Kornimate/medical-research-clean huggingface dataset:
breastfeeding education and support trial for obese women (bestow)

Conditions: Exclusive Breastfeeding; Breastfeeding Initiation

Summary: the primary objective of this study is to evaluate the efficacy of a specialized exclusive breastfeeding education and support program targeting obese, pregnant, low-income women in hartford, ct. specifically, the investigators will evaluate the impact of the intervention on exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. secondary aims of this study are: a) to characterize postpartum weight loss patterns and blood pressure values of obese women, by study group; and b) to evaluate potential differences in infant morbidity (diarrhea, otitis media and rehospitalization), by study group.


Eligibility criteria:
inclusion criteria: * obese (prepregnant bmi 27.0 or greater) * pregnant women delivering at hartford hospital * no more than 34 weeks gestation * considering breastfeeding this child * low income (\<185% federal poverty level) * planning to remain in the greater hartford area for 6 months postpartum * must have access to a telephone for follow-up interviews * delivery of a healthy, term, singleton exclusion criteria: * hiv positive or having other conditions which interfere with exclusive breastfeeding * infant admitted to the neonatal intensive care unit
high frequency intraoral ultrasound probe for early diagnosis of periodontal diseases

Conditions: Periodontal Diseases

Summary: the goal of this clinical investigation is evaluation the agreement between the periodontal pocket depth measurement obtained by periodontal probing (gold standard) and the measurement obtained by the ultrasound device

this is a single-center prospective clinical investigation in two steps: step 1 preliminary phase : collection and assessment of ultrasonic images to visualize dental and periodontal tissues and structures in order to manually perform periodontal measurements and generate data required for the artificial intelligence module training step 2 : performance evaluation : assessment of the ultrasonic probe performance for faster, automatic, accurate and repeatable periodontal measurements in more comfortable conditions for both operator and patient

Eligibility criteria:
patient inclusion criteria : age ≥ 18 years affiliated to a social security scheme free, informed and signed consent ability for participant to comply with the requirements of the study exclusion criteria (patient): surgical procedure performed in the area to be scanned osteosynthesis material under legal protection pregnant women, breastfeeding teeth inclusion criteria minimum of 10 teeth one tooth from each sextant presence of at least 1/3 of pathological sites (\>4mm and/or deep sites \>6mm)
autologous mesenchymal stem cells in spinal cord injury (sci) patients

Conditions: Spinal Cord Injury

Summary: the aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells intralesional transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.


Eligibility criteria:
inclusion criteria: * american spinal injury association impairment (asia) scale a, b and c * cervical (under c4), thoracic o lumbar spine lesion * complete or incomplete sci * platelet count over 100.000/ul exclusion criteria: * acute sci (less than 3 months) * active infectious diseases * pregnancy * neurodegenerative diseases * primary hematologic diseases * coagulopathies * hepatic dysfunction * pregnancy

Keywords: mesenchymal stem cell spinal cord injury
a study to evaluate safety and tolerability of qls-101 in ntg

Conditions: Normal Tension Glaucoma (NTG)

Summary: a randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of qls-101 versus timolol maleate preservative free (pf) 0.5% ophthalmic solution in subjects with normal tension glaucoma


Eligibility criteria:
inclusion criteria: 1. visual acuity +1.0 logmar or better 2. willing to give informed consent 3. ability to washout from current intraocular pressure lowering medications - exclusion criteria: 1. all secondary glaucomas 2. previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from screening) 3. refractive surgery 4. ocular infection or inflammation

Keywords: low tension glaucoma (ltg) glaucoma
coronary microvascular dysfunction in chronic kidney disease

Conditions: Kidney Disease, Chronic; Myocardial Dysfunction

Summary: this is an observational study assessing coronary microvascular function in healthy controls with normal kidney function, living kidney donors, pre-dialysis patients with chronic kidney disease stage 5 and patients on peritoneal dialysis.

the clinical syndrome of uraemic cardiomyopathy is prevalent in end stage renal disease and is associated with pathological cardiovascular changes including left ventricular hypertrophy, diastolic dysfunction and diffuse interstitial fibrosis. these combine to confer an elevated cardiovascular risk, including an increased risk of sudden cardiac death. the cause of this increased cardiovascular risk is not clear but it is thought that coronary microvascular dysfunction may play a role. coronary microvascular dysfunction is prevalent in many myocardial disease states, such as hypertrophic cardiomyopathy and heart failure with preserved ejection fraction, that share pathological similarities with uraemic cardiomyopathy. coronary flow reserve, a marker of coronary microvascular function, can be assessed non-invasively using echocardiography techniques. previous studies have shown a reduction in coronary flow reserve in patients with chronic kidney disease. however, it is not clear if kidney donors - individuals who have a reduced kidney function but do not have progressive kidney disease - also demonstrate microvascular dysfunction. similarly, although there is some evidence that patients on dialysis have improved coronary flow reserve compared to patients with pre-dialysis chronic kidney disease stage 5, there has been limited investigation into the role of peritoneal dialysis on coronary flow reserve.

Eligibility criteria:
inclusion criteria: * healthy control with normal renal function * living kidney donor who has donated \>12 months prior to enrolment in study * chronic kidney disease stage 5 who are pre-dialysis or on peritoneal dialysis * able to provide written informed consent exclusion criteria: * pregnancy * known ischaemic heart disease * diabetes mellitus * uncontrolled hypertension * evidence of 2nd or 3rd degree av block or sick sinus syndrome in absence of a pacemaker * history of allergic/adverse reaction to adenosine or sonovue * history of long qt syndrome * severe hypotension * significant valvular heart disease * significant chronic obstructive pulmonary disease or asthma with bronchospasm * unstable angina not controlled with medication * concurrent use of dipyridamole * decompensated heart failure * poor echo acoustic windows * chronic kidney disease stage 5 on haemodialysis

Keywords: coronary flow reserve living kidney donation peritoneal dialysis
multicenter follow up study of subjects who participated in an original protocol of exemestane vs. megestrol acetate in postmenopausal women with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs megestrol : study 971-onc-0028-080.


Eligibility criteria:
inclusion criteria: * previous participation in study 971-onc-0028-080. exclusion criteria: * subjects who had not previously participated in study 971-onc-0028-080.

Keywords: metastatic breast cancer advanced postmenopausal exemestane vs megestrol
modafinil augmentation in chronic schizophrenia and schizoaffective disorder

Conditions: Schizophrenia

Summary: this is an open label 8-week trial of modafinil up to 400 mg daily added to a stable antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in patients with chronic schizophrenia. we hypothesize that modafinil, a wake-promoting agent, will lead to improved cognition, increased wakefulness, and decreased weight in patients with schizophrenia who are on stable antipsychotic regimens

this study was withdrawn due to no source of funding to implement the study. no participants were enrolled for this study.

Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual-iv diagnosis of schizophrenia (all subtypes), illness duration greater than three years * auditory and visual acuity adequate to complete cognitive tests * stable dose of antipsychotics for at least 2 weeks prior to entry * good physical health determined by complete physical examination, laboratory tests, and ekg * capacity and willingness to give written informed consent. exclusion criteria: * inability to read or speak english * documented disease of the central nervous system * history of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation) * clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions; * hiv positive * patients on antidepressants, including monoamine oxidase inhibitors * uncontrolled hypertension * pregnancy * patients with a current diagnosis of substance dependence * significant history of violence * history of an eating disorder * ready for discharge within the following 8 weeks.

Keywords: schizophrenia cognition obesity sedation
clinical performance of posterior composite tooth fillings in adults

Conditions: Dental Caries; Dental Restoration Failure

Summary: the purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.

in this post-market prospective randomized controlled clinical trial, posterior class ii restorations will be evaluated for their clinical performance. the study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. the bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.

Eligibility criteria:
inclusion criteria: * be older than 18 years of age * have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings * both study teeth must be vital (tested with cold) * both study fillings must be visible on the cheek-side of the tooth. exclusion criteria: * do not meet all inclusion criteria * are under active orthodontic treatment * have severe medical complications * have dry mouth * have chronic gum disease or poor oral hygiene * are unavailable for long term recall (minimum of 2 years required) * cannot tolerate the rubber dam * have an unstable tooth contacts * have severe bruxing or clenching, or are in need of jaw joint therapy * are pregnant or breastfeeding.

Keywords: dental caries proximal surfaces posterior teeth carious lesions tooth diseases dental restorations composite resin
tavilermide ophthalmic solution for the treatment of dry eye

Conditions: Keratoconjunctivitis Sicca; Dry Eye

Summary: the purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.


Eligibility criteria:
inclusion criteria: * subject-reported history of dry eye disease in both eyes for at least 6 months; * history of use of artificial tear eye drops for dry eye symptoms; * total score of ≥40 on sande; * tfbut; * corneal fluorescein staining; * lissamine green conjunctival staining; * schirmer's test score. exclusion criteria: * have participated in a previous tavilermide (mim-d3) study; * have clinically significant slit lamp findings at visit 1; * have a history of lacrimal duct obstruction within 12 months of visit 1; * have an uncontrolled systemic disease; * be a woman who is pregnant, nursing or planning a pregnancy; * be a woman of childbearing potential who is not using an acceptable means of birth control; * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days prior to visit 1.
a phase 2a study of the safety and efficacy of od-07656 and of subsequent vedolizumab therapy in moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis (UC); UC - Ulcerative Colitis

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of od-07656 in participants with moderately to severely active ulcerative colitis (uc). in addition, the study will evaluate the potential of od-07656 to enhance the therapeutic benefit of vedolizumab when given after od-07656.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * has a confirmed diagnosis of ulcerative colitis (uc) * has moderate to severely active uc as defined by the 3-component modified mayo clinic score * has an inadequate response, loss of response, or intolerance/medical contraindication to at least one of the following therapies: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12/23 biologic, janus kinase inhibitors, or sphingosine-1-phosphate (s1p) modulators exclusion criteria: the main exclusion criteria include but are not limited to the following: * has diagnosis of crohn's disease or indeterminate colitis * has had extensive colonic resection * has colostomy or ileostomy * has uncontrolled primary sclerosing cholangitis

Keywords: ulcertative colitis inflammatory bowel diseases
s8809-s9800-s9911-s9704-a study of blood and tissue samples from patients with follicular lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone

Conditions: Lymphoma

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is looking at blood and tissue samples from patients with follicular lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone.

objectives: * to test for association of polymorphisms in fc-gamma (fcγ) receptors iia (h/r131) and iiia (v/f158) with progression-free survival and clinical response in patients with follicular non-hodgkin lymphoma treated with rituximab and chop chemotherapy comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone. * to assess novel polymorphisms in fcγ receptors for predictive and prognostic significance in patients treated with this regimen. outline: genomic dna extracted from paired samples of serum and formalin-fixed paraffin-embedded tissue is analyzed for r131h polymorphism in fcγ receptor iia and v158f polymorphism in fcγ receptor iiia by taqman-based assay. the dna is also analyzed for genotypes corresponding with several other polymorphisms in fcγ receptors, as determined by the hapmap project. the resulting fcγ receptor genotypes are then compared with clinical data from the southwest oncology group database to identify associations between particular genotypes and progression-free survival, overall response, and complete response. a multivariate analysis incorporating clinical prognostic variables (e.g., age, stage, serum ldh level, extranodal disease, and performance status) is also performed to determine whether fcγ receptor polymorphisms are independent predictive or prognostic markers for clinical outcome.

Eligibility criteria:
disease characteristics: * diagnosis of follicular lymphoma * meets either of the following criteria: * previously enrolled on clinical trial sw0g-8809 and treated with chemotherapy alone * excess tissue sections available * previously enrolled on clinical trial swog-9800 or swog-9911 and treated with a combination of chemotherapy and monoclonal antibody therapy * matched serum and tissue samples available from the swog lymphoma bank patient characteristics: * see disease characteristics prior concurrent therapy: * see disease characteristics

Keywords: contiguous stage ii grade 1 follicular lymphoma contiguous stage ii grade 2 follicular lymphoma contiguous stage ii grade 3 follicular lymphoma noncontiguous stage ii grade 1 follicular lymphoma noncontiguous stage ii grade 2 follicular lymphoma noncontiguous stage ii grade 3 follicular lymphoma stage iii grade 1 follicular lymphoma stage iii grade 2 follicular lymphoma stage iii grade 3 follicular lymphoma stage iv grade 1 follicular lymphoma stage iv grade 2 follicular lymphoma stage iv grade 3 follicular lymphoma
a study evaluating the efficacy and safety of aprepitant in autologous hematopoietic stem cell transplantation

Conditions: Vomiting

Summary: the purpose of this study is to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in autologous hematopoietic stem cell transplantation.

chemotherapy-induced nausea and vomiting (cinv) is a serious complication of treatments of hematological malignancies. although aprepitant has been shown to control cinv in highly emetogenic therapies for solid tumors, the antiemetic effect of aprepitant in hematological chemotherapies is still not clear. in this multi-central perspective randomized controlled study, the investigators are trying to evaluate the efficacy and safety of additional aprepitant to standard antiemetic regimen in autologous hematopoietic stem cell transplantation.

Eligibility criteria:
inclusion criteria: * men and women \>/= 18 years, \<65 years * patients with lymphoma receiving autologous hematopoietic stem cell transplantation for the first time * ecog 0-2 * tbil,ast and alt \< 2.5-fold upper normal range * female and male subjects of childbearing potential must agree to use a medically accepted method of adequate contraception. * signed informed consent exclusion criteria: * prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma * women who are pregnant or breast feeding. * serious or uncontroled infection * serious complications * severe renal or hepatic disease * severe mental or nervous system diseases

Keywords: lymphoma aprepitant chemotherapy-induced nausea and vomiting (cinv) autologous hematopoietic stem cell transplantation hematological malignancies
use of insorb absorbable vicryl staples in skin closure for cesarean section

Conditions: Wound Infection

Summary: the purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis.

procedures: a list will be compiled of patients who underwent cesarean section at memorial hermann hospital in the texas medical center from january 1st 2010 through january 1st 2011. only ut patients who had their skin closed with insorb or metal staples will be included in this list. patients' clinical charts will be reviewed for post-operative follow-up, and notes will be made of the wound assessment. any complications such as infection, seroma, hematoma, and wound separation or delayed healing will be recorded. additional notes will be made of any co-morbid conditions, including, but not limited to, \>30 bmi, chronic hypertension, diabetes mellitus, hiv, history of tobacco use. once the data is gathered, it will be compared with published national averages to determine if there is an increased risk of wound separation or wound infection at our institution. in addition, rated of infection and wound breakdown following closure with either absorbable or metal staples will be compared by fisher's exact test, to determine statistical significance. course of study: data will be obtained from ut patients who underwent cesarean section from january 1st, 2010 through january 1st, 2011. only patients who had skin closure with insorb or metal staples will be included in analysis.

Eligibility criteria:
inclusion criteria: * cesarean sections * ut patients exclusion criteria: * patients who have skin closed with suture, per attending choice.

Keywords: absorbable vicryl subcuticular staples metal staples wound healing cesarean section
phase 1 study of pemigatinib in patients with advanced malignancies with fgf/fgfr alterations

Conditions: Solid Tumor

Summary: this is a phase 1 study to investigate the characteristics of pk, pd and safety in subjects with advanced malignancies with fgf/fgfr alterations.


Eligibility criteria:
inclusion criteria: 1. men and women, aged 18 or older. 2. histologically or cytologically confirmed malignancy which was considered to be surgically unresectable advanced, relapse or metastatic . 3. radiographically measurable disease per recist v 1.1 4. documentation of fgf/fgfr alteration.. 5. documented disease progression after standard therapy ,or no standard therapy available. 6. ecog performance status of 0\~1. 7. life expectancy ≥12 weeks exclusion criteria: 1. prior receipt of a selective fgfr inhibitor. 2. history of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance). 3. currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination. 4. use of any potent cyp3a4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. topical ketoconazole will be allowed