Kornimate/medical-research-clean huggingface dataset:
intervention study to evaluate a probiotic in mild atopic dermatitis young patients

Conditions: Dermatitis, Atopic

Summary: the aim of the study is to evaluate the beneficial effect of a probiotic preparation with an antiinflammatory and modulating activity on immunological processes, with positive results on different inflammatory and atopic conditions.

in this study the investigators evaluate the safety and efficacy of a probiotic formulation in the reduction of symptoms and use of topic and systemic corticosteroids and antihistamines in the treatment of mild atopic dermatitis according to hanifin and rajka diagnostic criteria for atopic dermatitis, with a scorad (scoring atopic dermatitis) index of 20 to 40, in patients 4 to 18 years old, that require the use of said drugs due to disease flare-ups, and to whom the usage of topic corticoids to control said flare-ups is indicated.

Eligibility criteria:
inclusion criteria: * patients that are 4 to 17 years of age. * patients diagnosed of atopic dermatitis according to hanifin and rajka diagnostic criteria for atopic dermatitis. * patients with a scorad score ranging from 20 to 40. * patients that are actually using, or in which the use of topic corticosteroids to treat the atopic dermatitis flare-ups. * patients whose parents or legal representative have signed the informed consent. if the patient is 12 year old or older, the patient has to sign a consent to enter the trial. exclusion criteria: * pregnancy. * breastfeeding. * women of childbearing age that do not make a commitment to use any effective contraceptive method. * phototherapy treatments to atopic dermatitis * systemic corticoid therapy in the last two months. * immunosuppressive or cytostatic treatment in the last two months. * probiotic treatment in the last two months. * systemic antibiotic in the last four months. * fever (axillary temperature \> 37ºc or equivalent) * severe allergic diseases- * immunodeficiency or cancer related processes. * other dermatological pathologies that could difficult the atopic dermatitis evaluation, or that require the continued use of topic corticosteroids. * any contraindication to any product or drug used during the trial, according to their technical files. * participation in any drug clinical trial in the last 3 months.
russian non-interventional study on compliance of venous thromboembolism (vte)

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Summary: this is a local, prospective, multicenter, non-interventional, observational study. primary objective is to describe how in "real life" thromboprophylaxis is carried out after the discharge from a hospital in the patients who undergo elective knee and hip replacement and who receive xarelto during hospitalization.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years old * elective hip or knee replacement * planned vte prevention with xarelto * written informed consent * the decision for treatment type and duration is taken by the investigator and is made before inclusion into the study. exclusion criteria: * contraindications for the use of xarelto in accordance with the effective instruction * any reasons of medical and non-medical character, which in the opinion of the physician can hamper participation of the patient in nis, including a potentially low compliance, impossibility of making the final visit due to distant place of residence of the patient.

Keywords: non-interventional xarelto knee replacement hip replecement russia
effect of different doses of amg 706 on the gallbladder in advanced solid tumors

Conditions: Solid Tumors

Summary: the study involves the use of three different dosing regimens of amg 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. the study will be conducted in 11 sites in the us and australia. a total of 48 patients will be enrolled in the study with the possibility of enrolling 8 more in each treatment arm.


Eligibility criteria:
inclusion criteria: * histologically confirmed advanced metastatic solid tumor * ineligible to receive or progressed on standard of care therapies * measurable or non-measurable disease per modified recist * gallbladder must be in situ on screening ultrasound * ecog performance status of 0 to 2 * life expectancy of 6 months or more as determined by the investigator * adequate organ and hematologic function as evidenced by laboratory studies prior to randomization * men and women 18 years or older exclusion criteria: * uncontrolled cns metastases * known history of prior cholecystitis, prior biliary procedure or prior or ongoing biliary disease * radiation therapy within 14 days prior to randomization * peripheral neuropathy \> grade 1 per ctc ae v.3 * currently or previously treated with amg 706 or other vegf inhibitors such as su11248 (sunitinib), ptk787 (vatalanib), azd2171, bay 43-9006 (sorafenib), zd6474 (vandetanib) * previous treatment with bevacizumab is allowed if at least 6 weeks have elapsed from the last dose of bevacizumab to the date of randomization * any anti-coagulant therapy within 7 days prior to randomization; low dose heparin and warfarin for prophylaxis against central venous catheter thrombosis is allowed * less than 30 days have elapsed since participation in an investigational drug/device study or currently receiving investigational treatments * history of arterial or venous thrombosis within 1 year prior to randomization * history of bleeding diathesis or bleeding within 14 days of randomization * mi, cva, tia, ptca/stent, chf, grade 2 or greater pvd, uncontrolled arrhythmias or unstable angina within one year prior to randomization * uncontrolled htn defined by a resting bp of \>150/90 mmhg * surgery: major surgical procedure within 4 weeks or 28 days prior to randomization; minor surgical procedure, placement of access device or fine needle aspiration within 7 days of randomization; planned elective surgery while on study * non-healing or open wound, ulcer or fracture * known ongoing or active infection * known (+) for hiv, hep c or hep b surface antigen * known chronic hepatitis * known history of allergy or hypersensitivity to amg 706 or any of its components * pregnant, ie, (+) b-hcg; breastfeeding

Keywords: gallbladder amg 706 solid tumors phase 1b amgen
diet and physical activity program in colorectal cancer survivor: a randomized controlled trial

Conditions: Colorectal Cancer

Summary: colorectal cancers (crc) represent the 1st digestive cancer and the 3rd cancer in the world. the world cancer research fund summarized evidence from observational studies and concluded that low dietary fiber, and high red and processed meat (rpm) intakes were associated with higher risk of (crc), whilst physical activity (pa) protected against developing colon cancer. post-treatment management is essential for improving the health and quality of life of colorectal cancer (crc) survivors. the number of cancer survivors is continually increasing, which is causing a corresponding growth in the need for effective post- treatment management programs. to date, there is insufficient information available from the published literature as to the most effective way in promoting lifestyle changes in crc survivors. moreover, none of these interventions have been conducted in an african population. we aim to assess whether the proposed program may effectively modify the targeted behaviors, to evaluate whether the dietary and pa interventions of the "moving bright, eating smart" program are effective in reducing the consumption of red and processed meat (rpm) and refined grain (rg), increasing the physical activity (pa) levels in north african (libyan and tunisian) adult colorectal cancer (crc) survivors and to assess the efficacy of behavioral interventions on cancer outcomes (overall survival, disease free survival).


Eligibility criteria:
inclusion criteria: * histologically proven colorectal adenocarcinoma patients above the age of 18 years within one year of completion of main cancer treatment who are able to provide informed consent. exclusion criteria: * colorectal cancer patients who have persistent or recurrent disease at the time of the recruitment, are receiving cancer treatment, have known contraindication to physical activity, have psychiatric disease.

Keywords: diet physical activity
construction of an in vitro intestinal microbial ecological simulation system for obese people

Conditions: Obese Subjects

Summary: about 2.6 billion people ( about 40 % of the world 's population ) are affected by overweight or obesity. the prevalence of overweight and obesity in chinese adults has exceeded 50 %, and the prevalence is still on the rise.the gut microbiota is regarded as an endocrine organ and participates in energy balance. diet changes can disrupt the relationship between the microbiota and the host, leading to metabolic diseases.although human studies provide important information, there are limitations, such as the entry of complex gastrointestinal environment limiting components, the lack of dynamic microbial process information, and the uncertainty of drug side effects. in vitro methods can solve these problems, allowing dynamic sampling, standardized operation, high repeatability, and evaluation of potential toxins and pathogens. in vitro models are widely used to evaluate the effects on the human colon microbiome and to predict in vivo results.based on the above research background, this study aims to collect fecal samples from obese people to construct an in vitro intestinal microbial ecological simulation system. this will lay an experimental foundation for further exploring the effect of specific nutrient intervention on the composition and function of gut microbiota in obese people.


Eligibility criteria:
inclusion criteria: * screening in the physical examination population who intend to retain fecal samples in the physical examination center of our hospital. bmi ≥ 28, age range from 18 to 30. exclusion criteria: * previous history of intestinal disease, history of hypertension, diabetes, coronary heart disease and other chronic diseases, history of important organ disease or surgery, history of malignant tumor disease. * he had a history of heavy smoking and alcohol abuse. * in the past 6 months, she took antibiotics. * weight loss measures in the past 6 months, including but not limited to dieting, physical exercise, probiotic intervention and other medications. * subjects and their families who disagreed with the study protocol.
health economic assessment of lower extremity diabetic (healed) ulcers with primatrix

Conditions: Foot Ulcer, Diabetic

Summary: the objective of this study is to compare the effectiveness of primatrix moist wound therapy (mwt) with standard of care mwt for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.

this study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of primatrix mwt versus standard of care mwt in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). to measure wound recidivism and changes in functional quality of life, each subject will complete the cardiff wound impact schedule and the sf-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). additionally, the data obtained from the sf-36v2™ will be used in an economic evaluation of the treatment arms.

Eligibility criteria:
inclusion criteria: * type i or type ii diabetes * a diabetic foot ulcer located on the foot or ankle at least one square centimeter exclusion criteria: * suspected or confirmed signs/symptoms of wound infection * hypersensitivity to bovine collagen
cs scar impact on art outcomes

Conditions: Fertility Issues

Summary: cs scar impact on art outcomes, retrospective cohort study ivf outcome can be affected by the presence of caesarean section scar with or without defect in different ways

cs scar impact on art outcomes, retrospective cohort study ivf outcome can be affected by the presence of caesarean section scar with or without defect in different ways; increase difficulty of embryo transfer, presence intrauterine fluid at the time of transfer can affect the chances of embryo implantation and increase the rate of spontaneous miscarriages to compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without caesarean section, and who had caesarean section (with or without a niche) after euploid embryo transfer. does cs scar and cs scar defect affect ivf outcome? all women who underwent an embryo transfer with a euploid embryo between 2015 and 2022, who meet the inclusion criteria will be included in the study. * inclusion criteria: age 25-40 years old. euploid embryo transfer. medically free bmi less tha 30 kg/m2 hormone therapy preparation for fet. * exclusion criteria previous uterine scar other than cesarean section. congenital uterine abnormalities presence of intrauterine lesions e.g., polyp, fibroid, endometriosis or adenomyosis hydrosalpinx, chronic endometritis * primary outcome: clinical pregnancy rate, defined as a pregnancy with a detectable heart rate at 7 weeks of gestation or beyond. * secondary outcomes : early pregnancy complications ectopic pregnancy or miscarriage. caesarean section scar dehiscence or

Eligibility criteria:
inclusion criteria: * age 25-40 years old. euploid embryo transfer. medically free bmi less tha 30 kg/m2 hormone therapy preparation for fet. exclusion criteria: - exclusion criteria previous uterine scar other than cesarean section. congenital uterine abnormalities presence of intrauterine lesions e.g., polyp, fibroid, endometriosis or adenomyosis hydrosalpinx, chronic endometritis

Keywords: cs scar impact on art outcomes
observational study of parental feeding practices to improve child's food intake and weight status

Conditions: Obesity; Feeding Behaviors

Summary: background: a topic of interest in the etiology of child obesity is if and how parental feeding behaviors are associated with child food intake and weight status. objectives: the objective was to explore if and how directive (overt) and non-directive (covert and food environmental structure) types of parental feeding control were associated with children's food intake and weight status. design: this was a cross-sectional, exploratory study using structural equation modeling to determine directional associations between maternal feeding practices and their child's food intakes and weight status. researchers collected data from 330 dyads of 3-5yr children and mothers participating in a federal preschool program for low-income families (head start) in michigan. mothers' feeding practices (directive and non-directive control), children's food intakes, height and weight of both mothers and children were measured. structural equation models tested the relationships between maternal feeding practices, the child's food intake and weight status. hypotheses: 1. child weight is negatively associated with parents' directive feeding control practices. 2. less directive control or greater non-directive control is associated with healthier food intakes in children.


Eligibility criteria:
inclusion criteria: * dyads of child (3-5yrs) and the primary female caregiver * participating head start program in central michigan exclusion criteria: * children with disability except speech disorders * caregivers younger than 18 years old

Keywords: weight food intakes feeding
changes in inflammatory markers during pulmonary rehabilitation based on exacerbation states in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will examine the inflammatory response to exercise encompassed as part of a standard pulmonary rehabilitation programme in patients with chronic obstructive pulmonary disease (copd). patients will be split into two groups, frequent exacerbators or infrequent exacerbators, dependent upon exacerbation history to compare responses to pulmonary rehabilitation amongst phenotypes.

pulmonary rehabilitation has been proven to benefit copd patients in terms of quality of life and functional capabilities. the effects of pulmonary rehabilitation (exercise) on immune function are unclear despite clear benefits of exercise on immune function in healthy individuals being identified. moderate-intensity and frequency of exercise has been shown to decrease the risk of upper respiratory tract infections in healthy individuals in comparison to sedentary individuals. respiratory infections, also known as exacerbations, in copd are the main cause of hospitalisation and mortality. therefore, if exercise can modulate immune function in copd, it can be encouraged further in copd to reduce hospitalisation risk. however, it is important to compare the effects of exercise amongst different phenotypes as frequent exacerbators are known to have elevated inflammatory markers, and may consequently respond to exercise differently to infrequent exacerbators, paving a rationale for a different approach to this subset of patients.

Eligibility criteria:
inclusion criteria: * 58 frequent exacerbators and 58 infrequent exacerbators (116 in total) who have been diagnosed with any severity of copd (according to bts criteria, i.e. \>10 pack year smoking history and post bronchodilator spirometry fev1/fvc ratio \<0.70 and fev\<80%). exclusion criteria: * inability or unwillingness to sign informed consent * any unstable ongoing cardiovascular events which may be exacerbated by exercise * inability to complete walk tests due to physical or mental impairment * other active inflammatory conditions e.g. rheumatoid arthritis, cancer. * known asthma, allergic rhinitis or other respiratory disease (bronchiectasis, pulmonary fibrosis) healthy control group - patients who have not been diagnosed with copd or any other respiratory condition and are characteristically (age (between 45-85 years old) \& smoking status) matched to recruited copd patients.

Keywords: copd exercise immunity inflammation biomarkers
68ga-bmv101 pet/ct in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: inflammation mediated by macrophage infiltration plays a vital role in a diverse range of physiological conditions. in particular, recent evidence suggests this type of macrophage response is important for the disease pathology of pulmonary fibrosis. because cysteine cathepsins are proteases that are highly expressed in antigen presenting cells such as macrophages, they serve as promising biomarkers. employing non-invasive imaging agents 68ga-bmv101 that specifically recognize cysteine proteases in immune cells has the potential to not only aid early detection but also significantly aid efforts to monitor progression and patient response to therapy.

for interests in clinical translation of 68ga-bmv101, an open-label dynamic whole-body pet/ct study was designed to investigate safety and diagnostic performance of 68ga-bmv101 in patients with idiopathic pulmonary fibrosis (ipf). a single dose of nearly 111 mbq 68ga-bmv101 will be intravenously injected into healthy volunteers and patients with suspected ipf. visual and semiquantitative method will be used to assess the pet/ct images. changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. adverse events will also be observed in the patients.

Eligibility criteria:
inclusion criteria: patients with idiopathic pulmonary fibrosis * males and females, ≥18 years old * characteristic clinical signs, symptoms and laboratory tests suggesting the diagnosis of ipf. * the diagnosis of ipf is based on the centres for disease control and prevention (cdc) criteria for diagnosing ipf. they rely on a combination of clinical, radiological, operative and histological findings, in addition to results of other laboratory tests. exclusion criteria: * females planning to bear a child recently or with childbearing potential * renal function: serum creatinine \>3.0 mg/dl (270 μm/l) * liver function: any hepatic enzyme level more than 5 times upper limit of normal. * known severe allergy or hypersensitivity to iv radiographic contrast. * patients not able to enter the bore of the pet/ct scanner. * inability to lie still for the entire imaging time because of cough, pain, etc. * inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. * concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.

Keywords: pet interstitial pulmonary fibrosis (ipf) cysteine cathepsins macrophage
safety and efficacy study of dutogliptin in subjects with type 2 diabetes mellitus on a background medication of metformin

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.


Eligibility criteria:
inclusion criteria: * completion of all required visits of a qualifying phase 3 core protocol * current treatment of type 2 diabetes mellitus as in phx1149-prot302 exclusion criteria: * any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Keywords: diabetes dpp4 inhibitor dutogliptin