Kornimate/medical-research-clean huggingface dataset:
cytochrome p450's pharmacogenomics in chronic pain patients

Conditions: Analgesia; CYP2D6 Polymorphism; Opioid Use; Chronic Pain

Summary: the use of titrated drugs is at the base of a successful antalgic treatment in order to provide both an adequate relief and a satisfactory tolerability profile. these molecules, though, have a varying degree of efficacy in different subjects due to medical and genetic reasons. the latter are mainly represented by cytochrome (cyp) p450, in particular cyp2d6's polymorphisms are responsible for the diversified metabolism of analgesics used in chronic pain treatments. four main types of enzymatic metabolism make up the population, each one defined by a different cyp2d6 allele: extensive metabolizers, ultra-rapid metabolizers, intermediate metabolizers and poor metabolizers. moreover, regarding polytherapies, the analgesics' metabolism could be influenced by coadministration of other drugs, thus determining an inhibition or induction of the metabolic enzymes - known as phenocopying - and potentially also a change in the metabolic phenotype itself. the final outcome is the inconstancy of effectiveness and of the risk of developing side effects. the primary objective of this study is to define a genetic pattern for the gene cyp2d6 by assessing the incidence of poor or ultrarapid metabolizers in a population of chronic pain patients. this will also allow to observe phenocopying in the same population. hence 100 patients diagnosed with chronic pain will be enrolled. the genetic pattern of the gene cyp2d6 of such patients will be examined by taking mouth samples. at the same time parametric tests for paired data to survey the correlations between phenotypical patterns and pharmacological therapies will be conducted.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic pain exclusion criteria: -

Keywords: cyp2d6 chronic pain cytochrome p450 opioids
socknleg compression stocking kit : user friendliness

Conditions: Venous Insufficiency of Leg

Summary: the investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the socknleg, compared to a standard leg compression stocking of the same compression strength, the sigvaris cotton. the socknleg is not yet commercially available, whereas the sigvaris cotton has been successfully commercialized for many years. after an initial screening visit, a computer generated list will allocate the participants in either the socknleg or the sigvaris cotton group. all participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. the patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. the donning and doffing success will also be rated by the study investigator. leg volume measurements of the study leg will be taken at each visit to determine edema prevention.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * male or postmenopausal female patient, aged over 65 years of age * diagnosed venous insufficiency stage c3-c6 (according to ceap (clinical, etiologic, anatomic, pathophysiologic) -classification for venous diseases) exclusion criteria: * venous leg ulcer with a surface \>5cm2 * peripheral artery disease (pad) or media calcinosis (ankle-brachial-index \ 1.3) * difference in brachial blood pressure \>20mmhg in both arms * suspected polyneuropathy with ≥4 sensible test areas, measured with the semmes-weinstein-monofilament-test * inability to reach the forefoot with their hands * inability to follow the procedures of the study * bed-ridden hospitalized patients who are not able to leave the bed or sit upright for a few consecutive hours
effect of oral feeding in infants with pierre robin syndrome

Conditions: Pierre Robin Syndrome

Summary: this was a randomized controlled study. the infants enrolled were randomly divided into the ioe group (with intermittent oro-esophageal tube feeding) and the png group (with nasogastric tube feeding), all receiving systemic therapy. before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

pierre robin syndrome (prs) can cause dysphagia. in china, persistent nasogastric tube feeding (png) is the mainstream choice as nutrition support in the dysphagic infants with prs. however, png is associated with various complications, necessitating the exploration for a safer and more effective nutritional support approach. therefore, this study aims to observe the clinical effect of intermittent oro-esophageal tube feeding (ioe) compared to png in the dysphagic infants with prs who received systemic therapy. this was a randomized controlled study. the infants enrolled were randomly divided into the ioe group (with ioe) and the png group (with png), all receiving systemic therapy. before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for pierre robin sequence based on ct and x-ray examinations, combined with clinical manifestations and physical signs. * with spontaneous vaginal birth, aged 1 to 12 months. * with dysphagia. * before the treatment, the tube feeding was required and feasible after evaluation. * stable vital signs. * with nasogastric tubes placed before the treatment. * sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device). exclusion criteria: * abnormalities in brain development or other neurological lesions revealed by ct or mri scans. * dysphagia caused by other diseases. * other congenital malformations, such as down syndrome, cleft lip, and palate, etc. * severe systemic disease (such as severe infection, severe hepatic and renal dysfunction). * participants who need to receive other therapy which would potentially affect the result of this study
vitamin d and omega-3 trial (vital): fractures, vitamin d and genetic markers

Conditions: Fractures

Summary: the vitamin d and omega-3 trial (vital; nct 01169259) is a randomized clinical trial in 25,871 u.s. men and women investigating whether taking daily dietary supplements of vitamin d3 (2000 iu) or omega-3 fatty acids (omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. this ancillary study is being conducted among participants in vital and will examine (1) whether vitamin d reduces incident total, non-vertebral fractures, and hip fractures and (2) whether this reduction is modified by vitamin d levels

the vital: vitamin d, fractures, and genetic markers is an ancillary study of the parent vital trial (vitamin d and omega-3 trial). the study will require the adjudication of all self-reported incident fracture events among 25,871 men and women. findings from this ancillary study will inform clinical practice on the role(s) of vitamin d supplements in fracture prevention. this proposal will generate important positive or informative negative results about effects of supplemental vitamin d3 alone on fracture risk, while also elucidating the relative importance of vitamin d biomarkers and genetic variations in vitamin d-related pathways on bone. findings from the proposed ancillary study have the potential for major clinical as well as public health impact for both men and women in the u.s.

Eligibility criteria:
all participants from the vital parent study (nct01169259) were enrolled in this ancillary study.

Keywords: fracture
a.l.p.s. clavicle plating system pmcf

Conditions: Clavicle Fracture; Clavicle Injury

Summary: a commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the alps clavicle plating system for both the implant itself and the instrumentation used during surgery.

the objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the a.l.p.s clavicle plating system and its instrumentation by analysis of fracture healing, functional outcome and adverse events. the safety of the system will be assessed by monitoring the frequency and incidence of adverse events including re-operations. relation of the events to implant, instrumentation and/or procedure should be specified. the performance will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older. * patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws. * unilateral or bilateral fractures. * patient must be capable of understanding the doctor's explanation, following doctor's instruction, is able to and willing to complete the protocol required follow-up. * patient must have a signed irb/ec approved informed consent. exclusion criteria: * active infection. * patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone. * patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions. * foreign body sensitivity where material sensitivity is suspected, testing is to be completed prior to implantation of the device. * patient is a current alcohol or drug abuser * patient is a prisoner * patient known to be pregnant or breast feeding * likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study) * not expected to survive the duration of the follow-up program

Keywords: clavicle
the effect of the covid-19 pandemic on primary bladder cancer presentations

Conditions: Bladder Cancer; Covid19

Summary: in this study, investigators aim to reveal how the covid-19 pandemic process affects primary bladder cancer presentations, tumor stages and degrees, the time elapsed between diagnosis and intervention, tumor recurrence and progression, which are oncological results.

the rapid spread of the 2019 coronavirus disease (covid-19) caused by a novel betacoronavirus known as the severe acute respiratory syndrome coronavirus-2 (sars-cov-2) has had dramatic effects on individuals and health systems around the world. beyond those infected with sars-cov-2, the intense demand for limited health system resources has led to reduced capacity, rapid depletion of healthcare systems, and hospitals becoming a source of virus transmission. urology associations and reference centers have issued recommendations to inform urology care during the covid-19 outbreak. it is essential that urologists give priority to patient safety. potential delays in the diagnosis and treatment of urological conditions and the additional burden on healthcare resources must be balanced against the risks of exposure to covid-19. while this situation aims to conserve healthcare resources, it has created the risk of delaying cancer treatment. as a result, the transformation of health services and the increasing interest of the public in avoiding exposure to the disease has led to a decrease in the number of hospital admissions. the effects of the pandemic on patients with bladder cancer due to a decrease in emergency room and urology clinic admissions are not clear. during the covid-19 outbreak, the eau (european association of urology) panel of non-muscle invasive bladder cancer published an evidence-based guideline. according to this guideline, four priority groups were formed and a certain period of delaying treatment was defined for patients in each group according to their priorities.

Eligibility criteria:
inclusion criteria: * primary bladder cancer exclusion criteria: * previous history of urinary tract tumor * chronic kidney disease

Keywords: bladder cancer covid-19 transurethral resection
prospective clinical evaluation of the new aegis plate for anterior interbody fusions

Conditions: Degeneration; Spondylosis; Spondylolithesis; Stenosis

Summary: introduction: degenerative changes of the discs and facet joints in the lumbar spine can result in pain and disability from spondylosis, spondylolisthesis and stenosis. patients who are suffering with back and/or leg pain are potential candidates for an alif procedure. purpose: to assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented alif procedure. comparisons in all variables will be made across diagnostic categories. comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made

to assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented alif procedure. comparisons in all variables will be made across diagnostic categories. comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made. this study is part of a larger continuous quality improvement initiative at the columbia orthopaedic group. the purpose of this effort is to improve surgical and non-surgical outcomes by using rigorous statistical analysis of our outcomes to guide our treatment decisions. through an iterative feedback process we hope to optimize patient outcomes.

Eligibility criteria:
inclusion criteria: * standard of care exclusion criteria: * standard of care

Keywords: degeneration spondylosis spondylolisthesis stenosis
effect of liberal and restrictive fluids on nausea-vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: patients planned for laparoscopic cholecystectomy will be included in this study. the effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. the aim of this study is to investigate which regimen is more effective on postoperative nausea and vomiting in laparoscopic cholecystectomy.

postoperative nausea and vomiting (ponv) is a common and disturbing side effect of anesthesia and surgery, and while its incidence in all surgical procedures varies between 20-77% if antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting, such as cyclic vomiting syndrome . its incidence varies between 53 - 72%, especially in patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not administered. since most existing antiemetics are expensive and cannot completely eliminate ponv, pharmacological ponv prophylaxis may not be cost-effective. for this reason, the incidence of ponv can be reduced by increasing the amount of inexpensive fluid used during surgery instead of prophylactic drug treatment. there are several studies investigating the effect of different perioperative fluid administration schemes on ponv in the adult population, especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with variable results. based on this point, the inestigetors wanted to examine the effect of perioperative liberal and restrictive fluid treatments on ponv in patients who underwent laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: * patients planned for laparoscopic cholecystectomy * patients aged 18-70 exclusion criteria: * congestive heart failure. * diabetes. * epilepsy. * heart valve disease. * they are pregnant. * chronic liver disease. * chronic kidney disease. chronic gastrointestinal tract disease. those who used antiemetic drugs within 24 hours before surgery. those who developed intraoperative hypertension. those who develop excessive blood loss. patients whose surgery procedure takes more than 2 hours.

Keywords: postoperative nausea and vomiting laparoscopic cholecystectomy
hdtdcs in logopenic variant ppa: effects on language and neural mechanisms

Conditions: Primary Progressive Aphasia

Summary: this study aims to evaluate the effectiveness of a therapy called high-definition transcranial direct current stimulation (hd-tdcs) for the treatment of the language deficits experienced by people with a type of primary progressive aphasia. this study uses a combination of brain imaging, language assessment, language training sessions, and hd-tdcs therapy as well as placebo therapy sessions.

the logopenic variant of primary progressive aphasia (lvppa) is an untreatable neurodegenerative disorder that is often referred to as the 'language form' of alzheimer's disease (ad). transcranial direct current stimulation (tdcs) has emerged as a safe and potentially effective tool that appears to enhance language production when delivered during language training. this technology provides a critical opportunity to conduct disease intervention. in this study, the investigators will test the hypothesis that high-definition tdcs (hd-tdcs) will improve performance on language tasks by increasing functional connectivity and by regulating abnormal neuronal oscillatory patterns. the rationale for this project is that a determination of the therapeutic efficacy and the associated neural mechanisms of hd-tdcs in lvppa is likely to offer a scientific framework whereby new stimulation parameters, conditions, and target sites can be deciphered. this study will test the hypothesis that hd-tdcs will improve performance on language tasks by increasing functional connectivity and by regulating abnormal neuronal oscillatory patterns. the language performance and functional connectivity changes will be determined in a randomized, double-blind, sham-controlled crossover manner, in which a stimulation of up to 2ma in the targeted cortical tissue or sham is administered to 20 lvppa subjects age 45 years and older. the order of treatments is counterbalanced in a within-subject crossover design. in brief, study participants will receive sham during one treatment period and stimulation during the other treatment period.

Eligibility criteria:
inclusion criteria: * diagnosed with language variant primary progressive aphasia (lvppa) subtype, defined as either clinical lvppa or imaging-supported lvppa in accordance with the most recent diagnostic criteria (mesulam., 2001; gorno-tempini et al., 2011). * fluent in english. * 45 years of age or older. * structural brain mri performed within 3 years prior to enrollment. exclusion criteria: * severe cognitive, auditory or visual impairments that would preclude cognitive testing. * presence of major untreated or unstable psychiatric disease. * a chronic medical condition that is not treated or is unstable. * the presence of cardiac stimulators or pacemakers. * any metal implants in the skull * contraindications to mri * history of seizures * history of dyslexia or other developmental learning disabilities.

Keywords: adult primary progressive aphasia high-definition transcranial direct current stimulation hd-tdcs language logopenic magnetic resonance imaging mri magnetoencephalography meg brain aphasia
computed tomographic angiography or conventional coronary angiography in clinical decision making

Conditions: Coronary Artery Disease; Coronary Artery Stenosis

Summary: patients planned for elective conventional coronary angiography will undergo ct coronary angiography (dual source ct) in order to assess the correlation of stenosis detection and therapeutic advice between conventional and ct coronary angiography. we hypothesize that their is a good correlation between conventional and ct coronary angiography for stenosis detection and therapeutic advice.


Eligibility criteria:
inclusion criteria: * over 50 years of age * scheduled for elective coronary angiography exclusion criteria: * patients with known iodine allergy * severe renal insufficiency (creatinine levels \> 120 micromol/l) * hyperthyroidism * cardiac arrhythmias * unstable clinical condition * inability to follow breath-hold commands * previous pci or cabg were excluded.

Keywords: therapeutic advice
magic mouthwash plus sucralfate versus benzydamine hydrochloride for the treatment of radiation-induced mucositis

Conditions: Head and Neck Cancer; Mucositis

Summary: radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due to the radiation. when radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. there are several mouthwashes that are commonly used to prevent and treat mucositis, but none of these have been shown to be superior to another. this study is being conducted to see if using a combination of magic mouthwash and sucralfate is better than using a single mouthwash called benzydamine at decreasing the burden of mucositis.

sixty patients with head and neck cancer being treated with 6 or more weeks of radiotherapy, will be randomly assigned to receive either a combination of magic mouthwash (diphenhydramine, dexamethasone and nystatin) plus sucralfate or benzydamine. patients randomized to receive magic mouthwash plus sucralfate will rinse first with 5ml of the magic mouthwash for 2 minutes then swallow, followed by rinsing with 5ml of the 1g/5ml sucralfate for 2 minutes before swallowing, 4 times daily. patients randomized to receive 0.15% benzydamine hcl will be instructed to rinse with 15ml of the solution for 2 minutes before expectorating, 4 times daily. patients will start the mouthwash regimens prior to the initiation of radiotherapy, and stop 2 weeks after the completion of radiotherapy.

Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinoma of the head and neck. * receiving 6 or more weeks of external beam radiotherapy to a treatment volume that includes mucosal surfaces of the head and neck. exclusion criteria: * age less than 18 years * ecog performance score 2 or higher * patient is unable to understand the protocol and/or unable to provide informed consent * patient is unable or unwilling to complete the questionnaires which are written in english. * prior radiation to the head and neck region that would result in overlap of fields for the current study. * plan to receive a radiation treatment volume that only includes the larynx and or hypopharynx with no planned treatment of locoregional lymph nodes. * plan to receive a concurrent chemotherapy agent other than cisplatin. * plan to receive other investigational agents (eg. panitumumab). * investigational agent of any kind within 30 days prior to randomization. * concurrent administration of any other experimental intervention given for the purpose of preventing oral mucositis. * history of allergic or hypersensitivity reactions to any of the possible agents to be administered in the study. * patients who are pregnant or lactating.

Keywords: mucositis radiation magic mouthwash sucralfate benzydamine diphenhydramine dexamethasone nystatin