Kornimate/medical-research-clean huggingface dataset:
endometrial cancer biomarker changes following exposure to metformin

Conditions: Endometrial Cancer

Summary: the investigators will explore the chemopreventive role of metformin. the purpose of this study is to determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue. this is a phase iia study of metformin to be used to the pre-operative period of women diagnosed with endometrial cancer by comparing their endometrial biopsy specimens taken at their initial visit and after 4-6 weeks of treatment of metformin on the day of their surgical staging.

aim 1 to determine whether, among patients with endometrial cancer, treatment with the currently approved insulin sensitizing drug metformin increases or decreases pathway activation distal to the insulin receptor in endometrial cancer tissue. aim ii to compare specified biomarkers in each endometrial cancer patient before and after receiving metformin. our goal is to compare the following biomarkers in each patient before and after metformin administration: ki-67, tunel assay for apoptosis level, phosphor-ampk, phosphor-igf-1r, phosphor-irs1, phospho-akt, phospho-s6, phosphor-mtor, pacc. all patients diagnosed with endometrial cancer presenting to the jewish general hospital for surgical treatment will be invited to participate.

Eligibility criteria:
inclusion criteria: * have a confirmed diagnosis of endometrial cancer based on an endometrial sampling though biopsy or dilatation and curettage * must be able to undergo appropriate surgical staging for endometrial cancer * must consent to be in the study and must have signed and dated an irb-approved consent form conforming to government and institutional guidelines exclusion criteria: * patients with a contraindication to receiving metformin treatment * patients with cognitive impairment * renal or hepatic functioning \> 125% upper limit of normal * currently on medications for metabolic diseases, such as diabetes mellitus * history of lactic acidosis * treatment with medications that may increase metformin levels: cationic drugs, e.g., digoxin, amiloride, procainamide, trimethoprim, vancomycin, triamterene, and morphine * history of chronic alcohol abuse
variability in adrenergic response

Conditions: Vascular Reaction to Medications

Summary: the goal of this project is to determine the genetic factors contributing to interindividual differences in response to physiological and pharmacological vasoconstrictors and vasodilators.

the dorsal hand vein model is a relatively non-invasive and robust experimental model to examine the local in vivo effect of vasoactive drugs without elucidating systemic counterregulatory reflexes. infusion of incremental low doses of phenylephrine into a dorsal hand vein results in increasing local venoconstriction, without systemic effects. similarly, infusion of incremental low doses of nitroglycerin into a preconstricted dorsal hand vein results in increasing local venodilation, without systemic effects. systemic vascular responses can be measured by the cold pressor test (cpt),that leads to increase in blood pressure and heart rate , or mental stress that is also known to stimulate cardiovascular responses. individuals vary in their local and systemic vascular responses but the genetic determinants of these are not clear.

Eligibility criteria:
inclusion criteria: * age between 18 and 40 years, inclusive. * subject must be willing to give written informed consent and be able to adhere to diet and study schedules. * subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations. * subjects must have a normal or clinically acceptable physical examination and ecg. * clinical laboratory tests (cbc, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator. exclusion criteria: * any subject who has taken any prescription or over-the-counter drugs, other than oral contraception if female, within two weeks prior to study drug administration. * subjects who are presently, or were formerly, narcotic addicts or alcoholics. * subjects who have a clinically significant allergy/intolerance to phenylephrine. * females with a positive serum/urine pregnancy test at screening. * females who are nursing. * subject using sildenafil or other phosphodiesterase inhibitors.

Keywords: hand vein sensitivity phenylephrine nitroglycerin
comparison between ultra-narrow diameter implants (2,75 mm) without bone regeneration versus standard diameter implants (4,3 mm) in combination with bone regeneration

Conditions: Dental Implant; Narrow Implant; Implant Fracture; Guided Bone Regeneration

Summary: the main target of the study is to compare ultra-narrow diameter implants (2.75 mm) without bone regeneration versus standard diameter implants (4.3 mm) in combination with bone regeneration. to do so, patients with missing upper central incisors, canines, first or second premolars with alveolar ridges of 6 - 8 mm of thickness will be restored with dental implants. cone beam computed tomographic examination and clinical values will be registered before and after the surgical procedure at 6 and 12 months.


Eligibility criteria:
inclusion criteria: * one missing teeth in position: upper central incisor, canine or premolar * alveolar ridge thickness of 6 - 8 mm * alveolar ridge height of ≥ 10 mm exclusion criteria: * missing data * asa ≥ iii
prevalence of hypomineralized second primary molars and their association with dental hypersensitivity in egyptian children

Conditions: Hypomineralized Second Primary Molars; Dental Hypersensitivity

Summary: hypomineralized second primary molars and dental hypersensitivity in a group of egyptian children

the prevalence of the condition of hypomineralized second primary molars in a group of egyptian children and the association of this condition to dental hypersensitivity.

Eligibility criteria:
inclusion criteria: * egyptian children * cooperative patients both genders and included 4-9 years old children at least one hspm affected molar and one non affected molar absence of syndromes or craniofacial anomalies exclusion criteria: * other developmental defects(amelogensis imperfecta ...) children ongoing anti-inflammatory drugs children who caregiver will not sign the informed consent

Keywords: hspm dh hypo-mineralized second primary molars hypomineralized e
the relationship between nocturnal enuresis and spina bifida occulta

Conditions: Enuresis, Nocturnal; Spina Bifida

Summary: it is claimed that sbo may be responsible for bladder dysfunction in patients without known neurological disease. subsequently, it was reported that the frequency of sbo in ne cases was higher than normal children. however, in controlled trials, sbo frequency was not different in ne patients compared to the normal population. conversely, the incidence of dysfunctional bladder in the presence of sbo in ne patients was found to be higher and the response to treatment was worse than in non-sbo patients. the present study aimed to determine whether the frequency of sbo in patients with ne was higher than in healthy subjects, the effect of sbo on the severity of luts and whether treatment response of primary ne patients changed in the presence of sbo.


Eligibility criteria:
inclusion criteria: * patients aged 6 to 15 years * at least one night-time wetting weekly exclusion criteria: * neurological disease, * diabetes mellitus or insipidus, * spinal surgery history, spina bifida skin findings, * chronic renal insufficiency * and secondary enuresis

Keywords: lower urinary tract symptoms nocturnal enuresis spina bifida occulta treatment response
genetic factors and cp pregnancy outcomes

Conditions: Chronic Pancreatitis; Genetic Mutation; Pregnancy Related

Summary: to explore the impact of chronic pancreatitis (cp) susceptibility genes on pregnancy outcomes.

the goal of this observational study is to explore the impact of cp susceptibility genes (spink1, prss1, ctrc, cftr) on pregnancy outcomes (including both maternal and fetal outcomes) in a large chinese cohort. participants will be asked to provide their pregnancy-related data.

Eligibility criteria:
inclusion criteria: * female patients with a diagnosis of chronic pancreatitis * have known genetic backgrounds and pregnancy history * agree to join the study and provide informed consent exclusion criteria: * patients without documented pregnancy * patients who denied to provide pregnancy-related information, or with incomplete pregnancy characteristics and/or outcomes * patients with other autoimmune comorbidities that might influence pregnancy outcomes, such as systemic lupus erythematosus, autoimmune thyroid diseases, etc
study on early stage bulky cervical cancers

Conditions: Carcinoma Cervix

Summary: the aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.

early stage bulky cancers of the cervix, (defined as figo stages ib2, iia2 and iib) form a distinctive subset of "curable" cervical cancers with good 5 year survival rates with adequate treatment. concurrent chemo radiation with or without salvage surgery is at present the standard of care for this group of cervical cancers. however, when pelvic recurrences occur, the morbidity of salvage surgery after radiotherapy, especially brachytherapy is often higher than the morbidity of salvage radiotherapy following radical surgery. the advantages of downsizing the disease without the use of brachytherapy are tempting and open a completely new philosophy in radical treatment for "curable" early stage bulky cancers of the cervix. this approach is appealing especially in developing countries where the load of cervical cancers is high and radiotherapy (brachytherapy) resources are scarce. the results of two phase ii trials conducted at govt. royapettah hospital, chennai (neoadjuvant chemotherapy followed by radical hysterectomy: cisplatin + 5fu vs. cisplatin +paclitaxel) and at govt. general hospital,chennai (neoadjuvant chemoradiation with weekly cisplatin and 50 ebrt followed by radical hysterectomy) and one retrospective study ( preoperative 50 gy ebrt followed by radical hysterectomy) have shown similar response rates and acceptable toxicity profiles when compared to concurrent chemoradiation (ebrt + brachytherapy+ chemotherapy). similar studies have been published elsewhere with similar results. with this in mind we are planning to conduct a phase iii randomised control trial comparing neoadjuvant chemotherapy + radical hysterectomy and neoadjuvant chemoradiation + radical hysterectomy with concurrent chemoradiation in this subset of cervical cancers

Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed bulky cervical squamous cell carcinoma (figo stage ib2, ii a2, iib). 2. age 18-60 years 3. karnofsky performance status of ≥70%; ecog ps ≤ 2 exclusion criteria: 1. nonsquamous histologies 2. other systemic diseases, comorbidities precluding full participation in the study 3. concomitant treatment with any experimental drug 4. pregnant or nursing women 5. previous or concomitant malignant diseases other than non-melanoma skin cancer 6. previous radiation to the pelvis

Keywords: bulky cervical cancers neoadjuvant chemotherapy neoadjuvant chemoradiotherapy
establish quantitative pcr to measure bacteria load of the vre bacteremia

Conditions: Bacteremia

Summary: the investigators hypothesized that quantitative pcr can be used in vre bacteremia outcome monitoring. vancomycin-resistant enterococci (vre) was first found in 1988 and has become an important healthcare-associated pathogen due to rapid spread, limited options for therapy and the possibility of transferring vancomycin resistance to more virulent pathogens. vre infections not only contribute to more hospital cost and longer length of hospital stay, but also higher attributable mortality compared to those caused by vancomycin susceptible enterococci. two different meta-analyses have shown that vancomycin resistance is an independent predictor of death among patients with enterococcal bloodstrem infections (bsis). despite this, few effective antibiotics are approved by the us food and drug administration for the treatment of serious vre infections. though several studies have conducted to find the possible mortality predictors, but none has used bacterial load as a marker. schonheyder et al. have used semiquantitative culture, and demonstrate the relationship between high bacterial load and mortality. however, it may take more than two days before culture result available, and the sensitivity of culture is greatly affected by antimicrobial treatment. real-time pcr has been demonstrate good performance in early detection of bacteremia, and theoretically is less affected by antimicrobial usage. however, using quantitative real-time pcr to quantify vre in blood has not been explored, yet. the objective of this study is to establish a quantitative method to measure the amounts of vre in blood using the vre specific van gene. and test the hypothesis that higher vre load in blood results in higher mortality among patients with vre bsis. primers and probe of vre real-time pcr will be constructed first. the investigators will prospective enroll patient with vre bacteremia. clinical data and outcome will be monitored. bacteria load of vre bacteremia will be measured via established real-time pcr. the outcome and the association of bacteria load of vre bacteremia will be analyzed.


Eligibility criteria:
inclusion criteria: * \>18 y/o * vre bacteremia

Keywords: vre
clinic to community connections - broader distribution

Conditions: Gestational Diabetes; Gestational Diabetes Mellitus in Pregnancy

Summary: this study addresses education needs in gestational diabetes care and followup at the staff and patient levels. in the initial phase, nurses and community health workers will complete specific training modules on gestational diabetes developed for this study. the effectiveness of the education modules will be evaluated through pre/post surveys of participants assessing diabetes knowledge, attitudes, and self-efficacy.


Eligibility criteria:
inclusion criteria: clinic staff: nurses (rn, lpn, bsn), community health workers, and others involved in maternal child health care exclusion criteria: clinic staff: individuals not involved in maternal child health care or who do not consent to participate in study

Keywords: diabetes in pregnancy type 2 diabetes prevention diabetes care coordination care delivery care fragmentation community health worker community partnership community health aides federally qualified health center underserved population patient education
social interactions: ocular explorations and pupillometry in autism

Conditions: Autism Spectrum Disorders

Summary: the primary objective of this work will first to characterize in typical childhood, visual exploratory behavior and pupillary response associated with salience of human social stimuli (faces and body movements), and then to evaluate these markers in children with autism. the second objective of this work will be to achieve in a population of children with autism a longitudinal evaluation of these markers during development and therapeutics.

patients with autism have significant social difficulties and communication alterations. it has been shown in these patients difficulties to understand some clues indispensable to social relations, for example, faces and their emotions and motion of human bodies. the faces and human movements are an important source of information helping to interact with others. understanding the intentions of the others through facial expressions and gestures can help them to adapt their behavior and their interactions. while in healthy subjects, faces and human movements receive special attention, autistic patients seem to pay less attention to this kind of social stimuli. it has already been shown that children and healthy adults spend more time looking at faces and human movements (relative to objects), whereas the opposite behavior is observed in patients with autism. studying gaze behavior seems to be essential for progress in the understanding of autism pathology. eye-tracking systems allow to measure precisely what a subject looks on a picture. moreover, eye-tracking systems permit the measurement of the pupil size which variations are correlated with cognitive processes. the objective of this study is to analyze the ocular behavior (ocular scan path and pupil diameter) of young patients with autism when viewing faces and human movements and to compare these measurements with those of chronologically age-matched healthy children. this work will identify attentional problems concerning exploration of human faces and movements that can be related to their social difficulties. these disorders should be manifested by an atypical ocular scan path and by changes in pupil variation in response to face and human motion. then to follow the evolution of these indices will allow to evaluate the effect of therapies. these results will highlight new data essential to understanding disorders of social relations and to better adapt rehabilitative strategies.

Eligibility criteria:
inclusion criteria: * for autistic children, diagnosis of autism spectrum disorders according to dsm iv-tr and adi / ados criteria ; normal or corrected vision; no nervous system disease * for healthy children, normal schooling and normal or corrected vision * for all, parental consents exclusion criteria: * psychotropic treatment

Keywords: visual exploration pupil size social interactions faces human motion
an open label slv308 safety extension to study s308.3.002 in patients with parkinson's disease experiencing motor fluctuations.

Conditions: Advanced Stage Parkinson's Disease

Summary: this study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind s308.3.002 study.


Eligibility criteria:
inclusion criteria patients who have completed s308.3.002 trial exclusion criteria patients with medically relevant abnormal findings (ecg, physical examination, aes) at end of the maintenance phase (visit m6, week 24) of study s308.3.002

Keywords: parkinson disease
establish the pk of belinostat in patients with wild-type, heterozygous, and homozygous ugt1a1*28 genotypes

Conditions: Solid Tumors; Hematological Malignancies

Summary: this is a phase 1, open-label, nonrandomized study to determine the pk profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous ugt1a1\*28 genotypes and wild-type ugt1a1 gene. enrolled patients will be assigned to 1 of 3 cohorts (a, b, or c) based on their ugt1a1 genotype

this is a phase 1, open-label, nonrandomized study to determine the pk profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous ugt1a1\*28 genotypes and wild-type ugt1a1 gene. enrolled patients will be assigned to 1 of 3 cohorts (a, b, or c) based on their ugt1a1 genotype enrollment into all cohorts will occur simultaneously rather than sequentially. belinostat will be administered via a 30-minute infusion once daily from day 1 to day 5 of one 21-day cycle. clinical safety will be monitored in each patient. blood samples for pk analysis will be collected from day 1 to day 3, and urine samples for pk analysis will be collected from day 1 to day 4.

Eligibility criteria:
inclusion criteria: 1. patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists. 2. patient must have received at least 1 prior systemic therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening. 3. patient has adequate hematological and hepatic functions. exclusion criteria: 1. patient is taking ugt1a1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) at screening. 2. patient has hbv or hcv 3. patient has a known hiv positive diagnosis. 4. patient has congestive heart failure class iii/iv 5. patient has had previous exposure to belinostat.

Keywords: ugt1a1*28 belinostat beleodaq wild type genotypes heterozygous genotypes homozygous genotypes
diabetic retina exam rate does not increase with phone reminders in non-hmo population

Conditions: Diabetic Retinopathy

Summary: diabetic retinopathy is the major cause of blindness in working age americans, and screening for it is cost-effective. there are a quarter of a million people in southeast michigan with diabetes and pre-diabetes. only half of patients with diabetes are screened regularly for diabetic retinopathy, and this proportion has been difficult to increase despite various interventions. previous research focused on hmo patient groups because preventative care was thought to decrease plan costs. in addition, it was administratively feasible to track patient-doctor interactions. this project builds on published research and institutional experience to determine an effective method for increasing the screening rate, in a mobile, non-hmo population. it uses administrative methods and information technology infrastructures, such as large scale electronic medical records and patient demographic databases, to identify existing patients requiring examinations. patients were telephoned by a trained service representative who offered and scheduled firm examination appointment times. hypothesis: annual screening rates for diabetic retinopathy can be substantially improved in non-hmo patient groups by directly contacting patients and scheduling firm appointment times.


Eligibility criteria:
inclusion criteria: * were henry ford health system patients, * diabetic * using the bcbsm payer plan exclusion criteria: * retina examination in prior year

Keywords: diabetic retinopathy screening annual
long-term treatment effect with tildrakizumab in participants with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to evaluate the psoriasis disease control over time in participants who had received tildrakizumab for at least the last 5 years and have discontinued it and to describe blood and skin inflammatory biomarkers and its correlation disease relapse.


Eligibility criteria:
inclusion criteria: * participants provide signed written informed consent prior to perform any study-related activity * participants has completed the long-term extension of the resurface 2 study exclusion criteria: * participants unable to comply with the requirements of the study * participants who in the opinion of the investigator should not participate in the study

Keywords: human antibody interleukin (il) -23p19 tildrakizumab moderate-to-severe plaque psoriasis