Kornimate/medical-research-clean huggingface dataset:
levant japan clinical trial

Conditions: Femoral Arterial Stenosis; Stenosis of Popliteal Arteries; Femoral Artery Occlusion; Occlusion of Popliteal Arteries

Summary: to demonstrate the safety and efficacy of md02-ldcb for treatment of stenosis or occlusion of the femoral and popliteal arteries in the japanese population.

the study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. after successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either md02-ldcb (test arm) or standard pta catheter (control arm) using similar techniques. subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female ≥20 years of age; * rutherford clinical category 2-4; * length ≤15 cm; * ≥70% stenosis * lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau and ≥1 cm above the origin of the tp trunk; * a patent inflow artery as confirmed by angiography * at least one patent native outflow artery to the ankle exclusion criteria: * life expectancy of \< 2 years; * history of hemorrhagic stroke within 3 months; * previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure; * history of mi, thrombolysis or angina within 2 weeks of enrollment; * renal failure or chronic kidney disease * severe calcification that renders the lesion un-dilatable

Keywords: arms experimental drug coated angioplasty balloon active comparator standard angioplasty balloon
renal osteodystrophy: a fresh approach

Conditions: Renal Osteodystrophy

Summary: there are two major goals of this project: 1. comparison of dxa and qct for diagnosis of bone loss in ckd-5 patients and determination of the prevalence of low bone turnover in ckd-5 patients with bone loss. 2. identification of the optimal combination of noninvasive tests for definition of the turnover component of rod.


Eligibility criteria:
inclusion criteria: * aged 18 years or older; * chronic maintenance dialysis of at least 3 months' duration; * mental competence; * willingness to participate in the study; * calcidiol levels within normal range. exclusion criteria: * pregnancy; * systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus); * clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections). * chronic alcoholism and/or drug addiction; * participation in a study of an investigational drug during the past 90 days; * allergy to tetracycline. * planning to move out of the area within 2 years of the study; * on active transplant list; * treatment within last 6 months with drugs that may affect bone metabolism (except for treatment with calcitriol, vitamin d analogs and/or calcimimetics). * calcidiol level below the normal range. the current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin d according to serum calcidiol levels. it is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.
effect of diet on men and women with genetic alterations associated with abnormal blood tests

Conditions: Dyslipidemia

Summary: the purpose of this study is to evaluate different diets and the effects of blood measures or inflammation and endothelial function in association with genetics tending to abnormal blood test levels.


Eligibility criteria:
inclusion criteria: * polymorphism in apo c3 promoter and normal controls.

Keywords: diet triglyceride inflammation genetic polymorphism
vats versus thoracotomy for pulmonary hydatid disease

Conditions: Pulmonary Hydatid Cyst

Summary: the aim of this study is to evaluate the efficacy and safety of minimally invasive surgery and compare the outcomes with patients undergoing thoracotomy in treatment of pulmonary hydatid cyst. disease : pulmonary hydatid cyst. intervention: * group 1 : vats approach. * group 2 : thoracotomy approach.

after being informed about the study and the approach, all patients giving written informed consent to determine eligibility for study entry.

Eligibility criteria:
inclusion criteria: - all patients underwent surgery for pulmonary hydatid cyst exclusion criteria: * none

Keywords: pulmonary hydatid cyst video-assisted thoracic surgery thoracotomy
livet skal leves (a life to live)

Conditions: Heart Defects, Congenital

Summary: the overall objective of this project is to optimize the use of diagnostic methods and follow-up programs in infants with congenital heart defects (chds) in order to reduce death and complications

the project is designed as retrospective cohort study based on nationwide registry data of children born 2004-16. the project group has extensive experience of similar research, and includes representatives from different fields and levels of health care. the results will provide a solid fundament for improvement of today's clinical practice, including development of knowledge-based routines in neonatal medicine and planning of health care services. implementation is given particular attention, and will be managed in an interdisciplinary setting. the project will be of major relevance for the patients and their families as well as medical professionals at all levels of health care.

Eligibility criteria:
inclusion criteria: * fetuses with severe chds who were identified by antenatal ultrasound screening, and where the pregnancy was terminated * children with severe congenital heart defects born in norway 2004-18 exclusion criteria: * lack of parental consent
long term follow up of sub-retinal transplantation of hesc derived rpe cells in stargardt macular dystrophy patients

Conditions: Stargardt's Macular Dystrophy

Summary: the purpose of this study is to evaluate the long term safety and tolerability of ma09-hrpe cellular therapy in patients with advanced stargardt's macular dystrophy (smd) from one to five years following the surgical procedure to implant the ma09-hrpe cells.

this study is a long term, follow up to the act ma09-hrpe 001 phase i/ii trial, the phase i/ii trial (referred to as the core protocol) was an open-label, non-randomized, dose escalation, multi-center trial. thirteen smd patients were treated in this trial. ten patients with profound vision loss (visual acuity \<=20/400) received a single subretinal injection of ma09-hrpe cells, starting at a dose of 50,000 ma09-hrpe cells (three patients), 100,000 ma09-hrpe cells transplanted (three patients), 150,000 ma09-hrpe cells transplanted (three patients) and increasing to a maximum dose of 200,000 ma09-hrpe cells transplanted (one patient). three patients with severe to moderate vision loss (visual acuity \<= 20/100) received a dose of 100,000 ma09-hrpe cells. all patients who participated in the core protocol are eligible for participation in this follow-up protocol. the first visit of this long term follow-up protocol will correspond to the last visit of the core protocol, and will take place at 12 months post cell implantation. informed consent will be obtained at this visit. patients will be evaluated at 18, 24, 36, 48 and 60 months post-transplant (or more frequently as clinically indicated). follow-up will include obtaining information about ophthalmological findings and events of special interest as defined in the primary outcomes. at the last visit of this follow-up study, whether at 60 months post-transplant or at early discontinuation, patients will be invited to participate in a safety surveillance study for an additional 10 years, under a separate protocol, which will continue to monitor the long term risks of ma09-hrpe cell transplantation.

Eligibility criteria:
inclusion criteria: * must have been treated with hesc-rpe cell transplant in the core protocol. * able to understand and willing to sign the informed consent to participate in the follow-up study. exclusion criteria: * there are no exclusion criteria

Keywords: fundus flavimaculatus asp7316 smd long term follow-up juvenile macular dystrophy
evicel study on the peri-operative bleeding in total knee prothesis surgery

Conditions: Thrombosis

Summary: knee prothesis surgery is responsible of a risk of thrombosis and hemorrhage. to prevent thrombosis, patients have systematic anticoagulation after surgery which are responsible of hemorrhage. a local glue which improve local coagulation and have no impact of thrombosis can be a solution to limit hemorrhage. the purpose of this trial is to study the impact of a biological glue administration on the bleeding loss at five days after a total knee prosthesis surgery operation.

the orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.

Eligibility criteria:
inclusion criteria: * patient affiliated with or a beneficiary of a social security category: * having more than 18 years old * having signed the informed consent form * having undergone a total knee prosthesis surgery operation exclusion criteria: * incapacity to understand the protocol * patient having taken anti-coagulants or clopidogrel 10 days before excepted aspirin to a dose equal or less than 160 mg/day * women having period so generally women having less than 50 years old * pt less than 60% and act taller than 10 sec * contra-indications to the drug * erytropoietine treatment required before surgery

Keywords: gonarthrosis knee prosthesis insertion bleeding undergoing a total knee prothesis surgery knee prothesis surgery knee arthrosis thrombosis
video-visit behavior therapy for anxiety and depression in youth

Conditions: Anxiety; Depression

Summary: this project focuses on adapting and pilot testing an efficacious brief behavioral therapy (step-up) for youths with anxiety or depression to be delivered as a telehealth intervention by clinic staff in low-resource community health centers (chcs).


Eligibility criteria:
inclusion criteria: * youth is a patient at a participating community health center (chc) site * youth is clinically referred by a provider and / or has anxiety and / or depression as a diagnosis or target problem in their medical record * youth is in the physical and legal custody of the caretaker and is not currently involved in the foster care system * youth is able and willing to conduct study assessments and intervention sessions in english * primary caretaker is able and willing to conduct study assessments and intervention sessions in english or in spanish * youth is functioning at or above the academic level of a typical 8-year-old child (i.e., placed in at least the second-grade level school across all subjects in a general education classroom) * primary caretaker agrees that focusing on anxiety and / or depression would be a useful primary target for treatment * youth has clinically significant symptoms of anxiety and / or depression by youth or caretaker report exclusion criteria: * youth is receiving an alternate intervention for anxiety or depression * youth or parent reports that the youth is experiencing active suicidal ideation with plan or intent (i.e., within last three months) and / or has made a suicide attempt within the last six months * youth or parent reports that the youth is currently engaging in non-suicidal self-injury (i.e., within last three months) * youth or parent reports that the youth has experienced recent physical or sexual abuse (i.e., within last three months).

Keywords: child adolescent
long term outcome of hypospadias repair

Conditions: Hypospadias

Summary: hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy in 250. the opening of the urethra is located on the undersurface of the penis rather than the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe cases. although the most commonly practised corrective operation ( tip procedure) gives generally good results, recently published evidence points to a possible long term risk of stenosis ( narrowing of the reconstructed urethra). this comparative study will combine clinical assessment with non invasive measurements of urinary flow to assess the functional outcome of a large series of patients who have undergone hypospadias surgery . the study is primarily designed to answer this question : does a modification of the standard operation which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow and a decreased risk of stenosis? this has not been previously studied . the findings of our study could make an important contribution to improvements in the surgical treatment of boys born with hypospadias.


Eligibility criteria:
inclusion criteria: - 1 patients with hypospadias who have been treated one of the following two surgical proceduresstandard tubularised incised plate (tip) operation (group a) or tubularised incised plate (tip) procedure incorporating a free graft of preputial skin (in a layer of foreskin) into the urethral reconstruction (group b ) 2 the study will be confined to primary operations. patients in whom either of the techniques was used for a secondary or 'redo' procedure will be excluded from the study. 3 the study will be confined to boys over 3 years of age who are potty trained and able to pass urine for the non invasive flow rate test . exclusion criteria: - 1 patients whose hypospadias was corrected using some technique other than 'standard' or 'grafted' tip repair. 2 "redo" cases 3 boys under 3 years at the time of the study or patients who do not have full bladder control for some other reason.
defining core outcomes and data elements (code) in chronic subdural haematoma

Conditions: Chronic Subdural Hematoma

Summary: this study is aimed at improving reporting in chronic subdural haematoma (csdh) research studies, through development of a standardised core outcome set (cos), a unified csdh definition and set of data elements (de) for reporting. the study design includes a delphi survey process from two main stakeholder groups: health-care professionals or researchers (hcpr) and patients or carers. hcpr, patients and carers will all be invited to complete the survey on the cos, only the hcpr survey will include questions on definition and de. results of the delphi survey will be discussed at a final consensus meeting before results are confirmed and published.

chronic subdural haematoma (csdh) is a collection of blood and fluid surrounded by membranes that accumulates on the brain surface over weeks to months. it predominately affects older people and often has a delayed association with a preceding head trauma. there has been significant growth in the number of csdh publications in recent years mirroring progress in potential management options but there is wide variation in how and when patient outcome is measured amongst studies. much could be gained by agreeing a minimum set of standardized outcomes that should be measured and reported in all csdh studies, known as a core outcome set (cos). the overall study design includes a delphi survey process.this is a process whereby all outcomes and data elements from the csdh literature and expert opinion are presented to a large group of patients, carers and hcpr via a survey. each survey participant has the opportunity to rank the elements and outcomes in levels of importance to them, and the survey is then repeated including presentation of the results from the first round, in order to attempt to gain agreement between participants on what is important. all elements are then reviewed at a final "consensus" meeting

Eligibility criteria:
inclusion criteria: all invited participants who provide consent to take part in 2 rounds of survey

Keywords: head injury core outcome set elderly
buccal myomucosal flap and buccal pad of fat for the closure of oro-antral fistula

Conditions: Oro-Antral Communication

Summary: oroantral fistula (oaf) is a pathological communication between the oral cavity and the maxillary sinus. a variety of surgical techniques have been developed, with recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection. to increase the success rates of oaf closure procedures, the use of double-layered closure techniques has developed, but most of these techniques alter the original oral anatomy and may result in significant postoperative morbidity.


Eligibility criteria:
inclusion criteria: * large oro-antral fistula * recent or previously failed closure of oro-antral fistula exclusion criteria: * immuno-supressed patients * fistulae smaller than 5 mm in size

Keywords: oro-antral fistula buccal pad of fat myomucosal flap
web-based collection of data on obesity and health behavior

Conditions: Obesity

Summary: low socioeconomic status (low ses), as defined by educational attainment and income, has been associated with obesity in industrialized nations. low ses has been related to impulsive decision-making characterized by steep devaluation of future outcomes (delay discounting, dd) and a greater motivation to obtain food (food reinforcement, fr). dd and fr have been shown to interactively predict ad libitum energy intake in laboratory studies, such that participants exhibiting high fr as well as high dd consume the most food. obesity often results from energy intake in excess of physiologic needs, and thus a plausible mechanism is that low ses environments increase fr and dd, leading to overeating and obesity. the primary aims of this study are to determine whether fr and dd interact to predict bmi, and whether differences in fr and dd mediate the relationship between low ses and obesity, in a large sample of us adults of varying bmi. in addition, whether high fr and high dd are related to unhealthy food purchasing and eating behaviors will be assessed. it is anticipated that high fr and dd will be related to unhealthy food purchasing and eating behaviors.

in this study potential participants who log in to the amazon mechanical turk website as a worker and who have a hit approval rate of at least 90% will be allowed to view and participate in the study. if a potential participant agrees to participate in the study by accepting the hit, the participant will be asked to complete a brief survey (approximately 150 questions; see sample survey in "other supporting documents") and various decision making tasks (e.g., delay discounting assessment, reinforcer valuation assessment etc.). this survey and accompanying tasks will solicit: (a) general demographic information such as gender, age, income, and education; (b) information about their health and health behavior practices, such as eating habits, alcohol and cigarette use; (c) questions about their food preferences and value of foods; (d) information about their valuation of immediate versus distant events/rewards.

Eligibility criteria:
inclusion criteria: * be a registered amazon mechanical turk user.
impact of auriculotherapy on postoperative pain in patients undergoing surgery for scc

Conditions: Pain After Carpal Tunnel Surgery

Summary: auriculotherapy shows promising potential for pain management in patients with carpal tunnel syndrome (cts). studies have demonstrated encouraging results in pain reduction and improvement in quality of life. however, further research is required to strengthen these findings and fully integrate auriculotherapy into standard treatment protocols for cts. this prospective, double-blind comparative study aims to evaluate the effectiveness of auricular acupuncture in managing postoperative pain following outpatient carpal tunnel surgery


Eligibility criteria:
inclusion criteria: * subjects aged over 20 years * patients with carpal tunnel syndrome scheduled for endoscopic surgery * patients who have never undergone auriculotherapy sessions before * no participation in another clinical study exclusion criteria: * patients under 20 years of age * unable to undergo medical follow-up for the study * legally protected adult subjects, under guardianship or curatorship
characterizing the immune response and neuronal damage in covid-19

Conditions: SARS-CoV Infection; Covid-19

Summary: the investigators plan to study the innate and adaptive immune response, the inflammatory response, and associated complications such as complement activation and neurological damage in sars-cov-2 infected individuals. patients with mild, moderate and severe covid-19 disease will be enrolled.

the severity of coronavirus disease 2019 (covid-19) ranges from asymptomatic infection to severe illness requiring mechanical ventilation. immunological factors which lead to severe disease in certain covid-19 patients remain incompletely understood. neurological damage and complement activation may be a consequence of excess inflammation in severe covid-19. the investigators plan to study the innate and adaptive immune response and potentially associated complications such as neurological damage and complement activation in mild, moderate and severe covid-19 courses.

Eligibility criteria:
inclusion criteria: * pcr confirmed sars-cov-2 infection exclusion criteria: * refusal to participate * age \< 18 years

Keywords: innate immune response adaptive immune response inflammation neurological damage
effectiveness of the individualized metacognitive training (emc+) in people with psychosis of brief evolution

Conditions: Brief Psychotic Disorder; Psychosis; Episode

Summary: the main aim of the study is to evaluate the effectiveness of individualized meta-cognitive training (emc +), in people with psychosis of brief evolution on symptoms, especially on positive symptoms. secondary aims would be to assess the effect of emc+ in metacognition, psychosocial and neuropsychological functioning, and to assess the maintenance of program effects on 6 months.

this is a randomized clinical trial in which some patients receive the emc+ and others treatment as usual.the evaluator will be blind to the group to which the patients belong. the sample for the overall project will be a total of 70 people with a diagnosis of psychotic spectrum, less than 5 years of experience and with a score =\> 3 positive panss (last month) and treated in one of the participating institutions. the evaluation was performed at baseline, at post-treatment and at 6 months follow up. symptoms, metacognition, psychosocial and neuropsychological functioning were assessed. the emc consists of 10 therapeutic units with weekly sessions of 45-60 minutes. the material available for the individualized metacognitive training (emc) program is made up of power-point presentations.

Eligibility criteria:
inclusion criteria: * diagnosis of : schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, psychotic disorder not otherwise specified. * less than 5 years of evolution. * score at or above 4 on the panss during the last year (delusions, grandiosity, suspiciousness). exclusion criteria: * traumatic brain injury, dementia, or intellectual disability (premorbid iq ≤70). * substance dependence. * score at or above 5 on the panss ( hostility and uncooperativeness); score at or above 6 on the panss (suspiciousness).