Kornimate/medical-research-clean huggingface dataset:
the effect of iv nsaid's and corticosteroids on dysphasia and dysphonia following asdf

Conditions: Dysphagia; Dysphonia

Summary: this study is to assess the efficacy of intra-operative intravenous non-steroidal anti-inflammatory drug (ketorolac) versus intravenous (dexamethasone) administration on dysphagia and dysphonia after anterior cervical discectomy and fusion (acdf).

the purpose of this study is to assess the efficacy of two intra-operative, intravenous medications on dysphagia and dysphonia following anterior cervical discectomy and fusion (acdf). the medications include ketorolac, an anti-inflammatory versus dexamethasone, a corticosteroid. eligibility criteria includes adults aged 19 years of age or older who are scheduled to undergo a acdf for radiculopathy or myelopathy. participants will be recruited for a prospective, randomized, single-blinded clinical drug study and randomized into three cohorts: (1) control (no steroid or non-steroidal anti-inflammatory (nsaid), (2) iv nsaid(1-time dose of 30mg of iv ketorolac at time of closure), and (3) iv steroid (1-time dose of 10mg of iv dexamethasone at the time of closure. the primary outcome measures are patient questionnaires which include the eat-10 and bazaz classification for dysphagia and vhi-10 for dysphonia. in addition, the neck disability index (ndi) and visual analogue pain scale (vas) will also be collected. research follow-up will be subject completed questionnaires to be collected pre-operatively and then post operation at day 1, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year. post operative questionnaires may be collected at time of patient follow-up in clinic, by phone or mail.

Eligibility criteria:
inclusion criteria: * 19 years of age and older * undergoing anterior cervical discectomy and fusion (acdf) for radiculopathy or myelopathy * no known allergies or sensitivities to steroid or non-steroidal medications exclusion criteria: * procedure is being done for revision, trauma, infection or tumor * patients with known diagnosed metabolic diseases (diabetes, pancreatitis, gout, electrolyte imbalances, hypertension, hematological abnormalities including gastrointestinal bleeding...) * patients with known kidney disease or a creatinine level above the upper limit of normal \>1.27
efficacy and tolerability of suprep with and without simethicone for routine colonoscopy for colorectal cancer screening

Conditions: Colorectal Cancer

Summary: the purpose of this study is to investigate suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.

the study will investigate sodium sulfate/potassium sulfate/magnesium sulfate (suprep), with and without simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy. adult ambulatory outpatients who are scheduled for elective routine colonoscopy for colorectal cancer screening will be recruited to participate in the trial. patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (suprep) and will receive verbal and written instruction on administration of solutions. during colonoscopy, three areas of the colon (right colon, transverse colon, and left colon) will be assessed during removal of the colonoscope for overall colon cleansing, presence of bubbles, and degree of haziness; this will be scored by a blinded endoscopist. a separate written patient questionnaire will be used to assess acceptability and tolerability of the preparation, as well as any adverse events.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * outpatients who require elective colonoscopy for colorectal cancer screening at iowa endoscopy center and at university of florida - jacksonville exclusion criteria: * allergy or hypersensitivity to any constituent of the lavage solution or to simethicone * presence of any contraindication to colonoscopy (i.e. uncontrolled congestive heart failure, new york heart association classification iii-iv, history of myocardial infarction within 6 months, coagulopathy) * massive ascites * renal insufficiency * pregnancy * history of colonic surgery * history of anti-flatulence or laxative agent within one week * refusal/inability to give consent * patients undergoing colonoscopy for reasons other than colorectal cancer screening * mentally disabled * non-english-speaking patients

Keywords: suprep simethicone colorectal cancer screening routine colonoscopy sodium sulfate/potassium sulfate/magnesium sulfate bowel cleansing mass screening
retinal changes in vitamin d deficiency

Conditions: Pediatric Disorder; Vitamin D Deficiency; Retinal Disease; Choroidal Disease; Optic Nerve Diseases

Summary: retinal tissue parameters of pediatric patients with vitamin d deficiency will be evaluated in this prospective case-control study. the patients will be divided into 2 groups according to the vitamin d level. retinal vessel diameters, retinal nerve fiber evaluation, choroidal thickness will be evaluated. choroidal thinning decrease in retinal artery diameter and increase in retinal vein diameter will be detected in the vitamin d deficiency group.

the study of the relationship between vitamin d status and retinal diseases is a new concept, and there is a large gap in research focusing on the pediatric population in the literature. the importance of vitamin d in retinal maturation and its role in the development of retinal diseases at a young age is being investigated. in this sense, as far as known, it is the first study investigating retinal structure parameters in pediatric patients with vitamin d deficiency.

Eligibility criteria:
inclusion criteria:(group 1): 1. age \<18 years old 2. serum vitamin d \[(25(oh) d), calcitriol\] level \<20 ngr/ml in previous two weeks 3. visual acuity \>20/20 4. manifest refraction spherical equivalent \<3d 5. normal biomicroscopic and fundus examination. exclusion criteria: 1. history of any chronic ocular diseases, except for refractive error (e.g., uveitis, glaucoma, retinopathy of prematurity) 2. history of ocular surgery (e.g., cataract, strabismus, open globe injury, laser photocoagulation) 3. having an ocular abnormality (e.g., persistent fetal vasculature, optic disc hypoplasia, fovea plana) 4. history of systemic diseases that have the potential to affect ocular tissues (e.g., diabetes mellitus, graves' disease, albinism, down syndrome, fabry diseases, wilson syndrome) 5. history of any systemic diseases that can affect the serum vitamin d level (e.g., parathormone or calcium metabolism disorders) 6. already receiving vitamin d treatment.
de-117 spectrum 5 study

Conditions: Primary Open-angle Glaucoma and Ocular Hypertension

Summary: santen will evaluate the intraocular pressure (iop) lowering effect and efficacy of de-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with poag or oht


Eligibility criteria:
inclusion criteria: * patients with primary open-angle glaucoma or ocular hypertension in one or both eyes. * provide signed written informed consent. * diagnosis of poag or oht in both eyes. * qualifying corrected visual acuity in each eye. * qualifying central corneal thickness in each eye. * qualifying day 1 iop measurement at 3 time-points in both eyes after latanoprost run-in period. * qualifying anterior chamber angle. * qualifying iop measurement at 3 time-points during latanoprost run-in period. exclusion criteria: * patients who cannot safely discontinue use of ocular hypotensive medications during washout. * patients with prior exposure to de-117. * history of ocular surgery specifically intended to lower iop * advanced glaucoma in either eye. * any corneal abnormality or other condition interfering with or preventing reliable goldmann applanation tonometry. * any ocular surgery or ocular laser treatment within 180 days prior to visit 1 (screening) and throughout the study in either eye. * females who are pregnant, nursing, or planning a pregnancy.
shockwave™peripheral intravascular lithotripsy balloon for advanced endovascular aortic repair

Conditions: Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture; Abdominal Aortic Aneurysm Without Rupture; Thoracic Aortic Aneurysm Without Rupture

Summary: shockwave tevar is a nonrandomized, prospective, international, multi-center, pmcf, obervational study. the aim of this study is to evaluate the outcomes of the shockwave™ peripheral intravascular lithotripsy balloon (shockwave medical inc.) in the routine treatment of hostile iliac accesses during tevar and f/bevar.

standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. a 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure. in addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withshockwave peripheral intravascular lithotripsy balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.

Eligibility criteria:
inclusion criteria: 1. patient (m/f) age ≥ 18 years at time of enrollment. 2. diagnosis of thoracic and/or thoraco-abdominal (extent i-v) and juxta/para-renal/short-neck aneurysm requiring the implantation of a thoracic and/or thoraco-abdominal fenestrated/branched aortic endograft with delivery system introducer sheath diameter equal or larger than 18 fr (6 mm). 3. hostile iliac access was defined in the presence of: * heavily circumferential calcified iliac arteries * inner diameter ≤ 6 mm * severe stenosis (\> 50%; \> 2.5 m/s peak velocity; absence of triphasic duplex signal in ipsilateral common femoral artery) 4. we will accept the following presentations of aneurysm: * urgent cases, * elective, * symptomatic * and fast growing. 5. the repair was performed using shockwave™ before the introduction of the main endograft. the iliac procedures can be accompanied by angioplasty and/or stent and stent-graft positioning. exclusion criteria: 1. patients submitted to surgical conduit bypass. 2. not-severely calcified disease (absence of calcification). 3. in-stent restenosis/occlusion. 4. inability to cross with 0.014 guidewire. 5. any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study. 6. pre-stented iliac access vessels at the level of shockwave implementation.
diabeloop wp6.2 : crossover evaluation of glycemic control

Conditions: Closed Loop; Diabetes Mellitus, Type 1

Summary: the study will be conducted in crossover trial, with two 72-hour hospitalization separated by a period wash-out of at least one week. each hospitalization is a period of treatment. according to randomization, patients will be provided with either diabeloop system or the usual system. in both treatment periods: * patients in a situation of sedentarity or physical activity, will be equipped with actigraph (measuring motricity) and a actiheart ( measuring heart rate) * meals and physical activities will be similar in both periods * the same blood glucose meter will be used throughout the duration of the study. * the capillary blood glucose will be performed : before bolus and 2 hours after a meal, before exercise, in case of hypo or hyper-glycemic episodes and when the patient and / or investigator deem it necessary.


Eligibility criteria:
inclusion criteria: * type 1 diabetic patient for at least one year, treated by external insulin pump for at least 6 months * patient with 7.5 % \< hba1c \< 9.5 % * patient practicing functional insulin therapy * in the situation of physical activity , the patient must be able to perform one or more daily physical activities for 3 days in each treatment session * patient aged over 18 years * patient affiliated to social security * patient who agreed to participate in the study and who signed an informed consent exclusion criteria: * type 2 diabetic patients * any serious illness that may impair study participation\* * patient with insulin resistance defined in insulin requirements \> 1.5 u / kg / day * patient no longer sensing his hypoglycemia * patient enjoying a measure of legal protection * pregnant woman or likely to be
effects of rct on periapical healing, inflammatory markers, and kidney function indicators in ckd patients with ap

Conditions: Apical Periodontitis; Chronic Kidney Diseases

Summary: the purpose of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis.

it has been found that there is an association between prevalence of odontogenic infection and systemic diseases. an elevated level of systemic cytokines has been observed in conjunction with both ap and ckd . the proinflammatory status and impaired immune response associated with systemic diseases (chronic kidney disease ) can affect the reparative response of the dental pulp and periapical healing. one study observed significant positive relation between number of diagnosed ap and urea serum level . a 4.35-mg/dl increase in the urea serum level could be expected per 1-unit increase in the number of teeth with ap. improving oral health care through nonsurgical endodontic treatment(nset) may improve the systemic inflammatory status and improve renal function. the aim of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis 1. clinical and radiographic success rate will be considered as primary outcome, will be checked at baseline,6months,12months follow up.periapical status will be checked according to periapical index given by orstavik 2. reduction in inflammatory(hscrp) and kidney makers(serum urea , creatinine , egfr) will be considered as secondary outcome, will be checked at baseline,3months,6months follow up.

Eligibility criteria:
inclusion criteria: 1- known patient of chronic kidney disease \[ckd stages 1,2,3,4,5 with mature permanent teeth. 2. age18year or older . 3. ≥ to 12 natural teeth (excluding 3rd molars) 4 the periapical index (pai) was used to evaluate the periapical status patients with pai ≥3 are included in the study. exclusion criteria: 1. patients having systemic disorders other than chronic kidney disease (e.g hiv; diabetes mellitus; coronary heart disease; no history of secondary hyperparathyroidism) 2. patients with periodontitis , pocket depth and cal\>5mm( stage 3 ,4) will be excluded. 3. pregnancy; lactation \& contraceptives. 4. patients taking antibiotics, statins, corticosteroids and aspirin which can affect the level of inflammatory markers in past one month.
cognitive support program for patients with brain metastases

Conditions: Metastases, CNS

Summary: this study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.

cognitive impairments (such as problems with attention, executive functions, memory and language abilities) are common in people with brain metastases as a result of disease and/or treatment effects. these impairments can significantly limit functional independence, participation in valued roles and activities, and overall quality of life. building on research in other cognitively-impaired populations, we designed a brief, structured, patient-centered cognitive support program (csp) for brain metastases patients, who have the option of participating with a caregiver. program contents include supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration). this prospective, single-arm study will enroll 24 brain metastases patients to evaluate the feasibility and preliminary efficacy of the csp. a battery of outcome measures is administered (1) prior to intervention, (2) after completing the csp, and (3) after an additional 3 months to evaluate longer-term outcomes. feasibility assessment will include program retention and adherence. reliable change analyses will examine treatment effects, with regression analyses to explore moderating effects of select patient, disease and treatment factors (e.g., severity of baseline cognitive impairment, number of brain lesions, cranial radiation dose and distribution). results of this trial will inform further development and implementation of evidence-based supportive care for cognitively-impaired brain metastases patients.

Eligibility criteria:
inclusion criteria: * age 18 or older * able to provide informed consent to all procedures * diagnosis of one or more brain metastases, with primary cancer outside the cns * indication of cognitive deficits from self-report and/or cognitive testing * interest in participating in a cognitive rehabilitation program * able to complete study activities exclusion criteria: * concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition
ceftriaxone in the management of bipolar depression

Conditions: Bipolar Depression

Summary: we aim to study the efficacy of intravenous ceftriaxone in a four-week, inpatient, placebo-controlled, double-blind study, as an augmentation therapy in patients with bipolar disorder, currently depressed, who have failed to respond to conventional treatments.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of bipolar disorder * presence of a current major depressive episode on the scid * score of 17 or greater on the hdrs * failure to respond to two previous medication trials * capable of giving voluntary written consent exclusion criteria: * hypersensitivity to penicillin or cephalosporin, resulting in anaphylaxis * significant current substance dependence/abuse within 3 months preceding the trial * significant history of intravenous drug abuse * active suicidal ideation * pregnant/lactating mothers * significant medical history * patients on anticoagulation treatment * patients who test positive for hiv or hep b or c

Keywords: ceftriaxone acute antidepressant effects glutamatergic system double-blind mood disorders bipolar disorder depression affective disorders
efficacy, safety, tolerability, and pharmacokinetics of nbi-1117568 in adults with schizophrenia

Conditions: Schizophrenia

Summary: this is a phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (pk) of nbi-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.


Eligibility criteria:
key inclusion criteria: * completed informed consent. * subject has a primary diagnosis of schizophrenia. * the subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization. * subjects taking prohibited medications, including antipsychotics, must discontinue before study participation * subject is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements. key exclusion criteria: * an unstable medical condition, chronic disease, or malignancy. * considered by the investigator to be at imminent risk of suicide or injury to self or others. * diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening. * positive alcohol test or drug screen for disallowed substances. * have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.

Keywords: schizophrenia nbi-1117568 muscarinic
ischemic conditioning to enhance function (i-c-fun) in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of this research study is to determine if remote limb ischemic conditioning (rlic) can increase skeletal muscle power, enhance learning of motor (dynamic balance) task, and improve walking performance in children with cerebral palsy (cp).

ischemic conditioning is a phenomenon in which an organ exposed to a controlled, short-term, local, sublethal ischemia protects from subsequent ischemia. remote ischemic conditioning is another more practical approach where transient ischemia and reperfusion applied to a remote organ or tissue, protects other organs or tissues from further episodes of lethal ischemia/reperfusion injury. remote limb ischemic conditioning (rlic) is a clinically feasible way of performing remote ischemic conditioning where alternating, brief ischemia and reperfusion is delivered with cyclic inflation and deflation of a blood pressure cuff on the arm or leg. the overall goal of this research is to use ischemic conditioning to enhance muscle power, motor leaning, and mobility in children with cp. our previous work demonstrated that when paired with strength training, rlic improved muscle strength and activation in healthy, young adults and motor learning in healthy older adults. the current study extends that work to determine if rlic enhances muscle power, dynamic balance, and walking performance in children with cp. this phase ii study will yield the necessary information to design and execute subsequent randomized controlled trials in children with cp as well as other neurological conditions.

Eligibility criteria:
inclusion criteria: 1. children diagnosed with unilateral or diplegia cerebral palsy (cp) 2. gross motor function classification system (gmfcs) levels i-iii exclusion criteria: 1. children with other developmental disabilities such as autism, developmental coordination disorders, etc. 2. children with cognitive deficits or communication problem 3. children with balance disorders such as vestibular disorders, posterior fossa tumors etc. 4. children with known cardiorespiratory dysfunctions 5. children who are receiving other adjunct therapies such as tms, tdcs, vagal nerve stimulation 6. presence of lower extremity condition, injury, or surgery which could compromise conditioning and training 7. children with sickle cell disease