Kornimate/medical-research-clean huggingface dataset:
a clinical trial to assess fesoterodine on treatment satisfaction and symptom improvement in overactive bladder patients

Conditions: Overactive Bladder

Summary: to evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (oab) symptom relief in oab patients who were dissatisfied with their prior therapy with tolterodine.


Eligibility criteria:
inclusion criteria: * oab patients who present with oab symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary) * oab patients dissatisfied with their prior therapy with tolterodine exclusion criteria: * patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients. * patients with significant hepatic and renal disease or other significant unstable diseases. * oab symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
effects of metyrapone in patients with hypercortisolism

Conditions: Hypercortisolism

Summary: the aims of the present study are to evaluate in patients with mild hypercortisolism the effect of metyrapone treatment on glycometabolic control, blood pressure, thrombotic risk parameters, lipid profile, bone turnover markers, mental health and cortisol circadian rhythm.

this open prospective observational study will include patients with mild hypercortisolism of both adrenal and pituitary origin not candidate for surgery. patients taking metyrapone since less than a week will be followed up for 24 weeks. during this period of time, patients will be re-evaluated as far as blood pressure control, glycometabolic control, thrombotic risk parameters, lipid profile, bone turnover markers and cortisol circadian rhythm is concerned.

Eligibility criteria:
inclusion criteria: * patients with mild cushing's syndrome not candidate for surgery * current therapy with metyrapone since less than 1 week * cortisol levels at 08:00 after 1 mg-overnight dexamethasone suppression test (1mgdst) \>1.8 μg/dl * confirmed with 2 mg two days dexamethasone suppression test (2mgx2ddst) * presence of at least one out of the following conditions: type 2 diabetes mellitus, impaired fasting glucose (ifg) and/or impaired glucose tolerance (igt), arterial hypertension, bone mineral density (bmd) z-score \< -2.0 and/or fragility fracture at any skeletal site * stable anti-hypertensive therapies and blood pressure (bp) levels in the month before enrolment * stable anti-diabetic therapies and glycometabolic control during the month before enrolment * stable body weight during the month before enrolment exclusion criteria: * signs and/or symptoms of overt hypercortisolism (striae rubrae, moon facies, easy bruising, buffalo hump, hypertrichosis) * malignant hypertension and/or bp \<200/120 mmhg * severe hyperglycemia (i.e. fg \>350 mg/dl) * urinary free cortisol (ufc) higher than 1.5 fold the upper normal range * presence of pheochromocytoma or primary hyperaldosteronism * possible adrenal metastases or radiological features suggestive for adrenal malignancy (i.e. not homogeneous pattern, necrosis, calcifications, irregular margins, local invasion and high density at computed tomography) * congenital adrenal hyperplasia * intake of drugs influencing cortisol metabolism and/or secretion * women in child-bearing age * patients with body mass index (bmi) \>35 kg/m2

Keywords: cortisol metyrapone hypercortisolism mild hypercortisolism
the plasma metabolomics profiling of primary aldosteronism

Conditions: Primary Aldosteronism; Essential Hypertension; Idiopathic Aldosteronism; Aldosterone-producing Adenoma

Summary: primary aldosteronism (pa), characterized by overt renin-independent aldosterone production, is the most common form endocrine hypertension. compared with blood pressure-matched cases of essential hypertension (eh), pa is associated with a higher risk of cardiovascular morbidity and mortality. it is estimated that pa affects at least 10% of hypertensive patients and up to 25% of treatment-resistant hypertension. the major subtypes of pa are comprised of bilateral idiopathic hyperaldosteronism (iha) and unilateral aldosterone-producing adenoma (apa). the screening, confirmatory testing, and subtype differentiation of pa for therapeutic management is a multi-step and complex process, resulting in low screening rates and poor clinical recognition. pa is an independent risk factor for metabolic morbidity. metabolomic profiling is a relatively new strategy for the diagnosis and prognosis of disease through identification and quantification of various metabolites. in the current study, we aimed to investigate the potential biomakers for discriminating pa from eh, as well as subtype classification for pa, by untargeted metabolomics.


Eligibility criteria:
inclusion criteria: * according to 2010 chinese guidelines for the management of essential hypertension (eh), eh was defined as systolic blood pressure (sbp) ≥140 mm hg, diastolic blood pressure (dbp) ≥90 mm hg, and use of antihypertensive medicine within 2 weeks and excluded from pa through arr or confirmatory testing. * patients were confirmed to be diagnosed with primary aldosteronism (pa) in accordance with the endocrine society clinical practice guideline criteria. patients with an aldosterone-to-renin ratio (arr) \> 3.7 (ng/dl) further conformed with one of the following confirmatory tests: saline infusion test or captopril-inhibition test. adrenal ct scans and adrenal venous sampling (avs) were performed for pa subtype classification. * patients with idiopathic hyperaldosteronism (iha) were determined based on the absence of obvious adenoma on adrenal ct and bilateral aldosterone overproduction. * patients with aldosterone-producing adenoma (apa) were identified based on macroadenoma \>1 cm on adrenal ct, unilateral hypersecretion of aldosterone, and pathological confirmation. * signed informed consent and agreed to participate in this study. exclusion criteria: * other subtypes of secondary hypertension, including renal hypertension, renovascular hypertension, and adrenal hypertension (i.e., pheochromocytoma and cushing syndrome). * adrenal cortical carcinoma * acute infection at the time of assessment * severe cardiovascular or cerebrovascular disease, liver or renal dysfunction, tumors, autoimmune disease or mental disorders. * history of adrenalectomy * alcohol abuse or pregnancy
follow-up of patients with multivessel coronary artery disease after cabg

Conditions: Coronary (Artery); Disease

Summary: the famous trial is a single-center, prospective, randomized study aimed to compare three different strategies (clinical, anatomical, or functional) in preventing mace after cabg. a total of 600 patients will be included and followed for 5 years. patients will be randomly allocated (1:1:1) in one of the three follow-up strategies. patients in the clinical arm will be followed by regular medical visits only every 6 months; patients in the functional arm will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected to a coronary ct. non-invasive tests will be performed per protocol and regardless symptoms every 2 years after the first year post-surgery. the primary outcome will be the incidence of death, acute myocardial infarction or myocardial revascularization.

background: coronary artery disease (cad) is a highly prevalent clinical condition, usually associated with impairment in quality of life, and with a high risk for cardiovascular events including myocardial infarction and cardiovascular death. because of the anatomical and/or functional extension of the disease, combined with high-risk clinical features (left ventricular dysfunction, diabetes, or chronic kidney disease to name a few), many patients must undergo a coronary artery bypass grafting (cabg) surgery. in the usa, 400,000 cabg surgeries are performed annually. although the benefits of cabg for those high-risk patients have been well established in the long-term, the best follow-up strategy after surgery is still controversial. current guidelines generally recommend that the follow-up of patients after cabg should be based on the same strategies proposed for patients with stable angina. the investigators hypothesized that the early identification of myocardial ischemia or progression of coronary atherosclerosis, even in asymptomatic patients, may be superior to clinical follow-up alone for the prevention of cardiovascular events.

Eligibility criteria:
inclusion criteria: * documented obstructive coronary artery disease * isolated, recent cabg (\< 30 days from inclusion) exclusion criteria: * concomitant, severe heart disease from other etiologies including valvular heart disease, advanced dilated cardiomyopathy, etc * glomerular filtration rate \< 30ml/min/1.73m2

Keywords: coronary artery disease surgery angina myocardial ischemia non-invasive testing
comparative evaluation of 1.2% atorvastatin and 1.2% simvastatin gel local drug delivery and redelivery in chronic periodontitis subjects with diabetes mellitus: a randomized controlled clinical trial.

Conditions: Chronic Periodontitis Wth Diabetes Mellitus

Summary: statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme a (hmg-coa) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of bmp - 2, have paved way in periodontal regeneration. the present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% atorvastatin (atv) and 1.2% simvastatin (smv) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (srp) in chronic periodontitis (cp) subjects with diabetes mellitus(dm).

statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme a (hmg-coa) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of bmp - 2, have paved way in periodontal regeneration. the present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% atorvastatin (atv) and 1.2% simvastatin (smv) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (srp) in chronic periodontitis (cp) subjects with diabetes mellitus(dm). 120 subjects with intrabony defects were divided into three groups;group 1- srp plus 1.2% atv ; group 2- srp plus 1.2% smv; and group 3- srp plus placebo gel. clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . measurements were repeated again at 3 months i.e. 9 months from baseline.

Eligibility criteria:
inclusion criteria: * well controlled type 2 diabetes mellitus patients classified based on criteria given by american diabetes association with cp with pd≥5mm and cal ≥3mm and presence of ibd ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \[iopar\] after phase i therapy exclusion criteria: * 1)patients with known allergy to statins; 2) patients with systemic conditions / medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) hematological disorders 5) pregnancy/lactation; and 6) smoking and tobacco use in any form 7) immunocompromised individuals.8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade ii were excluded.
respiratory sarcopenia in institutionalized older adults in the region of murcia

Conditions: Sarcopenia; Respiratory Function Impaired

Summary: objectives: the objectives of this study are to describe the prevalence of respiratory sarcopenia in institutionalized older adults. methodology: a sample of approximately 120 older adults from 5 residences located in murcia capital will participate in the study. a prospective observational study will be carried out, with one year of follow-up, with patients who have been diagnosed with respiratory sarcopenia. sociodemographic and clinical variables, physical function (palm grip, 5sts, 4mgs), respiratory force variables (mip and pef) and diaphragmatic ultrasound (thickness, shortening fraction and diaphragmatic excursion) will be measured. descriptive statistics, univariate and multivariate logistic regression models, cox proportional hazards model and kaplanmeier curves will be used to analyze the data from the longitudinal study.


Eligibility criteria:
inclusion criteria: * to have functional ambulation and/or wheelchair. * preserved cognitive status. * have sufficient ability to oral occlusion for carrying out respiratory tests. exclusion criteria: * presence of respiratory diseases or in treatment of respiratory diseases. * serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia. * those who present any contraindication for carrying out the procedure will be excluded. * of the respiratory pressure measurement tests, as established in the separ guidelines.

Keywords: sarcopenia respiratory force institutionalized elderly
rc48 combined with egfr or her2 tki for locally advanced or metastatic nsclc patients with her2 alterations

Conditions: Non Small Cell Lung Cancer; ERBB2 Mutation-Related Tumors; ERBB2 Gene Duplication; Disitamab Vedotin

Summary: disitamab vedotin（rc48）combined with egfr or her2 tkis in locally advanced or metastatic nsclc patients with her2 alterations.

this study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with her2 mutation, amplification, or her2 protein overexpression, using disitamab vedotin（rc48）combined with egfr or her2 tkis, in the aim of providing new treatment strategies for lung cancer patients with her2 pathway activation.

Eligibility criteria:
inclusion criteria: 1. age: 18 (inclusive) or above, regardless of gender. 2. histologically or cytologically confirmed locally advanced or metastatic nsclc, not suitable for radical surgery or radiotherapy (tnm 8th edition).". 3. her2 alterations include her2 gene mutations, gene amplification and her2 protein over-expression; 4. number of treatment lines: * arm1: patients who have not previously received systemic treatment for advanced diseases; * arm2: previously received first line of third-generation egfr-tkis treatment with local progression, oligometastasis, or slow progression, and evaluated by the researchers to continue to benefit from third-generation egfr-tkis treatment; * arm3: previously received first line of third-generation egfr-tkis treatment with extensively progression, and evaluated by the researchers not likely to continue to benefit from third-generation egfr-tkis treatment; 5. there is at least one measurable lesion that meets the definition of the recist 1.1 standard at baseline. 6. ecog fitness status score: 0 or 1 point. exclusion criteria: 1. central nervous system metastasis or meningeal metastasis with clinical symptoms. 2. known hypersensitivity or intolerance to any component of the study protocol drug or its excipients. 3. have a history of severe cardiovascular disease. 4. have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia. 5. have a history of neurological disorders or mental illnesses, including epilepsy or dementia. 6. pregnant or lactating women. 7. the researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.
"liposomal encapsulated vitamin c in complex regional pain syndrome"

Conditions: Complex Regional Pain Syndrome I of Lower Limb

Summary: abstract: complex regional pain syndrome (crps) is a significant complication in operated osteoarticular pathology and may adversely affect patient's quality of life. vitamin c is an anti-oxidant and a neuro-modulating agent. intake of vitamin c appears to be the only preventative factor. the objective of this study seeks to assess the effectiveness of liposomal conditioning of vitamin-c in reducing crps and to show evidence that it is more effective than taking vitamin c in its usual form.

methods: three series of patients undergone for identical pathologies the same surgery performed in the same centre by a single surgeon using the same operative techniques and the same implants. the first group took vitamin c in liposomal form. the second one took classical vitamin c tablets while the third one received placebo pills. comparison was made between both groups which were identical in number and were the same average age. results were compared and analysed at the end of one-year follow-up.

Eligibility criteria:
inclusion criteria: * female, age \> 18 years * the woman of childbearing age - if applicable - must have a negative urine pregnancy test result and must agree to use adequate contraception (hormonal or barrier contraception method, or abstinence) during the study and one month later) * consenting patient * agrees to maintain the current level of physical activity throughout the study. * agrees to avoid vitamins and supplements for 30 days before enrolment and during the study. * avoid nutritious yeasts, whey protein, energy drinks, pomegranate, pomegranate juice, grapefruit, grapefruit juice and alcohol 7 days before enrolment and during the study * willingness and ability to comply with scheduled visits, cellular phone calls, treatment plans, laboratory tests and completion of other study procedures specified in the protocol. exclusion criteria: * pregnant, breastfeeding or considering pregnancy during the trial * diabetic women * no renal lithiasis * no deficiency glucose-6-phosphate dehydrogenase * unstable medical conditions * immunocompromised persons such as subjects who have undergone organ transplantation * subjects who planned surgery during the clinical study * history of blood disorders / bleeding * alcohol abuse (\> 2 standard alcoholic beverages per day) or drug addiction in the last 6 months * participation in a clinical research trial within 30 days of randomization * allergy or sensitivity to the product during the clinical study. * persons who have a cognitive impairment and/or are unable to give an informed opinion. * any other condition that, in the opinion of the physician, could affect the subject and lead to the successful completion of the study, action or pose a significant risk to the subject.
a long-term follow-up study to evaluate skg0106 in the treatment of patients with namd

Conditions: Neovascular (Wet) Age-related Macular Degeneration

Summary: this is a prospective, non-interventional, multicenter, long-term follow-up study to evaluate skg0106 in the treatment of patients with neovascular (wet) age-related macular degeneration (namd). all subject who completed the parent clinical study (nct06213038 and nct05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection.


Eligibility criteria:
inclusion criteria: subjects who only meet all of the following criteria are eligible for this study: * namd subjects who have been enrolled in the skg0106-related study and received skg0106 injection; * subjects who voluntarily sign an informed consent form (icf) and comply with the protocol to complete the study exclusion criteria: * subjects who are judged by the investigator unsuitable for this study

Keywords: namd wamd
turkish version of the affordance in the home environment for motor development-toddler (ahemd-t)

Conditions: Musculoskeletal Diseases; Genetic Disease; Metabolic Disease; Delays Developmental

Summary: this study aimed to translate the affordance in the home environment for motor development -toddler (ahemd-t) into turkish and examine its psychometric properties.

child motor development is a complex process which results from the interaction between genetics and the environment. the role of the home as the first environment for child experiences is very important for motor development, especially during infancy. thus, a more supportive and stimulating environment is associated with more affordances and challenges for infant motor development that may lead to improvement in social and cognitive development. there is no turkish questionnaire to evaluate home environment so we aimed to translate the ahemd-t for using with turkish children and to investigate psychometric properties.

Eligibility criteria:
inclusion criteria: * parent who have 18-42 months child * volunteers exclusion criteria: * parents who are not willing to participate in the study
relationship of position sense with gait and balance in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: balance and gait disturbances are among the most common problems in patients with multiple sclerosis (ms). there is evidence of decreased foot sole sensation in ms patients. studies conducted in healthy individuals have revealed the relationship between balance and foot sole sensation. these studies have demonstrated that sensory feedback from the cutaneous receptors of the foot sole plays an important role in maintaining balance. however, it is not yet known clearly to what extent the sensory impairment seen in ms patients affects balance and gait disorders. the aim of this study is to examine the relationship between lower extremity position sense and foot sole sense with gait and balance in ms patients.

patients with ms between 0-5,5 score according to the extended disability status scale (edss) and healthy individuals of similar age and sex to patients will be included in the study. the balance, gait, lower extremity position sense, and foot sole sense will be evaluated. the researchers will use t-tests to compare for quantitative variables and chi-square for the categorical variables between groups. in addition, the researchers will examine the correlations between balance, gait, lower extremity position sense, and foot sole using by pearson bivariate correlations.

Eligibility criteria:
inclusion criteria: * 18-65 years of age having a diagnosis of "multiple sclerosis" by a specialist physician relapse free in the last 3 mounts having an ambulatory status (expanded disability status scale score ≤ 6 ) no diagnosis of depression exclusion criteria: * any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research

Keywords: multiple sclerosis gait balance sensation
effectiveness and safety of implantable neurostimulation systems for chronic pain: a spanish multicenter study (stim-renased)

Conditions: Chronic Pain

Summary: chronic pain is a prevalent condition that negatively affects patients' quality of life. implantable neurostimulation therapies have been proposed as a treatment option for chronic pain. however, real-world data on the effectiveness and safety of these therapies in spain are scarce. this study aims to obtain real-world data on the effectiveness and safety of implantable stimulation systems for chronic pain treatment in spain.

all spanish hospitals that implant neurostimulation systems for pain treatment will be invited to participate in the study. patients will be recruited before the procedure, and before providing data to the registry, the study will be explained to them, and they will sign an informed consent form. demographic data related to the pathology and procedure will be collected. follow-up will be conducted at six and twelve months after the procedure.

Eligibility criteria:
inclusion criteria: * chronic refractory pain patients candidates for treatment with an implantable neurostimulation system. * accept to participate in the study and sign informed consent. exclusion criteria: * patients in whom it would be difficult to complete follow-up. * insufficient understanding of the spanish language. * pregnancy.

Keywords: spinal cord stimulation dorsal root ganglion stimulation peripheral nerve stimulation