Kornimate/medical-research-clean huggingface dataset:
effect of high-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy after percutaneous coronary intervention with drug-eluting stents; the escort trial

Conditions: Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation

Summary: this study sought to evaluate whether ezetimibe combination to high-intensity statin therapy will have more prominent beneficial effect compared to high-intensity statin monotherapy in patients who underwent coronary revascularization with newer generation drug-eluting stent (des) implantation. furthermore, the optimal oct-based optimal expansion criteria as well as the efficacy and safety of newer generation will be investigated.

all eligible patients who underwent coronary revascularization with newer generation des implantation will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent. at the time of enrollment, the investigators will stratify the patients according to ldl-cholesterol \<100mg/dl, acute coronary syndrome, and des type, and randomly assign them in two groups according to lipid-lowering therapy with a 1:1 ratio: "combination therapy group" vs. "statin monotherapy group". in this study, four types of new generation des will be used: orsiro (biotronik), firehawk (microport), genoss (genoss) or d+storm (cgbio). in this study, oct substudy will be performed for the patients with diffuse long lesions requiring total stented length ≥40 mm (targeted for 1000 patients in the trial). corresponding patients will be randomly assigned into two groups according to the oct-based optimal expansion criteria with a 1:1 ratio: meeting "absolute expansion" vs. "relative expansion". absolute expansion criteria indicate minimum stent area (msa) \>4.5mm2 and relative expansion criteria indicate msa \> 80% of average reference lumen area. the patients will receive des implantation under oct guidance and stent optimization will be performed to satisfy each expansion criteria.

Eligibility criteria:
inclusion criteria: 1. age 19-85 years 2. patients who underwent coronary revascularization with newer generation des implantation exclusion criteria: 1. allergy or hypersensitive to ezetimibe or statin 2. active liver disease or persistent unexplained serum ast/alt elevation more than 2 times the upper limit of normal range 3. history of any adverse drug reaction requiring discontinuation of statin 4. pregnant women, women with potential childbearing, or lactating women 5. life expectancy less than 3 years 6. inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 7. inability to understand or read the informed consent
pmcf study on the safety and performance of prospace 3d / prospace 3d oblique / tspace 3d

Conditions: Degenerative Instability; Spondylolisthesis; Post-discectomy Syndrome; Post-traumatic Instabilities

Summary: prospective, pure data collection of all prospace 3d, prospace 3d oblique, tspace 3d patients in selected centers (not interventional, multicenter

the study collects a data set for each patient receiving a prospace 3d, prospace 3d oblique, or tspace 3d implant. it is intended to collect data preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively containing * basic medical history * type of surgical procedure * treated segments * implant characteristics (including additional implants for anterior/posterior stabilization) * scores: odi, pain (vas), eq-5d * patient satisfaction

Eligibility criteria:
inclusion: * patient is minimum 18 years old * written informed consent for the documentation of clinical and radiological results * patient's indication according to ifu * patient is not pregnant exclusion: - patient is not willing or able to participate at the follow-up examination

Keywords: lumbar interbody fusion intervertebral implant
hemi-diaphragmatic paresis and erector spinae plane block

Conditions: Anesthesia, Regional; Shoulder

Summary: to assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (esp) block

the aim of the study is to assess the effect of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

Eligibility criteria:
inclusion criteria: * 18 - 85 years * american society of anesthesiology (asa) i-iii * elective shoulder surgery exclusion criteria: * patient's refusal * under 18 years of age or over 65 years of age * asa iv and above * known allergy to local anaesthetic drugs * the block cannot be applied due to bleeding disorders or localized skin infection at the injection site * history of neurological and/or neuromucular disease * history of severe bronchopulmonary disease * a moderate to severe decrease in preoperative pulmonary function, or abnormality in preoperative chest radiography data (pleural effusion, pneumothorax, or hemidiaphragm elevation)

Keywords: regional anesthesia shoulder surgery hemidiaphragmatic paresis erector spinae plane block
induction and expansion of t cell repertoire using growth hormone and vaccination in hiv-1 infected patients

Conditions: HIV Infections

Summary: concomitant administration of recombinant human growth hormone (rhgh) may boost the expansion of immune reconstitution and broaden specific t cell responses not achievable by vaccination alone. the main objective of that study is to test the validity of this hypothesis with vaccines which are routinely administered to hiv-1 patients(tetanus toxoid and hepatitis a virus vaccines) in order to, if proven of value, use this strategy of hiv vaccination in the near future. this is a pilot, randomized, clinical open label study aimed to investigate thymic functionality and the hiv-specific responses after administration of rhgh in hiv-1 infected patients in highly active antiretroviral therapy (haart) regimen.

the purpose of a therapeutic vaccine is to control, induce and expand humoral and cellular immune responses capable to control hiv infection. the administration of a conventional vaccine results in the expansion of peripheral clones. concomitant administration of rhgh may boost this expansion and reconstitute specific t cell responses not achievable by vaccination alone. in this study we want to investigate whether the administration of rhgh expand t cell repertoire and whether there is an increase in the specific cellular responses to hiv-1 and recall antigens and, lately, whether this responses can be further amplified after immunization with tetanus toxoid and hepatitis a vaccines. this hypothesis will be evaluated by the measurement of thymic volume, the expansion of naïve, memory and effector cell subsets, analysis of thymic emigrants (trecs) before, during and after rhgh administration and vaccination. moreover, t cell receptor rearrangement, specific antibodies and cellular responses to antigenic peptides will be determined.

Eligibility criteria:
inclusion criteria: 1. hiv-1 asymptomatic patients in haart regimen (\> 6 months) 2. viral load \< 50 copies/ml 3. number cd4 cells \> 250 cells/mm3 4. non responders to vaccination (tetanus toxoid and/or hepatitis a virus) 5. well-disposition to rhgh daily administration (6 months of treatment) exclusion criteria: 1. aids outbreak 2. allergy or hyperreactivity to rhgh or vaccines 3. diabetes mellitus 4. renal, hepatic, pancreatic disorders 5. chronic diseases 6. dementia 7. pregnancy

Keywords: growth hormone hiv-1 vaccination thymopoiesis hiv-specific responses treatment experienced
safety and efficacy study of adjuvanted prophylactic hepatitis b vaccine

Conditions: Exposure to Hepatitis B Virus

Summary: there is a need for more effective and better-tolerated hepatitis b vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. several approaches are available to enhance the potency of hepatitis b virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. a combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development

adjuvants are a critical ingredient in most vaccines and act by boosting the immune response to the target protein (e.g. hepatitis b surface antigen (hbsag)). despite considerable research, aluminium hydroxide or phosphate compounds (collectively referred to as "alum") remain the dominant adjuvants used in human hepatitis b virus vaccines. there is thus an unmet need for new hbv vaccine adjuvants, in particular, for adjuvants capable of boosting cell-mediated immunity (this is a particular type of immune response where killer t cells are activated that are then able to attack and destroy the infection) as alum, although good at stimulating antibodies is very poor at stimulating cell-mediated immunity. alum, whilst generally accepted as safe, can be associated with significant local vaccine reactions and this is another reason why newer better-tolerated vaccine adjuvants would be beneficial. this study will compare a range of experimental adjuvant formulations to identify those that provide the safest and most effective enhancement of t- and b-cell immunity against hepatitis b

Eligibility criteria:
inclusion criteria: * age 18 years and above * male or female * able to provide written informed consent * willing and able to comply with the protocol for the duration of the study. * has one or more of * age 40 years or above * impaired renal function (creatinine \>120 mmol/l or calculated glomerular filtration rate \<60mls/min) * diagnosis of diabetes mellitus (any type) exclusion criteria: * history of prior hepatitis b vaccination * history of serious vaccine allergy if in the opinion of the investigator this represents a contraindication to hepatitis b vaccination * women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device. * pregnant or lactating women. * history of systemic autoimmune disease including wegener's granulomatosis, systemic lupus erythematosus, guillain-barre, scleroderma or multiple sclerosis. * participation in another clinical trial with an investigational agent within 28 days of the scheduled date of first immunization. * any other serious medical, social or mental condition that, in the opinion of the investigator, would be detrimental to the subjects or the study.

Keywords: hepatitis b virus vaccine adjuvant prophylaxis
robotic-assisted peripheral intervention for peripheral arterial disease ii

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to evaluate the safety and performance of the corpath 200 system in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.

this is a prospective, single-arm, single center, non-randomized feasibility study of the corpath 200 system to examine its performance during complete interventions (dcb, stenting) of the femoropopliteal arteries and patient outcomes at 30 days.

Eligibility criteria:
inclusion criteria: general inclusion criteria * at least 18 years of age; * symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in the femoropopliteal arteries; and * the subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent. angiographic inclusion criteria femoropopliteal artery lesion(s) with stenosis (\>50%) or occlusion of up to 120 mm in length as determined by imaging (mra or angio) prior to index interventional procedure. exclusion criteria: general exclusion criteria if any of the following criteria are met, the subject cannot be enrolled in this study: * failure/inability/unwillingness to provide informed consent; * target vessel has been previously treated with bypass; or * enrolled in concurrent clinical study. angiographic exclusion criteria • target vessel: * shows evidence of previous dissection or perforation, or * has adjacent acute thrombus; or * has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.
study evaluating management of patients with moderate and severe psoriasis

Conditions: Psoriasis

Summary: this is an observational, naturalistic, multicenter, retrospective study to describe the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice in spain.


Eligibility criteria:
main inclusion criteria: ·over 18 years of age.·diagnosed with moderate or severe psoriasis.·initiated treatment with topical and/or systemic treatment between two and five years before enrollment in the study. ·has a clinical record at the dermatologist office. main exclusion criteria: ·currently participating in a clinical study. ·clinical record lacks minimum data required for observational analysis.

Keywords: psoriasis
a feasibility study with a novel, dynamic and disposable over-the-counter device for stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: this study was designed as an open label, feasibility, single-center, cross-over prospective study in women with stress urinary incontinence. subjects served as their own control.

the primary objectives of this feasibility study were to evaluate the short-term efficacy of the nolix device by measuring a reduction of sui following a modified 1-hour pwg test and to measure the safety of the nolix device based on adverse events that were reported by subjects during the study. the secondary objective was to assess usability and patient satisfaction using the nolix device.

Eligibility criteria:
inclusion criteria: * females aged 21 and above * suffering from stress urinary incontinence * women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written informed consent form prior to participation in the study exclusion criteria: * age ≤ 21 years * pregnant or planning to become pregnant during the study. * vaginal birth or cesarean section for the last 3 months prior to entering the study. * severely atrophic vagina. * a history of toxic shock syndrome (tss). * active urinary tract or vaginal infection. * patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year). * has experienced unusual or unexpected vaginal bleeding within the last 6 months. * vaginal surgery within the last 3 months prior to entering the study. * has experienced difficulties with the use of intra-vaginal devices, including tampons. * presence of any condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * average daily pwg as measured in the baseline pad period is less than 4 grams /12 hours.

Keywords: intravaginal device pad weight gain stress urinary incontinence
collecting blood and stool samples to detect colorectal cancer or advanced neoplasia in lynch syndrome patients, coral study

Conditions: Colorectal Carcinoma; Lynch Syndrome

Summary: this study collects blood and stool samples from patients with suspected or diagnosed lynch syndrome to evaluate a deoxyribonucleic acid (dna) screening technique for the detection of colorectal cancer in lynch syndrome patients.

primary objective: i. to determine the sensitivity and specificity of the multitarget stool dna (mt-sdna) 2.0 test, for colorectal neoplasia in patients with lynch syndrome. secondary objective: i. develop a biorepository of samples (stool and blood) from patients with lynch syndrome and early onset (\< 50 years old) colorectal cancer. outline: patients undergo collection of blood and stool samples no more than 90 days prior to or between 7-90 days after standard of care colonoscopy or flexible sigmoidoscopy. patients' medical records are also reviewed.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age * individuals diagnosed with lynch syndrome (mutation in mlh1, msh2, msh6, pms2, epcam) or suspected lynch syndrome or individuals diagnosed with early onset colorectal cancer (crc) (\< 50 years old) * colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection * patient has agreed to participate and has signed the study consent form exclusion criteria: * patient has known cancer (stage i-iv) 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible) * patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection * patient has had any abdominal radiation therapy prior to current sample collection * patient had therapy to the target lesion with intent to completely remove or debulk the lesion prior to sample collection \[examples include snare polypectomy, endoscopic mucosal resection (emr), endoscopic submucosal dissection (esd), surgical resection, trans anal excision\] * patient has prior diagnosis of non-lynch hereditary colon cancer syndrome \[familial adenomatous polyposis (fap), mutyh-associated polyposis (map), peutz-jeghers syndrome (pjs), juvenile polyposis syndrome (jps), pten, pol\] * additional stool exclusions: * bowel prep \< 7 days prior to stool collection * oral or rectal contrast given within 7 days prior to stool collection * removal of more than 50% of colon or presence of ileostomy * enteral feeds or total parenteral nutrition (tpn) * diagnosis of inflammatory bowel disease
a comparison of fluconazole and amphotericin b in the treatment of fungal infections

Conditions: Mycoses; HIV Infections

Summary: to compare the safety, tolerance and efficacy of fluconazole and amphotericin b as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without aids, aids related complex (arc), or extensive burns. hiv seropositive patients are allowed only if they also have a malignancy.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * immunostimulants under studies carried out under an irb approved protocol. * treatments of intercurrent non-fungal infection. * allowed but requires monitoring during fluconazole therapy: * barbiturates. * phenytoin. * oral hypoglycemics. * coumarin-type anticoagulants. patients must have the following: * diagnosis or presumption of fungal infection under defined conditions. * written informed consent either from the patient or the patient's legal guardian. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * burns \> 30 percent of the body. * diagnosis of aids or aids related complex (arc). * hiv positive unless they have a malignancy. * history of allergy to or intolerance of imidazoles or azoles. * moderate to severe liver disease as defined by specific lab values. * unlikely to survive more than 24 hours. * evidence of previous amphotericin b sensitivity. concurrent medication: excluded: * concomitant antifungal agents other than the study drugs. * immunostimulants, except for studies carried out under an irb approved protocol. concurrent treatment: excluded: * lymphocyte replacements. patients with the following are excluded: * defined disease conditions listed in exclusion co-existing conditions. * unlikely to survive more than 24 hours. * previous participation in this study; reentry for the same infection is not allowed. * known to be unable to take amphotericin b due to acute toxicities. prior medication: excluded: * previous fluconazole therapy for this infection.

Keywords: mycoses neoplasms neutropenia fluconazole amphotericin b
the effect of q10 and selen supplement on muscular adverse events in statin therapy

Conditions: Statin Therapy

Summary: the purpose of this study is to determine whether supplements of q10 and selen are effective in reducing muscular adverse events (ae) in statin therapy.

statins inhibit the synthesis of cholesterol by inhibiting the enzyme hmg-coa reductase. the reduction of intracellular cholesterol leads to an increase in the number of ldl-receptors, and subsequent increased uptake and metabolism of ldl in the liver. several large clinical trials have shown that the use of statins decreases morbidity and mortality in patients with risk factors for atherosclerotic disease. unfortunately, 5% of statin users experience adverse events (mainly gastrointestinal \[gi\] and muscular). statins inhibit not only cholesterol synthesis, but also synthesis of other substances in the mevalonate pathway. among these other substances are q10 and selenoproteins. it is well known that serum q10 levels decrease during statin therapy, and that q10 supplement inhibits this decrease. one study has shown reduction of q10 in blood-platelets during statin therapy. q10 is an important element in the mitochondrial respiratory chain. depletion of q10 leads to a reduction of high energy phosphates, anaerobe metabolism and mitochondrial dysfunction. this is suggested to be the cause of muscular adverse events in statin therapy. there are several reports of individuals relieved from muscular adverse effects after q10 supplement, but no randomized, placebo controlled studies have been conducted. symptoms of selenoprotein deficiency are very similar to adverse events seen in statin therapy, but no clinical trials have been conducted to evaluate the effect of selen supplement on adverse effects of statin therapy.

Eligibility criteria:
inclusion criteria: * men and women 18 - 75 years old * indication for statin * previous history of muscular ae on statin therapy. exclusion criteria: * if female, be of non-childbearing potential, i.e., post-menopausal (defined as \>12 months since last menstrual period) or surgically sterilised, or using adequate barrier contraception if of childbearing potential. * previously serious muscular ae * patients taking drugs interacting with statins, and where these drugs cannot be stopped. * allergy against selen * liver or kidney failure

Keywords: q10 coq10 coenzyme q10 selen selenoprotein selenoproteins adverse events adverse effects ae myalgia muscle statin therapy indication for statin therapy