Kornimate/medical-research-clean huggingface dataset:
assessment of elemental impurities level after multiple administration of dwj1230 or dwb2001 in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea.

Conditions: Diarrhea

Summary: this study aims to assess elemental impurities level after dministration of dioctahedral smectite in subjects with functional diarrhea or irritable bowel syndrome with predominant diarrhea. male or female subjects aged between 19 and 60 years will participate in the study. the study design is an opne-label, randomized, multiple dose paraller study. the patients were randomly assigned to dwj1230 or dwb2001. it is intended that a total of 60 subjects will be enrolled to ensure that at least 24 subjects will complete the study.


Eligibility criteria:
inclusion criteria: * subjects with chronic functional diarrhea. (included irritable bowel syndrome with perdominant diarrhea(ibs-d)). * male or female subjects aged between 19 and 60 years at screening. * body mass index(bmi) between 18 and 27kg/m2 in male, 17 and 26kg/m2 in female. ※ bmi (kg/m2) = body weight (kg)/\[height (m)\]2 * subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information. exclusion criteria: * no history or clinically significant symptoms or severe disease, including cardiac, neurological, pulmonary, hepatic, biliary, gastrointestinal, endocrinologic, or renal disorders, or cancer. * identified or strongly suspected organic cause to diarrhea. * celiac disease or intestinal malabsorption, unspecified intestinal malabsorption. * history of any serious adverse reaction or adverse event or hypersensitivity to any component of investigational product. * constipation, iron deficiency anaemia, hypocalcaemia, osteoporosis. * known domestic, leisure or professional exposure to elemental impurities. * women who are breastfeeding or are planning to become pregnant during the study. * positive pregnancy test at screening. * presence of clinically significant physical, laboratory, vital signs, or ecg findings. * blood lead level \> 3.3 μg/dl(=33.0 μg/l) at screening. * galactose intolerance, fructose intolerance, lapp lactase deficiency, sucurase-isomaltase deficiency, glucose-galactose malabsorption. * receipt of any investigational agent or study drug within 4 weeks prior to screening. * patients with history of alcohol or drug abuse. * subjects who donated whole blood within 2 months, donated blood components within 1 month. * subjects who have participated and taken investigational drug within 1 month prior to study drug administration. * subjects who the investigator considers inappropriate for the study due to other reasons.
study of the impact on the therapeutic alliance of a short initial psychoeducation programme in patients with early schizophrenia

Conditions: Schizophrenia

Summary: schizophrenia is a serious, disabling and unfortunately common disease. its prevalence is in the order of 0.6 to 1% in the general population, a figure that remains relatively stable in the various cultures. the overall prognosis, particularly in terms of function, remains largely negative. the investigators know that a global management can considerably slow down this unfavourable evolution: according to the recommendations, the patient suffering from schizophrenia requires an effective and well-tolerated pharmacotherapy, associated with an adapted psychotherapy as well as cognitive remediation workshops, training in social skills, and psycho-education. there are indeed a large number of studies that have shown these elements in patients with schizophrenic disorders that have been present for several years. the investigators now know that early treatment is a key prognostic element. indeed, the earlier care is provided during the first psychotic episode, the better the subsequent prognosis: the probability of further decompensation is reduced, as is the risk of developing deficits, such as cognitive difficulties. however, there is a lack of access to all the recommended aspects of management in the initial phase of the disorder, particularly concerning early psycho-educational programmes for patients, which have been relatively little studied in clinical research. in this context, it seems relevant to study the impact of a new programme of this type on a fundamental parameter, conditioning the subsequent access to care: the therapeutic alliance. "ppic" is a short psycho-educational programme in 4 sessions, specifically designed to accompany young patients, and focused on the issues of this crucial period of the care process.


Eligibility criteria:
inclusion criteria: * french speaking * presenting a first or second acute psychotic episode, corresponding according to dsm 5 criteria to: * a brief psychotic disorder * and/or a schizophrenic disorder evolving for less than 2 years, * hospitalized in full time or in day care, * understanding and accepting the constraints of the study, exclusion criteria: * patient under guardianship * patient participating in another study * patient in hospital under restraint
24 week study to compare systemic vegf-levels of ranibizumab and aflibercept in dme.

Conditions: Visual Impairment Due to Diabetic Macular Edema

Summary: the purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic vegf levels in dme patients in a detailed time course.

the purpose of the study is to compare the effect of monthly intravitreal injections of 0.5 mg ranibizumab and 2.0 mg aflibercept on systemic vegf levels in patients with visual impairment due to dme over a 24 week period. in addition, the study will also assess the effect on systemic vegf-a levels when patients are switched from aflibercept to ranibizumab.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * visual impairment due to dme * bcva of 78 to 24 (20/32-20/320) etdrs letters exclusion criteria: * stroke or myocardial infarction less than 3 months prior to screening. * presence of uncontrolled systolic blood pressure or diastolic blood pressure * renal failure requiring dialysis or renal transplant or renal insufficiency * untreated diabetes mellitus * use of any systemic anti-vegf drugs within 6 months prior to screening. * use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening. * women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception for either eye: * any active periocular or ocular infection or inflammation * uncontrolled glaucoma * neovascularization of the iris or neovascular glaucoma * history of treatment with any anti-angiogenic drugs for study eye: * atrophy or fibrosis involving the center of the fovea at the time of screening or baseline. * cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegm * irreversible structural damage within 0.5 disc diameter of the center of the macula * panretinal laser photocoagulation within 6 months prior to randomization. * focal/grid laser photocoagulation within 3 months prior to randomization. * any intraocular procedure (including cataract surgery, yttrium-aluminum-garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following * topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening. * application of intravitreal corticosteroids in vitreous within 6 months prior to screening. prior application of fluocinolonacetonid releasing implant in vitreous within 36 months prior to screening. for fellow eye - retinal or choroidal neovascularization or macula edema of any cause other protocol-defined inclusion/exclusion criteria may apply.

Keywords: diabetic macular edema.
anatomic stenosis severity as a prognostic marker in patients with low-flow low-gradient aortic stenosis undergoing tavi

Conditions: Low-Flow, Low-Gradient Aortic Stenosis

Summary: the atlas tavi registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent transcatheter aortic valve implantation (tavi) for classical or paradoxical low-flow, low-gradient aortic stenosis (lflg as) with available non-contrast msct data on aortic valve calcification (avc). the main objective of this study is the assessment of outcome after tavi according to avc density severity in patients with lflg as.

aortic valve calcification (avc) as assessed by msct is highly correlated with aortic stenosis (as) severity and, thus, has become an important tool for diagnosing severe as, especially in patients with low-flow low-gradient aortic stenosis (lflg as). moreover, in medically treated as patients avc is directly associated with poor prognosis. in contrast, the prognostic benefit of eliminating as by transcatheter aortic valve implantation (tavi) in patients with lflg as seems to be larger in patients with high avc density (avcd) compared to those with low avcd, at least in "classical" (low ef) lflg as. hence, we hypothesize that avcd might be a valuable marker for treatment response among tavi patients with lflg as, who are known to suffer from poor outcome even after elimination of as. the multicentric atlas tavi registry of lflg as patients, who underwent tavi, assesses the impact of avcd on outcome in these patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * patient gave written informed consent for data acquisition and transfer * for lflg as: -- available non-contrast msct data on aortic valve calcification (avc, agatston units) exclusion criteria: - lflg as without non-contrast msct data on avc

Keywords: aortic stenosis low-flow, low-gradient tavi
growth and asymmetric dimethylarginine

Conditions: Growth Hormone Deficiency; Small-for-gestational Age

Summary: principal objective : validation of a handy biochemical parameter, plasma concentration of asymmetric dimethylarginine (adma), based on a recognize biochemical parameter, the dilation of the brachial artery, at ultrasound examination, after the deflation of a cushion to evaluate artery dysfunction (vascular suffering) in growth diseases, growth hormone deficiency (ghd) and intrauterine growth retardation (iugr) secondary objectives: * comparison of adma plasma concentrations with dose of matched healthy control children * investigation of the mechanisms of arterial dysfunction, inflammation, oxidative stress and insulin resistance.


Eligibility criteria:
inclusion criteria: * group a: ghd, defined by 2 gh peaks less than 6.6 ng/ml (20 mu/l) at two stimulation tests * group b: iugr, defined by a birth length and/or a birth weight inferior to - 2 sd for gestational age according to usher and mclean charts * group c: control children matched to children matched to subjects of groups a and b, according to gender and age * informed consent signed by representative of the parental authority exclusion criteria: * chronic disabling disease (ex: diabetes, severe asthma) * evolving cancer * severe psychiatric disorder (ex: autism, schizophrenia; severe depression) * hypothalamic tumor (ex: craniopharyngioma) * anamnesis of cranial irradiation * overweight, obesity or thinness * precocious puberty * non-replacing therapy by glucocorticoids or sex steroids less than 1 month before the exploration * anterior treatment by recombinant human gh * other conditions, treatments or habits impacting arterial reactivity: acrocyanosis, cryoglobulinemia, beta adrenergic blocking habits, tobacco smoking or other drug addictions, dyslipidemia * pregnancy or lactation * acute infection less than three weeks before the investigation * participation to a therapeutic protocol * impossibility for the representatives of the parental authority to understand the objectives of the protocol * absence of social security coverage. refusal by the parents to sign the informed consent or oral refusal by the child to participate to the study

Keywords: endothelial dysfunction doppler ultrasound examination nitric oxide
virtual walking therapy for neuropathic pain following incomplete spinal cord injury

Conditions: Spinal Cord Injuries; Neuropathic Pain

Summary: the purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury.

many people with sci experience neuropathic pain. neuropathic pain is often described as sharp, burning, or electric. 'traditional' treatments often do not do a good job of reducing neuropathic pain. therefore, it is important to see if 'non-traditional' treatments might work. scientists think that neuropathic pain occurs in sci because the sensations coming from the eyes and up the spinal cord to the brain do not match what the brain thinks it told the body to do. this 'mismatch' may result in changes in the brain that make neuropathic pain possible. virtual reality walking may potentially reduce this 'mismatch' by creating the 'illusion' that the person is walking. the brain then thinks it is telling the body to walk and the information coming from the eyes matches its instructions. this 'matching' may reverse the brain changes that make neuropathic pain possible. the current study is specifically focused on individuals whose sci has been classified as incomplete (asia b, c, or d).

Eligibility criteria:
inclusion criteria: the study will recruit individuals with incomplete injury (american spinal injury association \[asia\] classification b, c, or d) with lumbar, paraplegic, or low tetraplegic (c5-c7) injury. additional criteria will include: 1. must have persistent np symptoms that are of daily severity of at least 4/10 for 3 or more months 2. must endorse more than 2 items on a 7-item spinal cord injury pain instrument, scipi 3. must be 18 years of age or older 4. must be more than one and a half years post-injury to begin study (can be screened at an earlier time for eligibility) 5. must have mobile connectivity with usable service 6. must be stable on pain medication for 1 or more months 7. must be cleared on the vrwalk physical activity clearance scale 8. must not have motion sickness that interferes with daily life 9. must use a wheelchair at least 75% of the time exclusion criteria: 1. individuals with injury levels between c1 and c4 2. individuals under the age of 18 3. individuals who were injured within the past year 4. individuals who cannot comprehend spoken english 5. individuals who are in prison 6. individuals who are blind 7. individuals who experience severe motion sickness

Keywords: spinal cord diseases central nervous system diseases trauma, nervous system peripheral nervous system diseases neuromuscular diseases pain neurologic manifestations spinal cord injuries neuralgia wounds and injuries
the effects of brain stimulation on speech fluency in adults who stutter

Conditions: Stuttering, Adult

Summary: the project is leading to investigate the effects of neuromodulation techniques on speech fluency among adults who stutter (aws). while stuttering is responsive to a variety of treatments in childhood, this is not the case for aws. behavioural treatments to reduce stuttering for adults typically consist of speech restructuring methods, which involves the person using one of the altered speech patterns known to increase fluency, such as chorus reading, speaking in rhythm, and prolonging (smoothing/stretching out) speech sounds. research has shown that behavioural interventions such as these change brain activation patterns in the regions associated with stuttering. unfortunately, around 70% of aws who receive these speech restructuring treatments do not maintain the benefits in the longer term and frequently re-present to speech clinics. the aim of this proposed research is to explore whether the brain stimulation using repetitive transcranial magnetic stimulation (rtms) can consistently enhance effects of behavioural stuttering therapy by examining their responsiveness to the treatment across different outcome measures including a) immediate effect on different speaking contexts, and b) the maintenance of effects over one week after therapy.


Eligibility criteria:
inclusion criteria: - adults who stutter without any other speech, language or cognitive problems exclusion criteria: * have any history of neurological and other speech and language problems * condition that are violating the safety criteria for tms * any history of epilepsy, and brain damage, * having any metal plant or cardiac pace-maker in the body, * current pregnancy

Keywords: tms stuttering supplementary motor area (sma)
adapting and expanding the asthma-educator app

Conditions: Asthma

Summary: this project seeks to test and refine an adapted/expanded version of a previously created asthmaxcel app.

the study will test the adapted app on participants ages 15-21 (recruited from outpatient primary and specialty care sites at montefiore) with asthma, for a period of 4 and a half months, and will conduct formative and summative evaluation of the application's functionality and usability. the investigators will also be collecting process and clinical outcomes.

Eligibility criteria:
inclusion criteria: * english-speaking individuals between 15-21 * persistent asthma (diagnosis made by a healthcare provider) * on a daily controller medication * able to give informed consent * smartphone (ios or android) access exclusion criteria: * use of oral corticosteroids in the 2 weeks prior to the baseline visit * pregnancy * severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol * patients that previously received the asthma-educator application

Keywords: asthma
evaluation of the ldl-c lowering effects of ezetimibe achieved in co-administration therapy with statins in an indonesian population (study p04276)(completed)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (ldl-c) lowering in an indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. in addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.

sampling method: invitation to the physician's patients.

Eligibility criteria:
inclusion criteria: * all subjects that were to receive ezetimibe 10 mg as prescribed in daily practice exclusion criteria: * n/a
safety study of mva smallpox vaccine in hiv-positive subjects who are vaccinia naive

Conditions: HIV Infections; Smallpox

Summary: the purpose of this study is to assess the safety and immunogenicity of two mva smallpox vaccine injections in healthy adults that are 18-35 years of age with hiv infection

this is a multi-center study 90 hiv-seropositive subjects. there will be an injection of mva smallpox vaccine or placebo on day 0 and day 28. subjects will be enrolled and vaccinated in two cohorts according to cd4 cell count levels and number of subjects vaccinated. excluding the screening period, the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208.

Eligibility criteria:
inclusion criteria: * adults at least 18 years old and who were born after 1971 who have never had a smallpox vaccination or exposure to a vaccinia-containing product * subjects must test positive for hiv infection * subjects must be in good general health except for hiv infection, including no aids-defining illnesses. * female subjects must not be pregnant or lactating, and all subjects must agree to practice birth control * subjects must be clinically stable for 6 months prior to study enrollment. exclusion criteria: * subjects with a known or suspected history of immunodeficiency (with the exception of hiv infection) * subjects with history or prior exposure to a vaccinia-containing product * subjects with current radiation treatment or use of immunosuppressive or antineoplastic drugs (with exceptions) * subjects with concomitant illnesses associated with impairment of immunologic function. * subjects with dementia * subjects with malignancy. * subjects with a known history of cardiac disease, or who have risk factors for ischemic coronary disease, or other abnormalities * current or past history of eczema * known allergies to any component of mva, including eggs or egg products, or allergies to blood products * females must not be pregnant and using approved contraceptives. * morbid obesity

Keywords: hiv smallpox mva
effect of oral supplementation with a fibre enriched paediatric sip feed for children with acute lymphocytic leukemia

Conditions: Acute Lymphocytic Leukemia

Summary: this is a randomised, controlled, open-label intervention study. it is hypothesized that supplementation with a fibre enriched sip feed will improve the nutritional status, gut microbiota and quality of life (qol) of children with acute lymphoblastic leukemia, and may enhance their immune response. this could give them a better chance to finish their induction chemotherapy successfully with fewer side effects.

study objectives: primary objective: to evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed on the nutritional status of egyptian children with acute lymphocytic leukemia (all) compared to standard dietary counseling. secondary objective: to evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed on the gut microbiota and quality of life (qol) of egyptian children with all compared to standard dietary counseling.

Eligibility criteria:
inclusion criteria:• newly diagnosed male and female paediatric all patients presenting in the study period. * age should be above 2 years and children should be pre-pubertal. * hospitalized for the entire (6 week) intervention period. * about to receive? induction chemotherapy. * able to tolerate oral feeding. * written informed consent from parents/guardian (and child, if applicable to local law). exclusion criteria: * all patients \< 2 years and those who show signs of puberty. * all patients who cannot tolerate oral feeding and/or are on parenteral nutrition. * all patients with a known history of cow's milk allergy/intolerance or galactosemia. * all patients requiring a fibre-free diet. * investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements. * participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Keywords: improve the nutritional status qol children enhance immune response induction chemotherapy fewer side effects