Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability study of apl-130277 for the acute treatment of off episodes in patients with parkinson's disease

Conditions: Parkinson Disease, Off Episodes

Summary: a 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, phase 3 study in l-dopa responsive pd patients with motor fluctuations ("off" episodes), designed to determine the efficacy, safety and tolerability of apl-130277.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age. * clinical diagnosis of idiopathic pd, consistent with uk brain bank criteria. * clinically meaningful response to l-dopa with well-defined early morning "off" episodes, as determined by the investigator. * receiving stable doses of l-dopa/carbidopa (immediate or cr) administered at least 4 times per day or rytary™ administered 3 times per day, for at least 4 weeks before the initial screening visit * no planned medication change(s) or surgical intervention anticipated during the course of study. * patients must experience at least one well defined "off" episode per day with a total daily "off" time duration of ≥ 2 hours during the waking day, based on patient self-assessment. * stage iii or less on the modified hoehn and yahr scale in the "on" state. * mmse score \> 25. exclusion criteria: a patient will not be eligible for study entry if any of the following exclusion criteria are met: * atypical or secondary parkinsonism. * previous treatment with any of the following: a neurosurgical procedure for pd; continuous s.c. apomorphine infusion; or duodopa/duopa. * treatment with any form of s.c. apomorphine within 7 days prior to the initial screening visit (sv1). patients that stopped s.c. apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered. * contraindications to apokyn®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of apokyn® (notably sodium metabisulfite); tigan® (trimethobenzamide hydrochloride; patients from us sites only); or domperidone (patients from non-us sites only). * participation in a clinical trial within 30 days prior to the initial screening visit (sv1). * currently taking selective 5ht3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. * drug or alcohol dependency in the past 12 months. * history of malignant melanoma. * clinically significant medical, surgical, or laboratory abnormality in the opinion of the investigator. * major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult. * history of clinically significant hallucinations during the past 6 months. * history of clinically significant impulse control disorder(s). * dementia that precludes providing informed consent or would interfere with participation in the study.

Keywords: parkinson disease, off episodes
development and validation of the bvq

Conditions: Chronic Respiratory Disease

Summary: the main aim of this study is the development of the beliefs about ventilation questionnaire (bvq).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * indication to non invasive ventilation (niv), in three slots: \ 4 e \<12; \<12 hours * outpatients or inpatients * obstructive or restrictive reparatory disorder * voluntary agreement to be involved in the study exclusion criteria: * psychiatric disorder * glasgow coma scale (cgs) \<14 * pure obstructive sleep apnea syndrome (osas) * tracheostomy with invasive ventilation (tiv) o invasive ventilation (iv)

Keywords: non invasive ventilation (niv) adherence beliefs development validation
documentation of cardiac arrhythmias after open heart surgery

Conditions: Cardiac Arrhythmias

Summary: this study aims at recording cardiac arrhythmias in patients after open heart surgery. the arrhythmias will be monitored during the entire first postoperative period, till six weeks after surgery.

approximately 30-50% of patients after cardiac surgery develop cardiac arrhythmias, most often atrial, and most frequently atrial fibrillation (af). various risk factors, inter alia, the type of surgery itself are risk factors. the major additional risk factors for postoperative atrial fibrillation are: age, valvular involvement, length of cardiopulmonary bypass and cross-clamp times. postoperative atrial fibrillation is associated with increased length of stay, higher morbidity and mortality including stroke. documentation of postopertive atrial fibrillation is well gathered during the postopertive length of stay, but scarce information exists regarding the development and occurence of atrial arrhythmias after the patient's discharge. additionally, the various management protocols which exists with regard to postoperative atrial fibrillation, rely on continuous treatment of the patients with amiodarone or various other anti-arrhythmic agents for the initial postoperative period, and the initial first month after discharge. so far there is not an unambiguous recommendation regarding the duration of treatment required with amiodarone after releasing the patient. the aim of this study is to document and record cardiac arrhythmias in patients after open-heart surgery within the time window since the release from hospital and up to six weeks after surgery. results of the study will allow us to fully characterize postoperative arrhythmias and their risk factors.

Eligibility criteria:
inclusion criteria: 1. 18 years or older. 2. patients after open-heart surgery (any type of surgery). exclusion criteria: 1. patients with internal pacemaker. 2. patients with known basic arrhythmia (pre-surgery) or patients who are discharged with some arrhythmias. 3. patients with low response which it is expected that there will not be able to use the monitoring device
nbi to detect post-rt mucosal residual npc

Conditions: Nasopharyngeal Carcinoma

Summary: nbi has been proven to be a useful tool to detect early npc, but they were few studies concerning the detection of post-radiotherapy mucosal residual npc using nbi system

background npc has a uniquely high prevalence in southern china. according to the hong kong cancer registry in 2012, npc was the sixth commonest cancer in men and thirteenth in women. it accounted for 2.9% of all new cancer cases. in 2012, there were 819 new cases of npc. npc is highly radiosensitive. radiotherapy and chemotherapy are the mainstay of treatment. despite the chemo-irradiation, disease control failure still occurred in npc patients presenting as persistent tumor. early detection of those post-radiotherapy residual npc is essential for early arrangement of salvage therapy. detection methods include imaging, plasma epstein-barr virus dna, endoscopy examinations and nasopharynx biopsy. nbi system has been well proven as a tool to detect early digestive tract cancer and head and neck cancer. however, there were only few studies targeting the detection of post-radiotherapy mucosal residual of npc using nbi system objective 1. to identify the vessel pattern of those confirmed npc case using nbi system 2. to identify the endoscopy features of post-radiotherapy mucosal residual nasopharyngeal carcinoma using nbi system 3. to establish the positive predicted value, negative predicted value, sensitivity and specificity of using nbi system for detecting mucosal residual npc method: 1. all newly biopsy confirmed npc patient will be assessed, their nasopharynx endoscopic image will be captured using both wl + nbi system 2. at post-radiotherapy 8th weeks, endoscopic examination will be arranged for patient using both wl + nbi system, biopsy will also be taken to detect mucosal residual npc

Eligibility criteria:
inclusion criteria: * all new npc patient exclusion criteria: * history of radiotherapy to head and neck region * poor premorbid status/ non-communicable patients * \<18 years old * pregnancy

Keywords: nasopharyngeal carcinoma narrow band imaging
dexrazoxane as a protective agent in anthracycline treated breast cancer

Conditions: Breast Cancer

Summary: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. radiation therapy uses high-energy x-rays to damage tumor cells. ctnt/ctni/anp/bnp were proved to be used as a biomarker of drug related cardiotoxicity. there are excellent correlations between the total cumulative dose of doxorubicin, the severity of the resulting cardiomyopathy, and the level of serum troponin-t.

patients with breast cancer receiving anthracycline chemotherapy randomized to 3 groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane, chemotherapy only.every patient receive at least 2 cycles anthracycline chemotherapy.

Eligibility criteria:
inclusion criteria: disease characteristics: * histologically confirmed primary infiltrating adenocarcinoma of the breast * confirmed by core needle biopsy or incisional biopsy or surgery * experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy * at least 2 cycles same anthracycline based chemotherapy are needed exclusion criteria: * accumulated dose of epi ≥1000mg/m2,adm≥550mg/m2 * with the following risk factors: uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); prior or concurrent radiation to heart * pregnant or nursing * other currently active malignancy except nonmelanoma skin cancer * uncontrolled or severe bleeding,diarrhea,intestinal obstruction * grade 2 or more cardiac toxicity (ctc ae3.0)

Keywords: cardioprotection anthracycline chemotherapy breast cancer
effects of long acting bronchodilators on cardiac autonomic control in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this interventional, randomized, double-blind, monocentric, cross-over study is to quantify the possible deleterious effect on the cardiac autonomic nervous system control of two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild copd.

this is a cross-over study with randomization in terms of 4 treatments: two long-acting muscarinic antagonists (tiotropium and glycopyrronium), one long-acting beta-adrenoceptor agonist(indacaterol) and placebo. each subject will pass 4 experimental random sessions, separated by at least 48 hours given the pharmacokinetic properties of the drugs tested. during each of the 4 sessions, blood pressure will be measured. drugs inhaled by the patient will be prepared and administered by the nurse according to the randomization schedule. patients and investigators will be blinded regarding the administered drug/placebo (anonymized inhaler). after 15 minutes (at rest, at neutral temperature), patients will have continuous measurement of blood pressure and heart rate (by a sphygmomanometer) (1) in supine position and (2) after a passive tilt test on a tilt test table. a flow-volume loop (bdv) will be performed after the tilt table test (measurement of forced expiratory volume in 1 second (fev1) and fvc).

Eligibility criteria:
inclusion criteria: * patients with fev1 / fvc \<70% exclusion criteria: * beta blocker * supraventricular rhythm disorder * previous history of respiratory disease other than copd * diabetes * autonomic dysfunction * dysautonomia * renal failure * long-term oxygen therapy * history of psychiatric illness

Keywords: copd bronchodilatators autonomic nervous system cardiovascular system
paclitaxel and cisplatin for thymic neoplasm

Conditions: Thymoma; Thymic Carcinoma

Summary: to assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed invasive thymoma or thymic carcinoma * unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator) * no previous systemic treatment for invasive thymoma or thymic carcinoma * at least one measurable lesion by recist criteria * 18 years old or older * ecog performance status 0, 1, 2 * adequate lab. findings neutrophil ≥ 1.5 x 10\^9/l platelet ≥ 75 x 10\^9/l hemoglobin ≥ 9.0 g/dl bilirubin ≤ 1.5 x upper normal limit ast, alt ≤ 2.5 x upper normal limit alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine \> 1.0 x upper normal limit, creatinine clearance ≥ 60 ml/min * patient who agree to written, informed consent exclusion criteria: * other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection) * active bacterial infection * history of clinical trial with investigational drug within 30 days * radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted) * pregnant, or lactating women * patient with organ transplantation * peripheral neuropathy, grade 2 or greater * severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year * uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance

Keywords: thymic epithelial tumor paclitaxel cisplatin thymic carcinoma invasive thymoma
prevalence of hospital malnutrition in afghanistan

Conditions: Malnutrition

Summary: this study aims to determine the prevalence of malnutrition among adult patients in hospitals across afghanistan.

malnutrition is associated with negative patient outcomes and increased healthcare costs. the purpose of this cross-sectional study is to determine the prevalence of malnutrition at admission or discharge in adult patients in hospitals across afghanistan. the secondary outcome is to assess risk factors for malnutrition.

Eligibility criteria:
inclusion criteria: * all admitted or discharged patients age 18-65 * males and females * conscious * informed consent provided exclusion criteria: * patients undergoing surgery on the data collection day * outpatients * pregnant females * pediatric patients patients with psychiatric or eating disorders patients on dialysis

Keywords: malnutrition nutrition disorders
ancillary study of methylation biomarkers in a randomized controlled trial of a personalized prevention of colorectal cancer

Conditions: Colorectal Cancer

Summary: based on the magnesium tolerance test (mtt, "gold standard" for assessing magnesium (mg) status), it was found that over 50% of participants in the us exhibited mg deficiency. studies suggest that the relationship between high mg intake and disease risks may be varied by an individual's mg status. despite its importance, mtt is not commonly employed in routine clinical practice or research studies. instead, serum mg levels are typically used for clinical diagnosis, although this method has shown limited efficacy in identifying mg deficiency accurately. consequently, there is a pressing need to develop practical, sensitive, and specific biomarkers that can efficiently identify individuals with mg deficiency. it is known that dna methylation changes are inducible by environmental exposures, including nutrients, and reversible when the exposure disappears. there are two major types of dna methylation modifications, 5-hydroxymethylcytosine (5-hmc) and 5-methylcytosine (5-mc). 5-mc is often associated with suppressed gene expression. 5-hmc, generated by the oxidation of 5-mc, is specifically enriched in expressed genes and play a critical role in activating and/or maintaining gene expression. we plan identify 5-hmc and 5-mc for mg deficiency by a 4- phase comprehensive epigenome-wide association study (ewas) using the samples collected in the "personalized prevention of colorectal cancer trial \[ppcct, r01ca149633; pi, dai \& yu\]" . the parent trial \[nct04196023\] that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of reducing the ca:mg ratio among those who consume high ca:mg ratio diets to decrease the risk of colorectal cancer. for this ancillary trial research, the investigators are examining ancillary measures of changes of cytosine modification in tmprss2.


Eligibility criteria:
inclusion criteria: 1. participants from our parent study (personalized prevention of colorectal cancer trial, nct#01105169, irb#100106); 2. participants consent to store/share biospecimens for future research. exclusion criteria: 1. participants cannot provide their blood samples in the parent study.
a single-center trial of patients with aortic dissection in the chinese xinjiang province

Conditions: Aortic Dissection

Summary: to evaluate epidemiological features of risk factors for aortic dissection (ad) in chinese xinjiang province patients.

the epidemiological features of risk factors for aortic dissection (ad) in china were obtained from developed population in east of china, however, such information was not available for the remote population. moreover, people in the western region have significant difference with developed population in lifestyle, diet, ethnic and so on. therefore, the aim of our study was to evaluate epidemiological features of risk factors for ad in chinese remote patients. we anticipated that this analysis would provide helpful information preventing and controlling ad in chinese xinjiang province.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of aortic dissection 2. ≥18 years old 3. good compliance with the instructions and cooperate with follow-up voluntarily signed the informed consent form exclusion criteria: 1. pregnant or lactating female 2. bad compliance with the instructions and follow-up 3. estimated remaining life is less than 12 months 4. aortic aneurysm、acute myocardial infarction、acute cerebral accident

Keywords: aortic dissection chinese xinjiang province
treatment of pemphigus patients with rituximab 1000mgx2 and assessment of immune status via cylex

Conditions: Pemphigus

Summary: the purpose of this study is to determine whether rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. it also tests immune function via the cylex assay in pemphigus patients before and after treatment with rituximab.


Eligibility criteria:
inclusion criteria: 1. pemphigus patients with moderate-severe disease exclusion criteria: 1. pregnancy or lactation 2. woman of reproductive age not using birth control measures. 3. prior severe allergy or anaphylaxis with a human monoclonal antibody 4. heart failure 5. unstable angina or ischemic heart disease 6. uncontrolled arrhythmia 7. hiv positive 8. active hepatitis b infection or positive for hepatitis c virus (hcv) antibodies. 9. severe dementia or a psychiatric illness 10. active acute infection

Keywords: pemphigus rituximab cylex
effectiveness of different methods in acute myofascial pain syndrome

Conditions: Myofacial Pain Syndromes

Summary: this study is a randomized controlled study. a total of 75 patients between the ages of 20-50 who have a diagnosis of acute myofacial pain syndrome in the trapezius muscle and have pain for a maximum of 5 days were included in the study. patients were randomly divided into 3 groups. group 1 patients received kinesio tape method (25 patients), group 2 patients received trigger point injection method (25 patients), and group 3 patients received neural therapy injection method (25 patients). a 10-15 cm sized i band was applied to the trapezius muscles of the first group patients with the patient's neck in lateral flexion. then, while the patient's neck is flexed, a y-shaped 15-20 cm tape will be affixed between c1-7 with the arms of the y up, and i tape of 5-10 cm is attached on the arms. in group 2 patients, 1 cc lidocaine diluted with 4 cc saline (sf) was applied to the trigger points palpated manually in the trapezius muscles. after the trigger point was squeezed between the thumb and index finger, a few cc of local anesthetic mixture was applied into the trigger point with the injector and exited. in the 3rd group patients, a few cc local anesthetic mixture will be applied intradermally over the trigger point without entering into the trigger points palpated manually in the trapezius muscles. patients were checked 72 hours and 1 week after the first applications. the pain at rest and during movement of the patients in all 3 groups were evaluated with a visual analog scale (vas 10 cm). the number of trigger points was determined by the physician by hand palpation. pressure pain threshold was evaluated with the algometer device. disability assessment of the patients was made using the neck pain disability index. evaluations were made at the beginning of treatment, 72 hours after and 1 week after treatment.


Eligibility criteria:
inclusion criteria: * patients diagnosed with acute myofascial pain syndrome * patients between the ages of 20-50 * patients with pain for up to 5 days exclusion criteria: * patients diagnosed with fibromyalgia * patients with systemic disease * patients with prominent cervical disc herniation * patients with cervical arthrosis * patients with cervical radiculopathy and myelopathy * patients with myofascial trigger point injection in the past 6 months * patients who received physical therapy in the past 6 months * patients undergoing shoulder and neck surgery * patients with drug allergies