Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of estracyt® in metastatic breast cancer

Conditions: Breast Cancer

Summary: this study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer rh+/ her2- and treated by estramustine phosphate.

for patients affected by metastatic breast cancer rh+/her2-, the conventional treatment is hormonotherapy. but, when patients don't react no recommendations exist. estramustine phosphate is currently prescribed for prostate cancer. the estramustine phosphate is an active anti-tumoral agent by oral route, associating a nitrogenous mustard with the estradiol, it settles on membrane receptor and the cytotoxic component acts essentially by dismantling microtubules inhibiting the mitosis. estramustine could be a therapeutic option when currently therapy are exhausted for patients reactive to hormonotherapy previous lines or chemotherapy.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer her2-/rh+ * progression after hormonotherapy * treated by taxanes, anthracyclines, capecitabine and eribulin * treated by everolimus * ecog ≤ 2 * hematological function: neutrophiles ≥ 1,5 x 109 / l, hemoglobin ≥ 9 g / dl, plaques ≥ 100 x 109 / l * hepatic function: albumin ≥ 2,5 g / dl, bilirubin serum ≤ 2 x n (superior border of the standard) (unless disease of gilbert), transaminases ≥ 3 x n * renal function: serum creatinine ≤ 1,5 mg / dl or clearance of the creatinine ≥ 40 ml / min * estimated life expectancy ≥ 3 months exclusion criteria: * hypersensitivity known about one of the constituents of the estramustine phosphates * preliminary treatment by estramustine phosphates * brain metastases * patients not being under effective contraception * minor, pregnant or lactating patients * patients not previously treated by everolimus * transaminases \> 3xn * other concomitant anticancer treatment less than 1 month before the inclusion * digestive function: malabsorption * history of other cancer in the previous 5 years (other than squamous-cell epithelioma or totally resected in situ carcinoma) * active thrombo-phlebitis * risk thromboembolic known, * unchecked cardiovascular pathology * grave hepatic affection
cvi alterations in fd: a prospective, multicenter, observational cohort study

Conditions: Fabry Disease, Cardiac Variant

Summary: fabry disease (fd) is a rare x-linked lysosomal storage disorder caused by α-galactosidase a (gla) gene mutations leading to reduced or undetectable α galactosidase a (α-gal a) enzyme activity, resulting in progressive accumulation of globotriaosylceramide (gl3) and its deacylated form globotriaosylsphingosine (lyso-gl-3) in multiple organs, causing neural, renal, cardiac, dermatological, gastrointestinal and ophthalmic manifestations, even leading to life-threatening complications. cardiovascular and cerebrovascular complications (i.e. heart failure, stroke, etc.) or end-stage renal disease even premature death can be seen in severe cases. the life expectancy of male patients is reduced by 15\~20 years, while that of female patients is reduced by 6\~10 years. the exact prevalence of fd is currently unknown. based on an estimated prevalence of 1:60,000, there are approximately 23,000 affected fd patients in china. the clinical manifestations of fd are diverse and non-specific, which may lead to misdiagnosis in patients with non-typical clinical manifestations in the absence of a family history of fd. cardiac involvement can be recognized in up to 68% patients with fd, significantly higher than in other organs, and the positive screening rate for fd in adults with unexplained left ventricular hypertrophy (lvh)/hypertrophic cardiomyopathy was 0.9%. cardiovascular disease is the leading cause of death in patients with fd cardiomyopathy (40.2%). the 2020 expert consensus document on the management of cardiovascular manifestations of fabry disease recommends early screening in patients with suspected lvh for early diagnosis. therefore, strengthened screening strategy in high-risk patients with lvh will improve the diagnosis and treatment of fd in china.


Eligibility criteria:
inclusion criteria: patients to be enrolled in this study should fulfill all 3 criteria (a, b, and c) at screening: 1. patients with a maximum myocardial wall thickness (left ventricular posterior wall or septum) of ≥13 mm at the end diastole on echocardiography; 2. at least two or more "warning signs" associated with fd ("warning signs" include cardiac "warning signs", extracardiac "warning signs", or family history) 3. aged 18 years old or older; cardiac "warning signs" of fd: concentric lvh or papillary hypertrophy or right ventricular hypertrophy on echocardiography ecg abnormalities (eg, shortened pr interval, wide qrs complex, right bundle branch block, st-segment depression, etc.) extra-cardiac "warning signs" of fd angiokeratomas acroparesthesia hypohidrosis premature stroke (\<50 years of age) corneal verticillate renal impairment accompanied by proteinuria hearing loss family history family history of x-linked inherited disorder (renal disease or cardiac disease) exclusion criteria: 1. lvh patients with a clear etiology; 2. combining any other clinical condition with a life expectancy less than 1 year; 3. refuse to give informed consent or refuse to be followed-up.
effects of continuous veno-venous haemofiltration on plasma lactate in critically ill patients

Conditions: Kidney Injury, Acute

Summary: continuous veno-venous hemofiltration (cvvh) can eliminate metabolic products effectively and replace renal function partly. it is widely used in intensive care units (icus), especially for patients with acute kidney injury/failure in an unstable hemodynamic status. lactate is a molecule smaller than glucose, which can pass through filtration membrane freely in cvvh. therefore, the blood lactate concentrations would no longer reflect tissue oxygenation status in patients with unstable hemodynamic status. however, there is no prospective study evaluated the effect of cvvh on lactate removal in critically ill patients. the influence of different dose of cvvh on lactate elimination is not clear in patients with different level of serum lactate. our study aimed to find out how the dose of cvvh effects on lactate clearance, and then re-estimate the prognostic value of lactate in critically ill patients with cvvh.


Eligibility criteria:
inclusion criteria: 1. the critical ill patients with acute kidney injury 2. patients requiring continuous veno-venous hemofiltration 3. apache ii scores more than 12 4. arterial lactate is higher than 0.5mmol/l but lower than 15mmol/l (due to the sensitivity and optimal measuring range of the equipment) 5. continuous veno-venous hemofiltration for at least 12 hrs 6. hemo-filter age of \<24 hrs exclusion criteria: 1. apache ii scores lower than 12 2. patients' age are more than 75y or lower than 18y

Keywords: continuous veno-venoous haemofiltration plasma lactate critical illness acute kidney injurytissue perfusion multiple organ dysfunction syndrome
caring letters for military suicide prevention

Conditions: Suicide; Suicide, Attempted

Summary: the purpose of this multi-site randomized controlled trial is to determine if the caring letters intervention is effective in preventing suicide and suicidal behaviors among u.s. service members and veterans. the primary aim of this project is determine whether caring communications following inpatient psychiatric treatment reduce suicide and self-inflicted injuries among u.s. military personnel and veterans. the investigators will also explore treatment utilization by comparing the frequency of treatment visits after enrollment into the study. the following specific hypotheses will be tested: hypothesis 1: during a two year follow-up after the index hospital discharge, the frequency of suicide will be lower among participants in the caring letters group compared to those in the usual care group. hypothesis 2: the frequency of medically admitted self-inflicted injuries will also be lower in the caring letters group compared to the usual care group. hypothesis 3: the time to suicidal act, among those who do subsequently exhibit one, will be longer among participants in the caring letters group compared to the usual care group.

this social/ behavioral study is a five year multi-site randomized controlled trial that will compare the caring letters intervention (with usual care) to usual care without the caring letters. participants will be recruited from inpatient psychiatry units of collaborating military and veterans affairs (va) sites and randomized to either a group that receives letters (caring letters group) or a group that does not receive letters (usual care group). the methodology of the intervention is updated with emails instead of postal letters. this study fills an important gap in the evidence base for the caring letter intervention through a methodologically rigorous research design.

Eligibility criteria:
inclusion criteria: * current psychiatric inpatients * possess an active email account * informed consent * active duty military, veteran, retiree, national guard or reserves status exclusion criteria: * not competent to consent * adverse behavioral problems * the primary psychiatric nurse or attending psychiatrist considers that study to be clinically inappropriate * currently under arrest/incarceration * involuntary committed for psychiatric care status

Keywords: suicide suicide, attempted
low and moderete flow anaesthesia on haemodynamics

Conditions: Hemodynamics Instability; Arrhythmias Cardiac; Cerebral Oxygenation

Summary: the study topic investigates the potential advantages of low-flow anesthesia in terms of physiological protection and resource saving.

the study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal qrs-t angle and cerebral oxygenation in laparoscopic cholecystectomy surgery. the primary objective was to evaluate the effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk; the secondary objective was to compare the total sevoflurane consumption in both methods.

Eligibility criteria:
inclusion criteria: * being asa1-2 status * between the ages of 18-70 * who are planned for laparoscopic cholecystectomy exclusion criteria: * patients who refuse to give informed consent * pregnant and breastfeeding patients * morbidly obese patients (body mass index over 40) * patients with uncontrolled diabetes mellitus, with serious cardiovascular, pulmonary, renal, hepatic disease, obstructive sleep apnea, with electrolyte imbalance- those with a history of alcohol or drug abuse, with perioperative hemodynamic instability * patients using drugs known to prolong myocardial repolarization * inability to increase spo2 above 95 despite necessary intervention

Keywords: low-medium flow anesthesia, hemodynamics, oxygenation
the effect of vitamin d3 supplementation on hepcidin and ferritin serum levels in children with chronic kidney disease

Conditions: Chronic Kidney Disease Stage 1; Chronic Kidney Disease Stage 2

Summary: the goal of this clinical trial is to analyze the effects of in vitamin d3 on serum hepcidin and ferritin levels among children with chronic kidney disease. the main questions it aims to answer is: "what is the effect of giving vitamin d3 on serum hepcidin and ferritin levels in children with chronic kidney disease?" we will compare the effect of vitamin d3 administration on hepcidin and ferritin between 2 groups. group a consists of children with gfr more 90 ml/min/1,73 m2. group b consists of children with gfr less than 90 ml/min/1,73 m2 participants will be given the same 2000 iu of vitamin d/day for 6 weeks.

the primary objective of the study is to analyze the effects of vitamin d3 administration on serum levels of hepcidin and ferritin in children diagnosed with ckd. the research aims to measure these serum levels before and after vitamin d3 supplementation across different stages of kidney function, categorized by glomerular filtration rate (gfr). specifically, it seeks to determine whether vitamin d3 can effectively reduce hepcidin levels and improve iron status as indicated by ferritin levels. the study employs a structured methodology involving children with ckd, divided into two groups based on their gfr: those with gfr \< 90 ml/min/1.73 m² and those with gfr ≥ 90 ml/min/1.73 m². serum levels of vitamin d, hepcidin, and ferritin will be measured at baseline (before supplementation) and after a defined period of vitamin d3 administration. the research will utilize statistical analyses to compare these values within and between groups to establish any significant changes attributable to the supplementation.

Eligibility criteria:
inclusion criteria: * patients aged 2 to 18 years diagnosed with chronic kidney diseases at dr. wahidin sudirohusodo hospital * parents have signed their child's consent to participate in the study exclusion criteria: * history of blood transfusion 3 months prior * liver dysfunction * sepsis * routine consumption of vitamin d * routine consumption of iron supplement * patients diagnosed with iron deficiency anemia

Keywords: chronic kidney disease vitamin d hepcidin ferritin vitamin d3
effect of acute statin treatment in patients undergoing percutaneous coronary intervention

Conditions: Coronary Artery Disease

Summary: the goal of this study is to determine if one dose of simvastatin will decrease the inflammatory response to coronary intervention. also to determine if one dose of simvastatin affects endothelial function (activity of the artery) as measured by noninvasive peripheral artery tonography.

the objective of this study is to determine if acute pretreatment with simvastatin, an hmg-coa reductase inhibitor will reduce the post inflammatory response after percutaneous coronary interventions (pci), and/or change endothelial function as assessed by peripheral arterial tomography (pat). percutaneous coronary intervention (pci), commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. patients will be pretreated with simvastatin 80 mg prior to undergoing pci. endothelial function will be assessed before and after treatment via pat. our working hypothesis is patients pretreated with simvastatin, will have 1) attenuated inflammatory response, as noted by decreased levels of serum high sensitivity crp and il-6 and 2) improved endothelial function as compared to patients not pretreated with statin therapy.

Eligibility criteria:
inclusion criteria: * patients undergoing pci/angiography * no previously known side effects of statins * patients who sign an informed consent * age \> 18 years old exclusion criteria: * patients with st elevation myocardial infarction * patients with cardiogenic shock * patients with hypersensitivity to statins * patients with unexplained muscle pain * patients with acute liver disease * patients receiving cyclosporine, antifungal azoles, macrolide antibiotics, niacin, fibrates\> 1 quart grapefruit juice/day or nefazodone * patients with creatinine \> 2.0 * patients with known malignancy * ejection fraction \< 25% * no coronary care unit patients * no outpatients
individualized vs. household mrsa decolonization

Conditions: Staphylococcal Skin Infection; Abscess; Furunculosis; Staphylococcus Aureus; MRSA Infection

Summary: the purpose of this research study is to compare the effectiveness of commonly used decolonization treatments (application of mupirocin antibiotic ointment to the nose and bleach baths) when performed by individuals with a history of skin and soft tissue infection (ssti) in the prior year (individualized approach) in comparison to decolonization of all household members (household approach) in an attempt to prevent staphylococcus aureus skin infections. the investigators hypothesize an individualized decolonization approach will be equally as effective as a household approach to prevent ssti.

methicillin-resistant staphylococcus aureus (mrsa) was once uniformly associated with hospital-acquired infections; however, mrsa strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant staphylococcus aureus (ca-mrsa). there is no available vaccine against s. aureus. thus, other preventive measures, including topical antimicrobial therapies, have been used in an attempt to prevent staphylococcal infections. these therapies include mupirocin (a topical antibiotic with activity against mrsa) and dilute bleach water baths. the effectiveness of these measures directed at patients colonized with traditional mssa and ha-mrsa strains in an attempt to prevent nosocomial infections varies across studies, and maintenance of eradication diminishes over time. with the emergence of the ca-mrsa epidemic, these measures have been extrapolated to patients in community settings. we aim to find a practical approach to decolonization which patients can feasibly perform at home to reduce the incidence of skin and soft tissue infections(ssti). specific aim: compare the effectiveness of decolonization of individuals with a history of ssti in the prior year (individualized approach) to decolonization of all household members (household approach) in reducing the incidence of recurrent ssti. primary hypothesis: an individualized decolonization approach will be equally as effective as decolonization of all household members to prevent ssti. secondary hypothesis: application of mupirocin to the anterior nares twice daily for 5 days will not result in a higher prevalence of colonization with mupirocin-resistant strains at subsequent longitudinal samplings.

Eligibility criteria:
inclusion criteria: * individuals who are enrolled in a 12-month observational study entitled "the community-associated methicillin-resistant staphylococcus aureus among household members and the home environment study." exclusion criteria: * households in which all members experienced ssti during the 12-month observational study * individuals with known allergies to mupirocin or bleach (sodium hypochlorite)

Keywords: abscesses furunculosis staphylococcus aureus colonization staphylococcal skin infection mrsa
the sinovuyo caring families project: a randomized controlled trial of a parenting programme

Conditions: Child Behaviour Problems

Summary: it has been established that children in families affected by either intimate partner violence or human immunodeficiency virus/acquired immunodeficiency syndrome (hiv/aids) are at substantially increased risk of poor parenting and child maltreatment. in the sub-saharan african context of high levels of hiv/aids and family violence, it is crucial that parents be supported to establish positive parenting practices and reduce harsh or abusive parenting within their families.this randomized controlled trial will be testing the sinovuyo caring families program (n = 296), a 12-session (2.5 hour per session) parenting intervention for primary caregivers of children between 2 and 9 years old. participants will not be restricted to biological parents and include primary caregivers of children between 2 and 9 years old, who live in the same house as the child at least 4 nights per week. participants will be recruited through systematic household sampling, liaising with western cape department of social development and local community-based ngos. self-reporting questionnaires and qualitative observational assessment data for intervention and control groups will be collected at pre- and post-test evaluation as well as 12-month follow-up. primary outcomes will include child behaviour problems, harsh and inconsistent parenting and positive parenting. secondary outcomes will include parental depression, parental stress, parental monitoring and supervision and parent perceived social support.


Eligibility criteria:
inclusion criteria: * caregiver must live with child at least 4 nights per week * child must be between 2 and 9 years old live in khayelitsha or nyanga * may include biological parents, relatives or non-kin foster caregivers, with no restrictions on biological relationship * participant must self-identify as the primary caretaker of the child * children scoring 15 or higher in the eyberg child behaviour inventory problem scale exclusion criteria: * children scoring 14 or lower in the eyber child behaviour inventory problem scale * participants with child not between 2 and 9 years old * participants not self-identifying as the primary care take of the child * participants not living with the child at least 4 nights per week.
structured aerobic and resistance exercise and gestational diabetes

Conditions: Gestational Diabetes Mellitus

Summary: gestational diabetes mellitus (gdm) is defined as impaired glucose tolerance of various degrees first manifested during pregnancy. the primary aim of treating gdm is to optimize glycaemic control and improve pregnancy outcomes. also, as part of treatment, it is recommended to continue or initiate exercising with moderate intensity. however, available data on the effects of physical activity on gdm are based on a small number of trials. the aim of the trial is to examine and add new scientific evidence on possible health-related effects of application of structured programme consisting of aerobic and resistance exercises on the course and outcomes of gdm. primary goal of research is to determine how proposed exercise programme effects glycaemic control, rate of complications during pregnancy, labour, delivery, immediate after delivery and health status of newborn. main hypothesis is that parameters of glycaemic control, course of gdm, complications during delivery and birth outcomes directly and significantly correlate with participation in structured programme of exercise. research will be conducted as experimentally designed randomized controlled trial. participants will be pregnant women diagnosed with gdm, age between 20 and 40, without comorbidities. women in the experimental group will be included in exercise programme two times per week with duration of 50 minutes. training sessions will start right after the diagnosis and will be performed until the end of the pregnancy. the training protocol will follow international guidelines (acog, 2001; acog, 2002; ada, 2008; nice, 2008; ada 2011). women in the control group will receive standard medical care.


Eligibility criteria:
inclusion criteria: * established diagnosis of gestational diabetes, * age between 20 and 40, * otherwise healthy pregnancy exclusion criteria: * pharmacological treatment with oral hypoglicemics and/or insulin therapy introduced prior to trial enrollment, * existing comorbidities and * contraindications for exercise

Keywords: gdm exercise diabetes pregnancy
preimplantation genetic screening in women over 35 year

Conditions: In Vitro Fertilization

Summary: in view of insufficient evidence to routinely use preimplantation genetic screening (pgs) to improve success rates after ivf, we test the hypothesis that patients with advanced maternal age (ama) have a higher implantation rate (ir) after embryo transfer (et) of chromosomally normal embryos following pgs compared to patients who had an et without pgs. in a randomized controlled trial (rct) in patients with ama (≥ 35 years), the clinical ir per embryo transferred will be compared after et on day 5 or 6 between the pgs group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, x and y) and the control group without pgs.


Eligibility criteria:
inclusion criteria: * all couples with a medical indication for ivf and with a female age of at least 35 years are invited to participate in the study. exclusion criteria: * cycles were excluded from the study if ≤ 2 fertilized oocytes were available on day 1 after oocyte retrieval (or), or if ≤ 2 ≥ 6c stage embryos were available on day 3 after or.

Keywords: aneuploidies in 7 chromosomes increased with advanced maternal age