Kornimate/medical-research-clean huggingface dataset:
neurophysiological effects of transcutaneous electrical nerve stimulation in persons with ms

Conditions: Fatigue; Walking, Difficulty; Multiple Sclerosis

Summary: transcutaneous electrical nerve stimulation (tens) is a treatment that could potentially reduce walking problems and fatigue in persons with multiple sclerosis. however, extensive use of tens in a clinical setting is hindered by a lack of neurophysiological understanding of the effects of tens. the primary objective of this pilot study is therefore to investigate the effects of tens on brain activity in pwms measured with fmri.

this study is an exploratory study to see if we can detect changes in fmri activity during tens in persons with ms. this is a randomized, single-blind crossover design. subjects will undergo an mri scan while they receive sham stimulation of the tibialis anterior, active stimulation of the tibialis anterior, stimulation of the quadriceps, perform continuous movements of the foot (plantar \& dorsiflexion) and a combination of stimulation of the tibialis anterior and movement of the foot. this study will include 15 subjects with relapsing remitting or progressive ms and 15 healthy controls. blood-oxygen-level-dependent (bold) activation changes and the interaction networks before, during and after active tens and differences in activation due to stimulation on quadriceps vs. tibialis anterior, stimulation on tibialis anterior vs plantar/dorsiflexion and stimulation on tibialis anterior vs stimulation combined with plantar/dorsiflexion. this will be compared between pwms and healthy controls. this study can add to the limited knowledge and possibly help to personalize and implement tens in the clinic.

Eligibility criteria:
inclusion criteria: * age: 18-65 years * edss score \< 7 exclusion criteria: * metal or electrical implants * bmi \> 40 * claustrophobia * being pregnant * having a psychiatric disorder * having cognitive or communication problems which reduces the capacity to understand instructions * having a neurological disorder other than ms * having cardiac arrhythmia
preference-based comparative study on definitive radiotherapy of prostate cancer with protons

Conditions: Prostate Cancer

Summary: protochoice-p is a prospective multicenter trial to evaluate proton therapy in patients suffering from prostate cancer. primary aim of the study is a decrease of moderate or severe genito-urinary or intestinal side effects (common terminology criteria for adverse events (ctcae) 4.0 grade 2 or higher) by the use of proton therapy. secondary endpoints contain assessment of quality of life, biochemical recurrence and recurrence free survival as well as overall survival and economic comparison between photon and proton therapy.

the hypothesis of the study is a 7.5% decrease of combined genito-urinary and intestinal side effects from 15% with photon therapy to 7.5% by the use of protons. with an alpha of 0.05 and 80% power it is therefore necessary to treat 131 patients with protons to detect such difference. with an estimated drop-out rate of 10% 146 patients have to be recruited to the proton arm. as randomization to photon or proton therapy is not possible in a multicenter setting with only few proton facilities available patients treated with photons will be prospectively matched to their proton counterparts. stratification criteria will include: age, high dose volume, androgen deprivation, history of surgery, obstructive disease, increased risk for rectal bleeding, socio-economic criteria and use of rectal balloon during radiotherapy. comparison of the primary endpoint will be restricted to patients without irradiation of lymphatic drainage.

Eligibility criteria:
inclusion criteria: * life expectancy ≥ 10 years * adenocarcinoma of the prostate confirmed by punch biopsy * locally limited to locally advanced adenocarcinomas without evidence of distant metastases i.e. t1-3b n0-1 m0 * stage-related indicated neoadjuvant / adjuvant androgen deprivation possible (neoadjuvant ≤ 6 months) * good general condition (ecog performance status 0 - 1) * marker seed implantation before irradiation (optional) or possibility of image-guided radiation therapy (igrt) by ct * adequate compliance for follow-up * written informed consent exclusion criteria: * distant metastases * previous radiotherapy of the lesser pelvis * previous or concomitant other malignant disease except when there is no impact on treatment or follow-up of the prostate cancer * participation in another clinical study, if it's excluded by the study protocols

Keywords: prostate cancer proton radiotherapy photon radiotherapy
miles-3: cisplatin in combination with gemcitabine for elderly patients with lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage IIIB

Summary: the purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.


Eligibility criteria:
inclusion criteria: * cytological or histological diagnosis of non small-cell lung cancer (nsclc) * stage iii b or stage iv disease * age \> or = 70 years * ecog performance status 0 or 1 * patient at first diagnosis or with recurrence after primary surgery * at least one target or non-target lesion according to recist criteria * life expectancy of at least 3 months * neutrophils \> 1500/mm3, platelets \> 100,000/mm3, hemoglobin \> 10g/dl * creatinine \< 1.5 x the upper normal limit * ast and alt \< 2.5 x the upper normal limits (\< 5 x the upper normal limit in the presence of hepatic metastasis) * bilirubin \< 1.5 x the upper normal limit * signed informed consent exclusion criteria: * previous chemotherapy for advanced disease * history of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated) * symptomatic cerebral or spinal cord metastasis * myocardial infarct within the last 12 months * systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy. * known or suspected hypersensitivity to any of the drugs used in the study * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent

Keywords: elderly chemotherapy
losartan in treating pulmonary fibrosis in patients with stage i, ii, or iii non-small cell lung cancer

Conditions: Dyspnea; Lung Cancer; Pulmonary Complications; Radiation Fibrosis

Summary: rationale: losartan potassium may be effective in treating pulmonary fibrosis caused by radiation therapy in patients with non-small cell lung cancer. purpose: this clinical trial is studying losartan to see how well it works in treating pulmonary fibrosis caused by radiation therapy in patients with stage i, stage ii, or stage iii non-small cell lung cancer.

objectives: primary * to evaluate the effects of losartan potassium on the disease progression in patients with stage i-iii non-small cell lung cancer and radiation-induced pulmonary fibrosis. * to determine the feasibility of losartan potassium as a possible treatment for radiation-induced pulmonary fibrosis. secondary * the evaluate the effects of losartan potassium on the degree of dyspnea, and lung function (fev_1 and fvc) in these patients. outline: this is a multicenter study. patients receive oral losartan potassium once daily for 6 months in the absence of disease progression or unacceptable toxicity. patients undergo assessment of pulmonary function (e.g., gas movement, lung capacity, and diffusion of gases) by spirometry and dyspnea by the visual analog scale (vas) at baseline and at weeks 12 and 24.

Eligibility criteria:
inclusion criteria: * at least 18 years of age or older * diagnosed with non-small cell lung cancer stage i, ii, iiia, or iiib * diagnosis of radiation-induced pulmonary fibrosis (as defined by national cancer institute's common terminology criteria for adverse events \[ctcae\] v3.0 grade i to grade iii) and within 2 years of the last radiation therapy treatment exclusion criteria: * patients with a pneumonectomy * allergy or allergic reaction to losartan or any other angiotensin ii receptor blocker * use of an angiotensin ii receptor blocker currently or within 6 months of study entry which include: losartan, valsartan, irbesartan, candesartan, cilexetil, eprosartan mesylate, and telmisartan * bilateral renal artery stenosis, hereditary or idiopathic angioedema, or uncontrolled hypotension * patients taking lithium * currently smoking or smoked within 6 months of study entry * pregnant, intending to become pregnant or breastfeeding * baseline systolic blood pressure \< 100 mmhg * history of lung transplant * history of kidney failure or liver disease * inability to attend clinic visits

Keywords: dyspnea stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer pulmonary complications radiation fibrosis
adhear bone conduction system

Conditions: Hearing Loss, Conductive; Hearing Loss, Unilateral

Summary: the purpose of this research study is to learn about the hearing outcomes of adult and pediatric patients who are treated with or are candidates for bone conductive devices (also termed "baha"). hearing outcomes will also be assessed with a second audio processor device called the adhear system.


Eligibility criteria:
inclusion criteria: aims 1 and 2: * adult english speaking patients who are experienced users of bone anchored implants (bais) for the indication of either single sided deafness or conductive hearing loss. * experienced will be defined as greater than 6 months of device use and no intermittent function of the device within 2 weeks of enrollment. * subjects will be limited to those who have normal hearing by bone conduction defined as a pure tone average of 25 dbhl or better at 500, 1000, 2000, \& 3000 hz in at least one ear. aim 3: * english speaking children 5 to 17 years of age and their primary guardian who present to the clinic for treatment by bai on a headband device for the indications of single sided deafness or conductive hearing loss. * subjects will be limited to those who have no prior use of a bai or bone conduction hearing device, normal hearing by bone conduction defined as a pure tone average of 25 dbhl or better at 500, 1000, 2000, \& 3000 hz in at least one ear. for those children where this cannot be definitively established, children will be included who display clinical signs of normal bone conduction hearing beyond a reasonable doubt and may include such evidence as (but not limited to): auditory brainstem response, speech awareness thresholds, visual reinforcement audiometry, conditioning play audiometry, ct scans, etc.) aim 3 a \& b: * pediatric bilateral or unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age * pediatric participants who are currently managed by the university of miami with a bone conduction device attached to a softband. exclusion criteria: aims 1 \& 2: * non-english speakers * participants reporting allergies to adhesives or highly reactive skin. aim 3: * pediatric participants who are non-english speakers. * children who have previous experience with a bai or bone conduction hearing device will not be included for study. * pediatric participants reporting allergies to adhesives or highly reactive skin. aims 3a \& 3b: * pediatric participants who are non-english speakers. * pediatric participants reporting allergies to adhesives or highly reactive skin.
a dose finding study of topically applied i-020201 as an adjunct to good standard-of-care in patients with chronic diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population ages. the large population affected by diabetic foot ulcers and the high rates of failure ending with amputation even with the best therapeutic regimens have resulted in the development of new therapies. i-020201 is a bioactive therapy intended for topical treatment of hard-to-heal diabetic foot ulcers, stimulating the granulation tissue formation. this study aims to evaluate the safety and efficacy of i-020201 in adjunct to good standard of care in patients with chronic diabetic foot ulcer.


Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years * given written informed consent * female of childbearing potential with a negative result from the pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or iud) or abstinence throughout the trial * type 1 or type 2 diabetes mellitus with hba1c =\< 12% * with only one diabetic foot ulcer on the foot to be treated on or below the ankle exclusion criteria: * pregnant or breast-feeding * known or suspected allergies to any of the components of the i-020201 * uncontrolled anemia (hb \< 9 g/dl in females and \< 10 g/dl in males) * hypoalbuminemia (albumin \< 3 g/dl) * overtly infected target ulcer (as judged by investigator) * highly exuding wounds (wounds that require a daily dressing change) * osteomyelitis * systemic infections * acute charcot foot and severe chronic charcot deformity * abpi \< 0.7 or ankle systolic pressure \< 70 mm hg * one of the following findings (only 1 out of 3 tests is required): * on doppler waveform analysis on the dorsalis pedis and posterior tibial arteries a monophasic or biphasic flow (with loss of reverse flow) in either foot artery, or * a toe: brachial index \< 0.7, or * transcutaneous oxygen pressure (tcpo2) \< 40 mm hg * suspicion, presence or history of systemic or local cancer or tumor of any kind

Keywords: diabetic ulcer topical pdgf gsoc
prospective evaluation of neurocognition in patients undergoing transcatheter aortic valve replacement

Conditions: Mild Cognitive Impairment; Aortic Stenosis

Summary: this trail is for patients with mild cognitive impairment (mci) who are receiving a transcatheter aortic valve replacement (tavr). we will assess changes in neurocognition following tavr with the 5 minute montreal cognitive assessment (mini moca) when comparing pre procedure with post procedure assessments.

patients with mild cognitive impairment who are being treated with a tavr can choose to take part in this trial. this trial will prospectively enroll patients at 4 baylor scott \& white facilities. 80 patients will be enrolled between all sites. the mini moca will be conducted at the following time points: pre tavr, 30 days post tavr, and 6 months post tavr. all other data will be collected from patient charts and are considered standard part of their care.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. undergoing a tavr procedure 3. possible mci as determined by procedures already used in the tavr clinics, including 1 of the 4: 1. mmse \< 27 2. history of mci, dementia, or stroke (cva or tia) 3. history of prescription treatment for mci 4. discretion of the investigator, physician, or clinic staff 4. scores 25 or less on the mini moca exam exclusion criteria: 1. in another research study that doesn't allow dual enrolment, or dual enrolment has not been granted.

Keywords: tavr transcatheter aortic valve replacement
effects of respiratory rehabilitation on icu patients

Conditions: ICU Acquired Weakness; Rehabilitation

Summary: effects of respiratory rehabilitation on patients after extubation

the purpose of this study is to evaluate whether sequential treatment with high-flow humidification therapy apparatus can improve the postoperative recovery and functional status of patients with invasive mechanical ventilation in icu after the withdrawal of the catheter.inclusion criteria: age 18-95;the hemodynamics were stable, that is, 50 \ 10 and\< 35 times/min.exclusion criteria: pregnancy;acute myocardial infarction.a total of 50 patients who are sequentially treated with high-flow humidification therapy apparatus after extubation in icu are randomly assigned. the experimental group receive respiratory rehabilitation therapy, while the control group only receive routine medical treatment. all the enrolled patients underwent rehabilitation evaluation and bedside diaphragmatic ultrasound measurement.this study was approved by the ethics committee of the cpla general hospital (project no.2018-212-01). the following clinical datas were recorded for all patients through the unified database software: the rehabilitation program was formulated according to the cluster management strategy of abcdef and the six-step method of early activities.all of the patients in monitoring vital signs, every day at hospital group and all peripheral muscle mrc assessment, 30 s sit stand trial, modified barthel index, borg dyspnea score, arterial blood gas analysis, diaphragm ultrasonic monitoring by the bed, finally the experimental process on the patients whether using noninvasive ventilator, whether for endotracheal intubation again, whether to have new complications (pressure sores, aspiration, thrombosis, etc.) and the patients bed time statistics for the first time. statistical analyses were conducted by spss 21.0 and a two-tailed p \< 0.05 was considered significant.

Eligibility criteria:
inclusion criteria: * aged above 18 * the hemodynamics are stable * 50 \< heart rate less than 120 beats/min * 90 \< systolic blood pressure \< 200mmhg * 55 \< mean arterial pressure \< 120mmhg * do not increase the dose of vasopressor for at least 2 hours * intracranial pressure was stable and there is no seizure within 24 hours * the breathing condition is stable * the oxygen satiety of the patient's finger vein is ≥88% * 10\<the breathing frequency \< 35 times/min exclusion criteria: * pregnancy * acute myocardial infarction (ami)

Keywords: icu，rehabilitation
comparison between 2 protocols for the treatment of class ii division 2 malocclusion

Conditions: Class II Div 2 Incisal Relationship

Summary: the aim of this prospective study was to compare between two different treatment modalities of class ii division 2; to start treatment in upper arch first until adequate overjet is obtained or to start in the lower arch first with removable anterior bite plane in upper arch.

fifty four subjects with class ii division 2 participated in this study. the subjects were randomly divided into two groups; group one (28 patients): orthodontic treatment with upper arch bond up first and lower arch was bonded when 4 mm overjet was reached. the treatment continued until 0.019 x 0.025 " stainless steel wires were reached in both arches. group 2 (26 patients): orthodontic treatment with lower arch bond up first with removable anterior bite plane in upper arch. when 0.019 x 0.025" stainless steel wire was reached, the upper arch was bonded. the treatment continued until 0.019 x 0.025" stainless steel wires were reached. three cephalograms were taken for each patient in both groups; pretreatment (t0) , after bonding the other arch (t1) and at the end of leveling and alignment in both arches (t2). cephalometric measurements and superimpositions were made. skeletal and dentoalveolar treatment changes were compared within and between the 2 groups.

Eligibility criteria:
inclusion criteria: * age ≥ 17 years and ≤ 26 years * class ii division 2 malocclusion. * overjet (oj) \< 4 mm. * overbite (ob) covering more than half of the lower incisor height. * mild to moderate crowding with tooth contact displacement no more than 2 mm. * good oral hygiene and healthy periodontium. exclusion criteria:- * systemic health problems and medications were taken. * history of previous orthodontic treatment.

Keywords: class ii division 2 alignment leveling
effect of intravitreal anti-vegf on retinal vessels diameter

Conditions: Age Related Macular Degeneration

Summary: patients who will be scheduled for intravitreal injection of ranibizumab or bevacizumab will be recruited in this prospective self-controlled trial. fundus photography will carried out at baseline immediately before injection and at 3, 7 days and 30 days after the first injection. using image analysis software, measurements summarized as the central retinal artery equivalent (crae) and central retinal vein equivalent (crve). null hypothesis: there is no significant difference between arteriolar/venular diameter before and after injection of intravitreal ranibizumab/bevacizumab in the treated and untreated eye


Eligibility criteria:
inclusion criteria: • patients who wish and need bevacizumab or ranibizumab treatment for underlying disease exclusion criteria: * history of previous systemic or ocular anti-vegf therapy * history of previous intravitreal injection with any drug * intraocular pressure ≥ 22 * glaucoma * history or presence of thromboembolic events * un-controlled blood pressure * blood donation during the previous 3 weeks * relevant media opacity of the lens

Keywords: anti vascular endothelial growth factor retinal vessels
study of capecitabine and oxaliplatin in combination with radiotherapy in patients with unresectable gastro-intestinal cancer

Conditions: Stomach Cancer; Gall Bladder Cancer; Bile Ductus Cancer; Pancreas Cancer; Colorectal Cancer

Summary: the purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors. the trial consists ot two separate studies; corgi-u in patients with stomach- bile ducts- gallbladder and pancreas cancer, and corgi-l in patients with colorectal cancer. corgi-u will be designed as a phase-i-ii-study,in which the first part will be a chemotherapy dose finding study, followed by a phase ii part to establish response rates. all subjects receives radiotherapy concommitant. corgi-l is a phase ii trial, in which patients are treated with chemotherapy at fixed doses with radiotherapy concommitant.


Eligibility criteria:
inclusion criteria: * over 18 years of age * measurable disease according to recist * ecog performance status 0-1 * anc over 1.5 x 10 9/l * platelets over 100 x 10 9/l * creatinine less than 1.5 x uln * bilirubin less than 1.5 x uln * alt less than 2.5 x uln * signed informed concent exclusion criteria: * prior radiotherapy to the same local * prior chemotherapy for locally advanced or metastatic disease * pregnancy or breast feeding * peripheral neuropathy more than grade 1 * uncontrolled diarrhéa * other serious uncontrolled concomitant illness * lymph node metastasis that can not be included in the gtv (gross tumor volume), without exceeding the stipulated radiotherapy doses in organs at risk

Keywords: stomach cancer gall bladder cancer bile ductus cancer pancreas cancer colorectal cancer chemo radiotherapy phase i-ii oxaliplatin capecitabine response
st elevation in acute chest pain; could measurement of lipoprotein-associated phospholipase a2 (lp-pla2) be helpful to the clinician?

Conditions: Acute Chest Syndrome

Summary: a blood test (2-3 cc peripheral venous blood) drawn /used from already available required lab tests to distinguish between pericarditis accompanied with electrocardiogram (ecg) signs mimicking infarction. a test of clinical potential if proven to be able to support either origin of acute chest pain etiology.

too many times young patients presenting with acute chest pain are referred to invasive angiography or treated with anticoagulation therapy a measure of detrimental effect in those inflicted with acute pericarditis. a simple blood test (the plac test) may have some value in aiding rapid diagnosis saving need for cath.

Eligibility criteria:
inclusion criteria: * acute chest pain * acute st elevation * elevated troponin i exclusion criteria: * patients with recent (\> 24 hour chest pain) myocardial infarction * refusing to provide blood samples

Keywords: lppla2 st elevation acute pericarditis