Kornimate/medical-research-clean huggingface dataset:
effect of curcumin on gut microbiota in ibs

Conditions: Irritable Bowel Syndrome

Summary: to evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome (ibs) and to review any correlation between the changes in the microbiota with symptoms.

this is a prospective, placebo-controlled, double blinded, randomized control trial. this study will evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome. curcumin is a commonly used spice in asian cooking and has a very good safety profile. developing preparation of this compound for targeted delivery in the gi tract would provide a novel way to treat common fgid. this study will provide preliminary data for future studies to evaluate the role of gut microbiota in the pathophysiology of pain predominant fgid and how food supplements can be used to manipulate the microbiota.

Eligibility criteria:
inclusion criteria: * 10 to 18 years old * fulfill the rome iv criteria for diarrhea predominant ibs * english speaking * able to swallow curcumin/placebo capsules exclusion criteria: * weigh less than 35 kg * on any form of dietary restrictions * taken probiotics one month before enrollment * antibiotic treatment one month before enrollment * ibd * celiac disease * peptic ulcer disease * h. pylori gastritis * abnormality of gastrointestinal tract * previous abnormal endoscope * previous abdominal surgeries * gall stones * biliary tract obstructions * liver pathologies * liver failure * active gi infection * positive stool cultures * drug or alcohol abuse * concomitant immunological/hematological/neoplastic/heart/ renal/pulmonary condition * any other medical condition or taking any form of drug(s) which can explain the current symptoms * take oral or intravenous drugs which could have potential drug interaction with curcumin * lactating or pregnant or planning to become pregnant * developmental delay * parents that are developmentally delayed * have a diet high in curcumin/turmeric

Keywords: curcumin ibs and microbiota
non-specific chronic back pain; insight from spatial aspects of lumbar spinal muscle activation

Conditions: Low Back Pain

Summary: there is evidence for altered muscle activity patterns in individuals with non-specific chronic back pain (nscbp). it is unknown why these alterations in activation pattern occur and how they may be linked to pain experience and to the development of cnsbp. the main objective of this study is to investigate the spatial aspects of muscle activation in relation to fatigue/endurance and cnsbp. a novel approach, utilizing a new multi-channel surface-emg (mcsemg) technique will be applied in this project to get insight in fundamental mechanisms related to motor control and fatigue/endurance. in this project data from healthy persons and from patients with nscbp will be collected and analyzed. nscbp patients will be compared to healthy persons. to minimize heterogeneity between groups the subject's age range will be from 30 - 50 years. the investigators main hypothesis is that motor control mechanisms of the lumbar muscles are disturbed in nscbp patients compared to normals, explaining the reduced tolerance for static postures. there has been little investigation of the lumbar musculature with mcsemg recordings. the lumbar musculature has a complex organization; many, relatively small muscles, in a restricted area. utilizing two hdsemg grids with 252 ag/agcl contacts will be the superior non-invasive method to investigate motor control mechanisms in this region, and further the investigators understanding of neuromuscular adaptations related to nscbp. the project may demonstrate changes that will lead us to new insight and new strategies for the treatment of back pain.


Eligibility criteria:
inclusion criteria: * patients * diagnosed with chronic nscbp \>3 months duration * healthy controls * no back pain. exclusively exclusion criteria for this group will be back pain in the previous year or back pain lasting longer than one week in previous 3 years. exclusion criteria: * anamnesis of medical or drug abuse * surgery on the musculoskeletal system of the trunk * known congenital malformation of the spine or scoliosis * body mass index \>27 kg/m2 * systemic-neurological-degenerative disease * history of stroke * psychiatric disorder * pregnancy and abnormal blood pressure.
high throughput screening device based on 3d nano-matrices and 3d tumors with functional vascularization

Conditions: NSCLC

Summary: almost 85% of new therapeutic molecules are abandoned before the clinical trial stage. most of these failures currently concern cancer therapies. in order to optimize the development of these molecules and allow the development of precision medicine, an innovative screening device that is as close as possible to in vivo is necessary. for this reason, the platform the investigators are setting up takes into account tumor vascularization as well as the 3d microenvironment. the platform the investigators intend to set up is based on 4 cornerstones: * the formation of patient-derived organoids seems to be the best option to take into account the microenvironment and cellular interactions. * the vascular network: the formation of a peri-tumoral vascular network, either by using huvecs cells or by using endothelial cells from the patient. * the extracellular matrix, and the set of proteins it contains, is a major element of in vivo interaction. moreover, the presence of a matrix is a key element for the development of vascularization in vitro. * functional tumor microenvironment: peri-tumor vascularization is necessary but not sufficient to claim to recreate a tumor microenvironment. it must be functionalized, and this implies the use of a microfluidic system. this ready-to-use platform will be used on tumor biopsies of the patient, to constitute a tool for personalized medicine. this could even be a future component of decision at multidisciplinary board meetings. the main objective of our research is the constitution of organoids derived from the patient in order to select, via a screening device, the best anti-tumor therapy to administer to the patient. a secondary objective is to collect lymphocytes from the patient's blood in order to test the effectiveness of therapies mediated by the immune system (immunotherapy).


Eligibility criteria:
inclusion criteria: * patient whose age is ≥ 18 years old * patient with non-small cell bronchopulmonary cancer (nsclc), at any stage, undergoing surgery in the thoracic surgery department of the new civil hospital, strasbourg. * patient who agreed to participate in this observational study. * patient affiliated to a social security system exclusion criteria: * refusal to participate in the study * known hepatitis, known hiv * subject under safeguard of justice * subject under guardianship or trusteeship * inability to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject) * pregnant women

Keywords: organoids drug testing immunotherapy
a clinical study to assess the efficacy and safety of sed80 for use in cataract surgery

Conditions: Cataract in Inflammatory Ocular Disorders

Summary: patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.

"patients undergoing traditional cataract surgery routinely develop inflammation and pain. this study will evaluate 4 arms of either dexamethasone or placebo.

Eligibility criteria:
inclusion criteria: * patients undergoing traditional cataract surgery. exclusion criteria: * patients with unusual ocular conditions.
assessment of maxillary arch depth and width in a group of surgically repaired unilateral cleft lip and palate children versus normal children .

Conditions: Cleft Lip and Palate

Summary: the aim of the present study is to determine the effect of surgically repaired uclp on dental arch dimensions and the need for orthodontic intervention in comparison with other healthy children , the presence of dental anomalies and the best possible standards of care among this group of egyptian children.

in arranging to distinguish and implement the best possible standards of care for uclp children by the pediatric dental practitioner, evaluation of early treatment results after essential surgical repair of cleft lip and palate with respect to arch dimensions is fundamental. although the dental arch dimensions for these children have been evaluated in previous studies , few examiners in egypt handled this issue due to racial contrasts in improvement of the dental arch and growth .the deficiency of data in egypt tending to this insufficient assemble of children presents a gap that prevents the transport of fitting dental care to them. this is considered objective to fulfill this gap by spotting the most characteristics of dental arch dimensions in surgically repaired uclp children and compares them with those of sound, coordinating, non-cleft.

Eligibility criteria:
inclusion criteria: * cooperative egyptian children aging from ( 9-12) years. * medically free children. * children whose families accepts to participate in this study. * children with surgically repaired uclp . exclusion criteria: * children with previous untreated dental trauma. * children with previous orthodontic treatment * children with upper respiratory disease * children having any systemic diseases * intellectual disabilities or syndromes * congenital anomalies other than uclp were excluded from the study .
preoperative psma pet/ct as triage for eplnd in patients scheduled for ralp (prepsma)

Conditions: Prostate Cancer

Summary: extended pelvic lymph node dissection (eplnd) is considered the gold standard for nodal staging in men with prostate cancer (pca). the aim of this project is to determine if preoperative prostate specific membrane antigen (psma) positron emission tomography (pet)/computed tomograpy (ct) can safely replace eplnd as a staging method in pca patients undergoing robot-assisted laparoscopic radical prostatectomy (ralp).

due to the latest change in eau guidelines in may 2024, all eligible patients will undergo psma pet/ct. patients will then be randomized between ralp and eplnd (arm a) and ralp +/- eplnd (arm b): if psma pet/ct detect suspicious pelvic nodes, the patient will undergo eplnd concomitant with ralp. if psma pet/ct is negative, only ralp will be performed . primary outcome measures: difference in biochemical recurrence (bcr) rate between arm a and arm b within 2 years after initiation of primary treatment (bcr ≥ 0.2 ng/ml). secondary outcome measures: difference between arm a and arm b for surgical complications, persistent psa after ralp and initiation of salvage therapy

Eligibility criteria:
inclusion criteria: * biopsy proven diagnosed adenocarcinoma of the prostate * indication for eplnd combined with ralp: * high-risk group (eau) and including mri findings indicating extra prostatic extension (likert scale ≥4) * -isup gg 3 with ≥1 of the following unfavourable risk factors * ct2b-c, * ≥50% percentage of positive biopsy cores, * psa 10-20 * cn1 selected to surgery * written informed consent * no known allergies for psma tracer * 18 years and older exclusion criteria: * history of previously actively treated pca * previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years * unwillingness or inability to undergo psma pet/ct and/or eplnd and ralp * presence of distant metastasis (cm1) on mri imaging

Keywords: psma pet/ct, eplnd
effects of maintaining steady albumin levels (tat 4) on survival and liver related complications in cirrhosis with ascites

Conditions: Liver Cirrhosis

Summary: investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (\<2.8g/dl) with ascites.

cirrhosis is characterized by progressive deterioration in liver functions. liver's synthetic functions are inferred by serum albumin and inr estimation. lower albumin level is a marker of severe liver disease and probability of worsening ascites, hepatorenal syndrome with increased risk for infections. of the three recent rcts on utility of long-term administration of albumin, two showed improvement in survival. the studies had included different patient populations (diuretic refractory ascites, high dose diuretics and patients on liver transplant waiting list) with different albumin infusion protocols and different end-points. these studies were done in advanced cases of cirrhosis. there is limited data on the utility of regular albumin infusions in early hepatic decompensation (albumin levels-\<2.8g/dl with ascites) and the effect of maintaining a targeted albumin level on survival or liver related side effects. investigators are trying to address this issue by starting regular albumin infusions at an earlier stage of liver decompensation.

Eligibility criteria:
inclusion criteria: * newly detected cirrhotic patients aged more than 18 years * cirrhosis deﬁned by standard clinical, analytical and/or histological criteria * serum albumin level \< 2.8g/dl with or without ascites * who would agree to give written informed consent exclusion criteria: * uncontrolled htn (sys\>150/ dis \>90 mmhg) or h/o any drug therapy for htn * prior h/o transjugular intrahepatic portosystemic shunt (tips) * hepatocellular carcinoma * active alcohol abuse within 3 months * patients presenting as acute on chronic liver failure * extrahepatic organ failure * known case of chronic heart failure or respiratory failure * diagnosed chronic kidney disease * patients with hydrothorax * prior liver transplant recipient * human immunodeficiency virus infection * use of albumin infusion in the last one month * ctp\>12, meld\>28 * total bilirubin \>3 g/dl * overt hepatic encephalopathy at presentation
trial to assess chelation therapy (tact)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (edta) chelation therapy in individuals with coronary artery disease.

edta chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system. participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. the primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. the results of tact will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.

Eligibility criteria:
inclusion criteria for participants: * heart attack at least 6 weeks prior to study start exclusion criteria for participants: * serum creatinie level greater than 2.0 mg/dl * platelet count less than 100,000/µl * blood pressure greater than 160/100 * chelation therapy within 5 years prior to study start * history of allergic reactions to edta or any of the therapy's components * coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization * cigarette smoking within 3 months prior to study start * childbearing potential * history of liver disease * active heart failure or heart failure hospitalization within 6 months. * diagnoses of additional medical conditions that could otherwise limit patient survival * inability to tolerate 500-ml infusions weekly.
autonomic and metabolic response to cardiac rehabilitation after acute mi

Conditions: Acute Myocardial Infarction: Rehabilitation Phase

Summary: ischemic heart disease remains the leading cause of death in the western world. the beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine).


Eligibility criteria:
inclusion criteria: * recent first acute myocardial infarction exclusion criteria: * severe diabetes

Keywords: myocardial infarction cardiac rehabilitation metabolomic autonomic nervous ststem
effect of protein intake on preterm infant body composition

Conditions: Premature; Infant, Light-for-dates

Summary: the investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.

american academy of pediatrics guidelines define the growth rate of preterm, underweight babies as adequate if it matches the age-equivalent weight gains typical of term infants, approximately 10-15 grams per kg per day. unfortunately, many pre-terms, especially very low birth weight ones, do not achieve this rate, resulting in neurodevelopmental deficits and low discharge weights. typical feeding regimens, designed to increase weight gain, however, have been shown to increase the rate of fat accretion and increase the risk of obesity and metabolic disorders, such as insulin resistance and type 2 diabetes, later in life. research has shown that higher protein diets can reduce the accretion of body fat in older, normal weight infants but this has not been systematically tested in low birth weight pre-terms. the current study will compare weight gain based on fat accretion and change in body composition in preterm infants receiving higher (4g/100 kcal) versus lower (3 g/100 kcal) protein-energy ratio diets. the hypothesis tested in this study is: increased protein intake will reduce the percentage of weight gain due to fat accretion in pre-term infants. the identification of an effective feeding regimen that would both allow pre-term infants to acquire age-equivalent growth rates similar to those of term infants while avoiding the excess accretion of body fat could significantly improve the long term health outcomes of this high-risk population.

Eligibility criteria:
inclusion criteria: * premature infants born less than 32 weeks ega * growth that is appropriate for gestational age (aga) * admitted to ou children's nicu, inborn or outborn * receiving enteral feedings \<100 ml/kg/day * hemodynamically stable exclusion criteria: * severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings * growth restriction, growth that is small for gestational age (sga) or large for gestational age (lga) * inborn errors of metabolism * history of necrotizing enterocolitis bell stage iii * cerebrospinal fluid indwelling shunt (affects body composition measurements) * expected death prior to 36 weeks ega (the end of the study period) * inability to meet pea pod® requirements for the first measurement * on vasopressor medications

Keywords: protein intake body composition
mortality in free-fall trauma patients

Conditions: Free Fall Trauma

Summary: in this study, the investigators aimed to analyze the demographic characteristics, patterns of injury, and mortality after free fall in the emergency department of the national taiwan university hospital, and the affiliations, hsin-chu branch, and yun-lin branch.

falls from a height are the leading cause of accidental deaths. the mechanism of free-fall injury is abrupt vertical deceleration and the severity is dependent on the height, body weight, posture and contact area...etc. most victims presented to the emergency department with major trauma, so initial evaluation and management are crucial for survival. the knowledge of the unique pattern of injuries helps clinicians to facilitate the diagnosis.

Eligibility criteria:
inclusion criteria: patients aged more than 20 years after free falls in the emergency department of the national taiwan university hospital, and the affiliations, hsin-chu branch, and yun-lin branch. exclusion criteria: patients aged less than 20 years after free fall in the emergency department of the national taiwan university hospital, and the affiliations, hsin-chu branch, and yun-lin branch.
study to evaluate the effects of trv120027 in patients with heart failure

Conditions: Heart Failure

Summary: in this study, trv120027 (or a placebo) intravenous infusion will be given to people with heart failure to learn about the effects of trv120027. the results of this study will help choose the proper range of trv120027 doses to use in future research studies involving patients with acute decompensated heart failure.


Eligibility criteria:
inclusion criteria: * diagnosis of congestive heart failure made at least 3 months prior to screening * nyha class iii or iv heart failure, ejection fraction \</= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated. * baseline mean pcwp \>/= 20 mmhg * systolic blood pressure at screening must be \>/= 100 mmhg. heart rate at screening must be \</= 90 bpm. exclusion criteria: * any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the investigator based on medical history, physical examination or laboratory tests. * significant valve disease * current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (acs) or coronary revascularization in the past 3 months. * sustained or uncontrolled ventricular arrhythmia. inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted.
phase iii study of ts-142 in patients with insomnia

Conditions: Patients with Insomnia

Summary: this is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.


Eligibility criteria:
inclusion criteria: 1. japanese male and female who are aged 18 years or older at the time of informed consent 2. outpatients 3. patients falling under the category of insomnia disorder according to the diagnostic criteria in the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) other protocol defined inclusion criteria could apply. exclusion criteria: 1. patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in dsm-5 2. patients with psychiatric disorders such as depression, schizophrenia, and anxiety 3. patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (\> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder other protocol defined exclusion criteria could apply.
exploratory study using nanotechnology to detect biomarkers of parkinson's disease from exhaled breath

Conditions: Parkinson's Disease; Parkinsonism

Summary: parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available. exhaled breath testing may yield a "breath-print" that can be used to distinguish healthy and diseased states.


Eligibility criteria:
inclusion criteria: * patients with parkinsonism exclusion criteria: * severe dementia

Keywords: parkinson's disease, parkinsonism biomarkers exhaled breath nanothechnology