Kornimate/medical-research-clean huggingface dataset:
korean post-marketing surveillance ngenla® pre-filled pen injection for the treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone

Conditions: Pediatric Growth Hormone Deficiency

Summary: this non-interventional study will be performed by design of post-marketing surveillance (pms) as an additional pharmacovigilance activity of the risk management plan (rmp) for ngenla® pre-filled pen injection, which is required by the ministry of food and drug safety (mfds) according to the local regulation. this post-marketing surveillance will investigate the safety and effectiveness of ngenla® pre-filled pen injection as the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone during 6 years under the setting of routine practice in korea.


Eligibility criteria:
inclusion criteria: - 1. children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone who have received treatment with somotarogon or have been determined to start treatment with somatrogon according to the approved indications of the medicinal product; 2. evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study. exclusion criteria: 1. patients concurrently participating in other studies involving therapeutic interventions and/or investigational products; 2. patients who have contraindications to somatrogon as specified in the approved lpd. 3. patients with hypersensitivity or case history to somatrogon or to any of the excipients in the product

Keywords: pediatric growth hormone deficiency somatrogon
peri-implant tissues on aesthetic slim abutment galimplant (psg)

Conditions: Dental Implant Failed; Dental Prosthesis Failure

Summary: this is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of peri-implant tissues (bone and soft tissues) in conventionally loaded galimplant implants, using a classic multi-position, anti-rotational abutment, comparing it to the new multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery. to this end, 80 galimplant implants with a diameter of 4 mm and 10 mm in length will be placed in areas of mature scarred post-extraction bone. patients be divided into 2 study groups, group c: straight pillar; group t: slim pillar. the bone and clinical radiological stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12-24 months post-prosthetic loading.


Eligibility criteria:
inclusion criteria: * patients without systemic pathology that are grounds for absolute contraindication * older adults who agree to be part of the study and sign the informed consent * consumption of tobacco less than 5 cigarettes / day * do not be completely toothless * absences of at least two pieces in posterior area with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques. in case of odd absences (3,5,7), a slim pillar will be placed, being the group to always be the majority. * area of mature bone healed at least 6 months post-extraction. * patients with a sufficient amount of bone to place implants 4 mm in diameter and 10 mm long exclusion criteria: * immunosuppressed * aesthetic edentulous areas of 13-23 and 33-43 * smokers of more than 5 cigarettes * index of bleeding greater than 30% * patients with less than 2 mm of keratinized gingiva * implants with primary stability with isq \<55 * implants with isq index \<55 at 8 weeks * when a margin of safety can not be assumed to the inferior dental nerve of at least 1 mm

Keywords: dental implant periimplant tissues
non invasive ventilation after cardiac surgery

Conditions: Respiratory Failure

Summary: patients with respiratory failure following cardiac surgery are randomized to receive standard therapy versus non invasive ventilation. the hypothesis is that patients receiving non invasive ventilation will perform better than those who received standard therapy.


Eligibility criteria:
inclusion criteria: * hypoxia exclusion criteria: * pneumothorax * cardiocirculatory instability * no written consent

Keywords: niv non invasive ventilation cardiac surgery continuous positive airway pressure
safety, tolerability, and efficacy study of cll442 in patients with cutaneous squamous cell carcinoma in situ (sccis)

Conditions: Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)

Summary: the purpose of this first in human and proof of concept study is to characterize the safety, tolerability and initial efficacy of cll442 in patients with squamous cell carcinoma in situ (sccis) to enable further clinical development of cll442.


Eligibility criteria:
inclusion criteria: 1. written informed consent has been obtained. 2. male and female patients, age ≥ 18 to ≤ 90 years (at the time of the screening visit). 3. a primary, clinically diagnosed and histologically confirmed cutaneous scc in situ lesion, with or without the involvement of the follicular unit, and histologically diagnosed within 30 days of the screening visit. the post-biopsy residual sccis lesion must be visually evident and at least 3 mm in either length or width. 4. the lesion must be located in a place easily accessible for topical application by the patient or their caregiver, excluding the genitals, perianal area, sub-ungual area, eyelids, ear and must be \>1 cm away from the eyes and mouth. exclusion criteria: 1. evidence of dermatological disease or histological evidence of a confounding skin condition in the treatment area, including but not limited to bcc, worse level/grade of scc, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa, verrucous lesions or any other tumor in the biopsy specimen. lesions with atypical histology such as: spindle cell scc, acantholytic scc, clear cell scc, adenosquamous scc, desmoplastic scc or lesions that have been present for a short time and have been fast growing. 2. treatment of the target sccis lesion within 8 weeks of screening visit by any of the following treatments: liquid nitrogen, photochemotherapy (puva), long wave ultra violet radiation (uvb light), surgical excision or curettage within 1 cm of target lesion.; systemic retinoids.; ionizing radiation or interlesional injections or; undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the target lesion; 3. treatment with the following topical agents within the 4 weeks prior to the screening visit: levulanic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod. 4. history of recurrence of the target sccis lesion. 5. systemic use of immunosuppressive drugs within 4 weeks prior to screening visit or during the treatment period - photodynamic therapy or immunomodulators, cytotoxic drugs, or interferon/interferon inducers within 4 weeks prior to study entry or expected during the study. 6. women of child-bearing potential, unless they are using at least basic methods of contraception during dosing of investigational drug. 7. pregnant or nursing (lactating) women.

Keywords: cutaneous squamous cell carcinoma (cscc) in situ, mtor kinase inhibitors, pi3k inhibitor.
safety follow-up on children and adolescents with type 1 diabetes treated with insulin detemir. an extension to trial nn304-1689

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial nn304-1689 (nct00435019) on antibody development.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject). the parents or legal representative of the subject must sign and date the informed consent form. * finalised 52 weeks of treatment with insulin detemir in trial nn304-1689. * fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (iud)) if there is any risk of pregnancy in the opinion of the investigator. for denmark and france only contraceptive pills or intrauterine device are considered as adequate contraceptive methods. exclusion criteria: * significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the investigator. * pregnant or the intention of becoming pregnant. * previous participation in this trial (defined as enrolment).
analysis of the nustep as an introductory fitness regimen

Conditions: Diabetes; Inactivity

Summary: the purpose of this research study is to determine if participation in a fifteen week introductory exercise regimen using the nustep by sedentary adults diagnosed with type 1 or type 2 diabetes will affect exercise adherence and lifestyle adjustment. this study will examine if using the nustep encourages participants to seek other modes and facilitates interest in exercise. age, gender, weight, height, waist-to-hip ratio, heart rate, blood pressure, 6-minute walk test, and a1c will be recorded pre, mid-point, and post-test. during each nustep exercise session heart rate, blood pressure, blood glucose level, oxygen saturation, mets, and the borg rate of perceived exertion will be monitored. associations between nustep use and exercise adherence are investigated through the following hypothesis and null hypothesis. there is an association between using the nustep as an introductory exercise regimen by sedentary adults diagnosed with type 1 or type 2 diabetes and exercise adherence. the null hypothesis states there is no association between using the nustep as an introductory exercise regimen by sedentary adults diagnosed with type 1 or type 2 diabetes and exercise adherence. the primary endpoint of the study is the qualitative measurement, by use of a questionnaire, of attitude and interest toward exercise in participants by assessing if they choose to seek and perform other modes of exercise. secondary endpoints are the quantitative measurement of the change in weight, waist-to-hip ratio, heart rate, blood pressure, 6-minute walk test, and a1c levels.


Eligibility criteria:
inclusion criteria: * sedentary adults diagnosed by a physician with type 1 diabetes or type 2 diabetes. sedentary adults are defined as persons 19 years of age and older that are not meeting the minimal physical activity recommendations from the u.s. surgeon general's report. exclusion criteria: * adults with: * severe cardiovascular disease (high blood pressure, abnormal heart rhythm, peripheral artery disease, atherosclerosis, congestive heart failure, congenital heart disease, valvular heart disease and coronary artery disease) * amputees * severe foot ulcers * severe neuropathy * an amplified susceptibility to hypoglycemia * those weighing 400 lbs. or more, or inability to adequately perform exercise
first in human study of cx-801 in advanced solid tumors

Conditions: Solid Tumor, Adult

Summary: the purpose of this first-in-human study, ctmx-801-101, is to characterize the safety, tolerability, and antitumor activity of cx-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.

the study is comprised of 2 parts. part 1 involves cx-801 dose escalation to identify the maximum tolerated dose (mtd) of cx-801 as monotherapy and as combination therapy (cx-801 combined with pembrolizumab). part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of cx-801 combination therapy in indication-specific expansion cohorts.

Eligibility criteria:
inclusion criteria: * metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy * eastern cooperative oncology group (ecog) performance status of 0-1 * measurable disease per recist v1.1 * consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue * adequate organ function * additional inclusion criteria may apply exclusion criteria: * recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated * known active central nervous system (cns) involvement by malignancy * prior immunotherapy discontinued due to grade 3 or higher immune related adverse event * systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment * investigational drug or device within 4 weeks prior to first dose of study treatment * radiation within 2 weeks prior to first dose of study treatment * serious concurrent illness * pregnant or breast feeding * additional exclusion criteria may apply
prognostic significance of preoperative hemoglobin a1c (hba1c) in renal cell carcinoma

Conditions: Carcinoma, Renal Cell; Pathology; Treatment Outcome; Hemoglobin A1c Protein, Human

Summary: the effect of preoperative glycemic control measured by hba1c on renal cell carcinoma (rcc) outcome remains controversial. thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical or partial nephrectomy. the investigators will prospectively collect the relevant data including preoperative hba1c in 238 patients of rcc patients undergoing nephrectomy. the associations between clinical variables and risk of adverse pathological features and disease recurrence will be tested using a multivariate logistic regression and multiple cox-proportional hazards model, respectively.

* this is the observational study as the single institutional, prospective cohort study. the investigators prospectively collect the clinicopathological information of the patients with renal cell carcinoma (rcc) undergoing partial or radical nephrectomy. * particularly, the investigators check the variables, including age at surgery, body mass index, sex, comorbidities, preoperative hba1c levels, blood urea nitrogen (bun)/creatinine levels, estimated-gfr, clinical tmn staging by ct scan, final pathological results (tmn stage, histology, and fuhrman nuclear grade), warm ischemic time and surgical margin status (in the case of partial nephrectomy), postoperative recurrence and distant metastasis, renal function changes during follow-up periods. * the study protocol is same with routine follow-up schedule of the patients with rcc treated with nephrectomy. typically, the investigators check the patients at 1, 3, 6, 12, 18, 24, 30 and 36 months. however, according to the patients status and preference, follow-up schedule can be changed within 3 months at specific time points. because the present study is the observational cohort study, not intervention study, subtle changes of follow-up schedule would not affect on the primary outcomes. * importantly, preoperative hba1c should be checked within 1 month before operation, same as the routine preoperative laboratory tests.

Eligibility criteria:
inclusion criteria: * renal cell carcinoma (rcc) by image work-up such as ct scan * clinically localized rcc * aged over 20 years * patients undergoing radical or partial nephrectomy exclusion criteria: * distant metastasis, preoperatively * preoperative targeted therapy * preoperative immunotherapy * medications affecting glucose status other than diabetes mellitus

Keywords: renal cell carcinoma hemoglobin a1c protein pathologic outcomes oncological outcomes nephrectomy
single-center, randomized, superiority pivotal clinical study to evaluate the efficacy of artificial intelligence-based upper gastrointestinal endoscopy image

Conditions: Gastric Neoplasm; Gastric Lesion; Artificial Intelligence

Summary: we will conduct a single-center retrospective study at a university hospital. a total of 3,385 gastroscopic white-light images from patients with pathologically confirmed findings will be analyzed. the ai software will automatically identify images as non-neoplastic or neoplastic (low-grade dysplasia, high-grade dysplasia, early gastric cancer with mucosal or submucosal invasion, or advanced gastric cancer) and highlighted lesion locations. two experienced endoscopists will independently review the same image set without ai assistance for comparison. primary outcomes are sensitivity and specificity of the ai in detecting gastric neoplasms (by category and overall), and the localization accuracy measured by the localization receiver operating characteristic (lroc) curve area. secondary outcomes is includes comparison of the ai's diagnostic performance with that of endoscopists.

we will conduct a single-center retrospective study at a university hospital. a total of 3,385 gastroscopic white-light images from patients with pathologically confirmed findings will be analyzed. the ai software will automatically identify images as non-neoplastic or neoplastic (low-grade dysplasia, high-grade dysplasia, early gastric cancer with mucosal or submucosal invasion, or advanced gastric cancer) and highlighted lesion locations. two experienced endoscopists will independently review the same image set without ai assistance for comparison. primary outcomes are sensitivity and specificity of the ai in detecting gastric neoplasms (by category and overall), and the localization accuracy measured by the localization receiver operating characteristic (lroc) curve area. secondary outcomes is includes comparison of the ai's diagnostic performance with that of endoscopists. inclusion criteria: age 19 or older at least one gastric lesion biopsied with a definitive pathological diagnosis availability of high-quality white-light endoscopy images of the lesion and surrounding mucosa exclusion criteria: poor-quality images (e.g., out of focus or obscured) lack of histopathological confirmation of the lesion each image will be paired with a reference standard diagnosis based on the pathology result for that lesion or region.

Eligibility criteria:
inclusion criteria: * age 19 or older * at least one gastric lesion biopsied with a definitive pathological diagnosis * availability of high-quality white-light endoscopy images of the lesion and surrounding mucosa exclusion criteria: * poor-quality images (e.g., out of focus or obscured) * lack of histopathological confirmation of the lesion
light emitting diode in the treatment of genitourinary syndrome of menopause

Conditions: Atrophy;Vaginal

Summary: introduction: the genitourinary menopause syndrome (mms) affects 50% of postmenopausal women and, due to a decrease in hormone levels, triggers functional changes in the vagina and vagina, and impairment of quality of life and sexual function. objective: to test the hypothesis that the 405 nm light emitting diode in the treatment of vulvovaginal atrophy is safe and effective, by reducing the symptomatology of the disease and histological alteration of the tissue. methods: this is a pilot study in 10 volunteers with sgm, followed by a randomized, blinded trial in a sample of 58 individuals that will be performed at the pelvic floor care center (caap). menopausal women up to 65 years of age and with clinical signs and symptoms of vulvovaginal atrophy syndrome (vaginal dryness and irritation, pruritus, pain or discomfort in intercourse, bleeding after sexual intercourse) and who voluntarily participate in the study will be included. will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, use of pacemaker, pregnant women, those who have performed oophorectomy or presented ovarian cancer, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases. three 405 nm light emitting diode (led) sessions will be performed, with a seven days interval between them. in the clinical trial, the study group will perform kinesiotherapy and led. the control group will perform kinesiotherapy and the led will be turned off. data collection will be performed initially and after the sessions through self-administered questionnaires containing socio-demographic and clinical information, medical outcomes study 36, short-form health survey (sf-36), female sexual function index (fsfi) - female version (qs-f), female genital self-image scale - 7 (fgsis-7). at the end of treatment, the visual analog scale and likert scale will be used to measure the individual's satisfaction. expected results: the 405nm led in the vaginal canal is expected to be safe and effective for sgm.


Eligibility criteria:
inclusion criteria: * menopausal women up to 65 years of age * presence of clinical signs and symptoms of menopause genitourinary syndrome :dryness and irritation of the vagina, pruritus, pain or discomfort in sexual intercourse, bleeding after sexual intercourse * voluntarily participate in the research. exclusion criteria: * patients undergoing hormone replacement for less than 6 months * diagnosis of vaginal infection * difficulty in understanding the proposed instruments * patients with chronic neurological degenerative diseases.

Keywords: phototherapy menopause women
screening protein markers in patients with rheumatoid arthritis and hot-dampness and blood stasis syndrome

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with ra.

ra is one of the main disabling diseases in nowadays, which is an autoimmune disease with complex networks mechanism involving multiple signaling pathways and existing cross path. the investigators consider that the "heat-dampness and blood stasis" syndrome is the main syndrome and major pathogenesis for active ra, which on the base of the theory of traditional chinese medicine and a large quantity of clinical practice, and also examined by mechanism experiments. but the material basis of this syndrome is remained unclear, lack of high specific objective basis to ensure the syndrome differentiation consistency accurately in clinical practice. proteomic techniques study cells or the body by all the protein expression and function, thus has the potential efficient for decoding syndrome biological basis. proteomic techniques are the most effective way to reveal the essence of tcm syndrome. the investigators will use proteomic technology to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with ra. with strong clinical applicability, this will reveal the scientific connotation of this syndrome, preliminarily guide the syndrome differentiation.

Eligibility criteria:
inclusion criteria: * subjects are made or confirmed diagnosis according to the american college of rheumatology criterion and "heat-dampness and blood stasis" syndrome according to traditional chinese medicine. exclusion criteria: 1. subjects have other serious diseases, such as liver and kidney disease, cerebral-cardio vascular diseases. 2. subjects, who belong to "non-heat-dampness and blood stasis" syndrome, have double syndrome of heat or dampness.

Keywords: rheumatoid arthritis heat-dampness and blood stasis syndrome protein markers