Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of xueshuanxinmaining tablet for the treatment of stable angina pectoris

Conditions: Coronary Heart Disease; Stable Angina

Summary: this study is a randomized, double-blind, placebo-controlled, parallel clinical trial in chinese population with stable angina pectoris. the purpose is to determine the efficacy and safety of xueshuanxinmaining tablet in the treatment of stable angina pectoris.

xueshuanxinmaining tablet is a chinese patent medicine composed of ligusticum chuanxiong, salvia miltiorrhiza, borneol and toad puff, etc. it has been widely used in cardiovascular diseases in china. clinical application suggested that xueshuanxinmaining tablet was safe and effective in the treatment of stable angina pectoris. however, it still needs to be further confirmed by high-quality, large sample randomized controlled trials. this randomized, double-blind, placebo-controlled clinical trial is to determine the efficacy and safety of xueshuanxinmaining tablet in the treatment of stable angina pectoris.

Eligibility criteria:
inclusion criteria: * participants are aged between 40 and 75 years. * meet the diagnostic criteria of stable angina pectoris. * meet chinese medicine syndrome differentiation of qi-yin deficiency and blood stasis syndrome. * voluntarily participate and sign informed consent. exclusion criteria: * patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases. * patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year. * any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases. * before screening, any laboratory inspection index meets the following standards: the results showed that glutamic aspartate transaminase (ast) or alanine aminotransferase (alt) were more than 1.5 times of the upper limit of normal value and serum creatinine (cr) was more than 1.2 times of the upper limit of normal value. * with a history of alcohol and drug abuse. * pregnant or lactating women. * patients who have participated in clinical trials of other drugs within 3 months before enrollment.

Keywords: coronary heart disease stable angina traditional chinese medicine xueshuanxinmaining tablet
abbreviated breast mri for second breast cancer detection in women with brca mutation testing

Conditions: Breast Cancer; BRCA1 Mutation; BRCA2 Mutation; Recurrent Breast Cancer; Metachronous Neoplasm

Summary: study purpose: a multicenter prospective study to evaluate the outcome of second breast cancer surveillance with abbreviated breast mr (ab-mr) or ultrasound (us) in addition to annual mammography in women with brca1/2 mutation testing study scheme: * ab-mr, us, and digital mammography will be performed on the same day and interpreted independently at baseline and then after 1 year. * after completion of study, patients are followed-up for at least 1 year.

for women with a brca1/2 mutation who are treated for breast cancer, screening of remaining breast tissue with annual mammography and breast mri is recommended. for women who met brca testing criteria but show an uninformative negative result or a variant of unknown significance (vus) result, there is no established recommendation for second breast cancer surveillance. abbreviated breast mri (ab-mr) is a fast and low-cost examination that show equivalent diagnostic accuracy to that of the standardized dynamic protocol breast mri. breast ultrasound (us) can detect additional cancers that are occult on mammography and is indicated in high-risk patients who cannot tolerate mri. the purpose of this multicenter prospective study is to evaluate the outcome of second breast cancer surveillance with ab-mr or us in addition to annual mammography in women with brca1/2 mutation testing. ab-mr, us, and digital mammography will be performed on the same day at baseline and then after 1 year and images will be interpreted independently according to the breast imaging reporting and data system (bi-rads) by experienced radiologists. the bi-rads category 3 or higher is defined as test-positive. the reference standard will be a biopsy or at least 1 year of follow-up.

Eligibility criteria:
inclusion criteria: * women aged between 25 years and 75 years with a personal history of breast cancer * brca mutation test done (meeting any of the following criteria): 1) early-age-onset breast cancer (40 years or younger), 2) bilateral breast cancers (synchronous) 3) personal history of ovarian cancer and/or other multiple primary cancers 4) family history of breast and/or ovarian cancer in first- or second-degree relatives * no symptom or sign of secondary breast cancer (no palpable mass, bloody nipple discharge, abnormal skin change, nipple retraction) * written informed consent is given exclusion criteria: * initial breast cancer stage iv * bilateral mastectomy done * diagnosis of second breast cancer or regional/distant metastasis * systemic chemotherapy for any cancer * pregnant or lactating * contraindication to breast mri with contrast enhancement
acute kidney injury in premature infants

Conditions: Acute Kidney Injury

Summary: our first aim is to describe how common a sudden decrease in renal function happens in premature infants in a neonatal intensive care unit. we also want to see how a sudden loss of renal function affects survival. finally, we will explore non-invasive markers to identify a sudden decrease in renal function from urinary samples.

advancements in the field of peri-natal medicine has improved the survival of critically ill neonates but yet many still do not survive, and many more are left with long-term damage to vital organ systems. very little data is available on the impact that acute kidney injury (aki) has on survival in premature infants, but adult and pediatric studies that show that even mild aki independently impacts survival after correcting for severity of illness. the role that aki impacts survival in premature infants is likely to be greater than adults as this acute injury occurs in context of impaired and ongoing kidney development.. our ability to improve outcomes in children and adults with aki has been hampered by the inability to recognize aki early in the disease process. thus, the work on early non-invasive biomarkers of renal injury has brought great optimism to the field of aki. serum and urinary levels of neutrophil gelatinase-associated lipocalin (ngal), urinary interleukin 18 (il-18) others are markedly elevated several hours after aki as opposed to serum creatinine which takes days to rise after the inciting event. early non-invasive biomarkers of aki have not been tested in premature infants. inclusion criteria - infants (birthweight 500-1500g) be asked to participate in the study. • exclusion criteria - infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded

Eligibility criteria:
inclusion criteria: * 500-1500 grams birthweight * \>=25 weeks gestation exclusion criteria: * infants who do not survive 24 hours of life * infants with severe congenital abnormalities

Keywords: kidney infants
randomized double-blind study on the treatment of osteoarthritis of the bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid

Conditions: Osteoarthritis, Knee

Summary: oa-bi-blind is a randomized double-blind study on the treatment of osteoarthritis of the bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.

a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . in randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.

Eligibility criteria:
inclusion criteria: 1. male or female patients, aged between 18 and 75 years; 2. bilateral symptomatic knee osteoarthritis (kellgren-lawrence grade 1-4); 3. failure after two months of conservative treatment; 4. capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol; 5. signature of informed consent. exclusion criteria: 1. patients incapable of discernment; 2. patients with malignancy 3. patients with rheumatic diseases; 4. patients with diabetes; 5. patients with metabolic disorders of the thyroid; 6. patients belonging abuse of alcohol, drugs or medications; 7. patients with misalignment of the lower limbs than 10 °; 8. body mass index\> 40; 9. patients with a history of trauma or intra-articular infiltration of therapeutic substances within 6 months prior to treatment.

Keywords: osteoarthritis autologous bone marrow concentrate
propylene mesh vs standard customized palatal stent as protective mechanical barrier

Conditions: Randomized Controlled Trial, Human Study

Summary: protection of the palatal wound is an essential step following harvesting a palatal soft tissue graft. during the last decades, several materials were used to avoid protect against the post-operative problems as bleeding, pain and possible infections. the aim of this randomized clinical trial was to assess the usage of polypropylene mesh, compared to the conventional custom-made acrylic stent for efficacy in protection of the palatal wound and reducing the bleeding tendency and post-operative pain. propylene mesh is a promising material for protection of the palatal wound due to its light weight, limited bacterial wicking, tissue compatible properties, however, the custom made acrylic palatal stent provides a more precise mechanical . more studies are required to deeply assess the benefits of this material in the periodontal plastic surgeries.

background: protection of the palatal wound is an essential step following harvesting a palatal soft tissue graft. during the last decades, several materials were used to avoid protect against the post-operative problems as bleeding, pain and possible infections. the aim of this randomized clinical trial was to assess the usage of polypropylene mesh, compared to the conventional custom-made acrylic stent for efficacy in protection of the palatal wound and reducing the bleeding tendency and post-operative pain. patients and methods: a single blinded, parallel group randomized controlled trial took place. twenty sites were approved to be treated using soft tissue grafting technique with the need for a palatally harvested free graft. the palatal wounds were protected with propylene mesh and custom-made acrylic palatal sten. participants were qualitatively assessed for bleeding duration, bleeding amount, pain duration, infection possibility, inflammation at 2, 4, 6, 8, 14 days post-operatively. the patient acceptance was also evaluated.

Eligibility criteria:
inclusion criteria:medically free, above 18 years old, non-smokers with healthy reduced periodontium (free of any active disease either gingivitis or periodontitis) - exclusion criteria:during selection, smokers, medically compromised, pregnant and lactating mothers, patients with gagging reflex, incompliant patients, presence of periodontal disease, presence of fixed orthodontic palatal appliance were excluded -

Keywords: palatal wound, propylene mesh, palatal protection
sonoelastography to predict rotator cuff tears

Conditions: Rotator Cuff Tear

Summary: large-to-massive rotator cuff tears accounts for 30% of all rotator cuff tears. these problems can be solved by surgeries, but only part of them can be completely repaired. the prognosis for partial repair is worse than complete repair, so evaluating the possibility of complete repair is so important that it will affect the decision of treatment. more and more recent researches focused on using magnetic resonance imaging (mri) for evaluation of fatty infiltration of rotator cuff muscles to predict the reparability of large-to-massive rotator cuff tears. however, the availability of mri is not that good as ultrasound, so some researchers are starting to use ultrasound to predict the reparability of large-to-massive rotator cuff tears. because it is hard to observe the tissue quality through the general ultrasound, many researchers use sonoelastography to evaluate the tissue elasticity and viability. this aim of this study is to: 1. check the reliability of sonoelastography. 2. associate the findings of sonoelastography to the results of mri. 3. build a predictive model for the reparability of large-to-massive rotator cuff tears.


Eligibility criteria:
inclusion criteria: 1. patients who are diagnosed with rotator cuff tear by an orthopedist. 2. the large-to-massive rotator cuff tears need to be confirmed by magnetic resonance imaging or ultrasound. the definitions of this diagnosis include a tear over 3 cm or any full-thickness of tears in more than two rotator cuff muscles. 3. being willing to cooperated with the arranged examinations before the operation. exclusion criteria: 1. patients who are only diagnosed with partial-thickness rotator cuff muscle tears or small- to large- sized full-thickness tears. 2. patients who have acromioclavicular arthritis that needs distal clavicle resection. 3. patients who had serious glenohumeral arthritis, pseudoparalysis, or any other shoulder trauma history.

Keywords: large-to-massive rotator cuff tears reparability sonoelastography magnetic resonance imaging
azd1152 in patients with advanced solid malignancies-study 3

Conditions: Solid Tumours

Summary: the primary purpose of this protocol is to investigate the safety and tolerability of azd1152 when given as a continuous 7-day infusion every week and every 2 weeks in patients with advanced solid malignancies.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of a solid, malignant tumour exclusion criteria: * participation in an investigational drug study within 21 days prior to entry or who have not recovered from the effects of an investigational study drug * treatment with radiotherapy/chemotherapy with 4 weeks of first dose * recent major surgery within 4 weeks prior to entry to the study

Keywords: advanced solid tumours
clinical utility of caduet in achieving blood pressure and lipid endpoints in a specific patient population

Conditions: Hypertension; Dyslipidemia

Summary: the purpose is to demonstrate the utility of caduet (amlodipine/atorvastatin) in the african american population


Eligibility criteria:
inclusion criteria: * african american men and women with concurrent hypertension and dyslipidemia that is either treated or untreated * subjects must satisfy the blood pressure and ldl-c inclusion criteria for their respective cardiovascular risk group determined at screening exclusion criteria: * subjects currently being treated with concomitant amlodipine and atorvastatin therapy, including caduet * subjects with blood pressure at goal
a post marketing study of angel of water™ for colon cleansing as preparation for colonoscopy

Conditions: Colon Diseases

Summary: the aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy to standard preparation solution. hypothesis: colon cleansing by hydrotherapy is as good as colon cleansing by standard preparation solution.

colonoscopy is the current standard method for evaluation of the colon. it has an indispensable place in the diagnosis and treatment of colon diseases. diagnostic accuracy and therapeutic safety of colonoscopy depends on the quality of the colonic cleansing or preparation. good preparation of the bowel is necessary prior to colonoscopy, to allow clear visualization of the bowel wall and any pathology within. the proposed study is a post-marketing study in which the study device, the angel of water system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy, instead of standard preparation solution. the effectiveness of the hydrotherapy in comparison to the standard preparation will be defined by evaluating colon cleanliness, subject's attitude and the duration of colonoscopy procedure.

Eligibility criteria:
inclusion criteria: 1. subject is \>= 18 and ≤ 80 years old, referred to colonoscopy 2. subject is able and agrees to sign the informed consent and follow the study requirements exclusion criteria: 1. myocardial infarction within the last 3 months 2. symptomatic congestive heart failure 3. established renal failure (serum creatinine \> 2.0 mg/dl) 4. previous abdominal surgery, colectomy, or recent colon or rectal surgery 5. abdominal hernia 6. partial or complete intestinal obstruction 7. acute exacerbation of inflammatory bowel disease 8. intestinal perforation 9. fissures or fistula 10. grade iii or iv hemorrhoids 11. carcinoma of the rectum 12. distal rectal anastomosis 13. cirrhosis 14. hypokalemia 15. pregnancy 16. subject's weight \> 400 lbs. /182 kg 17. participation in another study that may affect the results of this study

Keywords: a colon hydrotherapy system hydrocolonic preparation preparation for colonoscopy
a study evaluating the safety, pharmacokinetics, and efficacy of crovalimab versus eculizumab in participants with paroxysmal nocturnal hemoglobinuria (pnh) currently treated with complement inhibitors

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: a study designed to evaluate the safety of crovalimab with eculizumab in participants with pnh currently treated with complement inhibitors. this study will enroll approximately 190 participants.


Eligibility criteria:
inclusion criteria: * body weight ≥ 40 kg at screening (pediatric participants with body weight \< 40 kg) * treated with eculizumab or ravulizumab for pnh for at least 3 months prior to day 1 * lactate dehydrogenase levels ≤ 2x the upper limit of normal (uln) at screening * willingness and ability to comply with all study visits and procedures * documented diagnosis of pnh, confirmed by high sensitivity flow cytometry * vaccination against neisseria meningitidis serotypes a, c, w, and y \< 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration * women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label) exclusion criteria: * history of allogeneic bone marrow transplantation * history of myelodysplastic syndrome with revised international prognostic scoring system (ipss-r) prognostic risk categories of intermediate, high and very high * pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label) * participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment * positive for active hepatitis b and c infection (hbv/hcv) * concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study * history of or ongoing cryoglobulinemia at screening
multidisciplinary care for patients with chronic kidney disease to increase their self-management.

Conditions: Chronic Kidney Diseases

Summary: the purpose of this study is to investigate the communication and data sharing between the primary care physician and the nephrologist about patients with chronic kidney disease. also therapeutic interventions that change behavior and telemonitoring of the blood pressure will be explored and compared to the usual care. the most important aim of this study is to improve the quality of care for the patient with chronic kidney disease in cooperation with the primary care physician and the nephrologist.

through questionnaires with primary care physicians, nephrologists from the university hospitals of leuven and patients with chronic kidney disease, the problems will be known. after the exploration there will be an intervention with patients who meet the in- and exclusion criteria. around 150-200 patients will be included with a 1:2 randomisation in the control and intervention group. the relevant clinical data and the factors of lifestyle will be questioned at the baseline. the intervention group will receive individualized therapy by a nurse, for example to quit smoking, to eat healthier and to do more physical activities. this therapy is based on the most important risk factors and will be determined before the start of the therapy. further on, these patients will also be motivated to take their blood pressure more frequently by using a telemonitoring system.

Eligibility criteria:
inclusion criteria: * predialysis, hemodialysis, peritoneal dialysis, transplantation * included in the care program of chronic kidney diseases * dutch-speaking * signed and approved informed consent exclusion criteria: * no dutch-speaking * impaired cognitive condition or medically unstable
pelvic floor muscle training with and without hypopressive exercises in postmenopausal females.

Conditions: Pelvic Organ Prolapse

Summary: to compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females

in this randomized controlled trial multigravida, postmenopausal females with stage 1 and 2 pelvic organ prolapse will be taken (exclusion criteria includes cesarean section females, ovarian cysts ,utis and neoplasm). this study will be conducted in jinnah hospital , lahore. sample size of 36 will be taken according to inclusion criteria. study will be completed in 10 months after approval of synopsis. non-probability convenient sampling will be used. a written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the pelvic floor muscle training group or group with combined pelvic floor muscle exercise and hypopressive exercise. treatment period will be 12 weeks 3 days per week. the participants will be advised not to use other forms of treatment during the trial (pharmacologic or non pharmacologic treatment). all subjects will be assessed before and after treatment by pop-q, pelvic floor impact questionnaire and p-qol. data will be analyzed by using spss 25 statistical software.

Eligibility criteria:
inclusion criteria: * multigravida * previous spontaneous vaginal deliveries * diagnosed stage 1 and 2 pelvic organ prolapse * post-menopausal females exclusion criteria: * history of cesarean section * history of ovarian cysts * history of utis * history of neoplasm * instrumental deliveries

Keywords: pelvic organ prolapse postmenopausal females exercises