Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics study of dipeptidyl peptidase 4 inhibitor to control type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to confirm the mechanism of reduced response to dpp-4 inhibitor in some patients with type 2 diabetes and evaluate appropriate patients to treat with dpp-4 inhibitor

sitagliptin, a dpp-4 inhibitor was used as an incretin enhancer in clinical practice first. in clinical trials, sitagliptin showed effective control of blood glucose level in type 2 diabetes and 100 mg once daily with metformin was similar to sulfonylurea (glipizide) with metformin in lowering hba1c. mostly in practice, stable blood glucose levels were maintained after change of sulfonylurea to sitagliptin in type 2 diabetes treatment. however, in some cases, there were abrupt severe hyperglycemia and uncontrolled blood glucose level after drug change to sitagliptin. several mechanism could be considered for reduced response to dpp-4 inhibitor in some type 2 diabetes patients. firstly, significantly reduced secretion of glucagon-like peptide 1 (glp-1) more than expected in diabetes or functional defect of glp-1 activity could be the mechanism of loss of glp-1 effect irrespective of dpp-4. secondly, mutation or functional defect of dpp-4 enzyme could not be inhibited by dpp-4 inhibitor. thirdly, glp-1 receptor mutation or other defect in β-cell responsiveness to glp-1 leads to reduction of response to dpp-4 inhibitor.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients with less than 15 yrs of disease duration * bmi between 22-27 kg/m2 * hba1c ≤ 9% at recruitment 1. study group after change sulfonylurea to sitagliptin in case of metformin and sulfonylurea therapy 1. increase of fasting blood glucose over 20 mg/dl or postprandial glucose over 30 mg/dl within several days or 2. increase of hba1c over 1% within 2-3 months without abrupt increase of blood glucose levels within several days * sulfonylurea dose : less than glimepiride 4mg or gliclazide 120mg or glibenclamide 10mg * metformin dose : 500\~2000mg 3. reduced response to sitagliptin should be made a decision by investigators after understanding the condition of patients surely. 2. control group * age, sex, bmi matched patients with same condition of study patients * after change sulfonylurea to sitagliptin in case of metformin plus sulfonylurea therapy, no change of blood glucose levels like above or stable hba1c change within 1% within 2-3 months exclusion criteria: * other causes of increase of blood glucose levels except drug change * patients with history of insulin treatment * patients taking thiazolidinediones, alpha-glucosidase inhibitors, glp-1 analogue or dpp-4 inhibitors * patients with renal, hepatic dysfunction * patients with diabetic complications such as coronary heart disease, cerebrovascular disease, proliferative diabetic retinopathy or diabetic gastroparesis * patients taking medications affecting glucose level

Keywords: type 2 diabetes mellitus dipeptidyl peptidase iv inhibitors glucagon-like peptide 1
impact of subgingival instrumentation on masticatory performance and psychological distress

Conditions: Periodontitis

Summary: patients of stage iii and stage iv periodontitis will be assessed for masticatory dysfunction and psychological distress. subgingival instrumentation will be done for treating periodontitis. patients will be re-evaluated after 2 and 3 months in order to assess any change in masticatory dysfunction and psychological distress by improved periodontal health.

literature reveals that there occurs masticatory dysfunction in patients with stage iii and iv periodontitis. it has been hypothesized that masticatory dysfunction along with halitosis and aesthetics of the patient can have an effect on the psychological distress in a chronic state. patients of stage iii and stage iv periodontitis with the following criteria will be included : 1. adult patients with age group 30-50 years diagnosed with stage iii/iv generalized periodontitis. 2. presence of minimum 20 teeth (eichner group a1, a2, a3) excluding third molars. exclusion criteria: patients with 1. systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) 2. systemic diseases that may affect masticatory ability of the patient (sarcopenia, tmj disorders, xerostomia, acute pulpitis) 3. history of periodontal treatment within the 6 months 4. patients wearing orthodontic appliances 5. diagnosed psychiatric disorder 6. history of antibiotic use within the previous 3 months 7. history of use of steroid, immunosuppressive and psychiatric drugs 8. pregnant and lactating women 9. smoking or substance abuse 10. history of menopause periodontal clinical parameters: plaque index, gingival index, bleeding on probing, probing pocket depth, clinical attachment level, mobility psychological parameters: hospital anxiety and depression scale -14 and depression anxiety and stress scale -21 quality of masticatory dysfunction questionnaire and objective evaluation of masticatory performance by mixing ability of hubba bubba chewing gum. the sample of 84 patients consisting of 42 cases and 42 controls. the patients will be re-evaluated at 2 and 3 months follow up for clinical periodontal parameters, masticatory performance and psychological distress.

Eligibility criteria:
inclusion criteria: * adult patients with age group 30-50 years diagnosed with stage iii/iv generalized periodontitis. * presence of minimum 20 teeth (eichner group a1, a2, a3) excluding third molars. exclusion criteria: * systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) * systemic diseases that may affect masticatory ability of the patient (sarcopenia, tmj disorders, xerostomia, acute pulpitis) * periodontal treatment within the 6 months * patients wearing orthodontic appliances * any diagnosed psychiatric disorder * antibiotic use within the previous 3 months * steroid, immunosuppressive and psychiatric drug use * pregnant and lactating women * history of menopause * smoking or substance abuse
study of a urethral catheter coated with eluting silver salts (success)

Conditions: Catheterization

Summary: urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a cauti) may occur. this study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a cauti compared to patients who get an uncoated catheter.

this study is a prospective, multicenter, randomized controlled pivotal study designed to compare the time to occurrence and incidence of cauti in subjects catheterized with a new hydrogel-silver salts latex catheter (test) to those of subjects catheterized with a silicone elastomer-coated latex catheter (control).

Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age * life expectancy of 3 months or more * expected to require a urinary catheter for at least 48 hours exclusion criteria: * recent urinary tract surgery or instrumentation * presence of a urinary tract device * concurrent genitourinary tract infection * recent indwelling urinary catheter * requires use of a non-study urinary catheter

Keywords: urinary tract infection urinary catheter
effectiveness of the "tecaretherapy" in patients with lateral elbow tendinopathy

Conditions: Tendinopathy

Summary: this rct aims at investigating the effectiveness of the "tecaretherapy" in patients with lateral elbow tendinopathy. 60 patients will be randomized into one of the following 3 groups: * "conventional physiotherapy treatment (cpt)" (massage, eccentric exercises, stretching); * "cpt + tecare" (idem cpt group + tecaretherapy during the eccentric exercises) * "cpt + placebo tecare" (idem "cpt + tecare" group but with an inactive tecare device) the treatment will include 18 30-minute sessions

this rct aims at investigating the effectiveness of the "tecaretherapy" in patients with lateral elbow tendinopathy. 60 patients will be randomized into one of the following 3 groups: * "conventional physiotherapy treatment (cpt)" (massage, eccentric exercises by means of an isokinetic dynamometer, stretching); * "cpt + tecare" (idem cpt group + tecaretherapy during the eccentric exercises) * "cpt + placebo tecare" (idem "cpt + tecare" group but with an inactive "tecare" device) the treatment will include 18 30-minute sessions. the "tecaretherapy" consists in using a specific device providing high frequencies (between 300 khz and 1 mhz) supposed to accelerate the tissues healing process. outcome sessions will be organized at baseline, after the first 9 sessions, at the end of the treatment as well as 3 and 6 months after the initial treatment session.

Eligibility criteria:
inclusion criteria: * patient suffering from a chronic lateral elbow tendinopathy confirmed by echography exclusion criteria: patients: * with contra-indications for a tecaretherapy (pace maker, insuline pump, pregnancy, infection, fever, cancer, thrombophlebitis) * reporting injections and/or shockwaves in the past (for the tendinopathy) * with an associated neurogenic dysfunction

Keywords: elbow tendinopathy physiotherapy exercise electrotherapy
radical gastrectomy with/without hipec in advanced gastric cancer patients

Conditions: Malignant Neoplasm of Stomach

Summary: patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (aeg) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. there are two treatment groups (a and b). the d2 radical gastrectomy will be applied in both groups. patients randomized into group b will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5l ). patients randomized into group a will not accept intraperitoneal chemoperfusion. patients in both groups receive 6 cycles of postoperative chemotherapy (sox or xelox) within 4-12 weeks after the surgical procedure and are followed up for 24 months.

the objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with d2 radical gastrectomy and intraperitoneal chemoperfusion (hipec) and postoperative chemotherapy (group b) and patients treated with d2 radical gastrectomy alone and postoperative chemotherapy (group a). the hypothesis of the trial is that d2 radical gastrectomy with intraperitoneal chemoperfusion (group b) is superior to d2 radical gastrectomy (group a) in terms of overall survival. the trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Eligibility criteria:
inclusion criteria: * histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the aeg. * no evidence of distant metastases * preoperative examination (ct/mri) demonstrated resectable gastricc cancer with t3-t4 stage * written informed consent is obtained prior to commencement of trial treatment exclusion criteria: * any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer * active systemic infections * patients with known interstitial lung disease with new york heart association classification \> 2 * serious cardiac dysrhythmia or condition, new york heart association classification of iii or iv, congestive cardiac failure * cardiac arrhythmia * inadequate renal function at the beginning of the trial, defined as gfr less than \<60 ml/min * inadequate liver function at the beginning of the trial, defined as bilirubin \>1.5 times uln * inadequate bone marrow function at the beginning of the trial, defined as platelet count less than \<150 gpt/l or neutrophil granulocyte count less than \<1.5 gpt/ * active vaccination within 6 weeks prior to randomisation * active hepatitis b or c infection * female patients who are pregnant or breast feeding * missing of capacity to contract * contraindication to the drugs which are used in the trial * participation in another therapeutic clinical trial

Keywords: gastric cancer intraperitoneal chemoperfusion
68ga-p16-093 and 18f-fdg pet/ct imaging in the same group of clear cell renal cell carcinoma patients

Conditions: Clear Cell Renal Cell Carcinoma

Summary: psma is highly expressed on the cell surface of the microvasculature of several solid tumors, including clear cell renal cell carcinoma (ccrcc). this makes it a potentially imaging target for the detection of ccrcc. this pilot study was designed to evaluate the diagnostic performance of 68ga-p16-093, a novel radiopharmaceutical targeting psma, which was compared with 18f-fdg pet/ct in the same group of ccrcc patients.

renal cell carcinoma (rcc) is the most common solid tumor within the kidney and accounts for approximately 3% of all malignancies in the world. clear cell rcc (ccrcc) is the most common subtype and accounts for the majority of kidney cancer-related deaths. importantly, pro-angiogenic factors (vegf, pdgf) are strongly upregulated in clear cell rcc, leading to high vascularized tumors. prostate-specific membrane antigen (psma), as known as folate hydrolase i or glutamate carboxypeptidase ii, is overexpressed on the cells of prostatic adenocarcinoma. however, psma is also expressed by tumor cells or neovascular endothelial cells of various solid neoplasms, such as renal cell carcinoma. therefore, psma may be an ideal target for the diagnosis of ccrcc. 68ga-p16-093, a novel radiopharmaceutical targeting psma, with the urea fragment of a conjugate that employs the hbed-cc chelator for labeling with 68ga(iii). the hbed-based chelating ligand binds the 68ga3+ ion with high affinity in a pseudo-octahedral n2o4 coordination sphere by its two phenolate o, two amino-acetate carboxylate o, and two amino n donor atoms. this pilot study was designed to evaluate the diagnostic performance of 68ga-p16-093 in the same group of ccrcc patients, compared with 18f-fdg pet/ct.

Eligibility criteria:
inclusion criteria: * patients with confirmed or suspected clear cell renal cell carcinoma; * 68ga-p16-093 18f-fdg pet/ct within a week; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against psma; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
pilot bioequivalency study of exemestane 25 mg tablet under fasted conditions

Conditions: Breast Cancer

Summary: the objective of this study was to prove the bioequivalence of exemestane 25 mg tablet under fasted conditions


Eligibility criteria:
inclusion criteria: - no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to exemestane or any comparable or similar product.
wedged orthoses and knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the five-year goal of this project is to investigate the effect of in-shoe wedged orthoses on lower extremity function in patients with knee osteoarthritis. in general, our aims address the long-term effects of orthoses. the investigators hypothesize that subjects who use the lateral wedged in shoe orthosis will result in altered gait mechanics that reflect a reduction in the frontal plane knee joint moment compared to subjects who use a neutral in shoe orthosis.

introduction: in shoe wedged orthoses have been shown to be an effective conservative approach in reducing pain in patients with osteoarthritis (oa). the mechanism responsible for this pain reduction is not well-understood. it is not known whether placing a medial or lateral wedge in the shoe results in alterations in lower extremity alignment, knee joint moments or some combination of the two. the longterm effects of this intervention on oa patients' functional status as well the progression of their oa has not been studied. therefore, the purpose of this study is to examine the effect of in-shoe wedged orthoses in patients with knee oa on the frontal plane knee joint moment. methods: 38 patients between the ages of 40-70 yrs with knee oa (grades i-iv) will be recruited from within the medical community. subjects with a diagnosis of unilateral knee oa of greater than 3 months duration, as defined by the american college of rheumatology guidelines, will be included. 19 subjects will be assigned to a treatment group and 19 subjects will be assigned to a control group. the treatment group will receive custom molded orthotics with a lateral wedge. both the treatment and control groups will be tested initially and then again 1 year later. the dependent variable is peak knee adduction moment. statistics: a two-way anova will be used to test the hypothesis. this design will include 2 levels of group (control and treatment) and two levels of trial (pretest and 1 yr posttest). significance will be determined at a level of p\<.05.

Eligibility criteria:
inclusion criteria: * diagnosed unilateral knee osteoarthritis by a qualified physician * recent (within 3 months of entrance into the study) radiographic confirmation of oa grade (i-iv) as evidenced by joint space narrowing and the presence of osteophytes * a score of 50-90 mm on a 100 mm visual analogue pain scale for walking * ability to walk independently without the use of assistive devices exclusion criteria: * history of lower extremity joint surgery or other lower extremity injury that would hinder ambulation * severe foot deformity that would prevent the accommodation of the wedged orthotic device * other disease process such as neurologic, cardiac, or oncologic, that would hinder one's ability to ambulate * any condition, such as diabetes, that results in loss of sensation in the lower extremities

Keywords: knee osteoarthritis orthosis wedge gait
a study of serum protein profiling in patients with non-small cell lung cancer treated with gefitinib or erlotinib

Conditions: Non Small Cell Lung Cancer

Summary: we hypothesize that epidermal growth factor receptor tyrosine kinase inhibitors modulate tumor changes that may be reflected in the alteration of serum proteins. study objectives are: * to establish serum proteomic changes in patients with non-small cell lung cancer (nsclc) receiving erlotinib or gefitinib. * to identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in nsclc patients with and without egfr mutations. * to study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile.

background: although some success has been achieved in identifying epidermal growth factor receptor (egfr) mutations as a molecular predictive marker of response in patients with non-small cell lung cancer (nsclc), this strategy is likely only to be limited as not all responding patients have a mutation in their tumor and conversely, not all patients with a mutation were responders. furthermore, as the development of resistance to egfr tyrosine kinase inhibitors (tki) such as gefitinib, erlotinib is inevitable and poses a major clinical problem due to limited therapeutic options, the identification of a molecular profile that could predict sensitivity to erlotinib or gefitinib is warranted. hypothesis: using serum as an easily accessible biological fluid, we hypothesize that egfr tkis modulate tumor changes that may be reflected in the alteration of serum proteins. objectives: * to establish the serum proteomic changes in nsclc patients receiving erlotinib or gefitinib. * to identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in nsclc patients with and without egfr mutations. * to study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile. significance: an extensive profiling of the molecular circuitry affected by egfr tkis would be helpful in understanding the response and side effects of patients with nsclc treated with erlotinib or gefitinib and could guide therapy and thus improve patient outcome.

Eligibility criteria:
inclusion criteria: * any patient with nsclc receiving erlotinib or gefitinib. * patients with unexpected and/or severe treatment related toxicity whilst receiving egfr tki. * age ≥ 18 years * written informed consent.
evaluation of neoplasia with artificial intelligence in gastrointestinal endoscopy

Conditions: Gastrointestinal Neoplasms

Summary: this study aims to validate and evaluate ai algorithms for detection and characterization of early gi neoplasia.

this is an investigator initiated; multi-centre study and will be conducted in two phases. validation \& optimization phase, where routinely collected and anonymized endoscopic images and videos from the departmental teaching and training library will be used to validate, and if needed fine-tune and improve, the accuracy of an ai algorithm. testing phase, where the evaluation of ai algorithms performance will be conducted on a prospective basis. the ground truth (standard) will be expert assessment and histological diagnosis. this study has no direct impact on patient's clinical care, and collection of all endoscopic data will take place during standard endoscopy procedures done for purely clinical indications. no additional procedures, biopsies or interventions will be performed as a part of this study.

Eligibility criteria:
inclusion criteria: -the participant must meet all of the following criteria to be considered eligible for the study: * male or female, aged 18 years or above. * requiring gastroscopy and/or colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of gi neoplasia. * participant is willing and able to give informed consent for participation in the study. exclusion criteria the participant may not enter the study if any of the following apply: * patients with endoscopically active severe oesophagitis * poor bowel preparation

Keywords: gastrointestinal neoplasia artificial intelligence
conventional vs digital cad/cam splints for bruxism

Conditions: Bruxism

Summary: this is a randomized controlled trial with a crossover design, which intends to enroll 20 adult patients aged between 20 and 55 years with confirmed or probable sleep bruxism. participants will be randomized to receive either a conventional stabilization splint or a cad/cam splint. each patient will use one type of splint for 30 days, followed by a 15-day wash-out period, after which they will switch to the other type of splint. the study aims to compare the quality, precision, and comfort of the two types of occlusal splints. outcomes will include manufacturing time, amount of in-mouth adjustments, adaptation, occlusal contacts, and participant satisfaction.


Eligibility criteria:
inclusion criteria: * adult patients aged between 20 and 55 years. * probable or confirmed diagnosis of sleep bruxism. * no previous treatment with occlusal splints. * absence of periodontal diseases and/or dental fractures. * patients must have a minimum of 28 teeth. exclusion criteria: * patients with systemic diseases affecting the temporomandibular joint, such as rheumatoid arthritis, osteoarthritis, and osteoporosis. * chronic users of medications that may interfere with the study results, including analgesics, anti-inflammatory drugs, anxiolytics, antidepressants, and anticonvulsants. * patients with a history of temporomandibular joint surgery. * pregnant or breastfeeding women. * patients with severe dental misalignment or malocclusion that would affect splint fitting and evaluation.

Keywords: occlusal splints computer-aided design bruxism