Kornimate/medical-research-clean huggingface dataset:
effect of vitamin d supplementation on vedolizumab response in patients with ulcerative colitis

Conditions: Ulcerative Colitis; Vitamin D Deficiency; Vitamin D Supplement

Summary: it is uncertain whether vitd3 supplementation is beneficial for the remission of ulcerative colitis (uc). the effects of vitd3 supplements on the efficacy of vidrecizumab in chinese uc patients were retrospectively analyzed. methods: patients with moderate to severe uc were recorded. these patients were initially treated with vdz. vitd3 supplementation was defined as 400iu/d vitd3 supplementation during the first infusion of vdz and continued throughout the follow-up period. disease activity was assessed using the modified mayo score.


Eligibility criteria:
inclusion criteria: * moderate-to-severe uc * treated with vedolizumab exclusion criteria: * had recent supplementation of vitd3 * pregnant * had cognitive/developmental disorders that affected their ability to complete the study procedures * had medical illness or therapies potentially affecting bone, nutrition or growth status * unknown or untested baseline serum 25(oh)d level
s-adenosylmethionine plus choline in treatment of patients with alcoholic liver disease

Conditions: Alcoholic Liver Diseases

Summary: the study will assess the effect of treatment with formulation containing s-adenosyl methionine and choline, on patients with alcoholic liver disease. half of the patients included will receive named formulation once daily for 24 weeks while other half will receive placebo.

choline and s-adenosyl methionine are nutrients both showing hepatoprotective effects. choline helps liver metabolise glucose and lipids and repair cell membrane. s-adenosyl methionine is essential for the synthesis of glutathione, a main cellular antioxidant showing its protective effect against free radicals, among others in liver tissue. furthermore s-adenosyl methionine is involved in regulation of hepatocyte growth, differentiation, and death. it also enables endogenous production of small amount of choline. although human organism has capacity for production of small amount of s-adenosyl methionine, damaged liver can not produce it or produce it insufficient amounts. having this in mind it can be hypothesised that administration of choline and s-adenosyl methionine can be beneficial in patients with alcoholic liver disease.

Eligibility criteria:
inclusion criteria: * alcoholic liver disease exclusion criteria: * hepatitis b * hepatitis c * autoimmune hepatitis * hemochromatosis * wilson's disease * hepatocellular carcinoma

Keywords: alcoholic liver diseases s-adenosyl methionine choline
a prospective randomized controlled study of natural orifice medium-low rectal endometriosis resection

Conditions: Colon Rectal Resection

Summary: to evaluate the postoperative outcome of low medium-low rectal endometriosis: natural orifice surgery vs transabdominal surgery.

to evaluate the postoperative outcome of low medium-low rectal endometriosis: natural orifice surgery vs transabdominal surgery.both of the two kinds of surgery is conventional,but the comparison is still unclear.the investigators divide the patients into two groups, and compare the differences of postoperative outcomes by statistics.

Eligibility criteria:
inclusion criteria: childbearing age women, older than 18 years, diagnosed with intestinal endometriosis, rectum clinical symptoms for invalid medical treatment, dysmenorrhea, dyspareunia dyschezia, infertility, defecate carries blood, endometriosis in the lower rectum by intraoperative judgment exclusion criteria: without endometriosis rectum, history of colorectal surgery, intolerance to laparoscopic surgery
impact of night shift work on 24-hour blood glucose levels

Conditions: Circadian Rhythm; Inversion; Metabolic Disease

Summary: this study will determine whether nurses regularly working night shifts have elevated 24-hour glucose levels compared to nurses regularly working day shifts, using continuous glucose monitoring (cgm).


Eligibility criteria:
inclusion criteria: * • rns working at least a 0.6 fte and 12-hour night or day shift (not able to alternate between days and nights) for at least the past two months * free from presence of uncontrolled chronic illness and specifically prediabetes, type 1 or type 2 diabetes (but not including history of gestational diabetes) and not currently taking any glucose-lowering or steroid medication * not currently pregnant or breastfeeding * english speaking and able to provide informed consent * must own and know how to operate a smartphone * must be willing and able to wear two small sensors attached by adhesive for the study duration, the fibion sens activity monitor and the dexcom g6 continuous glucose monitor * must regularly consume food during shifts and refrain from actively attempting weight loss during the study duration * must work only one job at the time of study participation
effects of ketosis on muscle kinetics and signaling during critical illness.

Conditions: Intensive Care Unit Acquired Weakness; Critical Illness

Summary: background: patients with critical illness in the intensive care unit (icu) experience marked skeletal muscle weakness, muscle atrophy and disability in physical function, commonly termed icu-acquired weakness (icu-aw). the pathophysiology of icu-aw is complex, but a key feature of skeletal muscle wasting is disturbed protein metabolism reflected in both increased rate of muscle protein degradation and reduced synthesis. treatment with 3-ohb seems a promising new anticatabolic treatment in patients with critical illness, preventing icu-aw. to date, no data exist on the clinical and functional effects of ketone body modulation in patients with critical illness. objective: the aim to investigate the effect of exogenous 3-ohb administration on muscle protein kinetics and lipolysis in patients with critical illness, aiming towards preventing icu-aw. design: a randomized double-blind isocaloric placebo-controlled cross-over study in 10 mechanically ventilated patients with critical illness in the icu. methods: evaluation of whole-body and focal leg protein kinetics using labeled phenylalanine and tyrosine tracers. assessment of free fatty acid (ffa) turnover using a labeled palmitate tracer. femoral arterial blood flow (assessed with pulsed-wave doppler ultrasound) is evaluated once per study period. blood- and urinary samples are collected routinely throughout the study day. whenever feasible, muscle and fat biopsies will be taken for analysis of protein and adipocyte metabolic signaling and mitochondrial function. perspectives: this investigation may grant essential knowledge on ketosis in critical illness. this may lead to larger clinical trials, and hopefully a new and better treatment strategy aimed at preserving muscle mass and function during and improving recovery after critical illness.


Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation via a cuffed endotracheal or tracheotomy tube. * expected survival of icu admission. * adults (≥18 years). * multi-organ failure (sequential organ failure assessment score \[sofa\] score ≥2 in 2 or more domains). exclusion criteria: * moribund or expected withholding treatment within 48 hours as judged by the investigator. * palliative goals of care. * contraindication for enteral nutrition. * pregnancy. * known severe musculoskeletal or neurological disability. * diabetic ketoacidosis. * phenylketonuria. * bmi ≤17 or deemed malnourished as judged by the investigator. * bmi \>40.
study of descartes-30 in acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome; Covid19

Summary: emergency study to test the safety of descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ards) and covid-19


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older at the time of enrollment * patient maintains a diagnosis of moderate or severe ards according to the berlin definition of ards exclusion criteria: * patient is currently enrolled into another therapeutic clinical trial with an experimental therapy that has not received marketing approval by u.s. fda. * patient is in moribund state with expected survival \<24 hours.
music as a complement to pharmacological sedation in ventilator treated icu patients.

Conditions: Music Therapy

Summary: can music theraphy during mechanical ventilation in the icu, decrease the need of pharmacological sedation? included patients will listen to music selected by a music therapist via headphones two times one hour during two days. effects on heart rate, blood pressure, respiratory rate and dosing of pharmacological sedation will be observed. 100 patients will be included and radomized equally to earphones with and without music.


Eligibility criteria:
inclusion criteria: in the icu, entilator treated adults \> 18 years. - exclusion criteria: * children \>18 years. * deaf people. * children \<18 years

Keywords: music therapy, ventilator treated patients, need of sedation.
sponsor initiated expanded access protocol, intermediate-size patient population

Conditions: Ligneous Conjunctivitis

Summary: the purpose of this protocol is to provide compassionate use of kedrion human plasminogen ophthalmologic drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type i plasminogen deficiency until product licensure, and/or until a new clinical trial is available and the patients in treatment under expanded access are eligible to participate in the new trial.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with lc associated with type i plasminogen deficiency, confirmed by laboratory documentation at screening visit, with or without ocular pseudomembranes. the presence of membranes in different areas is not an exclusion criterion. * subjects and their legally authorized representative, in the case of subjects \<18 years of age, should be informed of the nature of the treatment, agree to its provision, sign and date the informed and data handling consent forms approved by the irb. * subjects must be available for the duration of the treatment and agree to be compliant with the protocol visit and follow-up schedule. * subjects agree to keep the treating physician or specialist in charge informed about any occurrence related to the treatment. exclusion criteria: * subjects with any condition which, in the opinion of the treating physician or specialist in charge might interfere with the treatment. * females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device \[iud\], abstinence or other prescribed birth control). enrolled males must agree to utilize appropriate contraceptive methods to prevent pregnancy in partners. * females who are breastfeeding.
a post market surveillance on infuse bone graft

Conditions: Intervertebral Disc Degeneration; Spinal Fusion; Lumbar Disc Disease

Summary: this study aims to evaluate the safety and effectiveness of infuse™ bone graft in the real-world setting in korea.

this study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of infuse™ bone graft for lumbar fusion via alif or olif. commercially available device will be used within its intended use. this study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in korea. according to the standard of care in korea, the patients will be followed at least 12 months post-surgery.

Eligibility criteria:
inclusion criteria: * has degenerative disc disease and is indicated for lumbar interbody spine fusion from l2-s1 with infuse™ bone graft via alif or olif technique * agrees to participate in the study and is able to understand and sign the informed consent * the procedure planned for the patient complies with the labeling of the devices that may be used in the surgical procedure * has at least six months of nonoperative treatment prior to the study treatment * is at least 18 years old at the time of informed consent exclusion criteria: * has a known hypersensitivity to recombinant human bone morphogenetic protein-2, bovine type i collagen, or to other components of the formulation * has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor * is skeletally immature (\<18 years of age or no radiographic evidence of epiphyseal closure) * is pregnant or lactating * has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone * the use of the infuse™ bone graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine) * repeat applications of the infuse™ bone graft component * has up to grade 1 retrolisthesis * has hepatic or renal impairment * has metabolic bone disease * has autoimmune disease * has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments * is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment * concurrent participation in another clinical study that may confound study results * has a considerable risk for surgery * has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment

Keywords: infuse bone graft lumbar interbody fusion anterior lumbar interbody fusion oblique lumbar interbody fusion
a study to evaluate the pharmacokinetics and the safety after administration of br1015 and co-administration of br1015-1 and br1015-2 in healthy volunteers fed conditions

Conditions: Essential Hypertension

Summary: the purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of br1015 and co-administration of br1015-1 and br1015-2 in healthy volunteers under fed conditions


Eligibility criteria:
inclusion criteria: * those weigh 50 kg or more and have body mass index (bmi) within the range of 18.0 to 30.0kg/m2 at screening visit. * those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(except for hormone drugs) from the date of consent to 14 days after the last administration and disagrees to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs, etc.) * those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (except for simple appendectomy, hernia surgery) * those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration. * in the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
a study of tar-200 in combination with cetrelimab versus concurrent chemoradiotherapy in participants with muscle-invasive bladder cancer (mibc) of the bladder

Conditions: Urinary Bladder Neoplasms

Summary: the purpose of study is to compare bladder intact-event free survival (bi-efs) in participants receiving tar-200 in combination with intravenous (iv) cetrelimab versus concurrent chemoradiotherapy.


Eligibility criteria:
inclusion criteria: * ineligible for or have elected not to undergo radical cystectomy * all adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (ctcae) version 5.0 grade less than (\<) 2 prior to randomization * eastern cooperative oncology group (ecog) performance status grade 0, 1, or 2 * thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results * adequate bone marrow, liver, and renal function: bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): absolute neutrophil count (anc) greater than or equal to (\>=) 1,500/cubic millimeters (mm\^3); platelet count \>=80,000/mm\^3; hemoglobin \>=9.0 grams per deciliter (g/dl); liver function: (total bilirubin less than or equal to (\ )1.5\*uln (except participants with gilbert's syndrome, who must have a total bilirubin \ =30 ml/min using the cockcroft-gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where cockcroft-gault formula is not a good predictor of estimating adequate renal function exclusion criteria: * must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. ta/t1/carcinoma in situ (cis) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study * must not have diffuse cis based on cystoscopy and biopsy. diffuse, or multi-focal, cis is defined as the presence of at least 4 distinct cis lesions in the bladder at the time of the screening re-turbt * participants must not have evidence of ct4b, or n1-3, or m1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using computed tomography \[ct\] or magnetic resonance imaging \[mri\]) within 42 days prior to randomization * presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of tar 200 * evidence of bladder perforation during diagnostic cystoscopy. participant is eligible if perforation has healed prior to randomization
smoking-induced dopamine release: a [11c]-(+)-phno pet study in humans

Conditions: Tobacco Use Disorder

Summary: this study will evaluate effects of smoking on the dopaminergic system by using pet tomography with new radioligand, \[11c\]-(+)-phno. our primary hypothesis is that smoking a cigarette will produce dopamine release and this release can be measured using pet imaging and the \[11c\]-(+)-phno radiotracer. the secondary hypothesis is that this smoking induced dopamine release will be correlated with subjective craving and anxiety ratings.

this will be a within-subjects study in healthy male and female smokers. there will be one within factor condition: smoking and non smoking. therefore, there will be a repeated measure of pet scans using \[11c\]-(+)-phno under two different conditions. ten subjects (n=5 male and n=5 female) included in the study will come on two different days and will have a smoking or non smoking session performed just before the pet study. subjective assessments will be conducted at each experimental condition.

Eligibility criteria:
inclusion criteria: * adult males or females * regular smoking of at least 10 cigarettes, excluding ultra-low nicotine cigarettes, per day for at least two years * score on the fagerstrom test for nicotine dependence of 4 or more * no intention to quit or reduce tobacco use, and no treatment for tobacco dependence currently * no history of abuse of or dependence on any other drug, defined by dsm-iv criteria exclusion criteria: * pregnancy * presence of metal objects in the body or implanted electronic devices, that preclude safe mr scanning * claustrophobia * cardiovascular or cerebrovascular diseases * major psychiatric disorders including mood, anxiety or psychotic disorders * history of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, cva or cns tumor * gross structural brain abnormalities as revealed by t1 weighted images * current use or use during the previous month of medication that may affect the cns (e.g. neuroleptics, bupropion) * learning disability, amnesia or other conditions that impede memory and attention

Keywords: smoking-induced dopamine release [11c]-(+)-phno pet study
efficacy, pharmacodynamics, safety and tolerability of oral bl-7040 in patients with moderately active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the objective of the proposed study is to determine whether bl-7040 demonstrates clinical efficacy in patients with inflammatory bowel disease (ibd).


Eligibility criteria:
inclusion criteria: 1. male or female, age 18 to 70. 2. moderately active ulcerative colitis as defined by mayo score of ≥ 5 and ≤ 9 within 9 days of first day of study treatment. 3. diagnosis of ulcerative colitis ≥ 3 months prior to study entry. 4. endoscopic sub-score of ≥ 2 and rectal bleeding sub-score of ≥ 1 on the mayo score and endoscopic evidence of disease activity a minimum of 20 cm from the anal verge, determined within 9 days of first day of study treatment. 5. female patients must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or declare that they are abstaining from sexual intercourse, from the screening visit through the study termination visit or be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal. postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form. 6. ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment exclusion criteria: 1. diagnosis of indeterminate colitis or clinical findings suggestive of crohn's disease. 2. subjects with ulcerative proctitis. 3. a diagnosis of ischemic colitis, fulminant colitis or toxic megacolon. 4. evidence of bowel infection. 5. body temperature ≥ 38°c at screening. 6. evidence of abdominal abscess at the initial screening visit. 7. extensive colonic resection, subtotal or total colectomy. 8. ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 9. receiving non-permitted ibd therapies 10. history of or current peptic ulcer disease. 11. pregnant or lactating women. 12. chronic hepatitis b or c infection or hiv seropositivity. 13. current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease. 14. drug or alcohol abuse (by history). 15. patients participating in any other clinical trials. 16. patients with inability to communicate well with the investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).

Keywords: ulcerative colitis ibd