Kornimate/medical-research-clean huggingface dataset:
social cognition in multiple sclerosis, from a study of eye movement and gaze strategies using video-oculography

Conditions: Multiple Sclerosis (MS); Multiple Sclerosis (MS) Relapsing Remitting; Multiple Sclerosis (MS) Primary Progressive; Multiple Sclerosis (MS) Secondary Progressive; Radiologically Isolated Syndrome; Clinically Isolated Syndrome; Healthy

Summary: this study aims to: * analyze prospectively the prevalence of subclinical oculomotor disorders (omds) in different phenotypes of multiple sclerosis (ms) and to study correlations with brain mri t2 data. * highlight link between modification of visual exploration strategies to decode emotions, and social behavioral disorders, in patients with demyelinating disease, from early to clinically definite stages.


Eligibility criteria:
inclusion criteria: * male or female. * 18 years old and above. * sufficient written and oral expression in french. * covered by a health insurance system * written informed consent signed by the patient. * for the ms group: \* patient diagnosed according to diagnostic criteria established by polman et al. (2010): radiologically isolated syndrome compatible with ms (ris), clinically isolated syndrome compatible with ms (cis), relapsing-remitting ms, secondary progressive ms, or primary progressive ms. \* hospitalized or coming to perform a consultation. * for the control group: no cognitive impairment (non pathological mini-mental state examination (mmse), according to age, gender and socio-cultural level). exclusion criteria: * general anaesthesia within 3 months. * ophthalmological problems preventing a video-oculography examination. * oculomotor disorders: * for the control group: "fixation disorders" or "ocular tracking disorders". * for the ms group: atypical disorders. * cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia. * other neurological or ophthalmological disorders than ms * history of stroke. * psychotropic drugs consummation.

Keywords: demyelinating disease video-oculography eye-tracking visual exploration strategies oculomotor behaviors oculomotor disorders emotions recognition social behavioral disorders social cognition brain mri
relationship between the gut microbiota and stress

Conditions: Psychological Stress

Summary: the relationship between the gut microbiota and stress is poorly studied in humans. in this study we aim to look for if stressed persons have different levels of key bacterial groups compared to the levels in non-stressed persons.

the gut microbial flora will be analyzed with molecular genetic methods. stress will be measured with cortisol levels in saliva and with questionnaire.

Eligibility criteria:
inclusion criteria: * healthy man between 19-35 years old exclusion criteria: * antibiotic intake * gastrointestinal diseases * diabetes * phsycological diseases * tyroid related diseases * cardiovascular diseases * celiaki * cortisone drugs
a study of dipeptidyl-peptidase iv (dpp-iv) ro4876904 in patients with type 2 diabetes.

Conditions: Diabetes Mellitus Type 2

Summary: this 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a dpp-iv inhibitor compared to placebo in patients with type 2 diabetes. patients will be randomized to receive dpp-iv(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. patients receiving metformin before the study will continue on the same dose of metformin. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes diagnosed \>= 1 month before screening; * drug-naive, or pretreated with maximum tolerated dose (mtd) of metformin; * bmi 25-45kg/m2. exclusion criteria: * type 1 diabetes; * any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.
cerebellar high-frequency rtms in balance of multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: background: multiple sclerosis (ms) is a chronic autoimmune disease affecting the central nervous system (cns), leading to progressive motor dysfunction and balance deficits. objective: to investigate the impact of cerebellar rtms in improving postural control, balance performance and functional ambulation in individuals with ms. forty patients were randomly assigned to receive repetitive transcranial magnetic stimulation (rtms) over the cerebellum to improve motor function and balance in 40 ms patients. outcome measures, including the expanded disability status scale (edss), static posturography (cop measures), the international cooperative ataxia rating scale (icars), and the 10-meter walk test (10mwt), were assessed before and after intervention.

background: multiple sclerosis (ms) is a chronic autoimmune disease affecting the central nervous system (cns), leading to progressive motor dysfunction and balance deficits. although disease-modifying therapies have advanced, there remains an unmet need for effective treatments that target motor and cognitive impairments. objective: to investigate the impact of cerebellar rtms in improving postural control, balance performance, and functional ambulation in individuals with ms. method: this randomized, single-blinded, placebo-controlled clinical trial evaluated the efficacy of repetitive transcranial magnetic stimulation (rtms) over the cerebellum in improving motor function and balance in 40 ms patients. outcome measures, including the expanded disability status scale (edss), static posturography (cop measures), the international cooperative ataxia rating scale (icars), and the 10-meter walk test (10mwt), were assessed before and after intervention.

Eligibility criteria:
inclusion criteria: * patient age ≥18 years. * patients with ms, established by clinical, laboratory, mri criteria and matched mc donald's criteria, mcdonald et al, 2006. * expanded disability status scale (edss) scores between 2.5-5 * only patients in "remitting" phase were included. * informed consent. exclusion criteria: * factors that prevent patient cooperation understanding that impede proper study participation. * disabling medical history as severe or recent heart disease and or severe head trauma. * cognitive impairment: \<24 points by mini-mental scale. (folstein mf et al., 1975). * diabetic patients. * patients with any other comorbidity that can affect balance, e.g, other neurological diseases that can affect posterior column function. * contraindications for rtms: 1. history of epilepsy. 2. metal (implants) in skull/scalp/head or fragments from welding or metalwork. 3. implanted device (as spinal cord stimulator, cardiac pacemaker, and cochlear implants). 4. pregnancy.

Keywords: multiple sclerosis, cerebellar rtms, balance in multiple sclerosis,
data collection in lutetium treated prostate cancer: recording of progression and tumor characteristics

Conditions: Prostate Cancer Metastatic

Summary: this prospective study aims to collect data and blood biomarkers from patients undergoing lu-psma therapy at the erasmus mc. in doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from lu-psma treatment.


Eligibility criteria:
inclusion criteria: * participants should be at least 18 years old. * participants should be able to understand the written information and be able to provide informed consent. * participants are planned to start treatment with lu-psma as a part of regular clinical care. exclusion criteria: none applicable

Keywords: mcrpc lu-psma prostate cancer radioligand therapy
effect of breakfast or omission of breakfast in t2d

Conditions: Type 2 Diabetes

Summary: the investigators will explore the effect of omission of breakfast on postprandial hyperglycemia and insulin and intact glp-1 response after subsequent meals in type 2 diabetic patients

in obesity and in type 2 diabetes eating behavior especially the lack of breakfast promote weight gain, increase hunger and carbohydrate craving. the present study is designed to address whether in t2d, a change in meal timing; specifically, by adding calories, protein and carbohydrates to the breakfast vs.the omission of breakfast will influence the postprandial elevation of glucose, insulin, intact glp-1, glucagon and free fatty acids (ffa) after subsequent meals at lunch and dinner. the investigators expect that compared to the day with breakfast condition the day when the breakfast will be omitted the postprandial glucose , free fattly acids, and glucagon response after lunch and dinner will be significative higher while insulin and intact glp-1 response after lunch and dinner will be reduced

Eligibility criteria:
inclusion criteria: 1. type 2 diabetics for \< 10yr 2. hba1c: 7-9 % 3. bmi: 22 to 35 kg/m2) 4. age: ≥30 and ≤70 years of age 5. habitually eat breakfast 6. naïve or treated with oral antidiabetic drugs and those with anti-hypertensive and lipid-lowering medication 7. those treated with insulin or glp-1 analogs or having major liver, heart or kidney illnesses will be excluded. 8. usually wake up between 06:00 and 07:00 and go to sleep between 22:00 and 24:00. 9. not dieting and no change in body weight \>10 lb = 4.5 kg within the last 6 months 10. stable physical activity pattern during the three months immediately preceding study initiation 11. normal liver and kidney function 12 no metabolic disease other then diabetes 13. usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00. 15. normal tsh and ft4 levels 16. acceptable health based on interview, medical history, physical examination, and laboratory tests 17. those who provide signed informed consent exclusion criteria: 1. type 1 diabetes 2. pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery. 3. abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate 4. anemia (hg \> 10g/dl) 5. serum creatinine level \> 1.5 mg/dl 6. pregnant or lactating 7. participating in another dietary program or use of weight-loss medications 8. documented or suspected history (within one year) of illicit drug abuse or alcoholism. 9. use of psychotropic or anoretic medication during the month immediately prior to study onset 13.work shifts within the last 5 years and did not cross time zones within the last month of the study.
z mini-plate with lingual extension versus conventional 2 mini plates

Conditions: Mandible Fracture

Summary: the collected patients according to the eligibility criteria will be randomly distributed into one of these groups: group i : 10 patients suffering class iii mandibular fracture will be managed by patient specific z shape mini-plate with lingual extension (study group). group ii : 10 patients suffering class iii mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group). the allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. all patients will provide the informed consent after declaration the procedures, benefits, and harms


Eligibility criteria:
inclusion criteria: * - class iii mandibular fracture * medically stable patient * aged above 21 years * no medical condition affect the bone healing exclusion criteria: * • absence of other facial trauma, mandibular condylar fracture * patient refuse the follow up
randomized control trial for overweight employees in worksites

Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome; Lifestyle Risk Reduction

Summary: impact of lifestyle intervention in at-risk asian indians at worksite remains largely unexplored. the aim of this study was to assess impact of the multi-component interventions on body weight, body fat patterning and cardio-metabolic risk factors in overweight individuals working in corporate worksites in new delhi, north india.

a randomized open label clinical trial is planned in 4 worksites. the total study duration is 18 months. four workplace sites will be divided into two active intervention and two control sites. intensive awareness generation activities for overweight and obese employees and a general awareness health, nutrition and physical education programme for the rest of the employees. the study subjects will be part of awareness sessions which will be conducted in the 6 month intervention period. besides group sessions individual diet charts will also be worked out by a trained nutritionist. physical activity advice will be provided to them keeping their specific requirements in mind. pedometers will be provided to them and they will be encouraged to walk for 15 minutes in pre-lunch period. leg movements at the desk will also be encouraged.

Eligibility criteria:
inclusion criteria: * overweight (≥23kg/m 2 ) individuals in the age group 25-55 years * individuals who are willing to participate in the study exclusion criteria: * previously diagnosed diabetics and patients with coronary artery disease. * have received any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, (e.g. metformin, thiazolidinediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors * pregnant and lactating women * severe end organ damage or chronic diseases:renal/hepatic failure, any malignancy, major systemic illness etc. * known case of hiv infection * unwillingness to participate in the study
ablation targets of scar-related ventricular tachycardia identified by dynamic functional substrate mapping

Conditions: Tachycardia, Ventricular

Summary: this study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques.

the study participants are patients presented with recurrent ventricular tachycardia. they will be divided into 2 groups in terms of mapping. the first group will use mapping during sinus rhythm to identify late potentials that may be incriminated in the tachycardia circuit. the other group will undergo mapping during right ventricular extrastimulus pacing to unmask hidden potentials. the identified potentials will be ablated in both groups.

Eligibility criteria:
inclusion criteria: * • patients with structural heart disease; previous myocardial infarction, left ventricular dilatation/systolic dysfunction, or normal left ventricular diameters/ systolic function with evidence of ventricular scar on contrast enhanced-cardiac magnetic resonance or electroanatomic map. * sustained monomorphic ventricular tachycardia documented by 12-lead ecg or implantable cardioverter defibrillator (electrograms resistant to antiarrhythmic drug treatment or requiring implantable cardioverter defibrillator therapies. exclusion criteria: * • patients with ventricular arrhythmias attributed to reversible causes.
metabolic signatures and biomarkers in schizophrenia

Conditions: Schizophrenia

Summary: we plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone. these drugs have inherently different risk for metabolic adverse effects and patients respond to them differently. metabolic signatures for the drugs capture significant biochemical information that could explain part of the basis for varied drug response within individuals and will highlight pathways implicated in drug action and in disease pathogenesis possibly enabling new drug design strategies. in addition, we will compare patients to healthy controls at baseline in regard lipid profiles.

schizophrenia (sch) is a devastating mental disease that affects the human population worldwide with an incidence of about 1%. most individuals with this illness benefit from long-term pharmacotherapy, however, the therapeutic effects of antipsychotic treatment are inconsistent, incomplete, and often countered by significant side-effects associated with long-term physical morbidity (e.g., tardive dyskinesia, obesity, hyperglycemia, hyperlipidemia. metabolomics is a powerful new technology that provides a snap shot of biochemical pathways at a particular point in time. it has been earmarked as an important area to develop under the nih roadmap initiative. we plan to use this platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone. these drugs have inherently different risk for metabolic adverse effects and patients respond to them differently. metabolic signatures for the drugs capture significant biochemical information that could explain part of the basis for varied drug response within individuals and will highlight pathways implicated in drug action and in disease pathogenesis possibly enabling new drug design strategies.in addition, we will compare patients to healthy controls at baseline in regard lipid profiles, to assess whether lipid profiles differ between unmedicated schizophrenia patients and healthy controls.

Eligibility criteria:
inclusion criteria: * age 18-60 years * diagnosis of schizophrenia * actively psychotic * no more than a single dose of antipsychotic in the preceding 2 weeks exclusion criteria: * mental retardation, epilepsy or history of head trauma * substance use disorder that explains the majority of the psychopathology * pregnant or lactating females

Keywords: schizophrenia metabolomics
steroid metabolism in obese and non-obese pediatric patients hospitalized for status asthmaticus

Conditions: Pediatric Obesity; Asthma in Children

Summary: single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation.

this is a prospective study aiming to characterize the pharmacokinetics of methylprednisolone in obese and non-obese children hospitalized for asthma, and to build a metabolomic profile for each cohort. the primary hypothesis is that the obese cohort will have increased methylprednisolone clearance compared to the non-obese cohort. the secondary hypothesis is that the obese cohort will have decreased amounts of 11-β-hydroxysteroid dehydrogenase in the serum which will correlate to abnormalities in steroid clearance. the tertiary hypothesis is that the obese cohort will have increased levels of branched chain amino acids and inflammatory markers which will correlate to disease severity.

Eligibility criteria:
inclusion criteria: 1. age between 2 years and 20 years inclusive 2. written informed consent provided by a parent or legal guardian 3. admitted to duke children's hospital for primary reason of asthma exacerbation (and treated with methylprednisolone) 4. bmi-percentile greater than 95th for obese subjects and bmi less than 95th percentile for non-obese subjects exclusion criteria: 1. patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the pi. 2. receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment 3. any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.
phase 3 study of qlg2198 in haemodialysis chinese adult subjects with moderate-to-severe pruritus

Conditions: Uremic Pruritus

Summary: this a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.

total study duration for a single subject is 31 to 32 weeks with a 4-week screening period, a 12-week double-blind period, a 14-week open-label extension period, and a 1-week follow-up period. qlg2198 will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session. the total dose of the investigational product will be determined based on the subject's prescription dry body weight. the primary objective of the study is: to evaluate the efficacy and safety of qlg2198 0.5 μg/kg compared to placebo in reducing the intensity of itch in hd subjects with moderate-to-severe pruritus.

Eligibility criteria:
inclusion criteria: * subjects with chronic kidney disease (ckd) on hd 3 times weekly for ≥12 weeks prior to screening who can continue hd without changing its frequency or method * if female, is not pregnant, or nursing. * agrees not to donate sperm or egg after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use contraceptive method from heterosexual intercourse during the study until 7 days after the last dose of investigational product. * subjects with a prescription dry body weight between 40 and 100 kg exclusion criteria: * planned to receive a kidney transplant during the study. * has localised itch restricted to the palms of the hands. * has pruritus only during the dialysis session * subjects with severe hepatic impairment (child-pugh class c) or concurrent hepatic cirrhosis. * subject is receiving ongoing ultraviolet treatment . * subjects with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely. * known or suspected history of alcohol or drug abuse/dependence within 12 months prior to screening. * new or change of treatment received for itch within 2 weeks prior to screening.