Kornimate/medical-research-clean huggingface dataset:
yoga versus home exercise program in children with enthesitis related arthritis

Conditions: Enthesitis Related Arthritis

Summary: the aim of this study is to compare the effectiveness of different exercises programs as 'yoga' and 'home exercise' in enthesitis related arthritis.

enthesitis is the localized inflammation in the attachments of muscles, ligaments, fascia to bone. enthesitis related arthritis is a sub-form of juvenile idiopathic arthritis (jia) and primarily lower extremities, spine, and sacroiliac joints. in the literature, exercise therapy is found beneficial to improve bone density, muscle strength and functionality without leading adverse effects in these children. recently yoga has emerged as a new exercise approach which consist of both physical an mental components to improve self-awareness and mindfulness. however, the effects of yoga did not investigated in jia patients. the only evidence is a case study which reports improvements in pain and stiffness in a child with jia.

Eligibility criteria:
inclusion criteria: 1. being between 13-18 years 2. having a diagnosis of enthesitis related arthritis 3. having a diagnosis at least 6 months ago 4. being able to understand exercise instructions 5. consent of family and the patient exclusion criteria: 1. any contraindication to perform exercise (neurological, cardiovascular etc.) 2. change in medication

Keywords: yoga home exercises juvenile idiopathic arthritis
prevention of depression with omega-3 fatty acids in chronic carriers of hepatitis c treated with interferon alpha.

Conditions: Chronic Hepatitis C

Summary: the purpose of the study is to check whether development of depression as a side effect of interferon alpha treatment in chronic carriers of hepatitis c can be prevented by omega-3 fatty acids.

omega-3 fatty acids are known as an alternative treatment for different conditions, including mental conditions, such as depression. we assume that combining omega-3 with the treatment by interferon alpha may prevent the development of depression, which is quite a common side effect of the interferon alpha.

Eligibility criteria:
inclusion criteria: * chronic carriers of hepatitis c who start a course of interferon alpha treatment, and are treated in the liver clinic of bnai zion hospital. exclusion criteria: * disagreement to participation in trial. * diagnosed and active mental illness. * encephalopathic patients. * patients with limited ability to understand the questionnaires or the informed consent process.

Keywords: interferon alpha depression omega 3
a multicenter, randomized, double-blind, placebo-controlled phase iii study of fuzuloparib combined with abiraterone acetate and prednisone (aa-p) versus placebo combined with aa-p as first-line treatment in patients with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Summary: to evaluate whether fuzuloparib plus aa-p is superior to placebo plus aa-p as first-line treatment by assessment of radiographic progression-free survival (rpfs) in mcrpc subjects unselected for deoxyribonucleic acid (dna) damage repair deficiencies (drd) status (cohort 1) to evaluate whether fuzuloparib plus aa-p is superior to placebo plus aa-p as first-line treatment by assessment of rpfs in mcrpc subjects harboring drd (cohort 2).


Eligibility criteria:
inclusion criteria 1. able and willing to provide a written informed consent 2. a score of 0 to 1 for ecog performance status 3. age of ≥ 18 years old 4. prostate adenocarcinoma confirmed 5. disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy. 6. the functional level of the organs must meet the requirements 7. blood and tumor tissue samples are provided during screening to determine the drd status exclusion criteria 1. prior treatment with any parp inhibitor 2. have received any systemic anti-tumor treatment during the mcrpc stage or non-metastatic crpc stage 3. have used any cyp3a4 inducers or inhibitors within 14 days prior to the first dose 4. plan to receive any other anti-tumor treatment 5. presence of radiologically confirmed tumor lesions in the brain 6. contraindications to the use of prednisone 7. history of uncontrolled pituitary or adrenal dysfunction 8. uncontrolled hypertension 9. presence of active heart diseases 10. human immunodeficiency virus-positive 11. presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption 12. active hbv or hcv infection 13. presence of concomitant diseases
pulsed-field ablation vs. radiofrequency ablation combined with vein of marshall ethanol ablation on mitral isthmus block and clinical outcomes in persistent atrial fibrillation

Conditions: Atrial Fibrillation (AF)

Summary: atrial fibrillation (af) is one of the most common clinical arrhythmias, and catheter ablation serves as a critical therapeutic approach. for persistent atrial fibrillation, several proposed ablation strategies-including the 2c3l technique, box lesion sets, and substrate modification-remain highly controversial regarding long-term success rates. multiple studies suggest that linear ablation beyond pulmonary vein isolation (pvi) often fails to achieve durable block due to incomplete ablation lines, which significantly contributes to postoperative recurrence of atrial arrhythmias. in recent years, electrophysiologists have explored various methods to improve mitral isthmus (mi) ablation, such as combined endo-epicardial ablation and radiofrequency ablation (rfa) combined with marshall vein alcohol ablation. while rfa combined with anhydrous alcohol injection into the marshall vein enhances mi block rates, it is associated with prolonged procedure time, unpredictable ablation zones, and higher complication risks (e.g., coronary artery spasm, pericarditis). pulsed field ablation (pfa), an emerging non-thermal ablation technology, offers potential advantages such as tissue selectivity, shorter procedure time, and fewer complications. studies report that rfa achieves near 100% immediate block rates; however, there is a lack of sufficient comparative studies on the efficacy and safety between these two ablation approaches. this study aims to compare the clinical outcomes and safety profiles of pfa versus rfa combined with marshall vein alcohol injection in patients with persistent af.


Eligibility criteria:
inclusion criteria: 1. persistent atrial fibrillation; 2. ejection fraction \>30%; 3. nyha functional class i-iii; 4. left atrial diameter \<55 mm on echocardiography; 5. signed informed consent form; exclusion criteria: 1. pregnant or lactating women; 2. patients with a life expectancy of less than 2 years due to non-cardiovascular factors; 3. uncontrolled hyperthyroidism, severe liver or kidney dysfunction; 4. history of atrial fibrillation ablation; 5. history of heart transplantation, complex congenital heart disease, or rheumatic heart disease; 6. contraindications to contrast agents, radiofrequency ablation, antiarrhythmic drugs, or anticoagulants; 7. acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular 8.accident within 12 weeks prior to enrollment; 9.other conditions deemed unsuitable for participation by investigators; 10.participation in other clinical trials.

Keywords: persistent atrial fibrillation pulsed field ablation ei-vom
preventing heart disease in underserved patients

Conditions: Hypertension; Diabetes Mellitus; Hyperlipidemia

Summary: the study will evaluate the impact of an internet based telemedicine system on cardiovascular risk profile of underserved patient populations. it is our hypothesis that a treatment plan and frequent communication via an internet based telemedicine system will improve the cardiovascular risk profile of underserved patient populations at increased risk for cardiovascular disease. our primary endpoint is a reduction over one year in the 10-year cvd risk score (atp iii risk model).

the insight telehealth system (itsmyhealthfile) is a disease-managment interactive health care delivery system. patients access the system through a special web site using a password. the system prompts the patient to enter their weight, blood pressure and heart rate and there is a text box available for unstructed comments. patients will be randomized to either the telemedicine group or usual care group (controls). individuals in the telemedicine group will be asked to transmit their health status weekly. both groups will be followed for one year with quarterly visits. patients of either sex, of any ethnic background or race, between 22 and 85years of age, who have a 10% or greater 10-year risk of cvd based on the framingham risk score, and risk factors that if properly treated would reduced the risk by 5% or greater will be eligible for the study. additional criteria * literate * telephone access * ablility to utilize the internet and telemedicine system (after training) primary outcome reduction in framingham risk index

Eligibility criteria:
inclusion criteria: * framingham risk score equal to or greater than 10% * literacy * 22 -85 years of age * access to phone * ability to use internet and system following training exclusion criteria: * class 3 and 4 heart failure * esrd * stroke with residual disability or dementia * unable to read or write

Keywords: cvd risk self monitoring internet telemedicine
a study of perampanel as add-on therapy in adult and adolescent participants with focal seizures

Conditions: Partial Seizures

Summary: the primary objective of the present study will be to assess the effectiveness of add-on perampanel in participants with focal seizures in a real-life clinical setting.


Eligibility criteria:
inclusion criteria: 1. prescribe perampanel according to the approved indication 2. participants with focal seizures with or without secondary generalization 3. participants with seizure frequency data available at the baseline visit 4. based on the physician's clinical judgment, the participant seizure activity is not controlled sufficiently with the current treatment with 1-3 aeds and it is in the participants best interest to be prescribed adjunctive perampanel 5. the decision to prescribe perampanel is made by the physician before and independently of his/her decision to include the participant in the study 6. treatment with perampanel is not yet started before baseline exclusion criteria: 1. participants contraindicated for perampanel use (according to smpc) 2. participants with moderate to severe renal impairment 3. participants with severe hepatic impairment 4. pregnant or lactating women 5. participants suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation

Keywords: perampanel partial seizures focal seizures
effect of fenofibrate conversion on triglyceride levels in patients on statin therapy

Conditions: Hyperlipidemias

Summary: the primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.

hypothesis: study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate. the primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (ldl), hdl, alanine aminotransferase (alt), aspartate aminotransferase (ast), and serum creatinine (scr), and the potential cost savings associated with prescribing 54mg instead of 160mg. electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. subjects will be recruited for enrollment via telephone by the principal investigator (pi), co-principal investigators (co-pis), or provider referral after eligibility screening and approval from their primary care physician. subjects must provide written informed consent and health insurance privacy and accountability act (hipaa) privacy rule authorization prior to participation in this study. subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). subjects in both study arms will have fasting lipid panels, alt/ast, and scr evaluated at baseline. all subjects will have repeat labs approximately 8 weeks after enrollment. all subjects will continue to receive standard care based on lipid values. the study period will begin approximately october 29, 2010 and run to june 30, 2011.

Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * patients actively taking fenofibrate 160mg and statin therapy * a fasting lipid panel within the past 9 months with most recent triglycerides levels less than 200mg/dl * primary care physician approves participation and fenofibrate conversion exclusion criteria: * impaired renal function defined as creatine clearance ≤ 50ml/min * current enrollment in other studies or clinical trials * previous fenofibrate 54mg use * a history of pancreatitis or known previous triglyceride levels \>1000mg/dl * pregnancy * members with plan benefits that include a deductible for lab services at kaiser permanente
avicena lvdp validation study

Conditions: Heart Failure

Summary: the purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (lvdp) using the vivio system, compared with invasively measured lvdp via direct measurement during left heart catheterization.

prospective study to document the utility of vivio in quantifying lvdp, using directly measured lvdp collected during left heart catheterization as the comparator.

Eligibility criteria:
inclusion criteria: 1. adult subjects \>21 years of age. 2. referred for non-emergent left heart catheterization inclusive of direct measurement of lvdp as part of routine clinical management, to be performed from a femoral or radial access site. 3. willing and able to participate in all study evaluations and allow access to medical records, including medical testing records. 4. ability to understand and sign informed consent or have a legally authorized representative to provide informed consent on behalf of the subject. exclusion criteria: 1. acute coronary syndrome, or documented mi within a week of scheduled catheterization, cardiogenic shock, or the need for intravenous inotropic or mechanical circulatory support. 2. carotid pulse is not palpable by a trained study researcher. 3. history of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck). 4. history of significant or symptomatic carotid artery disease, including tia, ultrasound evidence of \>60% carotid stenosis, or at the discretion of the investigator; history of carotid artery stenting or surgery. 5. open skin lesions at the site of vivio application / examination. 6. contraindication to placing a catheter in the lv in the judgement of the investigator (e.g., mechanical aortic valve, left ventricular thrombus, etc.). 7. inability to obtain brachial artery blood pressure.
efficacy evaluation of the activity of a cosmetic product (topical use) on hair regrowth vs placebo

Conditions: Hypertrichosis

Summary: aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects)


Eligibility criteria:
inclusion criteria: * healthy volunteers * female sex * with hypertrichosis * agreeing not to perform epilation or scrub/peeling treatment on the test area (legs) during the week preceding the inclusion * good general state of health exclusion criteria: * pregnancy * lactation * subjects whose insufficient adhesion to the study protocol is foreseeable * sensitive skin * oral contraceptive therapy started less than 1 year * presence of varicose or capillary veins of surface * hormonal therapies able to influence hair growth. * presence of cutaneous disease on the tested area, as lesions, scars, malformations. * diabetes * endocrine disease * hepatic disorder * renal disorder * cardiac disorder * cancer. * farmacological topical treatment and surgery and/or medical treatment on the treated side performed in the last 3 months * systemic corticosteroids * aspirin or non-steroid anti-inflammatory drugs (fans) * diuretic.
adiponectin and insulin resistance in diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: plasma adiponectin concentration is inversely associated with renal function. there is little literature on adiponectin levels and regulation by antihypertensive medication with an angiotensin ii-receptor blocker (arb), especially in subjects with type 2 diabetes in different stage of chronic kidney disease (ckd).


Eligibility criteria:
inclusion criteria: * type 2 diabetic nephropathy * ckd at stage 1\~4 exclusion criteria: * type 1 diabetes or nondiabetic renal disease * an elevated plasma k level.

Keywords: type 2 diabetes diabetic nephropathy glucose metabolism angiotensin ii type 1 receptor blockers
autologous adipose-derived stromal cells delivered intra-articularly in patients with osteoarthritis.

Conditions: Osteoarthritis

Summary: this will be an open-label, non-randomized, multi-center, patient sponsored study of adipose-derived stromal vascular fraction (ad-svf) implantation performed intra-articularly to affected joints. the intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the disease pathology of patients with diagnosed osteoarthritis.

ad-svf will be collected from the patient's adipose-derived tissue (body fat). using local anesthesia, liposuction will be performed to collect the adipose tissue specimen. the adipose tissue is then transferred to the laboratory for separation of ad-svf. in addition, patient's peripheral blood will be collected for isolation of platelet rich plasma (prp), which are then combined with the ad-svf for intra-articular administration of affected joint.

Eligibility criteria:
inclusion criteria: * males and females between age 18 and 80 years. * patient with current proven diagnosis of osteoarthritis, with consistent symptomatology * up to date on all age and gender appropriate cancer screening per american cancer society. exclusion criteria: * females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study. * life expectancy \< 6 months due to concomitant illnesses. * exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * active infectious disease. patients known to have tested positive for hiv, htlv, hbv, hcv, cmv (igm \> igg) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status * any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * patients on chronic immunosuppressive transplant therapy * systolic blood pressure (supine) ≤90 mm hg or greater than 180mmhg * resting heart rate \> 100 bpm; * known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * active clinical infection * unwilling and/or not able to give written informed consent.

Keywords: arthritis joint pain articular cartilage mesenchymal stem cells autologous adipose tissue
type iii dysbetalipoproteinemia

Conditions: Hyperlipoproteinemia Type III

Summary: evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.


Eligibility criteria:
inclusion criteria: * diagnosis of dysbetalipoproteinemia defined as vldl-c/vldl-tg mass ratio \>0.35 at visit 2 or the concurrence of mixed hyperlipidemia (fasting tc ≥ 200mg/dl, fasting tg ≥ 200mg/dl at visits 2 and 3) and a genotype of apoe published to be associated with dysbetalipoproteinemia exclusion criteria: * use of cholesterol-lowering drugs, lipid lowering dietary supplements or food additives after visit 1 except in accordance with the protocol as co-administered therapy (i.e., a fenofibrate) with rosuvastatin 40mg at weeks 30 to 36; current active liver disease or hepatic dysfunction, serum ck ≥ 3 times uln (unless explained by exercise) anytime during dietary period, serum creatinine \> 2.0 mg/dl or a history of renal transplantation before the treatment phase, fasting triglyceride \> 1000 mg/dl at any time during the dietary lead-in or a history of pancreatitis while on treatment for dysbetalipoproteinemia.
study to the optimal duration of therapy with oral angiogenesis inhibitors

Conditions: Renal Cell Carcinoma; Gastrointestinal Stromal Tumor

Summary: the purpose of this study is to determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy

until now, in trials it is common to stop therapy when progressive disease occurs; recist criteria are used, in which progressive disease is defined as \>20% increase of the sum of the longest diameter of the lesions, or occurence of new lesions. however, angiogenesis inhibitors have a rather cytostatic than cytotoxic effect compared to chemotherapeutics, as a result of which less frequently reduction of tumor volume is being seen. often in the centre of the lesion necrosis is shown. sometimes accompanied with edema; so even tumor volume increase can be the result without real progression being the case. recently, in our clinic, we found a number of patients, treated with oral angiogenesis inhibitors, a remarkable quickening of progressive disease and complaints after stopping this treatment. reintroduction of the same or another type of angiogenesis inhibitor subsequently lead to a new stabilization. the causality of this phenomenon is unknown. perhaps that the inhibitory effect of the angiogenesis is not fully exhausted at the moment that progressive disease on ct is observed. an alternative explanation is contra reaction of longterm angiogenetic inhibition through upregulation of proangiogenic factors with subsequent vascular expansion and edema. this study means to gain more insight information about the optimal treatment policy when progressive disease is found in patients treated with oral angiogenesis inhibitors. because of the increase of patients that is being treated with these products, both in trials as in daily clinical practice, this is important to investigate.

Eligibility criteria:
inclusion criteria: * metastatic or advanced solid cancer that is treated with an oral angiogenesis inhibitor, with clinical indication to stop this therapy based on progressive disease as defined by the recist criteria on the ct scan. it needs a minimum of 1 previous evaluation of stable disease and the patient must have been treated with angiogenesis inhibitors for at least 12 weeks. * age ≥18 years * given informed consent exclusion criteria: * pregnant or lactating * metastatic sites solely in bone or liver * contraindication for ct or avastin scan (claustrophobia, severe renal function disorder, allergy for contrast fluids, allergy for avastin) * insufficient condition to continue treatment with angiogenesis inhibitors. * contraindication for dynamic contrast mri (deteriorated renal functions with clearance \<60ml/min, metal in body, claustrophobia, pacemaker, defibrillator)

Keywords: angiogenesis inhibitor duration of therapy gist