Kornimate/medical-research-clean huggingface dataset:
study of disitamab vedotin combined with gemcitabine in neoadjuvant treatment of urothelial carcinoma

Conditions: Radical Cystectomy; Urothelial Carcinoma

Summary: a multicenter, open, single arm, phase ii clinical trial was designed for myometrial invasive bladder cancer to evaluate the efficacy and safety of rc48-adc combined with gemcitabine in preoperative neoadjuvant treatment of mibc, and provide high-level clinical evidence for gemcitabine combined with adc in the treatment of mibc

patients with myometrial invasive bladder cancer expressing her2 and not suitable for cisplatin chemotherapy were treated with vedixizumab (rc48) 2.0mg/kg, once every two weeks, intravenous drip (60-90min); gemcitabine is 1000mg/m2, once every two weeks. after completing 3 cycles of neoadjuvant combined therapy, imaging evaluation was performed. if the tumor is t0, radical surgery for bladder cancer was performed; otherwise, perform radical surgery for bladder cancer (total cystectomy+standard/extended lymph node dissection) after completing 1-3 cycles of treatment.

Eligibility criteria:
inclusion criteria: 1. subjects voluntarily joined the study, signed the informed consent form, and were able to follow the study and follow-up procedures 2. age 18-75 3. suitable and planned for radical cystectomy (including lymph node dissection) 4. clinical stage t2-t4an0m0 (ct/mr/pet-ct evaluation) 5. pathologically, it is urothelial carcinoma, and the patient has her2 expression and refuses neoadjuvant chemotherapy or physical condition/renal function \[glomerular filtration rate (gfr) 30-60ml/min\], which is not suitable for neoadjuvant chemotherapy (pathology allows urothelial carcinoma to merge with other variant subtypes, with urothelial carcinoma as the main type) 6. ecog score 0 or 1 7. there is residual tumor after turbt (cystoscopy or imaging evidence) 8. the blood test of subjects should meet the following requirements exclusion criteria: 1. receive live attenuated vaccine within 4 weeks before enrollment or during the study period. 2. have received systemic chemotherapy and targeted therapy of anti-pd-1, pd-l1 and her2 in the past 6 months 3. known allergy to gemcitabine/rc48 and its components 4. active, known or suspected autoimmune diseases. 5. a history of primary immunodeficiency is known.
fermented soy and heartburn symptom relief

Conditions: Heartburn; Acid Regurgitation

Summary: heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. typically, heartburn symptoms are treated with over-the-counter (otc) medications which may come with side effects. there is suggestive evidence of the efficacy of fermented soy (gastro-ad®) for the heartburn symptom relief. the aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset.

heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. usually it is caused by the regurgitation of gastric acid into the esophagus. the prevalence of heartburn is 10-20% worldwide and is increasing. typically, heartburn symptoms are treated with over-the-counter (otc) medications which may come with side effects. gastro-ad® is a commercially available food supplement produced by fermentation of soy by a specific strain of lactobacillus. there is suggestive evidence, in vivo as well as in vitro studies, of the efficacy of fermented soy (gastro-ad®) for the heartburn symptom relief. the aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset. it is hypothesized that the consumption of 1-3 g of fermented soy will relieve the heartburn symptom severity.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent in english. * willing to have height and weight measured and provide demographic information (e.g. age, race, sex) * experience heartburn symptoms at least 2 days a week during the past 3 months. * use otc product(s), supplements, or dietary manipulation to relieve heartburn symptoms in the last 3 months. * willing to take the study soy supplement before resorting to otc product(s) to control heartburn symptoms. * willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits. * willing to provide information about dietary intake; 3-day online 24-hr recalls during baseline, intervention, and washout. * willing and able to provide a valid social security for study payment purposes. exclusion criteria: * do not meet the above criteria. * soy allergy * severe heartburn problem (cannot be ignored and often limits your concentration on daily activities) during the last week * diagnosed or currently being treated for any gastrointestinal diseases including gerd, gastric ulcers, crohn's, celiac, ulcerative colitis, etc. * self-disclosed as pregnant or breast-feeding or planning on becoming pregnant during the study duration. * currently participating in another clinical study.
response profiles to high-concentration capsaicin desensitization in patients with peripheral neuropathic pain with or without allodynia: a regional multicenter prospective cohort

Conditions: Peripheral Neuropathic Pain

Summary: prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the auvergne rhône alpes region.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age on the day of inclusion * patient who has been informed and has not expressed opposition to participating in the study, * patient with peripheral neuropathic pain (whatever the etiology), defined by : * "neuropathic pain 4" score ("dn4" score) ≥ 4/10 * and pain according to the numerical scale (en) \> 4/10, * and stable analgesic treatment for at least 1 month, * and with or without mechanical allodynia according to the quantitative sensory testing (qst) : brush test (dynamic), von frey test (static) * and with or without thermal allodynia to hot or cold as determined by a rolltemp-ii® (rolltemp is a device designed for quick screening of temperature sensibility over large body areas). * patient responding to an indication of desensitization to high concentration capsaicin concentration and not presenting any contra-indication. * patient naïve of high concentration of capsaicin on the concerned zone * patient understanding french non-inclusion criteria: * patient with pain related to complex regional pain syndrome (criteria not meeting the indication for capsaicin) * patient with active cancer (underlying disease and treatments may modify pain perception), * patient receiving or having received in the last 3 months botulinum toxin a on the concerned area (this treatment of neuropathic pain may modulate the effect of capsaicin and disturb the demonstration of causality), * patient with planned surgery within the next 12 months on the painful site (surgery may cause neuropathic damage and/or bias the pain assessment), * patient included in an interventional research protocol, * patient under guardianship or curators, * patient under legal protection exclusion criteria: none
preventive effectiveness, safety and immunogenicity of a allantoic split inactivated seasonal influenza vaccine

Conditions: Human Influenza

Summary: the study is multicenter, phase 3, open-label trial that explored the preventive effectiveness, safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.

the study will include 2000 volunteers, 1,000 of whom will be vaccinated intramuscularly with a single dose of allantoic split inactivated seasonal influenza vaccine. all participants will be observed for 6 months to evaluate the effectiveness of the vaccine.

Eligibility criteria:
inclusion criteria: * healthy volunteers of both sexes aged from 18 years. * literate and willing to provide written informed consent. * a signed informed consent. * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * allergic reactions to chicken proteins, or any preceding vaccination. * acute illness with a fever (37.0 c). * vaccination against influenza in the 2017/2018 season. * current or recent (within two weeks of enrollment) acute respiratory illness with or without fever. * hypersensitivity after previous administration of any vaccine. * history of chronic alcohol abuse and/or illegal drug use. * a positive pregnancy test for all women of childbearing potential. * administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment. * acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. * history of leukemia or any other blood or solid organ cancer. * receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study. * participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study. * subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
dietary modulation of hepatic lipase (lipc) -514 c/t variant associations with lipids and glucose

Conditions: Dyslipidemia; Impaired Glucose Tolerance

Summary: the investigators evaluated dietary modulation of lipc rs1800588 (-514 c/t) for lipids and glucose using a randomized cross-over design comparing a high-fat western diet and a low-fat traditional hispanic diet in caribbean hispanics (n=42; 4 weeks/phase).

the lipc -514 c/t single nucleotide polymorphism (snp) has been inconsistently associated with high density lipoprotein cholesterol (hdl-c) in population studies, supporting the possibility of its modulation by dietary factors. to investigate the interaction between the common lipc -514(c/t) snp and dietary fat, the investigators compared changes in lipids and glucose in response to two levels of dietary total fat (20% energy intake vs. 39% energy intake) in a crossover, randomized dietary intervention study enrolling caribbean hispanics. individuals were screened for lipc rs1800588 genotype prior to enrollment, and genotype-associated differences in response to diet were evaluated. the study was designed to test the following hypotheses: 1. carriers of the t allele consuming a low fat (lf) diet will have decreased hepatic lipase activity as compared with subjects with the cc genotype at the -514(c/t) polymorphism. conversely, in individuals consuming a high fat (hf) diet, t carriers will exhibit an impaired ability to down regulate hepatic lipase activity. 2. based on differences in hepatic lipase activity, the investigators hypothesized that a significant and clinically relevant proportion of the individual variability in fasting plasma hdl-c responses to changes in dietary fat intake would be due to variability at the lipc locus. specifically, cc subjects will respond to increases in total dietary fat consumption with significant increases in hdl-c concentration. conversely, increased fat consumption in t carrying subjects will result in decreased hdl-c concentration.

Eligibility criteria:
inclusion criteria: * self-reported caribbean hispanics exclusion criteria: * diabetes * uncontrolled hypertension * self-reported liver disease; severe kidney dysfunction; angina; endocrine disease; preexisting cardiovascular disease or gallbladder disease, or pancreatitis within the past 12 months * use of lipid-lowering or hypoglycemic medications * bmi \>34 kg/m2 * alcohol consumption (\>2 drinks/day) * smoking within the past 6 months or illegal drug use * pregnancy or breastfeeding * weight gain or loss of more than 9 kg within the past 6 months * extreme levels of physical or athletic activity, strict vegetarians/vegans * egg, wheat, milk, fish, or nut allergies * unwillingness to discontinue fish oil or flaxseed supplements or drinking alcohol during the study * travel plans precluding availability for the two 4-week study phases

Keywords: hispanics single nucleotide polymorphism hepatic lipase
consolidation chemotherapy for locally advanced mid or low rectal cancer after neoadjuvant concurrent chemoradiotherapy

Conditions: Rectal Cancer

Summary: this trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of mid or low rectum 2. locally advanced rectal cancer confirmed by image (i.e. magnetic resonance image) * clinical stage t1-3n1or2 on mri * clinical stage ct3n0 (or depth of perirectal invasion by tumor \>5mm on mri) * suspicious of circumferential invasion on mri (or circumferential margin \<1mm) 3. ecog performance status of 0-2 4. asa grade ≤ 3 5. an informed consent has been signed by the patient exclusion criteria: 1. upper rectal cancer 2. clinical stage t1or2n0 on mri 3. clinical stage t4nany on mri 4. clinical stage tanynanym1 by image or histology 5. the patient received chemotherapy or radiotherapy during the past 6 months 6. the patient received any therapy for colorectal cancer or another malignancy during the past 5 years 7. the patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy 8. pregnant of breastfeeding women 9. the patient who participate in another clinical trial, or receives any drug for the trial 10. uncontrolled peripheral neuropathy (more than grade 2) 11. any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess 12. active gastrointestinal bleeding 13. patients with an active infection, which needs antibiotic therapy, during the randomization period

Keywords: rectal cancer consolidation chemotherapy
specified drug-use survey of trelagliptin tablets "survey on long-term use in patients with type 2 diabetes mellitus"

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

the drug being tested in this survey is called trelagliptin tablet. this tablet is being tested to treat people who have type 2 diabetes mellitus. this survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. the planned number of observed patients will be approximately 3000. this multi-center observational trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients exclusion criteria: 1. have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus 2. have severe infection, perioperative status, or serious trauma 3. have severe renal impairment or on dialysis due to end-stage renal disease 4. have a history of hypersensitivity to any ingredients of this drug
comparing the effectiveness of mcimt and bimanual training

Conditions: Cerebral Palsy

Summary: this study aimed to compare the effects of modified constraint-induced movement therapy (mcimt) and bimanual training (bit) based on the international classification of functioning, disability, and health, children \&youth (icf-cy) conceptual framework. our assumptions were that (1) mcimt is more effective on outcomes representing all subdomains of icf and (2) the possible improvements in the body structure and function, activity, and participation subdomains of icf are intimately related to each other.

thirty-two children with spastic hemiplegic cerebral palsy (mean age 10.43 years \[sd 2.9 years\]; 15 females, 17 males) whose functional profiles associated with manual ability classification system, gross motor function classification system, and communication function classification system changed between level i-iii were randomly distributed to one of the mcimt or bit groups with equivalent dosing frequency and intensity (10 weeks/3 days per week/2.5 hours per day). outcome measures categorized according to the domains of international classification of functioning, disability, and health, children \&youth (icf-cy) framework were used to document body functions, activity, and participation outcomes. assessments were carried out before (t1) and after treatment (t2), and at 16 weeks post-intervention (t3) by a physical therapist blinded to group allocation. before the study entry, informed consent was obtained from the parents. general and specific contents related to each intervention were delivered as individual sessions at the school (one session per week) or group sessions with two participants at rehabilitation centers (two sessions per week).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of spastic hemiplegic cerebral palsy * must be able to attend primary or secondary school exclusion criteria: * family-dependent problems interfering with participation in study sessions * the presence of behavioral problems interfering with the assessment periods or intervention sessions

Keywords: upper limb hand bimanual training constraint-induced movement therapy icf-cy hemiplegic cerebral palsy
pharmacogenomics of the variability in the in vivo response to glucocorticoids

Conditions: Glucocorticoids Toxicity; Glucose Intolerance

Summary: this study evaluates the effect of acute administration of oral prednisone in white blood cells counts and glucose tolerance and the relationship of these measures with changes in gene expression in healthy volunteers. white blood cells counts, glucose tolerance and gene expression will be study before and after prednisone administration.

prednisone is a potent anti-inflammatory drug that has large variability in its response. the large inter individual variability in the response to prednisone has a genetic component, but the genetic determinants of this variability remain unknown. we propose to use two relevant phenotypes, changes in white blood cell counts and changes in glucose tolerance induced by in vivo administration of prednisone, to characterize gene expression patterns and identify variants that are involved in the in vivo response to prednisone.

Eligibility criteria:
inclusion criteria: * 18 to 45 years old (to exclude the effect of age on glucose tolerance); * bmi between 20 and 25 kg/m2 (to exclude individuals that are likely to have impaired insulin response); * normal fasting glucose; * stable weight for three months before participation exclusion criteria: * bmi \>25kg/m2; * fasting glucose ≥126 mg/dl * shift work or disordered sleep (to exclude individuals with alterations in the hypothalamus-adrenergic axis); * any diseases; * use of any medication regularly (including over-the-counter); * previous exposure to glucocorticoids (within the last year); * pregnancy

Keywords: glucocorticoids efficacy metabolic toxicity
safety study of exablate for the treatment of uterine fibroids

Conditions: Uterine Fibroids

Summary: the objective of this phase iv study is to evaluate the safety of the exablate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins. the enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. this is an additional treatment tool available in the exablate system for the treatment of uterine fibroids. the safety profile of the enhanced sonication was investigated under an fda-regulated ide study. fda granted approval of enhanced sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.


Eligibility criteria:
inclusion criteria: * women age 18 or older * symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the uterine fibroid symptom and health-related quality of life questionnaire (ufs-qol) * women who have given written informed consent * women who are able and willing to attend all study visits. * patient is pre or peri-menopausal (within 12 months of last menstrual period). * patient should be family complete. * able to communicate sensations during the exablate procedure. * uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). * fibroids(s) clearly visible on non-contrast mri. * fibroid enhances on mr contrast imaging. exclusion criteria: * women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. * patients who are breast-feeding. * patients with active pelvic inflammatory disease (pid). * patients with active local or systemic infection. * patients experiencing chronic leg or lower back pain within the last 6 months. * contraindication for mri scan: * severe claustrophobia that would prevent completion of procedure in the mr unit * weight greater than 250 lbs (113kg) * implanted ferromagnetic materials and/or devices contraindicated for mr scan * known intolerance to mri contrast agent (e.g. gadolinium or magnevist) * any other contraindication for mri scan * extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam). * dermoid cyst of the ovary anywhere in the treatment path. * known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia. * intrauterine device (iud) anywhere in the treatment path. * undiagnosed vaginal bleeding. * pedunculated fibroids. * uterine size \>24 weeks.

Keywords: uterine fibroids mrgfus exablate focused ultrasound symptomatic uterine fibroids