Kornimate/medical-research-clean huggingface dataset:
predictive factors of anti-tnf response in luminal crohn's disease complicated by abscess

Conditions: CD

Summary: to identify predictive factors of adalimumab (anti tnf) response in patients with luminal crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection.

multicenter prospective observational cohort. initial management of sepsis and abscess (before anti-tnf therapy initiation) i. antibiotics. ii. percutaneous drainage will be performed every time when possible iii. surgical drainage will be performed if percutaneous drainage is not accessible or fails iv. concomitant medications : * steroids will be rapidly tapered and stopped. * azathioprine, 6-mercaptopurtine, 5-asa derivatives and methotrexate will be maintained at a stable dose. * if not present at inclusion, immunosuppressors could be introduced at the discretion of investigator * antibiotics could be used if needed for infections not related to intra-abdominal abscess recurrence and crohn's disease. v. supportive care including artificial nutrition will be started if necessary. 2. anti-tnf therapy: - the anti-tnf agent will be adalimumab, administered as subcutaneous injection of 160 mg at w0, 80 mg at w2, followed by 40 mg every 2 weeks.

Eligibility criteria:
inclusion criteria: * age greater than 18 years. * diagnosis of crohn's disease (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to european guidelines) * and diagnosis of spontaneous intra-abdominal and/or pelvic abscess according to radiologic criteria confirmed by us, ct or magnetic resonance enterography (mre). * in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies * written consent main exclusion criteria: * age under 18 years. - absence of written consent. - post-operative abscess (occurring within 12 weeks after intestinal resection). - isolated intra-parietal abscess of small intestine or colon. - need for immediate surgery including irreversible bowel obstruction, peritonitis or uncontrolled sepsis. - perineal abscess complicating perianal crohn's disease. - abscess developing under anti-tnf therapy. - previous failure or intolerance to adalimumab. - contraindication to anti-tnf therapy.
effects of intranasal nerve growth factor for acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: stroke remains one of the leading causes of death and adult disability worldwide. yet, currently, the only accepted treatment for acute ischemic stroke(ais) is recanalization of occluded arteries. thrombolysis with tissue plasminogen activator, limited by its narrow therapeutic time window and the concern of hemorrhagic complication, is still uncommon in use. the other approach is to try to impede the ischemic cascade by targeting various components of the cascade that are deemed to be of importance, namely, a neuroprotection strategy. nerve growth factor (ngf) plays extensive roles in preventing ischemic injury. besides that, it is also involved in neurogenesis of the central nervous system (cns). in addition, the levels of ngf protein and messenger rna significantly decreased in the cns at the first few hours and returned to normal levels several days later after middle cerebral artery occlusion (mcao) in animal models. these observed results suggested that ngf was demanded in ischemic brain injury, but endogenous ngf is insufficient for the requirement and delivering exogenous ones will be blocked in entering into the cns by the blood-brain barrier (bbb). intracerebroventricular or intracerebral injection of ngf or grafting of ngf-producing cells may be less practicable due to invasiveness and safety concerns. intranasal (in) administration is a noninvasive and acceptable delivery strategy for drugs bypassing bbb and can deliver ngf to the cns, which has been proved to show neuroprotective effects on brain injury. the effects of intranasal ngf in human ischemic stroke is still controversial that need further evaluation.

the proposed study is a randomized, double-blind, placebo-controlled trail of ngf, starting between 24 to 72 hours post acute ischemic stroke, continuing for 2 weeks.

Eligibility criteria:
inclusion criteria: 1. age ≥18years; 2. acute ischemic stroke consistent within 72 hours; 3. written informed consent from patient or surrogate, if unable to provide consent. exclusion criteria: 1. premorbid mrs ≥ 3 points; 2. currently in pregnant or lactating; 3. allergy to ngf; 4. current participation in another investigation drug or device study; 5. life expectancy less than 1 year.

Keywords: acute ischemic stroke nerve growth factor intranasal neurological function
prognosis of lung transplant candidates

Conditions: Lung Transplantation; Respiratory Failure

Summary: the purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in japan.

the significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

Eligibility criteria:
inclusion criteria: * new lung transplant candidates exclusion criteria: * heart and lung transplant candidates * uncontrolled severe comorbidities

Keywords: lung transplant candidates health-related quality of life patient reported outcome prognosis
study of the bdnf-val66met polymorphism in alcohol-dependent subjects in relation to abstinence after withdrawal

Conditions: Alcohol Dependence

Summary: this study is complementary to the main study "brain derived neurotrophic factor serum levels evolution during the six months after alcohol withdrawal " nct01491347. the purpose of this study is to evaluate the bdnf gene - val66met polymorphism in subjects with alcohol dependence according to their alcohol consumption status 6 months after withdrawal (relapse or abstinence), in relation to the presence of psychiatric co-morbidities.


Eligibility criteria:
inclusion criteria: * participation to the study "bdnf serum levels evolution during 6 months after alcohol withdrawal" (main study) * criteria from the main study exclusion criteria: * criteria from the main study * released or out from the main study before the follow-up at 4 months after withdrawal
fast-track in minimally invasive gynaecology

Conditions: Gynecologic Disease

Summary: objective: evaluate the effects of a fast-track (ft) protocol on costs and postoperative recovery. design: randomized trial setting: university hospitals population: 170 women undergoing total laparoscopic hysterectomy for a benign indication methods: a ft protocol included the combination of minimally invasive surgery, analgesia optimization, early oral refeeding and rapid mobilization of patients was compared to a usual care protocol. main outcomes measure: primary outcome was costs. secondary outcomes were length of stay, postoperative morbidity and patient satisfaction.

1. fast-track protocol: preoperative * anesthetic consultation * proposal of optimization of patient's general health state + family meeting if necessary * hospitalization on day of surgery * solids stopped 6 hours prior to surgery, drinking encouraged up to 2 hours prior to surgery during surgery * anti-infectious prophylaxis * anesthesia via iv propofol/remifentanil * anti-nausea prophylaxis * pain control based on limited systemic opioid use postoperative * balanced analgesia for pain control * antithrombotic prophylaxis * early oral refeeding * rapid mobilization * gum chewing * foley catheter removal at the end of surgery * peripheral iv catheter removal 6 hours postoperatively 2. usual care protocol : preoperative * anesthetic consultation * hospitalization on day of surgery * fasting beginning at midnight prior to surgery during surgery * anti-infectious prophylaxis * balanced anesthesia via halogen gas * anti-nausea medication if needed postoperative * balanced analgesia for pain control * antithrombotic prophylaxis * same-day refeeding according to patient's wish * same-day mobilization according to patient's wish * foley and peripheral iv catheter removal on day 1 postoperatively

Eligibility criteria:
inclusion criteria: * women undergoing total laparoscopic hysterectomy for a benign indication exclusion criteria: * the requirement for an additional surgical procedure, such as prolapse repair or urinary incontinence, because a prolonged operative time could compromise early patient discharge and * the inability to speak french because the patients were required to complete their data collection logbook in french.

Keywords: fast-track laparoscopic hysterectomy hospital costs
role of tirads and bethesda scoring systems in management of thyroid nodules

Conditions: Thyroid Nodule

Summary: role of tirads and bethesda scoring system in management of thyroid nodules as these methods are ultrasound clasification that helps increase the diagnostic effectiveness of thyroid nodules and reduces the use of preopeative fna .that nodules are usually divided into diffent categories based on tirads and are then referred to fna and follow up according to variable risk of maligneny.

this study is an observational study will be conducted on patiend with thyroid nodules will be admitted to general surgical department at sohag university hospital . patients will be approved to have single or multinodular goitre and thyroid nodules more than 1 cm . thyroid nodules are very common disease with great clinical importance although most cases are benign and only 4.5% to 6.5% are malignant ... itis necessary to distinguish those cases to reduce frequency of unnecessary thyroidectomies ... ultrasound classification and fine needle aspiration (fna) are first line diagnostic procedures and help in decrease cases undergoing unnecessary thyroidectomies as 50% of the nodules removed recently are malignant and the number of patients undergoing surgery is significantly reduced.

Eligibility criteria:
inclusion criteria: * patients will proved to have single or multinodular goitre thyroid nodules more than 1cm exclusion criteria: * thyroid nodules less than 1 cm history of thyroid surgery history of radiotherapy
a prospective pilot study (bio|select pilot)

Conditions: Heart Failure

Summary: enrolled patients implanted with biotronik crt-d and qp lead equipped with multipole pacing mode is grouped into which programmed into multipole pacing, or conventional bi-ventricular pacing mode. they are followed up by seven month post implantation, and predefined cardiac functional parameters are collected at each visit.

enrolled patients will undergo the baseline medical tests to assess the cardiac functions (e.g. echo, blood test, and 12-lead ecg) prior to the implantation of biotronik crt-d and qp lead featured with multipole pacing parameter. at implantation, lv-lv conduction delays are measured in predefined lv pacing and sensing configurations. one month after the successful implantation, the patients revisit the investigation site to be adjudicated for programming multipole pacing or continuing bi-ventricular pacing mode, based on their echo readings by then. patients are subsequently followed up at four and seven month post implantation to acquire the lv-lv conduction delays and echo readings, etc. at the time.

Eligibility criteria:
inclusion criteria: to be eligible for the study enrollment, candidate patients must meet all of the following criteria * indicated for a crt-d implantation * has never received crt * planned to be implanted with a quadripolar lv lead, and crt-d with multipole pacing feature, both manufactured by biotronik * geographically stable and willing to comply with the required follow-up schedule * with written informed consent exclusion criteria: candidate patients will not be eligible if either of the following criteria is applicable * underwent a cardiac surgery within last 3 months, or scheduled for cardiac surgery other than crt implantation * life expectancy is less than a year * can not be programmed to multipole pacing "on" * does not agree to the concept of homemonitoring system * with known pregnancy * at age below 20 years * participated in another interventional clinical study

Keywords: lv-lv conduction delay
prednisolone for pain reduction in knee oa

Conditions: Pain

Summary: background: osteoarthritis (oa), a common disabling condition, is the commonest type of arthritis worldwide. knee oa is the 4th leading cause of disability in women. pain is the leading symptom and is often chronic in nature leading to significant morbidity and decreased quality of life. synovitis is prevalent in knee oa and treatment to relieve this synovitis may reduce pain. objectives: a randomized double-blind placebo-controlled trial will be conducted to assess whether 6 weeks of daily low dose oral prednisolone will improve pain, mobility and systemic low-grade inflammation, in the short term and to determine if it sustained long term at 12 weeks in older adults with moderate to severe knee oa. methods: 125 community-dwelling older adults aged 65 years and above with primary knee oa diagnosed according to the acr criteria for diagnosis of primary oa of the knee will berandomized 1:1. sixty three will receive 7.5 mg/day of prednisolone and 62 will receive placebo together with their usual therapy for 6 weeks. the primary outcome measure will be pain reduction. secondary outcome measures will be reduction in systemic inflammation and improvements in physical functioning scores. alterations in dosage of analgesic/nsaid drugs used will be recorded. safety and tolerability were also assessed. data will be collected at baseline, 6 weeks and at 12 weeks to determine any change in results from those obtained at 6 weeks. exclusion criteria will include any inflammatory or serious medical condition. knee oa will be documented by radiographic examination using the kellgren-lawrence scale. symptomatic oa will be defined as the need to take nsaids daily and lequesnealgofunctional index (lfi)score \> 4. clinical assessment will be include: visual analogue pain scale (vas, 0-100), self-reported physical function as measured with the western ontario and mcmaster universities osteoarthritis index (womac), womac pain and stiffness scores, and six-minute walk distance (6mwd). all patients will undergo a physical examination and will be questioned about the number of flares, pain and analgesic use. blood samples will be collected and serum levels of il-1, il-6, tnf-alpha and hscrp will be measured in all patients.


Eligibility criteria:
inclusion criteria: * community-dwelling older adults aged 65 years and above with primary knee oa diagnosed according to the acr criteria for diagnosis of primary oa of the knee exclusion criteria: * any inflammatory or serious medical condition

Keywords: prednisolone, pain, inflammation, mobility function
skin elasticity measurements of the face and surgical scars stratified by age and skin type

Conditions: Skin Scarring; Skin Elasticity

Summary: the primary objective of part a is to compare the change in elasticity measurements at baseline and at 3 months between subjects who have had a resurfacing or tightening procedure and those who have not. the secondary objective for part a is to develop baseline elasticity scores for ages 18-35, 36-50, and 51-65 and for fitzpatrick skin types i-ii, iii-iv, and v-vi. the primary objective of part b is to compare the age of the scar and surrounding tissue with the elasticity measurements.


Eligibility criteria:
inclusion criteria: part a: * subject is 18-65 years of age * subject scheduled to have resurfacing or tightening procedure done as standard of care (arm 1, 25 subjects). * the subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator part b: * subject is 18 and over * subject has a linear surgical scar that is \> 2cm. * the subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator exclusion criteria: part a, group 1: -subject is planning on having a cosmetic procedure done to their face during the 3 months they are participating in the study (arm 2, 25 subjects). parts a and b: * under 18 years of age * pregnancy or lactation * subjects who are unable to understand the protocol or to give informed consent * subjects with mental illness

Keywords: skin elasticity scar elasticity cutometer dermal torque meter
improving diabetes equity and advancing care study

Conditions: Diabetes; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in chicago. the study aim is to determine optimization of intervention components. participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. after 6 months, participants will be rerandomized to a subsequent study arm (including a chw support program) depending on a tailoring variable of change in a1c. researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in a1c.

sinai health system is illinois' largest private safety-net healthcare system, serving predominantly low-income communities of color with large medicaid-eligible populations in chicago. in response to high diabetes rates and community calls for coordinated, multidisciplinary diabetes care, sinai designed the center for diabetes and endocrinology (the center) which launched in 2020. the center uses a comprehensive model with streamlined services to address the full spectrum of patient medical and non-medical needs. this study seeks to determine the appropriateness and fidelity of three intervention components of a team-based care model for patients served by the center to define the ideal sequence for improving patient outcomes. grounded in qualitative methodology and guided by a sequential multiple assignment randomized trial (smart), we propose evaluating the appropriateness of novel intervention components (aim 1); measuring fidelity of new intervention components (aim 2); comparing the effectiveness and determine optimization of intervention components (aim 3). we will evaluate aim 1 via key stakeholder interviews and focus groups. we will analyze aims 2 \& 3 by conducting descriptive statistics on all variables, giving special attention to outlier values. we will also run bivariate and multivariate analyses across variables of interest and time points to determine the optimal sequence of intervention activities.

Eligibility criteria:
inclusion criteria: * a diagnosis of type 1 or type 2 diabetes * 18+ years of age * able to provide consent * identify as african american/black or latinx * most recent hba1c \> 7%, * have a smartphone compatible with the glooko application * have completed at least one center appointment (i.e. current patient) * completed at least 3 months of their assigned study condition exclusion criteria: * already an active user of rgm * actively working with a chw * diagnosis of gestational diabetes (without type 1 or type 2) * has a power of attorney * be suffering from stage-v renal disease or undergoing dialysis. * be suffering from a severe form of cardiovascular disease (nyha class iii and iv)

Keywords: implementation science optimization study
evaluating the utility of bone grafts in open wedge corrective osteotomy and plate fixation

Conditions: Malunion of Fracture of Radius

Summary: introduction a variety of bone grafts and substitutes are available for filling bone defects in the distal radius after corrective osteotomy, but the harvesting of bone from the iliac crest is the gold standard as it allows easy access to corticocancellous bone of a desirable quality and quantity. the idea behind bone grafting is to provide optimal bone formation and structural stability, which is crucial for bone healing. however, the harvesting and use of bone from the iliac crest potentially comes with the risk of complications such as delayed union of the osteotomy defect; size mismatch between the graft and the osteotomy defect; longer operation time; donor site morbidity including nerve, arterial, and ureteral injury; herniation of abdominal contents; sacroiliac joint instability; pelvic fractures; hematoma and infection. as these disadvantages of bone grafting can have a major impact on patients' everyday lives, research is needed on whether bone grafting is genuinely necessary during corrective osteotomy and plate fixation of the distal radius objective the objective of this study is to investigate whether harvested bone graft from the iliac crest necessary is during corrective osteotomy and plate fixation in patients with malunited distal radius fractures. study design this is a prospective, randomized, controlled multicenter study. patients will undergo the following examinations once before the operation and five times afterwards: 1) the patients will fill out three questionnaires, 2) complications will be noted, 3) the wrist function will be measured, and 4) radiographs/ct scans will be made. study population all patients over the age of 18 years who have a symptomatic malunion after distal radius fracture and are eligible for surgical correction. intervention surgical correction in the form of open wedge corrective osteotomy and plate fixation without bone grafting. usual care open wedge corrective osteotomy and plate fixation with harvesting bone from the iliac crest. outcome measures primary outcomes: complications and quality of life. secondary outcomes: time to complete bone healing, functional outcomes, and cost effectiveness.


Eligibility criteria:
inclusion criteria: * patients of either sex over the age of 18 years * symptomatic malunion of the distal radius * eligible for open wedge osteotomy and plate fixation with or without bone grafting from iliac crest. * patients are able to undergo postoperative follow-up of at least 12 months. exclusion criteria: * patients who are pregnant * patients who have known systemic or metabolic disorders leading to progressive bone deterioration * patients who take chronic use of glucocorticoids.

Keywords: open wedge osteotomy bone grafting time of bone healing complications quality of life subjective and objective functional outcomes cost effectiveness