Kornimate/medical-research-clean huggingface dataset:
retrospective chart review of valstar

Conditions: Carcinoma in Situ of Bladder

Summary: this is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (cis) since october 2009.

initial treatment for bladder cis is turbt followed by intravesical immunotherapy with bcg. valrubicin is approved by the fda for the treatment of bcg-refractory bladder cis in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. the recommended course of therapy is 6 doses of 800 mg each administered intravesically once a week. while the benefit risk profile of valrubicin has been established in several clinical trials, current data on effectiveness and tolerability when used in clinical practice are lacking. this protocol outlines a retrospective study to evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the treatment of nmibc in a clinical practice setting.

Eligibility criteria:
inclusion criteria: * age 18 years old or greater * diagnosis of cis (physician defined in the medical record) * treated with at least one ive dose of valrubicin since 10/2009 and completed prescribed therapy or no longer receiving therapy at time of study enrollment * willing and able to provide informed consent (unless waiver of informed consent is applicable and in place at that clinical site per chapter 45 cfr part 46 subpart a 46.117 exclusion criteria: * route of administration of valrubicin other than intravesical

Keywords: bcg refractory nmibc cis non-muscle invasive
cold exposure with controlled breathing and meditation in patients with multiple sclerosis (cobrams)

Conditions: Multiple Sclerosis

Summary: the goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis. researchers will compare the effect to control groups of ms patients without intervention.


Eligibility criteria:
inclusion criteria: * rrms diagnosed according to the official 2020 mcdonald's criteria, * age 18-55 years, * ms duration up to 10 years, * edss 1.0-5.5, * willingness to participate exclusion criteria: * relapse or corticosteroid treatment within 3 months prior to study enrollment * severe/unstable comorbidity
aortic stenosis and cardiac amyloidosis

Conditions: Cardiac Amyloidosis; Aortic Stenosis

Summary: the dual pathology of aortic stenosis (as) and cardiac amyloidosis (ca) is increasingly recognized. even tough efforts have been undertaken to bring cohorts together, the largest cohort of as-attr to date is \<50 patients. it is the aim of the present international, multi-center registry to collect \~300 patients with as-ca creating a big enough cohort to allow 1. thorough characterization of this condition 2. assessment of log-term clinical outcomes of as-ca 3. assessment of effectiveness of amyloid-specific treatment on top of valve replacement

calcific aortic stenosis (as) and transthyretin (attr) cardiac amyloidosis are both conditions commonly affecting the elderly. bone scintigraphy using amyloid-avid tracers (99mtc-3,3-diphosphono-1,2-propanodicarboxylic acid, dpd; 99mtc-pyrophosphate; or 99mtc-hydroxymethylene diphosphonate) represents the key imaging modality for non-invasive attr diagnosis. recent studies have used this technology to screen as patients and demonstrated that as and attr may coexist in 8 to 16%. this is substantially higher than in non-cardiac referrals for bone scintigraphy (range 1-3% in individuals \>80 years), which is considered the most accurate approach to estimate the attr prevalence in the general population. while the dual burden of as and attr might suggest adverse prognostic implications, it has been shown that as-attr and lone as patients benefit equally from transcatheter aortic valve replacement (tavr) with comparable 1- and 2-year survival rates. yet, data on long-term outcomes are still missing. with increased recognition and valvular treatment of as-attr, the disease course after tavr becomes a key issue. our data suggest significantly different remodeling between lone as and as-attr, with the latter being transformed into a "lone-attr" cardiomyopathy phenotype at one-year post-tavr. novel attr-specific treatments are now available, with the potential to further improve prognosis in as-attr on top of valvular replacement. however, patients with significant as were not included in the attr-act trial, and treatment effectiveness in this patient population therefore remains unclear. also, despite increased attr screening globally, the case numbers for dual as-attr of individual centers are still low. the present international multi-center study is therefore designed to provide detailed characterization of dual as-attr, inform about long-term clinical outcomes and assess the effect of attr specific treatment.

Eligibility criteria:
inclusion criteria: * patients with significant as and a concomitant diagnosis of cardiac amyloidosis who are eligible for inclusion as per local permissions exclusion criteria: * patients without significant as (less than moderate as) * patients with other subtypes of cardiac amyloidosis (e.g., light chain)
comparing the effects of neck stabilization exercises verses dynamic exercises among patients having nonspecific neck pain with forward head posture

Conditions: Non-specific Neck Pain

Summary: the objective of this randomized clinical trial is to compare the effectiveness of neck stabilization exercises versus neck dynamic exercises in patients having non specific neck pain with forward head posture for pain intensity, correction of forward head posture, increasing range of movement and decrease functional disability. the study is being conducted at physiotherapy department of institute of physical medicine and rehabilitation (dow university of health sciences) total 60 patients with non specific neck pain with forward head posture recruited by non-probability sampling technique initially screening done by consultant physicians who is blinded to the treatment given to patients. patient are included in study who fulfill inclusion criteria and sign the consent form. patients then randomly allocated to both treatment groups using computer generated randomization sheet. baseline assessment is taken at first session after providing 9 treatment of stabilizing exercises to group1 and dynamic exercises to group 2 session post assessment will be done on goniometry, ndi, vas and plumb line at last session at third week.


Eligibility criteria:
inclusion criteria: * patients with nonspecific neck pain more than 3 weeks less than 6 months. * patients with forward head posture on plumb line assessment. * pain on vas moderate 4-7 * ndi score with moderate; 50-64%. * age ranges from 18-40. exclusion criteria: * previous history of any accident (whiplash), fracture, tumor etc. * patients not willing to participate.

Keywords: neck aches isotonic contractions muscle strength rehabilitation exercises treatment
mechanical interference versus neural mobilization on ulnar neuropathy post cubital tunnel syndrome

Conditions: Cubital Tunnel Syndrome

Summary: this study will be conducted to compare between mechanical interference and neural mobilization on ulnar neuropathy post-cubital tunnel syndrome

ulnar nerve neuropathies are the second most common entrapment neuropathy of the upper extremities after carpal tunnel syndrome. cubital tunnel syndrome (cts) is a condition that involves pressure or stretching of the ulnar nerve also known as the "funny bone" nerve, which could cause numbness or tingling in the ring and tiny fingers, pain in the forearm, and hand weakness. the ulnar nerve runs in a groove on the inner side of the elbow. conservative treatment of cubital tunnel syndrome is recommended for patients with mild and moderate symptoms and without changes in cutaneous sensation or muscle atrophy. in addition, a wide variety of conservative approaches including corticosteroid injections as a minimally invasive technique and splinting and bracing failure were recommended for cts depending on its severity. manual therapy techniques are part of the physical therapy treatment of cts, which are classified into two groups including nerve mobilization and mechanical interface mobilization. the aim of the study was to find which manual therapy method-technique directed to mechanical interface and nerve mobilization-has superior beneficial effects on clinical and electrophysiological findings in the conservative management of patients with cts. ninety patients with post-cubital syndrome will be allocated randomly to three groups; the first experimental one will receive mechanical interference, the second experimental will receive neural mobilization and the third one will receive conventional treatment for four weeks.

Eligibility criteria:
inclusion criteria: * the patients were diagnosed and referred by an orthopedist. * the patient's age ranged from 20 to 55 years old. * recent ncv for ulnar nerve confirming the diagnosis. * unilateral cubital tunnel syndrome with ulnar neuropathy exclusion criteria: * patients with cervical brachialgia. * patients with metabolic diseases such as diabetes, severe thyroid disorders, anemia, and -pregnancy. * hypertensive patients or patients who had a previous hand or elbow surgery. * patients with median nerve involvement in proximal areas such as thoracic outlet syndrome. history of carpal tunnel release surgery. steroid injection

Keywords: mechanical interference neural mobilization ulnar neuropathy post cubital syndrome
implementation of sglt-2 inhibitors in patients with heart failure through a new digital strategy

Conditions: Heart Failure

Summary: the implementation of new medical therapies and guidelines, is a long and complex process that takes up to 10 years on average. this prolonged process is a global challenge and is mainly due to the complexity of cross-institutional patient care, involving primary care, out-patient clinics, nursing homes and patient associations. the main objective of this clinical trial is to determine whether a new digital strategy that employs official digital letters to inform and invite patients to evaluate their eligibility for new therapies, specifically the sodium-glucose co-transporter-2 (sglt-2) inhibitor for heart failure patients, can facilitate and optimise the implementation. the aim is to increase the number of eligible patients with heart failure who start taking sglt-2 inhibitors and reduce the time it takes to initiate treatment compared to the current process. ultimately, this approach may improve patient outcomes.

the study is a prospective, multicenter, two-armed, randomised clinical trial that will be coordinated from the department of cardiology, herlev-gentofte hospital. the primary objective of the study is to determine whether a new digital strategy can be implemented to introduce novel medical therapies, specifically sodium-glucose co-transporter-2 (sglt-2) inhibitors to heart failure patients. the aim is to increase the number of eligible patients who initiate therapy and to reduce the time taken to initiate therapy compared to the current process. the study will recruit patients with a registered diagnosis of heart failure residing in the capital region of denmark and roskilde, who have not yet been started on sglt-2 inhibitor therapy. patient identification and recruitment will be carried out through danish nationwide registries, using their personal identification number (cpr-number), which is also linked to a secure digital mailbox where all official letters from public authorities are sent to danish citizens. patients will be randomly assigned (1:1) to receive a digital letter containing evidence-based information about the newly approved heart failure therapy option, sglt-2 inhibitors. the letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy. outcome measures will be obtained from danish nationwide registers at pre-specified time points and in collaboration with the danish health data authority.

Eligibility criteria:
inclusion criteria: 1. registered diagnosis of heart failure within the last 10 years 2. living in the capital region of denmark or roskilde 3. age ≥20 years exclusion criteria: 1. redeemed prescription of a sglt-2 inhibitor after 2015 2. type 1 diabetes 3. history of diabetic ketoacidosis 4. chronic kidney disease in long term dialysis 5. living in a nursing home 6. dementia 7. cancer diagnosis within the last year (except prostate cancer and non-melanoma skin cancer) 8. exemption from the public digital mailbox system

Keywords: heart failure sglt-2 inhibitors digital implementation cardiorenal disease
radiofrequency before to surgical removal of a recalcitrant morton´s neuroma

Conditions: Morton Neuroma; Radriofrequency

Summary: the purpose of this study is to perform a radiofrequency procedure prior to the removal of morton's neuroma. this procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact.


Eligibility criteria:
inclusion criteria: * patient aged between 18 and 70 years * patient with neuroma of morton of more than 1 year of evolution * patient treated by conservative treatments, stencils, various infiltrations, stretching and with symptomatology that limits his daily activities. * healthy patients without previous systemic pathologies (diabetes, coagulation or immunological disorders), asa i or ii that require and demand surgical treatment of their pathology in the participating centers and willing to participate in the study. * freely accept and sign the informed consent for participation in the study. exclusion criteria: * allergy to local anesthesia.

Keywords: foot morton neuroma radiofrequency
european trial of dronedarone in moderate to severe congestive heart failure

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to assess the efficacy, tolerability and safety of dronedarone versus placebo in patients with symptomatic congestive heart failure (chf) and left ventricular dysfunction (lvd) when added to evidence based treatments for chf.


Eligibility criteria:
inclusion criteria: * patients hospitalized with symptomatic chf, current new york heart association (nyha) class ii-iv requiring treatment with a diuretic, who had had within the last month at least 1 episode of dyspnea or fatigue at rest, or on slight exertion corresponding to nyha class iii or iv * wall motion index (wmi) ≤1.2 determined by a blinded central evaluation of a recorded standard echocardiography, equivalent to a left ventricular ejection fraction (lvef) ≤35%. exclusion criteria: * acute pulmonary edema within 12 hours prior to start of study medication * various heart conditions (cardiogenic shock, obstructive valvular disease, obstructive cardiomyopathy; acute myocardial infarction, cardiac surgery, acute myocarditis or constrictive pericarditis, history of torsades de pointes, bradycardia \ 500 ms, significant sinus node disease) * any illness or disorder other than chf (cancer with metastasis, organ transplantation) * current participation in another clinical study or currently taking an investigational drug including dronedarone or concomitant prohibited medication or treatment with other class i or iii anti-arrhythmic drugs * pregnant and/or breastfeeding women or women of child-bearing potential without adequate birth control * serum potassium \<3.5 mmol/l. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: heart disease morbidity
pangea - physical activity and nutrition for quality ageing

Conditions: Aging; Sarcopenia; Cognitive Decline

Summary: general objectives of the project defining healthy ageing factors; setting up content-related bases of the international excellence centre (slo-ita) in the field of health of elderly citizens; raising awareness on the significance of healthy ageing, social inclusion and mobility of less privileged populations (the elderly); reducing the costs of health care; connecting the existing health care, social and private entities and improving their mutual coordination.

physical activity, dietary habits, social and private entities strongly affect the quality of health and quality of life of the elderly. the main object of this study will be to evaluate physical and cognitive performance in combination with physical activity and dietary habits of the elderly. the investigators are interested in longitudinal monitoring of the elderly that participated in measurements in 2013 and measurements after a decade. the results of this study will give important epidemiological information about physical and cognitive status, health status in combination with physical activity which occurs in a longer period of time.

Eligibility criteria:
inclusion criteria: * singed written consent * age above 60 * healthy exclusion criteria: * severe musculoskeletal injuries * inability to follow instructions when performing the test

Keywords: elderly longitudinal physical activity cognition dietary habits
stereotactic body radiation therapy vs. microwave ablation for colorectal cancer patients with metastatic disease in the liver

Conditions: Colorectal Carcinoma; Liver Metastases

Summary: this study is a randomized phase ii trial between microwave ablation (mwa) and stereotactic body radiotherapy (sbrt) - two standard treatment modalities for colorectal patients with metastatic disease in the liver. primary endpoint is freedom form local lesion progression.

colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either mwa or sbrt. chemotherapy is allowed. curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. patients will be analyzed according to the intention-to-treat principle.

Eligibility criteria:
inclusion criteria: 1. colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of 1. non-resectability 2. small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection 3. previous extensive liver surgery 4. comorbidity 2. the multidisciplinary team should all agree that both percutaneous or open surgical mw-ablation and sbrt are safe as first treatment choice for the individual patient. 3. tumor sizes ≤4.0 cm 4. age \> 18 years 5. signed informed consent exclusion criteria: 1. previous radiotherapy to the liver 2. liver volume \< 700 ml 3. another active cancer disease within the past 36 months 4. not able to understand written or oral protocol information
balloon dilation of the eustachian tube

Conditions: Eustachian Tube Dysfunction

Summary: in this study, patients with dysfunction of the eustachian tube will be included. they will be randomized to one of two treatment groups. 1. balloon dilation of the eustachian tube or 2. nasal saline patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months

patients will eustachian tube dysfunction will be asked to participate in the study. they will be randomized to one of two groups group 1 - surgical dilation of the eustachian tube in general anaesthesia group 2 - daily nasal saline spray, twice a day regular follow up with tympanogram and questionnaire after three months patient in the control group (nasal saline) can switch in the intervention group. eustachian tube dilation will be carried out with a health canada and fda approved device, usually used for endovascular balloon dilation. it has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study.

Eligibility criteria:
inclusion criteria: * ≥18 years old (of both sexes) * diagnosed with persistent obstructive eustachian tube dysfunction (oetd) for at least 3 months prior to enrolment uni- and/or bilateral diagnosis (both required): i. persistent oetd symptoms assessed by eustachian tube dysfunction questionnaire (etdq-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment. ii. refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment). exclusion criteria: * patulous eustachian tube * prior eustachian tube intervention * presence of myringotomy ventilation tube or a tympanic membrane perforation * active chronic or acute otitis media * chronic otitis media with cholesteatoma * fluctuating sensorineural hearing loss or meniere's disease * chronic rhinosinusitis, allergies, or reflux disease not controlled with medication * history of head or neck surgery within 3 months * prior radiation to the head and neck * active temporomandibular joint disorders * cleft palate or craniofacial syndrome * cystic fibrosis or ciliary dysmotility syndrome or systemic immunodeficiencies * active acute upper respiratory infection * nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the eustachian tube * ct temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression * patient unable to follow protocol for any reason
validation of a quality of life metric "prolac-10"

Conditions: Prolactinoma; Prolactin-Producing Pituitary Tumor; Pituitary Tumor; Prolactinoma Macroadenoma; Prolactinoma Microadenoma

Summary: this is a short-term validation study of a quality of life metric "prolac-10" for patients diagnosed with a prolactinoma, undergoing new medical therapy.

this is a single-site validation study of a novel quality of life study for patients undergoing medical therapy for prolactinoma. patients will be consented before starting their medical regimen and complete the "prolac-10" questionnaire for baseline and will continued to be followed for 13-weeks into their medical care. the primary goal of this study is to validate the novel quality of life questionnaire in terms of sensitivity, repeatability, and consistency. secondarily, we aim to validate the test-retest characteristics to further validate sensitivity, repeatability, and consistency. the prolac-10 metric is copyright © 2019. the ohio state university. modification/derivative rights reserved, all other rights available.

Eligibility criteria:
inclusion criteria: * patient has been diagnosed with prolactinoma by use of appropriate blood tests and brain imaging. * 18 years of age or older * the subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent exclusion criteria: * patient is a prisoner * patient is not english speaking * patient has been previously treated for prolactinoma * patient is pregnant at time of diagnosis and treatment