Kornimate/medical-research-clean huggingface dataset:
evaluation of statin-induced lipid-rich plaque progression by optical coherence tomography (oct) combined with intravascular ultrasound (ivus)

Conditions: Coronary Artery Disease; Hyperlipidemia

Summary: many trials suggested that lipid lowering therapy could significantly reduce cardiovascular events. enhancing stability of vulnerable plaque is probably the main reason by which statins reduce adverse coronary events. the size of lipid core and the fibrous cap thickness (fct) are the major determinants of plaque vulnerability. so, it is very important to accurately evaluate changes in plaque after stains therapy. previous reports suggested that intensive lipid lowering therapy provide more significantly clinical benefit compared with moderate lipid lowering therapy.such benefit may contribute to the changes in following parameters: fct, lipid arc(quadrants), tcfa, macrophage, plaque disruption, and thrombus measured by oct, and plaque burden and remodeling index by ivus. current intravascular imaging modalities, such as optical coherence tomography (oct) and intravascular ultrasound (ivus) can provide in vivo quantitative and qualitative information of coronary plaques. however, there were few studies aimed at monitoring the progression of coronary plaques in patients receiving statin therapy by oct combined with ivus. therefore, the study we designed were to compare the effect of the rosuvastatin 10mg, atorvastatin 20mg and atorvastatin 60mg treatment on the changes in fct and lipid core arc by oct and plaque burden by ivus of coronary atherosclerotic plaques.


Eligibility criteria:
inclusion criteria: 1. age :18-75y 2. clinical indication for coronary angiography (cag). 3. cag demonstrates at least 1 de novo lesion with luminal diameter stenosis between 20% and 70% (visual estimation). 4. oct demonstrates the lesion is a lipid-rich plaque (fct ≤200μm and lipid arc ≥100o). 5. ldl-c range between 70mg /dl and 160mg /dl. 6. patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent. exclusion criteria: 1. life expectancy \<12 months due to another medical condition. 2. contraindication to the atorvastatin and rosuvastatin. 3. creatinine levels more than 2.0mg/dl or esrd. 4. severe hepatic dysfunction (ast and/or alt more than 3 times the upper limit of normal). 5. congestive heart failure (left ventricle eject fraction ≤35%). 6. female of childbearing potential with a positive pregnancy test within 7 days before study, or lactating, or intends to become pregnant during the following 12 months. 7. the patient is likely to require coronary bypass surgery, cardiac transplantation, surgical repair or replacement during the course. exit criteria 1. alt/ast ≥ 3times upper limit of normal after enrollment. 2. muscle ache/myopathy. 3. lose follow-up. 4. patient insists on exit.

Keywords: optical coherence tomography intravascular ultrasound coronary artery disease hyperlipidemia
refinement and assessment of new mri technologies for cardiovascular exams using the phillips cmr patch

Conditions: Cardiomyopathies

Summary: this study is being done to improve image quality and provide the collaborator with feedback on wide band imaging in patients with cardiac implantable electronic devices (cied).


Eligibility criteria:
inclusion criteria: have a clinically ordered cardiac mri exam at university of michigan - exclusion criteria: pregnant; contraindication to mri -
eus rfa for treatment of pancreatic ductal adenocarcinoma (pdac)

Conditions: Pancreatic Cancer

Summary: this is a single arm study in the treatment of pancreatic ductal adenocarcinoma (pdac). the investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (eus-rfa) using the rf electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.


Eligibility criteria:
inclusion criteria: * diagnosed and histologically confirmed pdac by biopsy * axial ct scan or mri consistent with pdac with at least 1 cm in greatest diameter * ecog performance status 0-2 * patients with locally advanced pdac, who have not responded or progressed on first line chemotherapy, are deemed not resectable based on multidisciplinary review, and show no evidence of distant metastasis * lesions between 1 - 4cm in size exclusion criteria: * patients that show evidence of distant metastasis * endoscopically non-accessible mass * pregnant patients * inability to provide informed consent * lesions \ 4cm in greatest diameter
single-dose administration trial of tlc599 in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: this trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of tlc599 in subjects with osteoarthritis of the knee.

protocol no: tlc599a1001 name of finished product: tlc599 title of study: a randomized, open-label, parallel, phase i/ii single-dose administration trial of tlc599 in subjects with osteoarthritis (oa) of the knee methodology this trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of tlc599 in subjects with osteoarthritis of the knee. study duration: the trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period.

Eligibility criteria:
inclusion criteria: 1. male or female subjects, at least 20 years of age 2. documented diagnosis of oa of the knee for at least 6 months 3. at least a grade 2 severity based on the kellgren and lawrence grading scale 4. vas score of ≥ 4 at baseline exclusion criteria: 1. subjects who received systemic corticosteroids for the last 30 days prior to baseline 2. subjects who received non-steroidal anti-inflammatory drug (nsaid), analgesics, or rehabilitations therapy within 7 days prior to baseline 3. history of rheumatoid arthritis or other autoimmune disease 4. clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing 5. history of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee 6. concurrent systemic active or uncontrolled infectious disease 7. a history of treated malignancy which is disease free for ≤ 5 years. (the malignancy does not include non-basal-cell carcinoma of skin or carcinoma-insitu of the uterine cervix) 8. history of acquired or congenital immunodeficiency diseases 9. platelet count \< 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia 10. stroke or myocardial infarction within 3 months prior to the screening visit 11. use of intra-articular corticosteroid, hyaluronic acid, or other intra-articular injection in the study knee joint within 3 months prior to the screening visit 12. unstable study knee joint, including anterior cruciate ligament, any surgery to the study knee within the 12 months prior to the screening visit, and any prior arthroscopic or open surgery of the study knee or any planned/anticipated surgery during the study period 13. any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space 14. female subjects who are pregnant, nursing, planning pregnancy, or who are of childbearing potential and not using reliable means of contraception 15.known allergy or hypersensitivity to the study drug or its components

Keywords: osteoarthritis of the knee tlc599 dexamethasone dsp
phase 2 daxibotulinumtoxina for injection for the management of plantar fasciitis

Conditions: Plantar Fasciitis

Summary: the specific aim of the study is to compare the safety and efficacy of a single administration of daxibotulinumtoxina for injection versus placebo for managing plantar fasciitis.


Eligibility criteria:
inclusion criteria: * written informed consent, including authorization to release health information * male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis * persistent heel pain for more than three months * women of child bearing potential must have negative pregnancy test at screening and injection visits and must use an effective method of birth control during the course of the study exclusion criteria: * previous surgery on the midfoot or hindfoot * neuromuscular disease * systemic muscle weakness * planning a pregnancy during the study * current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit

Keywords: heel pain
evaluation of protein bars on weight management and osteoarthicular health

Conditions: Overweight and Obesity; Articular Disease

Summary: the goal of this intervention study is to evaluate the efficacy in subjects with overweight or obesity of protein bars consumption. the main questions it aims to answer are: * does the regular consumption of these protein bars help to loose weight? * does the regular consumption of these protein bars help to improve the osteoarticular health? participants will be asked to follow the indications of consumption of the bars togather with healthy nutritional advice during 16 weeks. researchers will compare exparimental versus placebo groups to see if weight is lost in similar or different ways.

the intervention is designed to evaluate the efficacy of the consumption of a protein bar vs placebo on weight control and osteoarticular health. for this purpose, a total of 102 subjects will be randomised to either the experimental group or the placebo group, the only stratification performed will be acording to sex.

Eligibility criteria:
inclusion criteria: * bmi between 25 and 37.5 kg/m2 * normal physical examination and vital signs according to clinical examiners. * chronic pharmacological treatment is permitted if dosage is stable within at least three months prior the start of the intervention. exclusion criteria: * any funcitonal or structural impairment in digestive system (hitus hernia, ulcers, inflammatory bowel disease, etc.) * excessive alcohol consumption (\> 14 units/week in women and \> 20 units per week in men) * bariatric surgery or similar * arthritis, hepatic diseases, cancer. * alergy to any component of the products * subjects presenting any cognitive or psichiatric impairment, that may impel them to follow the protocol. * subjects following any weight loss program

Keywords: nutritional intervention
debulking effect of curretage on basal cell carcinomas - a histological assessment.

Conditions: Carcinoma, Basal Cell

Summary: the aim of this study was to compare histologically observed tumour infitration of basal cell carcinoma (bcc) lesions before and after curretage.a significant reduction of tumour depth would enable further bcc's included for superficial non-invasive treatment modalities such as topical photodynamic therapy.


Eligibility criteria:
inclusion criteria: * bcc with tumour depth two mm.or more exclusion criteria: * bcc tumours smaller than three mm in mean diameter.

Keywords: cytoreduction surgical procedures curretage photochemotherapy
mulligan mobilization with movement versus macquarie injury management group in function and pain of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: knee pain is one of the most usual pain that commonly affects people especially in the late age. it can be caused by osteoarthritis, poor posture or sitting position, bad bending or improper lifting. it is usually not caused by a serious illness. it is the most common cause of disability. to compare the long term effects of mulligan mobilization with movement versus macquarie injury management group on pain and function of knee osteoarthritis.

it was a randomized clinical trial conducted in revival physiotherapy center, lahore. a convenient sample of 26 diagnosed patients with osteoarthritis was included in the study. subjects were randomly distributed in to two groups with use of flip coin method group of randomization. group 1 patients got mimg with routine physical therapy and group 2 got mwm with routine physical therapy. visual analogue scale (vas),non modified womac were used to assess all patients before and after 4 weeks of intervention. statistical analysis was computed by spss 20.0.

Eligibility criteria:
inclusion criteria: * acr criteria for knee will be over age 50 * less than 30 minutes of morning stiffness, * crepitus on active motion, * tenderness * enlargement * no palpable warmth of synovium. * osteoarthritis grade 1 and 2 by kelly-green and lawrence method. exclusion criteria: * any surgical procedure done in past 6 months and metal implants in lower extremity. * any infection and neoplastic disorder. * post traumatic knee stiffness. * secondary knee o a peripheral vascular disease

Keywords: knee pain movement with mobilization
the comparison of the transversalis fascia plane block with ilioinguinal/iliohypogastric nerve block

Conditions: Postoperative Pain; Inguinal Hernia Unilateral; Children, Only

Summary: this study compares the transversalis fascia plane block with the ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery. half of participants will receive the transversalis fascia plane block, while the other will receive the ilioinguinal/iliohypogastric nerve block.

the ilioinguinal/iliohypogastric nerve block (ii/ih b)is a widely used regional anesthesia technique in inguinal hernia repair surgery. however, this block provides limited analgesia during and after surgery, and the patients feel pain when walking. the transversalis fascia plane block (tfpb) is a recently developed technique and several case reports presented its efficacy for inguinal repair surgery in adult patients. it may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the thoracolumbar fascia. therefore, we compare the effect of the tfpb and ii/ih b on postoperative pain and walking form.

Eligibility criteria:
inclusion criteria: * the patients undergoing unilateral open hernia repair surgery exclusion criteria: * known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage

Keywords: transversalis fascia ilioinguinal/iliohypogastric nerve inguinal hernia repair children
68 ga psma pet/mri for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called gallium-68 psma-11 (68ga-psma-11) for use in pet/mri evaluation of hepatocellular carcinoma

this is a prospective pilot proof-of-concept single-center study. primary objective using surgical histopathology as the reference standard, the investigators intend to achieve the following objectives in adult subjects with hepatocellular carcinoma (hcc) undergoing surgical resection or transplant: 1. to demonstrate the feasibility of 68ga-psma-pet/mri for imaging patients with hcc 2. to estimate the sensitivity of suvmax on psma pet for identification of li-rads® 5 (definitely hcc) observations or biopsy proven hcc(s). 3. to perform a radiology-pathology correlation of psma uptake at pet with hcc tumor psma immunostaining, tumor pathology features, and signal and enhancement characteristics at mri

Eligibility criteria:
inclusion criteria: * patients at risk for hcc with either an imaging diagnosis of hcc by cect or cemri (li-rads 5) confirmed by a board-certified abdominal radiologist or biopsy-proven hcc confirmed by a hepatobiliary pathologist * no prior treatment for hcc * subjects who are expected to undergo surgical resection of the hepatic lesion(s) and/or liver transplant * male or female with age greater than 18 years, with the capacity to give informed consent and willingness to provide a written consent. exclusion criteria: * subjects requiring emergent surgery for a ruptured/bleeding hcc * bilirubin \> 3.0 mg/dl, which is a contraindication for gadoxetate, the mri contrast agent * pregnant and/or breast-feeding subjects. a negative pregnancy test within 48 hours of the pet scan. * subjects with higher than the weight/size limitations of pet/mri scanner. * subjects with contraindication to mri including: subjects who have a heart pacemaker, subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, subjects who have implanted devices with magnets, subjects who have other implanted electronic devices, subjects who have deep brain stimulator, subjects who have vagal nerve stimulator, subjects with cochlear (ear) or auditory implants * subjects with history of allergic response to radiocontrast media * subjects with known history of claustrophobia.
evaluation on the characteristics of the true/false lumen and its prognostic value for coronary cto patients just before stent implantation

Conditions: Chronic Total Occlusion of Coronary Artery

Summary: ivus will be used to evaluate the ratio of false lumen to occluded segment, the ratio of false lumen to stent length, the location characteristics of false lumen and its prognostic value for perioperative complications, 1-year late lumen loss and macce events in patients with coronary cto.

at present, novel technologies of cto interventional therapy become mature. these technologies usually artificially cause dissection of coronary artery. the events such as collateral vessel loss, vascular injury and tear, perforation, pericardial tamponade caused by false lumen may theoretically affect the perioperative and long-term prognosis of patients. in this study, intravascular ultrasound (ivus) was used to evaluate the characteristics of true lumen and false lumen in cto segment, so as to determine its impact on the prognosis of patients.

Eligibility criteria:
inclusion criteria: * 18 to 80 years old; * be diagnosed with cto; * cto located in an epicardial coronary artery with a reference diameter of ≥ 2.5mm; * comply with all the evaluations and follow-up protocols. exclusion criteria: * suffered from acute myocardial infarction within the previous 3 months; * rheumatic valvular disease; * severe arrhythmia; * lesions unsuitable for pci; * severely abnormal hematopoietic systems, such as platelet counts \ 700\*10\^9/l and white blood cell counts \< 3\*10\^9/l; * with active bleeding or bleeding tendencies(active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency); * severe coexisting conditions, including severe renal function dysfunction \[glomerular filtration rate less than 60ml/min • 1.73 m2), severe hepatic dysfunction \[glutamic-pyruvic transaminase (alt) or glutamic-oxal acetic transaminase (alt) elevated more than three times that of the upper limit of the normal reference\], severe heart failure (nyha classification iii-iv), acute infectious diseases and immune disorders; tumors; surgery within 3 months; * a life expectancy less than 12 months; * pregnancy or planning to become pregnant; * history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents; * cannot tolerate dual antiplatelet treatment; * unable to communicate due to cognitive impairment, auditory, or visual impairment; * participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention.

Keywords: chronic total occlusion intravascular ultrasound percutaneous coronary intervention true lumen false lumen
interactive sections of an internet-based intervention increase patient empowerment: a study with chronic back pain patients

Conditions: Group 1 (Control): Access to a Static Version of the Website Containing Only Static Features (i.e. Library, First Aid, and FAQ); Group2 (Intervention) Access to an Interactive Version of the Website Containing Both Static and Interactive Features

Summary: the aim of the study is to study how to improve patients' management of chronic back pain, particularly their management of prescription medication, through increasing health literacy and patient empowerment through an internet based intervention. we do this by designing both patient education materials and physician communication strategies to increase literacy and volitional components of patients. we will test two conditions using a website called oneself: one providing only information (literacy-only control) and a second providing relational communications designed to increase both literacy and volitional empowerment. to test the self-management enhancing effects of empowerment and health literacy, we will conduct a longitudinal experiment with 51 chronich back pain patients over two months. this span of time is the minimum necessary to achieve a systematic change in self-management and literacy skills, increasing also the range of possible decisions to be made and actions to be real-ized by the patients.


Eligibility criteria:
inclusion criteria: 1. aged \> 18 years, 2. having suffered from back pain for at least 3 months, 3. no concurrent involvement in other studies. exclusion criteria: 1. no access/limited access to computer and internet 2. concurrent diseases