Kornimate/medical-research-clean huggingface dataset:
urodynamic feasibility study utilizing the urolift® system

Conditions: Benign Prostatic Hyperplasia

Summary: uds evaluates the impact of prostatic urethral lift (pul) as measured by pressure flow, urodynamic testing (uds) and an optional urocuff testing, an alternative urodynamic test. in addition, standard bph measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.


Eligibility criteria:
inclusion criteria: * male gender * diagnosis of symptomatic bph * age ≥ 45 years * international prostate symptom score (ipss) ≥ 13 * peak urine flow rate ≤ 12 ml/sec, voided volume ≥ 125 ml * prostate volume ≤ 80 cc per ultrasound exclusion criteria: * current urinary retention * post void residual (pvr) urine \> 250 ml * have an obstructive or protruding median lobe of the prostate * active urinary tract infection at time of treatment * current gross hematuria * previous bph surgical procedure * previous pelvic surgery or irradiation * history of neurogenic or atonic bladder * stress urinary incontinence * biopsy of the prostate within the past 6 weeks * life expectancy estimated to be less than 1 year * history of prostate or bladder cancer * elevated prostate-specific antigen (psa) without ruling out prostate cancer * history of compromised renal function or upper tract disease * known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure) * use of the following medications pre-screening (uroflow, questionnaires): * within 4 months of baseline assessment: estrogen, any drug producing androgen suppression, or anabolic steroids * within 3 months of baseline assessment: 5-alpha-reductase inhibitors * within 2 weeks of baseline assessment: alpha-blockers, gonadotropin-releasing hormonal analogs, anticholinergics or cholinergic medication or phenylephrine, pseudoephedrine, or imipramine medications * within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and antispasmodics * cystolithiasis within the prior 3 months * history of co-morbidities that would affect having an elective urological procedure including: prostatitis, conditions that preclude the insertion of the urolift system. * other co-morbidities that could impact the study results such as: * severe cardiac arrhythmias uncontrolled by medications or pacemaker * congestive heart failure new york heart assocation (nyha) iii or iv * history of uncontrolled diabetes mellitus * significant respiratory disease in which hospitalization may be required * known immunosuppression (i.e. aids, post-transplant, undergoing chemotherapy) * a known allergy to nickel, titanium, or stainless steel * unable or unwilling to complete all required questionnaires and follow up assessments * unable or unwilling to sign informed consent form * currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
computer assisted cognitive remediation program in schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether computer-assisted cognitive remediation therapy is effective in the treatment of cognitive deficits in schizophrenia.

schizophrenia can be considered a chronic illness that affects all aspects of daily life. cognitive deficits seems to play a key role that interferes directly in the functional adaptation. cognitive remediation therapy (crt) emerges as a psychological intervention that target cognitive impairment. but, the use of computerized or papel an pencil procedures for remediation cognitive deficits remains controversial. nonetheless, computer tasks offer a number of advantages compared to those of paper and pencil. the most noteworthy advantages are to enhance patient's motivation just because the sensory variety that the exercises presented or the possibility to provide immediate feedback. furthermore, the possibility to present custom-tailored and adapted tasks taking into accounts the patients deficits and their evolution in the process of the psychological therapy is another important feature of computer-assisted cognitive remediation therapy.

Eligibility criteria:
inclusion criteria: * dsm-iv (apa, 1994)criteria for schizophrenia disorder * estimated iq of 85 or superior by vocabulary subtest, wechsler adult intelligence scale-iii (wais-iii) * patients were considered sufficiently stable if they had a global assessment of functioning scale (gaf)score of 40 or superior and they maintained a stable dose and type of psychiatric medication for at least 1 moth prior to inclusion. exclusion criteria: * non presence of cognitive impairment confirmed by neurocognitive assessment * traumatic brain injury or history of neurologic illness. * electroconvulsive therapy in the last year. * psychiatric comorbidity. * plan to change medication during the trial.

Keywords: schizophrenia cognitive remediation therapy cognition quality of life
postural control in covid-19

Conditions: COVID-19; Performance

Summary: this study was planned to investigate how much the anaerobic performance of individuals who experienced fatigue with want (wingate) affected their postural sway parameters.

the postural sway parameters of the individuals will be evaluated using the "kistler force plate" and the anaerobic values will be evaluated using the wingate anaerobic strength test and the "excalibur sport ergometer" device. the data obtained will be compared with the data of patients with and without covid-19 disease using appropriate statistical methods.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-30, - being a volunteer - having had covid 19 in the last 3 month exclusion criteria: * presence of neurologic and oncologic disease - presence of orthopedic surgery - presence of active covid 19 disease - any cardiopulmonary disease
short transverse versus conventional hockey stick incision in kidney transplantation

Conditions: Kidney Transplantation

Summary: today the minimal invasive access is used for a lot of different operations. this technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection). especially patients under immunosuppressive therapy could benefit from this technique. first results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. benefits are expectable on postoperative pain, recovery, and surgical complications. another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic. the aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.


Eligibility criteria:
inclusion criteria: * age equal or over 18 years * sole kidney transplantation * consent form

Keywords: kidney transplantation minimal invasive short transverse hockey stick incision quality of life planned kidney transplantation
safety and efficacy of dextromethorphan and quinidine in the treatment of the pain of diabetic neuropathy

Conditions: Pain; Diabetic Neuropathy

Summary: the purpose of this study is to determine whether dextromethorphan (neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus * established diabetic therapy for at least 3 months * lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy * pain the previous three months * not pregnant exclusion criteria: * patient failed adequate trial of 3 or more medications or has required narcotics for pain * history of torsades de pointes * sensitivity to quinidine or opiate drugs (codeine, etc) * severe pain that could confound the assessment * patient has had any amputations * patient has participated in the past 30 days or is currently participating in another trial * patient has previously received treatment with dextromethorphan and quinidine

Keywords: distal symmetrical pain lower extremities dextromethorphan
catheter ablation of haemodynamically not-tolerated electrical storm in structural heart disease

Conditions: Ventricular Tachycardia

Summary: this is a multi-center, parallel-group, randomized, open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia (vt).

the prognosis of haemodynamically not-tolerated vt in structural heart disease is very poor, with a high 30-day mortality rate \>30%, resulting in extremely heavy medical burden. current guidelines lack specific recommendations for managing this condition. the prevailing treatment strategy involves a sequential approach-beginning with anti-arrhythmic drugs, sedation, and anesthesia, followed by haemodynamic mechanical support devices. catheter ablation is only used as the final rescue treatment. typically, patients undergo repeated electrical cardioversion and receive multiple vasopressors and antiarrhythmic drugs, facing increased risks of complications from enhanced haemodynamic support. studies have shown that these patients often eventually progress to irreversible pump failure, miss the window for effective catheter ablation, and ultimately die. early cardioversion and maintenance of sinus rhythm, may significantly reduce mortality rates in patients with haemodynamically not-tolerated vt. therefore, emergency catheter ablation is expected to reduce the mortality of haemodynamically not-tolerated ventricular tachycardia. in this study, we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia. current study will include 96 patients, and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 1:1 fashion. the follow-up duration is 1 year. the primary outcome is a composite outcome of vt recurrence, cardiovascular re-hospitalization, and all-cause mortality.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 80 years; 2. having structural heart disease, including ischemic cardiomyopathy and nonischemic cardiomyopathy; 3. haemodynamically not-tolerated, defined as persistent hypotension (systolic blood pressure \<90 mmhg and mean arterial pressure 30 mmhg lower than baseline or \<70 mmhg, with associated signs of end-organ hypoperfusion); 4. electrical storm, defined as \>3 vt episodes within 24 hours. exclusion criteria: 1. reversible causes of ventricular tachycardia or cardiomyopathy; 2. ventricular thrombosis diagnosed by echocardiography and/or cardiac magnetic resonance; 3. acute st-segment-elevation myocardial infarction within 60 days; 4. cardiac surgery within 60 days; 5. unstable angina; 6. pregnancy.

Keywords: catheter ablation mortality electrical storm
magnetic resonance tumour regression grade (mrtrg) as a novel biomarker - phase iii non ctimp trial

Conditions: Rectal Cancer

Summary: open to patients undergoing any pre-operative treatment for locally advanced rectal cancer, trigger is the only phase iii clinical trial in the uk offering watch and wait. all patients will have post treatment mri scans routinely performed, no change from the mercury trials high resolution mri protocol is required. patients will be randomised to either the control arm for management according to national guidelines - conventional mdt, clinical assessment post-treatment planning using the baseline mri. patients in the interventional arm will have their post treatment mri scans read by a radiologist trained and supported to reliably report the mrtrg grade and have their management directed accordingly - 'good response' (mrtrg 1\&2) - watch and wait (avoidance of surgery) offered. 'poor response' (mrtrg 3-5) - local colorectal mdt is informed and uses information to discuss and agree next steps in treatment and surveillance. patients are followed up for five years with qol questionnaires completed at registration, 3 and 5 years.

the only phase iii clinical trial in the uk offering watch and wait, the trigger trial aims to validate mrtrg as an imaging biomarker for the stratified management of patients with locally advanced rectal cancer. the 'good responders' (mrtrg1\&2) often have no evidence of tumour and it may be possible to avoid surgery in this group and so maintaining qol while not impacting survival rates. the 'poor responders' (mrtrg3-5) are at high risk of poor oncological outcomes and this knowledge is useful in planning ongoing treatment and surveillance. trigger is now a non-ctimp trial as the protocol does not specify chemotherapy or imp treatments. decisions about the use of chemotherapy will be based upon local mdt discussions as is normal practice and national policy and the trial crfs will capture these decisions and whether more treatment is given to patients or not. trigger does not mandate or recommend the use of any treatments: specifically it does not suggest the use of investigational medicinal products. if any centre wishes to use imps this would be in the context of separate trial protocols and would not preclude entry into trigger.

Eligibility criteria:
inclusion criteria: 1. mri defined locally advanced rectal carcinoma i.e. one or more: greater than or equal to mrt3c; mremvi positive; mr n1c; mr crm positive 2. biopsy confirmed adenocarcinoma of radiologically defined rectum 3. be deemed to require preoperative chemoradiotherapy (crt) or total neoadjuvant therapy (tnt) exclusion criteria: 1. metastatic disease 2. mri, radiotherapy and/or chemotherapy contraindications 3. a post-treatment mri performed more than 10 weeks after the completion of radiotherapy if given 4. previous malignancy within preceding 5 years if risk of recurrence \>5%

Keywords: rectal cancer magnetic resonance imaging chemoradiotherapy chemotherapy diagnostic imaging
microvascular flow assessment repeatability study: the mars study

Conditions: Obesity

Summary: the purpose of this study is to test a method of imaging (taking a picture) of the abdomen (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a drug which makes the pictures look clearer. ultrasound is a type of imaging that uses sound waves to create a picture of the inside of the human body. two sets of pictures will be taken on two different days to see if the results are the same each time. definity® is a drug given intravenously (through the vein). definity® is approved by the fda to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking pictures of the heart. in this study, definity® will be used while taking pictures of blood vessels in your abdomen (belly), neck, thigh and calf (lower leg). since this use of definity® is different than the use approved by the fda, this study will be performed under an fda investigational new drug (ind) application.


Eligibility criteria:
inclusion criteria: 1. men and non-pregnant/lactating women between the ages of 18 and 45; 2. lean (bmi ≥18 and ≤25) or obese grade i-ii(bmi\>30 and ≤35) 3. provide written informed consent and sign hipaa waiver of authorization 4. be able and willing to follow all instructions and attend all study visits exclusion criteria: subjects must not have been diagnosed with: 1. coronary artery disease 2. congestive heart failure 3. congenital heart disease (right-to-left, bi-directional, or transient right-to-left cardiac shunts) 4. hypersensitivity to perflutren 5. renal disease 6. chronic obstructive pulmonary disease or asthma 7. primary or secondary pulmonary hypertension 8. obstructive sleep apnea 9. thyroid disease 10. vasculitis 11. peripheral arterial disease. 12. cancer 13. any type of immunosuppression 14. any active infection (systemic or of the underlying skin or subcutaneous tissue). 15. taking any prescribed medication for hypertension, dyslipidemia or diabetes. 16. current or past smoking in the last 12 months. 17. positive urine pregnancy test 18. creatinine (cr) above 1.4 mg/dl on screening evaluation 19. hemoglobin (hb) less than 10 mg/dl on screening evaluation 20. aspartate transaminase (ast) or alanine transaminase (alt) two fold above upper limit of normal on screening evaluation
canadian edoxaban(lixiana®) registry in patients with atrial fibrillation/flutter with confirmed valvular heart disease

Conditions: Atrial Fibrillation and Flutter; Valvular Heart Disease

Summary: the objective of this registry is the characterization of patients with atrial fibrillation (af) and/ or atrial flutter (afl) with confirmed vhd who are prescribed edoxaban in a real life clinical setting.

this is an observational, prospective, multicenter, edoxaban canadian registry of adults (≥18) diagnosed or confirmed with af and/or afl with vhd, within the last 12 months, according to local standard procedures and judged by the investigator to be at risk of stroke and in whom anticoagulation with noac is clinically indicated and who are prescribed edoxaban. a total of about 300 patients will be enrolled from approximately 10 sites in quebec. patients will be treated according to standard local practices. there is no formal interventions. treatment decisions are left to the physician's discretion. registry data will be collected by the investigator or delegate at baseline, 6, 12 and 24 months and recorded in the electronic case report form (ecrf). data available in the patient's file will be collected. the only procedure to be performed in the context of this registry is the completion of questionnaires: the montreal cognitive assessment (moca©) test and the anti-clot-treatment scale (acts-q) questionnaire.

Eligibility criteria:
inclusion criteria: 1. male and female patients aged ≥ 18 years at baseline (signing of consent); 2. willing and able to provide written informed consent; 3. patient diagnosed or confirmed with af and/or afl within the last 12 months of signed consent form; 4. patient with vhd confirmed by echocardiography within the last 36 months of signed consent form except for mitral stenosis that must be confirmed within the last 12 months; 5. patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban. exclusion criteria: 1. patients with af and/or afl secondary to reversible cause; 2. patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis; 3. patients planned to have an intervention for valvular heart disease in the next 12 months; 4. pregnant or breastfeeding women. 5. short term anticoagulation post cardioversion or ablation.
patient similarity for decision-making in prevention of cardiovascular toxicity (pact): a feasibility study

Conditions: Heart Failure; Coronary Artery Disease; Peripheral Artery Disease; Ischemia; Hypertension; Diabetes Mellitus; Cardiomyopathies; Cardiotoxicity

Summary: this is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

for this feasibility study, the researchers will create the clinical decision aid and test the central hypothesis that this novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists and will favorably impact appropriate medication use and cardiac imaging surveillance. the hypothesis is supported by preliminary data suggesting that an initial and rudimentary version of the clinical aid increases appropriate medication use and imaging follow-up in cardio-oncology patients. success will be determined by ≥85% of clinic visits using the clinical decision aid resulting in pursuit of medication use and cardiac imaging surveillance patterns commensurate with recommendations specific to cancer survivors, with overall rates the same or higher than the group without the clinical decision aid, as well as overall favorable patient and physician focus group comments and survey responses.

Eligibility criteria:
inclusion criteria: 1. patients ≥18 years with a history of cancer. 2. have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis. 3. clinically at intermediate, high, or very high risk for cardiovascular diseases determined based on imprecise clinical risk models, such as those used for cardiac dysfunction. 4. ability to understand a written informed consent form, and willing to sign it prior to study registration. exclusion criteria: 1. patient \<18 years. 2. without a personal history of cancer. 3. existing cardiomyopathy diagnosed after cancer diagnosis. 4. documented cognitive impairment. 5. patient or patient representative who is unable and unwilling to sign the informed consent form.

Keywords: clinical decision aid cancer cardiac dysfunction cardio-oncology artificial intelligence machine learning adverse events
phase 2 study of abt-869 in advanced hepatocellular carcinoma (hcc)

Conditions: Advanced Hepatocellular Carcinoma

Summary: phase 2 study of abt-869 in advanced hepatocellular carcinoma (hcc)

an open-label, phase 2 study of efficacy and tolerability of abt-869 in advanced hepatocellular carcinoma (hcc)

Eligibility criteria:
inclusion criteria * subject must be greater than or equal to 18 years of age * subject must be diagnosed with unresectable or metastatic hcc * subjects must have a measurable lesion by recist on ct scan in at least one site which has not received radiation * subject has an eastern cooperative oncology group (ecog) performance status of 0-2 * no other active malignancy within the past 5 years exclusion criteria * subject has received targeted vegf/pdgf/tki therapy. prior avastin is allowed * subject has child-pugh grade class c hepatic impairment * the subject has proteinuria common toxicity criteria (ctc) grade \> 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment * subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure \> 100 mmhg or systolic blood pressure \> 150 mmhg. subjects may be re-screened if blood pressure is shown to be controlled with or without intervention * the subject has a documented left ventricular ejection fraction \< 50% * subject is receiving therapeutic anticoagulation therapy
short term group therapy for ocd

Conditions: Obsessive Compulsive Disorder

Summary: assessing ocd before and after group therapy


Eligibility criteria:
inclusion criteria: * ocd * eligibility to participate in group therapy exclusion criteria: * ptsd * suicidal thoughts * psychotic state * severe hostile personality disorder