Kornimate/medical-research-clean huggingface dataset:
study of the compliance with phosphorus restricted diet and phosphate binder therapy in hemodialysis patients

Conditions: Chronic Kidney Disease

Summary: hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. a phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. however, noncompliance is an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial proportion of hemodialysis patients. the present study aims at identifying risk factors for non compliance and also test the hypothesis that compliance can be improved by education patients on the consequences of hyperphosphatemia and the importance of diet and phosphate binder therapy.


Eligibility criteria:
inclusion criteria: * prevalent (\>3months) hemodialysis patients * aged \> 18 years * informed consent exclusion criteria: * decreased consciousness * unstable * medical contraindication for phosphorus restricted diet or phsophate binder therapy

Keywords: hemodialysis hyperphoshatemia compliance
the effect of intervention about dry mouth and thirst in patients with endotracheal tube

Conditions: Endotracheal Tube; Thirst; Dry Mouth

Summary: this is an experimental study aimed at exploring the effectiveness of using 4°c frozen gauze with normal saline for relieving dry mouth and thirst in patients with endotracheal tubes.

long-term placement of endotracheal tubes often causes discomfort, including lip ulcers, laryngeal pain, and dry oral mucosa, leading to frequent complaints of dry mouth and thirst among conscious patients. however, these symptoms are commonly overlooked in the nursing process, resulting in emotional distress and irritability in patients. although healthcare providers recognize the issue of dry mouth and thirst in patients with endotracheal tubes, effective management is challenging due to concerns about treatment limitations, aspiration pneumonia, and the risk of coughing or vomiting. this experimental study aims to explore the effectiveness of using 4°c frozen gauze soaked in normal saline to relieve dry mouth and thirst in patients with endotracheal tubes.

Eligibility criteria:
inclusion criteria: * endotracheal intubation. * aged 18 years or older. * patient or family members are willing to sign the consent form. exclusion criteria: * history of head and neck cancer. * oral mucosal damage, swelling, or bleeding that precludes placement of a moist gauze pad.

Keywords: dry mouth thirst endotracheal tube
exparel vs exparel plus acb in tkas

Conditions: Knee Osteoarthritis

Summary: patients will be randomized (like the flip of a coin) to receive exparel and a nerve block, standard of care for this procedure, or exparel alone for pain management after surgery. they will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 80 years at the time of surgery. * willing and able to give voluntary informed consent to participate in this investigation. * candidate for total knee arthroplasty. * bmi \< 35. exclusion criteria: * subject has had previous arthroplasty or fracture procedure(s) on the operative knee. * creatine level ≥ 1.5 * pre-existing gait disturbance or neuropathy. * allergy to local anesthetics. * inflammatory arthropathies. * female patient who is pregnant or nursing. * chronic use of narcotics * any other reason (in the judgment of the investigator).
strategy of crossing two ablation techniques (cryoballoon and radiofrequency) after the recurrence of paroxysmal af and the need for a new procedure

Conditions: Atrial Fibrillation

Summary: randomized phase iii clinical trial to compare the efficacy of the two most widely used ablation techniques (cryotherapy and radiofrequency) after recurrence of atrial fibrillation (af) in patients requiring a new ablation procedure.


Eligibility criteria:
inclusion criteria: * paroxysmal fa (one that ends, spontaneously or not, within 7 days of its onset. guidelines esc fa 2020) * have undergone an initial af ablation procedure using cryoballoon or point-to-point focal rf within the three years prior to the initial visit. * during the initial af ablation procedure only pulmonary vein isolation / ablation will have been performed * documented recurrence of af lasting more than 30 seconds after the first ablation procedure. * with the ability and willingness to sign the informed consent of the patient. * with a minimum follow-up capacity of 12 months. exclusion criteria: * patients aged \<18 years. * previous heart surgery. * moderate or severe mitral valve disease. * severe dilation of the left atrium, defined as a volume greater than 48 ml / m2 or a left atrial diameter greater than 50 mm in the parasternal long axis. * contraindication for anticoagulation. * pregnancy or pregnancy intention during the 12-month follow-up. * life expectancy less than 12 months. * unavailability for follow-up for 12 months. * simultaneous participation in another clinical trial
otological study of facial cleft patients over 10 years of age (excluding isolated cleft lip) (efeof)

Conditions: Serous Otitis; Tympanic Membrane Perforation; Retraction Pocket; Cholesteatoma; Otorrhea; Myringosclerosis; Tympanosclerosis; Audiometric Tests

Summary: studies published on the placement of transtympanic ventilatory tubes in children with cleft palate show heterogeneous results, highlighting the need for a new study with strong statistical power and long-term follow-up to clarify the real benefits of this intervention. mirashrafi (2022) and maina (2022), for example, emphasize the current uncertainties regarding the management of otitis media with effusion in children with cleft palate. mirashrafi conducted a study on 40 children and found no significant difference between those with a complete cleft palate and those with an incomplete cleft palate in terms of middle ear status after the placement of transtympanic ventilatory tubes. maina, in an ongoing review, identified a lack of consensus on the optimal management of chronic otitis media with effusion, with outcomes being varied and often of low methodological quality. the absence of convincing evidence justifies the need for further research to establish clear guidelines. the objective is to study the otological status of patients based on the presence or absence of ent surgical management involving the placement of transtympanic ventilatory tubes.

the primary evaluation criterion will be ent consultations: tympanic examination: anatomical analysis of the tympanic membrane, assessing the presence or absence of: serous otitis tympanic membrane perforation retraction pocket cholesteatoma otorrhea myringosclerosis tympanosclerosis audiometric tests: assessment of auditory results from bone and air conduction curves for frequencies ranging from 250 to 4000 hz, with analysis at every 250 hz.

Eligibility criteria:
inclusion criteria: presence of a facial cleft between 2004 and 2014 minor and adult patients followed up by ent services at the university hospital of brest or marseille exclusion criteria: patients under legal protection (guardianship, curatorship, etc.) refusal to participate objection from one of the parents isolated cleft lip no ent follow-up

Keywords: serous otitis tympanic membrane perforation retraction pocket cholesteatoma otorrhea myringosclerosis tympanosclerosis audiometric tests ent transtympanic ventilatory tubes. cleft palate
efficacy and safety study of naproxcinod in subjects with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: to study of efficacy and safety of naproxcinod vs. naproxen and placebo in the indication of signs and symptoms of osteoarthritis

this is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of naproxcinod, placebo and naproxen. the first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.

Eligibility criteria:
inclusion criteria: * men and woman (40 or older) with a diagnosis of primary oa of the knee. * must be a current chronic user of nsaids or acetaminophen * must discontinue all analgesic therapy at screening exclusion criteria: * uncontrolled hypertension or diabetes * hepatic or renal impairment * current or expected use of anti-coagulant * clinical relevant abnormal ecg * a history of alcohol or drug abuse * candidates for imminent joint replacement * participation within 30 days prior to screening in another investigational study

Keywords: arthritis degenerative
hormonal effects on tc-99m sestamibi uptake in the breast

Conditions: Breast Cancer

Summary: this study is to examine the effects of menstrual cycle, hormone therapy, and the use of tamoxifen on tc-99m sestamibi uptake.


Eligibility criteria:
arm 1 inclusion criteria: * age 35-45 * have regular menstrual cycles as defined by having menstrual cycle length of 25-31 days, with menstrual flow of 2-7 days, and no intermenstrual spotting or bleeding. * have had a negative screening mammogram within one year prior to the mbi studies that is available for comparison. exclusion criteria: * currently using any exogenous hormones (e.g., hormonal contraceptives, sex steroid hormones) or any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors * have a personal history of any cancer, except non-melanomatous skin cancer * unable to understand and sign the consent form * pregnant or lactating * physically unable to sit upright and still for 30 minutes arm 2 inclusion criteria: * scheduled to begin one of the following regimens of ht: * any dosage of any formulation of systemic estrogen therapy in the setting of a prior hysterectomy * any dosage of continuous estrogen plus monthly, cyclic progesterone therapy where the progesterone therapy is the oral, micronized formulation * had a negative screening mammogram within one year prior to the mbi studies that is available for comparison. exclusion criteria: * have a personal history of any cancer, except non-melanomatous skin cancer * unable to understand and sign the consent form * pregnant or lactating * physically unable to sit upright and still for 30 minutes arm 3 inclusion criteria: * scheduled to begin treatment with tamoxifen or are currently being treated with tamoxifen (for \> 1 month) and have had an mbi scan performed prior to its initiation * have had or will have the following test performed at mayo clinic: #87966, cytochrome p450 2d6 genotyping for tamoxifen hormonal therapy * have had a screening or diagnostic mammogram within one year of the mbi studies that is available for comparison. exclusion criteria: * are using or have used any exogenous hormones (e.g., hormonal contraceptives, sex steroid hormones), any estrogen receptor modulating drugs other than tamoxifen, or any aromatase inhibitors from the time of 1 month prior to the first mbi until completion of the second mbi. * have been treated or will be undergoing treatment with systemic chemotherapy or external radiation beam therapy to the breast from the time of 6 months prior to the first mbi until the completion of the second mbi. * unable to understand and sign the consent form * pregnant or lactating * physically unable to sit upright and still for 30 minutes

Keywords: breast menstrual cycle breast cancer hormone mbi molecular breast imaging breast imaging
internet based exercise training in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: type 2 diabetes mellitus (dm) is a disease which is characterized with insulin resistance and exercise has positive effects on glycemic control and cardiovascular disease (cvd) development in these patients. encouraging physical activity and exercise with using internet-based technology provides; potential to reach more people via comparatively low cost, 24 hour accessibility to services and for clinician, more frequent communication ability with the patient. in literature, there is no study examined exercise training via internet in patients with type 2 dm. for this reason, considering the lack of the literature, the investigators aimed to compare the effects of internet based combined exercise training on glycemic control, functional capacity and physical activity level with supervised group training in patients with type 2 dm. the purpose of the study is to provide convenience of rehabilitation access, glycemic control, offer an alternative physiotherapy and rehabilitation service which can help to improve physical activity level and obtain quantitative data for the applicability and contribution of internet based exercise training in patients with type 2 dm.


Eligibility criteria:
inclusion criteria: * hba1c level between %6,5-11 * patients who can reach 420 meters in 6 minutes walking test * patients who are available high speed internet from home, work or mobile phone exclusion criteria: * non-cooperation * uncontrolled hypertension and cardiac arrythmia * severe neurological and pulmonary disorder * patients who had percutan transluminal coronary angiography or cardiac pacemaker * previous myocardial infarction * previous amputation * major musculoskeletal problem * chronic renal failure * patients who had hip or knee prothesis within 5 years * diabetic ulceration pr neuropathy * pregnancy * breastfeeding * hemolytic anemia * renal anemia

Keywords: type 2 dm internet based exercise training group exercise training glycemic control
dose-comparison study of prednisone in heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.

heart failure is a leading cause of cardiovascular morbidity and mortality in the world. most patients with acute symptomatic heart failure are admitted with fluid overload. intravenous loop diuretics are an essential component of current treatment in such patients. newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor a (npr-a) in the kidney, and produce a potent diuresis. therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.

Eligibility criteria:
inclusion criteria: * hospitalized for symptomatic heart failure * dyspnea at rest or with minimal activity * nt-probnp \> 1000pg/ml * lvef ≤ 40% exclusion criteria: * any condition (other than chf) that could limit the use of prednisone; * acute decompensated heart failure * active myocarditis * obstructive or restrictive cardiomyopathy * cardiac surgery within previous 3 months * acute coronary syndrome

Keywords: heart failure diuresis prednisone
study of nitazoxanide in the treatment of clostridium difficile-associated disease

Conditions: Clostridium Infections

Summary: the primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of clostridium difficile-associated disease (cdad).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients with new onset of disease evidenced by diarrhea (≥ 3 unformed stools within 24 hours), and one or more of the following symptoms of cdad: * abdominal pain or cramps * peripheral leukocytosis * fever * c. difficile toxin a or b detected in a stool specimen obtained within 3 days before enrollment by enzyme immunoassay. * patients willing to avoid the following medications during the study: * oral and intravenous metronidazole * oral vancomycin * anti-peristaltic drugs * opiates (patients on opiates may be included in the study if they were taking opiates prior to enrollment and the dose is not increased during the study) * saccharomyces cerevisiae (baker's yeast) * lactobacillus gg * cholestyramine * colestipol exclusion criteria: * patients with other known causes of diarrhea or colitis (e.g., shigella, salmonella, cryptosporidium parvum, giardia lamblia, entamoeba histolytica, inflammatory bowel disease, irritable bowel syndrome, advanced aids or chemotherapy for malignancy). * patients that commonly have 3 or more stools per day and/or severe abdominal pain in the absence of cdad. * patients with severe lactose intolerance. * patients with more than 1 recurrence of cdad during the 6 months prior to enrollment. * patients unable to take oral medications. * use within 1 week of enrollment of any drug or therapy with anti-c. difficile activity such as oral or intravenous metronidazole and oral vancomycin. \[patients that have taken up to 3 doses of metronidazole or vancomycin can be included in the study\]. * females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active. * patients who are either clinically unstable (e.g., fulminant disease patients with signs of toxic megacolon, imminent perforation, colectomy or death) or unlikely to live throughout the 31-day duration of the study due to underlying illness. * history of hypersensitivity to nitazoxanide or vancomycin or any active ingredient in the formulations.

Keywords: clostridium difficile
post-authorization safety study to assess the safety of vimpat as add-on therapy in patients with partial-onset seizures

Conditions: Epilepsies, Partial

Summary: sp942 is a non-interventional post-authorization safety study (pass) to evaluate the long-term safety and tolerability of vimpat® (lacosamide, lcm) as add-on treatment in patients with epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.


Eligibility criteria:
inclusion criteria: * this study includes any subject 16 years or older who has an epilepsy diagnosis with partial-onset seizures; and whose seizure activity is uncontrolled on current therapy * patients who are prescribed vimpat or any other add-on antiepileptic drug (aed) may be included in the study * the initiation of an add-on aed therapy can not be more than 2 days before the patient's start of the study exclusion criteria: * n/a

Keywords: vimpat® lacosamide lcm epilepsy epilepsies seizure partial seizure partial onset seizure disorder single seizure motor seizure convulsions add-on aed anti-epileptic anti-epileptic drug seizure control open-label post authorization pass late stage trial study phase 4 phase iv
chatbot and activity monitoring in patients undergoing chemoradiotherapy

Conditions: Lung Cancer; Gastrointestinal Cancer; Head and Neck Cancer

Summary: evaluate the feasibility of using a chatbot combined with continuous activity monitoring to proactively identify, appropriately triage and help manage patients' symptoms during cancer treatment determine whether such an early outpatient clinic-based intervention can decrease rates of excess triage visits correlate changes in activity and early symptom management to emergency department visits, unplanned inpatient hospitalizations and treatment breaks


Eligibility criteria:
inclusion criteria: * adults (age \>18 years) with a diagnosis of a head and neck, lung, gastrointestinal cancer, that are receiving concurrent chemotherapy and radiation treatment. * possession of a mobile device that can receive sms texts and can deliver fitbit data wirelessly * ability read and respond in english * ability to provide informed consent to participate in the study exclusion criteria: * patients who are bed bound at baseline (ecog 4) * patients who rely on a wheelchair for ambulation
study investigating effects of foliglurax in patients with parkinson's disease (pd) and healthy subjects

Conditions: Parkinson Disease; Healthy

Summary: the purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with pd

all treatment periods (p1 to p3) consist of 7 days of dosing (d1 to d7) with either: * 10 mg foliglurax bis in die (bid) (treatment a) * 30 mg foliglurax bid (treatment b) * placebo bid (treatment c)

Eligibility criteria:
inclusion criteria: healthy subjects * the subject has an acceptable resting eeg at the screening visit, as judged by the investigator * the subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ecg, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. patients with pd * the patient has an acceptable resting eeg performed at the screening period, as judged by the investigator. * the patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ecg, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. * the patient has been diagnosed with idiopathic pd for ≥3 years, with a current disease severity of 2 to 4 on the modified hoehn and yahr scale in the 'off' state. * the patient has dyskinesia that is not too severe to cause discomfort for the patient during the eeg assessments exclusion criteria: * the subject has taken disallowed medication \<1 week prior to the first dose of investigational medicinal product (imp) or \<5 half-lives prior to the screening visit for any medication taken. * the subject has significant alcohol consumption * the subject has taken any investigational medicinal product \<3 months prior to the first dose of imp. * the subjects has a known genetic disorder of human udpglucoronosyltransferase * the subject is pregnant or breastfeeding. other in- and exclusion criteria may apply