Kornimate/medical-research-clean huggingface dataset:
vitamin d treatment of diabetic patients with foot ulcers

Conditions: Diabetic Foot Ulcers; Vitamin D Deficiency

Summary: the purpose of this study, is to determine whether daily supplements of vitamin d improves wound healing in diabetic patients with chronic foot ulcers.

project title "treatment with oral vitamin d in diabetic patients with chronic foot ulcers on the lower limb; a clinical controlled study of the effect on wound healing". abstract aims and objectives the purpose of this study is to determine whether daily supplements of vitamin d improves wound healing in diabetic patients with chronic foot ulcers. background lifetime risk of developing chronic lower extremity ulcers summarized in type i and type ii diabetics is about 25% and the prevalence is approximately 7%. there is often a long term resource consuming disorder where 47% of the diabetic leg and foot ulcers effectively can be treated within 12 months. in denmark in 2011 there were more than 300,000 diagnosed type i and type ii diabetics, and estimated about 200,000 undiagnosed type ii diabetics. therefore, approximately 35,000 diabetics each year are treated for chronic leg or foot ulcers in the danish health sector. the treatment of these chronic wounds are associated with significant costs, as well as emotional, physical and financial. vitamin d deficiency is a widespread problem, and it is estimated that worldwide there is 1 billion people suffering from vitamin d deficiency. a danish study from 2012 showed vitamin d deficiency in 52% of adults aged 30 60 years. vitamin d deficiency is more common in diabetics with chronic foot or leg ulcers, when compared with non diabetics and diabetics without ulcers. methods and materials 48 diabetic patients with chronic foot ulcers will be included in the study. the patients will be recruited from the outpatient clinic, department of orthopaedic surgery at zealand university hospital, denmark. the patients will randomly be divided into two groups, respectively treated with vitamin d or placebo. expected outcome and perspectives the investigators expect that this study will show that supplementation with oral vitamin d, will result in a significant effect on wound treatment and healing for a large group of diabetic patients with chronic foot ulcers. this will contribute to a changed procedure in this specific group of patients, leading to measurement of vitamin d status and supplementation with vitamin d if needed.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. diagnosed diabetes. 3. foot ulcers more than 6 weeks. 4. informed consent exclusion criteria: 1. pregnancy 2. granulomatous diseases such as tuberculosis, sarcoidosis and silicosis 3. hypercalcemia 4. supplementation of vitamin d \> 20 μg a day 5. renal disease 6. liver disease 7. osteomyelitis 8. skin cancer. 9. epilepsy. 10. high blod pressure (\> 150/100 mmhg). 11. indication for surgical revision.
pyrotinib after trastuzumab-based adjuvant therapy in patients with her2-positive breast cancer

Conditions: Breast Cancer

Summary: this trial is a multicenter, open-label, phase ii trial conducted at 23 centers in china. high-risk her2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.

patients must meet one of the following criteria: n stage ≥1; t stage ≥2; did not achieve pathological complete response (pcr) after neoadjuvant therapy; had pcr after neoadjuvant therapy but with tumor size ≥ 5cm or n stage ≥2; or tumor size less than 2cm but with high ki67; histologic grade 3 or with lymph node micrometastasis.

Eligibility criteria:
inclusion criteria: 1. women aged 18-75 years old 2. her2 positive breast cancer 3. ecog ps 0-1 4. known hormone receptor status 5. completed 1 year of trastuzumab-based adjuvant therapy within 6 months 6. patients at high risk exclusion criteria: 1. serious heart disease or discomfort 2. inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption 3. known allergic history of drug components of this regimen 4. a history of immunodeficiency, including hiv positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation 5. pregnant and lactating female patients
examining variation in the impact of school-wide positive behavioral interventions and supports (pbis)

Conditions: Problem Behavior

Summary: to conduct a randomized controlled trial of school-wide positive behavioral interventions and supports, which is a school-based prevention program aimed at reducing behavior problems in children.

to conduct a group randomized controlled trial of school-wide positive behavioral interventions and supports. pbis is a popular school-based prevention program aimed at reducing behavior problems in children. staff are trained to implement behavioral focused prevention programs to address issues related to student conduct and discipline problems.

Eligibility criteria:
inclusion criteria: * public elementary schools * all children attending the schools and staff employed were eligible for inclusion exclusion criteria: • none

Keywords: problem behavior
ex vivo cultured bone marrow derived allogenic mscs in ami

Conditions: Myocardial Infarction

Summary: this clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.


Eligibility criteria:
inclusion criteria: * patients with stemi aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful pci. * patient has global left ventricular systolic dysfunction with an ejection fraction of \ 30%. * ecg with sign of acute anterior mi with st-elevation ≥ 2 mm in at least 2 of the following leads i, avl, v1-v6, or ecg with sign of acute inferoposterior mi with st-elevation ≥1 mm on all of the following leads- ii, iii, v5-v6 or stelevation ≥ 2 mm in at least 2 of the leads. * the target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery. * patient with acute myocardial infarction within 10 days prior to ip administration. * normal liver and renal function. * able to understand study information provided to him. * able to give voluntary written consent. exclusion criteria: * history of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency. * severe co-morbidity associated with a reduction in life expectancy of less than 1 year. * advanced renal dysfunction and creatinine ≥ 2mg%. * advanced hepatic dysfunction. * have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the investigator, may be jeopardized by participation in this study or by the complications of this therapy

Keywords: mesenchymal stem cells myocardial infarction
triple negative breast cancer trial

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether there is greater activity for carboplatin than a taxane standard of care (docetaxel) in women with er-, pr- and her2- breast cancer. the trial aims to recruit between 370 and 450 patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed er-, pr-, primary breast cancer * histologically confirmed her2- primary breast cancer * measurable confirmed metastatic or recurrent locally advanced disease unsuitable for local therapy but suitable for taxane chemotherapy * patients with stable, treated bain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present. * patients with bone metastases currently receiving bisphosphonates for palliation will be eligible providing informed consent can be given and that other sites of measurable disease are present * ecog performance status 0, 1, or 2 * adequate haematology, biochemical indices (fbc, u \& es) * lfts = normal bilirubin, ast and/or alt = 3 x uln if alk phos \>5 x uln (or an isolated elevation ast/alt of ≤5 x uln * adequate renal function - creatinine clearance of \>25mls per minute * written informed consent, able to comply with treatment and follow up exclusion criteria: * original primary tumour or subsequent relapse known to be positive for any of er, pr, or her2 receptors * patients unfit for chemotherapy or those with neuropathy \>grade 1 (sensory or motor) * known allergy to platinum compounds or to mannitol * known sensitivity to taxanes * patients with inoperable locally advanced disease suitable for local radiotherapy or an anthracycline containing regimen * previous chemotherapy for metastatic disease other than an anthracycline as in inclusion criteria above * previous exposure to a taxane in adjuvant chemotherapy within 12 months of trial entry * previous treatment with a taxane for recurrent locally advanced disease * previous treatment with a platinum chemotherapy drug * lfts = abnormal bilirubin (\> uln), ast and/or alt \>3 x uln and alk phos \>5 x uln (or an isolated elevation ast/alt of \>5 x uln) * patients with a life expectancy of less than 3 months * previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous call carcinoma of the skin, unless there has been a disease free interval of at least 10 years * previous or synchronous second breast cancer (unless also confirmed er-, pr- and her2-) * patients with bone limited disease * other serious uncontrolled medical conditions or concurrent medical illness likely to compromise life expectancy and/or the completion of trial therapy * pregnant, lactating or potentially childbearing women not using adequate contraception

Keywords: breast cancer triple negative
pneumocystis in patients over 75 year

Conditions: Pneumocystis

Summary: pneumocystis pneumonia is an infectious disease caused by pneumocystis jirovecii that affects the lung parenchyma preferentially. historically described in an immunocompromised population through hiv. worldwide, the profile of patients affected by this pathology is changing due to two main factors: * the sustainable stabilization of hiv patients. * the emergence of new risk factors of immunosuppression. the geriatric population is particularly affected by these risk factors, increasing the incidence of pneumocystis in this population, which does not have hiv (solid cancer, hemopathy, immunosuppressive treatments, etc.). there is currently no work specifically studying pneumocystis in this age group. the main objective of this study is to describe the clinical, biological and therapeutic data of a cohort of geriatric patients with pneumocystis, not carrying hiv, from january 1, 2010 to december 31, 2021, in all the centers surveyed.


Eligibility criteria:
inclusion criteria 1. patient \> or equal to 75 years of age 2. microbiological diagnosis: * direct examination with standard stain, finding trophozoite and/or p.jirovecii cyst (bal or induced sputum) and/or * direct examination with immunofluorescence, finding trophozoite and/or p.jirovecii cyst (bal or induced sputum) * and/or * positive pcr (bal, sputum, nasopharyngeal swab or blood) and ct \< 35 3. absence of hiv infection 4. hospitalization in french hospitals between 2010 and 2021 non-inclusion criteria 1. opposition of the patient to participate to the study
therapeutic response of cannabidiol in rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Cannabis

Summary: the study will randomly assign rheumatoid arthritis (ra) patients on stable ra therapy to either placebo or cannabidiol (cbd). the overall goal of this proposal is to examine the efficacy and safety of cbd treatment as adjunctive to the medical management of ra patients.

this is a randomized, placebo-controlled, double-blind clinical trial at the university of california, los angeles evaluating the efficacy, safety, and tolerability of oral cannabidiol (cbd) as adjunctive for rheumatoid arthritis (ra) patients on stable therapy. patients with moderate to severe ra meeting study inclusion criteria will be randomly assigned to one of three treatment groups (cbd 200 mg bid, cbd 400 mg bid, or placebo). patients in all groups will receive cbd or placebo under observation for 12 weeks with an additional follow-up phone call occurring 4 weeks after.

Eligibility criteria:
inclusion criteria: * meet the american college of rheumatology/european league against rheumatism (acr/eular) 2010 classification criteria for rheumatoid arthritis * disease activity score (das28) \>= 3.2 * age \>= 18 * stable ra therapy for 12 weeks prior to baseline * power doppler score \>= 5 (for the pdus 34 joint score) * must use at least one highly effective method of contraception * written informed consent exclusion criteria: * prior exposure to cannabis \<= 28 days prior to baseline * current diagnosed substance use disorders (including alcohol use disorder) * moderate (child-pugh b) or severe (child-pugh c) hepatic impairment * chronic infections * \>10mg of prednisone daily use * daily use of central nervous system (cns) depressant medications (e.g. sedatives, hypnotics \[zolpidem, temazepam, alprazolam, lorazepam, diphenhydramine etc.\]) * women who are pregnant, planning to become pregnant, or breast feeding * sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception * deemed unsafe by the investigator * history of an allergic reaction or adverse reaction to cannabis is exclusionary.
cga in newly-diagnosed elderly mm patients: a multi-center, prospective, non-interventional study.

Conditions: Multiple Myeloma; Comprehensive Geriatric Assessment

Summary: this is a multi-center, prospective, non-interventional study. eligible newly diagnosed elderly multiple myeloma (mm) patients will receive comprehensive geriatric assessment (cga) including ecog scale, questionaires of adl（activities of daily living), iadl(instrumental adl),mna-sf(mini-nutritional assessment), gds(geriatric depression scale), mmse(mini-mental state examination), sf-36 and cci (charlson comorbidity index). patients will get standard care for mm and receive the above assessments at baseline and after cycle 1, 4 and 12 for treating mm.follow-up information and survival data of these mm patients would be collected. we would evaluate the cga status of these newly diagnosed elderly mm patients and investigate the association of cga parameters with patient's survival.

baseline: ecog, adl, iadl, mna-sf, gds, mmse, sf-36 and cci; after cycle 1: ecog,adl,iadl,gds and sf-36 after cycle 4: ecog,adl,iadl,gds, mna-sf and sf-36 after cycle 12: ecog,adl,iadl,gds, mna-sf and sf-36

Eligibility criteria:
inclusion criteria: * age\>=65 years old; * newly diagnosed and untreated mm patients; * able to provide informed consent exclusion criteria: * refused to participate; * with concomitant amyloidosis; * smoldering mm.
efficacy and safety study of individualized and standardized acupuncture treatment for low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to determine whether acupuncture treatment(individualized \& standardized acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture.

to determine whether individualized acupuncture is more effective than standardized acupuncture, 276 low back pain patients will be recruited and randomly assigned to 4 separate groups. experimental groups(individualized acupuncture group and standardized acupuncture group) and control groups (sham acupuncture and waiting list) the change of pain and physical functions will be compared among the four groups. so the efficacy of acupuncture, and the best acupuncture treatment model will be determined. also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.

Eligibility criteria:
inclusion criteria: * male and female patients suffering low back pain. * patients classified as class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or class 2(low back pain with radiation of pain not beyond the knee, no neurological signs) according to the quebec task force system * suffering pain which is more than 40mm on vas(visual analog scale) * voluntary participants who have completed the consent. exclusion criteria: * low back trauma history within 6 months. * low back surgery history within 6 months. * low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation. * pain in other parts of the body more severe than low back pain. * mental problems that can influence the pain or results of questionnaire. * diseases that can interfere absorption, metabolism and excretion of medicine. * history of alcohol or drug abuse within 12 months of the study. * pregnant, breastfeeding or childbearing aged women who are not using any birth control methods.

Keywords: individualized acupuncture standardized acupuncture low back pain randomized controlled trial
a 75 year old with dyspnea a case report.observational study

Conditions: Esophageal Perforation

Summary: clinical case report of spontaneous esophageal perforation in a 75 year old man. he prsented with breathlessness and on investigation found to have esophageal perforation

boerhaave's syndrome represents a diagnostic dilemma for the physician. boerhaave's syndrome is an uncommon condition where there is oesophageal rupture following forceful vomiting. we report a case of spontaneous rupture of the esophagus in 75-year-old male with chronic obstructive pulmonary disease who was referred to our hospital with acute onset of breathlessness. the absence of vomiting prior to presentation is the distinguishing feature of this particular case.

Eligibility criteria:
inclusion criteria: * male with esophageal perforation man with copd exclusion criteria: * iatrogenic perforation

Keywords: esophageal perforation copd
chewing disorders, gross motor function and trunk control in cerebral palsy

Conditions: Cerebral Palsy

Summary: the study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (cp).

the study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (cp). chewing performance level will be determined by the chewing performance scale. the gross motor function classification system (gmfcs) will be used to determine gross motor function levels. segmental assessment of trunk control (satco) will be used to measure trunk control. the correlations between chewing performance level and gross motor function, and trunk postural control will be assessed. the chi-square test will also be used to compare gmfcs levels and trunk control in children with and without chewing disorders.

Eligibility criteria:
inclusion criteria: * having a diagnosis of cerebral palsy * referring by a pediatric neurologist * aging between 2 to 12 years exclusion criteria: * aging under the age of 24 months * using any medicine and/or oral appliances that could affect the chewing performance
efficacy of ultrasound-guided needle knife release for trigger finger

Conditions: Trigger Finger

Summary: efficacy of ultrasound-guided tri-directional needle knife release in treating patients with trigger finger. the study evaluates safety, effectiveness, and recovery outcomes of a minimally invasive procedure compared to conventional approaches.

this is a clinical trial designed to investigate the efficacy and safety of ultrasound-guided tri-directional needle knife release in patients with trigger finger, especially those patients for whom conservative treatments have failed. trigger finger is caused by of thickening of the a1 pulley, leading to pain and stiffness, which results in limitation of the hand. the procedure will be carried out under local anesthesia and guided by ultrasound to be very accurate and safe, avoiding all possible risks. patients will be assessed for better improvement in hand functioning, pain scale basing on visual analog scale, and above all patient overall satisfaction.

Eligibility criteria:
inclusion criteria: * idiopathic tf at the level of a1 pulley * trigger finger of green's grades ii or iii or iv (moderate to severe) * symptoms persist for at least three months despite conservative treatments. * ability to provide informed consent and comply with follow-up requirements. exclusion criteria: * patients with secondary causes of tf like diabetes mellitus, rheumatoid arthritis, gout, hypothyroidism, amyloidosis, and sarcoidosis. * patients with tf of green's grade i. * previous surgical intervention on the affected digit. * allergy or contraindication to local anesthetics. * pregnancy or lactation. * inability to comply with follow-up assessments.

Keywords: trigger finger a1 pulley release ultrasound-guided technique
retinopathy of prematurity:summary of a decade

Conditions: Retinopathy of Prematurity

Summary: the aim of the study is to evaluate our 10 year experience of retinopathy of prematurity screening.


Eligibility criteria:
inclusion criteria: * neonates either with a bw of less than 1501 gram (g) or born at a ga of 34 weeks (wk) or less * selected infants with an unstable clinical course were included

Keywords: incidence neonatal care retinopathy of prematurity risk factors
endometriosis and obstetric outcomes

Conditions: Endometriosis; Obstetric Complication

Summary: the purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes

this is a retrospective, observational, case-control study. pregnancy, delivery and neonatal outcomes will be analyzed in two groups of patients (case and control group): women with diagnosis of endometriosis histologically confirmed and women without endometriosis. women with endometriosis will be matched to controls by age. a database with general medical and gynecological history, pregnancy course, delivery mode and newborn conditions will be analyzed.

Eligibility criteria:
inclusion criteria: * pregnant women who delivered at azienda ospedaliero universitaria policlinico di modena from 2000 to 2020 * histologic diagnosis of endometriosis before pregnancy for case group * age matched healthy patients for control group exclusion criteria: * clinical records not available

Keywords: endometriosis obstetric outcome delivery outcome neonatal outcome