Kornimate/medical-research-clean huggingface dataset:
dual action of liraglutide and insulin degludec in type 2 diabetes: a trial comparing the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (ideglira) versus insulin degludec (ideg) and liraglutide (lira) in subjects with type 2 diabetes. subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * hba1c 7.0-10.0 % (both inclusive) with the aim of a median hba1c of 8.3%. accordingly, when approximately 50% of the randomised subjects have a hba1c above 8.3%, the remaining subjects randomised must have a hba1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a hba1c of below or equal to 8.3%, the remaining subjects randomised must have a hba1c above 8.3% * male or female, age 18 years or above (taiwan: 20 years or above for a site 653 in taiwan: taichung veterans general hospital) * subjects on stable dose of 1-2 oads (metformin \[at least 1500 mg or max tolerated dose\] or metformin \[at least 1500 mg or max tolerated dose\] + pioglitazone \[at least 30 mg\]) for at least 90 days prior to screening * body mass index (bmi) maximum 40 kg/m\^2 exclusion criteria: * treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the investigator) * treatment with glp-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (dpp-4) inhibitors within 90 days prior to trial * impaired liver function, defined as alanine aminotransferese (alat) at least 2.5 times upper normal range (unr) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) * impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) * screening calcitonin at least 50 ng/l * subjects with personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2) * cardiac disorder defined as: congestive heart failure (nyha class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures * severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm hg or diastolic blood pressure at least 100 mm hg) * acute treatment required proliferative retinopathy or maculopathy (macular oedema) * history of chronic pancreatitis or idiopathic acute pancreatitis
ultrasound-guided percutaneous neuromodulation in anterior cruciate reconstruction

Conditions: ACL Injury

Summary: the objective of the study is to demonstrate the efficacy of the ultrasound-guided percutaneous neuromodulation technique in the femoral nerve in patients who underwent surgery for the anterior cruciate ligament.

after being informed about the study and the potential risks, all subjects who accept the study and give their informed consent in writing, the subjects will participate in a randomized, longitudinal and prospective clinical trial divided into two groups (control group and experimental group) with the main objective of demonstrating that the ultrasound-guided percutaneous neuromodulation technique is effective for the treatment of pain in subjects undergoing surgery for the anterior cruciate ligament. subjects belonging to the control group will perform a physiotherapy protocol and those belonging to the experimental group will undergo two interventions of the ultrasound-guided percutaneous neuromodulation technique combined with the physiotherapy protocol. the same number of measurements will be performed on all subjects.

Eligibility criteria:
inclusion criteria: * subjects aged between 18 and 55 years who have undergone surgery for an anterior cruciate ligament (acl) in a period of time between 2 and 6 weeks of evolution with or without meniscal injury (meniscal regularization / meniscal suture / meniscectomy, etc.). * have pain or loss of sensitivity in the operated knee and that they have signed the informed consent. exclusion criteria: * subjects with chronic joint disease; prosthesis or osteosynthesis in the intervention area, as well as heart disease, neoplasia and coagulopathy. * subjects consuming analgesics. * subjects with belonephobia or insurmountable fear of needles * history of lumbar pathology (lumbar hernia/protrusion) due to possible involvement of the lumbar plexus. * subjects with a history of neurological or orthopedic disorders * subjects with bilateral symptoms. * subjects with epilepsy, pacemaker or pregnant.

Keywords: percutaneous neuromodulation femoral nerve ultrasound acl reconstruction
a safety and efficacy study of saber®-bupivacaine for pain following hernia repair

Conditions: Postoperative Pain; Hernia; Surgery

Summary: this is a research study testing saber-bupivacaine (an experimental pain-relieving medication). saber-bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. this study is testing saber-bupivacaine in people having surgery to repair a hernia. the purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of saber-bupivacaine with saber-placebo.


Eligibility criteria:
inclusion criteria: * males and females, 18 to 65 years of age, scheduled for hernia repair surgery * patients must be in good health prior to study participation * patients must have blood pressure within normal range or with stage 1 high blood pressure * male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed * patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial * ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures exclusion criteria: * patients with previous abdominal surgery scar tissue * patients with clinically significant abnormalities of any body system unrelated to the disease under study * connective tissue disorders * patients who are pregnant or lactating * current or regular use of analgesic medication for other indications * patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening * use of any drugs or medication that may interfere with the study and its results * patients with known hypersensitivity to the study drugs or their components * patients with known or suspected alcohol abuse or illicit drug use * participation in another clinical trial at the same time or within 30 days of this trial * patient is unwilling to comply with the study procedures

Keywords: post-operative pain hernia surgery opioid
ultrasound-guided peng block for shoulder surgery

Conditions: Pain After Shoulder Surgery

Summary: significant pain after shoulder surgery induce worse experience and may delay recovery of patients undergoing shoulder surgery. interscalene brachial plexus block (isb) is a common and rapid-onset procedure for pain control of patients undergoing shoulder surgery. however, the high incidence of adverse events such as hemidiaphragmatic paresis, horner syndrome after interscalene block threatened patients' safety and raised clinicians' concerns on them. hence, effective analgesia alternatives to interscalene block with less complications are needed. recently, pericapsular nerve group (peng) block, a new technology is reported for block of articular branches of the shoulder and well pericapsular spread around the glenohumeral joint. in this study, we assume that peng block may offer a noinferior analgesia and less incidence of nerve block related adverse events compared with isb.


Eligibility criteria:
inclusion criteria: * asa i-iii * 18 years and older * shoulder surgery exclusion criteria: * severe pulmonary diseas * chronic pain disorders * infection of shouler skin * pregnant women * patients allergy to local anesthetics
managing post-operative pain in children with cerebral palsy using a pain pump

Conditions: Cerebral Palsy

Summary: the purpose of this study is to determine which pain management strategy continuous analgesic pump or orally-should be used in the management of children with cerebral palsy.

a prospective randomized controlled trial will be performed on up to 150 subjects who will undergo a tendoachilles lengthening, strayer's procedure, epiphysiodesis of the femur or femoral osteotomy metal work removal. subjects will be randomized into two groups: the first group will have an anesthetic pain pump device supplemented with oral analgesia and the second group will only receive oral analgesia. the anesthetic continuous device will be used continuously for 48 hours and with a flow rate of 2ml/hour of 0.25% bupivacaine diluted in accordance to patient weight. subjects in both groups will receive oral analgesia according to their pain requirements. the amount of oral analgesia used will be documented over 12-hour intervals in a patient diary over a 4 day period. subjects will have their pain score assessed daily with the use of the non-communicating children's pain checklist-postoperative version. their overall satisfaction with post-operative pain management will be assessed at the end of the study with the use of the parent total quality pain management questionnaire.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy between 3 and 17 years old. * american society of anesthesiologists (asa) intubation grade i, ii or iii. * ability of subject or primary caregivers to give informed consent, to understand what the study entails and to be able to complete the patient pain diary during the post-operative period. subjects should be available for daily telephone follow-up until the data is completed and they should be able to return the completed pain diary to the primary investigator. * willingness and understanding of parent or guardian to have their child randomized to receive either the continuous infusion pain pump device or oral analgesics for their child's pain management. * english or spanish-speaking care parent or guardians who are able to complete the pain diary. exclusion criteria: * asa iv or v, * known allergy or sensitivity to bupivacaine, * subjects who will have more than the above mentioned procedure performed during their surgical visit, * subjects with significant kidney or liver disease, * parents/guardians who are assessed by the pi or co-investigators to be unable or unwilling to complete the study's pain diary or behavioral tools, and * parents/guardians who are unwilling to allow their child to be randomly assigned to receive either the pain pump with oral analgesics or oral medications alone.

Keywords: pain pain management cerebral palsy
a phase ii/iii study of sargramostim

Conditions: COVID-19

Summary: this is a randomized, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as add-on treatment to the standard treatment in covid-19 patients.


Eligibility criteria:
inclusion criteria: japanese male or female subjects who have been confirmed to meet all the following criteria. 1. hospitalized patients under treatment who were severe acute respiratory syndrome coronavirus 2 \[sars-cov-2\] positive by polymerase chain reaction (pcr) test. 2. patients with clinically diagnosed pneumonia and a percutaneous oxygen saturation \[spo2\] of 93% or less on breathing of room air at bed rest. 3. patients for whom written informed consent has been obtained from those themselves or the legally acceptable representatives. 4. patients aged 20 years or older and younger than 85 years at the time of obtaining informed consent. exclusion criteria: subjects who meet any of the following criteria will be excluded. unless otherwise stated, the following criteria refer to those at the time of screening. 1. patients who have been participating in other intervention studies, such as studies on unapproved pharmacotherapy, within 90 days prior to screening. 2. patients who have experienced off-label use of approved drugs (including those for covid-19 treatment other than steroids as standard treatment) within 7 days prior to screening. 3. patients who are not expected to survive longer than 24 hours after commencement of study drug administration. 4. patients who are using invasive ventilator or extracorporeal membrane oxygenation (ecmo). 5. patients who have a chronic respiratory disease requiring continuous home oxygen therapy or ventilator use. 6. patients with an underlying condition that is considered very unlikely to withdraw ventilator (e.g., motor neuron disease, duchenne muscular dystrophy, rapidly progressive interstitial pulmonary fibrosis). 7. patients who have a disease including bronchial asthma, lower respiratory tract infections, and interstitial lung diseases that may affect the assessment of the clinical study, since before the symptom onset of covid-19. 8. patients who have a disease including leukemia and leukocytosis that causes leukocytosis. 9. patients who have a chronic kidney disease requiring dialysis. 10. patients who have severe liver failure (child pugh grade c). 11. patients aged 80 years or older with any of heart failure, cerebrovascular disease, obesity (bmi 30 or higher), dyslipidemia, hypertension or diabetes.
bimanual motor skill learning through robotics in stroke survivors and healthy individuals

Conditions: Stroke

Summary: to test the capacity of healthy and chronic stroke patients to learn and retain a complex bimanual motor skill, trained on the neurorehabilitation robot reaplan (r) (bimanual version).

over 3 consecutive days, healthy individuals and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabilitation robot reaplan(r). they will practice several tasks on the robot reaplan (r) (bimanual version), requiring either movements with the affected arm (unimanual tasks) and complex, coordinated movements with both arms (bimanual tasks). in addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...).

Eligibility criteria:
stroke patients : inclusion criteria: * having a chronic stroke (\>6 months) * aged 18-90 years * with demonstrate a stroke lesion on brain imaging. exclusion criteria: * difficulty in understanding or executing commands * drug/alcohol abuse * severe aphasia / cognitive deficits interfering with study * inability to voluntarily move the affected arm (i.e. complete paralysis of the arm) * multiple strokes / dementia / psychiatric condition * botulinum toxin injections (to be evaluated) healthy individuals : inclusion criteria: - 18-90 years exclusion criteria: * neurological conditions interfering with the study * drug/alcohol abuse * pyschiatric condition
danger response in polytrauma patients

Conditions: Multiple Trauma

Summary: the ntf_pt_2014 multicenter study aims to collect, store, and analyse plasma and serum from polytrauma-patients (injury severity score ≥25) and corresponding clinical data to address 1) how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers, 2) how the specific injury pattern affects the posttraumatic response and regenerative potential on an organ-, cell, and molecular level, and 3) how could a specific organ- and immune-monitoring predict the clinical outcome.

polytrauma is worldwide a major socio-economic problem. especially the polytrauma-induced complications, such as systemic inflammatory response, sepsis, organ dysfunction remain associated with a high morbidity and mortality rate. the underlying posttraumatic pathophysiology remains poorly understood, especially since the polytrauma patients present a highly variable patient cohort with complex injury patterns, comorbidities and different therapeutic strategies. therefore, the present "ntf_pt_2014" multicenter study of the trauma research network (ntf) of the german society for orthopaedics and trauma (dgou) with its established national polytrauma-serum-bank aims to collect, store, and analyse plasma and serum from polytrauma-patients and corresponding clinical data to address: 1. how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers? 2. how the specific injury pattern affects the posttraumatic response and regenerative potential on a organ-, cell, and molecular level? 3. how could a specific organ- and immune-monitoring predict the clinical outcome? blood will be drawn from anticipated 1000 patients with an injury severity score ≥ 25 at the time of hospital admission (in the emergency room), 8 h, 24h, 48, 120 h, and 240 h post injury. the biochemical and immune-monitoring data will be correlated to corresponding clinical data and data from the german trauma registry (traumaregister dgu®). blood from age- and sex matched healthy volunteers (n=200) will serve as a control group. the study will provide a detailed picture of the molecular danger response after multiple injury and may reveal novel therapeutic targets for posttraumatic complications.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * healthy exclusion criteria: * age \< 18 * gravidity

Keywords: polytrauma hemorrhagic shock sepsis mods
bullydown, a text messaging-based bullying prevention program for middle school-aged youth

Conditions: Bullying

Summary: given the limited impact of existing school-based interventions and the time associated with implementing them during school time, more efficient and effective intervention methods are needed. programs that can be delivered to middle school youth irrespective of whether they are attending school physically or virtually may be especially relevant as school boundaries become more fluid. bullydown addresses this critical need by providing a scalable program that could be quickly and cost-effectively disseminated nationally.


Eligibility criteria:
inclusion criteria: * 7th or 8th grade * english speaking * own their own cell phone * home internet * provide informed assent exclusion criteria: * non-english speakers * unable to read the screener * know someone else in the rct * know they are not on an unlimited text messaging plan
the effect of metformin on fecundability in an art(assisted reproductive technology) setting - the correlation to uterine flows

Conditions: Infertility Female

Summary: the basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus. insulin sensitizers ameliorate insulin resistance in obese patients. this study seeks to determine if metformin helps to increase fecundability by affecting the uterus in women undergoing art. as a surrogate marker- flows in the uterus will be tested during the treatment.

obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. however, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus. it is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. insulin sensitizers ameliorate insulin resistance in obese patients. this study seeks to determine if metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. as a surrogate marker- flows in the uterus will be tested during the treatment.

Eligibility criteria:
inclusion criteria: * age: from 18-40 years old. * bmi \> 30 * infertile women undergoing frozen-thawed embryo transfer in an art setting * women with at least one top graded embryo * normal uterine doppler indices at time of recruitment. exclusion criteria: * diabetes mellitus - uncontrolled. * hyperprolactinemia- uncontrolled. * hypothyroidism- uncontrolled. * women who are already treated with metformin * women with endometrial factor as the cause for infertility

Keywords: metformin fecundability uterine doppler
transvaginal cholecystectomy versus laparoscopic cholecystectomy in patients with biliary colic

Conditions: Biliary Colic

Summary: a safe and effective transvaginal approach accessing the abdominal cavity through the vagina rather than the abdominal wall is today considered a routine approach for many gynecologic surgeries. first described by dr. ott in germany in 1901, it is used routinely for transvaginal surgery, for example, transvaginal hysterectomies. this transvaginal technique has been shown to compare favorably to a laparoscopic abdominal approach because of less postoperative pain, the total elimination of abdominal wall hernias and wound infections, earlier recovery and better cosmesis. although routinely used in gynecological surgery, the advantages of the vaginal approach have not been utilized for general surgery applications such as cholecystectomies. open or laparoscopic cholecystectomy accessing the abdominal cavity through abdominal wall incisions is currently still considered the standard of care in general surgery for patients with symptomatic gallbladder disease. the investigators intend to access the abdominal cavity through the posterior vaginal fornix instead of the transabdominal approach that is now performed routinely. so far, this method of accessing the abdominal cavity through the transvaginal approach for the purpose of performing intraabdominal general surgery. the investigators' transvaginal approach has the strong potential to further decrease invasiveness and take minimally invasive surgery to the next level in order to benefit the patient even more by minimizing postoperative pain, eliminating the risk of abdominal hernias and wound infections, improving cosmetic appearance and enabling the patient to return to routine activity and work earlier. first preliminary studies show these advantages but further research needs to be done to confirm these early positive results.


Eligibility criteria:
inclusion criteria: * female. * age between 18 and 65 years old. * biliary dyskinesia with documented gallbladder ef \< 30% or diagnosis of biliary colic with documented gallstones or polyps by imaging. * body mass index (bmi) \< 45 kg/m2. exclusion criteria: * any female patient, who is pregnant, suspected pregnant, or lactating. * any patient with acute or acalculous cholecystitis. * any patient with an american society of anesthesiologists score \> 3. * any patient who is undergoing peritoneal dialysis (pd). * patients who are taking immunosuppressive medications or are immunocompromised. * patients on blood thinners or aspirin or abnormal blood coagulation tests. * patients who have a history of prior open abdominal surgery or prior transvaginal surgery. * patients with a history of ectopic pregnancy, pelvic inflammatory disease (pid) or severe endometriosis. * non english speaking patients.

Keywords: cholecystectomy