Kornimate/medical-research-clean huggingface dataset:
study in parkinson's disease of exercise

Conditions: Parkinson Disease

Summary: the purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with parkinson's disease (pd). the investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. the investigators think that exercise may reduce the symptoms the of pd, and the investigators hope to learn what level of exercise will offer the most benefit.

the overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of pd symptoms. the primary aim is to determine whether individuals with de novo parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% hrmax or 80-85% hrmax) and adhere to the exercise protocol.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary parkinson's disease * in a hoehn and yahr stage less than stage iii * disease duration is less than 5 years * not likely to require dopaminergic therapy within 6 months exclusion criteria: * use of any pd medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, rasagiline (azilect), selegiline (eldepryl), artane (trihexyphenidyl). * duration of previous use of medications for pd that exceeds 90 days * expected to require dopaminergic therapy in the next 6 months * poorly controlled or unstable cardiovascular disease * uncontrolled hypertension * hypo- or hyperthyroidism, abnormal liver function, abnormal renal function * mild cognitive impairment (montreal cognitive assessment score\<26/30) * depression that precludes ability to exercise (beck depression score\>13) * disorders that interfere with ability to perform endurance exercises * regular participation in vigorous endurance exercise * evidence of serious arrhythmias or ischemic heart disease * any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study

Keywords: parkinson disease basal ganglia disease central nervous system diseases nervous system diseases movement disorders neurodegenerative diseases brain diseases
comparison of prophylactic clip and detachable snare

Conditions: Colonic Polyp

Summary: although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. for prophylactic clip, there was no prospective randomized study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. so we designed a prospective, randomized study to compares the efficacy of application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps. application of prophylactic clip will be as effective and safe method as detachable snare in the prevention of postpolypectomy bleeding for the large pedunculated colonic polyps.


Eligibility criteria:
inclusion criteria: * patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included. exclusion criteria: * bleeding tendency * poor preparation * sessile polyp
lung microbiome and inflammation in early copd

Conditions: Chronic Obstuctive Pulmonary Disease

Summary: this is a cross sectional case controlled study to assess lung microbiome and inflammation in smokers with and without chronic obstructive pulmonary disease (copd). investigators will look at active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and host immune responses in copd and controls. investigators believe copd cases will have higher prevalence of pneumotype supraglottic predominant taxa (spt) than matched controls.


Eligibility criteria:
inclusion criteria: * case definition: smokers (\>20 pack-year) with airflow obstruction (fev1/fvc\ 50% predicted (early copd gold 1 or 2) * control definition: smokers with normal spirometry will serve as controls. exclusion criteria: * fev1 \< 50% not 70 * significant cardiovascular disease defined as abnormal ekg, known or suspected coronary artery disease or congestive heart failure. * diabetes mellitus * significant liver or renal disease * severe coagulopathy (inr \> 1.4, ptt \> 40 seconds and platelet count \< 150x103 cells). * pregnancy * etoh use of more than \>6 beers or \>4 mixed drinks daily * lack of capacity to provide informed consent. * antibiotic use within the prior 2months

Keywords: chronic obstructive pulmonary disease (copd)
the effect of high dose methylprednisolone on nailfold in early systemic sclerosis ( ssc )

Conditions: Systemic Sclerosis; Raynaud Phenomena

Summary: this is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early ssc, fulfilling the very early diagnosis of systemic sclerosis (vedoss) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. three-day treatment courses are given at week 0, week 4 and week 8. the final assessment is at week 12, and patients will be followed up to one year after baseline

systemic sclerosis is a disease with a high burden caused by morbidity and increased mortality. to date a cure for ssc is not available. in this trial, patients are treated very early in the disease which could change the long term outcome of ssc in these patients. in daily practice, patients so early in the disease course are not treated although they might be at risk for early escalation and internal organ involvement, reducing their prognosis. a trial to investigate the efficacy of a relative save, inexpensive and easy accessible treatment will provide us with the opportunity to change the disease course and reducing the disease burden of a portion of the ssc patients

Eligibility criteria:
inclusion criteria: * written informed consent * age over 18 years * fulfilling vedoss criteria (9): * raynauds' phenomenon and * positive for disease specific auto antibodies (anti-centromere or anti-topoisomerase antibodies) and * typical nail fold capillaroscopic findings * puffy fingers \< 3 years * modified rodnan skin score = 0 exclusion criteria: * presence of acroosclerosis, acrosteolysis and digital ulcers * presence of anti-rna polymerase iii auto antibodies previous systemic treatment for ssc, namely: * methotrexate, * prednisone (\> 14 days in previous 6 months), * mofetil mycophenolate * cyclophosphamide. clinically significant internal organ involvement: * diffusion capacity of lung for carbon monoxide (dlco) \< 80% predicted, * vital capacity (vc) \< 70% predicted * renal dysfunction with glomerular filtration rate (gfr) \< 60 ml/min * diastolic dysfunction \> grade 1 on echocardiography * pulmonary hypertension * weight loss \>10% in the last 6 months with unknown cause contra-indications for methylprednisolone, such as: * pregnancy, lactation * psychotic or depressive disorder * ulcus duodeni or ventriculi * untreated hypertension (\> 160-90 mmhg) * acute infections
pemetrexed chemotherapy in poor-risk patients with advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: this study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

rationale: patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. the possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. the current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. in addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and b12 vitamin supplementation. along with pemetrexed, the current study provides study participants with both folic acid and b12. purpose: the primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life. treatment: study participants will be given pemetrexed through intravenous infusions. pemetrexed will be administered once every three weeks. this schedule of pemetrexed once every three weeks will be repeated up to six times. study participants will also be provided with both folic acid and b12 vitamin supplementation before, during, and after study treatments with pemetrexed. vitamin supplementation is considered critical and compliance must be followed closely. several tests and exams will be given throughout the study to monitor patients. treatments will be discontinued due to disease growth and unacceptable side effects.

Eligibility criteria:
inclusion criteria: * advanced, metastatic, or recurrent head and neck cancers * poor risk patients with ecog performance status of 2 exclusion criteria: * prior treatment for recurrent or metastatic disease * no clinical or radiological evidence of brain metatases * patients with bone only disease are not eligible * patients with pleural or peritoneal effusion as only manifestation of diesase

Keywords: head and neck cancer
specified drug-use survey on abilify prolonged release aqueous suspension for im injection (prevention of relapse of mood episodes in bp)

Conditions: Bipolar Disorder I

Summary: to investigate the safety for an observation period of 52 weeks with use of abilify prolonged release aqueous suspension for intramuscular (im) injection in patients with bipolar i disorder for prevention of recurrence/relapse of mood episodes in the routine clinical setting. the early stage safety after the switching from oral aripiprazole to this im injection is investigated including extrapyramidal syndrome and malignant syndrome. information regarding efficacy is collected as well.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * patients with a known hypersensitivity to aripiprazole
the effect of hyperoxia on cardiac output

Conditions: Hyperoxia; Cardiac Output, Low

Summary: rational: preoxygenation is a standard procedure before (deep) sedation in the ed. however, there is literature suggesting that too much oxygen can be harmful. one potential detrimental effect is a decrease in cardiac output due to coronary vasoconstriction. so far, it is unknown if this effect is rate dependent and if it also occurs after only a short period of hyperoxia, as patients experience during procedural sedation pre-oxygenation. objective: to investigate if hyperoxia has a negative effect on cardiac index (ci) in patients undergoing procedural sedation in the ed.

methods: in patients needing sedation for a painful condition, non-invasive measurements of ci, stroke volume and total peripheral resistance are performed using the clearsight non-invasive cardiac output monitoring system.. measurements will be taken at baseline, after 1,2 and 5 minutes of 15l o2/min, and then after another 2 and 5 minutes of flush rate oxygen and during the subsequent sedation.

Eligibility criteria:
inclusion criteria: * patients presenting in the ed of the medical center leeuwarden (mcl) who have a painful condition for which procedural sedation is required. exclusion criteria: * - cardiogenic shock (sbp\<90 mmhg) * procedural sedation for cardioversion * pregnancy * general contra-indications for the procedural sedation according to local sedation protocol of the mcl. * hypoxia (sat \<90% or po2 \<8)) despite oxygen suppletion * age \< 18 years * non-invasive ventilation (niv) or intubation * no informed consent * use of bleomycin * copd gold iii of iv * copd gold i of ii with hypercapnia (pco2 \> 6,4 kpa) * patients in whom no reliable signal for clearsight measurement can be obtained

Keywords: procedural sedation cardiac output measurements non-invasive emergency department
surgical ablation for atrial fibrillation

Conditions: Atrial Fibrillation

Summary: minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone atrial fibrillation (af). this study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent af.

atrial fibrillation (af) patients with a previous stroke are often at a high risk of recurrent stroke and bleeding. minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone af. this study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent af. neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial doppler measurement.

Eligibility criteria:
inclusion criteria: * patients age \> 18 years * patients with paroxysmal, or persistent/long-standing persistent af according to the standard ehra definition. * patients with symptomatic af that is refractory to at least one antiarrhythmic medication. * absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease) exclusion criteria: * af secondary to a reversible cause (i.e., thyreopathy, etc.) indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.) * severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the af is clearly of secondary etiology * known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)
repeat - real-life perception of efficacy, attitude, satisfaction and safety of levitra therapy

Conditions: Erectile Dysfunction

Summary: the aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of levitra in routine treatment of erectile dysfunction. furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. treatment naive patients as well as pre-treated patients will be included in the study.the maximum observation period per patient is 12 months.besides the physician's documentation, the patient should fill out a questionnaire at every visit. the questionnaires will be handed out and collected by the physician. furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.


Eligibility criteria:
inclusion criteria: * outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe vardenafil. exclusion criteria: * exclusion criteria must be read in conjunction with the local product information. all contraindications listed in the local product information are applicable.
the impact of omega-3 fat emulsion on clinical outcome of post-operative cancer patients

Conditions: Carcinoma Surgery; Parenteral Nutrition; Post-Operative Hospital Stay

Summary: the purpose of this study is to evaluate clinical safety and effect of omega-3 fat oil emulsion on outcome in post-operative cancer patients.

as an essential component of parenteral nutrition, fat emulsion has been used more than 30 years. it provides energy and essential fatty acids. commercial fatty emulsion products mostly come from soy bean. the omega 6 fatty acids make up with the major fatty acids of this fat emulsion, and lack of omega 3 fatty acids generally. the imbalance of these two types of fatty acids may impact with negative clinical outcomes. there are lots of omega 3 fatty acids makes up with fish oil emulsion, especially with eicosapentaenoic acid (epa) and docosahexaenoic acid (dha).few clinical studies found its clinical efficacy in recently years. a commercial product of omega 3 fat emulsion by fresenius-kabi was registered in europe at 1998. there is no any clinical trial in asia to elaborate the efficacy of omega 3 fat emulsion, as well the lack of large scale clinical trial in the world. currently study is the first large scale, randomized, double blind and multi-center clinical trial to elaborate the impact of fish oil fat emulsion in asia and europe.

Eligibility criteria:
inclusion criteria: * post-operative male and female cancer patients * require post operative parenteral nutrition support at least 7 days based on nutritional risk screening(bmi 20-25) * sign an informed consent exclusion criteria: * diabetes mellitus * abnormal fatty metabolism (tg\>200mg/dl or cholesterol\>240mg/dl ) * renal dysfunction (cr\>1.6mg/dl or bun\>30mg/dl) * liver dysfunction (alt\>60u/l or tbil\>1.2mg/dl) * lienectomy * temperature\>37.5°c * undergoing hormone therapy * pregnancy

Keywords: impact of omega 3 fatty acid on outcome omega-3 fatty acid carcinoma surgery digestive system parenteral nutrition fat emulsions, intravenous clinical outcome sirs infectious complication postoperative hospital stay cost of postoperative period post-operative nutritional cost & total treatment cost
reduced pressure for less pressure ulcers

Conditions: Pressure Ulcer

Summary: pressure ulcers (pu) cause pain and discomfort to affected patients, as well as considerable costs for society. the present study will evaluate the effect of the continuous bedside pressure mapping (cbpm)- system on pu prevalence and incidence. a rct including 180 patients will be conducted in a geriatric setting in a swedish university hospital

background the first national pu prevalence study in sweden conducted in 2011 showed a prevalence of 16.6% (n=16 466) in hospital settings. high age and reduced mobility/activity are main risk factors. international evidence-based guidelines for prevention of pu are available. pressure relief (e.g repositioning, mattresses, chair cushions, heel cushions) is the main stay of preventive measures. recent research shows that pu prevention is not a high priority. for example, the corner stone of prevention, repositioning, is not conducted for risk patients. aim to evaluate the effect of the cbpm-system on the prevalence and incidence of pu in hospital setting method design: a randomised controlled trial will be conducted sample: all patients admitted to the geriatric unit. intervention: the cbpm-system will be used from admittance to discharge (not more than 14 days). standard pu prevention (pu reducing mattress, floating heels, repositioning) control group: standard pu prevention (pu reducing mattress, floating heels, repositioning) randomisation: sealed envelopes will be used. procedure: two study nurses are responsible for inclusion of patients and data collection on day 1,3,7 and discharge. a photo will be taken of any pu. a pu expert will assess the photos after completed data collection (pu category 1-4). she will be blinded to group allocation. power calculation: the primary outcome of interest is the pu prevalence. previous point prevalence studies in this geriatric unit shows a prevalence of 45%. the investigators goal is that the cbpm-system results in 20% decrease in the pu prevalence. in order to have 80% power to detect such a decrease with a two-sided two-sample proportions test at the 5% level, 89 patients per treatment group is needed. intention-to-treat principals will be used. discussion the prevalence of pu, as well as prevention to risk patients are quality indicators in health care. national studies reveal an urgent need for quality improvement, new nursing methods and equipment must be systematically and scientifically evaluated.the results of this study will be valuable for nursing education and in international and national patient safety work to prevent pu. the results will also be valuable for other health professionals (physicians, physical and occupational therapists).

Eligibility criteria:
inclusion criteria: * admitted to geriatric unit 30a during sunday after 4 pm to friday until 4 pm exclusion criteria: * expected to be discharged before data collection in day 3

Keywords: pressure ulcer prevention pressure mapping