Kornimate/medical-research-clean huggingface dataset:
inhibiting comt in parkinson's disease

Conditions: Parkinson's Disease

Summary: the overall aim of this observational study is to investigate the impact of comt inhibition on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in pd patients with certain comt genotype. it is designed to evaluate effect size of hcy lowering to secondary outcome parameters. assessment of outcome parameters will be rater-blinded or computer-based.


Eligibility criteria:
inclusion criteria: * age 60 - 75 years, * caucasian ethnicity, * diagnosed pd by uk brain bank criteria, * hoehn \& yahr scale 2 - 3, * fertile females have to use contraception * group 1: medication with stalevo® (l-dopa/ddi + entacapone) * group 2: medication with madopar® or sinemet® (l-dopa/ddi) exclusion criteria: * methotrexate therapy during the last 12 months, * treatment with tolcapone * vitamin b6, b12 and/or folic acid supplementation during last 6 months, * pregnancy, * intention to become pregnant during the course of the study, * breast feeding, * other clinically relevant concomitant disease states by discretion of the investigator * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, * participation in another study with investigational drug within the 30 days preceding and during the present study, * enrolment of the investigator, his/her family members, employees and other dependent persons.
does espb improve postoperative quality of recovery after vats

Conditions: Postoperative Pain

Summary: video-assisted thoracoscopic surgery (vats) is a minimally invasive surgery. despite reduced surgical trauma compared to the traditional thoracotomy approach, pain control after vats remains challenging. regional analgesia may be a crucial component of multimodal postoperative pain management. the use of nerve blocks, such as the recently described erector spinae plane block (espb) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery. this study aims to test the hypothesis that ultrasound-guided spb would improve the quality of recovery after vats by reducing acute postsurgical pain.

vats is a minimally invasive surgical technique to remove intrathoracic lesions. vats has become increasingly popular and gradually becoming the standard of care for lung surgery. although acute pain after vats is less than the traditional thoracotomy, patients still experience moderate amount of pain within the first 24 hours. however, the optimal regional analgesic technique for vats procedures has not been established. thoracic epidural analgesia (tea) and paravertebral block (pvb) have been tried to improve postoperative analgesia after vats. although tea and pvb provides superior analgesia, these technologies accompanied by the rare but serious complications involving epidural hematoma, pneumothorax and total spinal anesthesia. erector spinae plane block (espb) is a novel and simple ultrasound-guided regional anesthetic technique, providing analgesia for the ipsilateral hemithorax. ultrasound guidance is believed to improve peripheral and regional nerve block success rates and safety. espb is a technically easy to perform. espb has only been reported in case series but so far, no adverse events such as hypotension, hematoma or infection has been reported. given its safety, ease of performance and efficacy, the study aims to verify the hypothesis that combines espb with general anesthesia would accelerate functional recovery after breast cancer surgery. our secondary aims were to examine espb's effect on analgesic outcomes (e.g., postoperative pain intensity, cumulative opioid consumption, postoperative nausea and vomiting, dizziness, the postanesthesia care unit discharge time and patients' satisfaction) in patients undergoing vats.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists' physical status class of i or ii * scheduled for elective vats exclusion criteria: * a history of allergy to local anesthetics * known coagulation disorders * infection near the puncture site * chronic opioid use * inability to communicate, * other reasons that not appropriate for this study.

Keywords: ultrasound-guided erector spinae plane block quality of recovery
treatment with recombinant human growth hormone (gh) in children with short stature secondary to a long term corticoid therapy

Conditions: Endocrine System Diseases

Summary: * to assess the effect of a long-term treatment by genotonorm on linear growth in children with short stature receiving steroid therapy * to assess the effect of a long term treatment with genotonorm on bone mineralisation * to assess the effect of a long term treatment with genotonorm on body composition

this trial terminated on 10-jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. the decision to terminate was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * children with juvenile arthritis or nephrotic syndrome * before or during puberty exclusion criteria: * diabetes type 1 and 2 * endocrine disease, except well substituted hypothyroidism
a before and after study studying the impact of an analgesia protocol after discharge from outpatient surgery

Conditions: Postoperative Pain; Outpatient Surgery

Summary: the goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. the main question it aims to answer is: - measure the impact of the protocol on the proportion of patients with a vas greater than 3/10 on day one and who did not take the analgesics. the participants are divided into two groups. the control group leaves the hospital with instructions and prescriptions. the experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain.


Eligibility criteria:
inclusion criteria: * outpatient surgery * no age limit * accepted post-operative monitoring by text messages (sms) exclusion criteria: * refusal of post-operative follow-up by text messages (sms)
prospective validation study of a novel type iv home sleep apnea test

Conditions: Sleep Apnea

Summary: prospective validation study of the nightowl, a type iv home sleep apnea test (hsat), compared to a traditional type i and a type iv sleep monitor.

the purpose of this prospective validation study is the evaluation of the accuracy of the nightowl hsat to derive parameters relevant for the diagnosis of sleep apnea. the nightowl hsat comprises a finger or forehead mounted sensor and an automated analytics software. the sensor measures double-wavelength photo-plethysmography and accelerometry. the analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. for each patient in the cohort, the ahi derived by the nightowl will be compared to that of the type i sleep monitor (in-lab psg), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. on a randomly selected subset of patients, a type iv sleep monitor will additionally be applied for comparison of its automated ahi derivation to that of the nightowl.

Eligibility criteria:
inclusion criteria: * indication for a sleep study exclusion criteria: * mentally disabled people * known allergy to plexiglas (pmma) or other acrylates
educational efficacy of vr vs. simulator in emergency medical training

Conditions: Simulation Training

Summary: it has not been revealed which is more effective: an education program using virtual reality technology or a simulation education program using sim-man. in this study, the participants are new doctors who graduated from medical school and started working as interns at hospitals. the participants were divided into two groups. one group received a training program using virtual reality technology, and the other group received simulation training using sim-man. the investigators would like to compare the increase in confidence and satisfaction before and after training. after the classes and surveys are completed for each group, the participants will be able to receive other educational methods if they wish.

- the educational program was designed for participants to experience an emergency setting where a patient's oxygen saturation falls. the scenario starts with the decrease in the patient's oxygen saturation and the patient's condition could be changed according to the intern's management. the scenario includes various situations in which oxygen saturation could decrease, and the patient's condition changes depending on the expected responses of participants. the scenario has been revised and supplemented through expert meetings. * experience two types of cases: an easy case where the patient's condition improves just by connecting an oxygen line, and a difficult case where the patient's condition does not improve even after connecting an oxygen line. * a training program is prepared before the interns start work. the participants are divided into two groups (test group and control group). the test group wears an hmd (head-mounted display) and experiences both easy and difficult cases. * the control group participates in simulation training using sim-man, and the scenarios are the same for the test group (easy cases and difficult cases). * training on coping skills is provided through debriefing after vr and simulation. * after completing the assigned program, participants can take the program that was not assigned to them if they wish. * both the test and control groups will fill out questionnaires before and after training to see changes in confidence and coping skills before and after training.

Eligibility criteria:
inclusion criteria: * the medical interns who participate in the education program for medical interns, who will work as interns at seoul national university hospital from march 2024 * participants who agree to the purpose of the study and consent to participation exclusion criteria: * who do not consent to participate in the study

Keywords: emergency care performance
cusatuzumab in combination with background therapy for the treatment of participants with acute myeloid leukemia

Conditions: Leukemia, Myeloid, Acute

Summary: the purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * diagnosis of acute myeloid leukemia (aml) according to world health organization 2016 criteria . participants with acute promyelocytic leukemia (apl) are not eligible * must be ineligible for intensive chemotherapy * de novo or secondary aml * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * previously untreated aml except: emergency leukapheresis, hydroxyurea, and/or 1 dose 1-2 gram per meter square (g/m\^2) cytarabine during the screening phase to control hyperleukocytosis. these treatments must be discontinued greater than or equal to (\>=) 24 hours prior to start of study drug. empiric all trans retinoic acid (atra) treatment for presumed acute promyelocytic leukemia (apl) is permitted but apl must be ruled out and atra must be discontinued \>=24 hours prior to the start of study drug * contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies exclusion criteria: * leukemic involvement of the central nervous system * eligible for an allogeneic hematopoietic stem cell transplantation at study entry * received a live, attenuated vaccine within 4 weeks prior to initiation of study drug * a history of human immunodeficiency virus (hiv) antibody positive or tests positive for hiv if tested at screening * known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, azacitidine, or their excipients (example: mannitol, an excipient of azacitidine)
the effects of anodal and cathodal tdcs combined with conventional physical therapy in patients with acute stroke

Conditions: Stroke, Acute

Summary: the objective of the study is thus to compare the effects 5 consecutive sessions of anodal and cathodal tdcs combined with conventional physical therapy on upper and lower limb motor performance in acute stroke at immediate, and 1-month followup.

stroke is a major cause of long-term disability in stroke survivors that related with motor impairment. after stroke, the cortical excitability of ipsilesional hemisphere is decreased; in contrast, the cortical excitability of contralesional hemisphere is increased. conventional physical therapy is beneficial to motor recovery, but early rehabilitation was not always help the patients get full recovery. tdcs is an adjuvant tools which deliver weak direct current through scalp to promote motor recovery in stroke rehabilitation. the anodal-tdcs increases cortical excitability, while the cathodal-tdcs decreases cortical excitability. previous studies demonstrated that both monocephalic techniques of tdcs can improve motor function in chronic, subacute, and acute phase, but it is still inconclusive that which monocephalic montages had better effect, especially in acute phase. there are several studies supported the benefits of monocephalic tdcs combined with rehabilitation programs on upper and lower limbs motor function in acute stroke. however, there is no evidence that directly compared the effect of monocephalic tdcs in acute stroke patients. the objective of the study is to compare the effects of anodal and cathodal tdcs combined with conventional physical therapy for 5 sessions on motor performance in acute stroke at immediate, and 1-month follow-up.

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke patients who have aged between 18 and 75 years 2. having a first ever-ischemic stroke that are confirmed by mri/ct scan 3. post stroke onset 2-10 days 4. be able to follow command 5. be able to walk with or without assistive device (modified ranking scale ≤ 4) 6. free of any neurological antecedent or unstable condition (such as epilepsy) or cancer. 7. be able to initiate the upper limb movement exclusion criteria: 1. recurrent stroke 2. national institute of health stroke scale ≥ 20 points 3. presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker 4. having excessive pain in any joint of the lower limb (numerical pain rating score \> 4/10) 5. having an open wound or wound infraction on scalp 6. having neglect or psychological diseases (such as schizophrenia, major depression)
to evaluate the safety and efficacy of nvp-2203 tablet in patients

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to evaluate the efficacy and safety nvp-2203 in patients

this study is a multicenter, randomized, double-blind, parallel-group, phase 3 clinical trial to evaluate efficacy and safety of nvp-2203 in patients

Eligibility criteria:
inclusion criteria: * adults ≥ 19 years of age * primary hypercholesterolemia * subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing exclusion criteria: * the subject not meet the specified ldl-c level * patients who were diagnosed with a malignant tumor within five years before visit * inadequate subject for the clinical trial by the investigator's decision
combination casodex® and iressa™ in locally advanced prostate cancer

Conditions: Locally Advanced Prostate Cancer

Summary: the purpose of this study is to determine if the addition of zd1839 iressa™ to standard treatment with casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (psa) levels.


Eligibility criteria:
inclusion criteria: * 18 to 80 years of age. men with histologically confirmed locally advanced prostatic adenocarcinoma exclusion criteria: * no prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. no abnormal laboratory values. no co-existing malignancies and any other significant clinical disorder or laboratory finding.
the effect of intraoperative use of dexmedetomidine during the daytime operation vs the nighttime operation on postoperative sleep quality and pain under general anesthesia

Conditions: Postoperative Pain; Postoperative Sleep Quality; Intraoperative Dexmedetomidine; General Anesthesia

Summary: general anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep. some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (rem) and slow wave sleep (sws), which have signiﬁcant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.clinical trials have already proved that intraoperative use of dexmedetomidine (dex) for general anesthesia, a highly selective alpha-2 adrenergic agonist, was able to improve sedative and analgesia effects and promote sleep quality (by decreasing stage n1 sleep, increasing stage n2 sleep and sleep efficiency). however, wenfei tan et al reported that with the deeper sedative state provided by dex in the daytime, the elderly male patients undergoing turp under spinal anesthesia suffered worse sleep on the night of surgery. thus, what the effect of intraoperative using dex at different time periods under general anesthesia on postoperative sleep quality and pain will be needs further study.

patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were enrolled. patients were randomized to receive operation in the d group (8:00-12:00) and the n group (18:00-22:00). the portable sleep monitor (psm) was performed on the following 3 nights: the night before surgery (sleep1), the ﬁrst night after surgery (sleep 2), and the third night after surgery (sleep 3). postoperative pain scores using visual analogue scoring scale, subjective sleep quality using the athens insomnia scale, total dose of general anesthetics and pca pump press numbers were also recorded.

Eligibility criteria:
inclusion criteria: age between 30 and 55 years american society of anaesthesiologists physical status i or ii. exclusion criteria: cardiovascular disease long term use of analgesia preoperative heart rate (hr) less than 50 beats/min second- or third-degree atrioventricular block sleep disorder sleep apnea syndrome history of abnormal operation or anesthesia recovery psychosis or a patient with a language communication disorder not willing to cooperate with the experimenter.

Keywords: postoperative pain postoperative sleep quality dexmedetomidine general anesthesia
childhood acute lymphoblastic leukemia treatment protocol moscow-berlin 2015 (all-mb 2015)

Conditions: Childhood Acute Lymphoblastic Leukemia

Summary: questions and objectives of all-mb 2015 study 1. will the new risk group stratification (especially of t-all) to improve overall and event-free survival? 2. will the new protocol is effective and feasible in patients older than 15 years, and especially in young adults? 3. whether the intermittent dexamethasone administration in induction will result in a decrease in toxicity and mortality without loss of efficacy? 4. whether the methylprednisolone administration as basic glucocorticoids during induction, consolidation and maintenance therapy will lead to decrease of severe infections and early mortality rate, improve survival and therapy compliance in adolescents and young adults with b-precursor all? 5. whether the administration of bortezomib in patients with b-precursor all with initial wbc≥100,000/µl will improve treatment outcome? 6. whether the administration of idarubicin instead daunorubicin in low-risk t-all patients and two-phase induction in intermediate-risk t-all patients will reduce relapse rate and improve survival?


Eligibility criteria:
inclusion criteria: * age at diagnosis at 1 to 50 years. * the start of induction therapy within a time interval of study recruitment phase. * the diagnosis of all is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow (see "diagnostics"). patients with b-cell (burkitt) all are excluded. * informed consent of the patient parents (guardians) to be treated in one of the clinics included in this multicenter study. exclusion criteria: * all is a second malignancies; * the disease is a relapse of previously misdiagnosed and, therefore, inadequately treated all; * there is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.); * there is a lack of important data needed for the exact adherence to the cytostatic therapy according to a specific chemotherapy protocol (differential diagnosis of all-aml (acute myeloid leukemia) is not possible, stratification according to therapeutic group is not possible); * the patient was treated before for a long time with cytotoxic drugs; * there were treatment deviations not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease

Keywords: acute lymphoblastic leukemia, children, adolescents, treatment
the effect of omega-3 fa on glucose and lipid homeostasis disorders in obese/diabetic patients

Conditions: Hyperglycaemia (Diabetic); Hyperlipidemias

Summary: a double-blind and placebo-controlled study is conducted in the current human study. the purpose of this study is to investigate the effects of n-3 pufa intervention on glucose and lipid homeostasis in chinese diabetic/obese patients.

approximately 450 diabetic and 450 obese patients will be enrolled from lanxi in china. they will be randomly assigned into one of the following three groups: omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. blood, feces and urine samples will be collected before and after treatment. glucose and lipid parameters will be measured. diabetes comorbidities and complications will also be assessed. this study will also explore the new mechanisms of n-3 pufas on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.

Eligibility criteria:
inclusion criteria: * diagnosed type 2 diabetes for diabetic groups according to who diagnostic criteria; * bmi≥28 for obese groups; * aged between 40 and 75 years. exclusion criteria: * type 1 diabetes; * cardiovascular disease; * cancer; * liver or kidney disease; * premenopausal women, pregnancy or lactation; * allergy to fish; * have participated in other clinical trials in the last three months.

Keywords: type 2 diabetes obesity omega-3 fatty acids