Kornimate/medical-research-clean huggingface dataset:
in-stent restenosis post-approval study

Conditions: Peripheral Artery Disease; Vascular Disease

Summary: the objective of the isr 14-04 study is to evaluate post-market safety and effectiveness of gore® viabahn® endoprosthesis for treatment of in-stent restenosis of the superficial femoral artery.


Eligibility criteria:
inclusion criteria: * patient has a previously implanted (\> 30 days) non-covered stent(s) located in the sfa * patient has life-style limiting claudication, resting leg pain or minor tissue loss (rutherford category 2 - 5) * patient demonstrates an ankle brachial index (abi) \ 0.9 or not measurable, patient is eligible for study if toe brachial index is \<=0.5 * patient has \>=50% in-stent restenosis and / or an occlusion in a previously implanted (\>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch. * patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease * patient has a reference vessel diameter between 4.0 and 6.5mm * patient has at least one patent infrapopliteal runoff vessel (\<50% stenosis) not requiring reintervention * note: additional inclusion criteria may apply exclusion criteria: * patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene) * patient has a known intolerance to anticoagulation or antiplatelet therapy * patient has known coagulation disorder, including hypercoagulability. * patient has major distal amputation (above the transmetatarsal) * patient has any previous surgery in the target vessel * patient has had previous target vessel in-stent restenosis treated by relining with another stent * patient has untreated flow-limiting aortoiliac stenotic disease * note: additional exclusion criteria may apply

Keywords: bare metal stent in-stent restenosis
relationship between nutrition and sexual activity

Conditions: Sexual Dysfunction; Mediterranean Diet; Aphrodisiac Foods; Obesity; Healthy Eating Index

Summary: sexuality is integral to personality, influencing feelings, thoughts, actions, and physical and mental health. female sexual dysfunction is a fairly common condition that covers four main areas: hypoactive sexual desire disorder, arousal disorder, orgasmic disorder, and sexual pain disorder. although incidence and prevalence rates vary, it has been reported that women range between 30% and 50%. male sexual dysfunction is not a single disease. male sexual arousal refers to the entire process of sexual activity for men, including penile erection, penile penetration, ejaculation, and any obstruction in a single connection. it is a significant psychological distress for affected men, their sexual partners, and their health-related quality of life. sexual dysfunctions are common among men of all ages and ethnic and cultural backgrounds. it is reported in the literature that 52% of men between the ages of 40-70 experience various degrees of sexual dysfunction. cardiovascular disease, smoking, obesity, sedentary lifestyle, diabetes, hypertension, hyperlipidemia, and metabolic syndrome are risk factors for sexual dysfunction. although the positive effects of adopting healthy lifestyle changes and dietary habits in reducing the risks of these diseases have been proven, few studies have evaluated the impact of these treatment approaches on sexual dysfunction. studies evaluating the relationship between diet and erectile dysfunction have focused more on men with diabetes. some small studies have also shown that lifestyle modification and weight loss interventions improve erectile dysfunction in men with significant cardiovascular risks. the same is valid for female sexual dysfunction. the western diet and its components are indirectly associated with sexual morbidity. the western diet has processed foods, refined carbohydrates, and high sodium and monounsaturated fat content, which have been widely linked to the development of mets, obesity, and diabetes. these comorbidities are also risk factors for female sexual dysfunction as well. this study aims to evaluate the relationship between the eating habits of obese and non-obese men and women and their sexual functions.


Eligibility criteria:
inclusion criteria: 1. female patients with menstrual bleeding 2. sexually active male and female patients 3. 18 years and older age exclusion criteria: 1. \<18 years of age 2. female patients with menopause 3. female patients that have undergone hormone therapy in the last 12 months 4. sexually inactive male and female patients 5. patients with diabetes 6. patients with a history of psychiatric illness 7. patients with cognitive impairment 8. patients with hormone-dependent tumors 9. patients taking a drug known to reduce sexual desire

Keywords: shim ieff sexual dysfunction aphrodisiac foods mediterranean diet healthy eating index
rapid diagnosis of heparin-induced thrombocytopenia in surgical critically ill patients

Conditions: Heparin-induced Thrombocytopenia (HIT)

Summary: the early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical critically ill patients. if the use of rapid immunological diagnostic methods and pretest scoring systems has been proposed in the medical intensive care unit (icu), none of these methods have been specifically evaluated in the diagnosis of hit in surgical patients.

heparin-induced thrombocytopenia (hit) is of concern in critically ill patients, given the high prevalence of heparin use. the diagnosis of hit in surgical intensive care unit (icu) is problematic due to the lack of reliable diagnostic method. no gold standard currently exists and the definitive diagnosis is mainly based on the detection of heparin-dependent platelet-activating antibodies by elisa method, on the platelet serotonin release assay (sra) and on the changes of the blood platelet count after the discontinuation of heparin therapy. as a result, no early definitive diagnosis could be done. this could expose patients to thrombotic complications related to the hit or hemorrhagic complications related to the alternative anticoagulant prescribed. this complications can threaten the prognosis of these patients. particle gel immunoassay and automated immunoassay has been proposed for the early diagnosis of hit in medical critically ill and non-critically ill patients. many authors suggest that the accuracy of these immunological methods for the diagnosis of hit could be altered in surgical patients, but these tests has never been specifically evaluated in this population. the 4ts and the hit expert probability (hep) score systems sound interesting for the diagnosis of hit. these clinicobiological scores can be easily used by non-expert clinicians, but have also never been evaluated in the surgical icu.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * diagnosis of hit suspected * admitted in our surgical intensive care unit during the study period exclusion criteria: * age \< 18 years old * pregnancy and/or breast feeding * fondaparinux anticoagulation * withdrawal of consent

Keywords: diagnostic performance heparin-induced thrombocytopenia rapid immunological diagnostic method immunoassay pretest scoring systems 4ts score hep score
assessment of patients not concluded after neonatal screening of cystic fibrosis.

Conditions: CFTR-RD

Summary: assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. the aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis

among patients not concluded for the diagnosis of cystic fibrosis, some are carriers of cftr-rd mutations, therefore at risk of progressing to a symptomatic form, and may already have a subclinical involvement that it is important to identify. among patients who do not carry the cftr-rd genotype, other patients may be at risk of developing symptoms, if they are carriers of an undetected variant or wrongly classified as non-pathogenic. it is important to detect them to prevent the onset of symptoms

Eligibility criteria:
inclusion criteria: patients not concluded for the diagnosis of cystic fibrosis either because of intermediate sweat test or because extensive genetic study has identified 2 vrainats at least 1 being not cf causing - exclusion criteria: * patients carrying 2 cf causing variants of the cftr gene * patients carrying only 1 or no variants of cftr
energetic response to feeding and exercise in sci

Conditions: Spinal Cord Injuries

Summary: this study investigates the effect of various forms of upper extremity exercise on postprandial glycemia and lipemia in persons with spinal cord injury (sci). participants are measured at rest and fed a standardized meal following seated rest (con), moderate intensity continuous arm cycling (mict), high intensity interval arm cycling (hiit), and circuit resistance exercise (crt) matched for exercise energy expenditure.


Eligibility criteria:
inclusion criteria: * adult (\>/=18 years of age) * neurologically stable chronic (\>/= 1year) spinal cord injury (sci) * american spinal injury association impairment scale (ais) grade a, b, or c * sci at level \</= the first thoracic vertebrae (t1) exclusion criteria: * being of ≤ 18 years of age. * contraindication to exercise (acsm guideline, 10th edition) * lower extremity fracture or dislocation within 6 months of participation, * history head injury or seizures. * inability to consent. * restrictions in upper extremity range of motion that would prevent an individual from achieving an unhindered arm cycling motion or moving throughout a range needed to perform resistance maneuvers. * a pressure ulcer at ischial/gluteus, trochanteric, sacral, or heel sites within the last 3 months. * pregnancy determined by urine testing in sexually active females. * imprisonment in state or federal jail or prison.

Keywords: postprandial glycemia lipemia macronutrient metabolism physical activity
the prognostic value of interim pet/ct after 2 cycles of chemotherapy in predicting progression of non hodgkins lymphoma

Conditions: Lymphoma; Large Cell (Diffuse) With Small Cell, Diffuse

Summary: a retrospective analysis will be performed regarding the usefulness of pet/ct performed following 2 cycle of chemotherapy in evaluation of progression, free survival and overall survival of patients with aggressive non hodgkin lymphoma.

patients who were treated for aggressive non-hodgkin lymphoma with adriamycin containing regimen, chop and high dose chop with or without rituximab were evaluated post 2 cycles of chemotherapy to rule out disease progression . currently a retrospective evaluation of pet/ct as a predictive value for progression free survival and overall survival is evaluated

Eligibility criteria:
inclusion criteria: * aggressive non-hodgkin lymphoma b cells * age 18-70 * bilirubin less then 2 * creatinine less then 2 * pet/ct performed post 2 cycles exclusion criteria: * no pet/ct post 2 cycles performed * bilirubin \>2 * creatinine more then 2 * hiv positivity

Keywords: pet/ct aggressive non-hodgkin lymphoma
acetic acid 2% solution for skin ulcers

Conditions: Ulcer, Skin

Summary: the objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. the primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (prontosan®). participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * continued care (hospital or outpatient) in one of the consorci sanitari alt penedes i garraf (csapg) units. * presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region). * plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center. * ability to cooperate in necessary evaluations. * informed consent for inclusion in the study, either from the participant themselves or from their legal representative. exclusion criteria: * participants diagnosed with any of the following conditions: 1. ulcers with exposed bone tissue. 2. neoplastic-origin ulcers. 3. ulcers lasting more than 18 months. * participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial.

Keywords: skin ulcer acetic acid biofilms
multicenter randomized two-arms study evaluating the bk viral clearance in kidney transplant recipients with bk viremia.

Conditions: BK Virus Nephropathy After Kidney Transplantation

Summary: bk virus nephropathy (bkvn), a consequence of the strong immunosuppressive therapy given after kidney transplantation, represents a growing problem in the kidney transplant (kt) setting. in recent cohorts, bkvn concerns up to 10% of kidney transplant recipients and early signs of bk virus (bkv) infection as development of asymptomatic viruria and viremia are even much more frequent (40% and 20% of patients, respectively). in this context, finding strategies to prevent bkv infection or treat patients before the occurrence of bkv nephropathy is challenging. for several years, detection of bkv replication by real-time pcr in urine and/or blood of kidney transplant recipients at early stages of infection allowed adaptation of their therapy. as bkv reactivates essentially in patients with over-immunosuppression, the first step of the treatment is the reduction of immunosuppression. however, reducing immunosuppression (is) can lead to acute rejection and allograft loss. other treatments have been proposed (cidofovir, quinolones) but their toxicity profile or their lack of clinical efficacy are now demonstrated. hence, an efficient and safe strategy against uncontrolled bkv replication is urgently needed. mtor-inhibitors are well known immunosuppressive drugs used in organ transplantation to prevent graft-rejection. they have furthermore anti-viral effects that can be beneficial for prevention of viral infections after transplantation. recent evidence that inhibition of mtor pathway had an impact on bk infected cells provides additional insight into the observed benefits associated with these drugs. the aim of our study is to evaluate the effect of the mtor inhibitor everolimus on the prevention of severe bkv infection (bkv nephropathy or loss of the allograft) after kidney transplantation compared to the reduction of immunosuppression alone in kidney recipients with bk viremia.


Eligibility criteria:
inclusion criteria: * adult patients * kidney transplant recipients * patients treated by a calcineurin inhibitor and mycophenolic acid * viremia \>= 2.8 log ui/ml * patients who have given written informed consent * negative pregnancy test (blood β-hcg dosage) exclusion criteria: * known proved bkv nephropathy * hypersensitivity to everolimus, sirolimus or excipient * concomitant treatment by leflunomide, cidofovir, sirolimus, millepertuis (hypericum perforatum) * pregnant or lactating women * women of child bearing potential unless they are using a birth control method
a device designed to protect the perineum during labor

Conditions: Perineal Tear

Summary: objective: to investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth. design: a multicenter randomized control trial performed at three hospitals in sweden, in helsingborg, lund and malmö. participants recruited are women with vaginal delivery (n=1200), cephalic presentation. they will be randomized to an intervention group, with a perineal protection device, and a control group deliver as normal. main outcome measures: the effect on the frequency and extension of perineal ruptures grade i, ii and anal sphincter rupture are measured.

perineal rupture shall be measured with a ruler. anal sphincter ruptures be examined by physicians. drawing be made of the tears by the midwife.

Eligibility criteria:
inclusion criteria: * vaginal delivery exclusion criteria: * age below 18 years and no understanding of written and oral information.

Keywords: delivery rupture perineal protection device reduce perineal tears
a study comparing megestrol acetate at 800 mg/day, and placebo in aids patients with anorexia and cachexia

Conditions: Anorexia; Cachexia; HIV Infections

Summary: to compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia, calorie intake, and nutritional parameters of patients with a confirmed diagnosis of aids. to determine whether megestrol acetate relative to placebo improves the perception of well-being among aids patients with cachexia. to evaluate megestrol acetate's effect on immune function via skin test reactivity, t4/t8 ratio, and total lymphocytes.


Eligibility criteria:
inclusion criteria patient must have: * confirmed diagnosis of aids (cdc definition). * documented weight loss or anorexia. * life expectancy = or \> 20 weeks. * the perception that the weight loss is a detriment to their well-being. * ability to provide informed consent, read and write english. exclusion criteria co-existing condition: patients with the following conditions are excluded: * dementia or evidence of mental incompetence which would preclude compliance with the protocol. * severe diarrhea defined as 5 or more watery stools per day for at least 7 days. * active uncontrolled systemic infections at the start of treatment. * patients may not be entered for at least 2 weeks after acute infection. * clinical or radiologic evidence of ascites or pleural effusions. patients with the following are excluded: * obstruction to food intake or impaired digestive/absorptive functions. * contraindications to megestrol acetate (poorly controlled hypertension or heart failure or deep vein thrombosis). * inability to consent or be available for close follow-up. * active systemic infections at the start of treatment. * clinical or radiologic evidence of ascites or pleural effusions. * patients who have been hospitalized or have suffered an exacerbation of their illness associated with weight loss within the past 2 weeks are excluded. * menstruating female patients are excluded. prior medication: excluded: * corticosteroids. * anabolic steroids. * marijuana. * megestrol acetate. * patients who have been started on zidovudine (azt) within 8 weeks. (patients may have been previously treated with azt and failed or may currently be receiving azt for at least 8 weeks.) patients may not be started on any therapy designed to treat the underlying hiv infection or which may have a major impact on appetite and/or weight gain. * patients who have been started on zidovudine (azt) within 8 weeks. (patients may have been previously treated with azt and failed or may currently be receiving azt for at least 8 weeks.) history of substance abuse and questionable current and future abstinence.

Keywords: body weight t-lymphocytes nutritional status megestrol acquired immunodeficiency syndrome anorexia cachexia energy intake
problem solving education and neonatal intensive care unit (nicu) mothers

Conditions: Maternal Depression

Summary: premature infants are born at substantial risk for poor health and developmental outcomes, which commonly include hearing and vision problems, developmental delays, and poor school performance. premature infants of low-income families face additional social risks known to worsen these outcomes. the institute of medicine recognized this important public health problem in its 2006 report, preterm birth, which argued for the need to improve the quality of follow-up care for preterm infants discharged from the neonatal intensive care unit (nicu). the underpinning of this proposal is that maternal depression - common among families of premature infants - interferes with adherence to follow-up services, and (both through this mechanism and directly) adversely impacts child health and development. conversely, alleviating depressive symptoms among these women represents a promising strategy to improve adherence to nicu follow-up services and to improve the outcomes of this vulnerable population. this project aims to mitigate the adverse effects of maternal depression in this specific high-risk population by testing a theory-based, parent-directed empowerment strategy, called problem solving education (pse). in the past, similar strategies have been proven effective for improving the mood and functioning of depressed adults, and for improving adherence to medical treatment. however, they have never been tested in the setting of a parent-child relationship or among families of premature infants. this project involves a clinical trial of pse among 50 low-income mothers at risk for depression, who have premature infants in two boston nicus: boston medical center and tufts medical center. the investigators aim to determine the impact of pse on maternal depressive symptoms and functioning, and adherence to child health supervision and immunization schedules, vision screening, and early intervention evaluation for babies with suspected developmental delays. approximately 100,000 children are born prematurely to low-income families each year. parent-directed pse aims to improve outcomes for these children through the prevention and/or attenuation of maternal depressive symptoms, as well as through family activation and promotion of adherence to follow-up care. if successful, pse could also provide the cornerstone of a more generalizable empowerment strategy for families of children with chronic medical conditions.


Eligibility criteria:
inclusion criteria: * baby is ≤ 33 weeks gestational age and is expected to survive. * baby qualifies to receive wic * mother is comfortable in english or spanish. exclusion criteria: * mother has psychosis * mother endorses suicidal ideation * custody of baby is uncertain * mother is cognitively limited, per judgment of nicu attending physician * baby is critically ill, per judgment of nicu attending physician

Keywords: risk factors for maternal depression
octa study of choroidal vasculature in open angle glaucoma patients

Conditions: Glaucoma Open-Angle Primary

Summary: the aim of the present study was to examine and measure sfct and ccvd using respectively edi-oct and octa in preperimetric and advanced glaucomatous eyes, in order to shed light on the vascular pathogenesis of glaucoma disease.


Eligibility criteria:
inclusion criteria:• age older than 40 years * diagnosis of glaucoma * absence of diabetes, heart diseases, hypertension * absence of drug intake * absence of vitreoretinal, vascular retinal diseases * absence of previous ocular surgery and congenital eye diseases. * absence of errors of refraction * absence of lens opacities * absence of low-quality oct and octa images exclusion criteria: * age younger than 40 years * presence of diabetes, heart diseases, hypertension * vitreoretinal and vascular retinal diseases * previous ocular surgery and congenital eye diseases * errors of refraction * lens opacities * low-quality oct and octa images