Kornimate/medical-research-clean huggingface dataset:
post-approval registry study to evaluate the continued safety and probable benefit of the mid-c system for 5 years post-implantation in adolescent idiopathic scoliosis (ais)

Conditions: Adolescent Idiopathic Scoliosis

Summary: the apifix mid-c system is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. the mid-c system is designed to act as an internal brace. patients implanted with the device in the us within 2 years of fda's approval of h17001 should be enrolled in the study. a minimum number of 200 patients will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * adolescent idiopathic scoliosis classified as lenke type 1 or type 5 curves; * cobb angle between 35-60 degrees (inclusive); * flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray; * kyphosis angles of ≤ 55 degrees measured from t5 to t12; * appropriate candidate for posterior surgical approach; * patient has good general health; * patient has no known hypersensitivity or allergies to titanium; * patient's guardian signs a written informed consent form (icf). exclusion criteria: * any type of non-idiopathic scoliosis; * any main thoracic deformity that includes vertebral levels and cranial including to t2; * known history of existing malignancy, or any systemic or local infection; * spinal cord abnormalities that require treatment; * known neurological deficit (defined as motor grade \< 5/5); * known poor bone quality defined as t score -1.5 or less; * for female patient, pregnancy; * previous spine surgery that would prevent the successful performance of the mid-c system ; * active systemic disease, such as aids, hiv, or active infection; * active infection or the skin is compromised at the surgical site; * systemic disease that would affect the patient's welfare or overall outcome of the study.
spanish registry of mohs surgery

Conditions: Skin Neoplasms; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Dermatofibrosarcoma; Melanoma; Histiocytoma, Malignant Fibrous; Neoplasms, Adnexal and Skin Appendage

Summary: regesmohs (registro español de cirugía de mohs) aims at describing effectiveness of mohs surgery, and patient, tumor and technique factors related to adverse events and tumor recurrence. regesmohs is a prospective cohort, including all patients considered for mohs surgery in participating centers. all consecutive patients are included. the only exclusion criteria are being under 18-years-old or legally incompetent. pre-planned follow-up is as required by common clinical practice, but at least once a year for the study period.


Eligibility criteria:
inclusion criteria: * all consecutive patients considered for mohs surgery exclusion criteria: * under 18 years-old * legally incompetent

Keywords: mohs surgery
project insight: feasibility of a breast cancer screening decision support tool

Conditions: Breast Cancer Screening; Oncology; Preventative Medicine; Mammography

Summary: the purpose of this investigation is to conduct a feasibility study to evaluate the potential for implementing the developed decision support tool with latina, black, and non-latina white women. the investigators will collect feasibility data and assess the use of the decision support tool with end-users. the aim is to determine if women using the decision support tool make more informed choices measured by knowledge, attitudes, and intentions.


Eligibility criteria:
inclusion criteria: * latina, black, or non-latina white women * between the ages of 40-49 years * can write, read, and understand english exclusion criteria: -women with greater than an average self-reported risk of breast cancer will be ineligible for participation, as evidenced by any of the following: * self-reported personal history of breast cancer (invasive, ductal carcinoma in situ \[dcis\], or lobular carcinoma in situ\[lcis\]) * self-reported personal history of atypical hyperplasia * self-reported first degree family member with history of breast cancer (e.g., mother, sister) * self-reported known underlying genetic mutation such as a brca1/brca2 gene * self-reported prior thoracic or chest wall radiation therapy

Keywords: health literacy health disparities shared decision making
clinical and economic outcomes of ceftaroline fosamil for absssi documented or at risk of mrsa

Conditions: Skin Diseases, Infectious; Staphylococcal Skin Infections

Summary: the proposed study is a prospective, open-label, randomized, multi-center trial of ceftaroline versus vancomycin for the treatment of absssi in patients documented or at risk for mrsa. patients admitted to the detroit medical center, henry ford hospital, or st. john medical center in detroit michigan with a documented absssi between april 2012 and november 2015 will be evaluated for inclusion. patients must present with at least 3 of the following local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge, induration, and lymph node swelling/tenderness. patients will be randomized 1:1 ceftaroline or vancomycin with optional anaerobic and/or gram-negative coverage. the assignment of study drug will follow a randomized list that was previously generated via a computerized random mix block generator (nquery advisor® 7.0) and available at each of the study sites. patients will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours for patients with normal renal function. patients randomized to vancomycin will receive the standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and interval adjusted based on creatinine clearance and via institution-specific pharmacy protocol to target serum trough concentrations of 10-20 mg/l within the first 72 hours. outcomes measured in the clinically evaluable patient population include day two or three size reduction (percentage) and clinical response at end of therapy or discharge.


Eligibility criteria:
inclusion criteria: * acute bacterial skin and skin structure infection (cellulitis, major abscess, surgical site infection) * presence of mrsa or documented risk factors for mrsa (prior antibiotic use 60 days, prior hospital exposure 180 days, skin ulcers, central venous catheter) * anticipating no less than two days of hospital admission * signed informed consent exclusion criteria: * gas gangrene/progressive necrotizing infections * osteomyelitis * infections due to gram-negative pathogens or other gram-positive pathogens if s. aureus or streptococcus is not present * pathogens known at the study entry to be resistant to ceftaroline or vancomycin * anticipated to require non-study antibiotic active against s. aureus for another reason * treatment for the current episode of absssi for \> 24 hours with another intravenous anti-mrsa antibiotic * surgical (i \& d) as definitive/curative treatment * presence of prosthetic hardware or invasive devices suspected to be the source of infection but cannot be removed * life expectancy \< 2 months * open burn wound \> 30% total body surface area * pregnant or nursing mothers * known allergic reaction to vancomycin or ceftaroline

Keywords: ceftaroline fosamil vancomycin acute bacterial skin and skin structure infections methicillin-resistant s. aureus
intraocular pressure immediately following intravitreous injection of ranibizumab

Conditions: Choroidal Neovascularization

Summary: this study will quantify the intraocular pressure elevation in the immediate time period following intravitreous injection. with more widespread use of intravitreous injections in patients that may require several injections per year, it is important to document the sudden increase in intraocular pressure, including the maximum intraocular pressure and the time required for the intraocular pressure to return to baseline. this data may be useful in stimulating additional studies to evaluate the long term ocular effects of repeated intravitreous injections. we hypothesize that the intraocular pressure increases significantly following intravitreous injection and then returns to baseline during the initial thirty minutes following ranibizumab injection.

we will assess the trend of intraocular pressure immediately following intravitreal injection of ranibizumab 0.5 mg (0.05 ml) by taking serial intraocular pressure readings every five minutes for thirty minutes after injection. this study is a prospective descriptive data collection consisting of measuring intraocular pressure immediately following intraocular injection, and at 5, 10, 15, 20, 25, and 30 minutes following injection of ranibizumab 0.5 mg.

Eligibility criteria:
inclusion criteria: 1. male or female patients \>18 years of age 2. patients will have documented choroidal neovascular membranes on fluorescein angiogram and/or optical coherence tomography 3. requiring treatment or maintenance therapy for choroidal neovascular membrane 4. able and willing to provide written informed consent exclusion criteria: 1. history of arterial occlusive disease of the eye. 2. history of advanced glaucoma.

Keywords: intraocular pressure intravitreous injection ranibizumab
assessment of pattern of abdominal injury

Conditions: Abdominal Trauma

Summary: this hospital-based cross-sectional study was done at sphmmc and aabet hospitals from january 2018 to december 2019.the study aimed to assess the pattern of abdominal injury at st paul's hospital millennium medical college (sphmmc) and addis ababa burn, emergency and trauma (aabet) hospital, addis ababa ethiopia.data was collected from the trauma registry and patient files using a pretested structured questionnaire filled out by two trained data collectors.the collected data was entered and analyzed using statistical software spss version 25.0.

data was collected from the trauma registry and patient files using a pretested structured questionnaire filled out by two trained data collectors. the questionnaire was categorized into socio-demographics (age, sex, residency, and address), clinical profile (triage, v/s, type of injury, associated injury), management, and outcome (management, complication, disposition, and mortality). completeness of data was checked by the principal investigator.

Eligibility criteria:
inclusion criteria: - all patients who are diagnosed clinically to have abdominal trauma exclusion criteria: * patients who died before diagnosis

Keywords: abdominal injury road traffic injury emergency department
effect of high-intensity interval training on cardiac function and regulation of glycemic control in diabetic cardiomyopathy

Conditions: Diabetic Cardiomyopathies; Type2 Diabetes

Summary: according to data of the international diabetes federation (idf), diabetes in general affects approximately 415 million people worldwide and this number is still increasing. cardiovascular diseases, one of the major complications of diabetes, are the leading cause of mortality and morbidity in the diabetic population. one of the cardiovascular complications is diabetic cardiomyopathy, in which structural and functional changes occur in the heart impairing cardiac function. exercise training has already proven the benefits on glycemic control in diabetes. this is also the case for the effects on cardiac function. however, as results are conflicting, it remains unclear which elements of exercise training should be focused on. for instance, high-intensity interval training (hiit) is gaining interest as positive effects are already shown on glycemic control. therefore, the potential of hiit to improve cardiac function in diabetes should be investigated. further on, the effects of exercise training on cardiac function are mainly investigated during rest by the use of transthoracic echocardiography. therefore, as data are lacking, it remains unclear how the diabetic heart functions during exercise. the aim of the present study is to investigate the effects of different training modalities (e.g. hiit) on heart function in diabetes both during rest and during exercise itself. therefore, cardiac function will be evaluated by the use transthoracic (exercise) echocardiography. this will be combined by the evaluation of several biochemical parameters. the results will provide more insight in the pathology of diabetic cardiomyopathy as well as the potential of exercise training for this cardiovascular complication. eventually, this research will contribute to the optimization of exercise programs for patients with diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients: * bmi \> 20kg/m² * diagnosis of t2dm as stated in guidelines of ada (american diabetes association) * stable medication for at least 3 months * healthy controls: * bmi \> 20kg/m² * no diabetes exclusion criteria: * iron deficiency anemia * participation in another clinical trial * heart diseases: cad (coronary artery disease), ischemia, valvular diseases, congenital heart diseases * neurological, pneumological, oncological, orthopedic disorders * diabetes complications: renal diseases, retinopathy

Keywords: type 2 diabetes diabetic cardiomyopathy cardiac function exercise echocardiography exercise training
phase i/ii study of tsu-68 for advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of orantinib, an oral tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived growth factor receptor, and fibroblast growth factor receptor, in patients with advanced hepatocellular carcinoma (hcc).

as hcc is a highly vascular tumor, a number of antiangiogenic agents have been tested for the treatment of hcc. orantinib is an orally administered, small-molecule, multiple receptor tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2 (vegfr-2), platelet-derived growth factor receptor (pdgfr), and fibroblast growth factor receptor (fgfr). phase i studies that have been conducted in japan for patients with solid tumors recommended a dosage of 400 mg bid. as a potent antiangiogenic agent, orantinib is also expected to be effective against hcc. however, because most hcc patients have accompanying liver cirrhosis or hepatitis, its safety must be reevaluated in the presence of liver function impairment.

Eligibility criteria:
inclusion criteria: * age 20-74 * ps 0-2 * patients who did not respond to surgery, rfa, tae, chemotherapy, or radiotherapy * chid-pugh a or b * at least one measurable lesion by recist criteria exclusion criteria: * large amount of pleural effusion or ascites * esophageal varices * simultaneously active double cancer
studying survivorship care plans in head and neck cancer

Conditions: Head and Neck Cancer

Summary: the study will focus on survivorship care for head and neck cancer patients cared for within duke cancer center clinics. standardized survivorship care plans (sscp) are being implemented based on the american society for clinical oncology's criteria. these documents provide a summary of treatment received, and list side effects and follow-up information after cancer treatment. taking advantage of this transition, the investigator will study three groups of patients: (a) early survivors treated before the sscp was implemented, (b) early survivors treated after the sscp was implemented, and (c) current patients who will receive an individualized enhanced scp (escp), which will include additional information tailored to patient preferences. the investigators hypothesize that patients receiving enhanced survivorship care plans will increase their knowledge regarding their health care plan and wellness trajectory; increase their ability to identify the symptoms they most likely can expect as a result of their cancer treatment; and be more likely to engage in conversations with their pcp about healthy behaviors and screening guidelines.


Eligibility criteria:
inclusion criteria: * completed treatment for a head or neck cancer at duke cancer center within 4 months of consent or * will complete treatment for a head and neck cancer at duke cancer center within 3 weeks of consent and * able to read and understand english * capable of giving informed consent * are at least age 18. exclusion criteria: * incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer; or too sick to participate, as judged by a member of the research team

Keywords: survivorship care plan head and neck cancer survivorship
incidence of early pregnancy loss in patients with unexplained infertility

Conditions: Infertility

Summary: unexplained fertility could be partly caused by a higher incidence of early pregnancy loss in this group. 65 women with unexplained infertility and 65 healthy controls will collect daily urine samples form the luteal phase. hcg and creatinine levels are measured in order to detect pregnancies and early pregnancy loss.


Eligibility criteria:
inclusion criteria: * unexplained infertility exclusion criteria: * ivf treatment

Keywords: unexplained infertility hcg early pregnancy loss
covid-19 seroconversion among front line medical and paramedical staff in emergency, intensive care units and infectious disease departments during the 2020 epidemic

Conditions: Sars-CoV2

Summary: the epidemic due to the sars-cov2 virus is spreading in france, without knowning precisely since when the virus has actually circulated on the territory. data from china but also systematic samples taken from the passengers of the diamond princess boat also report almost 50% of asymptomatic forms of covid-19. the medical and paramedical staff of the front-line services for the care of patients infected with covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract covid-19 disease, including in its asymptomatic form.

the epidemic due to sars-cov2 is spreading in france, without it being knowning precisely since when the virus actually circulated on the territory. data from china but also systematic samples taken from the passengers of the boat diamond princess also report almost 50% of asymptomatic forms of covid-19. medical and paramedical staff are in fact potentially exposed to the risk of professional contamination, with probably a different risk between the first-line referent hospitals and the others, due to the large number of patients treated in the first, including in the pre-epidemic phase (average of 190 consultants per day at the emergency department pitié-salpêtrière for example). therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract covid-19 disease, including in its asymptomatic form. knowledge of this seroconversion rate, if it is found to be higher than that of the general population, could lead to a review of the measures to protect personnel from other emerging infectious risks.

Eligibility criteria:
inclusion criteria: * any permanent medical or paramedic staff of participating services who have given written consent to participate * having a social security insurance. exclusion criteria: * non-permanent staff (occasional staffing), administrative staff, technical staff of participating services. * staff who were not active during the inclusion period.
an efficacy and safety study of cisapride for improving symptoms associated with gastroparesis in patients with diabetes mellitus

Conditions: Gastroparesis; Diabetes Mellitus

Summary: the purpose of this study is to assess the effectiveness of cisapride at improving symptoms associated with gastroparesis (a stomach disorder) in patients with diabetes mellitus.

this is a double-blind (neither the physician nor the patient will know the name of assigned treatment) study to determine the effectiveness of cisapride tablets compared to placebo tablets (a tablet identical in appearance to cisapride but does not contain active drug) at improving symptoms associated with diabetic gastroparesis when administered orally (by mouth) to patients with insulin dependent or non-insulin dependent diabetes mellitus. gastroparesis is a disorder also called delayed gastric emptying, in which the stomach takes too long to empty food into the small intestine for digestion. symptoms of gastroparesis may include vomiting, nausea, early feeling of fullness after only a few bites of food, weight loss due to poor absorption of nutrients or low calorie intake, abdominal bloating, poor glycemic (blood sugar) control, lack of appetite, and pain in the stomach area. patients will take study drug (one 10-mg tablet of cisapride, or one tablet of placebo), orally, 4 times a day, for a period of 8 weeks. study drug will be taken approximately 15 minutes before each meal and, with a beverage, before going to bed.

Eligibility criteria:
inclusion criteria: * diagnosed with insulin dependent or non-insulin dependent diabetes mellitus * experienced inadequate responses to, or have been intolerant of, treatment with at least one previous drug therapy for gastroparesis * have exacerbation of gastroparesis symptoms requiring medical attention * demonstrate delayed gastric emptying as assessed by a \[1-13c\]-sodium acetate breath test within 14 days before randomization exclusion criteria: * received prior treatment with cisapride * have a glycosylated hemoglobin (hba1c) \>10% at screening, as determined by clinical laboratory testing * have any upper gastrointestinal (gi) pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial * have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes * currently vomiting, or receiving therapy for a severe exacerbation of gastroparesis, that would prevent the patient from receiving oral therapy or a diet

Keywords: cisapride (prepulsid) placebo diabetes mellitus diabetic gastroparesis