Kornimate/medical-research-clean huggingface dataset:
effect of lidocaine on postoperative pain and long-term survival in elderly patients undergoing colorectal surgery

Conditions: Colorectal Cancer

Summary: this study is a further observation and follow-up of the patients enrolled in the registration number nct05920980 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing colorectal cancer surgery.

this study is a further observation and follow-up of the patients enrolled in the registration number nct05920980 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing colorectal cancer surgery. patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group. in the lidocaine group, lidocaine 1.5mg/kg/h was continuously infused (using ideal body weight) during the whole procedure. postoperative analgesia pump with lidocaine (lidocaine 50mg/kg, sufentanil 2ug/kg, glassetron 12mg) diluted to 200ml with saline until 72h after surgery. in the placebo group, the same volume of normal saline will be administered during anesthesia. the postoperative pcia device will contain sufentanil 2μg/kg, granisetron 12mg diluted to 200ml in 0.9% normal saline solution with a total volume of 200ml.follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival and overall survival from postoperative 3 months to 5 years.

Eligibility criteria:
inclusion criteria: 1. participants were at least 60 years old; 2. american society of anesthesiologists (asa) physical status i to iii; 3. body-mass index of 18-30 kg/m2; 4. scheduled for elective colorectal surgery. exclusion criteria: 1. metastases occurring in other distant organs; 2. severe hepatic insufficiency (aspartate aminotransferase or alaninetransaminase or bilirubin \>2.5 times the upper limit of normal); 3. renal impairment (creatinine clearance \<60 ml/min); 4. cardiac rhythm disorders or systolic heart failure (second-and thirddegree heart block, ejection fraction \<50%); 5. allergies to any of the trial drugs; chronic opioid use; 6. inability to comprehend numeric rating scale.
a non-interventional pilot study to explore the role of gut flora in anxiety

Conditions: Anxiety; Anxiety Disorders; Anxiety Depression

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to infection with anxiety

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. may be signed by parent or legal guardian in the case of minor or adult unable to provide consent 2. male or female of all ages 3. diagnosis of anxiety based on dsm-v criteria exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition
tunneled pleural catheter in partially entrapped lung

Conditions: Malignant Pleural Effusion

Summary: an open randomized, prospective, single center; parallel group trial to compare efficiency and safety of pleurx-pleural catheter versus standard surgical treatment in patients with malignant pleural effusion and partial entrapment of the lung.

patients with malignant pleural effusions undergo vats-procedure. in the intraoperative finding of a partially entrapped lung, patients are randomized in 2 groups. arm 1: insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery. arm 2: insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery. additionally, a subcutaneous tunneled catheter will be inserted and will remain in situ follow up period is 3 months primary objective is the comparison of quality of life between the 2 arms. secondary objective is the reliability of the subcutaneous tunnelled catheter in practice as well as function and dysfunction of the drainage system. clinical parameters (respiratory function measured as fev1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) are observed.

Eligibility criteria:
inclusion criteria: * one-sided malignant pleural effusion, first occurrence, or following repeated pleuracentesis * history of dyspnea relieved after pleuracentesis * patient is suitable for vats * surgery is indicated by diagnostic necessity * ability of subject to understand character and individual consequences of clinical trial * written informed consent must be available before enrolment in the trial * for women with childbearing potential, adequate contraception. * histological proven pleural carcinosis by immediate sectioning * intraoperative: partial entrapment of the lung exclusion criteria: * prior lobectomy or pneumonectomy on the affected side * the patient is not operable for general reasons or karnofsky performance score \< 50 * intraoperative suspicion of a pleural empyema * chylothorax * prior attempts at pleurodesis * intended or prior intrapleural chemotherapy or radiotherapy * pregnancy and lactation * participation in other competing clinical trials and observation period of competing trials

Keywords: malignant pleural effusion subcutaneous tunneled drainage talc pleurodesis
evaluation of vitamin d status in children with acute burns

Conditions: Burns; Bone Demineralization

Summary: to see which vitamin d supplement (d2 vs d3) is most beneficial in burned children.

the purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis d is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.

Eligibility criteria:
inclusion criteria: * child is \> 6 months of age but \< 19 years old * burn injury \> 30% total body surface area * admitted to shc within 4 days of injury * attending physician decision that patient is likely to survive * parents or legal guardian give informed consent along with assent of the child as applicable exclusion criteria: * attending physician decision that patient is not likely to survive * prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin d use (\>1000 iu/d)

Keywords: vitamin d
osteonecrosis of the jaw (onj) and infection among nordic cancer patients treated with xgeva™ or zoledronic acid

Conditions: Osteonecrosis of the Jaw; Infection Leading to Hospitalization

Summary: a non-interventional study to assess incident rates of osteonecrosis of the jaw and infections leading to hospitalization in cancer patients treated with xgeva™ in sweden, denmark and norway.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * diagnosed with cancer * subsequent to cancer diagnosis, initiating cancer-related antiresorptive treatment during the treatment cohort identification period with xgeva or zoledronic acid or switching to xgeva from cancer-related treatment with oral or iv bisphosphonates at the dose indicated for sre prevention of less than 2 years duration (≤ 24 iv infusions or ≤ 24 monthly oral prescriptions) exclusion criteria: * history of radiation treatment for head and neck cancer before a subject's potential index date * hypercalcemia of malignancy as the sole indication for treatment with an anti-resorptive agent
project phakama: testing support strategies to empower young women on prep in south africa

Conditions: Pre-exposure Prophylaxis; HIV Infections

Summary: the goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (prep) use among female sex workers (fsw) and adolescent girls and youth women (agyw) in umgungundlovu, kwazulu-natal, south africa. participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use prep. the four strategies being tested are: case management, food vouchers, peer support buddies, and community-based prep pick-up points. the intention of this trial is to determine which prep support strategy or bundle(s) of strategies best promote(s) long-term prep use, so that these services can be scaled up to other districts in south africa.

the overall aim of this trial is to investigate which prep support strategies most effectively and efficiently optimize(s) prep persistence among female sex workers (fsw) and adolescent girls and youth women (agyw) in south africa. the trial will be implemented by tb hiv care, a south african non-profit organization that provides direct hiv service delivery to fsw and agyw across 10 districts in south africa. the investigators plan to individually randomize 304 fsw and agyw at the tb hiv care site in umgungundlovu, kwazulu-natal, to a fractional factorial trial, randomizing combinations of four separate strategies to support prep continuation. as fthe strategies are being tested, this results in 16 different intervention/study conditions, with one condition serving as a control where fsw and agyw will receive the standard of care and no additional prep support. the other 15 conditions will be a combination of the standard of care alongside different prep delivery and support strategies implemented by tb hiv care: case management, food vouchers, peer support buddies, and prep pick-up points. the intention of this trial is to determine which prep support strategy or bundle(s) of strategies best promote(s) long-term prep use and persistence, so that these services can be scaled up to other tb hiv care sites. by utilizing the fractional factorial design in alignment the multiphase optimization strategy framework (most) the trial is feasible to conduct even with 16 arms, as the design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.thus, each strategy will be received by half of the participants, though the combinations of strategies will vary.

Eligibility criteria:
inclusion criteria: * initiated prep within the past 48 hours by the tb hiv care prep programme in umgungundlovu through the female sex worker (fsw) or adolescent girls and young women (agyw) prep programme teams exclusion criteria: * not eligible for prep * currently on prep, but initiated onto prep more than 48 hours previously * under 16 years of age if agyw or under 18 years of age if fsw

Keywords: prep hiv prevention adolescent girls and young women female sex workers south africa
comparison by transoesophageal assessement of systolic right ventricle function measures in perioperative care of pulmonary transplant.

Conditions: Primary Lung Graft Dysfunction

Summary: the aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation. secondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.


Eligibility criteria:
inclusion criteria: * adult (over 18 years) * patient affiliated to a social protection scheme insurance * patient was informed of the study and w gave their consent * patient on the lung transplant list * patient eligible for a pulmonary transplantation after decision of a multidisciplinary team * patients with chronic lung disease with parenchymal dysfunctions (chronic obstructive pulmonary disease or copd, alpha-1 antitrypsin deficiency, cystic fibrosis, pulmonary fibrosis, bronchiolitis obliterans organizing pneumonia or boop) exclusion criteria:d * minor patients * patient under judicial protection, under guardianship * patient in exclusion period (determined by a previous study or in progress) * patient participating in parallel in another clinical trial that may interfere with the results of the study * inability to give informed patient information (emergency, understanding difficulties, etc ...) * the refusal of patient consent * the use of cardiopulmonary bypass during lung transplantation * uni-pulmonary transplant * a transplant for idiopathic or primary pulmonary hypertension * the presence of a cons-indication for transesophageal echocardiography: o absolute contraindications: * abnormalities of the esophagus: stenosis, tumor, diverticulum perforation, active bleeding o relative contraindications: * ancient cervicothoracic irradiation history (\> 10 years) * recent upper gastrointestinal bleeding history * presence of esophageal varices ≥ grade ii * zero cervical mobility * reflux esophagitis * severe coagulation disorders * pregnancy / breastfeeding

Keywords: right ventricle pulmonary transplantation strain isovolumic acceleration (iva)
bitter taste and weight loss in women

Conditions: Obesity; Weight Loss

Summary: individual food preferences are not considered in designing weight-loss therapies. this project will determine if short-term weight-loss is improved by matching participants with diets that reflect their genetically-determined food preferences.

dislike of the diet is a common complaint in weight loss therapy that contributes to poor outcomes. ironically, individual food preferences are rarely taken into account in designing weight-loss interventions. in the proposed research, we will utilize genetically-determined differences in food preferences, indexed by prop bitter taste phenotype to develop a novel approach to weight loss therapy. the overall goal of this project is to determine if weight loss following a 6 month intervention can be substantially improved by matching participants with diets that reflect their genetically-determined food preferences. the study is designed as a randomized clinical weight-loss intervention trial in women in which prop non-tasters and super-tasters. will be randomized to either the low-carbohydrate or the low-fat diet condition

Eligibility criteria:
inclusion criteria: body mass index (bmi) between 27 and 40 kg/m squared no weight loss for 3 months prior to the study stable hypertension, dyslipemia or type 2 diabetes - with permission from primary care provider oral therapy to treat type 2 diabetes - with permission from primary care provider. able to walk 2 block without stopping exclusion criteria: pregnant, lactating or planning to become pregnant during the trial history of cardiovascular disease (infarct, angina, arrhythmia or stroke) recent chemotherapy or radiation therapy liver, renal or thyroid disease concurrent or recent (last 6 months) participation in any other weight loss intervention insulin injection medications to control appetite or weight major psychiatric illnesses

Keywords: obesity weight loss body weight change taste taste phenotype lifestyle intervention
rtms and body weight-support treadmill training after incomplete spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the aim of this study is to verify the efficacy of body weight-support treadmill training combined with high-frequency rtms in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury.

a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions). active or sham rtms will be combined with body weight-support treadmill training to verify the improvement of sensory-motor function in patients with incomplete spinal cord injury. behavioral assessments will be performed before, after 6 and 12 therapeutic sessions and at the 30-day follow-up after the intervention, though: (i) the wisci-ii index; (ii) asia impairment scale (ais), (iii) asia lower extremities motor scale (lems), (iv) ashworth modified scale; (v) the functional independence measure (scim-iii), (vi) the short form health survey 36 (sf-36) and (vii) the patient global impression of change scale - (pgics).

Eligibility criteria:
inclusion criteria: * presented clinical diagnostic of incomplete thoraco-lumbar spinal cord injury, provided by a neurologist (below the t1 level). * duration injury of at least 8 months. * presented degree of c or d according to the asia impairment scale (ais) scale of the american spinal cord injury association. * patients who are not community walkers. exclusion criteria: * pregnant women; * pacemaker; * historic of seizures; * metallic implants in the head; * patients with clinical evidence of brain injuries; * patients with neurological and / or orthopedic pathologies that have repercussion on a gait and the disadvantages * use of neuroleptic medications.

Keywords: spinal cord injury transcranial magnetic stimulation body weight-support treadmill training gait
non-inferiority study comparing the subunit vaccines influvac and agrippal in china

Conditions: Healthy

Summary: in the study influvac will be compared to agrippal, another subunit influenza vaccine that is already on the market in china. the main objective of the study is to show that both vaccines are comparable with regard to efficacy. in addition, safety and efficacy data with influvac will be assessed in the chinese population.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent * being healthy * mental health enough to understand the study, the informed consent form and the questionnaire exclusion criteria: * known to be allergic to constituents of the vaccine * having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to hiv * having had a documented serious adverse reaction to previous influenza vaccination * having had documented influenza infection or vaccination in the six months prior to the start of the study * having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study

Keywords: influenza non-inferiority influvac agrippal healthy subjects
cerebellar deep brain stimulation or vns for chronic post-stroke motor rehabilitation

Conditions: Stroke

Summary: upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.in this open-label, randomized phase i trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. vagus nerve stimulation was also conducted for motor function after ischaemic stroke.we hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.


Eligibility criteria:
inclusion criteria: * eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery. * individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an fm-ue score of ≤42 * sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the fm-ue elbow flexion, elbow extension or finger mass flexion or extension). exclusion criteria: * excessive spasticity or contracture of the upper-extremity muscles (that is, modified ashworth scale = 4) * severe cognitive impairment (mini mental state examination \< 24)

Keywords: hemiparesis cerebellar deep brain stimulation vns limb motor function rehabilitation
immunogenocity and safety of flubio (influenza ha) vaccine in infants and children (bridging study)

Conditions: Healthy

Summary: to asses the immunogenicity and safety of flubio (influenza ha) vaccine in infants and children (bridging study)

too see percentage of subjects with hi titer \>= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.

Eligibility criteria:
inclusion criteria: * healthy * parents have been informed properly regarding the study and signed the informed consent form * parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial exclusion criteria: * subjects concomitantly enrolled or scheduled to be enrolled in another trial * evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature \>=37oc) * known history of allergy to egg and/or chicken protein or any other component of the vaccines * known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection * subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\>2 weeks)). * any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives. * subjects has been immunized with influenza vaccine within 1 year * subjects receives any vaccination within 1 months before and after immunization of flubio.

Keywords: flubio vaccine (influenza ha) infants children safety immunogenicity
qol, adl and pain before and after intervention with n3 from krill with d3.

Conditions: Quality of Life; Pain

Summary: the aim of this project is investigation of patients' with chronic pain self-rated quality of life, adl function and level of pain before and after 3 months of intervention with n-3 fatty acids from krill in combination with vitamin d3. furthermore, the compliance of the patients and the effect of the intervention on the patients' vitamin d status and cardiovascular risk factors are studied.


Eligibility criteria:
inclusion criteria: * 18 year + * can read and understand danish exclusion criteria: * shellfish allergy * intake of anticoagulants and vitamin d * pacemaker * participating other studies

Keywords: pain quality of life adl dolo test compliance d3