Kornimate/medical-research-clean huggingface dataset:
a study of obexelimab in patients with relapsing multiple sclerosis (moonstone)

Conditions: Relapsing Multiple Sclerosis

Summary: this study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis

the study consists of a screening period (day -28 to day -1), a 24-week treatment period (part a and part b), a 52 week open label extension and an expected 12-week follow-up period. patients with relapsing multiple sclerosis will be randomized in 2:1 ratio to obexelimab or placebo. randomization will be stratified by gd lesion status at screening (≥ 1 vs 0). part a is the 12-week randomized placebo-controlled period (rcp), during which obexelimab or placebo will be administered as weekly subcutaneous (sc) injections. following part a, all patients will enter the part b, a 12-week open-label period (olp), during which all patients will receive obexelimab administered as weekly sc injections. after part b, patients will enter part c, a 52-week open-label extension (ole), after which they will return for an in-clinic safety follow-up visit 12 weeks after the completion of part c (i.e. week 88). if at this time, b cells have not returned to baseline or above the lower limit of normal (lln), patients will be asked to return every 12 weeks until b cells return to baseline or above the lln (at minimum). the maximum expected duration of the study is 92 weeks (screening period = 4 weeks, parts a, b and c = 76 weeks, follow-up period = 12 weeks).

Eligibility criteria:
inclusion criteria: 1. diagnosis of rms (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the mcdonald diagnostic criteria 2. an edss of ≤ 5.5 at the screening visit 3. must have documentation of: 1. . at least 1 relapse within the previous year or 2. . ≥ 2 relapses within the past 2 years or 3. . ≥ 1 active gd-enhancing brain lesion on an mri scan within the past 6 months prior to screening 4. not of childbearing potential or willing to follow contraceptive guidance exclusion criteria: 1. primary progressive ms or secondary progressive ms without relapses 2. meet criteria for neuromyelitis optica spectrum disorder 3. relapse in the 30 days prior to randomization 4. ≥ 10 years disease duration from onset with patient's edss ≤ 2.0 (patient reported is adequate in absence of written medical record) 5. has \> 20 gd+ lesions on brain mri at screening

Keywords: relapsing multiple sclerosis rms ms multiple sclerosis
circadian rhythms and cardiovascular risk

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to understand how behaviors and the effects of the body's internal clock (called the circadian pacemaker) affect the control of the heart and blood pressure. people with obstructive sleep apnea (osa) are hypothesized to have altered circadian amplitudes in certain key indices of cardiovascular (cv) and an abnormally advanced circadian phase in some of the same key indices of cv risk. the investigators hypothesize that such changes, taken together, may explain the different timing of heart attack and sudden cardiac death in osa.


Eligibility criteria:
* bmi less than 40 * moderate to severe osa (ahi)\>15 * no current or previous pharmacological treatment for hypertension
vıdeo-assısted stoma care traınıng gıven to patıents wıth stoma adaptıng to stoma and complıcatıons

Conditions: Stoma - Ileostomy; Stoma Colostomy; Stoma; Education of Patients

Summary: objective: the aim of this study is to evaluate the effects of video-assisted stoma care training given to patients with stoma on postoperative anxiety, stoma compliance and complications. materials and methods: this study was conducted as a double-blind randomized controlled interventional study within the scope of a doctoral thesis between january 2021 and september 2022 at the general surgery clinics of aydın atatürk state hospital, aydın state hospital and aydın adnan menderes university practice and research hospital with 42 patients, 21 in the intervention group (who received video-assisted stoma care training in the postoperative period) and 21 in the control group, who met the sampling criteria. in the postoperative period, patients in the intervention group were given video-assisted stoma care training, while patients in the control group were given training using plain narration and demonstration methods. during the research process, patients were visited at 3 different time periods to determine the patients' anxiety levels, evaluate their compliance with the stoma and complications, and the patient follow-up was concluded.


Eligibility criteria:
inclusion criteria: * having a stoma * being over 18 years old * having no complications from the stoma exclusion criteria: * having developed any complications in the stoma

Keywords: stoma i̇leostomi colostomy education of patients
efficacy study of ly2422347 to treat insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to determine whether a compound known as ly2422347 is effective in treating people diagnosed with primary insomnia (difficulty sleeping with no other significant contributing factor, such as depression).


Eligibility criteria:
inclusion criteria: * must have been diagnosed with primary insomnia * must not be significantly overweight * must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day * must be able to read and speak in english and be able to see well enough to use the handheld electronic device * the patient's answer to the question "during the past month, how would you rate your sleep quality overall?" must be either "very bad" or "fairly bad" exclusion criteria: * cannot have a clinically significant and/or uncontrolled condition or other significant ailment including restless leg syndrome (rls) or periodic limb movement disorder (plmd) * cannot have obstructive sleep apnea (osa), or be considered by the study doctor to have probable osa based upon patient history and physical examination * cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep * cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic disorder.
effects of intrauterine administration of autologous pbmc modulated with ifnt on endometrial cell populations

Conditions: Infertility

Summary: the aim of this clinical trial is to investigate the change in endometrial composition during the window of implantation following intrauterine administration of pbmc immunomodulated with ifnt. patients seeking assisted reproductive therapy will be invited to participate. two endometrial biopsies will be obtained from each patient during mid-secretory phase of two consecutive menstrual cycles. the first biopsy will be obtained one month before the intervention, and the second one - a day after intrauterine administration of the tested cell treatment which will take place the following month. immunohistochemistry analysis of the cell composition of the endometrium will be performed.

female patients with no known uterine pathologies and good general health undergoing treatment for unexplained infertility will be identified and invited to participate in the study. endometrial biopsy will be obtained seven days after luteinizing hormone (lh) surge during a natural cycle. the following month, 5 days after lh surge, peripheral blood mononuclear cells (pbmc) will be isolated from patients' peripheral blood by density gradient (1.077g/ml) centrifugation and suspended in culture medium. the obtained pbmc will be incubated with 500 iu ifnt at 37˚c for 24 hours. this cell suspension will be carefully introduced in the uterine cavity by catheter on day 6 post lh surge. a second biopsy will be obtained the following day (lh+7). immunohistochemistry evaluation of endometrial tissue will be performed in terms of quantities and spatial distribution of various cell types.

Eligibility criteria:
inclusion criteria: * participating in assisted reproduction treatment * having primary infertility * having regular menstrual cycles * having signed informed consent exclusion criteria: * uterine pathologies * endometrial bacterial infections * active endometrial inflammation * polycystic ovary syndrome * presence of auto antibodies such as anti-tpo (thyroid peroxidase), anti-tg (thyroglobulin), aca (anticentromere antibodies), apa (antiphospholipid antibodies), ana (antinuclear antibodies), and anti-dsdna * presence of mutations involving the coagulation system such as deficiency of factor xii, pro c, pro s * oncological condition * positive hiv (human immunodeficiency virus), hcv (hepatitis c virus) or hbv (hepatitis b virus) tests

Keywords: intrauterine pbmc interferon tau endometrium endometrial cell populations window of implantation
fecal microbiota transplantation on type 2 diabetes mellitus

Conditions: Efficiency; Methodology

Summary: the gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the body's metabolism. evidence from animal and human studies strongly support the link between intestinal bacteria and type 2 diabetes mellitus. the present clinical trial aims to re-establish a gut functionality state of intestinal flora through fecal microbiota transplantation.

we established a standard bacteria isolation from donated fresh stool in lab.then the bacteria is transplanted to mid-gut (at least below the second part of duodenum ) through regular gastroscope. participants in this study will be randomly assigned to receive fecal microbiota transplantation only once or traditional therapy, and accept follow-up for at least one year. blood tests,ogtt and magnetic resonance spectroscopy will be used to assess participants at study start and at study completion.

Eligibility criteria:
inclusion criteria: type 2 diabetes mellitus exclusion criteria: with any cause of liver disease other than fatty liver known or suspected cirrhosis inability or unwillingness to undergo ogtt and magnetic resonance procedures requirement of long-term antibiotic therapy pregnancy, breast-feeding, or plans to become pregnant

Keywords: gut bacteria bacteria fecal transplant bacteriotherapy
cardio-metabolic diseases in immigrants and ethnic minorities: from epidemiology to new prevention strategies

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to evaluate the efficacy of the co-created, culture-sensitive intervention to promote healthy diet, physical activity, and to improve compliance to therapeutic protocols in immigrants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * immigrant status: self-identification of being born in high migration pressure countries from parents born in high migration pressure countries * age ≥ 18 years * type 2 diabetes newly diagnosed or with hba1c \> 8% in the last assessment within 24 months before the visit exclusion criteria: * patients who will not provide the informed consent * patients with hba1c ≤ 8% in the last assessment within 24 months before the visit * severe psychiatric disorders * pregnant women * critical illness * impaired cognitive or physical ability that could make the intervention not feasible, as judged by clinical staff members

Keywords: migrants health promotion ethnic minorities cardiovascular diseases obesity hypertension diabetes
physical and social benefits of multi-player interactive computer play games in youth with cerebral palsy

Conditions: Cerebral Palsy

Summary: as children with cerebral palsy (cp) become teenagers, they experience a decrease in their physical function and mobility. decreased mobility leads to increased social isolation for the teens and impacts negatively on their quality of life. this loss of function is multifactorial, but poor physical fitness and muscle weakness secondary to disuse are significant contributors. exercise video games are a novel approach to engage youth in physical exercise and social interaction with their peers. the objective of this study is to evaluate the impact of an exercise video gaming intervention to improve physical fitness and social wellbeing. our over-arching research questions are whether "exergames" can provide health benefits (improved physical fitness) and improved social wellbeing in youth with cp.

the primary objectives of this study are to evaluate the impact of exergaming on cardiovascular fitness and social wellbeing related to friends/peers in youths with cp. the secondary objectives of the study will be to evaluate the impact of the exergaming intervention on additional components of physical fitness including anaerobic fitness, and muscle strength. in addition, the effect of the exergaming intervention on overall health-related quality of life (hrql), self-esteem and motor participation will also be measured. finally, the effectiveness of a technique for balancing performance in multiplayer exergames will be evaluated. the objectives will be investigated using a randomized crossover study design.outcomes will be measured a total of four times: at study entry and after the first ten-week period (either comparison or intervention), at the end of a six-week washout period, then again after second period (either intervention or comparison). outcomes will be assessed by physiotherapists and research staff members who will be blinded to the condition of the participants.

Eligibility criteria:
inclusion criteria: * diagnosis of cp and gmfcs level iii * between 9 and 18 years of age inclusive * ability to operate a handheld videogame controller * high-speed internet in the home * able to commit for the entire study duration exclusion criteria: * orthopedic surgery in the preceding six months * exercise-induced asthma * any underlying heart condition * seizure disorder * visual, auditory or cognitive disabilities that will interfere with game play

Keywords: cerebral palsy interactive computer play multi-player gaming exercise
a noninterventional genotype/phenotype study of mglur mutations in children and adolescents with adhd

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this noninterventional study will assess genomic changes in the metabotropic glutamate receptor (mglur) network in children and adolescents with adhd.

male and female subjects 6 to 17 years of age with a primary psychiatric diagnosis of adhd will be enrolled in this study. the subject and his or her parent/guardian must agree to genotyping to determine whether the subject has disruptive mutations within any of the approximately 274 mglur-network genes, and complete an interview that will include information about the subject's adhd history, treatment, and co-morbidities.

Eligibility criteria:
inclusion criteria: * the subject is male or female ≥6 and ≤17 years of age. * the subject has adhd as defined by the diagnostic and statistical manual of mental disorders, 5th edition. * the subject, his or her legally responsible representative, and investigator agree to complete adhd history, treatment, and comorbidity electronic case report form (ecrf). exclusion criteria: * the subject or parent/legal guardian is in the opinion of the investigator mentally or legally incapacitated and unable to provide informed consent/assent for participation in the study.
hypertension in minorities database-workshop and publication

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to develop a comprehensive database publication (databook) utilizing available published and unpublished data on the prevalence of hypertension and its treatment and control in selected minority populations in the united states -- hispanic, asian and american indian.

background: data on hypertension among minority populations were lacking prior to the workshop and databook publication. several reasons why the data were lacking include the biological and cultural diversity of america's minorities, their wide dispersal across the country, and the fact that key data such as death certificate information have sometimes not been recorded. design narrative: the objective was accomplished in a two-phase approach as follows: phase l. in june, 1994 a workshop was held in washington, d.c. on the epidemiology of hypertension in minorities. the workshop, entitled "the epidemiology of hypertension in hispanic americans, native americans, and asian/pacific islander americans" included as participants the investigators who had relevant datasets and were willing to participate in the effort. the investigators were requested to use common definitions of hypertension in their workshop presentations when feasible. in addition, in preparation for a databook publication, each study was asked to provide summary data, using common definitions and a common format, on the prevalence of hypertension in the study population. data presentations and interpretations at the workshop enabled the investigators and consultants to identify further research needs, further feasible data analyses utilizing available data, and special target groups for demonstration research efforts to enhance the potential success of intervention efforts. phase 2. a database publication (databook) was designed to include a summary of the workshop proceedings with the appropriate data and interpretations along with summary data from the studies presented in a standard, unified format. the databook, entitled "hypertension in hispanic americans, american indians and alaska natives, and asian and pacific islander americans" was published in 1996 and presented the prevalence of hypertension and its treatment and control by age, sex, and minority status, along with other information the planning committee considered relevant.

Eligibility criteria:
no eligibility criteria
interest of a geriatric intervention plan associated to a comprehensive geriatric assessment on autonomy, quality of life and survival of patients aged 70 years old and more surgically treated for a resectable cancer (thoracic, digestive or urologic). randomized multicentric study

Conditions: Cancer

Summary: the curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. for patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. comprehensive geriatric assessment (cga) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. it has been proved that for old patient population without cancer, cga associated with a geriatric intervention plan (gip) allows autonomy preservation, decrease of institution admission, and survival improvement. the reference study showed that a cga associated to a gip improves survival of old patients who had a cancer surgery. however this study included patients from 60 years old and the gip consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge. we propose to perform a prospective and randomized study to evaluate the impact of a cga with gip in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. cga and gip will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. the impact of such a strategy on autonomy and survival has never been studied.


Eligibility criteria:
inclusion criteria: * male or female aged 70 years old or more * patient with a resectable cancer( thoracic, digestive ore urologic); * patients who have to undergo a surgery with general anaesthesia; * patients treated in one of the partner programme unit ; * patient able to fill in an auto-questionnaire alone or with some help; * patient who have signed an informed consent and who commits himself or herself to respect the protocol instructions. exclusion criteria: * patient younger than 70 years old; * patient who is not registered to the social ; * patient for whom surgery is performed under local anaesthesia; * patient unable to fill-in alone an autoquestionnaire (because of an inability to read french language or severe cognitive troubles); * patient treated with neuroleptic or lithium ; * patient with already known cognitive impairment (alzheimer, dementia, neurologic sequel); * patient under legal protection; * patient who has not signed informed consent.

Keywords: patients aged 70 years old thoracic, digestive or urological resectable
open reduction internal versus percutaneous sacroiliac screw fixation in unstable posterior ring injury of pelvic

Conditions: Orthopedic Disorder

Summary: surgical trearment of unstable posterior pelvic injuries can be performed with open reduction and internal fixation, closed reduction with percutaneous sacroiliac fixation. biomechanically, no significant difference was found between the two methods in the literature. the aim of our study is to compare the radiological and clinical functional results of these methods.

pelvic injuries are usually encountered in patients with polytrauma. these are injuries that need to be treated with a multidisciplinary approach. the primary approach is to stabilize the patient hemodynamically. mortality rate in pelvic injuries reaches 10-20%. the pelvis has a ring-shaped structure. it is the sacrum that transfers the load from the lower extremities to the axial spine from this structure. the joint between the sacrum and the ilium, that is, the joint that is exposed to the load, is the sacroiliac joint. for this reason, surgical treatments have been developed to stabilize the posterior pelvic ring, to mobilize the patient as soon as possible, to walk in a balanced way without leg length difference, to prevent loss of work force, and to shorten the hospitalization period. open reduction internal fixation and closed reduction percutaneous sacroiliac screw fixation surgical methods have been described to ensure the stability of the posterior pelvic ring in this study, we evaluated the radiological and functional results of patients with posterior pelvic ring injuries stabilized by open and closed surgical approaches; we have compiled and summarized the current literature on pelvic injuries. we aimed to contribute to the literature by sharing our knowledge and findings about these difficult, complex and prone surgical techniques. marks of conformity 1. surgical intervention for sacroiliac joint fracture-dislocation 2. 18-65 years old patient 3. patients who come to clinical follow-ups for at least 6 months

Eligibility criteria:
inclusion criteria: * surgical intervention for sacroiliac joint fracture-dislocation * 18-65 years old patient * patients who come to clinical follow-ups for at least six months * not paralyzed exclusion criteria: * patients under 18 years of age * patients older than 65 years * patients who did not come for their follow-up in our clinic * paralyzed patients * mentally retarded patients

Keywords: instabil pelvic injury, percutaneus sacroiliac screw