Kornimate/medical-research-clean huggingface dataset:
the role of atorvastatin on monocyte function in patients with coronary artery disease and hypercholesterolemia

Conditions: Coronary Artery Disease; Hypercholesterolemia; Monocyte Function

Summary: the aim of this study is to determine, whether an intensified atorvastatin therapy can improve monocyte function in patients with coronary artery disease and hypercholesterolemia.

hypercholesterolemia is one of the most important cardiovascular risk factors that significantly elevates the risk for the development and progression of arteriosclerotic diseases. statins such as atorvastatin have been shown to reduce atherogenic lipoprotein levels as well as cardiovascular morbidity and mortality in a large number of clinical trials. it is suggested that statins have- apart from their lipid-lowering properties- other pleiotropic effects that are responsible for their anti-atheroslerotic and and cardioprotective potential. monocytes are crucially involved in the process of arteriogenesis (i.e. the growth of preexisting arterioles). monocyte chemotaxis can be stimulated with arteriogenic molecules such as vascular endothelial growth factor a (vegf-a). in previous studies we could demonstrate that the vegf-a- induced monocyte chemotaxis is severely impaired in hypercholesterolemic patients. this reduced response to vegf seems to be associated with a decreased ability to form functional collaterals. therefore we hypothesize that an intensified therapy with atorvastatin 40 mg once a day can significantly improve monocyte function in patients with coronary artery disease and hypercholesterolemia compared to patients who are only treated with a placebo.

Eligibility criteria:
inclusion criteria: * coronary artery disease (angiographically proven) * diagnosis of hypercholesterolemia (either ldl-c ≥ 4 mmol/l or already treated with lipid-lowering medication) exclusion criteria: * diabetes mellitus * uncontrolled arterial hypertension (repeated bp ≥ 160/90 mmhg) * smoking * active infections * acute coronary syndrome (\< 8 weeks) * malignant diseases * nephropathy

Keywords: statin atorvastatin hypercholesterolemia coronary artery disease monocyte collateral formation arteriogenesis chemotaxis migration growth factors vascular endothelial growth factor a placenta growth factor 1 hepatocyte growth factor monocyte chemotactic protein 1
anti-pd-1 immunotherapy combined with sbrt for patients with oligometastatic escc

Conditions: Esophageal Squamous Cell Carcinoma; Oligometastatic Disease

Summary: the goal of this phase ii clinical trial is to explore the efficacy and safety of anti-pd1 combined with stereotactic body radiation therapy (sbrt) for patients with oligometastatic esophageal squamous cell carcinoma. participants will receive anti-pd1 and sbrt to the metastatic lesions which are amenable to the delivery of sbrt after 4\~6 cycles of systemic chemotherapy and anti-pd-1.


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group performance status ≤ 2; 2. histologically confirmed squamous cell carcinoma of the esophagus; 3. diagnosed with stage ivb disease (according to uicc tnm version 8) with less than five metastatic lesions within three organs; 4. received 4 to 6 cycles of standard chemotherapy (fluoropyrimidine or taxane-based platinum doublet chemotherapy) and anti-pd1 treatment, and no progression disease was confirmed; 5. at least one metastatic lesions amenable to the delivery of sbrt; 6. estimated life expectancy \>4 months; 7. the function of important organs meet the following requirements: a. white blood cell count (wbc) ≥ 4.0×109/l, absolute neutrophil count (anc) ≥ 1.5×109/l; b. platelets ≥ 100×109/l; c. hemoglobin ≥ 9g/dl; d. serum albumin ≥ 2.8g/dl; e. total bilirubin ≤ 1.5×uln, alt, ast and/or akp ≤ 2.5×uln; f. serum creatinine ≤ 1.5×uln or creatinine clearance rate \>60 ml/min; 8. ability to understand the study and sign informed consent. exclusion criteria: 1. progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-pd1 treatment; 2. patients with intracranial metastasis disease at diagnosis; 3. history of thoracic irradiation; 4. known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: capecitabine, paclitaxel, or platinum; 5. patients have spinal bone metastases combined with spinal cord compression; 6. a history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer; 7. patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia; 8. inability to provide informed consent due to psychological, familial, social, and other factors; 9. female patients who are pregnant or during lactation; 10. active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive hiv test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation; 11. a history of interstitial lung disease or non-infectious pneumonia; presence of active hepatitis b (hbv dna ≥ 2000 iu/ml or 104 copies/ml), hepatitis c (positive for hepatitis c antibody, and hcv-rna levels higher than the lower limit of the assay).

Keywords: esophageal cancer; oligometastases; pd-1; sbrt
to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wet age-related macular degeneration (wamd) or diabetic macular edema (dme) in routine clinical practice in canada.

Conditions: Wet Macular Degeneration

Summary: to describe the use of intravitreal aflibercept in routine clinical practice and to describe follow-up as well as treatment patterns in patients with wamd or dme in routine clinical practice in canada for a study population of treatment naive patients and those who have received prior therapy (anti-vegf injections, laser, steroids, etc).


Eligibility criteria:
inclusion criteria: * age: \>= 18 years of age * male or female * patients with wet amd (wet age-related macular degeneration) or diabetic macular edema (dme) who will be treated by intravitreal aflibercept according to the canadian product monograph recommendations and routine clinical practice. * decision to treat with intravitreal aflibercept prior to patient enrolment as per the physician's routine clinical practice. exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice. * patients currently being treated with intravitreal aflibercept. this study will only include patients new to intravitreal aflibercept, both naïve and previously treated with other anti-vegf therapies. * patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. * patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. * ocular or peri-ocular infection * active intraocular inflammation * scar, fibrosis, or atrophy involving the center of the fovea in the study eye. * any concomitant therapy with another agent to treat wet amd or dme in the study eye.

Keywords: diabetic macular edema wet age-related macular degeneration
pets-d (parent education thru simulation-diabetes)

Conditions: Type 1 Diabetes

Summary: hypothesis: parents who receive parent education thru simulation-diabetes (pets-d) will have significantly higher diabetes knowledge (cognitive visual schemata), better technical and problem-solving competence and confidence, and lower fear and stress/anxiety levels; and provide better diabetes management at 14 weeks compared to those parents receiving standard diabetes education.


Eligibility criteria:
inclusion criteria: * parents 18 years and older who have a child newly diagnosed with type 1 diabetes mellitus (t1dm) from 5 years old to under 13 years of age exclusion criteria: * exclude children with developmental delays (such as down syndrome, autism) or steroid induced diabetes (cancer treatment related or cystic fibrosis) * exclude parents who require insulin treatment -or- those that have another child with tidm

Keywords: parent education
home: home monitoring of high-risk pregnancies

Conditions: Hypertensive Disorder of Pregnancy; Premature Preterm Rupture of Membranes; Preeclampsia; High Risk Pregnancy; Previous Adverse Obstetric Outcome

Summary: high-risk pregnancies often require long-term hospitalization or outpatient maternal and/or fetal monitoring, placing a burden on patients, hospital resources and society. the demand for intensified pregnancy surveillance and interventions is increasing, due to the increased prevalence of risk factors like obesity and advanced maternal age, as well as altered guidelines resulting in increasing labor induction rates.the main aims of the home study (home monitoring of pregnancies at risk) are to assess if home monitoring of selected high-risk pregnancies for maternal and fetal wellbeing is feasible, safe (in a clinical trial), cost-efficient, and simultaneously empowers the users.


Eligibility criteria:
inclusion criteria: * preeclampsia * gestational hypertension * premature preterm rupture of membranes * high risk pregnancy * previous adverse obstetric outcomes exclusion criteria: * multiples (twins, triplets etc) * patient or fetus in immediate need for delivery * not understanding norwegian * not mastering the technological aspects of home monitoring * long travel distance to obstetric department
a pilot feasibility study of fibroblast calcium and glucoregulation in health and disease

Conditions: Type 2 Diabetes

Summary: the purpose of this research is to better understand how calcium and glucose may play a role in people developing diabetes. by doing this study, the investigator hopes to learn whether abnormal calcium and glucose responses in skin biopsies from healthy patients and patients with type 2 diabetes can identify and predict patients at greatest risk for later complications.

the overall goal of this proposal is to establish a pathophysiological index of a patient's status through imaging of calcium and glucose in skin fibroblasts. the investigator will obtain skin samples from patients in the barnstable brown obesity and diabetes center at the university of kentucky to test the hypothesis that calcium and glucose dysregulation are present in fibroblasts from patients with type 2 diabetes, and are exaggerated in more difficult-to-treat patients or those with poor glucose control. the innovation of the project focuses on results that can potentially lead to earlier treatment for patients with diabetes and thereby reduce the risk for long-term complications. three levels of analyses will be conducted to assess the relationship between ca2+ and glucose homeostasis in four patient groups (lean non-diabetics, obese non-diabetics, type 2 diabetics with good glucose control, and type 2 diabetics with poor control. participants will be required to attend only one study visit that will last approximately 2-3 hours. during the study subject will undergo the following: 1. collection of two 4 ml tubes of blood for adiponectin analysis, 2. a skin biopsy, 3. collection and review of medical history and current/past medication use 4. collection of demographic information, 5. height and weight measurement 6. body mass index evaluation, 7. vital signs assessment (blood pressure, pulse). follow-up for all enrolled patients will occur on a yearly basis through a phone interview. the punch biopsy will be performed under local anesthesia.

Eligibility criteria:
inclusion criteria: * healthy * type 2 diabetes exclusion criteria: * under 40 years of age * over 55 years of age * pregnant or breastfeedig * will not agree to a skin biopsy * talking calcium channel blockers
the effect of dronabinol on the acquisition and consolidation of trauma-associated memories

Conditions: Intrusive Memories

Summary: the aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma. a well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. in a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. the primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls. this project will contribute to the current understanding of intrusive memory formation in ptsd and may guide the development of future pharmacological preventions.

recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (ptsd) after traumatic events. in own of our own studies, we found reduced concentrations of the endocannabinoid arachidonylethanolamide (aea) in bpd patients compared to healthy women (see fig 1a). furthermore, we found a correlation between hair concentrations of aea and cortisol (p = .06; fig 1b). low endocannabinoid signaling has been found in ptsd patients and might even present a precondition to develop ptsd after trauma. in consequence, increased endocannabinoid signaling during acquisition and consolidation of traumatic events might be a promising approach to prevent the development of ptsd. the aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma. a well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. in a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. the primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls. this project will contribute to the current understanding of intrusive memory formation in ptsd and may guide the development of future pharmacological preventions.

Eligibility criteria:
inclusion criteria: * healthy female volunteers * german on a native level exclusion criteria: * former or present disorder according to the diagnostic and statistical manual of mental disorders 5 (dsm-5) * any physical illnesses * any medication intake (except oral contraceptive) * history of traumatic experience, e.g. history of sexual abuse or rape * pregnancy or lactation period * follicular phase of menstrual cycle for all women not using oral contraceptives
lestaurtinib with or without chemotherapy agents in samples from young patients with leukemia

Conditions: Childhood Acute Lymphoblastic Leukemia; Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Summary: this research study is studying lestaurtinib with or with chemotherapy in samples from young patients with leukemia. studying the effects of lestaurtinib with or without chemotherapy in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of this treatment on cancer cells. it may also help doctors identify biomarkers related to cancer.

primary objectives: i. determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia. ii. determine whether flt3 protein expression level and/or activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia. iii. determine whether lestaurtinib activates stat5, akt, and ras-mapk and other pathways. iv. determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells. outline: this is a multicenter study. cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents. samples are analyzed for flt3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of stat, akt, and ras-mapk and other pathways by western blot. the most effective treatment from this study is then validated in vivo in a nod/scid xenograft model.

Eligibility criteria:
inclusion criteria: * cryopreserved samples from infants with leukemia available
a window of opportunity study of pre-operative endocrine therapy with and without prometrium in postmenopausal women with early stage breast hormone receptor positive (hr+) human epidermal receptor 2 negative (her2-) breast cancer.

Conditions: Early-stage Breast Cancer; Hormone Receptor Positive Tumor

Summary: a phase ii randomised, open label study of pre-operative endocrine therapy with \& without prometrium in postmenopausal women with early stage breast hormone receptor positive (hr+) human epidermal receptor 2 negative (her2-) breast cancer.

there is bidirectional interplay between the progesterone receptor (pr) and oestrogen receptor (er) in human breast cancers. there is evidence for a reprogramming of er chromatin binding sites with 470 genes differentially regulated by dual treatment with estrogen plus progestogen compared to estrogen alone in breast cancer cell lines. functionally, there was an additive anti-cancer effect with the addition of natural progesterone to endocrine therapy in preclinical breast cancer models. this is a phase ii multi-site, randomised, open-label, three-arm, study in 200 postmenopausal women with early-stage er+, pr+, her2-negative breast cancer. eligible patients will be randomised (1:1:1) to receive 14 days of intervention with either letrozole 2.5mg po daily (arm 1), letrozole 2.5mg + prometrium 300mg po daily (arm 2) or tamoxifen 20mg + prometrium 300mg po daily (arm 3), between diagnosis of breast cancer and definitive surgery.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed er+ and pr+ breast cancer (defined as ≥10% positive staining cells) 2. histologically confirmed her2-negative breast cancer (defined as ihc 0-1 and/or fish/cish \<2.2) 3. tumour size ≥1 cm as measured by ultrasound and/or mammogram 4. ability to understand all patient information and informed-consent documents, written informed consent to participate in the trial, and to avail tissue and blood samples for research 5. aged 18 years or older exclusion criteria: 1. women currently on hormone therapies, including hormone replacement therapy and oral contraceptive pill 2. locally advanced/inoperable and inflammatory breast cancer 3. planned for a mastectomy (due to increased risk of venous thromboembolism) 4. clinical evidence of metastatic disease 5. patients treated with other preoperative systemic therapies 6. nut allergy (prometrium contains peanut oil) 7. prior history of uterine cancer, deep vein thrombosis, pulmonary embolism or clotting disorder 8. women who are pregnant or breast-feeding

Keywords: early stage breast cancer prometrium progesterone post-menopausal endocrine therapy
bleaching effect of solo and combined kiwi extract and ozone and their impact on enamel

Conditions: Discoloration, Tooth

Summary: ozone therapy has been extensively used in dentistry to manage wounds healing, dental caries, oral lichen planus, gingivitis and periodontitis, halitosis, osteonecrosis of the jaw, post-surgical pain, plaque and biofilms, root canal treatment, dentin hypersensitivity, tempro-mandibular joint disorders and teeth whitening, and based on the above, in this study kiwi extract and ozone gas will be used individually and combined to evaluate the resultant effects on bleaching, enamel microhardness and micromorphology.


Eligibility criteria:
inclusion criteria: * a total of the 40 participants aged between (18-35 years) with no gender prediction. * the participation will be entirely voluntary, and a signed statement of informed consent will be obtained prior to the start of the study. * systemically healthy subject based on medical and drug histories, a subject requiring scaling and polishing with moderate calculus with at least two non-adjacent hypersensitive teeth with schiff scale scores \&gt;1 with air blast stimulus. * access to sound maxillary anterior teeth. * vitapan classical shades should be a3 or darker and lighter shades are not included. exclusion criteria: * participants with poor oral hygiene. * participants with missing anterior teeth. * participants with unrealistic expectations. * participants with dental caries, those undergoing orthodontic treatment. * participants with a history of periodontal treatment, pregnant or lactating women and individuals with a history of asthma. * those who are allergic to kiwi or ozone skin therapy were excluded from the study. * smokers are excluded from the present study.
evaluation of cham jam increasing physical activity levels in students

Conditions: Physical Activity; Obesity

Summary: the purpose of this study is to determine if the "moving smart" program, a daily 10-minute classroom-based exercise program, increases physical activity levels during the school day in bronx elementary school students.

background: medical and national public health authorities recommend daily school physical education for all ages due to well-known health benefits of physical activity. nevertheless, daily physical education among elementary and secondary school students is not common in united states' (us) schools. moreover, some of the schools in many us cities, such as the bronx, do not even have gymnasiums or physical education teachers. objective: we propose to implement and test the effectiveness and feasibility of the "moving smart" (ms) program, a daily, 10-minute classroom-based physical activity program led by teachers that integrate academic objectives with physical activity, on increasing physical activity (pa) levels during the school day in bronx elementary school students. design/ methods: a cluster-randomized, wait-listed control trial of four bronx elementary schools with one-year follow-up longitudinal study. students in two intervention schools will receive the ms 3-times daily, for 10-minutes each time, in addition to regular physical education classes. two wait-listed control schools will receive their regular physical education classes only. subjects in the wait-listed control group will be offered the ms after the program is withdrawn from the intervention group at the end of the first year of study. a pedometer, an objective measure of pa in children, will be used to determine mean number of steps each student takes during school hours for 5 consecutive days at baseline, and every 3-months during the 2-year study period. for longitudinal follow-up, we will collect data from intervention group students and teachers on pa levels every 3-months for one-year after the intervention cessation. we will also collect yearly bmis as a measure of overweight status. descriptive statistics will be used to portray baseline characteristics of each group based on school, district, region, and nyc-wide data. the impact of the intervention on pa will be measured by comparing intervention and control schools using pedometer measurements as the primary dependent variable and students as the unit of analysis. we will collect fidelity measures by randomly selecting classes from the intervention schools and directly observing the level of pa present. we will determine the extent to which the ms becomes a part of the routine school policy by following the students and teachers from the intervention schools for 1-year after the intervention cessation.

Eligibility criteria:
inclusion criteria: * elementary school students in k-3 grade in the bronx, new york exclusion criteria: * inability to participate in basic exercise program * students whose parents signed the opt-out letter

Keywords: physical activity obesity