Kornimate/medical-research-clean huggingface dataset:
the effect of low pressure pneumoperitoneum during laparoscopic colorectal surgery on early quality of recovery

Conditions: Pneumoperitoneum; Neuromuscular Blockade; Surgery

Summary: randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery.

rationale: the laparoscopic approach reduced trauma as compared to open surgery, however, the pressure used to create a pnp with sufficient surgical workspace still leads to significant tissue injury. prior studies show that the use of low-pressure pneumoperitoneum (pnp) during laparoscopic surgery reduced postoperative pain scores, cumulative opioid consumption and improved bowel function recovery. deep neuromuscular blockade (nmb) as compared to moderate nmb decreases the amount of intra-abdominal pressure required to achieve similar surgical conditions and enables the use of low-pressure pnp without compromising the quality of the surgical field and patient safety. therefore, the use of deep nmb with low-pressure pnp could be a significant addition to the conventional enhanced recovery after surgery (eras) protocols. objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery. study design: a multi-center, blinded, randomized controlled clinical trial. study population: adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis. intervention: participants will be randomly assigned in a 1:1 fashion to either the experimental group (group a): low pressure pnp (8 mmhg) with deep nmb (ptc 1-2) or the control group (group b): normal pressure pnp (12 mmhg) with moderate nmb (tof count 1-2). primary endpoint: quality of recovery score (qor-40) 24 hours after surgery. secondary endpoints: qor-40 score (day 3 and 7 after surgery), mcgill pain- and rand-36 score (1 day before and 3 months after surgery), pain scores, ponv, analgesia use, length of hospital stay, postoperative complications, surgical conditions and time to reach discharge criteria.

Eligibility criteria:
inclusion criteria: * scheduled for laparoscopic colorectal surgery with a primary anastomosis * obtained informed consent * age over 18 years exclusion criteria: * insufficient control of the dutch language to read the patient information and to fill out the questionnaires * primary colostomy * neo-adjuvant chemotherapy * chronic use of analgesics or psychotropic drugs * use of nsaids shorter than 5 days before surgery * known or suspected allergy to rocuronium of sugammadex * neuromuscular disease * indication for rapid sequence induction * severe liver- or renal disease (creatinine clearance \<30ml/min) * bmi \>35 kg/m² * deficiency of vitamin k dependent clotting factors or coagulopathy

Keywords: quality of recovery laparoscopic surgery deep neuromuscular block low pressure pneumoperitoneum
magnetic resonance imaging of injectate in thoracic 2 paravertebral block

Conditions: Cervical Spinal Stenosis

Summary: the purpose of this study is to analyze the spread of local anesthetic using magnetic resonance imaging after thoracic 2 paravertebral block in patients with cervical radiculopathy.

1. ultrasound guided thoracic 2 paravertebral block will be done using sagittal scan or transverse scan. 2. clinical parameters will be monitored (temperature, perfusion index, assessment of sensory block and analgesic effect, vital sign, adverse events) after the nerve block. 3. cervical mri will be taken 1 hour after the nerve block. 4. follow up 7 days and 28 days after the mri at outpatient clinic (numeric rating scale, medication quantification scale)

Eligibility criteria:
inclusion criteria: 1. patients with unilateral radiating pain in the upper extremity whose pain persists for more than 3 months despite conservative treatment 2. diagnosis: cervical degenerative disc disease, cervical foraminal stenosis, cervical stenosis with/without myelopathy 3. numeric rating score ≥ 4 4. 19 years or older exclusion criteria: 1. cervical or upper thoracic spine surgical history 2. if the body mass index is 35 kg/m2 or more 3. if you have an allergy or hypersensitivity reaction to a local anesthetic 4. coagulation disorders 5. local infection at the injection site 6. claustrophobia 7. if you have a metal insert such as a pacemaker 8. pregnancy 9. patients who are unable to communicate and have cognitive impairment 10. if a person who cannot read the consent form is included among the subjects (e.g., illiterate, foreigners, etc.)
a randomized clinical trial about use of 3d laparoscopy versus 2d laparoscopy in adrenal surgery

Conditions: Adrenal Mass; Adrenal Adenoma; Adrenal Gland Neoplasms

Summary: comparison between 2d traditional laparoscopic surgery and 3d laparoscopy for adrenal surgery.

laparoscopic adrenalectomy is today considered the gold standard of treatment for adrenal tumors. this technique was described for the first time by gagner in 1992 and in the past years several studies have shown the advantages of laparoscopic approach with decrease of the perioperative morbidity, lower complication rates, less operative blood loss, less postoperative pain and shorter hospital stay compared with open adrenalectomy. laparoscopic surgery is more difficult to learn and requires different psychomotor skills than open laparotomy. in fact, the surgeons have to work in a three-dimensional space, but are guided by two-dimensional images. the development of high definition cameras does not eliminate the major limitation of two-dimensional (2d) laparoscopy: lack of depth perception and lose of spatial orientation with potential increasing the strain for the surgeon, the risk of errors and the operative time. three-dimensional (3d) hd laparoscopy was developed as an alternative to conventional 2d laparoscopy. in literature there are still few clinical studies on use of 3d in laparoscopic adrenalectomies with different results. for these reasons the investigators propose an international multicenter study to compare 3d laparoscopic adrenalectomy with standard laparoscopic adrenalectomy.

Eligibility criteria:
inclusion criteria: * patients competent to give consent * aged between 18 and 85 years * functioning and not functioning benign adrenal lesions, * adrenal malignancies candidate to laparoscopic adrenal surgery. exclusion criteria: * open adrenal surgery * preoperative signs of local periadrenal invasiveness

Keywords: adrenal surgery laparoscopic adrenalectomy
prospective clinical performance evaluation of the in-vitro diagnostics medical device magia ibc for the combined screening of hiv, hepatitis b and hepatitis c

Conditions: Combined Point of Care Diagnostic of HIV, HBV and HCV

Summary: prospective, cross-sectional, adaptative study to evaluate the clinical performance of the in-vitro diagnostics medical device magia ibc (a multiplex point-of-care test for the detection of hiv, hbv and hcv) in detecting anti-hiv antibodies (hiv-ab), anti-hcv antibodies (hcv-ab), and hbs antigens (hbs-ag) in serum, plasma, venous blood and capillary blood. if not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study. the study includes a technical adjustment phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a validation phase (to validate the concordance between the matrices and to evaluate the specificity and the sensibility of the diagnostics)


Eligibility criteria:
inclusion criteria: ic1. a male or female aged of at least 18 years ic2. a person taken care at hôpital européen de marseille and responding to at least one of the following conditions: * known or suspected having hiv infection * known or suspected having hbv infection * known or suspected having or having had hcv infection ic3. a person having given consent to participate the study, ic4. a person covered by a medical insurance. exclusion criteria: ec1. a person for whom blood sampling would represent a risk, ec2. a person protected by law (minor, under guardianship or curatorship, childbearing, or breastfeeding female, hospitalized without consent, under administrative or judicial supervision)

Keywords: point of care diagnostic hiv hcv hbv
analysis of the glutathione cycle in children with rett syndrome

Conditions: Rett Syndrome

Summary: analyis of the glutathione cycle in children with rett syndrome

to analyze the levels of glutathione and relevant glutathione metabolites in children with rett syndrome in an effort to better understand disease pathology and biochemistry.

Eligibility criteria:
inclusion criteria: * age between 2 and 10, inclusive * genetically-confirmed diagnosis of rett syndrome with mecp2 mutation * no change in dietary supplements in three months prior to the initial blood draw * no participation in interventional pharmaceutical clinical trials in prior 12 months exclusion criteria: * none other than meeting inclusion criteria

Keywords: rett mecp2 glutathione cysteine ros
immunogenicity of an inactivated covid-19 vaccine

Conditions: COVID-19

Summary: this study is an open phase 4 clinical trial of an inactivated covid-19 vaccine (coronavac) manufactured by sinovac research and development co., ltd. the purpose of this study is to evaluate the immunogenicity of the coronavac in healthy children aged 3-11 years old.

this study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated covid-19 vaccine(coronavac)in healthy children aged 3-11 years old.a total of 400 healthy subjects who have received two doses of inactivated covid-19 vaccine(coronavac) manufactured by sinovac research \& development co., ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.all of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the coronavac.

Eligibility criteria:
inclusion criteria: * have received two doses of inactivated covid-19 vaccine(coronavac) manufactured by sinovac research \& development co., ltd and is currently 28-42 days after the second dose; * the subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form); * the subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood; * proven legal identity. exclusion criteria: * haven't received two doses of inactivated covid-19 vaccine(coronavac); * have received covid-19 vaccines from other manufacturers; * the interval between blood collection and the second dose is less than 28 days or more than 42 days; * the subjets and their legal guardians can't cooperate to complete 3ml venous blood collection. * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
robotic hemi-prostatectomy with urethral preservation in low and intermediate risk monolateral prostate cancer

Conditions: Prostate Cancer

Summary: on the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy/hemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients. the hypothesis is that with this technique it is possible to achieve excellent levels of disease control, in terms of positive surgical margins (psm) and biochemical recurrence of the disease (bcr), against a minimal impact as regards postoperative functional outcomes (continence and sexual power).


Eligibility criteria:
inclusion criteria: * signature of the informed consent and consent to the use of personal data * prostate specific antigen (psa) \< 20 ng/ml * unilateral organ-confined disease on mri (performed according to esur recommendations and reported according to pirads v.2) or pet-psma (performed according to the recommendations of the eanm and reported according to "eanm standardized reporting guidelines v1.0 for psma-pet") * histological diagnosis of acinar-type prostate cancer unilateral on target biopsy and/or standard biopsy with isup \< 3 and ipsilateral on imaging investigations * eastern cooperative oncology group (ecog) performance status 0-1 * life expectancy ≥ 5 years * availability of the patient's pre-operative clinical data * patients must be available to carry out the follow-up visits defined by the protocol * absence of retroperitoneal, lymph nodal, bone or visceral metastatic lesions * patients eligible for robot-assisted radical prostatectomy exclusion criteria: * special histotypes of prostate cancer * patients with psa \> 20 ng/ml at diagnosis * impossibility to perform mri (with pacemakers, claustrophobia...) or pet-psma * previous prostate surgery (turp, adenomectomy) * concomitant treatment with other antineoplastic drugs including investigational endocrine therapies * serious underlying disease or uncontrolled medical condition including active and uncontrolled infections * patients with dementia or psychiatric illness that limit compliance with study requirements or that could prevent understanding and/or signing the informed consent.
transcranial direct stimulation in chronic pelvic pain

Conditions: Pelvic Pain; Healthy

Summary: the purpose of this study is to determine whether transcranial direct current stimulation (tdcs) is effective in reducing pain in subjects with chronic pelvic pain. our hypothesis is that tdcs will decrease pain significantly when compared to sham stimulation.

the study encompasses two experiments: the first one involves patients with chronic pain, receiving 10 sessions of stimulation, active or sham (parallel design). the second experiment involves involves healthy subjects, receiving active or sham tdcs over the primary motor cortex (crossover design).

Eligibility criteria:
inclusion criteria: 1. providing informed consent to participate in the study 2. 18 to 64 years old 3. having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 vas scale (for pelvic pain subjects only) 4. no history of or current genitourinary tuberculosis as self reported 5. no history of urethral cancer as self reported 6. no history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported 7. no occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported 8. no current vaginal infection as self reported 9. no active herpes in previous 3 months as self reported 10. no antimicrobials for urinary tract infections in previous 3 months as self reported 11. never treated with cyclophosphamide as self reported 12. no radiation cystitis as self reported 13. no neurogenic bladder dysfunction (due to a spinal cord injury, stroke, parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported 14. absence of bladder, ureteral or urethral calculi for previous 3 months as self reported 15. no urethritis for previous 3 months as self reported 16. no urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported 17. must not be pregnant 18. eligible to mri according to mri screening checklist 19. no contraindications to tdcs: 20. no history of alcohol or drug abuse within the past 6 months as self reported 21. no use of carbamazepine as self reported 22. does not have severe depression (with a score of \>30 in the beck depression inventory) 23. no history of neurological disorders as self reported 24. no history of unexplained fainting spells as self reported, 25. no history of head injury resulting in more than a momentary loss of consciousness as self reported 26. have had no neurosurgery as self reported 27. no history of psychological disorders as self reported 28. must have the ability to feel pain as self reported

Keywords: transcranial direct current stimulation chronic pelvic pain
single and dual task balance exercises in substance use disorders

Conditions: Substance Use Disorders

Summary: changes in the brain reward pathway and brain tissue in alcohol and substance addiction cause balance disorders, cognitive problems, depression, and substance cravings in individuals. the aim of this study is to examine the effects of balance exercises and dual task balance exercises in individuals with alcohol or substance addiction who are receiving treatment.

this randomized controlled trial was conduces in ankara training and research hospital, alcohol and substance addiction treatment center, turkey. individuals who used substances for more than 1 year, between the ages of 18-50 and with a mini-mental state examination score of 24 and above were included in the study. individuals with orthopedic, neurological or systemic disease, problem with vision and hearing, a neurodevelopmental or neurocognitive disorder and active infection were excluded from the study. in addition, individuals under the effect of substances that negatively affect their cognitive functions were not included in the study. before starting the study, the mini-mental state examination was used to determine that the individuals were at a cognitive level to complete the tests to be applied. the demographic characteristics of the individuals were saved. the stroop test-çapa form was used to evaluate executive functions. y balance test, time up go test and 10 meter walk test were used to evaluate balance. patients were randomly divided into 2 groups. the first group received only balance exercise and the second group received balance exercise with motor and cognitive dual tasks.

Eligibility criteria:
inclusion criteria: * being literate, * having a diagnosis of alcohol and substance use disorder according to the diagnostic and statistical manual of mental disorders-5 (dsm-5), * more than 1 year of substance abuse, * receiving treatment within the scope of the fight against addiction, * not participating in a regular exercise program in the last six months. exclusion criteria: * scoring 23 and below on the mini mental test, * having a neurodevelopmental or neurocognitive disorder, * being under the influence of drugs or alcohol in a way that negatively affects the person's -cognitive functions, * having a psychiatric disorder that requires treatment other than opiate and tobacco use disorder according to dsm-5 diagnostic criteria, * cognitive impairment due to mental retardation, drug/substance abuse or other medical condition that may cause difficulty in understanding the study instructions, * being diagnosed with any orthopedic, neurological and systemic disease, * having an active infection, * having problems with vision and hearing.

Keywords: substance abuse balance exercise dual task
utilization of diagnostic ultrasound in the detection and therapy of acute coronary syndromes

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Summary: the study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of mrx 801 are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.

pre-clinical studies have indicated that, during a continuous infusion of intravenous perfluorocarbon-containing microbubbles, the ultrasonic power delivered from a diagnostic ultrasound transducer is capable of restoring microcirculatory flow and improving epicardial recanalization rates following acute coronary thrombotic occlusions. since both diagnostic ultrasound and intravenous infusions of microbubbles are a class i indication to assess regional and global left ventricular function and risk area in patients with st segment elevation myocardial infarction (stemi), this pilot study will examine whether diagnostic assessments of left ventricular function and risk area size impacts epicardial recanalization rates and infarct size in stemi. the aim of this study is to test whether guided high mechanical index impulses from a diagnostic transducer during a continuous infusion of intravenous microbubbles are capable of improving microvascular recanalization and epicardial recanalization rates in stemi, as assessed by coronary angiography, and recovery of regional microvascular perfusion and function in the post-infarction period.

Eligibility criteria:
inclusion criteria: 1. male or female, age ≥ 30 years. 2. chest pain occurring lasting less than six hours from onset, and ekg evidence of an acute st segment elevation myocardial infarction. 3. arrival in the emergency department with above inclusion criteria between 7 am and 7pm. exclusion criteria: 1. known or suspected hypersensitivity to ultrasound contrast agent used for the study. 2. complicated hemodynamic instability (i.e., nyha class iv heart failure, unstable angina at rest despite medical therapy). 3. life expectancy of less than two months or terminally ill. 4. heart transplant recipient, hypertrophic cardiomyopathy, severe valvular disease, acute myo- or pericarditis. 5. contraindication to heart catheterization 6. known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors or aspirin.

Keywords: st elevated myocardial infarction acute coronary syndrome mrx 801 echocardiography
trunk strength study

Conditions: Ventral/Incisional Hernia Repairs

Summary: the purpose of this study is to measure abdominal wall strength both preoperatively and postoperatively in patients undergoing ventral/incisional hernia repairs. the investigators hypothesize that abdominal wall strength is improved in hernia repairs that reapproximate the rectus musculature to the midline. abdominal wall strength measurements would be obtained utilizing various abdominal strength testing.


Eligibility criteria:
inclusion criteria: * patients who are scheduled for hernia repair. exclusion criteria: * pregnant females.
effect of continuing versus holding metformin during hospitalizations.

Conditions: Diabetes Mellitus, Type 2

Summary: a randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality.

the purpose of this study is to determine what the effects of the routine practice of holding metformin in hospitalized patients with type 2 diabetes are on outcomes. the objectives of this study are to determine how holding versus continuing metformin during hospitalization to an internal medicine service affects the incidences of lactic acidosis, mean anion gap, mean glucose levels, low and very high blood sugars, gi effects after discharge, lack of continuation of metformin upon discharge, mean glucose levels, lengths of stay, and 30-day mortality.

Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * admitted to an internal medicine service. * on metformin prior to admission. exclusion criteria: * inability to take oral medications * egfr \< 30 ml/min/1.73 m2 * dialysis * current acidosis (ph \< 7.35) including diabetic ketoacidosis * child-turcotte-pugh class c hepatic cirrhosis * acute decompensated heart failure * cognitively impaired and/or unable to consent * lack of or unwillingness to share contact information * pregnant women