Kornimate/medical-research-clean huggingface dataset:
arterial stiffness as a predictor of response to renal sympathetic denervation

Conditions: Therapy Resistant Arterial Hypertension

Summary: this trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation

regardless of the ongoing debate on the general effect of renal sympathetic denervation in therapy resistant hypertension, all trials published so far face the problem of a certain proportion of nonresponders to treatment. previous data shows, that to some extent this might be attributable to arterial stiffening. elevated invasive pulse wave velocity as an established marker for arterial stiffness has been found to be associated with nonresponse to renal denervation treatment in a smaller trial population. this trial attempts to assess the predictive value of different invasive and non-invasive markers for arterial stiffness in an adequately powered population.

Eligibility criteria:
inclusion criteria: * patients with therapy resistant arterial hypertension (\>=3 antihypertensive drugs including at least one diuretic without any dosage change in the preceding 4 weeks) and office bp \>160 mmhg systolic or 90 mmhg diastolic exclusion criteria: * average systolic daytime bp \<135 mmhg in 24h ambulatory blood pressure measurement (abpm) * pregnancy * known renal artery stenosis * \>= 1 renal artery diameter \< 4 mm * life expectancy \<6 months * participation in any other clinical trial
topical 2% lidocaine for the treatment of symptomatic hemorrhoids

Conditions: Hemorrhoids

Summary: the primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in the therapy of symptomatic hemorrhoids. efficacy will be determined by: 1. the change from baseline in pain, itching, bleeding, swelling, discomfort, general well-being and improvement since the beginning of treatment as separate components of corrects scale 2. the change in overall corrects values from baseline 3. the change in degree of hemorrhoids from baseline

this is a double blinded randomized clinical study into the effect of topical 2% lidocaine in patients with symptomatic hemorrhoids. calculated sample size is 69 patients per arm, based on expected improvement of pain and healing by 30% at p\<0.05 and power goal of 95%. taking into account a drop-out rate of 50%, total number of 69 patients in each arm is estimated as sufficient to close the study. patients will be randomly assigned into 2 arms, arm 1 (treatment): topical 2% lidocaine and arm 2 (control): vaseline base. each arm will consist of 69 patients. patients will be assigned to either treatment or control arm according to the randomization table. * treatment arm - topical 2% lidocaine. topical application of 2% lidocaine in vaseline base repeated two times per day, * control arm - vaseline base. topical application of pure vaseline base twice per day. in addition to the aforementioned topical treatments, all patients will be given written instructions to perform dietary modifications and anal hygiene. all patients with bleeding hemorrhoids will be given detralex 2 tablets twice per day. those patients in whom a technically successful procedure has been completed will be considered as valuable for the efficacy evaluation. a technically successful procedure is defined as the completion of treatment procedures stipulated in this protocol and consists of correct drug dose and frequency of application, adherence to written instructions for dietary modification and anal hygiene and presence at follow-up visits.

Eligibility criteria:
inclusion criteria: * clinically present enlarged hemorrhoids, grade 1-4 (for definition see appendix 1) * symptoms of pain or itching * age 18 years or more * willing and able to comply with the study * geographically suitable, meaning with reliable transportation for outpatients to the testing site exclusion criteria: * actual pregnancy * inability to provide informed consent * any anal topical medication applied in the last 7 days * any anal surgery (including surgical or instrumental procedures defined in the section 4.3) in the last 60 days * known allergy to vaseline, lidocaine or dulcolax * other anal disorders and diseases including crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections * contraindication for topical anal application of vaseline or lidocaine

Keywords: hemorrhoids lidocaine
rasagiline tablets special drug use-results survey "survey on long-term safety"

Conditions: Parkinson's Disease

Summary: the purpose of this survey is to evaluate the long-term safety of rasagiline (azilect) in patients with parkinson's disease in daily clinical practice and also collect efficacy information.

the drug being tested in this survey is called rasagiline tablet. this tablet is being tested to treat people with parkinson's disease. this survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. the planned number of observed patients will be approximately 1000. this multi-center observational trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: -patients with parkinson's disease should be surveyed. exclusion criteria: -participants who have contraindications on package insert of rasagiline.
a trial investigating the pharmacodynamic response of faster acting insulin aspart in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of faster acting insulin aspart (fiasp) in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * male or female aged 18-64 years (both inclusive) at the time of signing informed consent * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.5-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
autonomous syncope onset prediction and prevention

Conditions: Syncope

Summary: syncope prediction on tilt table

a tilt table is used to provoke syncope. syncope prediction is achieved through sensor measurements (ecg, icg, spo2, breathing rate, bp, nirs, gsr, oculography).

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: -
kegel exercises prior to strength training to improvestress urinary incontinence

Conditions: Urinary Incontinence,Stress

Summary: this comparative pre-post intervention study investigates the feasibility and benefits of kegel exercises amongst incontinent women, prior to commencing resistance training, to reduce the risk of stress urinary incontinence compared to a group of women without prior kegel exercises.

the aim of the study is to determine whether a program of kegel exercises prior to a resistance training program will result in reduction of stress urinary incontinence and whether this should be prescribed to incontinent women prior to performing resistance training. it is hypothesized that performing kegel exercises prior to resistance training would improve pelvic floor muscle strength and reduces the odds of experiencing sui during resistance training.

Eligibility criteria:
inclusion criteria: * being female * over eighteen years of age * suffer from stress urinary incontinence * did not perform kegel exercises * had no experience in regular resistance/strength training * completed a physical activity readiness questionnaire (par-q) form. exclusion criteria: * pregnancy, breastfeeding
a study to learn about the safety medicine (called mylotarg) in people with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this clinical trial is to learn about the safety and effects of the study medicine (called mylotarg) for the potential treatment of acute myeloid leukemia (aml). aml is a disease that affects the body's white blood cells. this study is seeking participants in korea who: * are 18 years of age or older * are adults and newly diagnosed with aml * currently receive mylotarg for aml treatment in a hospital * are capable of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study. participant's health will be closely monitored for any unwanted reactions during mylotarg treatment. disease progression will also be monitored. this will help determine if mylotarg is safe to use and its effect on aml treatment.

this is a prospective, single-arm, open-label, non-interventional, multi-centre, pms to evaluate safety and effectiveness of mylotarg® in patients with newly-diagnosed cd33-positive aml. as this is a non-interventional study (nis) all treatment and monitoring of the patients will be at the discretion of the investigator as part of routine practice. the study can be performed in korean health care centers where mylotarg® is prescribed to treat aml after obtaining informed consent from the patients as whole case enrollment method. this study is conducted to determine any problems or questions associated in regard to the following clauses under general clinical practice after marketing mylotarg®, in accordance with the "re-examination guideline of new drugs, etc.": 1. serious adverse event (sae)/adverse drug reaction (adr) 2. unexpected adverse event (ae)/adverse drug reaction (adr) that has not been reflected in the approved drug label. 3. known adverse drug reaction (adr) 4. non-serious adverse drug reaction (non-sadr) 5. other safety and effectiveness information

Eligibility criteria:
inclusion criteria: * adult patients newly diagnosed as cd33-positive aml who have been treated\* or are being treated\* or determined to be treated with mylotarg® by the investigator's medical decision under routine clinical practice (\*patients that have been treated or are being treated with mylotarg® will be eligible for inclusion during the whole case enrollment period, 2 years after approval date) * evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * patients to whom mylotarg® is contraindicated as per the local labeling (patients with a history of hypersensitivity including anaphylaxis to the active substance in mylotarg® or to any of its components or to any of the excipient.) * any patients (or a legally acceptable representative) who does not agree that pfizer and companies working with pfizer use his/her information
autologous transplantation of bone marrow mononuclear stem-cells for dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: this study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class iii or nyha.


Eligibility criteria:
inclusion criteria: * diagnosis made at more than one year and symptomatic at functional class iii-iv by the new york heart association classification (nyha) despite optimal pharmacologic therapy * left ventricular ejection fraction (lvef) less than 35% by echocardiogram * age below 70 years * absence of neoplasm * abscence of hematologic disease or systemic disease * no previous cardiac intervention exclusion criteria: * episodes of tachycardia or ventricular fibrillation * severe or moderated mitral insufficiency * any other valvulopathies * previous cardiac surgery

Keywords: cardiomyopathy stem cell cardiac failure
endoscopic ultrasound (eus) artificial intelligence model for normal mediastinal and abdominal strictures assessment

Conditions: Abdomen; Mediastinum; Anatomic Abnormality; Strictures

Summary: therefore, a high number of procedures is necessary to achieve eus competency, but interobserver agreement still varies widely. artificial intelligence (ai) aided recognition of anatomical structures may improve the training process and inter-observer agreement. robles-medranda et al. developed an ai model that recognizes normal anatomical structures during linear and radial eus evaluations. we pursue to design an external validation of our developed ai model, considering an endoscopist expert as the gold standard.

endoscopic ultrasound (eus) is a high-skilled procedure with a limited number of facilities available for training. therefore, a high number of procedures is necessary to achieve competency. however, the agreement between observers varies widely. artificial intelligence (ai) aided recognition and characterization of anatomical structures may improve the training process while improving the agreement between observers. however, developed eus-ai models have been explicitly trained or only with disease samples or for detecting abdominal anatomical features. in other fields as radiation oncology, developed ai models have been widely used. they must recognize in unison healthy and disease strictures throughout any part of the human body during the contouring. it avoids unnecessary irradiation of normal tissue. eus-ai models not trained with healthy samples can cause an increase in false-positive cases during real-life practice. it implies potential overdiagnosis of abnormal/disease strictures. eus-ai models not trained with samples outside using an automated machine learning software, robles-medranda et al. have previously developed a convolutional neuronal networks (cnn) ai model that recognizes the anatomical structures during linear and radial eus evaluations (ai works, md consulting group, ecuador). to the best of our knowledge, this eus-ai model is the first trained with eus videos from patients without pathologies and, thus, with normal mediastinal and abdominal organ/anatomic strictures. in this second stage, we pursue to design an external validation of our developed ai model, considering an endoscopist expert as the gold standard.

Eligibility criteria:
inclusion criteria: * patients with no history of the thorax and abdominal abnormalities confirmed through an imaging test requested for healthcare purposes in the last twelve months (e.g., thorax x-ray and abdominal ultrasound or thorax and abdominal ct) * patients who undergo eus assessment due to chronic dyspepsia. exclusion criteria: * morphological alteration on at least one mediastinal and abdominal organ/anatomic strictures documented through any imaging test or eus. * uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with a meaningful impact on cardiac risk assessment (nhya iii/iv); * refuse to participate in the study or to sign corresponding informed consent.

Keywords: endoscopic ultrasound artificial intelligence
ultraslow full-power swl versus slow power-ramping swl in stones with high attenuation value

Conditions: Renal Stones

Summary: ultraslow full-power swl versus slow power-ramping swl in stones with high attenuation value

to evaluate the efficacy of ultraslow rate of swl versus slow rate, power ramping swl.

Eligibility criteria:
inclusion criteria: * single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones) * radio-opaque stone * high attenuation value (≥ 1000 hu) stone exclusion criteria: * abnormal renal anatomy * renal insufficiency * solitary kidney * coagulopathies * uncontrolled hypertension * renal artery or aortic aneurysm * active urinary tract infection * pregnancy * severe skeletal malformations (spinal deformity) precluding proper stone localization * skin to stone distance (ssd) \> 11 cm * bmi \> 30 kgm/m2

Keywords: renal stones swl high density stones ultraslow swl slow swl ramping pause
pain reduction produced by different treatments in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: pain reduction effects of the median nerve neural mobilization technique (a physiotherapy treatment) will be compared to those produced by a pharmaceutical treatment and the absence of treatment, in subjects who suffer carpal tunnel syndrome.

the present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of median nerve neural mobilization (non invasive and non pharmaceutical physiotherapy treatment), to the pain reduction effect produced by an oral ibuprofen treatment or the lack of treatment (waiting list control group) in subjects diagnosed with carpal tunnel syndrome. additionally, effects over the functionality of the affected upper limb will be evaluated and compared. subjects will be invited to participate and randomly allocated to 3 different groups.

Eligibility criteria:
inclusion criteria: * participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings). * full understanding of written and spoken spanish (language). * participants must freely consent to participate. * the presence of positive phalen an tinel sings. * the presence of carpal tunnel syndrome signs and symptoms exclusion criteria: * the lack to meet inclusion criterions, the presence of cognitive impairment, kinesiophobia * tumors * cancer * upper limb surgery or trauma * pregnancy * deformities of the (affected) upper limb * recent skin injuries or infections (in the affected upper limb) * autoimmune inflammatory conditions or flu type symptoms. * allergy to gabapentin, ibuprofen or ibuprofen arginine * participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).

Keywords: ibuprofen median nerve neural mobilization waiting list control group physiotherapy pain management
clinical study to compare the efficacy and safety of rituximab biosimilar hlx01 and rituximab in combination with chop, in previously untreated subjects with cd20+ dlbcl

Conditions: B-cell Non Hodgkin's Lymphoma

Summary: multicenter, randomized, double-blind, parallel, phase iii clinical study to compare the efficacy and safety of rituximab biosimilar hlx01 and mabthera in combination with chop, in previously untreated subjects with cd20+ dlbcl


Eligibility criteria:
inclusion criteria: * untreated cd20-positive dlbcl confirmed. * ipi score of 1 to 2, stage i \~ iv, score 0 needs to accompanied by bulky disease, which is defined as the presence of a tumor mass with a diameter of more than 7.5 cm. * ecog performance status of 0 to 2. * more than 6 months life expectancy. * at least one measurable lesion: for nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; for extranodal tumor mass, more than 1.0 cm in the long axis. * 18 years to 70 years; male or female patients. exclusion criteria: * known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins. * known allergic reactions against any component of chop regimen. * previous treatment for nhl, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, monoclonal antibody therapy or surgical treatment (excluding lymph node biopsies and surgical resection for non-lymphoma lesions). * history of cytotoxic drugs treatment or anti-cd20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis). * prior use of any monoclonal antibody within 3 months. * primary central nervous system(cns) lymphoma, secondary cns involvement, grey zone lymphoma (gzl) between burkitt and dlbcl, primary effusion lymphoma, plasmablastic lymphoma, primary cutaneous dlbcl, anaplastic lymphoma kinase(alk) positive dlbcl or transformed lymphoma.
continuous topical instillation for open abdomen in the septic patients with complicated intra-abdominal infections

Conditions: Wound Infection

Summary: the closed systems, such as conventional negative pressure wound therapy (npwt), were usually avoided in infected or critical colonized wounds. to our observation, the additional continuous irrigation tube attached beside the suction tube in the npwt system could provide the effective drainage by reducing the occlusion of suction tube, enable effective debridement by diluting infected/necrotized tissues and decrease the incidence of fistula by providing relatively moist ambient. at our institutions, the modified system combined with a "triple-tube" device to allow a continuous instillation became more active and efficient. the study is to investigate if a continuous triple-tube instillation and suction could improve the outcomes of acute severely infected open abdomen.

this study was performed on the patients with a severely complicated infected open abdomen treated with topical triple-tube irrigation and suction, compared with a control group of the patients treated with standard npwt without topical irrigation. the clinical outcomes were recorded. profiles of cytokines/proteinase in wound fluid were quantified weekly.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years patients with complicated intra-abdominal infections who needed open abdomen (oa) and vacuum-assisted wound closure and mesh-mediated fascial traction (vawcm) * eligible patients were properly consented before enrollment. if the patient was incapable, the patient's legal representative was asked to provide consent on the patient's behalf. * patients with grade 1b (contaminated oa without adherence between bowel and abdominal wall), 2b (contaminated oa developing adherence) open abdomen, as classified by bjorck. exclusion criteria: * \< 18 years, * pre-existing large ventral hernia * frozen oa with adherent bowel (oa of grade 4), * clean wound (oa of grade 1a or 2a) * chronic wound infection * critical wound ischemia * severe systemic infection * end-stage renal disease * severe liver disease * uncontrolled diabetes mellitus * any issue with an obviously high risk of delayed wound healing

Keywords: negative pressure wound therapy acute wound infection complicated abdominal infection cytokines matrix metalloproteinase
a study of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma treated with lisocabtagene maraleucel in the post-marketing setting

Conditions: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Summary: the purpose of this study is to characterize the long-term safety of lisocabtagene maraleucel (liso-cel), focusing on patients treated in the chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) indication, and will be part of post-marketing liso-cel pharmacovigilance activities


Eligibility criteria:
inclusion criteria: • participants must have been treated in the post-marketing setting with ≥1 infusion of lisocabtagene maraleucel used for the treatment of relapsed/refractory (r/r) chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) within the approved indication and dosage per the united states prescribing information (uspi) and product specifications approved for commercial release in the usa exclusion criteria: * participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion * patients treated with non-conforming car t-cell product

Keywords: chronic lymphocytic leukemia (cll) small lymphocytic lymphoma (sll)