Kornimate/medical-research-clean huggingface dataset:
depomedrol for genicular nerve block.

Conditions: Postoperative Pain

Summary: this study is designed to test the efficacy of adding depomedrol a long-acting steroid to bupivacaine for relieving postoperative pain and reducing opioid requirements following total knee replacement surgery. for this purpose, depomedrol will be added to bupivacaine for ultrasound-guided genicular nerve block combined with spinal anesthesia.

tka remains a challenge for physicians as more than half of these patients experience extreme knee pain immediately after surgery. the management of pain in patients undergoing total knee arthroplasty (tka) remains a challenge for the anesthesiologist even with regional anesthesia as no single regional technique is adequate to balance effective analgesia with minimal muscle weakness. severe postoperative pain following tka has been shown to negatively affect early mobilization, physical rehabilitation, time to discharge, and overall post-op recovery. multimodal analgesia incorporating regional anesthesia techniques provides optimum analgesia and minimizes the use of opioids and their side effects. proximal nerve blocks such as the lumbar plexus, femoral nerve, and proximal sciatic nerve blocks provide excellent analgesia but frequently cause motor weakness, which reduces the patient's mobility. a distal blockade of genicular branches has also been described using ultrasound in acute and chronic pain management with fewer side effects. the superior medial genicular nerve and lateral genicular nerve can be identified using ultrasound and blocked at the level of the medial intramuscular, and lateral femoral epicondyles deep to the vastus medialis and lateralis, respectively. the inferior medial genicular nerve can be also targeted medial to the tibial plateau adjacent to the genicular vessels. methylprednisolone acetate (mpa)(depomedrol) is a lipophilic glucocorticoid commonly used in chronic pain procedures. it has a good safety record and its analgesic action can last from days to weeks.(8) the literature supporting its role as an adjuvant to local anesthetic in peripheral nerve block are scanty. however, some studies showed that depo-methylprednisolone as an adjuvant to 0.5% lidocaine showed excellent results in neuropathic pain resulting from nerve injury. this study aims to evaluate the efficacy of adding depomedrol as an additive to bupivacaine in genicular nerve block for evaluating postoperative pain, opioid use, and ease of ambulation in patients undergoing tka.

Eligibility criteria:
inclusion criteria: * subjects scheduled for primary elective total knee arthroplasty. * american society of anesthesiologists physical status i-iii. * bmi 18-35 kg/m2. exclusion criteria: * bleeding disorders. * allergy to any of the drugs used in the study. * renal insufficiency. * liver failure * neurological abnormalities (uncooperative or psychologically unstable patients). * patient refusal. * contraindication to a peripheral nerve block. * asa iv or v. * skin lesions/infection at block site.
concomitant vaccination with the japanese encephalitis vaccine ic51 and harvix® 1440

Conditions: Japanese Encephalitis

Summary: the objective is to investigate the immunogenicity of the japanese encephalitis vaccine ic51 (je-piv) single and concomitant with havrix® 1440

this is a randomized, controlled, multi-center, single-blind phase 3 study. the study population consists of male and female healthy subjects, aged at least 18 years. 192 subjects will be enrolled at 2 sites in europe.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * in female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception * written informed consent obtained prior to study entry exclusion criteria: * history of clinical manifestation of any flavivirus infection * history of vaccination against japanese encephalitis (je), yellow fever and dengue fever (an anti-jev neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis) * history of any previous hepatitis a vaccination and infection * use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine * planned administration of another vaccine during the study period * immunodeficiency including post-organ-transplantation or immunosuppressive therapy * a family history of congenital or hereditary immunodeficiency * history of autoimmune disease * administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. * any acute infections within 4 weeks prior to enrollment * infection with human immunodeficiency virus (hiv), hepatitis b (hbsag) or hepatitis c
effects of cataract extraction surgery and limbal relaxing incision on corneal sensation and dry eye

Conditions: Dry Eye

Summary: this is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (lri) on corneal sensation and dry eye signs and symptoms.


Eligibility criteria:
inclusion criteria: * patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism exclusion criteria: * uncontrolled systemic disease * have undergone refractive surgery or any surgery involving a limbal or corneal incision * use of topical cyclosporine (restasis) within three months of baseline/randomization visit * temporary or permanent occlusion of the lacrimal puncta
study of selumetinib (azd6244)(arry-142886) in combination with irinotecan in previously treated patients with colorec

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine whether treatment with selumetinib (azd6244) (hyd-sulfate) in combination with irinotecan as a second treatment in patients with k-ras or b-raf mutation will prevent tumor progression and prolong progression free survival.

a dose finding and phase ii study of selumetinib (azd6244) (hyd-sulfate) in combination with irinotecan, in 2nd line patients with k-ras or b-raf mutation positive advanced or metastatic colorectal cancer

Eligibility criteria:
inclusion criteria: - histological or cytological confirmation of advanced or metastatic colorectal cancer with available tissue and tumor sample confirmed as k-ras or b-raf mutation positive. current failure of 1st line anti-cancer therapy with an oxaliplatin and bevacizumab based regimen or patients relapsing within 12 months of completing adjuvant folfox . exclusion criteria: - treatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drug prior treatment with a mek or b-raf inhibitor or any irinotecan-containing regimen prior treatment with a mek or b-raf inhibitor or any irinotecan-containing regimen

Keywords: colorectal second line therapy k-ras or b-raf mutations response rate progression free survival
the impact of a societal lockdown on those with spinal cord and brain injuries

Conditions: Brain Injuries; Stroke; Spinal Cord Injuries

Summary: document and evaluate the impact of societal restrictions due to the pandemic on sci- and abi-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with sci/abi.

the investigators will conduct a longitudinal survey to examine the impact of covid19 on those with sci and abi. an a priori sample size of 117 individuals based on an alpha level of .05 and level of acceptable error at 3% was calculated. anticipating for loss to follow up rate of up to 20%, a total of 142 participants will be recruited. patients will be recruited among those who attend virtual medical appointments at parkwood institute for abi and sci. we will also liaise with sci-ontario and the ontario brain injury association to assist in the recruitment of additional participants. those who consent will complete an online survey on enrollment into the study, and subsequently at 3 and 6 months. demographic data of the individuals participating in the study will be recorded. participants' access to health care services will be evaluated using the following subdomains: medical care, complementary care, medications/equipment, satisfaction/acceptability, affordability, ability to engage, and indirect support.

Eligibility criteria:
inclusion criteria: * stroke, spinal cord injury (traumatic and non-traumatic) or acquired brain injury (of all severities, including concussion) * live in the community * have the cognitive capacity to understand and complete the measures exclusion criteria: * does not have the cognitive capacity to understand and complete the measures * does not speak english

Keywords: stroke spinal cord injury brain injury covid access to health care mental health
study of vedolizumab in patients with moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: this study in patients with moderately to severely active crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

after completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study c13008; nct00790933) if study drug was well tolerated, and no major surgical intervention for crohn's disease occurred or was required. participants who did not enroll in study c13008 were to complete the final safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

Eligibility criteria:
inclusion criteria: * age 18 to 80 * diagnosis of moderately to severely active crohn's disease * crohn's disease involvement of the ileum and/or colon * demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol * may be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (ibd) as defined by the protocol exclusion criteria * evidence of abdominal abscess at the initial screening visit * extensive colonic resection, subtotal or total colectomy * history of \>3 small bowel resections or diagnosis of short bowel syndrome * ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine * have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol * chronic hepatitis b or c infection; human immunodeficiency virus (hiv) infection * active or latent tuberculosis
post-operative complications and smoking habits in colorectal surgery

Conditions: Colorectal Disorders

Summary: passage is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled.

the first part of the study is retrospective and data collection will be done the first 6 months. the enrolled patients will be divided into three groups (ft: tobacco smokers; nrt: nicotine replacement therapy; nf: non-smokers) and the data will be compared between groups to evaluate whether there are statistically significant differences regarding postoperative complications. the nf group will also be divided into patients who have never smoked and patients who have stopped smoking. a further analysis of ex-smoking patients will be performed to evaluate whether the incidence of complications differs from that observed in patients who have never smoked. the second part of the study will be prospective and will last one year. also in this study the enrolled patients will be divided into three groups (nf group, ft group, and nrt group) and data obtained from all recorded variables will be compared between the groups. the data obtained retrospectively and prospectively will be analyzed together for each group. the hypothesis of the study is that tobacco smoking plays a significant role in the appearance of postoperative complications. in particular, it is hypothesized that the group of patients taking nrt (defined as the group of nrt patients) has a higher incidence of postoperative complications after colorectal surgery than that observed in the control group of non-smoking (nf) or ex-smoking patients and lower to the group of tobacco smoking patients (ft).

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old. * patients who have read, understood, accepted and signed the informed consent to the study. * patients with benign or malignant colorectal disease. * patients undergoing colorectal surgery with any type of approach (open or minimally invasive) in italy. * patients undergoing elective and emergency colorectal surgery. * patients nf (non smoker), ft (tobacco smokers), nrt (nicotine replacement therapy). are considered smokers that patients who have smoked for at least 30 days at the time of surgery exclusion criteria: * patients \< 18 years old. * patients who have not accepted informed consent.
probiotics in the treatment of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement mutaflor, in the treatment of irritable bowel syndrome.

irritable bowel syndrome (ibs) is a chronic gastrointestinal (gi) disorder that affects around 11% of the population globally. several factors have been implicated in the pathogenesis of ibs, including psychological stress, gastrointestinal motility, and diet. more recently, it has become clear that the gastrointestinal microbiota may play a critical role in the pathophysiology of this functional gi condition. gut microbiome manipulation, for example through the use of probiotic and prebiotic supplements, has shown some promise in the treatment of ibs. however, the research in this area is still in its infancy, and it remains unclear what type of intervention that is the preferred choice in cases of ibs. many, if not most, probiotic supplements on the market today contain bacteria that are incapable of colonizing the human gut, which may partly explain why the health effects associated with the use of probiotics tend to be temporary, rather than permanent. several studies have investigated how the use of probiotic supplements containing bifidobacteria and lactobacilli affect the clinical outcome of patients with ibs. however, to date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic bacteria, are useful in the treatment of ibs. moreover, little is known about how other types of probiotic bacteria, such as those belonging to the genus escherichia, affect symptoms of ibs.

Eligibility criteria:
inclusion criteria: rome iii criteria (criteria fulfilled for the last 6 months with symptom onset at least 3 months prior to diagnosis): recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following: 1. improvement with defecation 2. onset associated with a change in frequency of stool 3. onset associated with a change in form (appearance) of stool exclusion criteria: * psychiatric disorder * metabolic disease * chronic infection * organic gastrointestinal disorder * pregnancy * breastfeeding

Keywords: irritable bowel syndrome the human microbiome microbiota gut microbiota probiotics sauerkraut
italian registry on multipoint left ventricular pacing

Conditions: Heart Failure; Ventricular Fibrillation; Ventricular Tachycardia

Summary: the iron-mpp is a prospective multicenter, observational registry designed to collect clinical and device data from a large cohort of hf patients treated in clinical practice with a crt-d device with the ability to deliver multi point pacing. the purpose of the registry is to collect data on how mpp-devices are being used by physicians in order to better understand how to improve the clinical care of patients and effectiveness of mpp therapy.


Eligibility criteria:
inclusion criteria: - patients implanted with a st. jude medical crt-d system with mpp capability exclusion criteria: - patients currently participating in any other clinical investigation

Keywords: cardiac resynchronization therapy multipoint left ventricular pacing
regulatory t cell infusion for lung injury due to covid-19 pneumonia

Conditions: COVID19; ARDS

Summary: to assess the safety and efficacy of ck0802 in treatment of patients with covid-19 induced moderate-to-severe pna-ards.


Eligibility criteria:
inclusion criteria: * documented to have an rt-pcr-based diagnosis of sars-cov-2 infection by rt-pcr * moderate-to-severe ards as defined by the berlin criteria: ratio of partial pressure of arterial oxygen (pao2) to the fraction of inspired oxygen (fio2) of 200 mm hg or less assessed with a positive end-expiratory pressure (peep) of \>5 cm h2o. * intubated for less than 120 hours * age ≥18 years * ability to provide informed consent or duly appointment health care proxy with the authority to provide informed consent. exclusion criteria: 1. in the opinion of the investigator, unlikely to survive for \>48 hours from screening. 2. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study. 3. currently receiving extracorporeal membrane oxygenation (ecmo) or high frequency oscillatory ventilation (hfov). 4. females who are pregnant. 5. patients with active bacteremia at start of therapy enrollment or concurrently active moderate to severe other infectious which in the opinion of the investigator may possibly affect the safety of ck0802 treatment. 6. patients who have been intubated for more than 120 hours. 7. known hypersensitivity to dmso or to porcine or bovine protein. 8. any end-stage organ disease which in the opinion of the investigator may possibly affect the safety of ck0802 treatment. 9. high dose steroids. 10. receiving an investigational cellular therapy agent.

Keywords: covid19 ards ck0802 t regulatory cells cord blood
homeostatic and non-homeostatic processing of food cues in anorexia nervosa

Conditions: Anorexia Nervosa; Healthy

Summary: the goal of the present study is to investigate metabolic gut-brain signaling and the neural correlates of distraction from visual food cues in patients with anorexia nervosa and healthy controls.

anorexia nervosa (an) is an eating disorder with high morbidity and lifetime mortality. this eating disorder is mainly characterized by restricted food intake despite a severely low body weight. given the pronounced self-starvation in an, the investigation of homeostatic food processing, and its interaction with the reward system is of great scientific interest. previous research in an patients has almost exclusively focused on cortical, non-homeostatic (e.g., reward related) food processing. therefore, the primary aim of the present study is to investigate metabolic gut-brain signaling by focusing on the responsivity of the hypothalamus (i.e., the core region of homeostatic control) and the mesocorticolimbic reward system. a secondary aim is to study the interaction between the mesocorticolimbic reward system and the homeostatic (i.e., hypothalamus) system. metabolic gut-brain signaling will be assessed by applying a single-blind, randomized, crossover design of intragastric infusion of glucose or water. this approach allows the study of gut-brain signaling to the hypothalamus and the reward system by controlling for sensory aspects of food intake (sight, smell, and taste) in an patients and healthy controls. furthermore, we will measure how cognitive strategies to control the desire for visual food cues (top-down control) affect the mesocorticolimbic and hypothalamic systems in an patients differently than in healthy controls. the interaction between the hypothalamus and the mesocorticolimbic reward system will be investigated using an effective connectivity analysis. functional magnetic resonance imaging with high spatial resolution and with an optimized protocol for the investigation of the hypothalamus and the mesocorticolimbic reward system will be used to study for the first time homeostatic and non-homeostatic food cue processing in an patients.

Eligibility criteria:
inclusion criteria: * patients that meet the diagnostic criteria for an (dsm-v criteria) * medically stable patients with a bmi \ 13 kg/m²; healthy controls with a bmi \ 18.5 kg/m² * over age of 18 years * no other lifetimes or current medical illness that could potentially affect appetite or body weight * right-handedness * normal or corrected-to-normal vision exclusion criteria: * history of head injury or surgery * history of neurological disorder * severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse) * smoking * borderline personality disorder * current psychotropic medication * inability to undergo fmri scanning (e.g. metallic implants, claustrophobia, pacemakers) * pregnancy
hypnosis in interventional electrophysiology

Conditions: Flutter, Atrial; Over 18 Years Old

Summary: hypnosis has already shown to decrease pain and anxiety in different surgical specialities. nevertheless, its input has never been studied in cardiology. this research is a prospective, monocentric, controlled and randomized study. patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis. global pain will be assessed by a visual analogue pain scale. anxiety, morphine consumption, and patient sedation will also be assessed. the aim of this study is to improve the care given to patient undergoing atrial flutter ablation.


Eligibility criteria:
inclusion criteria: * over 18 years old * surgery ablation of atrial flutter * agreement to participate of the study exclusion criteria: * person who does not speak french or deaf * chronic pain with the visual analogue scale \> 5 * psychiatric pathology * contraindication to paracetamol, lidocaine, morphine * pregnant women, or breast-feeding women or without effective contraception
prevention of depression in at-risk adolescents

Conditions: Depression

Summary: this study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.

depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. there is an increasing need to conduct large-scale depression prevention studies in adolescents. this study evaluates a cognitive-behavioral prevention (cbp) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. the study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in "real world" settings. participants in this study are randomly assigned to receive either cbp for eight weekly and 6 monthly continuation sessions or usual care. depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake.

Eligibility criteria:
inclusion criteria: * a parent has had a depressive disorder during child's life * adolescent has had a past depressive episode or has current subsyndromal depressive symptoms measured on the center for epidemiological studies depression scale (ces-d) exclusion criteria: * adolescent or parent ever diagnosed with bipolar i or schizophrenia; * adolescent has a current dsm-iv mood disorder diagnosis

Keywords: adolescent