Kornimate/medical-research-clean huggingface dataset:
effects of vitamin d in parkinson's disease (pd)

Conditions: Parkinson Disease; Accidental Falls

Summary: a trial to measure the effects of vitamin d (versus a placebo) on balance, gait, falls, strength, and cognition in persons with parkinson's disease.

the proposed study is a randomized, double-blinded, placebo controlled intervention trial to measure the effects of vitamin d at (10,000iu/day) versus placebo on balance and falls in parkinson's disease. the investigators will measure static, dynamic, and ambulatory balance, as well as strength, falls, and cognition before and after 16 weeks of therapy. dynamic posturography will be used to measure static and ambulatory balance, a device called imobility will measure a timed up and go, and strength will be measured with the biodex machine checking knee flexion and extension. multiple quality of life and cognitive tests will also be performed.

Eligibility criteria:
inclusion criteria: * parkinson's disease; * ability to ambulate 50 feet; * ability to cooperate with balance testing; * vitamin d level less than 40ng/ml; * balance problems; * ability to walk 50 feet without the help of another person exclusion criteria: * mmse \< 25; * another neurological or orthopedic deficit that in the examiner's opinion would affect testing; * history of renal stones or hypercalcemia; * unwillingness to not be on other vitamin d supplementation during the study

Keywords: vitamin d parkinson disease accidental falls
reliability and validity of urdu version of ronald morris disability questionnaire in patients with low back pain

Conditions: Low Back Pain

Summary: purpose of this research is to convert ronald morris disability questionnaire into urdu language and check the accuracy and logic in pakistani low back pain population. also check its correlation with oswestry disability index and visual analogue scale.

the ronald morris disability questionnaire will be translated into urdu and culturally adapted for people with low back pain. ronald morris disability questionnaire will be given to 80 people who will be chosen by using a convenient sampling method. method of sampling based on pre-determined inclusion and exclusion criteria. to examine intra-observer reliability of the final ronald morris disability questionnaire, two observers will fill out oswestry disability index and visual analogue scale questionnaires on the same day to test inter-observer evaluation. after 30 minutes of the initial treatment, the second application will be applied. the first observer will do the third assessment after seven days. statistical package of social sciences version 24 will be used to enter and analyse data. the alpha value of cronbach's alpha will be examined.

Eligibility criteria:
inclusion criteria: * average age of patient 48 years. * patient with chronic low back pain have at least 3 month duration . * patient with mechanical low back pain exclusion criteria: * patient with non - mechanical low back pain * patient have neurological deficits .

Keywords: ronald morris disability questionnaire urdu version reliability validity low back pain
performance and safety of the surgical hemostatic agent "hemocollagene®" in patients requiring oral surgery

Conditions: Oral Hemorrhage

Summary: the aim of this study is to collect performance and safety data relating to the use and the follow-up of the hemocollagene® medical device in routine clinical practice from various hospitals and medical centers in oral dental surgery. patients will the data collected from the post-market clinical follow-up study will be used to support the regulatory requirements of post-market monitoring (risk management, residual risks, instructions for use...) and to increase the manufacturer's clinical data. patients will be followed for 1 month. adverse events (safety) and device performance will be collected by the dentist during the routine follow-up visits.


Eligibility criteria:
inclusion criteria: * patient requiring oral surgery * patient with a bleeding requiring the use of an adjuvant hemostatic * patient implanted with hemocollagene® in dental surgery. * patient who signed his informed consent form exclusion criteria: * inform consent not signed * patients with acute oral infection. * patients with an unstable hemodynamic state (acute and/or chronic cardiovascular pathology, low arterial pressure, cardiac rhythm problem) * pregnant and / or breastfeeding patients. * patient with hypersensitivity or allergy to bovine collagen

Keywords: surgical hemostatic oral surgery
hydrocephalus treatment on persistent disorder of consciousness

Conditions: Disorder of Consciousness

Summary: after acute brain injury or haemorrhagic stroke, hydrocephalus might participate to consciousness disorder. we plan to explore whether ventriculoperitoneal shunt insertion improves consciousness in patients with vegetative or minimally conscious state and hydrocephalus. patients with acute brain injury, persistent consciousness disorder and hydrocephalus will be shunted with a detailed follow-up at 3 months combining: clinical evaluation, fluorodésoxyglucose positron emission tomography imaging, high density electroencephalogram, electrocardiogram holter and sympathetic activity by microneurography.

persistent disorder of consciousness following acute brain injury is a major public health problem. advances in intensive care allow a growing number of patients to survive after acute brain injury. however, one third of patients in coma following acute brain injury will not recover a consciousness. to date, no specific treatment has shown its effectiveness in the cognitive recovery of those patients. few clinical cases suggest that hydrocephalus, which is the impairment of cerebrospinal fluid circulation in the brain, may participate to prolonged disorder of consciousness. hence treating hydrocephalus with a shunt might improve disorders of consciousness. it is possible to gauge intracranial fluid circulation, that is hydrodynamics quantification, and measure resistance to cerebrospinal fluid outflow. demonstration of an altered hydrodynamics favours the implantation of a shunt to improve cerebrospinal fluid circulation that might modulate brain region involved in the emergence of consciousness. the study hypothesis is that shunting a patient with persistent disorder of consciousness due to acute brain injury and hydrocephalus might improve his state of consciousness. the neural processes underlying will be assessed through comparative analyses of brain metabolic and electrophysiological signatures.

Eligibility criteria:
inclusion criteria: * adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt. exclusion criteria: * pregnancy, no consent

Keywords: consciousness disorder hydrocephalus ventriculoperitoneal shunt autonomic nervous system
study of carbetocin nasal spray for the treatment of hyperphagia in prader-willi syndrome

Conditions: Hyperphagia in Prader-Willi Syndrome

Summary: 12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in prader-willi syndrome (pws)

this is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing carbetocin nasal spray 3.2 mg tid with placebo (matched placebo nasal spray tid) in subjects with pws.

Eligibility criteria:
inclusion criteria: * male or female and 5 through 30 years of age * prader-willi syndrome with a documented disease-causing mutation * increased appetite with decreased satiety accompanied by food seeking (consistent with pws nutritional phase 3) * hq-ct total score of ≥13 at screening and baseline * cgi-s score for hyperphagia in pws of ≥4 at screening and baseline * lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits exclusion criteria: * genetically diagnosed with schaaf-yang syndrome or another genetic, hormonal, or chromosomal cognitive impairment besides pws * an active upper respiratory infection at the screening visit or the baseline visit * any clinically significant cardiovascular disorder, renal, hepatic, gastrointestinal, or respiratory disease, including severe asthma * history of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. a history of febrile seizures is not exclusionary * nasal surgery within 1 month of screening visit or planning to have nasal surgery during the study. * unwilling to abstain from nasal saline, other nasal irrigation, and other intranasal medications during the screening period and through the treatment period of the study * clinically significant irritability or agitation, requiring initiation of or increase in the dose of antipsychotic medication, within the 6 months prior to the screening visit * used prostaglandins, prostaglandin analogues, or prostaglandin agonists in the 3 months prior to the baseline visit. inhibitors of prostaglandin synthesis, such as nonsteroidal anti-inflammatory drugs, are not exclusionary. * started a glucagon-like peptide 1 (glp-1) agonist within the 6 months prior to the screening visit. treatment with glp-1 agonist is allowed if the subject has been taking it for more than 6 months prior to screening. * used oxytocin, desmopressin (ddavp), or tesofensine within 6 months prior to the baseline visit * active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder * history of suicide attempt or inpatient psychiatric hospitalization * new food-related interventions, including environment or dietary restrictions, within 1 month of the screening visit additional inclusion/exclusion criteria apply. subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Keywords: randomized placebo-controlled
the effects of alginate ag dressing in the pressure injury patients

Conditions: Pressure Injury; Long-Term Care

Summary: wound infection and bleeding is a risk factor for pressure injury. calcium alginate silver dressing (casd) has been shown to be beneficial in a variety of wounds. however, evidence of its benefit in pressure injury(pi) patients in long-term care institutions, especially with respect to taiwan population, is sparse. this study was to evaluate the effect of casd and conventional wound dressings on the pi patients in long-term care institutions.

background: wound infection and bleeding is a risk factor for pressure injury. calcium alginate silver dressing (casd) has been shown to be beneficial in a variety of wounds. however, evidence of its benefit in pi patients in long-term care institutions, especially with respect to taiwan population, is sparse. objective: to evaluate the effect of casd and conventional wound dressings on the pi patients in long-term care institutions. the study hypothesis that when using the casd will improving wound bed status more than conventional dressing change. design: prospective, randomized trial setting: multiple center long-term care institutions in taiwan. methods: in this clinical trial, 200 pi patients will randomly assigned to treatment with either calcium alginate silver dressing or conventional wound dressings for up to 14 days or to the point of full reepithelialization of the wound. the length and depth of the studied wounds were recorded once a week. the instruments will using the pi measurement tool measured on day0, day7 and day14.the collected data were analyzed by descriptive and inferential statistical methods . the mann-whitney test was applied to compare primary endpoint between groups. differences in secondary endpoint were also compared. expected results: pi is an indicator of care quality in long-term care institutions. however, as the population ages, pi are prone to infection and bleeding problems, causing patients to have potential health problems such as sepsis and hemoglobin reduction. the results of this study will provide evidence-based care for wound dressing in long-term care institutions, thereby improving patient care.

Eligibility criteria:
inclusion criteria: 1. age between 20-90 years old 2. stage ii or stage iii pressure injury 3. pressure injury wound size: length, width and depth are less than 10\*10\*2 cm 4. the patient or family agree to be willing to participate in and cooperate with the interventional treatment of this study exclusion criteria: 1. the wound has a underming wound or a tunnel wound 2. black crust on the wound bed 3. participant's with unstable vital signs 4. those who have used silver dressings or silver hydrofiber dressings in the past 30 days 5. the patient has any other related disease symptoms that may interfere with the safety and efficacy of the study results 6. long-term care institutions are protected resettlement or homeless people without legal representatives

Keywords: pressure injury patient wound infection nurses
imatinib mesylate and decitabine in treating patients with chronic myelogenous leukemia

Conditions: Accelerated Phase Chronic Myelogenous Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Childhood Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Relapsing Chronic Myelogenous Leukemia

Summary: this phase ii trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. giving imatinib mesylate together with decitabine may kill more cancer cells

objectives: i. determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine. ii. determine the survival rate of patients treated with this regimen. iii. determine the toxicity of this regimen in these patients. iv. determine the effects of this regimen on gene methylation in the leukemic cells of these patients. outline: patients are stratified according to prior exposure to imatinib mesylate (yes vs no). patients receive oral imatinib mesylate daily and decitabine iv over 1 hour daily, 5 days per week, for 2 consecutive weeks. courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed chronic myelogenous leukemia * philadelphia chromosome positive by cytogenetics or fluorescent in situ hybridization * accelerated or non-lymphoid blastic phase * performance status - ecog 0-2 * bilirubin no greater than 2 times upper limit of normal (uln) * ast no greater than 2 times uln * creatinine less than 2.0 mg/dl * normal cardiac function * no new york heart association class iii or iv heart disease * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior decitabine * at least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered * concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease * prior imatinib mesylate allowed * patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression * no concurrent grapefruit or grapefruit juice
clinical trial to assess efficacy of cyclosporine plus standard of care in hospitalized patients with covid19

Conditions: COVID19 Infection

Summary: the study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with covid19 infection may improve their prognosis.


Eligibility criteria:
inclusion criteria: 1. women and men over 18 years old 2. clinical diagnosis of covid19 infection (to be subsequently confirmed by pcr or specific igm isotype ac and with entry criteria according to the protocol of action (see annex 2) 3. acceptance and signing of the consent for the study after having received the appropriate information. exclusion criteria 1. known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components. 2. contraindication for the use of any of the medications included (\*) * csa: ir est 4.5 (fg \<30 ml / min according to the cockcroft-gault formula) * antimalarials (chloroquine, hydroxychloroquine): retinopathy, myasthenia gravis. * lopinavir / ritonavir: severe liver failure * remdesivir, darunovir-ritonavir * doxycycline, azithromycin 3. kidney failure (stages 4 and 5: gfr \<30 ml / min according to the cockcroft-gault formula). 4. decompensated liver disease (child-pugh stages b or c) or chronic infection with virus b 5. pregnancy or lactation 6. age over 75 years 7. participants in another clinical trial with medication in the 28 days prior to the start of recruitment. participation in observational studies is allowed. 8. refusal to participate 9. patient with a poor state of health or nutrition who, in the opinion of the researcher, has sufficient criteria of severity to interfere with the development of the study or its conclusions 10. at the investigator's discretion, the patient's inability to understand or comply with the study procedures
the effect of education on self-efficacy and adaptation to stoma of individuals with stoma

Conditions: Stoma Ileostomy; Stoma Colostomy; Self Efficacy; Adjustment; Colorectal Cancer; Colorectal Disorders

Summary: the aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. in addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.

after discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the association of wound ostomy incontinence nurses and video conference in four interviews. the first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. individuals with stoma in the control group received the training routinely given in the hospital. self-efficacy and compliance with stoma were measured at baseline and at 2 months. the ability to care for one's own stoma was evaluated at the end of the study.

Eligibility criteria:
inclusion criteria: * opening stoma for the first time, * stoma opening surgery dr. abdurrahman yurtaslan ankara oncology training and research hospital, 3rd floor surgical oncology clinic, * whether the opened stoma is a colostomy or an ileostomy, * able to speak and understand turkish, * be over 18 years old, * not having any mental problems that prevent them from being trained and practiced on stoma care, * not having an obstacle to performing stoma care on their own in terms of vision, hearing and motor skills, * possibility of meeting via video conference, * he voluntarily agrees to participate in the research. exclusion criteria: * previous stoma opening experience, * not being discharged within 10 days after the operation, * refusal to participate in the study.

Keywords: adaptation, colostomy, education, ileostomy, self-efficacy
3-4 year outcomes following endovenous steam ablation for venous insufficiency

Conditions: Varicose Veins

Summary: the aim of this study is to evaluate the long-term effects of endovenous steam ablation (evsa). postoperative data at 3-4 year follow-up will be collected from patients treated with evsa.

endovenous steam ablation (evsa) of saphenous veins (saphenous vein reflux) is one of the endothermal methods in the modern treatment of venous insufficiency. good results and long-term follow-up have been published for endovenous laser ablation (evla) and radiofrequency ablation (rfa), while long-term effects of evsa are less documented. therefore, the aim of this study is to evaluate the effect of evsa in 200 consecutive patients treated with evsa and conduct prospective evaluations at 3-4 year follow-up. standardized and validated measures will be compared to preoperative measures to evaluate change in patient-reported and clinical outcomes over time.

Eligibility criteria:
inclusion criteria: * received steam ablation for treatment of saphenous vein reflux (clinical classes c2-c4) at lovisenberg diakonale hospital 3-4 years (i.e, 36-48 months) prior to study enrollment. * ability to speak, understand, read, and write norwegian in order to complete follow-up exams and questionnaires. exclusion criteria: * \<18 years of age

Keywords: steam ablation endothermal ablation varicose vein treatment venous insufficiency saphenous vein reflux recurrent varicosity
use of a brief phone call after ed discharge

Conditions: Discharge Planning; Emergency Medicine; Geriatrics; Patient Readmission

Summary: the purpose of this study is to determine whether a phone call from a nurse within 1-3 days after discharge from the emergency department (ed) decreases return visits to the ed/ hospital admissions/ death (combined outcome) in patients age 65 and above. as secondary outcomes, time to follow up appointment with physician and economic impact of this intervention will be assessed. patients 65 years of age and older will be randomized following discharge from the ed into one of two groups. group 1(intervention) will receive a phone call collecting information about understanding of ed discharge instructions and guiding patient through the discharge instructions, and group 2 (placebo) will receive a follow up phone call for a satisfaction survey. we hypothesize return visits to the ed and readmission to the hospital will decrease as a result of the nurse phone call intervention.

procedures: all patients age 65 and above will be randomized to one of two groups within 1-3 days after discharge from the unc ed: 1) interventional follow-up phone call; or 2) placebo phone call, implementing only a satisfaction survey. the intervention phone call will ask whether patients have obtained the newly prescribed medicines, ask if the patient understands the instructions for taking the medicines and inquire if a patient has made an appointment with his/her personal physician. the caller will attempt to answer questions about the medicines, and encourage patients to take the medicines as directed. the caller will also encourage the patients to follow-up with their own physician in a timely manner and offer to help with setting up follow up appointments if needed. subsequently, 30-35 days after ed discharge, all patients will receive a phone call to evaluate rates of compliance with medicines and scheduling follow-up appointments. all calls will be made by trained nurses. using an α 0.05 and β 0.80 we will need to enroll 2235 patients to detect a decrease in ed return visits/re-admission/ death of 6%. there will be one interim analysis 1 year into the two year planned study.

Eligibility criteria:
inclusion criteria: * all patients age 65 and above discharged from the ed * english speaking exclusion criteria: * younger than 65 years of age * unable to pass 6-item memory screener * lives in skilled nursing facility

Keywords: geriatrics emergency medicine care transitions