility criteria:
inclusion criteria: * patients undergoing ercp, asa i-iii * normal renal function * bmi ≥ 18kg/m 2 and ≤ 30kg/m 2 exclusion criteria: * previous serious cerebrovascular accidents and other neurological diseases * mental diseases, long-term use of drugs that affect the function of the central nervous system, benzodiazepines or opioids * history of anesthetic allergy * preoperative hypotension or preoperative spo2 \< 90%, or chronic respiratory failure * patients suspected of having difficult airways * screening for drug addiction and alcohol abuse within the first 3 months (\> = 6standarddrinks/day) * patients diagnosed with severe cardiopulmonary disease, or respiratory or respiratory diseases such as sleep apnea syndrome; * bradycardia or atrioventricular block. * participate in other clinical trials within 4 weeks; * cognitive or communication abnormalities determined by the researchers; * emergent and critical conditions during the operation; * other conditions that the researchers believe are not suitable to participate in the study.

Keywords: ciprofol propofol intravenous anesthesia elective endoscopic retrograde cholangiopancreatography hypoxia
ketogenic diet for refractory status epilepticus

Conditions: Status Epilepticus; Seizure; Epilepsy; Refractory Status Epilepticus; Medically Resistant Status Epilepticus

Summary: this research is being done to observe the safety, tolerability, side effects, and effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus) being treated in a neurointensive care unit.


Eligibility criteria:
inclusion criteria: * patients 18 years and older in refractory status epilepticus (continuous or recurrent seizures without return to baseline mental status between seizures, lasting \> 30 minutes) placed on anesthetics/sedating agents (barbiturates or benzodiazepines) after at least one first- and second-line agent failed to control seizures, and with clinical and/or electrographic seizures following attempt to wean anesthetic/sedating agents after 24 hours. exclusion criteria: 1. unstable metabolic condition 2. hemodynamic or cardiorespiratory instability 3. coagulopathy 4. liver failure 5. total cholesterol \> 300 mg/dl 6. inability to tolerate enteral feeds, including ileus 7. pregnancy 8. family refusal/no consent 9. received any propofol infusions within 24 hours 10. known fatty acid oxidation disorder or pyruvate carboxylase deficiency

Keywords: status epilepticus seizure epilepsy ketogenic diet modified atkins diet
bioavailability study of ondansetron 24 mg orally disintegrating tablets under fasting conditions

Conditions: Healthy

Summary: single-dose cross over comparative bioavailability of ondansetron 24 mg odt and zofran 24 mg odt

to compare the single-dose bioavailability of kali's ondansetron 24 mg odt with that of glaxosmithkine's zofran 24 mg odt under fasting conditions

Eligibility criteria:
inclusion criteria: * availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form(icf) duly signed by the volunteer * males and females aged between 18 and 55 years with a body mass index (bmi) greater or equal to 19 and below 30 kg/ m2 * clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance(laboratory tests are presented in section 6.1.1.3) * healthy according to the laboratory results and physical examination. * non- or ex- smokers exclusion criteria: * significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs. * presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects. * presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease. * females who are pregnant, lactating or are likely to become pregnant during the study phases. * females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body. * positive pregnancy test before and during the study. * maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (\>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease. * any clinically significant illness in the previous 28 days before day 1 of this study. * use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.). * participation in another clinical trial in the previous 28 days before day 1 of this study. * donation of 500 ml of blood (canadian blood services, hema-quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study. * positive urine screening of drugs of abuse (drug names are presented in section 7.1.4). * positive results to hiv, hbsag or anti-hcv tests.

Keywords: bioequivalence ondansetron odt fasting to determine bioequivalence under fasting conditions