Kornimate/medical-research-clean huggingface dataset:
a clinical trial of the study medicine (pf-07081532) in people with diabetes and kidney dysfunction

Conditions: Type 2 Diabetes; Renal Impairment

Summary: the purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (pf-07081532). people with certain level of kidney functional impairment may process pf-07081532 differently from healthy people. pf-07081532 is developed as a potential treatment for type ii diabetes. participants will take the study medicine as a tablet by mouth once at the study clinic and then will stay at the study clinic for about 7 days. during that time, the study team will monitor their treatment experience and take some blood samples to test the level of pf-07081532. this will help us understand if certain degree of kidney functional impairment will have an effect on the study medicine pf-07081532.


Eligibility criteria:
inclusion criteria: 1. stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of bsa-unnormalized egfr 2. a prior diagnosis of t2dm with an hba1c ≥6% and ≤10.5% 3. women may be of child-bearing potential 4. bmi of 17.5 to 45.4 kg/m2 5. normal function (group 1): normal renal function (mean egfr ≥90 ml/min) based on an average of measures from screening visits s1 and s2 (egfr should be calculated using the 2021 ckd epi scr-scys combined equation: * demographically comparable to participants with impaired renal function at screening * a body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (groups 2, 3 and 4) * an age within ±10 years of the mean age of the pooled renal impairment groups (groups 2, 3 and 4) * attempts will be made to ensure that the male to female distribution in group 1 is comparable to that in the pooled renal impairment groups (groups 2, 3 and 4). exclusion criteria: 1. diagnosis of type 1 diabetes mellitus or secondary forms of diabetes, or history of diabetic ketoacidosis. 2. history of myocardial infarction, unstable angina, arterial revascularization, stroke, new york heart association functional class ii-iv heart failure, or transient ischemic attack within 3 months of screening 3. personal or family history of mtc or men2, or participants with suspected mtc per the investigator's judgement. 4. history of acute pancreatitis within 6 months before screening or any history of chronic pancreatitis. 5. urinary incontinence. 6. participants with acute renal disease. 7. renal allograft recipients. 8. participants who have previously received a kidney, liver, or heart transplant.

Keywords: type 2 diabetes renal impairment
a master protocol for orforglipron in participants with obstructive sleep apnea and obesity or overweight

Conditions: OSA; Overweight or Obesity

Summary: study gzra is a master protocol that will support 2 independent studies, gz01 and gz02. participants will be assigned to the appropriate study prior to randomization. the purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe osa and obesity or overweight. study gz01 will include participants who are unable or are unwilling to use pap therapy. study gz02 will include participants who are on pap therapy for at least 3 months at time of screening and plan to continue pap therapy during the study.


Eligibility criteria:
inclusion criteria: master gzra inclusion criteria * have ahi ≥15 on psg as part of the trial at screening (v1). * have body mass index (bmi) ≥27 kg/m² study 1 gz01 inclusion criteria * participants who are unable or unwilling to use pap therapy. * participants must not have used pap for at least 4 weeks prior to screening. study 2 gz02 inclusion criteria * participants who have been on pap therapy for at least 3 consecutive months prior to study start and plan to continue pap therapy during the study. exclusion criteria: master gzra exclusion criteria * have type 1 diabetes (t1d) or type 2 diabetes (t2d), history of ketoacidosis, or hyperosmolar state/coma * have hba1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at visit 1. * had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery * have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of cheyne stokes respiration * diagnosis of obesity hypoventilation syndrome or daytime hypercapnia. * active device treatment of osa other than pap therapy * respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator. * have a self-reported change in body weight \>5 kg within 3 months prior to screening * have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening) * have a prior or planned endoscopic and/or present device-based therapy for obesity. * have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity. study 2 gz02 exclusion criteria * have personal or job-related responsibilities, or in the opinion of the investigator have any situation that would make it unsafe to stop pap therapy for 7 days prior to psg testing during the study. * are unwilling to temporary discontinue pap therapy for 7 days prior to psg testing during the study.
clinical responsiveness of dermatomyositis using cutaneous dermatomyositis disease area and severity index (cdasi)

Conditions: Dermatomyositis

Summary: the evaluation of clinical responsiveness using the cutaneous dermatomyositis disease area and severity index (cdasi), established in 2008, is a one-site database study conducted at the university of pennsylvania. the database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. the cdasi database incorporates the cutaneous dermatomyositis disease area and severity index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis. the cdasi database has led to publication of comparison studies of cdasi and other clinical instruments and the effect of dermatomyositis on quality of life (qol). the cdasi database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. data will be analysed over a 5 years.


Eligibility criteria:
inclusion criteria: * gender/age: males or females above 18 years old * diagnosis: cutaneous dermatomyositis * subjects able to give informed consent exclusion criteria: * subjects without cutaneous dm * penn employees * penn students * cognitively impaired persons
determining the risk of stress fracture in idf soldiers based on snps identified for osteoporosis

Conditions: Stress Fracture

Summary: the study is a genetic historical cohort study in a military combat recruits - this study does not examine a specific treatment but rather examines a statistical link between medical history of traumatic fractures, clinical diagnosis of stress fractures and the presence of unique snps in subjects dna.

finding a statistically significant correlation between snps associated with bmd - osteoporosis, with recruits who were diagnosed with stress fractures during basic and advanced infantry training. greatest importance will be shown in the power calculation: we suggest that the p-value threshold value of the selected snps be adjusted downwards to a lower threshold of p \<1.0x10-3 (i.e. equal to 50 independent tests). we will examine the presence or absence of 96 snps - 76 snps that were previously validated as significant with low bmd or osteoporosis and 20 snps offered for stress fractures with recruits who were diagnosed with stress fractures during basic training (basic training lasts four months - six months) using snp genotyping analysis-taqman assays. the buccal swab will be taken from recruits who served for at least four months and up to six months in the idf - infantry corps. buccal swabs will be taken at a single meeting from recruits serving between 4 and 6 months in the idf - infantry corps, which will be used to compare using snp genotyping analysis-taqman assays with the snps listed above. in addition, in this single meeting, the recruits will fill out a questionnaire in which they will be asked whether they experienced traumatic fracture from their youth to the time of filling the questionnaire (recruits who experienced traumatic fractures but are not diagnosed with stress fractures constitute as a control group in the research). there will be one meeting with recruiters who served for at least four months and up to six months in the idf - infantry. at this meeting, the recruits will be sampled with a buccal swab and fill out a questionnaire.

Eligibility criteria:
inclusion criteria: * all participants (440) in the research are male. * all participants (440) are recruits who serve 4-6 months in the idf - infantry - basic training. * 110 recruits with a stress fracture diagnosis in their medical portfolio. * 110 recruits who have section 4161x flaw (section eclipse: a long bone fracture) * 220 recruits without the aforementioned impairment clause and the above mentioned diagnosis (referred as control group). exclusion criteria: * recruit who left the unit before conducting the research. * a recruiter who did not complete his training due to a course that lasted over two weeks while carrying out basic training. * a recruiter who did not complete his basic training due to absenteeism. * a recruiter who has not completed his basic training due to problems with the service conditions. * a recruiter who has not completed his basic training due to the reduction of a medical profile. * a recruiter who did not complete his basic training due to a decrease in the recruitment cycle.
the effect of blood on the pc ratio during pregnancy

Conditions: Proteinuria in Pregnancy

Summary: this study will examine the effect if blood on the the protein to creatine (pc) ratio in pregnant patients by adding blood to urine samples.

the purpose of the research: the purpose of this study is to examine the effect of blood on the protein to creatine (pc) ratio in pregnant patients. the scientific or scholarly rationale: the pc ratio is used to diagnosis proteinuria in pregnancy. it is thought that blood in the urine will cause the pc ratio to be elevated but there are no current studies to prove this hypothesis. the procedures to be performed: upon presentation to the labor and delivery triage or the antepartum unit, patients will be enrolled in the study. urine collection that is not needed for medical workup will be collected and saved, and an extra 8 mls of blood will be drawn during routine lab collection by phlebotomy team. additional lab costs will be covered by marshall obstetrics \& gynecology. lab protocol: divide urine into 4 different specimen cups with 20 mls of urine each to measure urinalysis (ua) and pc ratio: 1. ua and pc ratio on original sample 2. ua and pc ratio with 1 ml of whole blood added 3. ua and pc ratio with 2 ml of whole blood added 4. ua and pc ratio with 5 ml of whole blood added subjects medical records will be reviewed for past obstetrical history after consent to be in the study. the risks and potential benefits of the research: risks: 8 mls of additional maternal blood will be drawn for study purposes. possible risks could include pain, bleeding, fainting, bruising, infection, or hematoma (blood clot under the skin) at the injection site. please note that routine blood would be drawn regardless of study enrollment. benefits: our hypothesis is that the pc ratio will be elevated by contamination with blood. it is unknown if this hypothesis is correct. complete inclusion/exclusion criteria (may be submitted separately if extensive): inclusion criteria includes patients presenting to labor and delivery triage or antepartum unit at cabell huntington hospital between the ages of 18 and approximately 45 years and gestational age of \>20 weeks. exclusion criteria includes pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine).

Eligibility criteria:
inclusion criteria: * labor and delivery triage or antepartum unit at cabell huntington hospital between the ages of 18 and approximately 45 years and gestational age of \>20 weeks exclusion criteria: * pre-existing proteinuria (excess protein in the urine) or hematuria (blood in the urine)
rigid versus flexible cystoscopy in women

Conditions: Hematuria; Urination Disorders; Voiding Dysfunction; Recurrent Urinary Tract Infection

Summary: the study will help define the best tolerated approach to cystoscopy in women by randomly comparing flexible to rigid cystoscopy. previous randomized studies evaluated rigid cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. as a result of these studies, flexible cystoscopy is performed in the clinic setting generally in males. however, many women have rigid cystoscopy performed in the clinic while the men have flexible cystoscopy. no studies to date have evaluated whether flexible cystoscopy is better tolerated in women compared to rigid cystoscopy in women in the clinic setting.


Eligibility criteria:
inclusion criteria: * female exclusion criteria: * minors * incarcerated individuals

Keywords: bladder cancer surveillance voiding dysfunction cystoscopy
postoperative pain control following vitreoretinal surgery

Conditions: Retinal Detachment; Proliferative Vitreoretinopathy; Retinoschisis

Summary: the aim of this study is to evaluate if patients receiving a steroid (triamcinolone acetonide) combined with local anesthesia and antibiotic following retina surgery have better postoperative pain control those receiving local anesthesia and antibiotic alone.

currently, patients undergoing vitreoretinal surgery at the emory eye center and emory university hospital receive a injection of local anesthesia behind the eye (retrobulbar) at the start of surgery to minimize discomfort felt during the surgery. at the end of surgery all patients receive a periocular antibiotic and steroid injection. some patients also receive a retrobulbar injection of local anesthesia (bupivicaine) at the conclusion of surgery in order to decrease postoperative pain and discomfort. it has been our observation that when the local anesthesia is combined with a steroid (triamcinolone acetonide) in a retrobulbar injection at the conclusion of surgery, patients tend to be pain free for longer intervals then when local anesthesia is used alone. the objective of this study is to evaluate if patients receiving triamcinolone acetonide combined with local anesthesia and antibiotic compared to those receiving local anesthesia and antibiotic alone do better with postoperative pain control. all eligible patients undergoing vitreoretinal surgery at the emory eye center and emory university hospital will be offered enrollment. about 60 patients will be invited to participate in this study. patients will undergo standard of care surgery. at the conclusion of surgery, patients will receive a retrobulbar antibiotic and anesthetic as standard of care. half of the patients will receive this mixture plus steroid and the other half will receive this mixture plus saline. on postoperative day 1, patients will be given a questionnaire to assess pain. pain levels in the two groups will be compared.

Eligibility criteria:
inclusion criteria: * patients undergoing vitreoretinal surgery at the emory eye center ambulatory surgery center and emory university hospital by retina attending faculty surgeons exclusion criteria: * unable to verbalize level of pain control * pediatric patients (\<18 years old) * glaucoma, ocular hypertension, or glaucoma suspects * allergy to local anesthetic * pre-existing chronic pain requiring narcotic pain medication * drug addiction * impaired periorbital sensation (history of herpes simplex, zoster, corneal graft)

Keywords: retina vitreoretinal surgery
histological evaluation of btl-899 device´s effect on fat tissue

Conditions: Fat Burn

Summary: this study will evaluate the safety and performance of the btl-899 device for non-invasive treatment of subcutaneous fat. the changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. the study is a prospective single-center single-blinded two-arm study. the subjects will be enrolled and assigned into two study groups; group a which will receive active treatment and group b which receives sham treatment and will serve as a control to verify the treatment outcomes. subjects will be required to complete only one (1) treatment visit and three (3) follow-up visits (at 8 hours, 24 hours and 7 days post treatment). all of the study subjects will receive the treatment (either active or sham) with the subject device. at the baseline visit, health status will be assessed. inclusion and exclusion criteria will be verified and informed consent will be signed. punch biopsies from the treated abdominal area will be taken to examine the changes related to caspase-3 activity.


Eligibility criteria:
inclusion criteria: * age \> 21 years * voluntarily signed an informed consent form * bmi ≤ 35 kg/m2 * women of child-bearing potential are required to use birth control measures during the whole duration of the study. * willingness to abstain from partaking in any treatments other than the study procedure * willingness to comply with study instructions, to return to the clinic for the required visits and to undergo punch biopsies in the abdominal area. exclusion criteria: * electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators) * metal implants in the treated area * drug pumps * malignant tumor * pulmonary insufficiency * injured or otherwise impaired muscles in the treated area * cardiovascular diseases * disturbance of temperature or pain perception * hemorrhagic conditions * septic conditions and empyema * acute inflammations in the treated area * systemic or local infection such as osteomyelitis and tuberculosis * contagious skin disease * elevated body temperature * application during pregnancy, postpartum period, nursing, and menstruation * graves' disease * skin related autoimmune diseases that may contradict the biopsy * poor healing and unhealed wounds in the treatment area * any disease or condition contradicting the skin tissue biopsy * any disease or condition that may compromise the histologic observation at the pathologist discretion
nonsurgical periodontal treatment combined with anti-tnf-α in patients with rheumatoid arthritis and periodontitis

Conditions: Peridontal Disease; Rheumatic Arthritis

Summary: periodontitis is a multifactorial disease of the periodontium that can lead to destruction of the alveolar bone and supporting connective tissue and subsequent tooth loss. recent studies have shown that periodontitis is associated with age, smoking habits, genetic predisposition, socioeconomic status, and various systemic diseases such as diabetes mellitus, atherosclerosis, obesity, osteoporosis, and rheumatoid arthritis (ra). ra is a chronic, systemic inflammatory disease of unknown etiology that primarily affects the joints. periodontitis and ra have similar clinical and pathogenic features. clinically, both diseases are characterized by local destruction of hard and soft tissues. their pathogenesis involves the release of cytokines and matrix metalloproteinases (mmps) from inflammatory cells. expression of proinflammatory cytokines such as tumor necrosis factor-alpha (tnf-α) leads to the release of high levels of inflammatory mediators that cause bone destruction and the spread of inflammation. tnf-α is the main regulatory cytokine in both ra and periodontitis. tnf-α inhibitors (anti-tnf-α) reduce the number of inflammatory cells, osteoclast formation and bone loss. in addition, many immunological processes have been identified that are similar to both diseases. autoreactive t cells, natural killer cells, heat shock proteins, autoantibodies and genetic factors are reported to play an important role in the inflammatory pathway of ra and periodontitis. recently, tnf-α blocking agents (anti-tnf-α) have been developed and used for the treatment of ra. animal and human studies have suggested that anti-tnf-α treatment may reduce the severity of periodontitis. the aim of this study was to investigate the effect of nonsurgical periodontal treatment combined with anti-tnf-α on alveolar bone loss and oxidative stress in individuals with ra and periodontitis.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * having a confirmed diagnosis of rheumatoid arthritis (ra), * having a diagnosis of stage iii-iv periodontitis, * having at least 20 teeth, exclusion criteria: * having used antibiotics for the 3 months before the study, * being pregnant and lactating, * having received periodontal treatment in the last 6 months, * being diabetic. * smoking.

Keywords: rheumatoid arthritis periodontal disease inflammation
primary-care-provider identification and notification

Conditions: Emergency

Summary: new york-presbyterian hospital has created a system that notifies its primary care providers whenever their patients are admitted to the hospital. in this study, the investigators want to evaluate how accurate this system is and how it is affecting the primary providers and their health care delivery.

the investigators will interview the participating providers to understand if they were aware of the admission of their patients, and how they want to get involved in the care of that patient while he/she is in hospital. the investigators will also look at the data in the electronic health record system to understand how providers are acting in response to the notifications. lastly, the investigators will determine if the notifications have resulted in any change in the care of the patients, specifically in terms of the number of days from discharge until the next clinic visit.

Eligibility criteria:
inclusion criteria: * primary care provider at the new york presbyterian. exclusion criteria: * no clinic rotation during the study period

Keywords: emergency visit secure health messaging inpatient
the correlation between femoral component implanting flexion angle and posterior condyle offset in cruciate retaining total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: the main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. the results may identify the influence of the flexion component implanting flexion angle on the femoral component posterior offset.


Eligibility criteria:
inclusion criteria: * the patients undertaken the primary cruciate retaining total knee arthroplasty; * using the curiate retaining total knee arthroplasty prothesis from biomet and smith\&nephew; * complete surgery documents and radiologic data,such as standard x-ray postoperative both at antirior-posterior position and medial-lateral position(overlap of the medial and lateral femoral condyle). exclusion criteria: * the patients without standard x-ray postoperative both at antirior-posterior position and medial-lateral position(poor overlap of the medial and lateral femoral condyle); * complex primary total knee arthroplasty, using extra component such as trabecular metal,stem or et al.

Keywords: sagittal flexion angle posterior femoral offset cruciate-retaining total knee arthroplasty