Kornimate/medical-research-clean huggingface dataset:
peers excel trial to improve glycemic control

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to gather input about the value of adding a newly developed diabetes self-management program to an existing diabetes self-management program. participants will self-identify as african-american/black with type 2 diabetes, and prescribed a diabetes medication. participants can expect to be in the study for 6 months.

both programs utilized in this study focus on topics such as diet, exercise, and stress. both programs offer ideas to manage diabetes symptoms, discuss appropriate exercises, provide guidance on healthy eating, review the use of medicine, and offer tips on communicating with healthcare providers and voicing concerns to family members. the new program is culturally-tailored for african americans and focuses on helping patients take their medicines as prescribed. the purpose of this research study is to evaluate this newly developed combined diabetes self-management program.

Eligibility criteria:
inclusion criteria: * between 18-90 years old * self-identify as african-american * diagnosis of type 2 diabetes * able to speak/read english * self-report having a primary care provider who prescribes one diabetes medication * diagnosed with diabetes for ≥1 year at point of care * will reside in the geographical area throughout the study period * self-reported nonadherence on the dose-nonadherence survey * ≥7.5% a1c exclusion criteria: * self-reported bipolar or personality disorders, schizophrenia, alcohol and other drug abuse (aoda), dementia * older adults who have a history of severe hypoglycemia requiring medical assistance or glucagon administration * participating in another lifestyle or medication adherence program

Keywords: african-american medication adherence diabetes self-management
breast cup immobilization device ii (gcc 1047)

Conditions: Breast Cancer

Summary: the study is designed to assess the accuracy of patient breast reproducibly using the revised bcid. this study would provide data for target verification and quality assurance to eventually allow treatment of breast cancer patients for either a tbb or accelerated partial breast irradiation. the bcid is a low-risk device similar to immobilization devices used routinely in radiotherapy for other disease sites.

breast conserving therapy (bct) has become the standard of care for treating early-stage breast cancers based on six prospective randomized trials with 20 years of follow-up data (fisher). during lumpectomy, the surgeon removes the tumor and a surrounding rim of normal tissue (margin), leaving surgical clips to help designate the resection bed. radiation treatment is directed at the whole breast for 5 1/2 weeks and is generally followed by a 1-2 week boost directed at the lumpectomy site plus a margin of normal breast tissue. the benefit of adding the tumor bed boost, (tbb) has been shown in two studies to decrease local failures \[romestaig; bartelink\]. studies have evaluated the role of radiation following lumpectomy in very select groups which have not been able to define a group who do not benefit from the addition of radiotherapy. in the group of patients who received surgery alone, 85% of the breast recurrences occurred in the tumor bed. due to these two facts, radiotherapy directed only at the tumor bed has been evaluated. treating this smaller tumor volume has allowed higher doses of radiation to be delivered safely shortening the treatment course from 6-7 weeks to one week.

Eligibility criteria:
inclusion criteria: 1. the patient must consent to be in the study and have signed an irb-approved consent form. 2. the patient must have a diagnosis of invasive or non-invasive breast cancer. 3. the patient must be planned for or have already had breast conservation surgery (i.e. lumpectomy). 4 age \> 18. 5. there are at least two metal clips in the surgical cavity placed at the time of surgery for guiding the radiation oncologist in delineating the target of irradiation; or one radiographic clip placed at the time of stereotactic core needle biopsy with the intact tumor. 6. patients who have already been treated by radiation therapy and are being seen in follow-up can also participate exclusion criteria: 1. male gender 2. patients who cannot be set up comfortably in the prone position (e.g. physical disability) 3. tumor/lumpectomy site located in a portion of the breast that cannot be visualized easily on the ct scan (e.g. superior portion of the upper outer quadrant). 4. mastectomy was or is the recommended surgical approach.

Keywords: breast cancer lumpectomy breast irradiation
fit families program: fundamental motor skill intervention in children with autism spectrum disorders and their parents

Conditions: Autism Spectrum Disorder

Summary: the investigators aim to identify the effect of a 12-week fundamental motor skills (fms) (e.g., throwing, catching, running) intervention on the active participation in physical recreation activities and a variety of other factors (child behaviors, communication, and adaptive skills) and to identify patterns, benefits, constraints, and strategies to active participation in physical recreation activities among families of children with autism spectrum disorders (asd) (pre-post) through in-person or via phone interviews with parents and children with asd.

participants will be randomly assigned to one of three protocols: 1) workshop group, 2) home-based group, and 3) wait-listed home-based group. participants in all groups will receive an activity booklet and physical education-related activity items (e.g., ball, hoop). the hypothesis is that both the workshop and home-based groups will improve in all measures from pre to post compared to the wait-list control group. the investigators want to determine if the differences in the workshop and home-based groups differ significantly or are equitable in terms of gains in all areas. note: due to covid-19 for the post-test, instead of parents attending the uw-facilities, they will be asked to videotape themselves and their children while performing the test of gross motor development (tgmd) activities. for the follow-up test (fall 2020) we will expect to conduct these in person. however, if the situation due to covid-19 remains the same, the investigators will ask families to follow the same procedures (videotape themselves and their children).

Eligibility criteria:
parents (one per family) and children with asd ages 4 to 11 will be included (recruited as a dyad). inclusion criteria: * asd must be the primary disability of the child * children will be considered to have asd if they score above the clinical cutoff or 15 on both the lifetime and current versions of the scq. diagnostic severity of asd will not be a factor in recruitment. * children must be able to participate in the program activities. * children must be ambulatory and able to follow verbal or picture directions with support * children with significant communication needs will still be considered for the study * no age restriction for adults (parents of children with asd) * parents should be ambulatory and not have any restriction to do physical activity exclusion criteria: * parents of children with other primary disabilities, or parents who do not have children with asd will be excluded. * participants cannot exhibit aggressive behavior * children who are non-ambulatory, or participants (children) with significant behavioral or sensory impairments will also be excluded based on application information, including existing behavior intervention plans and existing school information
serum prostatic specific antigen changes after bipolar and monopolar turp

Conditions: PSA Changes After TURP

Summary: to use psa levels after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia as an indicator of the quality of resection .

psa is a protein produced from the prostate epithelium and secreted in semen in huge amounts , small amount find its way to the circulation ,its function is to allow mobility of the sperms by interacting with the semenogelin . clinical bph can be defined as prostate adenoma/adenomata, causing a varying degree of boo, which may eventually cause harm to the patients ,treatment of this condition varies from conservative, medical and surgical depending on factors related to the patient and the surgeon preference . the early reports of minimally invasive treatment of the prostate dated back to 1937, since then and remarkable development is noticed . turp is the golden treatment in the bph . studies compare between the methods according the blood transfusion , operation time retention after catheter removal , urethral complications , tur syndrome and hospital-stay which show that bipolar is better. to our knowledge after few studies compare between the techniques according psa also these studies show weakness in their statistically analysis with no difference between the methods .investigators aim is to study the effect of the operations on psa levels as an indicator of the quality of resection.

Eligibility criteria:
inclusion criteria: * patients agreeing to participate, clinically fit, age from 50 to 80 years with luts related to benign prostate enlargement with no neurological disorder exclusion criteria: * prostate cancer * previous urethral or prostate surgery * neurogenic bladder * urethral stricture * patient unfit for surgery
a pilot study - comparison of two hologic 3d mammography systems

Conditions: Breast Cancer

Summary: study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.

a perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. the purpose of the pilot study is to compare the images acquired from two hologic tomosynthesis systems. information obtained from the study will be used to determine endpoints for a future larger study. study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.

Eligibility criteria:
inclusion criteria: * female, any ethnic origin * no contraindication for diagnostic mammography exclusion criteria: * any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants. * under 30 years of age at the time of consent * unable to understand and execute written informed consent

Keywords: breast cancer tomosynthesis
studies on the pathogen, vector control and clinical treatment of dengue fever in guangzhou

Conditions: Dengue Fever

Summary: the purpose of this study is to elucidate the local epidemic problem and epidemiological characters of dengue fever in guangzhou, to establish diagnostic and treatment standard and clinical treatment system of severe cases to reduce the morbidity and mortality of dengue fever.

to study the epidemiological and pathogenic of dengue virus in guangzhou, which help to reveal the regular prevalent pattern and the natural epidemic focus of dengue fever. to establish dengue virus sequence database of guangzhou region, research the biological characteristics and molecular characteristics of dengue fever epidemic strains especially in 2014 in guangzhou region, to determine the source and variation of this epidemic strains , which finally help to reveal the cause of the pandemic. to investigate the serum epidemiology of 7800 large groups of people in 12 county-level cities in guangzhou by stratified random sampling method. it will enrich the research database of the dengue fever serological antibody level survey of people in guangzhou. after that the investigators could provide a scientific reference for setting up a risk evaluation and implementation of targeted control measures, and also provide reference for analysis of the epidemic situation in other areas. to study on molecular markers predictive of severe dengue fever and protective immunity after dengue virus infection. the investigators will obtain both serotype-specific and cross-reactive antibodies, which is highly protective neutralizing antibodies. then the investigators will explore the potential for clinical application about these neutralizing antibodies. the dengue virus were sequenced which caused dengue fever or severe dengue fever in 2014, and do bioinformatics analysis to find the genetic loci which may be responsible for virulence of dengue virus. to sum up the clinical and laboratory data of dengue fever in 2014, to carry out the research on the diagnosis and treatment of dengue fever, to explore the effectiveness, safety and mechanism of integrated chinese and western medicine treatment for dengue fever patients，to establish of a more perfect system for the diagnosis and treatment of dengue fever in china.

Eligibility criteria:
inclusion criteria: * dengue patients confirmed by dengue virus ns1 or rna exclusion criteria: * pregnant women * fever diseases caused by other viruses * combined bacterial infection * without complications such as diabetes and tumor.
long-term safety study of inhaled insulin: an up to four-year extension of therapy in subjects with type 1 or type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: this is a long-term safety study for phase 2 subjects who choose to remain on exubera® (inhaled insulin).

the study was terminated on oct. 18, 2007. this study is not a post approval commitment study. pfizer decided to cancel new trials because of the decision to withdraw exubera® (inhaled insulin) due to lack of market performance and not for safety reasons.

Eligibility criteria:
inclusion criteria: * subjects with type 1 or type 2 diabetes mellitus who participated in previous phase 2 extension protocols exclusion criteria: * smoking * pregnancy
comparative study of cycloplegic refraction and subjective refraction with fogging in school age children

Conditions: Myopia; Refractive Error

Summary: a thorough ophthalmic examination of a child must include a refraction and this is often done with cycloplegia. in our study, we aim to determine at which age group a non-cycloplegic refraction technique closely correlates with a cycloplegic refraction and hence, would obviate the need for cycloplegic refraction in our routine clinical practice.

the accommodative response in young phakic patients has been known to result in over-estimation of myopia and subsequently inappropriate prescriptions. therefore, the rationale for cycloplegia is to inhibit the accommodative response in order to obtain a true measurement of the refractive error. different cycloplegic agents have been in common use for the last five decades. cyclopentolate is widely used and is commercially available in concentrations of 0.5% and 1%. tropicamide is another widely used cycloplegic agent and is available in 0.5% and 1% concentrations. the advantages of a non-cycloplegic technique would be firstly, the avoidance of any possible harmful effects from the cycloplegic agents used. secondly, it would vastly reduce waiting times for parents and children and allow for a much more efficient clinical service. finally, there may be a significant cost-saving feature involved if these cycloplegic agents are no longer required. this will be a prospective clinical audit/survey involving children between the ages of 4 years and 13 years who attend the paediatric ophthalmology clinics in kk women's and children's hospital as well as the singapore national eye centre. all eligible children will have had a cycloplegic refraction and a non-cycloplegic refraction with fogging. a survey of children between the ages of 4 and 13 years who have had refraction with both these techniques will be undertaken and the difference in spherical error between the 2 techniques will be recorded for each child. we aim to accumulate 15 children from each age group.

Eligibility criteria:
inclusion criteria: 1. as part of the ophthalmic evaluation, will undergo non-cycloplegic and cycloplegic refraction. 2. informed consent has been obtained from a parent or guardian. 3. aged between 4 years and 13 years old. 4. able to cooperate with examination(s) as stated. exclusion criteria: 1. known allergy or adverse reaction to cyclopentolate. 2. unable to cooperate with examination(s) stated. 3. parent or guardian objection.
sleep apnea and lung cancer

Conditions: Locally Advanced Non Small Cell Lung Cancer

Summary: cases of locally advanced non small cell lung cancer (diagnosed by pet/ct scan and histopathological confirmation) will be screened for sleep disorders by epworth sleepiness scale then confirmed by full night polysomnographic study. blood sample to detect some genetic determinants will be withdrawn


Eligibility criteria:
inclusion criteria: * patients with locally advanced non small cell lung cancer exclusion criteria: * unable or refuse to perform sleep study * metastatic cases
vigabatrin in post-anoxic status epilepticus - phase iia

Conditions: Status Epilepticus, Electrographic; Coma

Summary: this is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.

this pilot trial aims to demonstrate the feasibility of enteral administration of a single load of vigabatrin within targeted 48 hours of post-anoxic status epilepticus onset in unconscious survivors of cardiac arrest undergoing targeted temperature management. the load of vgb is in addition to the load of a commonly used intravenous second-line therapy given at the discretion of the treating neurologist. serial blood tests will be obtained, including vigabatrin levels, taurine levels, neuron specific enolase, light chain neurofilament, and glial fibrillary acidic protein. in survivors that regain consciousness and survive to follow up, 6 months visual field perimetry will be obtained.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * non-traumatic cardiac arrest (regardless of non-perfusing rhythm, etiology, or location of arrest) in whom the decision to treat unequivocal electrographic status epilepticus (as defined by the american clinical neurophysiology society: having generalized spike/sharp-wave discharges ≥ 3hz or any evolving pattern reaching \> 4hz, lasting ≥ 10 minutes, or comprising \> 50% of any hour of recording) has been made * requiring anesthetic infusion for any reason * have reliable arterial access for frequent blood sampling * established enteral access within 48h of post-anoxic status epilepticus onset. exclusion criteria: * prior history of generalized epilepsy * history of gastrointestinal surgery within the last 21 days * pregnancy * status epilepticus onset preceding initiation of electroencephalography monitoring

Keywords: post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin
procalcitonin level to discontinue antibiotics on icu patients with no obvious site of infection

Conditions: Infection; Bacterial Infection; Sepsis

Summary: the purpose of this study is to test whether a u.s. food and drug administration (fda) approved laboratory test (pct kryptor) can help doctors make better decisions on the need for antibiotic therapy in icu patients with suspected infections.

the study is undertaken as prospective, randomized, controlled, multicenter trial. the study population, icu patients with empiric antibiotic treatment due to suspected but unproven infection, is randomly assigned to either a standard care group or a procalcitonin (pct) guided group. in the standard care group, antibiotic treatment would be based totally on clinical decision making with "traditional thought processes" (i.e., cultures, response to antibiotics, risk of untreated infection, other laboratory findings, etc.). the pct guided group will use the same "traditional thought processes" and in addition the physician will be given access to a pct value for day 1 and day 4 along with the recommended thresholds for likelihood of infection. in conjunction with other laboratory findings and clinical assessments the threshold of pct is used to continue or discontinue empiric antibiotic treatment.

Eligibility criteria:
inclusion criteria: * suspected infection (no clear-cut source of infection) as defined by the treating physician * empiric antibiotic treatment * no clear-cut source of infection by clinical or microbiological criteria * icu patient * informed consent exclusion criteria: * age \<18 years * pregnancy * hemodynamic instability defined as persistent hypotension, need for on-going aggressive resuscitation and/or vasopressor support to maintain an adequate mean arterial blood pressure * need for antibiotic prophylaxis * patient withdrawn from empiric antibiotic treatment before day 4 * severely immuno-compromised patient (liver cirrhosis (child-pugh class c), immunosuppressive drugs after transplantation, neutropenia (absolute neutrophil count \<1000 counts/l), cd-4 count less than 200) * patient with suspected bacterial or fungal endocarditis * patient with suspected meningitis * cardiopulmonary bypass within the last 7 days1) * major surgery within the last 7 days (surgery that induces a major inflammatory response such as heart or aortic surgery or major abdominal surgery (i.e. duodenopancreatectomy) or any surgery requiring massive blood transfusion.) * multiple trauma within the last 7 days * cardiopulmonary resuscitation (cpr) within the last 7 days * burns \>20% body surface area * patient in terminal status referred for palliative care * patient with advanced directives or do not resuscitate (dnr) orders * patient who is already enrolled in another therapeutic clinical study

Keywords: bacterial infection empiric antibiotic treatment duration antibiotic treatment reduce antibiotic treatment procalcitonin pct kryptor sepsis intensive care unit antibiotic treatment
prevention of recurrent clostridium difficile infection (cdi) in patients with inflammatory bowel disease (ibd).

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease; C. Diff. Infections

Summary: the study will compare the effectiveness of bezlotoxumab in individuals with active c. diff ( clostridium difficile) infection who are diagnosed with inflammatory bowel disease.

bezlotoxumab is administered during a course of antibiotic therapy. the dose is administered as one time treatment. patients will receive 10 mg/kg iv over 60 minutes as a single dose via central line.

Eligibility criteria:
inclusion criteria: * \>18 years old * active cdi receiving therapy * diagnosis of ibd * and history of cdi. exclusion criteria: * \<18 years old * no ibd * no cdi * history of colectomy * history of preexisting congestive heart failure * pregnant or nursing women * tcp\<50 * past cardiac history.

Keywords: c.diff c. difficile ibd uc bezlotoxumab recurrent c. diff