Kornimate/medical-research-clean huggingface dataset:
the associations between gut length, gut microbiota and food assimilation

Conditions: Healthy Nutrition; Food Preferences; Metabolic Syndrome, Protection Against

Summary: the purpose of this observational study is to explore the relationships between gut length, the microbiota and food energy assimilation rates in humans.

the focus of this work is to characterize the relationship between gut length, gut microbiota and food energy assimilation rate in healthy individuals. the gut will be scanned using magnetic resonance imaging (mri) to calculate gut length. to obtain clearer images, volunteers will be asked to drink 1/1.5 sachet of he shuang (polyethylene glycol electrolyte powder, molecular weight of 4000) and injected raceanisodamine hydrochloride injection with 10 mg by intramuscular. volunteers will be asked to drink he shuang, which dissolved in 1/1.5l of water for the purpose of filling the intestines. as a contrast to improve imaging during scanning. volunteers will be given the experimental meal, which providing enough energy for volunteers to eat as much as they want. feces and urine will be collected to calculate the assimilation rate. to more accurately label the food, edible polyethylene glycol with a molecular weight of 3350(peg3350) is used. provides 1.5g of peg3350 per day, to be used with meals. peg3350 reaches a steady state in the intestinal tract for 3 days. food will be provided for seven days during the test period, the first three days are aimed at stabilizing the peg3350 in the intestine, and the samples to be counted are mainly collected in the last four days. food assimilation rate and metabolizable energy will be calculated for the 4-day. the gut microbiota will be analyzed by metagenomics and metabolomics. this study combines metabolomics analysis techniques with imaging and physiological measurements to focus on the potential relationship between gut length and food absorption rates. researchers anticipate recruiting up to 100 healthy volunteers (body mass index ≥ 18.5).

Eligibility criteria:
inclusion criteria: * age between 18-40 years old, healthy and disease free. * bmi ≥ 18.5; * regular bowel movements. exclusion criteria: * individuals who are constipated or suffer from intestinal disorders; * individuals with mental illnesses such as depression and claustrophobia; * individuals with glaucoma and prostate hypertrophy; * metal implants in the body; * pregnant and lactating women; * individuals with blood phobia, pathologic hypotension or hypertension; * use of antibiotics, probiotics, oral laxatives within 8 weeks; * individuals with metabolic diseases (e.g., chronic diseases such as diabetes mellitus); recent weight loss due to various medical reasons; * individuals with infectious diseases (e.g. hiv); * irregular diet, lifestyle, addiction to tobacco, alcohol or drugs.

Keywords: metabolism microbiome/microbiota body composition food intake food preference
non-inferiority analysis of two titration methods for hypoglossal nerve stimulation therapy

Conditions: Obstructive Sleep Apnea; Sleep Apnea; Apnea

Summary: hypoglossal nerve stimulation (hns) therapy (inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (osa) who cannot be effectively treated with the first-line treatment options. approximately 3 months after activation of hns therapy, a fine-tuning sleep study is performed. to date, the standard of care involves an in-laboratory overnight titration psg, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. recently, the feasibility of using a daytime psg as an alternative to a conventional overnight psg for titration of hns therapy was demonstrated. the aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight psg for titration of hns therapy in patients with osa.

this study is a prospective and retrospective, single-center non-inferiority study. the study population consists of two cohorts: (1) osa patients treated with hns that previously underwent an overnight titration psg as part of the routine clinical care pathway and (2) osa patients treated with hns that recently underwent or will be undergoing a daytime titration psg. data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (epworth sleepiness scale, functional outcomes of sleep questionnaire-30, visual analogue scale (vas) snoring. data will be collected from different visits including: pre-implant, implant, activation, titration, follow-up (6 and 12 months post-implantation).

Eligibility criteria:
inclusion criteria: * patients diagnosed with osa and implanted with hns therapy (inspire system) * cohort 1: patients that previously underwent an overnight titration psg as part of their routine clinical care at the antwerp university hospital * cohort 2: patients that recently underwent or will be undergoing a daytime titration psg at the antwerp university hospital * able to give informed consent exclusion criteria: * not able to understand the language of the questionnaires

Keywords: hypoglossal nerve stimulation titration polysomnography
a multicenter assessment of lbr-101 in high frequency episodic migraine

Conditions: Episodic Migraine Headache

Summary: the purpose of this study is to determine whether monthly subcutaneous administration of lbr-101 (fremanezumab) is safe and provides migraine prevention in subjects with high frequency episodic migraine.


Eligibility criteria:
inclusion criteria: * males or females aged 18 to 65 years of age. * a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments. * subjects fulfilling criteria for episodic migraine as per the second edition of the international headache society (olesen and steiner 2004), who experience migraine at high frequency as follows: i. history of headaches on more than 8 days per month for at least 3 months prior to screening ii. verification of headache frequency through prospectively collected baseline information during the 28-day run-in phase demonstrating headaches (of any type) on at least 8 days with at total of 8 to 14 days\* fulfilling criteria for migraine. \*operational definition for migraine and probable migraine days are presented in the statistical section of this protocol. * body mass index (bmi) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and 120 kg, inclusive. * demonstrated compliance with the electronic headache diary during the run-in period by entry of headache data on a minimum of 22/28 days (80% compliance). exclusion criteria: * subject has received onabotulinum toxin a for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the six months prior to screening. * subject uses medications containing opioids (including codeine) or barbiturates (including fiorinal®, fioricet®, or any other combination containing butalbital) on more than 4 days per month for the treatment of migraine or for any other reason. * failed \> 2 medication categories or \> 3 preventive medications (within two medication categories) due to lack of efficacy for prophylactic treatment of episodic or chronic migraine after an adequate therapeutic trial * treatment with an investigational drug or device within 30 days of study entry or any prior exposure to a monoclonal antibody targeting the cgrp pathway.

Keywords: high frequency episodic migraine headache episodic migraine headache migraine headache
the influence of 11+ on injury incidence and fms-score in veteran soccer players

Conditions: Injury

Summary: according to available data the injury rate in male veteran soccer is high. interventions to prevent injuries are requested. the 11+ warm-up program was developed by fifa-experts and consists of several exercises with an overall-length of about 20 min. this study shall investigate the influence of 11+ on injury incidence and functional movement screen (fms)-score in male veteran soccer players. additionally it is to be examined if there is a relationship between fms-score and injury incidence. for this purpose the 11+-program is accomplished under supervised conditions over one regular season in a randomized-controlled study design. injuries are documented via questionnaires in accordance with the fifa-consensus-statement. fms-score is evaluated before and after the interventional period.


Eligibility criteria:
inclusion criteria: * male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis exclusion criteria: * major time-loss injury, chronic inflammatory joint disease

Keywords: injury incidence, male veteran soccer, 11+, functional movement screen, fms, warm-up
the prognostic value of biomarkers and the effect of tolperisone in acute low back pain and sciatic pain "beta"

Conditions: Low Back Pain

Summary: the main purpose of the trial is to identify biomarkers from the blood as well as electrophysiologic and morphometric features (chemical, electrophysiologic and ultrasound biomarkers) that reflect the intensity of pain and/or foretell the efficacy of pharmacological (non-surgical) treatment in patients with acute low back pain.

the investigators include patients aged 18-80 years with acute (less than 1-month) low back pain with or without radicular signs, who do not have severe diseases (abscess, tumor, etc) in the background, already had ct or mri scan during routine workup, and who have given written consent to participate in the study. exclusion criteria are pregnancy, hypersensitivity to tolperisone in the history, severe liver or kidney disease, other severe diseases (abscess, tumor, etc) in the background of pain. the patients will be given 3 times daily 150 mg tolperisone or placebo in addition to standard therapy in a randomized double-blind design. treatment will last for 14 days and a final follow-up is performed at 21 days. clinical condition and biomarkers will be tested before treatment and at 14 days. patients fill in a diary on a daily basis.

Eligibility criteria:
inclusion criteria: * healthy pain-free volunteers (n=30) outside of the randomized study, will participate to establish normal values of blood biomarkers. exclusion criteria: * pain, inflammation,

Keywords: back pain sciatic pain biomarkers
mammography screening with artificial intelligence (masai)

Conditions: Breast Cancer

Summary: the purpose of this randomized controlled trial is to assess whether ai can improve the efficacy of mammography screening, by adapting single and double reading based on ai derived cancer-risk scores and to use ai as a decision support in the screen reading, compared with conventional mammography screening (double reading without ai).

european guidelines recommend that mammography exams in breast cancer screening are read by two breast radiologists to ensure a high sensitivity. double reading is, however, resource demanding and still results in missed cancers. computer-aided detection based on ai has been shown to have similar accuracy as an average breast radiologist. ai can be used as decision support by highlighting suspicious findings in the image as well as a means to triage screen exams according to risk of malignancy. eligible women will be randomized (1:1) to the intervention (ai-integrated mammography screening) or control arm (conventional mammography screening). in the intervention arm, exams will be analysed with ai and triaged into two groups based on risk of malignancy. low risk exams will be single read and high risk exams will be double read. the high risk group will contain appx. 10% of the screening population. within the high-risk group, exams with the highest 1% risk will by default be recalled by the readers with the exception of obvious false positives. ai risk scores and computer-aided detection (cad)-marks of suspicious calcifications and masses are provided to the reader(s). in the control arm, screen exams are double read without ai (standard of care). considering the interplay of number of interval cancers and workload, the study will be considered successful if the interval-cancer rate in the intervention arm is not more than 20% larger than in the control arm. if the interval-cancer rate is statistically and clinically significantly lower in the intervention arm than in the control arm, ai-integrated mammography screening will be considered superior to conventional mammography screening.

Eligibility criteria:
inclusion criteria: women eligible for population-based mammography screening. exclusion criteria: none.

Keywords: mammography screening artificial intelligence
effect of ranolazine on echocardiographic indices of diastolic dysfunction

Conditions: Ranolazine; Diastolic Heart Failure; Tissue Doppler Ultrasound; Echocardiography

Summary: the purpose of this study is to evaluate the effects of ranolazine, an fda-approved medication for the treatment of angina, on heart function by using echocardiography.


Eligibility criteria:
inclusion criteria: * moderate of severe diastolic dysfunction, e/ea\>12 * preserved systolic function * nyha class i-ii exclusion criteria: * qtc \>450 msec at enrollment * taking medications that prolong qt interval or are potent inhibitors of cyp3a * significant coronary artery disease * severe valvular disease * hepatic disease * severe kidney disease * women of childbearing age * prior serious ventricular arrhythmia
a study of glwl-01 in patients with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: the aim of this study is to evaluate efficacy, safety, and pharmacokinetics of glwl-01 in the treatment of patients with prader-willi syndrome (pws).

participants will be assigned to one of two treatment sequences (glwl-01/placebo or placebo/glwl-01), with each sequence consisting of two treatment periods separated by a washout period

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pws based on genetic confirmation using dna method * body mass index (bmi) of 27 to 60 kg/m2 * no evidence of weight excursion beyond 10% of baseline weight * patients must provide assent and have a reliable caregiver (must have been caring for the patient for at least 6 months) who provides a separate written informed consent to participate. the caregiver is expected to be the primary caregiver throughout the study and must be in frequent contact with the patient (defined as at least 4 awake hours per day). the caregiver must be able to communicate with site personnel and in the investigator's opinion must have adequate literacy to complete questionnaires. if a caregiver cannot continue, 1 caregiver replacement is allowed * are on a stable diet and exercise regimen for \>2 months prior exclusion criteria: * current enrollment in or discontinuation within the last 30 days from a clinical trial involving any investigational drug or device * are currently living in a group home for more than 50% of the time * a history or presence of other medical illness that indicates a medical problem that would preclude study participation * have an estimated glomerular filtration rate \ 300 μg/mg) or hematuria * are hypertensive (defined as sitting systolic blood pressure (bp) greater than or equal to (≥)140 millimeters of mercury (mmhg) and diastolic bp ≥90 mmhg) * patients on weight loss medications within 30 days of dosing, or with a history of bariatric surgery * unable to refrain from or anticipates the use of: 1. any drugs known to be significant inhibitors of cytochrome p450, family 3, subfamily a (cyp)3a enzymes and/or p-glycoprotein (p-gp) including regular consumption of grapefruit or grapefruit juice for 14 days prior to the first dose. acetaminophen (up to 2 grams per 24-hour period) may be permitted 2. any drugs known to be significant inducers of cytochrome p450, family 3, subfamily a (cyp3a) enzymes and/or p-gp, including st. john's wort 3. any medications that prolong the qt/qtc interval, unless the participant has been stable on the medication for at least 3 months and has a corrected qt interval (qtc) \<450 msec * currently taking simvastatin \>10 mg per day, atorvastatin \>20 mg per day, or lovastatin \>20 mg per day, or have a history of statin-induced myopathy/rhabdomyolysis * unsuitable for inclusion in the study in the opinion of the investigator
scandinavian starch for severe sepsis/septic shock trial

Conditions: Severe Sepsis; Septic Shock

Summary: * by tradition hydroxyethyl starch (hes) is used to obtain fast circulatory stabilisation in critically ill. * high molecular weight hes may, however, cause acute kidney failure in patients with severe sepsis. * now the low molecular weight hes 130/0.4 is the preferred colloid in scandinavian intensive care units (icu) and 1st choice fluid for patients with severe sepsis. * hes 130/0.4 is largely unstudied in icu patients. * this investigator-initiated scandinavian multicentre trial will be conducted to assess the effects of hes 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis. * the trial will provide important data to all clinicians who resuscitate septic patients.

fluid is the mainstay treatment in sepsis resuscitation, but the effects of different crystalloid and colloid solutions on outcome remain unknown. previously, a high molecular weight hydroxyethyl starch, hes 200, was used, but this was found to cause acute kidney failure in patients with severe sepsis. as kidney failure is an independent risk factor for death in these patients, hes 200 is not used anymore. in stead a lower molecular weight starch, hes 130, has been developed. presently, this is the preferred colloid in scandinavian intensive care units (icu), but the effects of hes 130 in icu patients are currently unknown. the proposed scandinavian multicentre study will be conducted to assess if hes 130 contributes to acute kidney failure in patients with severe sepsis. as hes 130 is widely used, the trial will provide important safety data to clinicians who resuscitate septic patients.

Eligibility criteria:
inclusion criteria: all adult patients who * undergo resuscitation in the icu * and fulfillment within the previous 24 hours of the criteria for severe sepsis (sccm/accp) * and consent is obtainable either from the patient or by proxy (physician and/or next of kin) exclusion criteria: the following patients will not be evaluated for inclusion: * age \< 18 years old * previously randomised in the 6s trial * allergy towards hydroxyethyl starch or malic acid * treatment with \> 1000 ml's of any synthetic colloid within the last 24 hours prior to randomisation * any form of renal replacement therapy * acute burn injury \> 10% body surface area * severe hyperkalaemia, p-k \> 6 mm * liver or kidney transplantation during current hospital admission * intracranial bleeding within current hospitalisation * enrollment into another icu trial of drugs with potential action on circulation, renal function or coagulation * withdrawal of active therapy

Keywords: sepsis shock fluid therapy plasma expanders
induction of ho-1; a therapeutic approach to reduce ischaemia reperfusion injury (iri) following deceased donor renal transplantation

Conditions: Graft Failure; Ischemia-reperfusion Injury

Summary: this is a blinded, placebo-controlled, randomised controlled trial looking at the effects of heme arginate (ha) on cadaveric renal transplantation. the investigators know that ha can upregulate ho-1, which has been shown to have a protective effect on animal transplants. the investigators will be giving ha/placebo to participants prior to transplant and repeat again on day 2 post-transplant and compare outcomes.

patients will be recruited from the east of scotland transplant waiting list and consent when they arrive in the hospital. the investigators will randomise them to drug or placebo and give the infusion prior to induction for their transplant. a blood sample will be taken prior to infusion and a renal biopsy will be taken before the graft is implanted. these will be used as baseline values. patients will receive standard care from our unit. the investigators will use the routine blood test results (urea and creatinine) to determine the function of the graft. the investigators will take blood samples 24 hours after infusion of drug/placebo and use this to determine the primary outcome. blood tests will be taken daily and a renal biopsy taken on day 5 to fulfil secondary objectives.

Eligibility criteria:
inclusion criteria: * all patients receiving a cadaveric single kidney transplant * patients on a standard immunosuppressive regime exclusion criteria: * patients on different immunosuppressives * patients receiving 3rd or subsequent kidney transplant * patients are fully anti-coagulated * patients unable to take heme arginate * patients unable to give informed consent * patients on combined anti-platelet agents

Keywords: renal transplantation ischemia-reperfusion injury heme-oxygenase 1 heme arginate
effect of postoperative additive systemic steroids in crswnp

Conditions: Sinusitis, Chronic

Summary: this study investigate the additive effect of systemic postoperative steroids in patients with chronic rhinosinusitis (crswnp). all patients receive a functional endoscopic sinus surgery (fess) followed by topical steroid spray for 3 months. postoperatively, patients will be randomized to either an additional systemic steroid or a placebo for 1 month. patients will be followed for 2 years. effect on nasal polyp score (nps), lund-kennedy-score (lks), recurrence rates, smell scores, rhinosinusitis disability index (rsdi), short-form 36 (sf-36) and mucus/serum biomarkers will be measured.


Eligibility criteria:
inclusion criteria: * crswnp * refractory to medical therapy * no previous sinus surgery * lund-kennedy-score ≥ 1 * lund-mackay-score ≥ 10 exclusion criteria: * ciliary impairment * autoimmune disease * cystic fibrosis * immunodeficiency

Keywords: steroid recurrence smell biomarker endoscopy
a study of bgm0504 in overweight or obese participants

Conditions: Overweight or Obese

Summary: the purpose of the study is to evaluate the influence of bgm0504 injection on gastric emptying and pharmacokinetics of metformin and warfarin in overweight or obese participants


Eligibility criteria:
inclusion criteria: √ have a body mass index (bmi) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (\<) 28 kg/m². √ willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff. exclusion criteria: √ history of chronic or acute pancreatitis. * history of severe drug allergy or specific allergic disease or severe allergies. * family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2(men-2). * history of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\]. * suspected or confirmed history of alcohol or drug abuse; * any chronic infections likely to interfere with study conduct or interpretation such as hepatitis b (hbv), hepatitis c (hcv), human immunodeficiency virus (hiv) or treponema pallidum (tp). * donation or loss of 400 ml or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial. * pregnant or lactating woman. * any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.