Kornimate/medical-research-clean huggingface dataset:
effect of alpha lipoic acid on uterine scar healing after cesarean section

Conditions: Cesarean Section; Dehiscence; Cesarean Scar Niche

Summary: the aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar healing after cesarean section by using saline contrast sonohysterography

this is a triple blind randomized placebo controlled prospective clinical trial that will be conducted in ain shams university maternity hospital. in which a consecutive series of participant attending emergency room 102 women undergoing cesarean section for the first time will be randomized into two groups. group a (study group): 51 women will receive alpha lipoic acid drug ( 600 mg twice daily) for 6 weeks after cesarean section and saline sonohysterography will be done after that. group b (control group): 51 women will receive a placebo drug twice daily for 6 weeks after cesarean section and saline sonohysterography will be done after that.

Eligibility criteria:
inclusion criteria: * term pregnancy (gestational age between 37-41 weeks). * women undergoing cesarean section for the first time. * normal vaginal ultrasound examination and exclusion of any pelvic abnormality. * uncomplicated cesarean section. * lower uterine segment cesarean sections while the women not in labor. exclusion criteria: * women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound * women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant. * women who will use intrauterine device as a contraceptive method * women with uterine abnormality as cervical stenosis or fibroid uterus * women with pelvic infection at the time of saline sonohysterography
performance of novel simplified score for chronic hepatitis b treatment eligibility in thailand

Conditions: Chronic Hepatitis B

Summary: international and national guideline for chronic hepatitis b (hbv) infection treatment recommend initiated antiviral in high hbv viral loads patients with significant liver inflammation and significant liver fibrosis. in thailand, hbv viral loads and liver elastography are limited available in seconds to tertiary care hospital. recently, many of simplified scoring system (treat-b score, who (world health organization)-simplified score and reach-b score) were developed for assessment of antiviral initiation. this study aim to evaluate the performance of simplified score for chronic hbv treatment compare to thailand and international standard guideline.

according to who global health sector strategy on viral hepatitis 2016- 2021, who aim to global eliminate hbv infection within 2030. main strategies for achievement are effective prevention and treatment. international and national guideline for hbv infection treatment recommend initiated antiviral in high hbv viral loads patients with significant liver inflammation and significant liver fibrosis. thus, hbv viral load and liver elastography are required for indication assessment. in low-to-middle income country such as thailand, hbv viral loads and liver elastography are limited available in seconds to tertiary care hospital. recently, many of simplified scoring system (treat-b score, who-simplified score and reach-b score) were developed for assessment of antiviral initiation. this study aim to evaluate the performance of simplified score for chronic hbv treatment compare to thailand and international standard guideline.

Eligibility criteria:
inclusion criteria: * treatment naive chronic hepatitis b infection patients who visited at liver clinic and internal medicine clinic siriraj hospital during january 2015-december 2021 * age \> 18 years exclusion criteria: * treatment experience chronic hepatitis b infection patients * hiv co-infection * hcv (hepatitis c) co-infection * concomitant hcc (hepatocellular carcinoma) * pregnancy * incomplete data

Keywords: chronic hepatitis b, treat-b, reach-b, who criteria
combination of cryosurgey and nk immunotherapy for recurrent laryngeal cancer

Conditions: Recurrent Laryngeal Cancer

Summary: the aim of this study is the safety and efficacy of cryosurgery plus nk immunotherapy to recurrent laryngeal cancer.

by enrolling patients with recurrent laryngeal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (nk) cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: laryngeal cancer cryosurgery nk immunotherapy
feiba and use of blood products in cardiac surgery

Conditions: Cardiovascular Disease

Summary: the purpose of this pilot study is to evaluate the feasibility of the prophylactic administration of factor viii inhibitor bypass activity (feiba) at termination of cardiopulmonary bypass (cpb) period. specifically, the proposed study is designed to demonstrate the potential role of feiba administration in reducing the need for allogeneic transfusion to treat refractory coagulopathy in high risk patients.

factor eight inhibitor bypassing activity (feiba) is currently approved for use in this country for the treatment of patients with hemophilia and inhibitors at a dose of 50-100 units/kg. there is a large body of evidence demonstrating the safety and efficacy of feiba for hemophilia patients with inhibitor and has a theoretical advantage compared to current blood product transfusion methods, as it replenishes multiple depleted factors that are lost with prolonged exposure to cpb. this pilot study is a single center, randomized, double-blinded, placebo controlled trial assessing the feasibility and safety of factor eight inhibitor bypass activity (feiba) in patients undergoing major cardiovascular surgery requiring prolonged cpb. the study population will consist of adult patients undergoing elective cardiac surgery at ohsu. twelve participants will randomly assigned to receive feiba or placebo during their surgical procedure. patients will be followed to review for adverse events while in the icu, and up to four weeks after discharge.

Eligibility criteria:
inclusion criteria: * age 18 or older * elective aortic or aortic valve procedures, coronary re-implantation (bentall) with cardiopulmonary bypass, and/or deep hypothermic circulatory arrest. * written informed consent exclusion criteria: * contraindications to the administration of fieba or known anaphylactic or severe hypersensitivity reactions to feiba or any of its components * disseminated intravascular coagulation (dic) * acute thrombosis or embolism, including myocardial infarction * pregnant women * decisionally impaired adults * prisoners * expressed unwillingness or are otherwise deemed unable to provide written informed consent.

Keywords: cardiopulmonary bypass aortic valve repair coronary re-implantation deep hypothermic circulatory arrest factor viii inhibitor bypass activity transfusion
impact of dietary sodium supplementation on growth & intestinal microbiome

Conditions: Preterm Birth

Summary: the purpose of this project is to determine the direct impact of sodium supplementation in preterm infants and to see the overall improvement of their growth and health status. from this study will help us develop a better treatment for in the future.

premature infants are at an increased risk of postnatal growth failure and as well as developing short or long-term impaired neurodevelopment and cardio metabolic health. for many years, it has been recognized that ideal growth is attainable with sufficient sodium intake and a positive sodium balance. the results of this study could have a significant impact on the care of preterm infants. infants will be randomized into one of two groups. one group will receive sodium supplementation as guided by a urine sodium concentration algorithm, one group will be managed by current standards. randomization will occur at 2 weeks of postnatal age standard of care group care for the participant will remain the same as if they were not in the study. nutritional information, including sodium intake will be collected on three separate days weekly for 8 weeks. stool samples will be collected for determining intestinal microbiome at 2 weeks, 5 weeks, 8 weeks and the day they are discharged from the hospital. the study team will also collect detailed health information from participants hospital stay from the medical chart. which will include gestational age, birth weight, sex, race ,ethnicity, mode of delivery and exposure to any steroids, antibiotics and clinical diagnoses. sodium supplementation group: participants will receive sodium supplementation per the urine sodium concentration algorithm. urine sodium will be determined weekly, and if urine sodium concentration is below set value, dietary sodium supplementation is provided.

Eligibility criteria:
inclusion criteria: * birthweight \>500 grams and * gestational age at least 25 0/7weeks but less than 30 weeks. * \<14 days of age at time of randomization exclusion criteria: * non-english speaking parents * major congenital anomalies * grade underlying renal dysfunction (serum creatinine \> 1.0 mg/dl or increase of \>0.3 mg/dl between any two consecutive measurements) * use of diuretics at the time initiation of intervention (approximately 14 days of age) but this is not completely an exclusion-the research can wait 2 days and at the time of 2 week time period of the study we can re check their levels * any structural genitourinary criteria.
topical steroids & bacterial decolonization for radiation dermatitis

Conditions: Radiation Dermatitis

Summary: the purpose of this study is to determine whether bacterial decolonization of the nares and skin, topical steroid therapy, or a combination of the two regimens prior to treatment with radiotherapy (rt) for breast and head and neck cancer patients can prevent grade 2 or higher grade radiation dermatitis (rd) graded via the common terminology criteria for adverse events (ctcae) scale and improve quality of life.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 * diagnosis of a breast or head and neck cancer with plans for fractionated rt (greater than or equal to 15 fractions in 40 gy (gray)) with curative intent, including post-operative patients deemed eligible for rt by their surgeons and radiation oncologists exclusion criteria: * prior rt to the region of interest * existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds; known allergy to intervention therapies)
99mtc-rhannexin v-128 imaging and cardiotoxicity in patients with early breast cancer

Conditions: Breast Cancer; Doxorubicin Induced Cardiomyopathy

Summary: this was a single center, proof-of-concept (poc), phase ii study. patients with histologically confirmed early stage (stage i, ii or iii) her-2 negative breast cancer and scheduled to receive doxorubicin-based (neo)adjuvant therapy to be followed by paclitaxel or docetaxel as per clinical practice. the planned doxorubicin-based chemotherapy treatment consisted of doxorubicin 60 mg/m2 in combination with cyclophosphamide 600 mg/m2 (ac) intravenous (iv) every 2 or 3 weeks for 4 cycles. patients were scheduled for cmri and 99mtc-rhannexin v-128 imaging (planar and spect / ct) at the following visits: 1. screening/baseline, i.e. 2 weeks prior to initiating ac treatment (visit 1) 2. after the 2nd and before the 3rd cycle of ac treatment (visit 2) 3. after the 4th cycle of ac treatment and within 2 weeks (visit 3) 4. at 12 weeks after the 4th cycle of ac treatment (visit 4). the imaging procedures were conducted and analyzed. bloodwork for cardiotoxicity biomarkers (troponin, n terminal pro b-type natriuretic peptide \[nt-probnp\]) was performed at each visit.

overall, it was planned to recruit 30 adults with early stage breast cancer. the first 10 patients were to be enrolled in the poc phase of the study to assess the potential of 99mtc-rhannexin v-128 in terms of imaging quality, uptake and medical relevance. based on the results of the first 10 patients, the dmc was to decide whether to terminate the study or continue to the phase ii and enroll the next 20 planned patients. the maximum study duration was 26 (±4) weeks per patient (including the screening and follow-up periods). the sponsor decided to terminate the study earlier than planned due to strategic decisions to focus the aaa development portfolio on oncology theragnostics and not based on safety concerns.

Eligibility criteria:
inclusion criteria: 1. females \>= 18 years of age with histologically confirmed early stage (stage i, ii or iii) her-2 negative breast cancer and planned for (neo)adjuvant doxorubicin-based chemotherapy (ac every 2 or 3 weeks x 4 cycles) 2. eastern cooperative oncology group status (ecog) ≤ 2 3. able and willing to comply with the study procedures exclusion criteria: 1. pregnancy or lactation 2. moderate or severe valvular stenosis or regurgitation 3. history of atrial fibrillation or flutter 4. history of any disease or relevant physical or psychiatric condition which may interfere with the study objectives at the investigator judgment 5. know hypersensitivity to the investigational product (ip) or any of its components 6. prosthetic valve or pacemaker 7. claustrophobia or inability to lie still in a supine position 8. contraindication(s) to the cmri procedure 9. participation in another clinical trial within 4 weeks before study inclusion, except for patients who have participated or who are currently participating in a study without any study drug administration 10. unwillingness to provide consent
esthetic expectations of edentulous patients followed in a french dental clinic

Conditions: Complete Edentulism

Summary: esthetic is a major factor in complete denture (cd) success. patient involvement in esthetic project plays a crucial role in denture acceptance and patient satisfaction. historically, teeth choice and arrangement were made according to frush and ficher's recommendations focusing on natural looking of esthetics. dentists may also propose to restore the dentate state looking for denture when preextraction data are available. recently, a patient-centered approach based on attractivity has been proposed and may lead to in an appearance transcending the laws of nature. the aim of the present study was to investigate actual denture esthetic expectations in a french edentate population followed in a university dental clinic (rothschild hospital , ap-hp).

inclusion criteria : being currently edentulous within at least within the maxillary arch, literate french speakers, willing and able to complete the survey in a single sitting. clinical data collection was made by a unique examiner and concerned length of edentulism, antagonist arch, existence of preextraction data, smile attractivity opinion. the respondents completed a questionnaire identifying their age, sex, educational and income level. patients were also asked for their denture look preference among 4 esthetic projects: 1) restoring pre-extraction (dentate) looking, 2) restoring actual denture looking, 3) creating natural looking, 4) creating perfect looking, 5) no opinion. each project was explained similarly by the same examiner. statistical analysis using a pearson chi-squared test at a 0.05 level of significance was conducted for associations between esthetic projects preference and tested variables.

Eligibility criteria:
inclusion criteria : currently edentulous maxillary arch, literate french speakers, willing and able to complete the survey in a single sitting. inclusion criteria: exclusion criteria: aged under 18 years.
efficacy and safety of deep sea water on the blood glucose level

Conditions: PreDiabetes

Summary: this study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia

this study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.

Eligibility criteria:
inclusion criteria: * fasting plasma glucose concentration of 100-140 mg/dl or 2h-postprandial plasma glucose concentration of 140 \~199 mg/dl exclusion criteria: * patients with type 1 or type 2 diabetes * hba1c ≥9.0% * weight decreased by more than 10% within past 3 months * have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc. * hypoglycemic agent, obesity medicine, lipid lowering agent within past 6 months or functional food within past 2 month * subjects who have taken corticosteroid within past 1 months * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test by show the following results * serum ast (aspartate aminotransferase) or alt (alanine aminotransferase) \> 2 times the upper limit of normal range * serum creatinine \> 2.0 mg/dl * pregnancy or breast feeding * if a woman of childbearing doesn't accept the implementation of appropriate contraception * principal investigator judged inappropriate for participation in study because of laboratory test result, etc
foley's catheter balloon plus tranexamic acid during cesarean delivery for placenta previa

Conditions: Placenta Previa

Summary: placenta previa (pp) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (pph). the bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. it has been used in cases of uterine atony and placenta previa with a success rate of 90%. however, bakri balloon is not available in all countries. the aim of this study is to evaluate the efficacy of the use of intrauterine inflated foley's catheter balloon with or without intravenous tranexamic acid to control pph during cesarean delivery in cases of placenta previa.

eligible participants were allocated to one of two groups. group (i): patients managed by intrauterine inflated foley's catheter balloon after delivery of the fetus. group (ii): patients received 1 gm tranexamic acid (ta), (2 ampoules of capron® 500 mg /5 ml; cairo, egypt) intravenous just before skin incision plus intrauterine inflated foley's catheter balloon. in group i, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. neither the surgeon nor the anesthetist will know the nature of the iv administered drug before cesarean section.

Eligibility criteria:
inclusion criteria: * all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa exclusion criteria: * patients with a cardiac, hepatic, renal or thromboembolic disease * patients with the high possibility of the morbid adherent placenta * known coagulopathy or thromboembolic disease * those presented with severe antepartum hemorrhage * hypersensitivity or contraindications of use of tranexamic acid * patient refuses to consent

Keywords: placenta previa tranexamic acid cesarean section foley's catheter balloon
evaluation of safety of acellular dermal matrix(adm) in breast reconstruction

Conditions: Breast Cancer Female; Breast Reconstruction

Summary: the goal of this observational study is to evaluate the safety of acellular dermal matrix(adm) processed by co2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.

outline: the total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group. the test group will receive sc derm recon(adm processed by co2 supercritical fluid technology) during the implant-based breast reconstruction surgery. the control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using adm from other companies between march 1, 2021, and march 31, 2024. after surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks. primary objectives i. to assess whether the test group with applying the adm processed by the supercritical fluid technology will have less short-term major complications than the control group with the adm processed by detergents.

Eligibility criteria:
inclusion criteria: 1. prospective subjects (test group) 1) adult women aged 19 to 79 years. 2) patients who received sc derm® recon, an acellular dermal matrix product, during breast reconstruction surgery with implants following a mastectomy due to breast cancer. 3) individuals who have voluntarily provided written informed consent after receiving an explanation of the study's purpose and methods, are willing to comply with the study protocol, and are willing to visit the hospital for the evaluation of observational parameters. 2. retrospective medical record collection 1) patients who received an acellular dermal matrix product during breast reconstruction surgery with implants following a mastectomy due to breast cancer at seoul national university hospital between march 1, 2021, and march 31, 2024. exclusion criteria: 1. prospective subjects (test group) 1) individuals deemed inappropriate for study participation by the principal investigator or other investigator's judgement. (e.g., those unable to undergo the required tests for this study). 2. retrospective medical record collection 1) patients who received an acellular dermal matrix product but have no recorded follow-up visits after application.