Kornimate/medical-research-clean huggingface dataset:
a post-approval registry for exablate 4000 type 1.0 and type 1.1 for unilateral thalamotomy for the treatment of medication-refractory tremor dominant idiopathic parkinson's disease

Conditions: Tremor Associated With Tremor Dominant Parkinson's Disease

Summary: the objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant parkinson's disease (tdpd) using the exablate neuro system.

this is a post-approval registry which is required by of the approval under pma p150038/s006 for the exablate® model 4000 (exablate neuro) type 1.0 and type 1.1 for unilateral thalamotomy in the treatment of medication refractory tremor dominant parkinson's disease (tdpd). subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available exablate neuro for the treatment of essential tremor and tdpd. the following assessments will be collected at baseline,1, 3, 6, and 12 months post exablate procedure and annually thereafter for 5 years: * adverse events (aes) (does not apply to baseline visit) * medication usage * clinical rating scale for tremor (crst) on medication * unified parkinson's disease rating scale part iii on medication * eq-5d-5l * wpai-gh

Eligibility criteria:
inclusion criteria: 1. men and women, age 30 years and older 2. subject undergoing an exablate procedure for their planned tdpd treatment; per local institution standard of care. 3. subject is willing to cooperate with the registry requirements including compliance with the regimen and completion of all study visits 4. subject has signed and received a copy of the approved informed consent form exclusion criteria: subject does not agree to participate or is unlikely to participate for the entirety of the study.
delirium at the intensive care unit - a retrospective cohort study

Conditions: Delirium; Intensive Care Unit Syndrome

Summary: this project seeks to describe the incidence of delirium in the intensive care unit (icu) and to identify risk and preventive factors associated with development of delirium. especially, the investigators want to investigate if an imitated natural light/dark cycle influences frequency of delirium.

a common problem for patients in the icu is episodes of delirium. recent trials have described incidences ranging from 60-87% of patients in a number of different countries. delirium is a condition with fluctuating conscience, disorganized thinking and disturbance of the sleep/wake cycle. many patients with delirium experience hallucinations and agitation which can be very unpleasant for both patients and their families. some risk factors for the development of delirium well known, e.g. dementia, hypertension, illness severity (saps ii score), delirium on the previous day, mechanical ventilation, emergency surgery and metabolic acidosis. the effect of sedative drug administration is not clear, as studies has been inconclusive. even though studies regarding the impact of sleep deprivation on development of delirium have been inconclusive, there is no doubt that delirious patients have a disturbed sleep-wake cycle, sleep architecture and circadian rhythm. at the intensive care unit at the department of anesthesiology at køge hospital, three out of nine rooms have a simulated circadian light installed. the idea is that this light rhythm may help to keep a natural circadian rhythm, minimizing the risk of delirium. with this descriptive and retrospective cohort study, the investigators therefore want to describe the incidence and possible risk- and preventive factors of delirium for the participants (icu patients at køge hospital), and with a special focus on the possible effect of imitated circadian light..

Eligibility criteria:
inclusion criteria: * patients \>18 years of age admitted to the icu at køge hospital in the study period exclusion criteria: * richmond agitation sedation score (rass): -4 or -5 during the whole study period * no cam-icu scores during the icu stay * unable to communicate in danish (aphasic, deaf, non-danish speaking, severe brain damage) * severe dementia documented in electronic patient charts (opus) * patients not receiving active treatment (moribund patients)
isoflavones & lycopene in localized prostate ca:prior to radical prostatectomy

Conditions: Prostate Cancer

Summary: rationale: eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer. purpose: randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage i or stage ii prostate cancer.

objectives: * compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer. * compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients. * compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients. * compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients. * compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group. outline: this is a randomized, multicenter study. patients are stratified according to disease stage (stage i vs stage ii) and presence of high-grade prostatic intraepithelial neoplasia. patients are randomized to 1 of 7 treatment groups. projected accrual: a total of 87 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed localized prostate cancer * stage i or ii * scheduled prostatectomy between 4-6 weeks after initial biopsy patient characteristics: age: * 45 to 80 performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * no known history of hepatic disease renal: * no known history of renal disease other: * no known history of thyroid disease * body mass index no greater than 32 * omnivorous diet * no known allergy to study supplements * no evidence of prostatitis or urinary tract infection * no other prior malignancy except nonmelanoma skin cancer * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * no concurrent thyroid hormone replacement medications radiotherapy: * not specified surgery: * see disease characteristics other: * at least 30 days since prior antibiotics * at least 30 days since prior diet high in soy and/or lycopene products (e.g., greater than 40 mg soy/day and/or greater than 15 mg lycopene/day) * no other concurrent nutritional supplements, including modular supplements with other carotenoids and isoflavones * no prior or concurrent therapy for prostate cancer

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer
treating patients with renal impairment and altered glucose metabolism with therapeutic carbohydrate restriction and sglt2-inhibiton - a pilot study

Conditions: Chronic Kidney Diseases; Diabetes Mellitus; PreDiabetes; Overweight and Obesity

Summary: this randomized controlled trail will evaluate the efficacy and safety of a simultaneous therapeutic carbohydrate restriction and treatment with the sodium-glucose-transporter-2-inhibitor dapagliflozin in comparison to the standard of care treatment in patients with chronic kidney disease and prediabetes or type 2 diabetes mellitus. participants will be randomized 1:1. the interventional group will be educated on how to implement a therapeutic carbohydrate restriction (50-100 grams of carbohydrates per day). regarding safety, the patients of the interventional group will be provided with continuous glucose monitoring systems and blood ketone meters. the participants of the control group will continue to receive the standard of care therapy for the treatment of chronic kidney disease and prediabetes or type 2 diabetes mellitus. both groups will be treated with dapagliflozin.


Eligibility criteria:
inclusion criteria: * chronic kidney disease stage kdigo 3a-4 (egfr egfr 25-59 mg/min/1.73m²) * prediabetes or diabetes according to the guideline of the american diabetes association (hba1c \>5,7 percent, or fasting glucose values \> 100 mg/dl, or glucose levels \> 140 mg/dl at 2h during an oral glucose tolerance test) * being overweight (body mass index \> 25.0 kg/m²) * being able to independently: * - perform measurements of blood glucose and ketone levels * - use a continous glucose monitor * - contact the study team exclusion criteria: * patients who are allergic to sglt-2-inhibitors * patients with autoimmune diabetes (typ 1 or lada) * patients with pancreoprivic diabetes * patients with a history of ketoacidosis or lactate acidosis * patients with severe hypoglycemic episodes in the 6 moths prior to inclusion * patients with bariatric surgery (in the past or planed) * patients with nephritic range proteinuria (\>3,5g of albumin/day) * patients with active malignant diseases * pregnant or breastfeeding patients

Keywords: low carbohydrate diet carbohydrate restriction sglt-2-inhibitors
kinesio taping versus oromotor training on drooling in children with spastic cerebral palsy

Conditions: Drooling; Kinesiotape; Cerebral Palsy

Summary: statement of the problem : which is more effective for treatment of drooling in children with spastic cerebral palsy; kinesio taping or oromotor training? null hypothesis: there will be no difference between the effectiveness of kinesio taping and oromotor training on drooling in children with spastic cp.

subjects: the study targets the children with spastic cerebral palsy from both sexes , sample size estimation will be carried out to determine the recruited number of children ,children participating in this study will be selected randomly from cairo pediatric physical therapy centers to participate in this study. study design: a comparative experimental design (prospective pre-test post-test design with 2 months follow-up evaluation) . children will be assessed by measuring the drooling before and after two months of receiving intervention.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of spastic cerebral palsy with drooling problem. 2. the age of the selected children will range from 4to 8 years old. 3. severe degree of drooling according to drooling severity and frequency scale. 4. child with good head control exclusion criteria: 1. congenital problems of mouth and soft palate such as cleft lip and palate, jaw anomalies and salivary gland pathologies. 2. epilepsy. 3. child receiving drugs that could affect saliva production or other treatments to control drooling just before or during the study. 4. allergic reactions to the kinesio tape.
combined bronchodilators in chronic obstructive pulmonary disease and the risk of adverse cardio-pulmonary events

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: background: recent observational studies have reported possible arrhythmogenic effects with long-acting beta-agonists (laba), while the long-acting anticholinergic tiotropium has been associated with cardiovascular and cerebrovascular events. finally, pneumonia was the object of a recent signal in trials of labas submitted for marketing approval. aim: to assess the potential cardio-pulmonary risk arising from the concurrent use of two long-acting bronchodilators as well as from monotherapy use of each of the long-acting bronchodilators. methods: a series of population-based cohort studies, using both cohort and nested case-control analyses will be conducted using data from the united kingdom's clinical practice research datalink (cprd). the base cohort will consist of new users of long-acting bronchodilators from jan 2002 until aug 2012, age \>= 55 with chronic obstructive pulmonary disease (copd) and at least two years of baseline medical history information. the high-dimensional propensity score technique will be used to match new users of each long-acting bronchodilator and new users of two bronchodilators with comparable subjects from the base cohort, with one-year follow-up for outcomes of acute myocardial infarction, stroke, heart failure, arrhythmia and community acquired pneumonia. data will be analysed using time-dependent cox proportional hazard regression models and conditional logistic regression models.

purpose:

Eligibility criteria:
inclusion criteria: * new users of long-acting bronchodilators, either a laba or tiotropium, between january 2002 and august 2012 * age \>= 55 years exclusion criteria: - use of laba or tiotropium in the two years prior to cohort entry
radiation dosimetry, metabolism, safety, tolerability and positron emission tomography/computed tomography (pet/ct) imaging with bay 85-8050 in healthy volunteers and patients

Conditions: Neoplasm

Summary: this study is a visual assessment of diagnostic pet/ct images obtained after a single intravenous injection of bay85-8050 in patients with cancer


Eligibility criteria:
inclusion criteria: * healthy volunteers only * males/females, \>/=50 and \</= 65 years of age * cancer patients only * males/females \>/= 35 years and \</= 75 years of age * patient had an fdg pet/ct for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass exclusion criteria: * concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay85-8050, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study * known sensitivity to the study drug or components of the preparation

Keywords: neoplasm pet/ct diagnosis pet tracer
assessment of hemostasis disorders in rtpa-treated patients requiring endovascular treatment for ischemic stroke

Conditions: Stroke, Acute

Summary: stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery occlusion and sometimes neurosurgery. it rises questions regarding hemostasis: thrombolysis induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of these effects are unknown. thus management of antithrombotics and hemostasis during thrombectomy and surgery is an issue. objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis, coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to evaluate the time required for the normalization of these disorders. methods : observational monocentric study including rtpa-treated patients requiring endovascular treatment for stroke. blood sampling within the first 48 hours after rtpa administration to assess of fibrinolysis, coagulation and platelet functions with point of care devices and specific laboratory tests. record of clinical and biological data.


Eligibility criteria:
inclusion criteria: * patient over 18 * treatment with rtpa for an acute stroke * endovascular treatment required exclusion criteria: * opposition to participate in the study * long term anticoagulant-treated patient * pregnant patient
managed access programs for lee011, ribociclib

Conditions: Breast Cancer

Summary: the purpose of this registration is to list managed access programs (maps) related to lee011, ribociclib

clee011a2408 - no longer available - managed access program (map) cohort to provide access to ribociclib (lee011, kisqali®), for locally advanced or metastatic cancer resistant or refractory to available treatment options and candidate for therapy with a cdk inhibitor (including tumors with d-cyclin-cdk4/6-ink4a-rb pathway abnormalities) clee011a2006m - available - managed access program (map) cohort to provide access to ribociclib for patients diagnosed with early-stage hr+her2 (stages ii and iii) - breast cancer requiring adjuvant treatment with an et based regimen

Eligibility criteria:
inclusion criteria: 1. an independent request was received from a licensed physician. 2. the patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. 3. the patient is not eligible or able to enroll in a clinical trial or continue participation in such trial. 4. there is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. 5. the patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). 6. provision of the product will not interfere with the initiation, conduct, or completion of a novartis clinical trial or overall development program. 7. managed access provision is allowed per local laws/regulations.

Keywords: map manage access program breast cancer clee011 ribociclib
ultrathin bronchoscope and radial endobronchial ultrasound (r-ebus) with fluoroscopy versus standard fiberoptic bronchoscopy (fb) (p00029233 )

Conditions: Pulmonary Lesions; Pulmonary Nodules; Pulmonary Mass

Summary: the purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: procedure #1: standard fiberoptic bronchoscopy (fb) with fluoroscopy, and procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (r-ebus). these two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) use fluoroscopy, which is a technique that uses x-rays to see your lungs. this will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if r-ebus provides better results than standard bronchoscopy.


Eligibility criteria:
inclusion criteria: 1. patients with a solid lung lesion 2-5cm identified on chest ct with the intention to undergo bronchoscopic evaluation. if the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up \>75% of the lesion and measure at 2-5cm.the decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. this will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment. or 2. patients with a solid lung lesion 2-5cm identified on chest ct that are surgical candidates with a high probability of cancer (\>65%) will be referred for surgical evaluation. if the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up \>75% of the lesion and measure at 2-5cm. if the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study. all sites will use the same online calculator to document probability of malignancy. 3. are at least 22 years old, 4. lack bleeding disorders, and 5. are able to provide informed consent exclusion criteria: 1. patients with a pure ground-glass opacity identified on chest ct 2. patients with endobronchial involvement seen on chest ct. 3. patients who refuse to participate, 4. are less than 22 years of age, 5. lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, and 6. are unable to provide informed consent 7. pregnant

Keywords: peripheral pulmonary lesions solitary pulmonary lesions multiple pulmonary lesions
dimensional validation of the hallux valgus orthosis

Conditions: Hallux Valgus

Summary: the goal of this project is to optimize the design of the orthosis by establishing the key volumetric characteristics of the custom iterations in order to subsequently transpose them to a standard model and establish the increment proportions of the different sizes. the final product should reduce the pain by repositioning the phalanges of the first toe with the first metatarsal in its axis.


Eligibility criteria:
inclusion criteria: * painful hallux valgus * three people maximum per shoe size exclusion criteria: * people with diabetes ; * people with severe obesity ; * people with hallux rigidus; * people wearing full-time foot orthosis; * people wearing high heel shoes regularly ; * people with degenerative disease ; * people with neuromuscular pathology ; * people with a circulatory disorder ; * people who have had major lower body surgery; * people with epilepsy or with a history of epilepsy.
effects of preoperative anxiety and depression on short-term postoperative recovery in early gastric cancer

Conditions: Postoperative Complications; Anxiety; Depression; Coping Behavior

Summary: this study aims to investigate preoperative anxiety, depression, and coping strategy of the patients undergoing laparoscopic gastrectomy for early gastric cancer and their effects on short-term postoperative recovery measured by quality of recovery-15 (qor-15). the findings of the study would improve the perioperative management of early gastric cancer patients.

the researchers plan to investigate preoperative psychological factors such as anxiety, depression, and coping strategy in association with short-term quality of recovery from surgery in 100 patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy). the following items are investigated before surgery; age, sex, bmi, level of education, occupation, marital status, ecog performance status, asa physical status, apfel score, history of mental disorder, type of surgery, past surgical history, the number of days from diagnosis of cancer to surgery, clinical stage of cancer, histological type of cancer, presence of chronic pain, quality of recovery-15 (qor-15), hospital anxiety and depression scale (hads), amsterdam preoperative anxiety and information scale (apais), coping and adaptation scale-short form (caps-sf). the qor-15 is investigated for 24, 48, and 72 hours after surgery. the severity of postoperative pain by the 11-point numerical rating scale (nrs) is concurrently measured at 24, 48, and 72 hours after surgery. in addition, the researchers measure postoperative complications, particularly nausea/vomiting, at 24, 48, and 72 hours after surgery and length of stay by counting the number of days from the day of surgery to discharge.

Eligibility criteria:
inclusion criteria: * age 18 years or above * patients scheduled for early gastric cancer surgery (laparoscopic gastrectomy) under general anesthesia * asa status i or ii * able to read and understand the information sheet, the questionnaires, and the consent form. exclusion criteria: * unable to read and understand the information sheet, the questionnaires, and the consent form. * age above 80 years * with severe medical or psychological diseases

Keywords: postoperative complications anxiety depression coping behavior