Kornimate/medical-research-clean huggingface dataset:
sivextro in acute bacterial skin and skin structure infection (absssi) in hospitalized patients. a global observational study

Conditions: Skin Disease, Infectious

Summary: this open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intended to provide real life data on the treatment duration, effectiveness and safety of tedizolid and linezolid when treating absssi hospitalized patients in a real practice setting.

the primary objective of this study was to assess the treatment duration in the real life in 2 cohorts consisting of patients treated by 200 mg once daily iv/po tedizolid or treated by 600 mg twice daily iv/po (intravenous/per oral) linezolid.

Eligibility criteria:
inclusion criteria: * adult female and male in-patients with clinical diagnosis compatible with absssi (cellulitis/erysipelas, major skin abscess or wound infections) with a clinical suspicion of infection by gram positive bacteria (with or without laboratory confirmation). * patients for whom the decision to initiate treatment with tedizolid phosphate or linezolid was made as per physician's routine treatment practice. * signed informed consent. exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice. * patients who have been enrolled in this study before.

Keywords: acute bacterial skin infection acute bacterial skin and skin structure infection (absssi) abscess cellulitis erysipelas wound infection methicillin resistant staphylococcus aureus (mrsa)
early intervention to promote cardiovascular health of mothers and children (enrich) during pregnancy

Conditions: Cardiovascular Diseases; Pregnancy Related; Sedentary Behavior

Summary: this pilot study aims to examine the feasibility and acceptability of adding a cardiovascular health module to the existing nurse family partnership (nfp) home visitation program delivered by trained nurses in the northern appalachian region of central pennsylvania.

the promoting cardiovascular health of northern appalachian women during and after pregnancy: pilot study is a single arm pilot study that will enroll pregnant women (\<28 weeks' gestation) participating in the nfp home visitation program in the northern appalachian region of central pennsylvania. this pilot study will include an enhanced version of the nfp standard care plan delivered by trained nurses to promote cardiovascular health among women by targeting decreased sedentary time and enhanced physical activity (and where applicable smoking cessation) during and after pregnancy. this pilot study will also examine the feasibility and acceptability of digital devices (actigraphy, digital scale, blood pressure monitor) during this same time period.

Eligibility criteria:
inclusion criteria: 1. nulliparous pregnant woman 2. age ≥ 18 years old 3. enrolled in and receiving the nurse-family partnership program through the geisinger clinic or upmc home health care of central pa 4. english speaking 5. women with a singleton viable pregnancy confirmed by nfp home visitors 6. access to reliable internet service required for data collection 7. a minimum of 5 women with use of nicotine containing products (cigarette, cigar, hookah, chewing tobacco, e-cigarette, patch) within the past 3 months exclusion criteria: 1. unable or unwilling to comply with the study visits and procedures 2. participation in a concurrent interventional study 3. diagnosis of cancer 4. a personal history of complex congenital heart disease 5. a fetus in the current pregnancy with known chromosomal abnormalities or birth defects inconsistent with survival to 2 years will be excluded
prevention of surgical site infections: effectiveness of nasal povidone-iodine and nasal mupirocin

Conditions: Surgical Site Infection

Summary: we hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term staphylococcus aureus(sa)suppression. our overall study objective is to measure the rate of deep and superficial surgical site infections (ssis) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery. secondary study objectives include: 1. measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups. 2. measure adverse events related to mupirocin and povidone-iodine. 3. measure rate of sa resistance to mupirocin.

we hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term staphylococcus aureus(sa)suppression. our overall study objective is to measure the rate of deep and superficial surgical site infections (ssis) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.

Eligibility criteria:
inclusion criteria: * primary arthroplasty or spinal fusion surgery * age greater than 18 years exclusion criteria: * revision arthroplasty * revision spinal fusion surgery * primary spine surgery without implantation of prosthetic material * allergy to mupirocin * allergy to povidone-iodine * pregnancy * breastfeeding
effectiveness of a home based exercise program on temporomandibular dysfunction syndrome

Conditions: Temporomandibular Disorder

Summary: patients with chronic refractory temporomandibular dysfunction were prescribed home exercise and were followed for 6 months. pain , mouth opening and fonseca's were done at day 1 and after 6 months of the study.

each patient was seen by the rheumatologist who did the following; full history taking including special habits like chewing gums or biting nails, pain level measured by visual analogue scale 100 (both at rest and during temporomandibular joint movement) clinical examination of the temporomandibular joint including localized tenderness and amount of mouth opening after that the patients were prescribed the rehabilitation program in the form of heat modalities and transcutaneous electric nerve stimulation on the on the temporomandibular joint, given an individual demonstration of the home based exercises and were given a reminding handout. the rehabilitation program consisted of the following exercises: lateral deviation, protrusion/retraction and mandibular opening. isometric cervical muscle strengthening exercises were also prescribed for the patients. assessment of the severity of temporomandibular joint affection using the fonseca's questionnaire were done twice; the first at the entry point to the study and once again after 6 months.

Eligibility criteria:
inclusion criteria: * patients suffering painful temporomandibular joint exclusion criteria: * patients with history of face trauma * patients with surgery at the temporomandibular joint * dental procedure in the last 6 months period * patients with rheumatic diseases

Keywords: temporomandibular dysfunction exercise treatment pain
bone to skin thickness study: obese versus normal population

Conditions: Fracture

Summary: the purpose of this study is to determine the bone to skin depth for groups of lean, obese and morbidly obese patients. this information will be potentially helpful with implant design for obese and lean patients.

this study will examine pelvic ct scans of injured patients to determine skin thickness in several distinct regions important in orthopedic surgery. all patients admitted to the university of mississippi medical center with a pelvic ring injury or acetabular fracture obtain a pelvic ct scan as a standard part of patient evaluation. the ct scans attempt to encompass the entire soft tissue sleeve from the skin edge to the pelvic bones. several landmarks described below have been described to measure important surgical sites where obesity is problematical. therefore this study is an attempt to quantify the size of the soft tissue envelope in patients however, patients who are markedly obese may be too large for the entire soft tissue sleeve to be imaged with the ct scan. the second part of the study then is to validate the ct scan measurements obtained using clinical measurements. the clinical measurements will be obtained during operative management of displaced pelvic ring injuries and/or acetabular fractures. during surgical exposure, a measuring tape will be used to measure the soft tissue thickness in those areas corresponding to the ct scan measurements. these measures will be compared to validate the effectiveness of ct scan measurements to accurately document the soft tissue dimensions.

Eligibility criteria:
inclusion criteria: * anyone admitted to the university of mississippi medical center with a pelvic ring or acetabular injury exclusion criteria: * those not fitting the inclusion criteria

Keywords: acetabular fracture pelvic ring injury
gene therapy for chronic granulomatous disease in korea

Conditions: Chronic Granulomatous Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of administration of autologous hematopoietic stem cells transduced with mt-gp91 retroviral vector for patients with x-linked chronic granulomatous disease.


Eligibility criteria:
inclusion criteria: * gp91 defective male patients with chronic granulomatous disease: confirmed by dhr * weigh greater than or equal to 15 kg * history of severe infections: more than 2 times * performance status: ecog 0-2 * patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. * heart: a shortening fraction \> 28%; qtc interval \< 0.44 * liver: total bilirubin \< 2 × upper limit of normal; alt \< 3 × upper limit of normal; ast \< 3 x upper limit of normal * kidney: creatine \< 2 x normal * blood: wbc \> 2,500/ul; platelet \> 100,000/ul; hematocrit \> 26% * written informed consent obtained from patient (or guardian if patients age \< 19) exclusion criteria: * presence of a hla-matched sibling for stem cell donation * evidence or history of malignant tumor * presence of a severe infection * presence of an active tuberculosis * uncorrectable electrolyte, ca, p * unable to comply with the protocol or to cooperate fully with the investigator or site personnel

Keywords: chronic granulomatous disease retroviral vector gene therapy
pilot study of the neuro-spinal scaffold for the treatment of ais a cervical acute sci

Conditions: Traumatic Cervical Acute Spinal Cord Injury

Summary: pilot study of clinical safety and feasibility of the neuro-spinal scaffoldtm for the treatment of complete (ais a) traumatic acute spinal cord injury at the c5-t1 neurological levels the purpose of this study is to support an expansion to support marketing applications as well as future studies.


Eligibility criteria:
inclusion criteria: * 16-70 years of age, inclusive * ais a classification of traumatic spinal cord injury with a neurological level within c5-t1 inclusive * recent injury * non-penetrating sci exclusion criteria: * terminally ill subjects not likely to be able to participate in follow-up * incomplete spinal cord injury (ais b, c, d, and e injuries) * no identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a scaffold can be placed * spinal cord injury associated with significant traumatic brain injury or coma that * radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the investigator where the contusion completely bridges a full cross-section of the spinal cord * subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds

Keywords: spinal cord injury sci complete (ais a) traumatic acute spinal cord injury
vibone in cervical and lumbar spine fusion

Conditions: Spondylosis; Cervical Spondylosis; Spondylolisthesis; Herniated Nucleus Pulposus; Degenerative Disc Disease

Summary: assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (acdf) or lumbar interbody fusion (tlif, plif, alif, or llif) using vibone.

this study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of vibone in patients undergoing acdf or lumbar interbody fusion. data will be gathered for subjects undergoing acdf surgery and subjects undergoing lumbar fusion surgery using vibone. total enrollment is expected to be approximately 100 subjects. the purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level acdf or lumbar interbody fusion surgery using vibone. subjects will be followed for 12 months following surgery.

Eligibility criteria:
inclusion criteria: * male or female, 18-80 years of age * for cervical cases - acdf surgery at 1, 2, or 3 contiguous levels between c2-c7 * for lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between l1-s1 * patient signed consent form with hipaa authorization * appropriate candidate for surgery * patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). pre-operative and post-operative visits include x-ray (required) and ct scan (if available). exclusion criteria: * long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, dmards, etc.) * treatment with radiotherapy * acute or chronic systemic or localized spinal infections * instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for acdf patients) or lumbar (for tlif, plif, alif, or llif patients) spine * previous pseudoarthrosis at any level of the cervical (for acdf patients) or lumbar (for * tlif, plif, alif, or llif patients) spine * nursing mothers or women who are pregnant or plan to become pregnant during the course of the study * current or recent history of malignancy or infectious disease. patients with current or recent history of basal cell carcinoma are eligible. * inability to provide informed consent * rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density score of ≤-2.5). * other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (wbc), or marked left shift in the wbc differential count. * active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.

Keywords: anterior cervical discectomy and fusion (acdf) transforaminal lumbar interbody fusion (tlif) posterior lumbar interbody fusion (plif)
ivl and ra in treatment of balloon-crossable severely calcified coronary lesions

Conditions: Coronary Calcification

Summary: this study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before des implantation.

coronary artery calcification (cac) occurs in over 90% of men and 67% of women older than 70 years old . severe coronary calcification may be present in about 20% of patients undergoing percutaneous coronary intervention (pci) . coronary calcification may impair stent delivery and expansion and damage the polymer/drug coating, resulting in impaired drug delivery and predispose to restenosis and stent thrombosis. intravascular imaging as intravascular ultrasound (ivus) and optical coherence tomography (oct) are good tools to assess calcium burden, distribution and thickness. among the two imaging techniques, oct was found to be more accurate than ivus in defining calcium burden, calcium area , thickness and calcium length. rotational atherectomy (ra) as a method of severely calcified lesions modification before drug-eluting-stent (des) implantation has shown good outcomes in recent studies. however, its efficacy is reduced in presence of deep calcification. recently, intravascular lithotripsy (ivl) has been introduced as a novel modality for severely calcified coronary lesion preparation with good preliminary outcomes . currently the two techniques are regularly being used in combination in order to achieve optimal results . whether ivl is a method equally good (or superior) to rotablation in cases where anatomy does not exclude the use of either technique (for example balloon-crossable, heavily calcified lesions) has not yet been discussed.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years undergoing pci because of stable angina (uncontrolled symptoms on optimal medical treatment) or post stabilized acute coronary syndrome (acs). * patients have severe calcification: defined either angiographically or by oct (or ivus) as calcium arch \>180º in at least one cross section , calcium length \>5mm, calcium thickness \>0.5 mm (2, 6). * vessel diameter ≥2.5mm and ≤4.0mm . * heavily calcified lesion length less than 40mm. * all patients must have been discussed in the heart team of the hospital and accepted for coronary intervention exclusion criteria: * severe coronary calcification with lesion uncrossable from a balloon. * pcis in the setting of stemi or nstemi with persistent complains. * patients in cardiogenic shock. * heart failure new york heart association (nyha) class iv.

Keywords: ivl ra
efficacy and safety of ckd-501 added to d150 plus d745 25mg therapy in patients with type 2 diabetes

Conditions: Type2 Diabetes

Summary: the purpose of this study is to prove that the group treated with ckd-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.

the aim of this phase iii study was to evaluate the efficacy and safety of additional combined ckd-501 administration for 24 weeks in patients with type 2 diabetes who were not adequately controlled for blood glucose by the combination of d150 and d745 25mg . furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of actual drug as an oral hypoglycemic agent.

Eligibility criteria:
inclusion criteria: * between 19 years and 75 years old(male or female) * type ⅱ diabetes mellitus * the patient who has been taking oral hypoglycemic agent at least 8weeks with hba1c 7 to 10% at screening test * body mass index between 21kg/㎡ and 40kg/㎡ * c-peptide \> 1.0 ng/ml * agreement with written informed consent * hba1c 7 to 10% after run-in period exclusion criteria: * type i diabetes or secondary diabetes * continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening * treatment with thiazolidinedione within 3months or patient who has experience such as hypersensitivity reaction, serious adverse event with thiazolidinedione(tzd), sodium glucose cotransporter 2(sglt2) inhibitor, biguanide. * chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening * treatment with anti-obesity drugs within 3months * past history: lactic acidosis, genetic problem such as galactose intolerance, etc. * acute or chronic metabolic acidosis including diabetic ketoacidosis * history of proliferative diabetic retinopathy * patient with severe infection, severe injury * patients with urinary tract infection including urinary tract sepsis and pyelonephritis * malnutrition, weakness, starvation, hyposthenia, pituitary insufficiency or adrenal insufficiency * history of malignant tumor within 5years * drug abuse or history of alcoholism * severe pulmonary dysfunction * severe gi disorder * history of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage or unstable angina within 6 months * abnormal lab result: ① fasting plasma glucose \> 270 mg/dl ② triglyceride ≥ 500 mg/dl ③ significant liver dysfunction or ast(aspartate transaminase)/alt(alanine transaminase) ≥ normal range\*3 or total bilirubin ≥ normal range\*2 ④ hemoglobin\<10.5g/dl ⑤ abnormality of thyroid function(significantly out of normal tsh(thyroid stimulating hormone) range) * egfr(estimated glomerular filtration rate) is less than 60ml/min/1.73m\^2 * pregnant women or nursing mothers * fertile women who not practice contraception with appropriate methods * participated in other trial within 4 weeks or participating in other trial at present * in investigator's judgment
artificial intelligence based models for primary sjögren's syndrome diagnosis

Conditions: Primary Sjögren&#39;s Syndrome (pSS)

Summary: the goal of this observational study is to develop and validate artificial intelligence (ai)-driven models for improving the diagnosis of primary sjögren's syndrome (pss) using routine laboratory test data. the main question it aims to answer is: can ai-based algorithms accurately diagnose primary sjögren's syndrome by analyzing laboratory test results, and do they outperform traditional diagnostic criteria in chinese populations? researchers will retrospectively analyze anonymized clinical records and laboratory data (e.g., autoantibody levels, inflammatory markers) from patients with suspected or confirmed pss across multiple medical centers in china. no new interventions will be administered, as the study utilizes existing historical data to train and validate the ai models. the performance of ai algorithms will be compared with current diagnostic standards (e.g., acr/eular criteria) in terms of sensitivity, specificity, and clinical utility.


Eligibility criteria:
inclusion criteria: * patients with clinician-diagnosed primary sjögren's syndrome (pss) meeting the 2016 acr/eular or 2002 aceg classification criteria (objective oral/ocular dryness, positive anti-ssa/ro antibodies, or focal lymphocytic sialadenitis on biopsy). * control groups: individuals with non-pss autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) or non-autoimmune conditions (e.g., dry eye/sicca symptoms without systemic autoimmunity). exclusion criteria: * pregnancy, breastfeeding, with a clear diagnosis of other autoimmune diseases, severe infection and malignant tumors. * not newly diagnosed in any of the hospitals. * without any available laboratory tests.