Kornimate/medical-research-clean huggingface dataset:
telehealth lifestyle program for black adolescent girls at risk for type 2 diabetes

Conditions: Obesity, Childhood; Type2Diabetes

Summary: the aim of this study is to look at changes in diabetes-related risk factors in black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week telehealth lifestyle program.

enrolled adolescent/caregiver dyads will participate in the 12-week program. each week, participants will engage in 2 activities: a live virtual wellness session and an at-home cooking experience using ingredients sent to them via grocery delivery service. the study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. investigators hypothesize that after the program, participants' diets will be higher in quality than before.

Eligibility criteria:
inclusion criteria for adolescent participants: * 12-18 years of age * self-identify as black or african american * have obesity exclusion criteria of adolescent participants: * pregnant or within 3 months postpartum. * participated in a formal weight management program within 6 months prior to study. * currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function. * have previously undergone bariatric surgery. * have type 2 diabetes. * unable to speak english or have developmental conditions that interfere with ability to communicate. inclusion criteria of caregiver participants: * 18 years or older. * proficiency in speaking english. * live in the same household as the adolescent who will also be enrolled * prepares the majority (\>50%) of meals in the household exclusion criteria of caregiver participants: * pregnant or within 3 months postpartum. * unable to speak english or have developmental conditions that interfere with ability to communicate.

Keywords: adolescents telehealth lifestyle program diabetes prevention black girls obesity
intestinal microbiota and colorectal cancer in inflammatory bowel disease

Conditions: Inflammatory Bowel Disease; Colorectal Cancer

Summary: build a collection of fecal microbiota in order to determine the characteristics of gut microbiota associated with colorectal cancer in inflammatory bowel disease (ibd).

inflammatory bowel disease (ibd) are chronic and relapsing disabling disease. crohn's disease (cd) and ulcerative colitis (uc) are the two main types of ibd. patients with ibd are at greater risk of intestinal infection including viral infections (including cytomegalovirus) and bacterial (especially clostridium difficile). in the long term, patients with colonic involvement are at an increased risk of colorectal cancer (crc). moreover, it has been reported in several cohort studies that patients with primary sclerosing cholangitis (psc) associated with ibd (psc-ibd), have an even increased risk of crc (about 10 to 20% at 10 years). other studies also suggest that the microbiota has an impact on liver diseases. conversely, cholestatic liver diseases (such as psc) can influence the microbiota, notably through modification of the production of bile acids. finally, the role of the gut microbiota in the development of the crc in ibd has been well established in animal models. the pathophysiological mechanisms are not well understood but may involve an alteration of the balance between protective bacteria against harmful microbiota. this study aims to investigate the link between gut microbiota, intestinal inflammation, colorectal cancer, bile acid and liver diseases and this, through the creation of a biological collection of fecal microbiota from fecal samples from 8 groups of subjects: (i) ibd without ccr (ii) ibd with ccr, (iii) ibd with dysplasia, (iv) non ibd without ccr, (v) non ibd with ccr, (vi) ibd-csp without ccr, (vii ) ibd-csp with ccr, (viii) ibd-csp with dysplasia. in these patients, microbiota composition will be assessed by sequencing technology.

Eligibility criteria:
inclusion criteria: * patient with the capacity to give informed consent. * age ≥ 18 years. * a patient with ibd (crohn's disease or ulcerative colitis) or healthy subject having a screening colonoscopy scheduled. * diagnosis of pathologies in question established or confirmed in any of the services involved in the study and according to international diagnostic criteria (consensus ecco). * patient follow-up in one of the services involved in the study exclusion criteria: * trusteeship, guardianship or safeguard justice. * subject does not speak french. * subject unable to answer questions or to speak. * previous history of colonic resection * taking antibiotics within 8 weeks preceding the stool sample temporary exclusion criterium) * taking a bowel preparation for colonoscopy within 6 weeks before the stool sample (temporary exclusion criterium). sampling is possible before bowel preparation or on the first stool after starting the bowel preparation. * ostomy at the time of sampling * current treatment by radiotherapy, chemotherapy

Keywords: inflammatory bowel disease crohn's disease ulcerative colitis colorectal cancer primary sclerosing cholangitis
honghe fujie lotion for the treatment of bacterial vaginosis

Conditions: Bacterial Vaginitis

Summary: this is a randomized, positive -controlled, multi-center trial enrolling 240 subjects with bacterial vaginosis who will be randomized at a ratio of 1:1 to receive active honghe fujie lotion or metronidazole suppositories. the primary objective is to assess the safety and tolerability of honghe fujie lotion compared to metronidazole suppositories.


Eligibility criteria:
inclusion criteria: 1. premenopausal women with sex history. 2. age: 20 - 50 years. 3. clinical diagnosis of bacterial vaginosis. 4. nugent scale ≥7. 5. patient is willing to participate voluntarily and to sign a written patient informed consent. exclusion criteria: 1. evidence of other female genital tractor infectious diseases (e.g. trichomonas vaginitis, vvc, suspected gonorrhea，hsv infection and pointed condyloma etc.). 2. pruritus vulvae or pain caused by nonneoplastic epithelial disorders of vulva（e.g. vulvar squamous epithelial hyperplasia ,vulvar lichen, diabetic vulvitis etc.). 3. server gynecopathy（e.g. gynecological malignant tumor etc.）. 4. liver function impairment with the value of alt or ast over 2-fold of normal value.renal dysfunction with the value of serum creatinine over normal value. 5. patient accompanied with server systemic diseases (gastrointestinal, cardio,cerebral, blood circulatory, endocrine, and renal system). 6. receiving locally applied drugs within 1 week or currently using vaginal medicines. 7. significant drug or alcohol abuse or a history of mental illness patients. 8. researchers determine poor adherence, or any other unsuitable reasons for patients to participate in this study. 9. diagnosis with other disease that necessities immunosuppressant or hormone therapy. 10. pregnancy, breast feeding and the possible pregnancy during study. patient who is participating in other trials or has been participated in other trials in recent 1 months. 11. allergic to one or more components of study medicine.
addressing anxiety in 2-3-year-olds: a pilot intervention study

Conditions: Anxiety Disorder of Childhood; Fear; Shyness

Summary: the purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental fear and/or shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child cognitive behavioral therapy (cbt) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. before the covid-19 pandemic, study visits and treatment sessions were conducted in office. now all visits and treatment sessions are conducted remotely.


Eligibility criteria:
inclusion criteria: * the child scores \>1 standard deviation (sd) above reported means for the fear or shyness scales on the early childhood behavior questionnaire (ecbq) (if child is 21-35 months) or the child scores \>1sd above reported means for the total anxiety, generalized anxiety, social anxiety, physical injury fears, or separation anxiety scales on the preschool anxiety scale (pas) (if child is 36-47 months) as completed by a parent * the parents are able to speak, understand, and read english * the child must have a working knowledge of english. exclusion criteria: * autism spectrum disorder (asd) or global developmental delay in the child * the child has disruptive behavior so severe as to interfere with participation in intervention sessions * the child has a different primary disorder for which cbt for anxiety is inappropriate (e.g. severe depression, depression in the mother, significant medical disorder).

Keywords: anxiety disorders toddlers preschoolers cognitive-behavioral therapy
evaluation of the iy tcm program in norwegian school and day-care settings

Conditions: Behavior Problem

Summary: the purpose of this study is to evaluate whether training teacher and staff in the incredible years (iy) teacher classroom management (tcm) program reduce behavior problems and promote social competence in student aged 6-8 years (school) and in children aged 3-6 year (day-care). to examine group differences from baseline to 8-9 months after, a quasi-experimental control group design with pre- and post-measurements was used.

evaluation of the incredible years (iy) teacher classroom management (tcm) program implemented as a school-wide preventive intervention in regular school and day-care settings, have the potential to change negative behaviors in children aged 3 - 8 year. forty-four schools were recruited; comprising 1518 students aged 6-8 year, and 91 day-care units comprising 1049 children aged 3-6 year. multilevel analyzes were used to examine group differences pre-post changes for behavior problems measured with the sutter-eyberg student behavior inventory-revised (sesbi-r) and the teacher report form (trf), as well as group differences pre-post change for social behavior measured the social skills rating system (ssrs). for secondary findings, group differences pre-post changes for teacher- student and teacher-children relationship were measured with the student-teacher relationship scale (strs) (teachers n= 444), and teacher-parents interactions were measured with the teacher-parent involvement questionnaire (involve-t/p) (parents n = 2109), as well as group differences pre-post change for teachers self- and collective efficacy measured the norwegian teacher self-efficacy scale (ntses) and the collective efficacy scale (ces) (teachers n = 3240).

Eligibility criteria:
inclusion criteria: * schools who met predefined criteria for program implementation of iy tcm (intervention) and school who not have implemented any iy program (comparison). * students/children aged 3-8 year (until 7 randomly selected from each class) with parents who speak norwegian. * teachers and staff who worked with students/children aged 3-8 years. exclusion criteria: * schools who did not met predefined criteria for program implementation of iy tcm. * students/children aged 3-8 year with parents who did not speak norwegian. * teachers and staff who did not worked with students/children aged 3-8 years, and who have known the students/children for fewer than 3 weeks.

Keywords: behavior problem social competence student children
performance of bioactive low viscosity composite in deep marginal elevation restorations

Conditions: Deep Caries; Caries, Dental

Summary: the goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive giomer shofu flow plus x f03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.


Eligibility criteria:
inclusion criteria: * adults patients (20-50) * good oral hygiene (plaque index 0 or 1 ) * patient approving to participate in the study * absence of parafunctional habits and/or bruxism exclusion criteria: * patients with known allergic or adverse reaction to the tested materials. * systematic disease that may affect participation. * xerostomic patients. * bad oral hygiene (plaque index 2 or 3 ) * heavy smokers * patients undergoing or will start orthodontic treatment * patients with removable prothesis
comparative study between shear and strain elastography in monitoring the response to nac in breast cancer patients

Conditions: Monitoring the Response of Breast Cancer to Neoadjuvant Chemotherapy Using SE and SWE

Summary: the aim is to evaluate tumor stiffness changes through a comparative study between shear and strain elastography in monitoring the response of breast cancer to neoadjuvant chemotherapy

breast cancer (bc) is one of the most common malignant tumors in global population, with the highest morbidity and mortality rates among female.(1) neoadjuvant chemotherapy (nac) has become an important supplement of comprehensive and precise treatment of bc. neoadjuvant chemotherapy (nac) is increasingly used to induce tumor shrinkage, thereby allowing smaller surgical resection, eliminating clinically silent micro metastases, and providing prognostic information based on the extent of pathologic response(.2-4) pathological complete response (pcr) is increasingly seen after neoadjuvant chemotherapy (nact) for invasive breast cancer. confident identification of pcr may lead to less radical breast surgery and to sentinel node biopsy rather than axillary clearance in women with pre-treatment positive nodes.(5)response to nact is routinely assessed using magnetic resonance imaging (mri), greyscale ultrasound (us), and mammography.(6) in some studies, mri has been shown to be superior to us.(7-8) however, mri has the disadvantages of being time-consuming, expensive, requiring intravenous contrast agent . ultrasonic elastography (ue) has been widely used to qualitatively and quantitatively evaluate differences in lesion stiffness or elasticity. currently, the two most frequently used ue techniques for examination of breast diseases are strain elastography (se) and shear-wave elastography (swe). in practice, ue is a complementary technique for differentiating benign from malignant breast masses (9,10). breast cancers with more aggressive pathological properties tend to have higher stiffness values .strain elastography (se) may be predictive of response in the early stage of treatment with high sensitivity (sen) and specificity (spe).(11,12) pretreatment tumor stiffness measured by shear wave elastography (swe) has a significant relationship with the subsequent reduction in tumor cellularity.(13) in case of nact, early evaluation of relative changes in tumor stiffness could effectively predict the response and might indicate better therapeutic strategies.(14)

Eligibility criteria:
inclusion criteria: 1. histologically confirmed invasive ductal carcinoma . 2. age equal or above 18 exclusion criteria: 1. previous radiation therapy or chemotherapy 2. mass not detected by us 3. non mass lesion by mri 4. ductal carcinoma in situ
clinical trial for liquid food (inslow)

Conditions: Diabetes

Summary: a carbohydrate adjusted liquid formula (inslow) using palatinose as the major carbohydrate (\>50%) was devised. consumption inslow for a long term (3-5 months) is reported to improve glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired glucose-tolerant subjects (igt). the present study intends to understand the mechanism on postprandial glycemic responses.

the test enteral nutrition formula (inslow) and the standard balanced formula (meibalance) were administered in a randomized crossover design to 11 healthy people, 13 igt and 12 type-2 diabetes, judged by the postprandial state after in taking the two test meals in a random order with a washout period of one week. on the day prior to the test day, subjects were asked to stay at the same facility and to take the same supper with 450 kcal controlled, after 21:00 with only water allowed as ad libitum and not do any exercise. each participant was taken a fasting blood sample, and then requested to consume one of is energetic test meals (200 kcal per serving) inslow or standard balanced formula at 7:00 am. subsequent blood samples were collected at 30,60,90,and 120 min after meal consumption. the plasma concentrations of glucose, insulin, and free fatty acids were measured for each blood sample. plasma glucose was measured by hexokinase method, plasma insulin by serum radioimmunoassay method and plasma free fatty acid by enzyme chemical method.routine blood test and biochemical test were performed using the same blood sample only at fasting stage,including rbc, wbc, tp, alp, t-cho, etc., to confirm the status of each subject. collected blood was applied to analyses at shanghai meizhong clinical measurement centre. the enteral nutrition meal inslow was designed by palatinose, dextrin and fiber as carbohydrate for 56%,23% and 15%, respectively. the standard balanced meal was included dextrin as the main carbohydrate for 85%, together with sugar and fiber.

Eligibility criteria:
inclusion criteria: * type 2 diabetes (symptoms of diabetes plus fasting plasma glucose level higher than 7.0 mmol/l and glucose levels after 75g oral glucose tolerance test (ogtt) or casual blood glucose level higher than 11.1mmol/l) and igt patients (glucose levels after 75g ogtt between 7.8 and 11.1mmol/l). exclusion criteria: * these patients or subjects have no infectious diseases and were not using any drug.
perform humeral system study

Conditions: Osteoarthritis Shoulder; Avascular Necrosis; Post-traumatic Arthrosis of Other Joints, Shoulder Region; Rotator Cuff Tear Arthropathy

Summary: this study is an international, single arm, multicenter, prospective, non-significant risk, post-market clinical follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. data collected from this study will be used for purposes, including but not limited to, post-market surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

this study is an international, single arm, multicenter, prospective, non-significant risk, post-market clinical follow-up study. data will be collected for the commercially available perform™ humeral system. the objective of this study is to demonstrate the safety and performance of the perform™ humeral system devices after implantation over a standard follow-up period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. safety and performance measures will be evaluated throughout the patient's participation in the study.

Eligibility criteria:
inclusion criteria: * 18 years or older at the time of the informed consent or non-opposition (when applicable). * informed and willing to sign an informed consent form approved by irb or ec (when applicable). * willing and able to comply with the requirements of the study protocol. * considered a candidate for shoulder arthroplasty using a study device. * meets indications for use requirements or other local, regional, or geographic specific regulatory requirements exclusion criteria: * not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times) * patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a legally authorized representative (lar), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the iso 14155 norm). * active local or systemic infection, sepsis, or osteomyelitis * poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid * significant injury to the brachial plexus * inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components * neuromuscular disease (e.g., joint neuropathy) * patient with known allergy to one of the product materials * metabolic disorders which may impair bone formation * patient pregnancy * planned for two-stage surgery
retrospective natural history study of retinitis pigmentosa

Conditions: Retinitis Pigmentosa (RP)

Summary: this is natural history study of rods and cones degenerations in patients with retinitis pigmentosa (rp) caused by pathogenic mutations in rho, pde6a or pde6b gene mutations.

this is a retrospective, longitudinal, observational case history study to determine the natural history of rods and cones degeneration in patients diagnosed with rp caused by pathogenic mutations in genes with selective expression in rods: rhodopsin (rho), phosphodiesterase 6a (pde6a) or phosphodiesterase 6b (pde6b). 113 participants will be enrolled in this study at the single center: chno-cic quinze-vingt paris in france.

Eligibility criteria:
inclusion criteria: * patients with rp caused by pathogenic mutations in rho, pde6a or pde6b genes. exclusion criteria: * patients with a pathogenic mutation in any other gene known to be involved in rp. * patients with any ocular disorder other than rp, likely to impact the retinal function.

Keywords: retinitis pigmentosa rho pde6a pde6b pathogenic mutation retrospective natural history retinal disease eye diseases blindness inherited eye diseases vision disorders inherited retinal disorders rod-cone dystrophy