Kornimate/medical-research-clean huggingface dataset:
relationship between the development of impaired glucose tolerance, the phenotype of cfld, and the risk of liver fibrosis

Conditions: CF - Cystic Fibrosis; Cystic Fibrosis-related Diabetes; Cystic Fibrosis Liver Disease

Summary: this study proposes to examine the relationship between the development of impaired glucose tolerance, the phenotype of cfld, and risk of liver fibrosis.

pancreas insufficiency is a well-established risk factor for development of cf related diabetes (cfrd), but increased insulin resistance has also been demonstrated in this population. cystic fibrosis liver disease (cfld) is a well-established risk factor for the development cfrd. in addition, patients with cfld and cfrd at high risk of development of severe cfld and cirrhosis. recent work has shown that male cf patients with abnormal oral glucose tolerance tests were noted to have elevations in alt but the significance of this finding has yet to be fully explored. specifically, an unresolved question remains on whether the elevation in alt reflects a steatohepatitis as would be observed in a non-cf population or if the increased insulin resistance contributes to fibrosis progression in the classic biliary type cirrhosis seen in cystic fibrosis (cf). metabolic dysfunction with increasing insulin resistance has been shown to be a key component to the development of non-alcoholic steatosis hepatitis in a non-cf population. the presence of hepatic steatosis has been demonstrated in the cf population, but thus far not been linked to the development of significant steatohepatitis or cirrhosis. one potential explanation for this discordance between effects of hepatic steatosis in the cf and non-cf population, is in the non-cf population it requires multiple decades for hepatic steatosis to result in steatohepatitis and progression to cirrhosis, therefore the progressive fibrosis may not be seen in the cf population due to limited life expectancy. however, as the life expectancy in of patients with cf is increasing with new therapy, the longer-term consequences of hepatic steatosis maybe apparent alternatively, the presence of increased insulin resistance has been correlated to increase fibrosis progression in other forms of liver disease such as hepatitis c. therefore, another potential mechanism is the insulin resistance seen in patients with cfrd results in increased fibrosis and development of cirrhosis in patients with classic cfld. thus, further characterizing the underlying liver disease phenotype and fibrosis risk in this population is of interest. we propose to examine the relationship between the development of impaired glucose tolerance, the phenotype of cfld, and risk of liver fibrosis.

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 with cf and one of the following: * normal ogtt * elevated ogtt * known cfrd exclusion criteria: * men and women without cf
a study to evaluate the pharmacokinetics and safety of brivaracetam in healthy chinese subjects

Conditions: Healthy Participants

Summary: the purpose of the study is to assess the pharmacokinetics, safety, and tolerability of brivaracetam after a single dose and multiple doses in healthy adult chinese study participants.


Eligibility criteria:
inclusion criteria: * an institutional review board (irb)/independent ethics committee (iec) approved written informed consent form is signed and dated by the subject * subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the investigator * subjects are chinese males and females born in china between 18 and 45 years of age (both inclusive) whose parents are of chinese origin * subjects with body mass index (bmi) from 19 to 24 kg/m\^2 (both inclusive). minimum body weight is equal to or more than 50 kg * subjects with supine blood pressure levels of between 90 to 150 and 60 to 90 mmhg (inclusive) for systolic and diastolic, respectively, with pulse rate of 50 to 100 beats per minute (bpm) (supine position, inclusive) at screening visit * subjects without clinically relevant abnormalities in a standard 12-lead electrocardiogram (ecg) at screening visit judged by the investigators * subjects with laboratory values within the reference range at screening visit, or those with values exceeding the reference range but judged by the investigators to be not clinically significant to their participation in the study exclusion criteria: * subject has participated in another study of an investigational medicinal product (imp) (or a medical device) within the previous 30 days or is currently participating in another study of an imp (or a medical device) * subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study * pregnant, lactating, or sexually active women with childbearing potential who are not using a medically accepted birth control method * subject has a known hypersensitivity to any components of the imp or any of its excipients * subjects with any previous or current cardiovascular, respiratory, hepatic, renal, digestive, endocrine, or nervous system disorder that may affect absorption, secretion, metabolism, or excretion of the investigational product per investigator judgement * subjects showing a positive result for hepatitis b surface antigen, hepatitis c virus antibody, human immunodeficiency virus antibody, or syphilis test at screening visit

Keywords: epilepsy healthy participants phase 1 brivaracetam
study to assess the effect of consumption of fish oil encapsulated on inflammatory markers in colorectal cancer

Conditions: Colorectal Cancer; Inflammation

Summary: the purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil modifies inflammatory markers in individuals with colorectal cancer in chemotherapy

the study will recruit patients with newly diagnosed colorectal cancer and that has not yet undergone any chemotherapy treatment. individuals that meet the inclusion criteria are randomized by means of a computer program on two study groups: 1) supplemented experimental: receive 2g/day supplementation encapsulated fish oil for 9 weeks. 2) no intervention - control: not receive supplementation of fish oil or placebo. will be assessed the effects of supplementation on the standard profile of cytokine production, nutritional status, and proportion of incorporation of these fatty acids in blood cells (mononuclear and red blood cells). blood samples are collected before the start of first chemotherapy and nine weeks later. supplementation in the experimental group also will start on the first day of chemotherapy.

Eligibility criteria:
inclusion criteria: * age ≥ 19 years * histopathological diagnosis of colorectal cancer * beginning of chemotherapy in the target institution * agree to participate in the study \[signature of ic\] exclusion criteria: * age \<19 years * being in palliative care * inability to oral intake * allergic to the fish and fish products * owning with hyperlipidemia requiring drug treatment * consumption prior to the study of fish oil or supplements containing omega-3 pufa * being in medical treatment with some nonsteroidal anti-inflammatory * have some kind of infection

Keywords: inflammatory markers colorectal cancer cytokines fish oil
effects of textured insoles and exercise in children with joint hypermobility

Conditions: Child, Only; Joint Laxity; Exercise; Textured Insoles

Summary: joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. in children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. it is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. the aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children.

it was planned to include 40 children with joint hypermobility in the project. children's joint hypermobility will be determined by the beighton score. children will be divided into two groups. children in both groups will be offered an exercise program consisting of home and park activities that will improve their motor and sensory aspects. children in the intervention group will be asked to additionally use textured insoles. before and after the study, children's plantar foot tactile sense, balance, foot load distribution and quality of life will be evaluated. pre- and post-treatment values and change values in both groups will be compared with each other.

Eligibility criteria:
inclusion criteria: * children with a beighton score of 6 and above * being between the ages of 5-18 * being cooperative in the assessments and treatment * having a body mass index between 18.5-24.9 exclusion criteria: * having had any surgery or trauma in the last 6 months * having any neurological, metabolic, rheumatological or chronic disease. * having a vestibular system problem * being diagnosed with ehlers-danlos syndrome * having foot wounds and anomalies that may affect sole sensation * having chronic pain.
acute pain and inflammation after surgery

Conditions: Knee Injuries

Summary: the purpose of this study is 1. to observe acute pain after surgery and measure the natural course of inflammatory mediators 2. study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac

randomizized controlled trial

Eligibility criteria:
inclusion criteria: * day case surgical patients above 18 years old * non pregnant exclusion criteria: -

Keywords: acute pain inflammatory pain inflammatory mediators pain relief microdialysis
a study to assess the safety, tolerability and clinical activity of td-1211 in patients with opioid-induced constipation

Conditions: Opioid-induced Constipation (OIC)

Summary: a dose-escalation study to assess the safety, tolerability and clinical activity of td-1211 in patients with opioid-induced constipation.


Eligibility criteria:
inclusion criteria: * males and females between 18 and 65 years of age, inclusive * subjects with documented oic on stable opioid regimen * willingness to stop all laxatives throughout run-in and treatment period exclusion criteria: * any clinically significant findings in subjects with oic * have participated in another clinical trial of an investigational drug 30 days prior to screening * history of chronic constipation prior to opioid therapy in oic subjects * active medical disorders associated with diarrhea or intermittent loose stools in oic subjects

Keywords: constipation opioid induced
effects of an intervention to enhance resilience in physical therapy students

Conditions: Psychological Stress

Summary: health professional students experience high levels of psychological stress. individuals with higher levels of resilience are better equipped to handle stress. the purpose of this study is to evaluate the effects of an 8-hour resilience curriculum on stress levels, resilience, coping, protective factors, and symptomatology on students enrolled in a doctor of physical therapy (dpt) program. hypothesis: the curriculum will decrease stress levels, increase resilience, coping flexibility, protective factors (optimism, positive affect, and social support), and reduce symptomatology (negative affect, illness). research on stress and its consequences experienced by physical therapy students in particular is limited. if the results of this study support this hypothesis, it may establish the benefit of adding a resilience component to the curriculum for students of physical therapy.

the study involves curriculum development and evaluation by randomized controlled trial. participants will be randomized to the intervention group to receive a resilience curriculum or to a wait-list control group to receive a condensed version of the curriculum following the post-intervention assessments. pre- and post-intervention assessments will be administered to both groups, with baseline assessments administered in the first two weeks of the semester. the assessments will include measures of stress levels, levels of resilience, coping flexibility, optimism, positive and negative emotions, social support, and symptoms of illness. the intervention, the presentation of a resilience curriculum, will be delivered to the intervention group during the week following the baseline assessments and it will last for four weeks. the resilience curriculum will provide education for participants about methods to increase protective factors against stress, the use of effective coping strategies, and the importance of accessing social support, with the goal of better managing stress and enhancing resilience. the intervention will include a didactic component, skills-building training, and homework exercises to encourage the application of the skills. the curriculum will be delivered in four 2-hour modules, with one module delivered each week. the follow-up assessments will occur after midterm examinations are concluded. an abbreviated curriculum which will last approximately two hours will be delivered to the wait-list control group.

Eligibility criteria:
inclusion criteria: * current enrollment in doctor of physical therapy program at either indiana university or the university of indianapolis exclusion criteria: * none

Keywords: resilience optimism stress coping curriculum
psilocybin with intracranial neural sensing

Conditions: Chronic Pain

Summary: this is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (dbs) devices. outcomes include multi-site neural recording from previously placed ambulatory sensing-capable dbs devices, quantitative sensory and cognitive testing, and self-reports of pain. we hypothesize that psilocybin will change functional connectivity, decrease clinical and task-based pain reports, and improve cognitive functions.

this is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (dbs) devices. outcomes include multi-site neural recording from previously placed ambulatory sensing-capable dbs devices, quantitative sensory and cognitive testing, and self-reports of pain. we hypothesize that psilocybin will change functional connectivity, decrease clinical and task-based pain reports, and improve cognitive functions.

Eligibility criteria:
inclusion criteria: * currently implanted chronic brain sensing device (such as rc+s or percept) * not currently enrolled in another trial * ability to speak and read english * able to attend all in-person and virtual visits * no changes in medication or major surgical procedures anticipated for the trial * able to identify someone to accompany from the research unit at the end of drug administration day or agreement to have a study team member accompany them from the research unit exclusion criteria: * a health condition that makes this study unsafe or unfeasible, determined by study physicians * use of medication, vitamins, or supplements and unwilling or unable to discontinue medications that have problematic interactions with psilocybin * adulthood epilepsy or other seizure disorder * require supplemental oxygen * medical finding or diagnosis that would make participation in this trial unsafe

Keywords: chronic pain psilocybin psychedelic pain dbs
clinical trial of gene therapy for leber congenital amaurosis caused by rpe65 mutations

Conditions: Leber Congenital Amaurosis

Summary: the purpose of this clinical trial is to examine the safety of gene therapy for lebers congenital amaurosis (lca) caused by rpe65 mutations using a recombinant adeno-associated virus serotype 2 (raav2) vector carrying the human rpe65 (hrpe65) gene. recently, three independent short-term gene therapy studies in humans with lca due to rpe65 mutations were published, suggesting that subretinal delivery of raav virus carrying the rpe65 gene is safe. as a secondary outcome, improvement in visual function was observed in seven of the first nine treated patients. the proposed study is a similar open label, phase i clinical trial of uniocular subretinal raav2-hrpe65 administration to individuals with rpe65-associated retinal disease. two cohorts of three subjects each and one cohort of four subjects will be included in this trial. cohort 1 and 2 will consist of individuals 18 years of age and older and cohorts 3 will consist of individuals 8 years of age and older. in cohort 2, a larger volume of vector will be administered. enrollment in cohort 3 will begin only after confirming the safety of raav2-hrpe65 administration in the older group of participants.


Eligibility criteria:
inclusion criteria: * retinal disease caused by homozygous or compound heterozygote rpe65 mutations; * clinical diagnosis of leber congenital amaurosis (lca) with severely impaired visual and retinal function, and best corrected visual acuity of 20/50 or worse in the study eye; * ability to perform tests of visual and retinal function; * good general health; * ability to comply with research procedures; * specific for cohort 1 and 2: 18 years of age and older; * specific for cohort 3: over 8 years of age; exclusion criteria: * immune deficiency or use of immunosuppressive medications; * pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints (for example, glaucoma or ocular media opacities); * complicating systemic diseases; * impaired coagulation or use of anti-platelet agents within 7 days prior to study agent administration; * pregnancy or breastfeeding; * individuals (males and females) of childbearing potential who are unwilling to use effective contraception for 1 year following agent administration and barrier contraception for 3 months following agent administration; * any other condition that would prevent a subject from completing follow-up examinations during the course of the study; * any other condition that, in the opinion of the investigator, makes the subject unsuitable for the study; * current or recent participation in any other research protocol involving investigational agents or therapies, including recent (within past 6 months) receipt of an investigational biologic therapeutic agent. subjects will not be excluded based on their gender, race or ethnicity.

Keywords: leber congenital amaurosis lca rpe65 rpe65-associated leber congenital amaurosis retinal disease due to rpe65 mutations
fetal renal artery doppler indices in borderline isolated oligohydramnios

Conditions: Oligohydramnios

Summary: the purpose of the study is to investigate third trimester fetal renal artery doppler indices in borderline idiopathic isolated oligohydramnios and relationship between neonatal outcomes.

during a routine pregnancy examination at 34-37 weeks gestation, the fetus was evaluated using ultrasound with the toshiba xario 200 3.5-megahertz probe. fetal biometric measurements were obtained and placental structure and the amniotic fluid amount were evaluated in four quadrants. after detailed ultrasonography of the fetus, eligible pregnant women were included in the study. borderline idiopathic isolated oligohydramnios was defined according to the four quadrants technical with ultrasound examination and diagnosed with amniotic fluid index \>5.0 and ≤8.0cm. after first ultrasound examination all patients in borderline isolated oligohydramnios group were hydrated with one to two liters of water daily. all patients monitored with non stress test and amniotic fluid index twice weekly until delivery after treatment with hydration. for evaluating renal artery blood flow, an axial image of the fetal abdomen was obtained at the level of the fetal kidneys. using color flow doppler, the renal arteries were evaluated at the level of their origin from the abdominal aorta. the doppler gate was placed within the lumen in a straight segment of the vessel. a minimum of three consecutive waveforms was used to calculate the pi. the umbilical artery doppler measurements were studied in a free loop of cord, far from the fetus and placenta. pulsatile index and resistance index values were recorded. the study consisted of two groups. the first group was formed of the patients who had normal amniotic volume and meets the inclusion criteria. in second group the investigators included patients who diagnosed borderline idiopathic isolated oligohydramnios. after delivery the investigators compared fetal renal artery doppler indices and neonatal outcomes between groups.

Eligibility criteria:
inclusion criteria: * singleton pregnancies * between 34-37 gestational weeks * the age of them ranged from 18 to 35 years exclusion criteria: * uteroplacental insufficiency * preeclampsia * chronic hypertension * collagen vascular disease * nephropathy * chromosomal abnormalities * congenital abnormalities, especially those associated with impaired urine production * growth restriction * ruptured fetal membranes * twin pregnancies

Keywords: borderline idiopathic isolated oligohydramnios fetal renal artery doppler indices neonatal outcomes maternal hydration
registry for primary ciliary dyskinesia

Conditions: Primary Ciliary Dyskinesia

Summary: primary ciliary dyskinesia (pcd) is a rare disease, which means that any single pcd center has experience with a limited number of patients. pcd registry is the collection of data about pcd from many centers and countries who treat children with pcd. collecting data about pcd increase the knowledge on pcd, better describe the course of the disease, and help to better understand the progression of the disease and be used to develop new treatments. in the pcd registry of alberta, important information about pcd such as time of diagnosis, symptoms, and tests which led to the diagnosis, state of health at diagnosis, the progression of lung function, the occurrence of severe infections, tests and treatments data will be collected from the patients' medical records.

in order to better characterize the clinical course, and improve the diagnosis and treatment of pcd, the investigators propose to establish a provincial pcd registry in alberta. this registry will be securely linked to the currently existing international registry for pcd and will allow more researchers to use the information to do research on pcd. the investigators will collect demographic data: current age, sex, age, diagnostic findings and symptoms at diagnosis; in addition, clinical data about pcd which are recorded during the past and future clinical visits and encounters (e.g. lung function, weight, height, infections, treatments, and complications) will also be collected.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pcd * abnormal findings in at least two of the following tests: high-frequency video microscopic finding, transmission electron microscopy finding, immunofluorescence finding, low nasal no concentration/production, demonstration of biallelic disease-causing mutations by genotyping. exclusion criteria: • failure or unwillingness to give written informed consent.