Kornimate/medical-research-clean huggingface dataset:
in vivo evaluation of growth and risk of rupture of dilated ascending aorta using 4d cardiac magnetic resonance

Conditions: Aortic Rupture

Summary: ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture. there is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.

although there is an increased lifetime risk when the aortic diameter exceeds 6 cm, predicting aneurysm progression is nearly impossible and dissection and rupture also occur at diameters under 6 cm. the assessment of aortic hemodynamics and the presence of altered flow patterns, as well as distribution and changes in wall shear stress (wss) and the oscillatory shear index (osi), using 4d phase contrast cardiovascular magnetic resonance (cmr) may provide further insights in how aneurysms develop and in assessing the risk of dissection. the purpose of this study was to investigate in patients with dilated ascending aorta the flow patterns and vessel wall parameters in order to correlate these hemodynamics factors with changes in aorta size.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * supra-coronary aortic diameter measured by ct-scan or transthoracic/trans-esophageal echocardiography between 40 and 45 mm in case of presence of aortic valve disease, bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of absence of aortic valve disease, bicuspid aortic valve disease or connective tissue. * informed consent for participation in the study exclusion criteria: * contraindication to mri * patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.

Keywords: ascending aorta aneurysm aortic wall shear stress 4d phase contrast cardiovascular magnetic resonance aortic dissection
study to evaluate changes in cd4 on replacing tdf with abc or ddi+tdf with abc+3tc

Conditions: HIV Infections

Summary: the study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddi or whether it is better to perform a double replacement of tenofovir and ddi with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

different works have shown a high rate of virological failure among patients on abacavir + lamivudine + tenofovir or ddi + 3tc + tenofovir, thus rendering the use of these combinations actively unadvisable. furthermore, recent studies have also shown that abc+3tc are associated with a significantly higher increase in cd4 than the current treatment standard formed by azt+3tc. this provides us with grounds to suppose that patients with tdf+ddi may recover their cd4 with abc+3ht. similarly, and recently, the existence of pharmacokinetic interactions between tenofovir + abacavir has begun to be questioned. finally, the replacement of tenofovir with abacavir or tenofovir + ddi with abacavir + lamivudine does not detract from the potency of haart, the toxicity profile is different and their behaviour at mitochondrial level is similar. this study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddi or whether it is better to perform a double replacement of tenofovir and ddi with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * hiv-1 infected patients. * patients on triple haart therapy including ddi + tenofovir plus a pi or nnrti for at least 3 months. * patients with an undetectable hiv-1 viral load (\< 50 copies rna / ml or \< centre's limit of detection) over the last 6 months. * not be on treatment with immunosuppressives, such as: hydroxyurea, interferon, ribavirin or cytostatics. * not be on treatment with interleukin-2 or other immunomodulators. * women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study. * signature of the informed consent. exclusion criteria: * incapacity to give informed consent. * bad adherence or treatment interruptions over the previous 6 months. * prior exposure to abacavir. * haart therapy including ddi at a dose of 400mg + tenofovir if weight \> 60 kg or ddi 250 mg + tenofovir if weight \< 60 kg. * suspicion of cross resistances to abacavir and lamivudine. * hepatic or pancreatic analytical alterations 4 times above the limit of normality. * presence of opportunistic infections and/or recent tumours (\< 6 months). * patients participating in another clinical trial.

Keywords: antiretrovirals cd4 cell count toxicity
friendship bench mental health intervention for adolescent girls and young women in south african prep delivery settings

Conditions: Depression; Pre-Exposure Prophylaxis

Summary: adolescent girls and young women (agyw) at risk of hiv in sub-saharan africa, frequently (20-50%) have symptoms of common mental disorders, including depression, anxiety, and stress. these symptoms are associated with suboptimal adherence to hiv pre-exposure prophylaxis (prep), a highly effective hiv prevention approach. in this project, the team seeks to address poor mental health and consequent impacts on prep adherence and among agyw at risk of hiv by testing an evidence-based mental health intervention (the youth friendship bench sa) adapted for prep delivery programs.

this is a randomized hybrid implementation-effectiveness trial which will be conducted in a real-world healthcare setting. eligible women who accept open-label daily oral prep (n=110) will be enrolled and randomized to either the youth friendship bench sa intervention (plus standard-of-care mental health services as needed) or standard-of-care mental health services alone. randomization will be conducted in a 1:1 ratio with randomly-sized blocks of ≤10. hiv-uninfected women ages 18-25 in johannesburg, south africa, who have symptoms of common mental disorders as evidenced by a score greater than or equal to 7 on the srq-20 will be eligible to enroll. the investigators hypothesize that the youth friendship bench sa will significantly improve prep adherence and reduce symptoms of common mental disorders among agyw at month 3.

Eligibility criteria:
inclusion criteria: * female 18-25 years of age at screening * documentation of symptoms of a common mental disorder, as evidenced by a score greater than or equal to 7 on the self reporting questionnaire 20-item (srq-20) * willingness to enroll and be randomized to either the youth friendship bench sa or standard-of-care mental health services * written informed consent (obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study. * able to verbally communicate in one or more study languages to ensure participation in the counseling sessions (english, isizulu) * taking prep at the ward 21 clinic, as determined by clinic records. prep provision will be conducted by the clinic following national prep guidelines and will not be part of study-specific procedures. exclusion criteria: * not on prep and/or not intending to use prep for the duration of the study * planning to relocate in the next three months * report of suicidal intent or self harm * active, unmanaged mental health disorders, including untreated or severe somatic symptoms and active psychiatric symptoms (e.g., hallucinations) * reactive or positive hiv test at enrollment (based on clinic records only; hiv testing will not be performed under this protocol)
staphylococcus aureus nasal carriage

Conditions: Nasal Carriage of Staphylococcus Aureus

Summary: the repeated exposition to s. aureus is considered as a determining factor of acquisition of the nasal colonization. the healthcare professionals are regularly in touch with this pathogenic bacterium. prevalence of the nasal carriage of s. aureus in this population was the object of several studies but little took into account the respect for the rules of good hygienic practice. the results of our previous study carried out during the international congress of staphylococci (isssi, lyon in august 26-30th, 2012) showed an association between the work in a hospital environment and the increase of the risk of nasal carriage. on the contrary, the use of the hydro-alcoholic solutions had a protective effect against this carriage. however, sized of the health care population of our study was limited. the goal of this study is to confirm our previous results on a larger cohort of healthcare professionals. the main objective is to estimate the prevalence of nasal carriage according to the professional category and by taking into account the degree of conformity with good hygiene practices including the use of hydro-alcoholic solutions.


Eligibility criteria:
inclusion criteria: - employees with consent. exclusion criteria: - presence of contraindicating medical conditions preventing nasal swabing

Keywords: nasal carriage staphylococcus aureus good hygiene practices
robotic gait training vs.conventional rehabilitation in sci

Conditions: Spinal Cord Injury

Summary: until now, there's still no any strong evidence supported "which is the best way to restoration walking ability" in spinal cord injury. most of the evidence suggest that, there is somehow better after gait rehabilitation for asia classification c and d but not improved walking ability for asia classification a and b. there is an rct showed the evidence of repetitive locomotor training and physiotherapy could be improved walking and basic activities of daily living after stroke, these might be also really effect in sci patients.

this study aim to study the effectiveness of conventional rehabilitation compare with robotic gait training machine in subacute sci patients.

Eligibility criteria:
inclusion criteria: * subacute spinal cord injury ( c5-t12 level) patients. * asia classification c and d. * no previous joint contracture. * no severely active medical condition. * can easily communicate with no obvious cognitive impairment. * given signed inform consent. exclusion criteria: * previous injury or other neurological condition that related to neurodeficit in key muscles.

Keywords: sci gait rehabilitation robotic
safety of vitamin d supplementation in older persons

Conditions: Vitamin D Deficiency

Summary: this study will evaluate the safety over 6 months of two different doses of vitamin d (cholecalciferol) in men and women age 65 and older. it will also evaluate if supplementation with vitamin d improves physical performance.

120 ambulatory men and women ages 65 to 95 will be enrolled in this study. each subject will participate in the clinical trial for 6 months. parathyroid hormone, vitamin d, and serum and urinary calcium will be measured periodically. physical performance will be tested at baseline and throughout the study.

Eligibility criteria:
inclusion criteria: * ambulatory exclusion criteria: * hypercalcemia * hypercalciuria \> 4 mg/kg body weight/day * primary, secondary, or tertiary hyperparathyroidism * renal insufficiency (serum creatinine \> 2 mg/dl ) * history of nephrolithiasis * treatment with vitamin d (ergocalciferol, cholecalciferol, calcitriol) * treatment with anticonvulsants * paget's disease * severe cardiac, pulmonary, hepatic, renal, or neurological disease * life expectancy \< 1 year * participation in another trial

Keywords: vitamin d deficiency elderly
tdcs for chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the goal of this study is to investigate the role of central neural pathways in mediating chronic pain. the aim of the study is to test the effect of stimulating brain regions that are part of a network underlying central pain processing using a non-invasive brain stimulation technique, transcranial direct current stimulation (tdcs). prior studies have used tdcs to target both sensory related cortical areas and those important for higher-order representations of pain. this study will target brain regions important for the behavioral response to the chronic sensation of pain. the hypothesis is that stimulation of these brain regions can modulate not only the affective component of pain, but ultimately also improve functioning and quality of life. this hypothesis will be tested by treating study participants eighteen and older with chronic low back pain (clbp) of greater than six months using tdcs. to be part of this study, participants must meet all the inclusion and exclusion criteria.


Eligibility criteria:
inclusion criteria: * chronic low back pain ≥ 6 months duration in the lumbar region, present more than half the days of the month, and on average be at a moderate level of severity in the last month * at least one trial of physician recommended medication (e.g. acetaminophen, nsaids, skeletal muscle relaxants) * pre-existing opioid and non-opioid pain medication must be non-existent or stable (medications have not changed for one month) * be able to understand, read and write english * if female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method) exclusion criteria: * lifetime diagnostic and statistical manual (dsm) iv diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition * current dsm-iv diagnosis of substance dependence for alcohol, sedative/hypnotic drugs, stimulants, cocaine * current cancer, infection, or inflammatory arthritis * broken skin or other lesions in the area of the electrodes * uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation * presence of metal in the cranial cavity * holes in the skull made by trauma or surgery * pacemakers, medication pumps, and other implanted electronic hardware * pregnancy

Keywords: back pain
a study of the safety and effectiveness of different doses of 1592u89 in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if giving 1592u89 to hiv-infected patients is safe and effective in lowering viral load (level of hiv in the blood) and raising the level of cd4 cells (cells of the body that help fight infection).

patients are randomized to receive one of three doses of 1592u89. during this randomized dosing phase, if a patient meets one of the following criteria, he/she is offered open-label 1592u89 (300 mg) plus zidovudine (zdv) plus lamivudine (3tc) (or other licensed antiretrovirals according to standard practice). criteria are based on falling cd4 counts (return to baseline on two occasions at least 1 month apart), disease progression (defined as occurrence of a new aids-defining event according to cdc classification excluding cd4 counts less than 200 cells/mm3), or lack of virus suppression (defined as less than 0.7log10 reduction in viral load at week 4 with a repeat value 1 week later, more than 5000 copies/ml hiv rna at weeks 12, 16, 20, or 24, or 5000 copies/ml or more anytime after week 24).

Eligibility criteria:
regular physical exercise extends honeymoon phase in type 1 diabetes subjects

Conditions: Type 1 Diabetes; Physical Activity

Summary: in diabetes, the honeymoon period is characterized by the presence of a functional reserve of β-cells that favours an adequate metabolic control and low insulin needs in order to control glycaemia. therefore, the extension of this period could have evident benefits in diabetes management. the investigators aimed to study the influence of regular physical activity on the prolongation of the honeymoon period

observational study of two groups of type 1 diabetic patients from onset to a two-year period. one group exercised regularly (5 or more hours/week) before onset and continued doing so with the same regularity (group a). the second group either did not perform physical activity or did so sporadically (group s). consultations were initially performed on a weekly basis for the first month, then once a month for the remaining period. in each consultation, patients were asked about diet accomplishment, glycaemia monitoring, insulin injections and exercise performance. all individuals from group a declared to practice regularly intervallic routines, playing team sports (basketball for n=1 and soccer for n=6). only one individual declared to perform aerobic exercise (long distance running and swimming). at the end of the first year a second blood sample was extracted in the same conditions from each individual to determine the same parameters. exercise routine accomplishment and follow-up of diet and insulin injections was followed monthly during one more year. at the end of this period, the study was considered finished and the last blood extraction was performed in order to measure the same parameters. other subjects were excluded because they were not capable to provide data required for study follow up.

Eligibility criteria:
inclusion criteria: * undergo type 1 diabetes. * to practice a moderate-vigorous exercise during 1h, 5 days or more/week before onset and continuing practicing for 2 more years for group a (active). * to practice any or less than 5h weekly before and after onset for group s (sedentary). * capable to provide data and blood samples during follow up. exclusion criteria: - not capable to provide data and blood samples required for study follow up.

Keywords: honeymoon type 1 diabetes
exploring a breast cancer early screening model based on cfdna

Conditions: Breast Cancer; Breast Fibroadenoma; Breast Hypoplasia

Summary: the goal of this observational study is to use cfdna multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. the main questions it aims to answer are: * evaluate the sensitivity and specificity of the early detection model for breast cancer screening * evaluate participants' tefei™ score participants will be collected peripheral venous blood before surgery or systemic treatment. the blood will then be sent to the collaboration company for sequencing. the collaboration company will analyze the sequencing results and build a cfdna multi-omics signature library. finally, the collaboration company will use deep learning algorithms to train and optimize the feature library. researchers will compare the cancer group with a benign control group to determine the model's effectiveness in differentiating between them.


Eligibility criteria:
inclusion criteria: 1. patients ≥18 years old and ≤70 years old; 2. plasma of the participant can be obtained; 3. willing to sign the informed consent; 4. meet one of the following criteria: 4.1)patients diagnosed with invasive breast cancer or carcinoma in situ of the breast for the first time; 4.2)patients with breast fibroma or breast adenosis and breast fibrocystic hyperplasia; exclusion criteria: in any of the following situations, subjects should not participate in the trial: 1. pregnant or lactating; 2. unable to obtain the participant's plasma; 3. patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment; 4. the patients had suspected imaging (b-ultrasound, ct, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation; 5. received any blood product transfusion in the past 30 days; 6. participants considered by the investigator to be inappropriate to participate in this research-type clinical trial.

Keywords: cfdna deep learning
thumb ecg incident atrial fibrillation in diabetes mellitus

Conditions: Diabetes Mellitus; Atrial Fibrillation

Summary: cardiac thromboembolism attributed to atrial fibrillation (af) constitutes at least one-third of ischemic strokes. indeed, stroke may be the first manifestation of previously undetected af. the prevalence is projected to increase 20% the coming decades, especially in age group 65 years and above of age. to add to incidence, the diabetic population have an increased risk yet not properly investigated. in patients with confirmed af, assessment using the cha2ds2-vasc score (congestive heart failure, hypertension, age 65 years and above, diabetes mellitus, stroke, vascular disease, age 75 years and above, sexual category), is applied for risk stratification. if the cha2ds2-vasc score is at least 1, or definitely 2 points typically a non-vitamin k antagonist oral anticoagulant (noac) should be prescribed. the chest- and thumb-electrocardiogram (ecg) system coala heart monitor has proven efficacious in detecting af following recent cryptogenic stroke. this system also showed to be feasible from a patient perspective. thus, in patients aged 65 years and above with diabetes mellitus at least 2 points are reached. therefore, patient with these risk factors should be considered for further evaluation for noac to prevent stroke, which provides the rational for this study.

cardiac thromboembolism attributed to atrial fibrillation (af) constitutes at least one-third of ischemic strokes.the prevalence is projected to increase 20% the coming decades, especially in age group 65 years and above of age. to add to incidence, the diabetic population have an increased risk yet not properly investigated. in patients with confirmed af, assessment using the cha2ds2-vasc score (congestive heart failure, hypertension, age 65 years and above, diabetes mellitus, stroke, vascular disease, age 75 years and above, sexual category) , is applied for risk stratification. if the cha2ds2-vasc score is at least 1, or definitely 2 points typically a non-vitamin k antagonist oral anticoagulants (noac) should be prescribed. the chest- and thumb-electrocardiogram (ecg) system coala heart monitor will be used to detect af, which showed to be feasible from a patient perspective. thus, in patients aged 65 years and above with diabetes mellitus at least 2 points are reached. therefore, patient with these risk factors should be considered for further evaluation for noac to prevent stroke, which provides the rational for this study.

Eligibility criteria:
inclusion criteria: * age 65 years and above * diabetes mellitus (both type 1 and type 2) exclusion criteria: * treatment with anticoagulation (eliquis, lixiana, pradaxa, xarelto, waran) * pacemaker, implantable cardioverter defibrillator, insertable cardiac monitor * not able to participate in 90 days follow-up

Keywords: atrial fibrillation diabetes mellitus thumb-ecg