Kornimate/medical-research-clean huggingface dataset:
diabetes prevention program feasibility study of breastfeeding

Conditions: Pregnancy; Overweight and Obesity

Summary: the purpose of this study is to learn about the impact of the diabetes prevention program (dpp) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood sugars and blood pressure, and increase duration of breastfeeding their infant.

this pilot randomized controlled trial seeks to determine the feasibility and efficacy of a combined breastfeeding, dpp-based program in a cohort of overweight/obese women to be followed during pregnancy through 6 months postpartum. the pilot trial will have three study arms: dpp + breastfeeding (tx1), dpp only (tx2), and usual care (tx3). specific aims are: 1) to test the efficacy of tx1 to improve 6-month postpartum weight loss among women with a bmi \>/= 25. 2) to test the efficacy of tx1 to improve 6-month postpartum mean blood glucose (hba1c) and mean arterial blood pressure among women with a bmi \>/= 25. 3) to test the efficacy of tx1 to increase any breastfeeding through 6 months postpartum among women with a bmi \>/= 25.

Eligibility criteria:
inclusion criteria: * pregnant, 1st trimester or early 2nd trimester * interested in breastfeeding * bmi \>/= 25 and \<35 * able to read and understand english * able to learn and use facebook * able to learn and use skype, facetime or zoom for virtual meetings * must have a cell phone exclusion criteria: * pregnancy complications that require emergency care * thyroid disease * multiple gestation * substance abuse within last 3 years * art (assisted reproductive technology) pregnancy * current smoker * prior bariatric surgery * in weight-loss program within 3 months of conception * bmi \>/= 35 * unable to attend intervention / follow-up visits * unwilling to self-monitor data collection * unable to complete intervention * presence of any condition that limits walking * presence of any condition that limits following diet recommendations * pregnancies complicated with fetuses diagnosed with lethal malformations / conditions

Keywords: diabetes prevention program breastfeeding prediabetes
covid-19 infection in pregnancy

Conditions: Perinatology

Summary: prospective study of both maternal and fetal outcomes of those pregnancies that were complicated by covid-19 infection at various gestational ages. the follow up will be from the time the diagnosis was made till discharge of the mother and her baby from the hospital.

pregnancies that have a confirmed covid-19 infection by nasopharyngeal swab whether taken at our laboratory or confirmed at private or ministry of health (moh) laboratories will be followed up till delivery and discharge from the hospital. they will be followed up for hospitalization, intensive care unit (icu) admission, any complications (organ failure, dic, renal failure, septic shock), intubation, mortality, miscarriage, congenital malformations, intra-uterine growth restriction (iugr), oligohydramnios, spontaneous preterm birth, mode of delivery, birth weight, apgar score at 1 and 5 minutes, neonatal infection with covid-19, neonatal icu admission and breast feeding. those patients will be followed up prospectively at our hospital and those with missed follow up and delivered outside our unit will be contacted to bring all the above-mentioned parameters. there will be no exclusion of cases.

Eligibility criteria:
inclusion criteria: * pregnant women exclusion criteria: * none
oral vancomycin to prevent recurrent c difficile infection with antibiotics

Conditions: Clostridium Difficile Infection

Summary: this study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

this study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. previous cdi diagnosis 3. current admission with a suspected or a confirmed bacterial infection requiring antibiotics exclusion criteria: 1. active chronic diarrheal illness (eg, crohn's disease, ulcerative colitis, short bowel syndrome) 2. previous adverse reactions to oral vancomycin 3. requiring metronidazole during hospitalization 4. known pregnancy 5. expected survival \<72 hours 6. patients receiving antibiotics only for surgical prophylaxis 7. patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study

Keywords: vancomycin clostridium difficile clostridium difficile infection recurrent clostridium difficile infection
plasma brain natriuretic peptide levels in pregnancy

Conditions: Cardiomyopathy; Pregnancy

Summary: to evaluate the maternal blood concentrations of brain natriuretic peptide (bnp) during the second and third trimesters of a normal pregnancy. we will attempt to define a normal range for pregnancy and any outliers that may serve as markers for abnormal cardiovascular physiology.

the brain natriuretic peptide (bnp) is a useful marker for volume overload, increased filling pressures and stretching of the myocardium. the current literature contains limited and unreliable information regarding normal bnp values in pregnancy. after baseline echocardiogram to detect individuals with asymptomatic structural defects, the participants will submit to 3 blood draws during the second and third trimester and at delivery to determine normal pregnancy values.

Eligibility criteria:
inclusion criteria: * women age 18 to 40 * second trimester of pregnancy exclusion criteria: * known cardiac or valvular disease, * atrial fibrillation or other arrhythmia, * pulmonary hypertension, * chronic hypertension, * hypertensive disorders of pregnancy, * morbid obesity (bmi \> 40 kg/meter squared) * history of sleep apnea * multiple gestation * known renal dysfunction * medications known to affect cardiac function * current or past abnormal echocardiogram

Keywords: brain natriuretic peptide pregnancy biomarker
effects of oral alfacalcidol on maturation of dendritic cells in graves' disease patients

Conditions: Graves Disease

Summary: maturity level of dendritic cells (dc) plays a pivotal role in initiating and regulating autoimmunity. in graves' disease (gd), dcs have more active immune responses than those in healthy subjects. our previous study demonstrated immunoregulatory effects of in vitro 1,25-d3 on maturation of dc in gd patients. this study aims to evaluate the effect of oral 1α-d3 on dc maturation in gd patients.

patients with graves' disease were divided into two groups: groups receiving oral 1α-d3 in addition to propylthiouracil (ptu) and groups receiving placebos in addition to ptu. comparison of dc maturation were performed before and after the oral 1α-d3. dc maturation was assessed based on the expression of dc markers (hla-dr, cd80, cd40, cd83, cd14 and cd206) and the ratio of cytokines interleukin-12/il-10.

Eligibility criteria:
inclusion criteria: * patients with graves' disease and still have not gone into remission * willing to participate in the research exclusion criteria: * pregnant patient * suffered from severe liver disease * suffered from severe kidney disease * taking vitamin d substitution therapy * suffered from another autoimmune disease * suffered from malignancy

Keywords: vitamin d graves' disease dendritic cells
cetuximab (erbitux®), capecitabine and radiotherapy in neoadjuvant treatment of patients with rectal cancer

Conditions: Rectal Cancer

Summary: this is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.

preoperative radiotherapy and 5-fu based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.capecitabine has the potential to replace 5-fu as standard agent. cetuximab is a monoclonal antibody directed against egfr. both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.the trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage ii and iii rectal cancer.

Eligibility criteria:
inclusion criteria: * age 18 to 80 if judged fit for surgery * who performance status 0-1 * histologically proven rectal adenocarcinoma located below the peritoneum * t3-t4 or/and nodal involvement determined by rectal ultrasound or computed tomography (ct) or mri * no distant metastases * adequate haematological, cardiac, liver and renal function * signed informed consent * appropriate measures for contraception for men and women, if applicable exclusion criteria: * prior radio- and/or chemotherapy * others synchronous cancers * history of other malignant disease * significant heart disease * known hypersensitivity to biological drugs * pregnant or lactating patient

Keywords: cetuximab capecitabine radiotherapy rectal cancer
all polyethylene tibia-vega kiel

Conditions: Degenerative Osteoarthritis; Rheumatoid Arthritis; Post-traumatic; Arthrosis; Other Instability, Knee; Stiffness of Knee, Not Elsewhere Classified; Deformity of Knee Joint

Summary: obligatory post-marketing clinical follow-up (pmcf) as part of the post marketing surveillance plan for the product under investigation for this pmcf only ce-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to mpg §23b).

this non-interventional clinical study (nis) is conducted to clinically confirm the safety and performance of the aesculap® apt vega system® ps components under routine conditions. the vega system® ps is an established tka design, and there is a long-lasting experience in the use of pe for tka in general and for apt components in particular; thus a nis is thought to be sufficient to give the required confirmation. for this nis only ce-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to mpg §23b). as part of the post marketing surveillance plan an obligatory post-marketing clinical follow-up (pmcf) is required for the product under investigation.

Eligibility criteria:
inclusion criteria: * patients requiring primary tka because of severe knee joint conditions that cannot be treated through other therapies; * degenerative osteoarthritis; * rheumatoid arthritis; * posttraumatic arthritis; * symptomatic knee instability; * knee stiffness or deformation of the knee joint; * age ≥ 18 years; * patient signed informed consent exclusion criteria: * age younger than 18 years * any prior joint replacement at the index knee * unable or unwilling to return for postoperative follow-up * patient did not sign informed consent * joint conditions that can be treated by reconstructive surgery (e.g. osteotomy) * acute or chronic infections near the joint, or systemic infections * secondary diseases that could influence joint implant functionality * systemic diseases and metabolic disorders * severe osteoporosis or osteomalacia * severely damaged bone structures that could prevent stable implantation of implant components * bone tumors in the region of implant fixation * bone malformations, axial misalignments or other bone conditions that rule out implantation of a prosthetic joint * expected overload on the joint implant, especially due to high patient weight or intense physical strain and activity * dependency on pharmaceutical drugs, drug abuse, or alcoholism * fever, infection or inflammation (systemic or local) * pregnancy * mental illness * severe osteopenia (or any other medical or surgical finding) that would preclude any benefit from the implants * combination with implant components from other manufacturers * inadequate patient compliance * foreign body sensitivity to the implant materials * all cases not listed under indications

Keywords: tka tkr all-poly posterior stabilized
study of yili lactoferrin shuhua milk in the improvement of human immunization

Conditions: Immunization; Human Influenza; Common Cold

Summary: the purpose of this study is to determine whether yili lactoferrin shuhua milk are effective in reducing the occurrence of flu symptoms.


Eligibility criteria:
inclusion criteria: * age 6 to 12 years, catch cold for 4 to 6 times in last year; * age 35 to 45 years, catch cold for 4 to 6 times in recent 3 month; * age 60 to 75 years, catch cold for 4 to 6 times in last year; * bmi 18.5to 29.9kg/m2; * able to understand the nature and purpose of the study including potential risks and side effects exclusion criteria: * recent (within 6 months of screening) been vaccinated influenza vaccine, or recent (within 15 days of screening) been vaccinated ther vaccines; * suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. such as chronic allergic rhinitis, asthma, copd; * long-term use of any prescription or otc medication that inhibit or prevent flu symptoms, including but not limited to, antihistamine, pectoral, high doses of vitamin c; * recent use (within 3 months of screening) of any prescription or otc medication that significantly affects immune response, such as antibiotic; * known allergies to dairy and any substance in the study product; * history of alcohol, drug, or medication abuse * pregnant or breastfeeding women * recent daily use (within 3 months of screening) of any probiotics, clabber or yogurt; * any comorbidity that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
the predict h trial

Conditions: Intraoperative Hypotension

Summary: the aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the hypotension prediction index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy affects tissue oxygenation and organ perfusion.

background: intraoperative arterial hypotension is associated with poor postoperative outcomes. the hypotension prediction index developed from machine learning, predicts the occurrence of arterial hypotension from the analysis of the arterial pressure waveform. the use of this index can reduce the duration and severity of intraoperative hypotension in adults undergoing noncardiac surgery. methods: we will conduct a multicenter, randomized, controlled trial (n=80) in high-risk surgical patients scheduled for elective major abdominal surgery. all participants will be randomly assigned to a control or intervention group. hemodynamic management in the control group will be based on standard hemodynamic parameters. hemodynamic management of patients in the intervention group will be based on functional hemodynamic parameters provided by hemosphere platform (edwards lifesciences ltd), including dynamic arterial elastance, dp/dtmax and the hypotension prediction index. tissue oxygen saturation will be non-invasively and continuously recorded by using near-infrared spectroscopy technology. biomarkers of acute kidney stress (ctimp2 and igfbp7) will be obtained before and after surgery. the primary outcome will be intraoperative time-weighted average with a mean arterial pressure \< 65mmhg. discussion: the aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the hypotension prediction index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy affects tissue oxygenation and organ perfusion.

Eligibility criteria:
enrolled patients will be at least 65 years old and/or american society of anesthesiologist (asa) physical status iii/iv, scheduled for elective major abdominal surgery (general surgery, urology, or gynecology, through laparoscopic or open approach), with general or combined anesthesia. surgery will be considered to be major if the expected duration is \> 2 h, or the estimated blood loss is \> 15% of blood volume, or if the expected required transfusion is ≥ 2 packed red blood cells. exclusion criteria will be pregnancy, surgery performed only under regional anesthesia, preoperative glomerular filtrate \< 60 ml/min/1.73m2 according to the ckd-epi 2009 formula, persistent atrial fibrillation, known cardiac shunts or if the patient received a kidney transplant, and refusal of the patient to participate in the study.

Keywords: goal directed hemodynamic therapy machine learning acute kidney injury
quality of life in pediatric transplant patients

Conditions: Kidney Transplantation; Liver Transplantation; Heart Transplantation

Summary: the goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. it is hypothesized that there will be significant differences between parent and child perceptions.

there are numerous studies that report on the quality of life in solid organ transplant recipients. however, very few studies target quality of life parameters for these children and their families across all solid organ transplantation. furthermore, no literature directly addresses a comparison of perceptions and wellness, impact on family, and vulnerability in a comparative format by these distinct, but definitely related populations. the goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. it is hypothesized that there will be significant differences between parent and child perceptions. outcomes will be measured by using five different instruments: 1. pediatric quality of life inventory (pedsql) 2. pedsql family impact module 3. pedsql family information form 4. functional status ii-r 5. child vulnerability scale (cvs) patients will be enrolled at the time of transplant listing, or after transplant. patients and families will complete the survey once every 6 months while the patient is active on the respective transplant waiting list. after transplant, the patients and families will be asked to complete the survey once every 6 months for the first two years and annually thereafter. this study may provide us with an improved understanding of parent and child perceptions in wellness, impact on family, and vulnerability within each transplant group. the results may also indicate trend differences between these three populations. these differences may help to provide insight into family perspectives allowing for greater anticipatory guidance and targeted interventions.

Eligibility criteria:
inclusion criteria: * between newborn and 21 years old * parent/child pairs of patients listed for or who have received a liver transplant, kidney transplant, or heart transplant exclusion criteria: * unwilling or unable to participate * not in one of the above transplant groups * non-english speaking

Keywords: solid organ transplant
twins and the risk of parkinson's disease: a clinical and imaging study

Conditions: Parkinson's Disease

Summary: the purpose of this study is to examine the role of genetic and environmental factors in the cause of parkinson's disease.

parkinson's disease (pd) is a growing health problem in the elderly, and genetic factors may provide substantial clues toward eventual treatment and/or prevention of the disorder. the national academy of sciences/national resource council (nas/nrc) world war ii (wwii) veteran twins cohort registry is one of the few population-based groups of elderly twins. previous studies in this group indicated that genetic factors were involved only in early-onset pd, however there was no follow-up to these studies. the purpose of the "twins and the risk of pd" study is to follow-up previous studies and confirm the initial findings. in this study, investigators will use the nas/nrc wwii veteran twin cohort registry to compare the concordance rates for pd in monozygotic and dizygotic twins-at least one of whom has pd. the overall goal of this research is determine the contributions of genetic and environmental factors in the cause of pd. the study will involve traditional clinical research methods, such as a clinical examination, as well as innovative imaging techniques, such as single photon emission computed tomography (spect). spect-a nuclear imaging test involving blood flow to tissue-is used to evaluate certain brain functions. findings from this study may help to set research priorities in pd, and to develop tools for early detection of the disorder.

Eligibility criteria:
inclusion: * participants will be recruited from a closed cohort-the national academy of sciences/national resource council (nas/nrc) world war ii veteran twins cohort

Keywords: parkinson's disease twins spect national academy of sciences/national resource council (nas/nrc) world war ii veteran twins cohort registry nas/nrc world war ii veteran twins
evaluation of the covidseq test in nasal swab and saliva from a covid-19 asymptomatic population

Conditions: SARS-CoV-2

Summary: "this is a prospective, single-center specimen collection study. subjects 18 years of age or older who do not have symptoms of covid-19 will be enrolled. two nasal swab samples and one saliva sample will be collected from each subject. the saliva sample will be tested with the covidseq test and one nasal swab will be tested with an eua approved covid test. the other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the covidseq test. results of all testing will be provided to the sponsor for statistical analysis. results from the comparator eua test will be provided to the collection site investigator or designated collection site study staff. no medical treatment, guidance on treatment decisions, nor medical care will be provided. "


Eligibility criteria:
subject inclusion criteria: an individual must meet the criteria below to be eligible. * individual is attending or invited to visit a participating collection site. * individual is 18 years or older at the time of consent. * individual is feeling well at the time of consent or specimen collection and does not have any of the following symptoms of covid-19 per the current cdc guidance such as cough, shortness of breath or difficulty breathing, fatigue, fever or chills, muscle or body aches, headache, sore throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, or diarrhea. * individual is willing to participate in study procedures and able to provide written informed consent in the english language. subject exclusion criteria: an individual cannot meet the below criteria. * individual is confirmed to have covid-19 and continues to require isolation in accordance with current cdc guidelines at the time of consent or specimen collection. * individual is asymptomatic but suspected to have covid-19 due to recent close contact (as currently defined by the cdc) with a person with covid-19 and continues to require quarantine in accordance with current cdc guidelines at the time of consent or specimen collection. \[5\] * individual had symptoms of covid-19 less than 10 days before time of consent or specimen collection."