Kornimate/medical-research-clean huggingface dataset:
trial investigating the effect of semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride metabolism and gastric emptying in obese subjects compared with placebo

Conditions: Diabetes; Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in europe. the aim of the trial is to investigate the effect of semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride metabolism and gastric emptying in obese subjects compared with placebo.


Eligibility criteria:
inclusion criteria: * male or female, age above or equal to 18 years at the time of signing informed consent * hba1c (glycosylated haemoglobin a1c) below 6.5% * a bmi (body mass index) between 30-45 kg/m\^2 (both inclusive) exclusion criteria: * females who are pregnant, breast-feeding or intend to become pregnant or is of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local law or practice, uk requirements: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods together with the use of spermicide, and sexual abstinence) * any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol * diagnosis of type 1 or 2 diabetes mellitus * anticipated change in lifestyle (e.g. eating, exercise or sleeping pattern) during the trial * use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: 1) within 12 months prior to screening any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers, 2) within 3 months prior to screening use of statins, antihyperlipidemics including fibrates or nicotinic acid and its derivates, 3) supplementation with omega 3 fatty acids from 1 month prior to screening, 4) co-treatment with antihypertensive drugs is allowed if treatment has been stable for at least 1 month prior to screening and treatment should be kept unchanged during the trial * significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week for females and 28 units of alcohol per week for males (1 unit of alcohol equals ½ pint \[285 ml\] of beer or lager, 1 glass \[125 ml\] of wine, or 1/6 gill \[25 ml\] of spirits) * smoking or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive cotinine test
registry study on intraocular lenses manufactured by teleon surgical b.v.

Conditions: Aphakia; Cataract; Clear Lens Exchange; Refractive Lens Exchange

Summary: this is a retrospective, observational (registry) study aiming to collect safety and performance data on the use of intraocular lenses (iols) manufactured by teleon surgical b.v. according to routine practice.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * diagnosis of cataract in at least one eye or seeking clear/refractive lens exchange * provide consent to retrospective data collection exclusion criteria: * patients younger than 18 years * patients with congenital primary aphakia or secondary aphakia

Keywords: pseudoaphakia
neuroimaging study of dexmedetomidine-induced analgesia

Conditions: Analgesia; Anesthesia

Summary: neuroimaging data will be collected for patients that are given low doses of dexmedetomidine in order to understand its analgesic effects.

in this trial, participants will be given dexmedetomidine using a single-arm study design. fmri will be conducted during this time. cognitive assessments and pain monitoring will be administered at various points before and after dexmedetomidine is administered.

Eligibility criteria:
inclusion criteria: * between the ages of 18 to 45 * normal body weight and habitus, bmi ≤ 30 * non-smoker * american society of anesthesiologists (asa) physical status classification p1 * active health insurance coverage * fully vaccinated against covid-19 exclusion criteria: * cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension * respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath * hepatic: hepatitis, jaundice, ascites * neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, meniere's disease, parkinson's disease, neuropathy, peripheral stenosis * gastrointestinal: esophageal reflux, hiatal hernia, ulcer * endocrine: diabetes, thyroid disease * renal: acute or chronic severe renal insufficiency * hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy * musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia * psychiatric: history or treatment for an active psychiatric problem, depression * reproductive: pregnancy, breast-feeding * medications: regular use of prescription and non-prescription medications expected to affect cns function, st. john's wort * allergies: dexmedetomidine, ondansetron, glycopyrrolate, phenylephrine * dermatologic: ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement. * mri reasons for exclusion: history of head trauma, surgical aneurysm clips, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, metal rods, plates, or screws, intrauterine device, hearing aid, dentures, metal injury to eyes, metallic tattoos anywhere on the body or near the eye.
a study of epx-100 (clemizole hydrochloride) in participants with dravet syndrome

Conditions: Dravet Syndrome

Summary: this is a multicenter, phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hcl (epx-100) as adjunctive therapy in children and adult participants with dravet syndrome.

this is a global multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of clemizole hcl as adjunctive therapy in children and adult participants with dravet syndrome. the study consists of a 4-week observational period, a 16-week double-blind (db) period and an open-label extension (ole) period for up to 156 weeks.

Eligibility criteria:
key inclusion criteria: 1. male and female participants 2 years and older at time of consent. 2. participant or parent/legally authorized representative (lar) willing and able to provide written informed consent, assent (if applicable) prior to initiation of any study related procedures. 3. clinical diagnosis of dravet syndrome. participants must have seizures which are not completely controlled by aeds with the following criteria: * onset of seizures prior to 18 months of age, * normal development at onset, * history of at least one type of countable motor seizure (cms), * brain mri without cortical malformation (not including mild atrophy associated with the natural progression of dravet syndrome), * genetic mutation of the scn1a gene must be documented. key exclusion criteria: 1. known sensitivity, allergy, or previous exposure to clemizole hcl. 2. exposure to any investigational drug or device \<90 days prior to screening or plans to participate in another drug or device trial at any time during the study. 3. seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol \[thc\] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system (cns) disease deemed progressive, metabolic illness, or progressive degenerative disease. 4. prior or concurrent use of lorcaserin. 5. concurrent use of fenfluramine. 6. epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to screening.

Keywords: clemizole hydrochloride convulsive seizure pediatric epilepsy dravet syndrome
acceptance and commitment therapy for chronic pain in sci: development and testing of an ehealth program

Conditions: Spinal Cord Injuries

Summary: this study will test the newly-developed my spinal cord injury (sci) toolkit program in two formats - unguided use of the program and use supported by a coach. these two active treatment formats will be compared to treatment as usual (waitlist control) in adults with chronic pain and sci. hypotheses include: * treatment adherence, participant satisfaction, and perception of positive change will be high and drop-out rates low for both treatments but will be better in the coached compared to the unguided arm * in terms of pre- to post-treatment changes in pain interference, coached my sci toolkit program will be superior to treatment as usual

all participants will also be asked to complete online surveys at baseline (before being randomized to a group), half-way through the 8-week study period, and after the 8-week study period is over. the surveys are online and can be completed from home. participants in the unguided and coached programs will also be asked to complete a weekly online survey asking about use of the website in the past week, taking approximately 5 minutes to complete.

Eligibility criteria:
inclusion criteria: * diagnosis of sci (all injury levels included); * average pain intensity over the past 3 months greater or equal to (≥) 4/10 on 0-10 numerical rating scale * fluent in english and able to read english at a 6th grade level * access to internet connected device (phone, tablet, computer) and telephone * willingness to maintain stable analgesic regimen during study period exclusion criteria: * currently in inpatient care or intensive outpatient physical therapy * significant cognitive impairment as indicated by scores ≥2 on cognitive screener

Keywords: my sci toolkit ehealth-delivered acceptance and commitment therapy (act) intervention chronic pain
a study of kw-6356 in patients with parkinson's disease on treatment with levodopa-containing preparations

Conditions: Parkinson's Disease

Summary: the primary objective of this study is to determine the recommended dose and evaluate the effect of kw-6356 on motor symptoms in parkinson's disease and the primary endpoint is the change from baseline in movement disorder society-unified parkinson's disease rating scale(mds-updrs) partiii score between kw-6356 and placebo in patients with parkinson's disease on treatment with levodopa-containing preparations as an adjunctive therapy.


Eligibility criteria:
inclusion criteria: * subject fulfills the uk parkinson's disease society brain bank clinical diagnostic criteria. * parkinson's disease patients in stages 2 to 4 on the modified hoehn and yahr scale. (mh\&y, evaluation at on state for patients who experience wearing-off phenomenon) * mds-updrs partiii score of \>= 15. (evaluation at on state) * subject who are responsive to levodopa/dci (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment. * subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment. exclusion criteria: * use of any cyp3a4/5-related drugs within 2 weeks prior to enrollment. * use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection * treatment by transcranial magnetic stimulation (tms) within 6 months prior to enrollment. * neurosurgical operation for parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife) * subject who have received administration of adenosine a2a receptor antagonist. * either of the following criteria consecutively at screening and enrollment; resting pulse \> 100 bpm resting systolic blood pressure \> 140 mmhg, or diastolic blood pressure \> 90 mmhg * significant dementia or a mini-mental state examination (mmse) score of =\< 23. * subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the columbia-suicide severity rating scale (c-ssrs) at baseline. * anyone otherwise considered unsuitable for the study by the investigator or subinvestigator including those who are unable to communicate or to cooperate with the investigator or subinvestigator.
prehabilitation and posttransplant training program in liver transplantation

Conditions: Liver Transplant; Complications; Cirrhosis, Liver; Hepatic Carcinoma

Summary: preliver-t consists of a prospective randomized clinical trial conducted in an adult population that is a candidate for liver transplantation (lt) at the hospital la fe valencia (spain). the study is structured in three phases: i) prehabilitation (2 months before lt); ii) training, divided in two successive periods: supervised training (months 3-6 after lt) and unsupervised training (6-12 months after lt); iii) long-term follow-up (2 years after lt). primary outcomes are related to post-surgery evolution (morbidity and mortality, hospitalization length, etc.). as a secondary outcomes are collected those related to: functional capacity, muscle strength and quality of life.

the main objective is to study the post-surgical impact (post-s) of a prehabilitation program on candidates for liver transplantation (lt), as well as to study the effects of posttransplant training on the clinical and functional evolution of the recipients. also this project pretends to assess the influence of functional capacity (fc) improvement on the short and long term post-s evolution of the lt candidates. this is a prospective randomized clinical trial in which three phases follow: prehabilitation, training and follow-up. the sample will be constituted by 60 candidates for lt, randomized in a control group (cg, n=20), a prehabilitation group (pg, n=20) and a prehabilitation-posttransplant training group (ptg, n=20). to conventional care, a prehabilitation program will be added to the pg and ptg. after the lt, just ptg will follow a posttransplant training program. the long-term follow-up will be extended to 2 years post-lt. the variables under study will be: complications and post-s evolution; fc; quality of life; etc. the individualization of prehabilitation and posttransplant training program, and also medical control, will ensure safety and offer the potential benefits that these types of programs can provide.

Eligibility criteria:
inclusion criteria: * indication of elective liver transplant with favorable cardiorespiratory evaluation that does not contraindicate the transplant. exclusion criteria: * any orthopedic, motor, functional, neurological, cognitive or linguistic limitation that prevents the realization of the prehabilitation program * inability to perform psychometric tests * esophageal varices not treated with ligature or beta-blockers * varicose veins with a high risk of digestive hemorrhage * hemoglobin \<80 g/l * contraindication to weight loading * impossibility to comply with the prehabilitation program (hospital admission, work, geographical location) * multi-organ transplantation and liver retransplantation * refusal or lacks capacity to give informed consent

Keywords: prehabilitation therapeutic exercise functional capacity
the culture of ovarian cancer organoids and drug screening

Conditions: Ovarian Cancer

Summary: the tumor organoids platform can provide the precise genetic information and phenotype, as well as the heterogeneity of the tumor, thus provide information on drug sensitivity specific to the patient.this is an exploratory research to see if organoids testing could help guide precision treatment for ovarian cancer(oc) patients.

tissue will be received from operative specimens( primary ovarian carcinoma) at time of primary cytoreductive surgery.ovarian cancer(oc) organoids will be then cultured. organoids will be validated with a combination of next generation sequencing (ngs) analysis and immunohistochemistry (tp53, pax8 etc). after then, the patient-derived organoids cultured from oc will be compared the sensitivity to standard regimens (chemotherapies and targeted agents) recommendated by nccn guidlines versus patients treated in clinical practice.

Eligibility criteria:
inclusion criteria: 1. ovarian cancer patients who will accept primary cytoreductive surgery, with histopathological type: low/high grade serous carcinoma, clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma. 2. ecog score 0\~1,age 18\~70 years old 3. expected survival over 6 months 4. the serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial 5. cbc：hb≥70g/l、wbc≥3.5×109/ l 、anc≥1.5×109/l、plt≥80×109/l； 6. serum alt≤2×ul, ast≤2×uln；serum creatinine≤1.5×uln； exclusion criteria: 1. activity or uncontrol severe infection 2. liver cirrhosis, decompensated liver disease 3. history of immune deficiency, including hiv positive or suffering from congenital immunodeficiency disease 4. chronic renal insufficiency or renal failure 5. has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated 6. myocardial infarction, severe arrhythmia and nyha (new york heart association)≥2 for congestive heart failure 7. during the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Keywords: tumor organoids drug sensitivity precision treatment
teneligliptin and atorvastatin ddi study

Conditions: Diabete Mellitus

Summary: a randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between teneligliptin and atorvastatin in healthy male adults


Eligibility criteria:
inclusion criteria: 1. healthy male adult 19 to 45 years 2. body weight ≥ 50kg, and bmi between 18-29kg/m2 at screening 3. subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose. 4. subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.
trauma registration at st. olavs hospital 2000-2003

Conditions: Injuries, Multiple; Norway/Epidemiology; Trauma Centers/Statistics & Numerical Data; Trauma, Multiple; Trauma Severity Indices

Summary: st. olavs hospital is a trauma referral center in the region of midtnorge. admitting trauma patients locally and those referred from hospitals in nord-trøndelag, sør-trøndelag and møre-romsdal.an active trauma team was defined in 1992, but it's work has not been evaluated earlier. prospective studies of these patients were established 1st of january 2004 at st. olavs hospital.

this mapping is a observational retrospective study of trauma patients admitted to st.olavs hospital from 2000 until 2003. patient journals (electronic and paper), autopsy reports and the emergency medical respons systems (amk) database have been reviwed. we are reviewing the local traumaepidemiology, traumateam performance, mechanisms of injury and the potenially avoidable deaths in trauma.

Eligibility criteria:
inclusion criteria: * trauma team activation * motor vehicle crash with ejection * pedal cyclist, motorcyclist or pedestrian hit by vehicle \>30 km/h * fall \> 5 meters * fatality in same vehicle * interhospital trauma transfer within 24 hrs * injury to two or more body regions * fracture to two or more long bones * spinal cord injury * amputation of a limb * penetrating injury to head, neck, torso or proximal limb exclusion criteria: * burns * strangulations

Keywords: adult child hospitalization/statistics & numerical data retrospective studies
modifying treatment expectations in depression: the role of social learning

Conditions: Health Care Utilization

Summary: research has shown that treatment expectations play a major role in the course of mental disorders and that positive expectations have a beneficial impact on treatment outcomes. expectations can develop in different ways, whereby an emerging body of research has shown that social learning plays a significant role in this process. to date, most studies have investigated the impact of social learning on treatment expectations in the context of pain relief. little is known about the impact of social learning in the psychotherapeutic treatment of depression. therefore, this study investigates whether treatment expectations regarding the treatment of depression can be modulated via social learning, i.e., showing positive treatment testimonials. hypotheses: h1: the investigators predict that individuals who are provided with treatment testimonials (experimental groups) show a greater change toward positive treatment expectations compared to individuals who do not view such testimonials (control groups). h2: the investigators predict that individuals provided with treatment testimonials will, compared to the control groups, show a greater change in secondary outcome variables in the following ways: a greater decrease in perceived uncertainty/ barriers; a greater decrease in stigma/ negative attitudes toward psychotherapy; a greater increase in intentions to seek therapy; a greater willingness to try the specific technique described in the videos. h3: inter-individual differences in the effect of provided testimonials are associated with pre-existing factors: level of depressive symptoms; intolerance of uncertainty; treatment experience; locus of control; general self-efficacy; dispositional optimism and cognitive immunization tendencies. exploratory questions: 1. an exploratory aim of this study is to assess whether viewing different types of testimonials (clinician delivered; patient-delivered; combination of both) has differential effects on treatment expectation change. 2. furthermore, the investigators want to assess whether implicit treatment expectations change in a similar pattern as explicit treatment expectations. 3. based on the results of h1 and h2, the investigators aim to assess possible mechanisms of change: e.g. assess whether a change in treatment expectations is mediated by a decrease in perceived uncertainty or a change in stigma/ attitudes toward therapy.


Eligibility criteria:
inclusion criteria: * at least 18 years old * be able understand german (at least b1 level) * have access to a computer device with internet access exclusion criteria: * age below 18 years old * non correctable hearing or visual impairment

Keywords: treatment expectations social learning psychotherapy depression testimonials