Kornimate/medical-research-clean huggingface dataset:
a study of intravenous mircera for the treatment of anemia in dialysis patients.

Conditions: Anemia

Summary: this study will assess the efficacy and safety of intravenous (iv) mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. the anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * chronic renal anemia; * on dialysis therapy for at least 12 weeks before screening; * receiving darbepoetin alfa iv for at least 8 weeks before screening. exclusion criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of another investigational drug within 4 weeks before screening, or during the study period.
hearing aid processing and working memory in realistic spatial conditions

Conditions: Hearing Loss, Sensorineural

Summary: the goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). we anticipate the outcomes of this study to be applicable to realistic listening conditions.

hearing aids have specialized features to improve access to sounds for the hearing-impaired listener. the choice of appropriate hearing aid settings is integral to the hearing rehabilitative process. researchers and clinicians have been influenced by previous work showing that individual cognitive abilities, including working memory, are associated with hearing aid benefit, especially in adverse listening conditions. however, previous research is limited to omnidirectional microphone settings and unrealistic listening conditions. such conditions fail to recognize that most hearing aids are fit with directional processing that may improve the listening environment, and that typical environments contain speech and noise signals in a range of spatial locations. therefore, the broad goal of this research is to understand how patient variables interact with hearing aid signal processing in realistic listening conditions in order to effectively treat hearing-impaired individuals in communications situations that are most important to them.

Eligibility criteria:
inclusion criteria: * \> =18 years of age; any sex * sensorineural hearing loss with pure-tone thresholds between 25-70 decibel hearing level (db hl) at octave frequencies between 250 and 3000 hz * speak english as their primary language * normal or corrected-to-normal vision (\<=20/50) * participants will be in good health (self-report) exclusion criteria: * clinically significant unstable or progressive medical conditions * participants who score \< 23 on the cognitive screening test (montreal cognitive assessment) * evidence of conductive hearing loss or middle ear issues * significant history of otologic or neurologic disorders * evidence of significant asymmetry between ears * non-english-speaking or non-native english speaking

Keywords: hearing aids directional microphones cognition compression
effects on organ damage and surgical outcome of a new cardiopulmonary pass system (evado)

Conditions: C.Surgical Procedure; Cardiac

Summary: the primary purpose of this study is to assess the effects of the use of evado with respect to a conventional cardio-pulmonary bypass (cbp) system on surgical morbidity and mortality. as secondary aim this study wants to conduct appropriate laboratory investigations in order to detect the major biological mechanisms potentially responsible for the beneficial effects of the evado system on the coagulation cascade and inflammatory activation.

the present study is designed as a prospective, multicentre, randomized, open label, controlled, 2-arm parallel group, superiority trial. participating centres are selected based on previous experience with the use of the evado system. patients elected to open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination in the participating centers will be screened. this study as secondary aim wants to confirm the results of earlier investigation by a multicentre trial conducted on a larger population of patients undergoing a wide spectrum of open heart cardiac operations and either assess a number of cost-efficacy-efficiency indicators.

Eligibility criteria:
inclusion criteria: patients elected to undergo open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination and fulfilling the following additional criteria: * written informed consent * age 18-85 years exclusion criteria: * severe renal or liver failure * uncompensated diabetes * autoimmune disease requiring immunosuppressant therapy * coagulation disorders * emergent or redo surgery

Keywords: extracorporeal vacuum assisted device optimised (evado)
efficacy of lactobacillus reuteri protectis on functional abdominal pain (fap) in children 8-14 years old

Conditions: Abdominal Pain

Summary: the present clinical trial will examine the use of l. reuteri protectis in children with functional abdominal pain. the aim of the study is to evaluate the use of l. reuteri protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (fap).

subject will be asked to consume a tablet every day for 4 weeks. supplementation will be stopped after 4 weeks, and the subjects will be followed up for an additional 4 weeks. the subjects will complete a diary to record frequency and intensity of pain, use of medication, deviation from the usual diet, physical activities, and absence from school and other activities. gastrointestinal symptoms are assessed.

Eligibility criteria:
inclusion criteria: * fap (functional abdominal pain) according to rome iii criteria for * child/adolescent (rasquin, 2006); * 1 or more abdominal pain episodes per week over the past 8 weeks; * informed consent by study participant and at least one parent / legal guardian; * age 8-14 years; * pain severity at study entry must be at least 40 mm on a 100 mm vas scale; * ability to understand and comply with the requirements of the trial; * stated availability throughout the study period. exclusion criteria: * chronic illness; * surgery of gastrointestinal tract; * any organic symptoms and/or clinical signs of disorder or disease other than fap; * weight loss of 5% or more in body weight over the preceding 3 months; * any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance; * exposure to any drug or medication (antidepressants, ssris, laxatives) in the past 3 months or regular use of this medication; * exposure to probiotics or antibiotics within 4 weeks prior to study; subjects can be included following a wash-out period of 4 weeks. * participation in other clinical trials in the past 3 months; * subjects with anemia; * subjects with special dietary needs
mesenchymal stem cells in central nervous system injury2017

Conditions: Central Nervous System Injury

Summary: central nervous system (cns) injury leads to morbidity in patients, which has few good rehabilitation measures. mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. the investigators design this study to infuse mesenchymal stem cells (mscs) intrathecally to cns injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of msc in rehabilitate cns injury.


Eligibility criteria:
inclusion criteria: * cns injury \> 3 months * age \> 18 years * willing to give consent * stable vital signs * absence of active infectcion exclusion criteria: * any contradiction to intrathecal infusion * age \< 18 years * cns injury \< 3 months * cns injury \> 3 years
3v- improve venous access in pediatric anesthesia

Conditions: Cardiovascular Diseases

Summary: our hypothesis is that a new medical device called vein-viewer vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.the main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.

randomized study comparing the delay of peripheral access with or without using the device. monosite study, including children undergoing surgery.

Eligibility criteria:
inclusion criteria: * children aged less than 7 * diva score ≥ 4 * patient needing venous peripheral access for general anesthesia exclusion criteria: * no social security * opposition of the parent(s) to the participation of their child in the trial

Keywords: anesthesia venous access
the use of a minimally invasive internal fixation device for treatment of unstable pelvic ring fractures

Conditions: Unstable Pelvic Fractures

Summary: pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% \[4\], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature. minimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. the application of a pelvic internal fixator (infix) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.


Eligibility criteria:
inclusion criteria: * patients who had apc-ii * patients who had apc-iii * patients who had lc - ii * patients who had lc -iii exclusion criteria: * patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases. * open fractures. * stable pelvic ring fractures. * patients who had combined acetabular fractures * patients who had a hernia or previous lower abdominal surgery. * pregnancy.
efficacy of cortex stimulation in neuropathic pain

Conditions: Rebel Neuropathic Pains

Summary: the pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. the pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). it is within this framework that recently the stimulation of the sensorimotor cortex developed. principal objective: evaluation of the technique of stimulation under cortical on neuropathic pains .

the pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. the pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). it is within this framework that recently the stimulation of the sensorimotor cortex developed.

Eligibility criteria:
inclusion criteria: * neurofibromatosis, * rebel chronic neuropathic pain with duration \> 1 year and avs \> = 4 exclusion criteria: * cancer * epilepsy * cognitive deterioration

Keywords: cortex stimulation ,rebel neuropathic pains
does caffeine affect the sensitivity of adenosine perfusion scans?

Conditions: Coronary Artery Disease

Summary: we are studying the affect of caffeine on the sensitivity of detecting coronary artery disease (blockages in the blood flow to the heart) with adenosine tracer scans. adenosine is a drug used routinely in patients to relax heart blood vessels in order to assess for the presence of coronary artery disease. often, if patients have had caffeine, the adenosine scan is not used because of the belief that caffeine may reduce the ability to detect coronary artery disease. we would like to test whether caffeine affects our ability to detect coronary artery disease with adenosine tracer scanning. we will perform an imaging study of the heart with adenosine after you have received caffeine.


Eligibility criteria:
inclusion criteria: * patients who have already completed rest/stress 99mtc sestamibi or 99mtc tetrofosmin imaging will be given a form describing this protocol and asked to volunteer for the additional scan exclusion criteria: * history of asthma, bronchospastic copd, or renal failure

Keywords: adenosine tracer scans coronary artery disease caffeine
tsn2898-201 safety and efficacy of tsn2898 in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to determine the safety and effectiveness of tsn 2898 topical gel in the treatment of moderate to severe acne.

tsn2898 is an inhibitor of stearoyl-coa desaturase-1 (scd-1), an enzyme present in sebaceous glands and a key regulatory enzyme in lipogenesis. this study will assess the safety and efficacy of tsn2898 topical gel and matched gel vehicle, applied daily on the face for the treatment of moderate to severe acne vulgaris.

Eligibility criteria:
inclusion criteria: * healthy males or females, 16 to 55 years of age * must be diagnosed as having moderate or severe acne vulgaris * ≥ 20 inflammatory lesions on the face * ≥ 20 non-inflammatory lesions on the face * ≤ 3 nodule/cyst acne lesions * medically healthy * females must be of non-childbearing potential exclusion criteria: * systemic therapy with retinoids within six (6) months prior to study start * topical use of prescription retinoids within four (4) weeks prior to study start * oral antibiotics within four (4) weeks prior to study start * topical dapsone, sulfacetamide, benzoyl peroxide, α-hydroxy/glycolic acid and retinol/retinaldehyde-containing products, and topical antibiotics, anti-inflammatory medications and corticosteroids on the face within two (2) weeks prior to study start * facial procedures, including lasers, peels, and dermabrasion, within two (2) months prior to study start

Keywords: acne, topical, scd-1 inhibitor, moderate, severe
genetic study of severe zinc deficiencies

Conditions: Acrodermatitis Enteropathica

Summary: given the structural essential, catalytic and co-catalytic played by zinc in many sections of protein metabolism, carbohydrate and lipid (zinc is involved in the function of more than 300 metalloenzymes and metalloproteins), one can imagine the impact of a deficiency or even a sub-chronic zinc deficiency on the health of the individual. studies multiply that show that, long-term, marginal zinc deficiency is a risk factor for the development of cancer or neurodegenerative complex diseases (eg alzheimer's disease). in addition, the short-term zinc deficiencies foster the development of skin conditions and susceptibility to viral and bacterial infections. the aim of this project is to identify, in the population of patients with pseudo-acrodermatitis enteropathica (ae) tested in the investigators laboratory, rare variants (mutations "real" epimutations or polymorphisms) located in solute carrier family 39 member 4 (slc39a4) gene or in 55 other genes chosen for their role in zinc homeostasis.


Eligibility criteria:
inclusion criteria: * are included all patients (minors included) with suggestive symptoms and biological signs of a hereditary deficiency of zinc, appeared for the first time at birth or weaning (see description given in the introduction); * clinical diagnosis of zinc deficiency must be made by a specialist dermatologist, pediatrician or gastroenterologist; * zinc deficiency has been audited by an assay of serum zinc, erythrocyte, plasma, urine or hair; * the response of all symptoms and signs to zinc oral supplementation should be rapid and complete. exclusion criteria: * all patients with homozygous or compound heterozygous mutations in the slc39a4 gene are excluded because they have a proven acrodermatitis enteropathica (ae); * all patients who developed their first symptoms of zinc deficiency outside the neonatal period, most likely because they have an acquired deficiency and not congenital; * all patients with probable cause of zinc deficiency that is surgery of the digestive tract, chronic digestive disease, or total parenteral nutrition.
effect of bm-mscs on early graft function recovery after dcd kidney transplant.

Conditions: Kidney Transplantation; Acute Kidney Tubular Necrosis

Summary: this study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (bm-mscs) can promote function recovery in patients with poor early graft function after kidney transplantation from chinese donation after citizen death (dcd). dcd kidney transplant recipients with poor early graft function (with or without dialysis) post transplant are equally randomized into mscs group or control group. patients in mscs group are administered mscs treatment. allogeneic bm-mscs (1\*10\^6/kg) from third party are given intravenously for four consecutive doses every week after enrollment. patients in control group receive placebo. renal allograft function (egfr), rejection, patient/graft survival and severe adverse events up to 12 months post enrollment are monitored.


Eligibility criteria:
inclusion criteria: * primary kidney transplantation * kidneys are from donation after chinese citizen death * poor early graft function with or without dialysis after transplantation * patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months exclusion criteria: * secondary kidney transplantation * combined or multi-organ transplantation * women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration * panel reactive antibody (pra)\>20% or cdc crossmatch is positive * donors or recipients are known hepatitis c antibody-positive or polymerase chain reaction (pcr) positive for hepatitis c * donors or recipients are known hepatitis b surface antigen-positive or pcr positive for hepatitis b * donors or recipients are known human immunodeficiency virus (hiv) infection * patients with active infection * recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow- up. * patients with severe cardiovascular dysfunction * wbc\<3\*10\^9/l or rbc \<5g/dl * highly allergic constitution or having severe history of allergies. * patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption * patients with a history of cancer within the last 5 years * prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness

Keywords: kidney transplantation mesenchymal stem cell therapy poor early graft function delayed graft function ischemia reperfusion injury donation after cardiac death
peers pilot: peer recovery support program to support engagement in medication for opioid use disorder

Conditions: Opioid Use Disorder

Summary: the goal of this pilot study is to evaluate the feasibility and acceptability of implementing a peer recovery support program to support patient engagement in medication treatment for opioid use disorder (moud). the program, entitled "promoting enhanced engagement through recovery support" (peers) was developed in collaboration with community and clinical partners for the moud outpatient setting. information gathered during this pilot study will inform refinements to the program and study components for a future clinical trial that will evaluate the effectiveness of the peer recovery support program in increasing patient retention in moud. the investigators will recruit 12 participants to the pilot study, all of whom will receive the peers program. the study will take place in geisinger outpatient addiction treatment clinics in northeast pennsylvania. patients initiating moud treatment at one of the clinics will be eligible for participation, and will be recruited via email, patient portal messages, and phone. each participant will receive the peers program, entailing regular sessions with a certified recovery specialist (crs) for 6 months. participants will also be asked to complete assessments at baseline and 12 weeks and will be invited to provide qualitative feedback on their experience with the program through an interview conducted between 8-12 weeks. as the focus of the pilot pertains to the feasibility and acceptability of the program and the study components, study outcomes focus on participant engagement in and acceptance of the program, crs fidelity to the program, barriers to implementation, and feasibility of data collection.


Eligibility criteria:
inclusion criteria: * adult ≥ 18 years of age * initiated medication for opioid use disorder at a geisinger outpatient addiction treatment clinic within the past 45 days * willing to participate in the peer recovery support program * able and willing to provide consent exclusion criteria: * received medication for opioid use disorder at a geisinger outpatient addiction treatment clinic in the 90 days prior to the treatment initiation date * not proficient in english

Keywords: opioid use disorder