Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of biliary tissue sampling with ercp

Conditions: Cholangiopancreatography, Endoscopic Retrograde; Biliary Stricture; Biliary Tract Diseases; Cholangiocarcinoma

Summary: the purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (soc) directed biopsies, transpapillary biliary biopsies (tpbx), brushings and bile aspiration for cytology and fish in patients undergoing ercp.


Eligibility criteria:
inclusion criteria: * adults \> 18 years * diagnosis of indeterminate biliary stricture * scheduled clinically indicated ercp procedure exclusion criteria: • adults \<18 years, children
pain control using neuromodulation in patients undergoing definitive chemoradiotherapy for head and neck cancer

Conditions: Cancer of Head and Neck

Summary: the purpose of this study is to determine if transcranial direct current stimulation (tdcs) can reduce pain perception associated with the effects of receiving definitive radiation therapy or chemoradiotherapy in head and neck cancer (hnca) patients.

the goal of this study is to investigate the effectiveness of tdcs as a novel pain relief modality for odynophagia due to mucositis in patients with locally advanced head and neck cancer undergoing definitive radiation therapy or chemoradiotherapy. participants will be randomized into one of two arms: (1) treatment: radiation/chemoradiotherapy standard of care + tdcs neuromodulation or (2) control: radiation/chemoradiotherapy standard of care only. patients in the treatment arm will undergo tdcs stimulation on the day of their radiation/chemoradiotherapy appointments, prior to receiving treatment when doing tdcs session in clinic or after to receiving treatment when doing tdcs session at home. this will occur daily (5 days per week) during the second and third weeks of therapy, three times per week during the fourth and fifth weeks, and twice per week during the sixth and seventh weeks. patients will also have eeg and fnirs recordings during the study. this will occur at the pre-study visit, the first stimulation appointment, the third week, the 7th week, and during the follow-up appointments (one-week and one-month).

Eligibility criteria:
inclusion criteria: * patients with ajcc stage iii-iv head and neck malignancy scheduled for definitive radiation therapy or chemoradiotherapy, and who are capable of understanding and adhering to the protocol requirements. exclusion criteria: * substantial dementia * patients are actively being treated for another cancer at the time of enrollment. * any condition that would prevent use of tdcs including skull abnormality, implanted metal, implanted electronic device, seizure disorder, neurologic condition. * use of an investigational drug or device within 30 days of study screening

Keywords: cancer pain eeg fnirs tdcs
effect of neuromuscular electrical stimulation applied to the lumbar multifidus muscle on sit to stand kinematics in individuals with low back pain

Conditions: Low Back Pain

Summary: the goal of this randomized controlled trial, is to investigate the effect of functional nmes and conventional nmes applied to the lumbar multifidus muscle on body kinematic and kinetic values during the sit-to-stand in individuals with non-specific low back pain. our study will include 24 participants between the ages of 18-65. which physiotherapy intervention will be applied to the participants will be determined by the block randomization method, using a table of random numbers. after randomization; nmes to the participants' lumbar multifidus muscle during physiotherapy intervention will be applied in two groups; in the first group, nmes will be applied with the conventional technique during prone position and in the second group, nmes will be applied with the functional technique during the sit-to-stand activity. evaluations will be made twice for each participant- before and after the intervention. during the evaluation, data regarding the change in body kinetics and kinematics of individuals during the sit-to-stand activity will be recorded with a vicon camera system. for secondary outcome measures, a visual analog scale will be used to evaluate pain, the roland morris disability questionnaire and the oswestry disability index will be used to evaluate functional status, and the tampa kinesiophobia scale will be used to evaluate fear-avoidance behavior.


Eligibility criteria:
inclusion criteria: * history of chronic low back pain (12 weeks\<) * pain in the lumbar and/or hip area (vas\>3) * volunteering to participate in the study exclusion criteria: * history of neurological, metabolic, cardiovascular disease * having had spinal surgery, specific lumbar pathology, scoliosis, pregnancy, history of systemic or degenerative disease * musculoskeletal system pathology in the last year * body mass index being over 30 kg/m2 * continuing any exercise program

Keywords: low back pain electric stimulation sit to stand kinetic kinematic
efficacy of l-methylfolate and methylcobalamine in treating resistant hypertension associated with elevated serum homocysteine in hemodialysis patients.

Conditions: End Stage Renal Disease; Hypertension, Renal

Summary: the aim of the study is to evaluate the efficacy of l-methylfolate in combination with methylcobalamine in reducing homocysteine blood levels in hypertensive end-stage renal disease patients on regular hemodialysis and its association with blood pressure control in treatment of resistant hypertension

1. ethical committee approval has been obtained from ethics committee of faculty of medicine, alexandria university 2. agreement from all participants should be taken in this clinical study by assigning an informed consent 3. adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension will be recruited from hemodialysis unit in alexandria university hospitals 4. patients will be screened for resistant hypertension as determined by the mean of mid-week pre-dialysis bp \> 140/90 mm hg, post-dialysis bp \> 130/80 mm hg over a period of one month. 5. a blood sample will be collected for homocysteine measurement at baseline 6. patients will be randomized using simple randomization technique via computer based program to take one tablet daily containing l-methylfolate and methylcobalamine or no treatment. 7. patients will be followed over a period of 3 months after which blood pressure measurement and blood sampling would be repeated and compared to baseline values 8. as a measurement of the prognosis of elevated homocysteine, we should follow the development of myocardial infarction, stroke and cardiovascular events for 3 months 9. the appropriate statistical tests will be held according to the study design and parameters to evaluate the significance of the results 10. results, conclusion, discussion and recommendations will be given

Eligibility criteria:
inclusion criteria: * adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis bp \> 140/90 mm hg, post-dialysis bp \> 130/80 mm hg despite the use of three or more drugs exclusion criteria: * age \> 75 years * excessive use of alcohol or smoking * severe hepatic impairment * acute kidney injury on top of chronic kidney disease * pregnant females * allergy or intolerance to any component of the formulation * medication side effects (methotrexate, theophylline, phenytoin, and cyclosporine) or any drug proven to cause hyperhomocysteinemia

Keywords: l-methylfolate methylcobalamine homocysteine
biomarkers in severe asthma patients on omalizumab treatment

Conditions: Severe Asthma

Summary: eosinophil infiltration and degranulation in airways has been implicated in the pathology of asthma. periostin is considered to be a marker of eosinophilic inflammation and is one of the highly expressed genes in epithelial cells and lung fibroblasts in asthma. omalizumab is approved as add-on therapy in the treatment of severe allergic asthma. the aim of the study is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and il-6 as long-term clinical outcomes of omalizumab therapy.

anti-ige (omalizumab) has been shown to be an effective add-on therapy for patients with allergic severe asthma. in this observational study patients aged over 18 year with uncontrolled severe persistent asthma are selected for add-on therapy with omalizumab. patients were on high dose of ics and had a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with \>15 mg/day prednisone or other medications at similar dose, for at least 3 days). the individual dose and frequency of omalizumab administration is assessed from the dosing table. lung function tests and asthma questionnaires (acq, aqlq and rqlq) are used in the aim of assessing clinical improvement after omalizumab treatment. induced sputum (is) and exhaled breath condensate (ebc) are used as a simple non-invasive methods for monitoring cellular and biochemical changes in the airways. total blood eosinophil count, is cytology, is and ebc periostin and il-6 concentrations are measured. analyses are performed at entry and after 16, 52 and 104,156 weeks of omalizumab treatment.

Eligibility criteria:
inclusion criteria: 1. positive history of atopy 2. serum total ige level between 30 and 700 iu/ml 3. body weight not more than 150 kg 4. high dose of ics and laba 5. a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with \>15 mg/day prednisone or other medications at similar dose, for at least 3 days). exclusion criteria: 1. smoking 2. pregnancy

Keywords: severe asthma anti-ige periostin induced sputum, exhaled breath condensate
safety, tolerability and pharmacokinetic profile of levodopa administered with continuous administration of nd0611

Conditions: Parkinson's Disease

Summary: the study hypothesis is that continuous nd0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations the study will help determining the safety and tolerability of nd0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (ld/cd) and continuous delivery of nd0611


Eligibility criteria:
inclusion criteria: * healthy caucasian males between 18 and 50 years (inclusive) of age * normal body weight * subjects with negative urinary drugs of abuse, hiv, hepatitis b or hepatitis c serology tests * subjects must be able to adhere to the protocol requirements * subjects must provide written informed consent to participate in the study. * haemoglobin level \>12.5 mg /dl exclusion criteria: * history of significant psychiatric disorder, neurological diseases or sleep disorders * history of significant systemic diseases, by medical history or tests performed during screening examinations * clinically significant laboratory tests at screening * history of drug or alcohol abuse. * allergy to levodopa, carbidopa or any inactive component of the test formulation. * subjects with dark skin * subjects with skin diseases or neoplasms * subjects with narrow-angle glaucoma * subjects with significant allergic response to other drugs. * subject with known atopic disorders * known allergy or hypersensitivity to adhesive tapes. * use of any prescription or over-the-counter (otc) medications * subjects who donated blood or received blood, in the last 3 months * participation in another clinical trial in the last 30 days * subjects which do not have the ability to communicate well or will not adhere to the protocol procedures
post marketing surveillance of fesoterodine in filipino patients with over active bladder

Conditions: Over Active Bladder

Summary: this is an observational study and will determine the safety profile of fesoterodine in filipino patients prescribed the drug. this is in compliance with the requirements of the philippine food and drug administration.

sampling method is not applicable in this study. only patients prescribed fesoterodine will be enrolled.

Eligibility criteria:
inclusion criteria: * over-active bladder * prescribed with fesoterodine exclusion criteria: * hypersensitivity * urinary retention

Keywords: observational
validation of a mobile phone based on epro tool in subjects with systemic lupus erythematosus

Conditions: SLE; Lupus Erythematosus, Systemic; Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) may involve a variety of organ systems expressed differently from patient to patient, and so can be difficult to characterize clinically. patient reported outcomes (pros), which consist of feedback directly from patients regarding their symptoms without interpretation by a clinician, are typically used in sle to supplement other clinical measures. standard pros typically used in sle include the 36-item short form health survey (sf-36), the functional assessment of chronic illness therapy - fatigue (facit-f), and the patient global assessment (ptga), administered by paper or electronic tablet during the clinic visits. the recent development of electronic mobile device technology, such as the smartphone, has made it possible to collect pro information away from the clinical site in the subject's environment. this study will assess by measurement equivalence testing whether data collected via a smartphone are comparable to that collected in standard fashion and whether pros obtained in the subject's environment may be more informative than that collected in the physician's office on paper.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent 2. males or females, aged 18 years or older 3. classification of sle by either the american college of rheumatology (acr) or systemic lupus international collaborating clinics classification (slicc) criteria 4. on a stable sle treatment regimen consisting of any of the following medications for a period of at least 30 days prior to screening * corticosteroids (\<30 mg prednisone or equivalent per day) * hydroxychloroquine or equivalent anti-malarial * other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil or sodium), cyclophosphasmide, belimumab, calcineurin inhibitors (e.g. tacrolimus, cyclosporine) 5. willing to perform and comply with all study procedures, including attending clinic visits at baseline, month 1, and month 2 as scheduled exclusion criteria: 1. rapidly progressive neurologic disease 2. cognitive dysfunction that might interfere with the capacity to use the epro device 3. any condition that might in the investigator's opinion might preclude completion of the study 4. current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 1 year prior to screening 5. clinical evidence of significant unstable or uncontrolled acute or chronic diseases not caused by sle (e.g., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
red cell distribution width as a predictor for post operative atrial fibrillation after open heart surgries

Conditions: Atrial Fibrillation; Inflammatory Marker; Heart; Surgery, Heart, Functional Disturbance as Result

Summary: in this study we investigate the correlation between rdw and poaf, as we use the rdw as a predictor for inflammation for prediction of poaf

in this study we investigate the relation between red cell distribution width and post operative atrial fibrillation after open heart surgery as it's a major complication with high incidence, this complication prolong the in hosoital stay, postulated mechanism of post operative atrial fibrillation that it's due to inflammation and oxidative stress, after applying specific inclusion and exclusion criteria, recording the preoperative labs including rdw and follow up patients 48 hours post operative in the icu and recording post operative labs and ecg, and compare the rdw of patients developed poaf and patients who didn't develop poaf

Eligibility criteria:
inclusion criteria: * female or male patient with range of age 35-65 years * elective cardiac surgery * cardiopuomonary bypass machine used * normal sinus rhythm exclusion criteria: * echo showing left atrial diameter above 4 cm * patient on rythm control medications * patient undergoing emergency surgery * history of cardiac tachyarrhythemia
dehydrated human amnion/chorion membrane micrografts(dhacm) injectable in the treatment of recalcitrant plantar fasciitis

Conditions: Plantar Fasciitis

Summary: this is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dhacm).


Eligibility criteria:
inclusion criteria: 1. at least 18 years old. 2. both male and female patients will be selected. 3. plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities * rest, ice, compression, elevation (rice) * corticosteroid injection * stretching exercises * non-steroidal anti-inflammatory drugs (nsaids) * orthotics 4. females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). 5. patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen. 6. patient has read and signed the irb/iec approved informed consent form before screening procedures are undertaken. exclusion criteria 1. prior surgery at the site. 2. site that exhibits clinical signs and symptoms of infection. 3. history of chronic plantar fasciitis of more than twelve months. 4. evidence of significant neurological disease of the feet. 5. non-ambulatory patients. 6. the presence of comorbidities that can be confused with or can exacerbate the condition including: * calcaneal stress fracture * nerve entrapment syndrome (baxter's nerve entrapment or tarsal tunnel syndrome) * plantar fascial rupture * systemic disorders associated with enthesiopathy (such as gout, reiter's syndrome, rheumatoid arthritis, etc.) * achilles tendonitis * fat pad atrophy * fibromyalgia * diabetics with neuropathy 7. patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. 8. patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening. 9. history of radiation therapy at the site. 10. known history of having acquired immunodeficiency syndrome (aids) or hiv. 11. study foot has been previously treated with tissue engineered materials within the last 30 days. 12. patients who are unable to understand the aims and objectives of the trial. 13. presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment. 14. pregnant or breast feeding. no pregnancy within the past 6 months. 15. allergy to gentamicin and/or streptomycin.

Keywords: plantar fasciitis
11c-metomidate pet versus adrenal vein sampling in primary aldosteronism

Conditions: Primary Hyperaldosteronism

Summary: rationale: primary hyperaldosteronism (pa) is the most frequent and possibly curable form of secondary hypertension. the diagnosis and targeted treatment of pa is essential because of high vascular morbidity associated with pa as compared to essential hypertension with comparable blood pressure levels. pa is usually caused by either a unilateral aldosterone-producing adenoma (apa) or by bilateral adrenal hyperplasia (bah). distinction between apa and bah is critical since the former may be cured by adrenalectomy, and the latter needs life-long medical therapy with mineralocorticoid receptor antagonists (mra). studies demonstrate that adrenalectomy benefits also bah patients with dominant nodule(s) producing the most of aldosterone excess. the distinction between unilateral and bilateral pa can be made by adrenal vein sampling (avs), as recommended by the endocrine society 2008 guideline. currently, in finland the diagnosis is based on computed tomography (ct) scanning which does not distinguish between aldosterone-producing and common non-functioning adrenal nodules and has limited accuracy detecting small adrenal masses. since avs is invasive, dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive functional imaging such as 11c-metomidate positron emission tomography (mto-pet). objective: to assess diagnostic ability of mto-pet as compared to avs in pa. secondary objectives: to compare if standardized uptake values (suvs)in mto-pet imaging are similar in histologically diagnosed nodular hyperplasia versus adenoma. to assess the diagnostic accuracy of adrenal ct as compared to mto-pet and avs. to assess the complete and partial remission rates (blood pressure response expressed in daily defined dosages, medical therapy, use of potassium supplements) after allocating subjects to mra-therapy or adrenalectomy at 1 and 5 years.


Eligibility criteria:
inclusion criteria: * biochemically proven pa * good general health enabling possible adrenalectomy * bmi less than 35 exclusion criteria: * any contraindication for avs, mto-pet or ct * subjects not willing to consider adrenal surgery * pregnancy * familial pa * suspicion of other tumor than adenoma or hyperplasia in adrenal ct scan

Keywords: primary aldosteronism aldosterone producing adenoma bilateral adrenal hyperplasia metomidate-positron emission tomography