Kornimate/medical-research-clean huggingface dataset:
non-interventional study to investigate whether information provided to patients influences their satisfaction with toviaz therapy

Conditions: Urinary Bladder, Overactive

Summary: collect information on treatment with toviaz (fesoterodine) under ordinary prescribing conditions, and to investigate whether additional educational information affects satisfaction with treatment as perceived by the patient.

patients will be identified and monitored during routine clinical practice visits, and will not be specifically selected as this would interfere with the representativeness of the results. the study will be conducted with office-based urologists and office-based general physicians, practitioners and internists (gps) in germany, thus representing a wide range of practices and populations. each urologist or gp may invite patients to participate who have already been diagnosed with overactive bladder and prescribed toviaz according to their usual standard of care. study enrollment stopped on december 31, 2011 due to difficulty in recruiting patients. no safety issues were related to the decision to stop patient enrollment.

Eligibility criteria:
inclusion criteria: patients with increased urinary frequency and/or imperative urgency and/or urge incontinence, as can occur in patients with overactive bladder syndrome, for whom toviaz was prescribed for treatment of the symptoms. patients will complete the oabv8 questionnaire and will need to meet a minimum score in order to be eligible for the study. exclusion criteria: patients who meet the contraindications in the toviaz prescribing information (active ingredient fesoterodine) will be excluded.

Keywords: non-interventional study fesoterodine educational materials
effect of patient education on healthy lifestyle behaviors and diabetes self-management in diabetics

Conditions: Diabetes Mellitus, Type 2; Myocardial Infarction

Summary: the purpose of this study is to determine the effect of planned education given to individuals with diabetes mellitus who had myocardial infarction on healthy lifestyle behaviors and diabetes self-management.

many coronary heart patients have diabetes. for this reason, it is thought that patients need education in order to gain healthy lifestyle behaviors and to provide self-management of diabetes, which is a major risk factor for coronary artery disease. when the literature was examined, no study could be found that focused on diabetes patients with myocardial infarction and emphasized the importance of patient education. it is thought that this study will make an important contribution in terms of patient education to be given to individuals with diabetes mellitus who have had myocardial infarction.

Eligibility criteria:
inclusion criteria: * 18 years or older, * no advanced hearing and vision problems, * able to speak and understand turkish, * easy to communicate, * literate, * agreeing to participate in the research voluntarily, * hospitalized due to myocardial infarction in the last month, * have stayed in the intensive care unit for at least 24 hours, * no chest pain * patients who have been diagnosed with type 2 diabetes mellitus for at least one year exclusion criteria: * sedative or narcotic analgesic drug treatment, * use of antipsychotic medication * patients receiving continous positive airway pressure treatment, * patients with cognitive dysfunction

Keywords: diabetes patient education diabetes self-management myocardial infarction healthy lifestyle behaviors
gastrointestinal panel in kidney transplant patients

Conditions: Kidney Transplant; Complications; Diarrhoea;Acute; Diarrhea Infectious

Summary: this project focuses on the evaluation of the impact of the rapid mutltiplex test on changes in anti-infectious treatments in kidney transplant patients with diarrhea. a higher number of infectious agents detected on the same day of sampling could improve the etiological diagnosis of diarrhea in kidney transplant patients and optimize therapeutic management. a prospective study will be conducted to evaluate the impact of a rapid multiplex test with a wide panel of bacteria, viruses and parasites on the clinical management of kidney transplant patients with acute diarrhea. this impact will be evaluated using a control group of kidney transplant patients with acute diarrhea whose infectious diagnosis will be performed by standard methods. the main objective is to determine the impact of the rapid multiplex test on changes in anti-infectious treatments (initiation, change of molecule, total duration of treatment).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * informed consent * patient who received a kidney transplant at least 3 months ago * acute diarrhea (at least 3 unformed or liquid stools per day for at least 3 consecutive days or 3 per day and / or weight loss ≥2 kg and / or mucoid and / or bloody stool) or absence of diarrhea for at least a month (asymptomatic non randomized control group) * affiliation to social security in accordance with the recommendations of the french law exclusion criteria: * patients who received an identical hla transplant from a related donor * patients without health insurance * patients under guardianship or curatorship * pregnant (or breastfeeding) patient
optimized programming in spinal cord stimulation (scs) system

Conditions: Neuropathic Pain; Pain

Summary: the objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.

the clinical results from this study may help to validate predictions made by mathematical models of neurons that are activated by scs and increase scientific knowledge about the way in which different programs relate to satisfactory outcomes, such that use of the model may help in the development of new products.

Eligibility criteria:
inclusion criteria: * be previously implanted with precision scs system (3-36 months post permanent implant) having 2 parallel percutaneous leads placed between t8-t10. * be implanted with precision scs system for the treatment of neuropathic pain of trunk and/or limbs * be 18 years of age or older * be extremely satisfied, very satisfied, or satisfied with scs therapy for treatment of pain condition * be able to use pen tablet to document regions of paresthesia and pain * be able to lie in the supine position for 45 minutes at a minimum * be able to verbally report qualitative and quantitative aspects of paresthesia sensations. * have a paresthesia threshold on a standard program below 4ma while in the supine position * have at minimum the upper contact of one lead below t8 and the lower contact above t11 vertebral levels * be willing and able to comply with study-related procedure * agree to study requirements and provides written informed consent exclusion criteria: * unable to read, write, speak, and understand english * currently pregnant or planning to become pregnant during the course of the study * have negative finding in any of the pre-screening and screening requirements * upon fluoroscopy, location of both leads is identified to be outside t8-t10 vertebral levels * unable to perceive the sensation of paresthesia associated with stimulation in the trunk and/or lower extremities * have a drug pump and/or a non-precision neurostimulation device (regardless of whether active or inactive) * have had any interventional pain procedure or surgeries (including interlaminar epidural steroid injection, transforaminal epidural steroid injection, caudal epidural steroid injection, selective nerve root block, intraarticular lumbar facet injection, sacroiliac joint injection, piriformis muscle injection, trochanteric bursa injection, hip/knee joint injections, medial branch block (innervates facet joint), pulsed radiofrequency neurotomy medial branches, pulsed radiofrequency dorsal root ganglion, thermal (high temperature) radiofrequency neurotomy medial branches, trigger point injections, and botulinum toxin injections) involving the spine within the past 30 days * have any condition that is likely to confound evaluation of study endpoints. conditions that may make paresthesia coverage variable over the course of the study include multiple sclerosis, partial spinal cord injury, diabetic peripheral neuropathy, peripheral vascular disease, scoliosis, deafferentation, etc.

Keywords: spinal cord stimulation
a clinical trial to assess the clinical benefit of ssr411298 as adjunctive treatment for persistent cancer pain

Conditions: Pain; Breakthrough Cancer Pain

Summary: the primary objective of this study is to evaluate the efficacy of ssr411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on numeric rating scale (nrs). secondary objectives are: * to evaluate the effect of ssr411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life; * to evaluate the tolerability and safety of ssr411298 as adjunctive treatment for persistent cancer pain; * to characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment; * to evaluate the pharmacokinetic (pk) exposure of ssr411298 as adjunctive treatment for persistent cancer pain; * to assess endocannabinoid plasma concentrations.

the total study duration for a participant is 6 weeks (1-week screening, 4-week treatment and 1-week post-treatment follow-up). participants continue to receive who step 2 or 3 cancer pain treatment as background therapy.

Eligibility criteria:
inclusion criteria: patient with moderate or severe, persistent cancer pain who is receiving the world health organization (who) step 2 or 3 cancer pain treatment: * pain generator (source of pain) must be primarily due to underlying cancer or cancer treatment; * pain generator (source of pain) must be classified as either primarily nociceptive or primarily neuropathic; * pain severity must be moderate or severe with an average nrs score ≥4 during the screening week. exclusion criteria: * instability of pain during the screening week; * use of prohibited adjuvant pain treatment in the week prior to study entry or plan to use these medications during the study; * current use of medication containing tetrahydrocannabinol (thc); * chemotherapy within 4 weeks before study entry or chemotherapy planned during the study (a stable regiment of hormonal therapy is permitted); * radiotherapy within 4 weeks before study entry or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted); * cancer related surgery within 4 weeks before study entry or cancer-related surgery planned during the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
feasibility of an early initiated physiotherapy intervention among patients with deep vein thrombosis.

Conditions: Deep Vein Thrombosis

Summary: the project will investigate the feasibility of a physiotherapy intervention for patients diagnosed with deep vein thrombosis for whom a physiotherapy intervention is not currently part of clinical practice in denmark. specifically, the project will investigate if an early-initiated physiotherapy intervention for patients who are admitted acutely with first-time deep vein thrombosis (dvt), can be carried out and is experienced as valuable for the patients.

this study aims to investigate whether it is possible for patients diagnosed with dvt to complete early mobilization combined with progressive walking during their hospitalization and the first month after discharge. this study is twofold. part one is a clinical cohort study and will investigate the feasibility using quantitative outcomes. part two is a qualitative study using interviews to investigate the patients' experiences with and attititudes towards a physiotherapy guided intervention of early mobilization combined with progressive walking during their hospitalization and one month after discharge to their own home. if the physiotherapy intervention is deemed feasible and acceptable, a future randomized controlled trial will investigate the effect of the intervention on quality of life.

Eligibility criteria:
inclusion criteria: 1. 18 years or above 2. first time lower extremity dvt 3. hospitalized at the emergency department exclusion criteria: 1. patients without a danish social security number 2. terminal patients 3. patients who do not understand or speak danish
pmcf study of the achillocordplus system implant set for acute achilles tendon repair

Conditions: Achilles Tendon Rupture

Summary: this is a post market clinical follow up study in orthopaedics, it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the acute repair of the achilles tendon. the medical device in this study achillocordplus is a class iib ukca-marked device manufactured by xiros ltd.

this is a post market clinical follow up study in orthopaedics, it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the acute repair of the achilles tendon. the medical device in this study achillocordplus is a class iib ukca-marked device manufactured by xiros ltd. achillocordplus is a single-use device, indicated for patients with acute achilles tendon ruptures. it is particularly suited to active patients where an extended period of postoperative immobilisation is undesirable. this study is a prospective, single-centre, consecutively recruited non-randomised study. the total length of the study is expected to be 3 years. this includes a recruitment period of approximately 12 months and a 2-year follow-up. this study has now closed to follow-up, with a recruitment of 19 participants. follow up is at 2,4,6,8 and 12 weeks, 6 months and 1 and 2 years. all subjects treated with the achillocordplus for acute achilles tendon repair will be consecutively recruited into the study.

Eligibility criteria:
inclusion criteria: * patients must be skeletally mature and be 18 years old or above. * patients requiring end to end repair for acute achilles tendon rupture. * patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and has provided written informed consent as approved by the research ethics committee (rec). exclusion criteria: * patients with chronic ruptures of the achilles tendon. * patients with bilateral ruptures. * patients with known hypersensitivity to implant materials. appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation. * patients with infections or any structural or pathological condition of the bone or soft tissue that would be expected to impair healing or prevent secure fixation. * patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.
a study to assess the incidence of egfr mutation in patients with newly diagnosed locally advanced or metastatic non-small cell lung cancer in the uk, and of tarceva (erlotinib) as first-line therapy in egfr mutation positive patients.

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this study will assess the prevalence of epidermal growth factor receptor (egfr) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (nsclc). patients with positive egfr mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line tarceva (erlotinib) therapy. patients will receive tarceva at a dose of 150 mg orally daily. anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. patients with negative egfr mutation results will be offered treatment as per the centre's standard of care.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * locally advanced or metastatic (stage iiib/iv) non-small cell lung cancer (nsclc) * ecog performance status 0-3 * treatment phase: histologically confirmed egfr exon 19 deletion or exon 21 mutation in the diagnostic phase of the study * adequate haematological, liver and renal function * female patients must be postmenopausal, surgically sterile, or agree to use a barrier method of contraception * male patients must be surgically sterile or agree to use a barrier method of contraception exclusion criteria: * previous treatment for nsclc with chemotherapy or therapy against egfr, either with antibody or small molecule (tyrosine kinase inhibitor) * symptomatic cerebral metastases * pregnant or lactating women * any other concomitant anti-cancer therapy (until disease progression and discontinuation of tarceva therapy)
elevated platelet count as prognostic factor in colorectal cancer with synchronous liver metastases

Conditions: Colorectal Cancer; Colorectal Carcinoma; Stage IV Colon Cancer

Summary: colorectal cancer (crc) is the third most common malignancy worldwide and is often metastatic at diagnosis. despite progresses in surgical techniques and the introduction of novel chemotherapy regimens, many patients still suffer from a poor prognosis. it is therefore of utmost importance to identify prognostic markers that may improve selection of patients. in recent years several studies demonstrated that preoperative blood tests as platelet count or neuthophil-to-lymphocyte ratio could be prognostic factors in crc as well as other malignancies. the aim of this study was to evaluate the role of preoperative platelet count (pc) in patients with synchronous colorectal liver metastases.


Eligibility criteria:
inclusion criteria: * colorectal cancer with synchronous liver metastases * possibility to retrieve pre-operative platelet count * age of 18 years or older * availabilty of clinical-pathological data * minimum follow up of 12 months exclusion criteria: * none

Keywords: platelets thrombocytosis prognosis
screening and secondary prevention rheumatic heart disease study

Conditions: Rheumatic Heart Disease

Summary: after basic clinical screening including history and physical, point of care ultrasound will be performed to look at mitral, aortic and tricuspid valves for regurgitation or stenosis. for patients with confirmed rheumatic heart disease (rhd), treatment and referral depending on stage of disease. antibiotic prescription could be shifted to community health workers delivering preventive medications via practical clinical algorithms, diagnostic tools, availability of appropriate antibiotics, and supportive supervision. patients will have repeat imaging at 2 years and 5 years to look at the outcome of delayed progression of valve disease.

screening for rhd should be carried out since it is a major health concern that has been shown to have a treatable and detectable latent stage that can be diagnosed using a simple sensitive test (point of care ultrasound) and early treatment (secondary prevention using antibiotic prophylaxis) can provide a better outcome (slow progression of disease) in a cost effective way. the investigators aim to study the incidence and prevalence of rhd in community and school settings and aim to intervene depending on the stage the disease is picked up in.

Eligibility criteria:
inclusion criteria: * rural communities in sindh exclusion criteria: * refused to participate in the study
clinical value of noninvasive intracranial pressure measurement

Conditions: Intracranial Hypertension

Summary: the aim of the study is to evaluate accuracy and precision of non-invasive intracranial pressure measurement device (vittamed 205) for selected patients compared with cerebrospinal fluid pressure measured during lumbar puncture

non-invasive intracranial pressure (icp) measurements with vittamed 205 aicp meter will be compared to simultaneous cerebrospinal fluid (csf) pressure measurements during lumbar puncture. measures of pressure in mmhg will be compared. these measurements will be compared in chronic daily headache, normal pressure hydrocephalus and multiple sclerosis patients groups. for stroke patients noninvasive measurements will be compared with cerebral lesion in brain mri/ct.

Eligibility criteria:
inclusion criteria: * chronic daily headache with suspected idiopathic intracranial hypertension * diagnosed of suspected multiple sclerosis (ms) * intracranial hemorrhage/ stroke exclusion criteria: * patient not able to understand information about the trial * uncooperative patient * intracranial hemorrhage volume \ 40ml * stroke area larger than 1/3 of the middle cerebral artery

Keywords: icp, intracranial hypertension, vittamed 205
real-world experience with lutetium vipivotide tetraxetan in metastatic castration resistant prostate cancer

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: the purpose of this study is to describe routine clinical practice with lutetium (177lu) vipivotide tetraxetan on health related quality of life (hrqol) at baseline, on treatment, and post progression.

this non-interventional observational, prospective cohort study is using primary data collection to describe the routine clinical practice and hrqol of patients with metastatic castration-resistant prostate cancer (mcrpc) initiating lutetium (177lu) vipivotide tetraxetan using patient questionnaires. data will be collected at the following time points: pre-index (if patient is eligible), index date (first application of lutetium (177lu) vipivotide tetraxetan), during treatment, at eot, and during follow-up. the duration of a treatment cycle is 6 weeks (± 1 week). patients will be treated for up to 6 cycles (as per local label). eot visit / assessments will be performed after the last lutetium (177lu) vipivotide tetraxetan application. follow-up period: patient data will be collected if available up to 1 year after eot.

Eligibility criteria:
inclusion criteria: all patients must meet the following inclusion criteria during the identification period: * adult male patients diagnosed with mcrpc and initiating lutetium (177lu) vipivotide tetraxetan by treating physician as per local label. after treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of cycle 1. * ≥ 18 years old at the time of enrollment * written informed consent must be obtained prior to any data collection * willing to participate in quality of life post treatment date collection for 1 year exclusion criteria: patients must not meet the following exclusion criterion during the identification period: - simultaneous participation in any investigational trial or simultaneous participation in another novartis-sponsored non-interventional study with lutetium (177lu) vipivotide tetraxetan

Keywords: metastatic castration resistant prostate cancer mcrpc prostate cancer lutetium vipivotide tetraxetan 177lu