Kornimate/medical-research-clean huggingface dataset:
treatment of digital ulcers in korean patients with systemic sclerosis: a prospective cohort study

Conditions: Raynaud Disease; Systemic Sclerosis; Digital Ulcer

Summary: this study evaluates the efficacy and safety of routine medical treatments of digital ulcers in patients with systemic sclerosis in a prospective cohort study.

systemic sclerosis (ssc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. ssc manifests by fibrosis of skin and internal organs. although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in ssc. a hallmark feature of ssc is the presence of raynaud phenomenon (rp) that is caused by reversible vasoconstriction of digital arteries triggered by exposure to cold or emotional stress. in up to 33-43% of ssc patients, the ischemia can progress to digital ulcers (dus), which are often associated not only with pain but also with severe limitation in the daily activity, anxiety and depression among others. in severe cases, rp can be complicated by superinfection or gangrene, requiring surgical amputation. the mainstay treatment of rp is restoration of the decreased blood flow using calcium channel blocker, protstanoids, phosphodiesterse v inhibitor, and endothelin receptor blocker. however, the efficacy and safety of those medications in rp-associated ulcers have not been definitive, especially in korean patients with ssc. in addition, it remains unknown whether korean ssc patients respond better to a treatment over others. study aims include 1. to establish a new prospective cohort of ssc patients with du in korea.. 2. to investigate the current situation of ssc patients in korea. 3. to investigate and compare the efficacy and safety of current medical treatments of du in ssc patients in korea

Eligibility criteria:
inclusion criteria: * age of 18 years or older * ssc diagnosis according to 1980 or 2013 acr classification criteria * 1 or more active du * patients who start or change medical treatment for du * patients who are willing to participate exclusion criteria: * pregnancy or active breast feeding * patients with life expectancy \< 6 months
uterine fibroid embolization (ufe) for symptomatic fibroids: comparison of gel-bead to commonly used embolic agents.

Conditions: Uterine Fibroid; Embolization; Symptoms

Summary: the purpose of this post-market study is to evaluate ufe agents for the treatment of symptomatic uterine fibroids, using gel-bead compared to four other commonly used embolic agents.

this single-center, prospective study will be conducted at one site in the united kingdom. up to 30 subjects will be enrolled and treated with gel-bead. prospectively. enrolled gel-bead subjects will be followed at 1-month and 3-months post-procedure. data from subjects treated with gel-bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the university hospital southampton. this study evaluated 20 subjects in five different treatment groups for the treatment of symptomatic uterine fibroids. the five treatment groups include gelatin foam slurry, embospheres, polyvinyl alcohol (pva), bead block and embozenes.

Eligibility criteria:
inclusion criteria: 1. female, age 18 years or older 2. symptomatic uterine fibroid(s) requiring treatment per the investigators assessment 3. negative serum pregnancy test at the baseline visit and practicing effective contraception during the study 4. willing to provide written informed consent prior to initiation of study procedures 5. willing to comply with the specified study assessments and follow-up requirements exclusion criteria: 1. known hypersensitivity to porcine products or intravascular contrast material 2. vascular anatomy or blood flow precluding correct catheter placement or embolic injection 3. presence of collateral vessel pathways potentially endangering normal territories during embolization

Keywords: uterine fibroid embolization symptoms gel-beads
a study to evaluate the product performance of a new silicone hydrogel contact lens

Conditions: Myopia

Summary: the objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.


Eligibility criteria:
inclusion criteria: * subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logmar) or better (distance, high contrast) in each eye * subjects must have clear central corneas and be free of any anterior segment disorders. * subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand. * subjects must be myopic and require lens correction from -0.25 d to -6.00 d in each eye. * subject must wear their current lenses for a minimum of 12 hours per day at least four days per week. * subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, ereaders). * subjects must habitually wear soft contact lens. * subject must have no active ocular disease or allergic conjunctivitis. * subject must not be using any topical ocular medications. * subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses. * subjects must habitually use a lens care product for cleaning, disinfection, and storage. exclusion criteria: * subjects who have worn gas permeable (gp) contact lenses within the last 30 days or who have worn polymethylmethacrylate (pmma) lenses within the last three months. * subjects with any systemic disease currently affecting ocular health or which in the investigator's opinion may have an effect on ocular health during the course of the study. * subjects using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * subjects with an active ocular disease or who are using any ocular medication. * subjects who are not correctable to 32 letters (0.3 logmar) in each eye with soft spherical contact lenses. * subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses. * subjects with an ocular astigmatism of 1.00 d or greater in either eye. * subjects with anisometropia (spherical equivalent) of 2.00 d or greater in either eye. * subjects with any grade 2 or greater finding during the slit lamp examination. * subjects with corneal infiltrates, of any grade, are not eligible. * subjects with any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * subjects with any scar or neovascularization within the central 4 mm of the cornea. * subjects who are aphakic. * subjects who are amblyopic. * subjects who have had any corneal surgery (eg, refractive surgery). * subjects who are allergic to any component in the study care products. * subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.
the effect of exercise on the brain in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the goal of this clinical trial is to learn if exercise training of high or moderate intensity is most optimal to improve brain health and prevent neurodegeneration in type 2 diabetes patients. the main question it aims to answer is: what is the effect of exercise training of high vs. moderate intensity on brain metabolism, brain perfusion, and cognition in type 2 diabetes? researchers will compare the exercise training groups to a control group without exercise training to determine the effect of exercise training on the brain in type 2 diabetes. participants will exercise for 6 months, 3 times per week. before and after these 6 months, they will undergo: * a brain mri scan * cognitive tests * blood sampling


Eligibility criteria:
inclusion criteria: * type 2 diabetes * no insulin therapy * 30-75 years old * right handed * physically inactive exclusion criteria: * left handed * mri contraindications * psychological disorders * exogenous insulin therapy * history of coma, transient ischemic attack, head trauma, brain tumor, stroke, epilepsy, and other central nervous system diseases that could cause dementia or presence of dementia before t2dm * suffering from any disease with significant impact on exercise intervention participation such as: chronic heart disease (e.g. valve insufficiency ≥ grade 2) or significant arrhythmias, cardiac events less than one year ago (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), clinical heart failure (oedema, shortness of breath), percutaneous coronary intervention less than one year ago, chronic obstructive pulmonary disease (copd), cerebrovascular or peripheral vascular disease * severe hypertension (\>160/110 mmhg) * ongoing cancer, severe neuropathy (limiting exercise participation) * renal disease (grf \<45 ml/min/1,73 m2) * inability to regularly participate in the exercise intervention * pregnancy * breastfeeding

Keywords: type 2 diabetes exercise intervention brain cognition neurometabolism dementia cerebral perfusion
pharmacokinetics and safety of regorafenib (bay73-4506) in cancer subjects with severe renal impairment

Conditions: Neoplasms

Summary: to characterize the pharmacokinetics and safety of regorafenib in cancer subjects with severe renal impairment when compared to the control group (cancer subjects with normal or mildly impaired renal function)


Eligibility criteria:
inclusion criteria: * subjects with histologically confirmed, locally advanced or metastatic, refractory solid tumors who are not candidates for standard therapy * male or female subject ≥ 18 years of age * women of childbearing potential must have a negative urine pregnancy test performed within 7 days before start of study treatment * life expectancy at least 8 weeks * adequate bone marrow, and liver function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * for subjects with normal or mildly impaired renal function (control group); to be tested within 7 days of starting the study treatment: * estimated creatinine clearance (clcr) ≥ 60 ml/min as calculated using the cockcroft-gault equation * for subjects with severely impaired renal function; to be tested within 7 days of starting the study treatment: * clcr 15-29 ml/min as calculated using the cockcroft-gault equation exclusion criteria: * symptomatic metastatic brain or meningeal tumors * major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication * history of organ allograft * non-healing wound, skin ulcer, or bone fracture * pheochromocytoma * uncontrolled concurrent medical illness including uncontrolled hypertension * history of cardiac disease * pleural effusion or ascites that causes respiratory compromise * interstitial lung disease with ongoing signs and symptoms at the time of screening * arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication * subjects with evidence or history of bleeding diathesis; any hemorrhage or bleeding event nci-ctcae grade ≥ 3 or higher within 4 weeks of start of investigational treatment * dehydration nci-ctcaeversion 4.0 grade ≥ 1 * unresolved toxicity higher than nci-ctcae version 4.0 grade 1 attributed to any prior therapy/procedure (excluding alopecia or anemia or grade 2 neuropathy that is not reversible due to oxaliplatin) * seizure disorder requiring anticonvulsant therapy (such as steroids or anti-epileptics) * for subjects with severely impaired renal function: * renal failure requiring hemo- or peritoneal dialysis * acute renal failure * acute nephritis * nephrotic syndrome

Keywords: regorafenib pharmacokinetics safety severe renal impairment solid tumors
exploring the relationship between icope framework and frailty among community-dwelling elderly individuals

Conditions: Community-dwelling Elderly

Summary: this study aims to (1) compare the assessment outcome of the icope-i and icope-s, and (2) investigate the correlation between both versions of the icope step 1 screening tools and frailty in taiwan.

the prevalence of frailty among the elderly increases annually as the population ages. the world health organization (who) has introduced the integrated care for older people (icope) framework, which aims to support healthy aging by evaluating the intrinsic capacity (ic) of the elderly in six different areas. in taiwan, two versions of the icope step 1 screening tools are available: an interview-based version (icope-i) and a self-administered version (icope-s) based on the who's model. there are two main models for frailty status assessments: dr. fried's phenotype of frailty and dr. rockwood's accumulation of deficit models. a comparative study is necessary to assess the consistency of both versions of icope in taiwan and their associations with frailty.

Eligibility criteria:
inclusion criteria: * ≥ 65 years old * community-dwelling elderly * walking independently (with/without assistive devices) exclusion criteria: * participants with a moca score \< 26 * being unable to give informed consent (e.g., aphasia, deafness, and blindness) * being unable to finish all the physical and screening assessment assessments

Keywords: frailty icope intrinsic capacity community-dwelling elderly
a study of participants with β-thalassemia treated with betibeglogene autotemcel

Conditions: Beta-Thalassemia

Summary: the main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. to assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel.


Eligibility criteria:
inclusion criteria: * participant must be treated with beti-cel in the post marketing setting at a center in the us that participates in the registry. * participant must sign an informed consent and/or assent prior to enrollment as required under applicable laws and regulations. * participant must have signed an informed consent and/or assent permitting data to be shared with center for international blood and marrow transplant research (cibmtr). * participant must be followed by a hematologist based in the us. exclusion criteria: - there are no exclusion criteria for registry participation.
chemoprevention of colorectal adenomas

Conditions: Adenomatous Polyps

Summary: the purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas.

this is a multicenter, randomized, parallel group, prospective, double blind, placebo controlled clinical trial of chemoprevention in patients at increased risk of developing colorectal cancer (crc). the colotech combination treatment (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) will be compared to placebo with regards to safety and efficacy during 3 years of treatment. the randomized treatment period will be preceded by a 3-week single blind placebo run-in period, which will assess patient's compliance to treatment. in order to collect data on the durability of treatment effect, follow-up data from a surveillance colonoscopy will be collected two years after the 3-year colonoscopy.

Eligibility criteria:
inclusion criteria: * patients 40-75 years of age, both sexes. * colonoscopy including the cecum at trial entry * the removed adenoma(s) have be to tubular, tubulovillous or villous, and fulfill one of the three following criteria: 1. one adenoma with diameter ≥ 1 cm 2. ≥ 2 adenomas of any size 3. an adenoma of any size and familial disposition for colorectal cancer, as long as the person is a first degree relative with a colorectal cancer patient exclusion criteria: * familial adenomatous polyposis syndrome * member of a family with hereditary non-polyposis colorectal cancer (hnpcc) * proctocolectomy (colonic and/or rectum resection permitted). * inflammatory bowel disease (crohn´s disease, ulcerative colitis). * ischemic cardiovascular disease. * patients with known gastro-duodenal ulcer at time of inclusion. * cancer within the past 5 years

Keywords: colorectal, adenomas, prevention
autologous nerve graft breast reconstruction neurotization

Conditions: Breast Reconstruction; Breast Cancer Patients; Nipple-sparing Mastectomy

Summary: the goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. the patient-reported outcome was assessed by questionnaire.


Eligibility criteria:
inclusion criteria: * patient who receive breast reconstruction * patient who is willing to fill in the questionnaire exclusion criteria: * patient who receive breast reconstruction for the reason other than breast cancer

Keywords: breast reconstruction nipple-sparing mastectomy breast neurotization quality of life autologous nerve graft nipple sensation
medications for the treatment of dysthymic disorder and double depression

Conditions: Depression; Dysthymia

Summary: the purpose of the study is to evaluate the efficacy and safety of flexible doses of escitalopram (lexapro) compared to sertraline (zoloft) for treatment of dysthymic disorder.

dysthymic disorder is a common, chronic type of depression that is often seen as a mild condition and is under-treated. because of its chronic course, it is often complicated by episodes of major depression and may require long-term treatment. this is a twelve week study during which daily doses of escitalopram (10-20 mg) or sertraline (50-200 mg) will be given to outpatients meeting criteria for dysthymic disorder or double depression. medications will be assigned 1:1 and clinicians will be blinded to treatment. efficacy will be based on scores for the hamilton depression rating scale, patient subjective reporting, and clinician observation. the study will have a total of 8 visits over 12 weeks, with a one-week medication taper period at the end. subjects will have a physical exam, labs, and vital signs monitored at first visit and vital signs monitored at every subsequent visit. women of childbearing potential must have a negative urine pregnancy test at screening. all subjects will remain on the lowest medication dose for the first four weeks of the study.

Eligibility criteria:
inclusion criteria: * primary diagnosis of dysthymic disorder or major depressive disorder with antecedent dysthymia * women of childbearing potential must have negative pregnancy test at screen and agree to practice acceptable method of birth control * score of at least 12 on the 24-item hamilton depression scale at study entry * initial screening labs grossly within normal limits * signed written informed consent exclusion criteria: * other axis-i diagnoses such as delirium, dementia, and substance dependence (active in last year) or any substance abuse including alcohol within the past six months * actively suicidal * cns neoplasm, demyelinization disease, degenerative neurological disorder, active cns infection, or any progressive cns disorder that may confound interpretation of study results * history of seizure disorder, or eeg showing paroxysmal activity or head ct showing gross structural abnormality * acute systemic medical disorder * use of any psychotropic medications within 2 weeks prior to screen or 4 weeks prior to screen in the case of fluoxetine * current use of any herbal medication such as st. john's wort, * uncontrolled renal, hepatic, endocrine, cardiovascular, pulmonary, immunological, hematological or gastrointestinal disease * any other abnormal medical screening tests judged by the investigator to be clinically significant * received any experimental medication within 30 days prior to study entry * patients presently in or soon to be starting psychotherapy * prior treatment non-response to an adequate trial of citalopram, escitalopram, or sertraline * history of allergy to citalopram, escitalopram or sertraline

Keywords: depressive disorders
an evaluation of polymer based fiducials for use in imaging patients receiving treatment for prostate cancer

Conditions: Prostate Adenocarcinoma

Summary: this trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the mri image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal x-ray imaging for daily prostate positioning.

the investigators will also be assessing the following: 1. whether polymer-based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers. 2. whether polymer-based markers are visible on ultrasound imaging. 3. to determine if the polymer-based marker produces fewer artifacts on treatment planning ct scans than gold markers.

Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma * diagnosis of low risk or intermediate risk prostate cancer * approved for proton therapy treatment at cdh procure proton therapy center * prescribed and consented for the placement of fiducial markers into the prostate as part of the standard treatment procedure * capable of receiving an mri of the pelvis region for prostate localization * the prostate gland of eligible patients must be capable of imaging from an anterior trans-abdominal ultrasound as determined by the treating investigator * must be fluent in the english language; must be able to provide written study consent exclusion criteria: * evidence of a large turp defect per investigator discretion * previous prostate cancer surgery including prostatectomy, hyperthermia and cryosurgery * previous pelvic radiation for prostate cancer * current grade 2 or above incontinence * history of orthopedic procedures in the area of the treatment, specifically no prior hip replacement or procedure in which metallic or high density material remains which would be within stereoscopic kilovoltage imaging area * prior permanent placement of any metallic or high density material within the prostate * known allergy to ultrasonic gel

Keywords: prostate cancer low risk intermediate risk t1 t2a t2b gleason 6 gleason 7 psa 10 psa 20