Kornimate/medical-research-clean huggingface dataset:
motiv bioresorbable scaffold in btk artery disease

Conditions: Peripheral Arterial Disease; Critical Limb Ischemia

Summary: the objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the motiv™ bioresorbable scaffold (reva medical) in a controlled prospective investigation for the treatment of patients with rest pain or minor tissue loss (cli) due to the presence of lesions of max 100mm in length at the level of the below-the-knee arteries.


Eligibility criteria:
inclusion criteria: * patient is willing to comply with specified follow-up evaluations at the specified times * patient presenting with rest pain or minor tissue loss (rutherford classification from 4 to 5) * patient is \>18 years old * patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study - patient has a projected life-expectancy of at least 24-months * patient is eligible for treatment with the motiv™ bioresorbable scaffold * male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure * de novo lesion or restenotic lesion after pta in the infrapopliteal arteries, suitable for endovascular therapy * target vessel diameter visually estimated to be ≥2.5mm and ≤3.50mm * guidewire and delivery system successfully traversed the lesion * total target lesion is maximally 100mm * definition of target lesion is: 1. short de novo or restenotic lesion after pta or 2. a short residual flow-limiting dissection or restenosis after pta of a longer lesion exclusion criteria: * the reference segment diameter is not suitable for the available stent design * untreated flow-limiting aortoiliac stenotic disease * perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment. * any previous surgery in the target vessel * aneurysm located at the target vessel * non-atherosclerothic disease resulting in occlusion (e.g. embolism, buerger's disease, vasculitis) * severe medical comorbidities (untreated cad/chf, severe copd, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy. * major distal amputation (above the transmetatarsal) in the study or non-study limb. * septicemia or bacteremia * any previously known coagulation disorder, including hypercoagulability * contraindication to anticoagulation or antiplatelet therapy * known allergies to scaffold or scaffold components * known allergies to contrast media that cannot be adequately premedicated prior to the study procedure * patient with known hypersensitivity to heparin-induced thrombocytopenia (hit) type ii * currently participating in another clinical research trial
standardized fecal microbiota transplantation for ulcerative colitis

Conditions: Bacteria; Microbiota; Fecal Microbiota Transplantation; Inflammatory Bowel Disease; Ulcerative Colitis

Summary: the gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (ibd). dozens of studies reported its efficacy in treatment of severe clostridium difficile colitis. preliminary studies using fmt for ulcerative colitis (uc), crohn's diseases, irritable bowel syndrome (ibs) and constipation have also met with some success. this is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for uc, the investigators propose to determine the efficiency and safety of fmt in a series of 500 patients with moderate to severe uc (montreal classification).

the present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through fmt as a therapy for uc. investigators established a standard bacteria isolation from donated fresh stool in lab. then the bacteria is transplanted to mid-gut through regular gastroscope. patients in this study will assigned to receive fmt(s) or traditional treatments according to associated guidelines and follow-up for long term. all data were recorded in china microbiota transplantation system.

Eligibility criteria:
inclusion criteria: patients who had been diagnosed with uc through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for uc from the previous therapies. exclusion criteria: patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent fmt or wmt before.

Keywords: gut bacteria gut flora bacteriotherapy fecal microbiota transplantation inflammatory bowel disease ulcerative colitis
vektor vmap™ clinical validation study

Conditions: Cardiac Arrhythmia; Atrial Fibrillation; Ventricular Arrythmia; Premature Ventricular Complexes Multiple; Ventricular Tachycardia; Ventricular Fibrillation; Premature Atrial Complex; Atrioventricular Reentrant Tachycardia

Summary: this is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ecg mapping system (vmap™).


Eligibility criteria:
inclusion criteria: 1. patient has one of the following clinical arrhythmia/pacing types: * atrial pacing * atrial fibrillation * ventricular pacing * premature ventricular complex * ventricular tachycardia * ventricular fibrillation * focal atrial tachycardia * premature atrial complex * atrioventricular reentrant tachycardia 2. patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (ep) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as ct or mri. 3. patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system. 4. patient has undergone a successful ablation procedure. 5. arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records. 6. patient was between 22 and 100 years of age at time of ep study and ablation procedure. exclusion criteria: patients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ecg data quality, and/or data included in the device training dataset.
tongue image database and diagnostic model for digestive tract disease diagnosis

Conditions: Digestive Tract Diseases; Liver Diseases; Colorectal Disease; Gastric Diseases; Small Bowel Disease

Summary: the tongue images of patients with gastrointestinal diseases and healthy people will be collected and the tongue image database will be established. through deep learning and artificial intelligence, early screening models of various gastrointestinal tumors based on tongue images were constructed.


Eligibility criteria:
inclusion criteria: 1. be older than 18 years old; 2. clinical or pathological diagnosis of digestive tract diseases; 3. patients before receiving surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy and other treatment measures； 4. the patient had no tongue disease 5. patients understand and are willing to sign written informed consent. exclusion criteria: 1. patients unable to complete the process as required (mental disorder or poor compliance, etc.); 2. the patient or guardian is unwilling to participate in this study; 3. combined with other serious systemic diseases (heart failure, renal failure,hematopoietic system disease or uncontrollable acute infection);
study of amiloride on vascular phenotypes in young adults with prehypertension

Conditions: Prehypertension

Summary: primary specific aim: to test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.


Eligibility criteria:
inclusion criteria: * prehypertensive: having systolic bp between 120 to 139 mmhg and/or diastolic bp between 80 to 89 mmhg during screening visit. bp will be measured manually tree times at 10 minutes interval after subjects sit quietly for at least 5 minutes in a chair. the average of last two bp measurements will be taken into consideration. * male or female of caucasian or african-american origin. * no history of any major past and current medical illness (such as diabetes, renal disease, liver disease etc.) * not taking any medication that affects blood pressure. exclusion criteria: * hba1c \> 7.0 % during screening visit. * serum potassium \> 5.5 meq/l during screening and/or any testing visit due to risk of developing hyperkalemia. * serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 50 ml/min\* (glomerular filtration rate estimate by abbreviated mdrd study equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction. * female having positive pregnancy test during screening and/or any testing visit.

Keywords: prehypertension flow mediated dilation pulse wave velocity carotid compliance prehypertension and amiloride
evaluation of the quality of life of patients with dbb with the installation of opep

Conditions: Bronchiectasis; Quality of Life; Physiotherapy

Summary: to carry out an assessment of compliance and quality of life in a population (children and adults) with ddb before and after the use of an oscillating pep. the aim is to determine the impact of the use of oscillating pep on the daily life of this population in particular.


Eligibility criteria:
inclusion criteria: * children (from 8 years of age) and adults over 18 years of age with ddb who doesn't use oscillating pep. the study population will be clinically stable and will be seen in follow-up consultations. exclusion criteria: * children under 8 years of age. * patients who use an opep * patients in the acute exacerbation phase of their ddb * patients who are not under regular consultation * patients with severe, uncontrolled co-morbidities * patients with cognitive or psychiatric disorders preventing proper adherence to the study protocol * patients taking part simultaneously in another clinical study that could interfere with the results of the opep study

Keywords: quality of life bronchiectasis oscillating pep devices physiotherapy
does bipolar disease program (bdp) intervention improve long term manic and depressive symptoms.

Conditions: Bipolar Disorder

Summary: based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. the major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.

primary hypothesis: the primary hypotheses are that bipolar disease program (bdp) intervention will significantly improve (1) manic and (2) depressive symptom scores, as well as total treatment costs as compared to usual care of bipolar patients. secondary hypothesis: secondary hypotheses include significant improvement in bdp patients as compared to usual bipolar treatment care with respect to functional outcome, quality of life, intensity of somatotherapy, patient satisfaction, and provider attitudes. intervention: usual (psychiatric) care vs bipolar disorder program primary outcomes: the primary outcomes are: (1) manic symptom score; (2) depressive symptom score; and (3) total treatment costs. study abstract: based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. the major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills. patients with bipolar disorder will be randomly assigned to either standard care or the high intensity ambulatory program for three years. outcome variables will cover three distinct domains: disease-specific outcome (number, length, and severity of manic and depressive episodes), functional outcome (social and occupational role function and subjective quality of life), and total treatment costs (direct treatment costs and indirect costs of illness). preliminary data indicate that these domains are related but not redundant. each of these is relevant to patient well-being and to vha management.

Eligibility criteria:
inclusion criteria: patients with bipolar disorder. index episode of manic, major depression or both requiring hospitalization on acute unit. at lease two hospitalizations, three or more months apart within the past 5 years. exclusion criteria:

Keywords: bipolar disease program intervention
ataxia in essential tremor: describing the differences between disease process and treatment effect

Conditions: Essential Tremor; Deep Brain Stimulation; Ataxia; Cerebellar Diseases

Summary: the proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with dbs.

objectives: in recent years, there has been a growing amount of evidence tying essential tremor (et) to cerebellar dysfunction. this has been clinically observed, demonstrated through specific gait measures of ataxia (often involving tandem gait), and confirmed through positron emission tomography (pet) imaging. deep brain stimulation for et has become a widely utilized therapeutic intervention for patients, and the bilateral thalamic ventralis intermedius (vim) is most commonly implanted. however, it has been noted that in some patients gait ataxia significantly worsens post-op. this initially was thought to be a result of disease progression, but recent studies have in fact shown that this is a dbs related phenomenon. methods: participants will have two visits to either the portland va or oregon health \& science university (ohsu). at each visit, several assessments of balance, tremor, gait and balance, and dbs settings will be made. the gait and balance assessments will be performed by a unblinded and a blinded rater.

Eligibility criteria:
inclusion criteria: * essential tremor diagnosis at least 3 years duration * absence of other neurological signes (such as dystonia, ataxia, or parkinsonism) * patients must be able to walk 2 minutes unassisted. * patients must be able to understand and consent to be in the study. exclusion criteria: * patients who have had changes in dbs settings within the last 3 months. * patients who have had no initial improvement or response to dbs. * et medication changes in the last month. * actively abusing alcohol. * a neurologic diagnosis other than et that in the investigator's opinion could affect gait and/or balance. * atypical tremor disorder including by not limited to tremor due to multiple sclerosis, medication-induced tremor, parkinson's disease, or parkinsonian syndrome. * dementia

Keywords: essential tremor dbs
clinical trial on the efficacy of raloxifene on disease activity in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the investigators select 40 postmenopausal women suffering from ra with 2.5\<das28\<5.5 referring to rheumatology clinics of mashhad university of medical sciences and randomly divide them into intervention group and placebo group. evista tab 60mg/day and placebo are administered double blind. in the beginning, total bone mineral density (bmd) assessment is carried out from all patients and then alendronate is discontinued in 2 groups. in first 3 months, in addition to evista and placebo, mtx tab 2.5mg is given to patients and they are allowed to consume nsaid with accurate record of its dosage. patients visit rheumatologist monthly in these 3 months and nsaid should be discontinued 48 hours before every visit. at the end of month 3, disease activity and probable complications are evaluated and compared in 2 groups. classic regimen should be started for every patient who doesn't enter remission phase in first 3 months. in 4th month, dmard regimen is administered and then patients are visited every 2 months. clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. after 12 months, another total bmd test is carried out and then data are analyzed including changes in bmd, das28, eular response criteria and haq-di score.


Eligibility criteria:
inclusion criteria: * patients are postmenopausal women. * patients should fit at least 4 criteria of acr-1987 criteria for rheumatoid arthritis. * patients should be in range of 2.5 \<das28-esr \<5.5 exclusion criteria: * patients with history of thrombotic events * patients suffering from another rheumatic diseases simultaneously * patients with sever symptoms of menopause * patients with known psychological diseases

Keywords: rheumatoid arthritis raloxifene disease activity
microbiota upper respiratory tract

Conditions: Microbiota Upper Respiratory Tract

Summary: the aim of this study is to investigate whether the microbiota in the upper respiratory tract (urt) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (crs) patients is disturbed compared to healthy individuals. therefore, bacterial dna from swabs, aspirates and tissue will be isolated via commercially available dna extraction kits, followed by illumina miseq sequencing in order to identify the bacterial species present in these samples. special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics). a better understanding of the urt microbiome might help us to better understand the pathology of crs and might help to develop new microbiota-based strategies for crs.


Eligibility criteria:
exclusion criteria healthy population: * no use of antibiotics in the past year * no acute or chronic airway infections * no cancer * no autoimmune diseases * pregnant women exclusion criteria crs population: --\> no exclusion criteria
circulating bdnf in patients with atrial fibrillation undergoing catheter ablation or exercise training

Conditions: Atrial Fibrillation

Summary: the main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating bdnf concentrations in patients with atrial fibrillation. it also seeks to determine if there is a relation between circulating bdnf concentrations and mental health (depression severity, quality of life and symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or exercise training.

the main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating bdnf concentrations in patients with atrial fibrillation. it also seeks to determine if there is a relation between circulating bdnf concentrations and mental health (depression severity, quality of life and symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or exercise training. using a pre-post study design, the investigators will explore interventions in two subsets of patients at the opposite end of the atrial fibrillation clinical spectrum. arm 1: patients with paroxysmal atrial fibrillation will undergo catheter ablation (n=100). arm 2: patients with permanent or persistent atrial fibrillation will perform exercise training 2 times weekly for 12 weeks (n=100). total sample size will be 200 participants. all measurements will be performed at baseline and follow-up.

Eligibility criteria:
inclusion criteria: 1. subjects must be either currently enrolled in the opportunity trial (nct02602457) or have paroxysmal atrial fibrillation and be scheduled to undergo catheter ablation (for the first time) through the electrophysiology clinic at the university of ottawa heart institute. 2. subjects must be willing and able to provide a blood sample. 3. subjects must be willing and able to provide informed consent. exclusion criteria: 1. subject is not either currently enrolled in the opportunity trial (nct02602457) or scheduled to undergo catheter ablation (for the first time) through the electrophysiology clinic at the university of ottawa heart institute for paroxysmal atrial fibrillation. 2. subjects with congestive heart failure with heart failure admission in the past 3 months. 3. subjects with a cerebrovascular accident in the past 3 months 4. subjects with severe dementia. 5. subjects with a history of severe psychiatric illness (e.g., schizoaffective disorder, bipolar disorder, or schizophrenia). 6. subjects with an active infection or inflammatory condition. 7. subjects who are pregnant, lactating or planning to become pregnant during the study period. 8. subject is unable to read or understand english or french. 9. subject is unable to provide informed consent.

Keywords: atrial fibrillation
pet/ct scan as a tool to rationalize the treatment of of advanced nsclc patients undergoing first chemotherapy

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

Summary: the purpose of this study is to test whether an early metabolic response, measured by pet/ct scan after the first cycle of chemotherapy, is able to predict which patients with advanced nsclc have a better prognosis.


Eligibility criteria:
inclusion criteria: * diagnosis of cytologically or histologically confirmed non-small cell lung cancer. * metastatic (stage iv, both m1a or m1b) or locally advanced (stage iiib, with metastasis to supraclavicular nodes) according to tnm vii edition. * both patients at first diagnosis or those with disease recurrence after initial surgery are eligible. * at least one target or non-target lesion according to recist revised version 1.1. * age \> or = 18 years . * ecog ps 0-2. * life expectancy \> 3 months. * signed informed consent. exclusion criteria: * uncontrolled diabetes (glucose \> 200 mg/dl * egfr mutation, for those patients who have had testing done. (egfr test is not required for participation in the study, but may be conducted as part of normal clinical practice, and patients with egfr mutation would not be candidate for first-line chemotherapy.) * any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal psa). * pregnant or lactating females. * previous medical therapy for metastatic disease (prior surgery, radiation therapy are permitted, as well as adjuvant medical therapy completed at least 6 months prior to study entry). * any poorly controlled illness (including active infections, significant hepatic, renal, metabolic or cardiac disease, myocardial infarction within previous 12 months) that may, according to physician's judgement, interfere with the patient's ability to undergo chemotherapy and/or the examinations within the study protocol * inability to provide informed consent.

Keywords: metabolic response chemotherapy