Kornimate/medical-research-clean huggingface dataset:
the use of prostaglandin e1 in head and neck microsurgery

Conditions: Microsurgery; Head and Neck; Prostaglandin E1; Thrombosis; Complications

Summary: prostaglandin e1 (pge1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. however, pge 1 may also causes some complications, like pleural effusion or deep vein thrombosis. therefore, it remains uncertain whether a routine use of pge 1 after head and neck microsurgery is justified. we aim to test the hypothesis that pge 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a comparable complication rate as the control group.

despite meticulous microsurgical techniques, free flap failure due to postoperative vessel thrombosis cannot be completely eliminated. postoperative pharmacological augmentation of the established blood flow is considered as a feasible solution to this problem. prostaglandin e1 (pge1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. however, pge 1 may also causes some complications, like pleural effusion or deep vein thrombosis. therefore, it remains uncertain whether a routine use of pge 1 in every patient after head and neck microsurgery is justified. we aim to test the hypothesis that pge 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, and yielded a comparable complication rate as the control group.

Eligibility criteria:
inclusion criteria: * patients requiring microvascular reconstruction after head and neck cancer resection exclusion criteria: * patients with coagulation dysfunction

Keywords: microsurgery head and neck prostaglandin e1 thrombosis complication
general anesthesia versus loco-regional anesthesia for transcarotid trancatheter aortic valve replacement

Conditions: Aortic Stenosis

Summary: transcarotid transcatheter aortic valve replacement (transcarotid tavr) has been increasingly used as an alternative to the transfemoral approach. the general anesthesia, locoragional anesthesia or local anesthesia are three anesthesia techniques that can be used for transcarotid tavr. we aim to compare the locoregional approach to gerneral anesthesia.


Eligibility criteria:
inclusion criteria: * adult patients who underwent a transcarotid tavr at the university hospital of caen between october 2021 (when the first tavr was performed under locoregional anesthesia) and december 2024 exclusion criteria: * patient's refusal to allow data collection and lack of data regarding the primary endpoint

Keywords: general anesthesia cervical block locoregional anesthesia tavr cardiovascvular intervention
opioid free anesthesia in bariatric surgery

Conditions: Opioid Use; Postoperative Pain; Postoperative Nausea and Vomiting; Bariatric Surgery Candidate

Summary: this study compares the intraoperative opioid free anesthesia approach in laparoscopic bariatric surgery to a conventional opioid- based anesthesia. half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

since optimal analgesia for the obese patients undergoing bariatric surgeries has always been challenging, and knowing the comorbidities and physiological changes in this population, use of opioid-sparing agents during anesthesia has attracted substantial research.the use of opioids in the perioperative period in obese patients is associated with an increased risk of complications . they are especially more sensitive to the respiratory depressant effect of opioids , thus any analgesic alternative without further compromising airway tone would be a desirable choice. dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic and sedative properties, without compromising airway tone and reflexes . lidocaine, a local anesthetic that has been shown to be an effective multimodal strategy to minimize postoperative pain was evaluated in one study involving obese patients undergoing bariatric surgery. its usage was associated with an improved quality of recovery compared to placebo .

Eligibility criteria:
inclusion criteria: * age group: 18-65 years old * american society of anesthesiologists (asa )class i and ii * indicated laparoscopic bariatric surgery exclusion criteria: * renal, hepatic or cardiac insufficiency * positive pregnancy test * alcohol or drug abuse * psychiatric disease * history of chronic pain * allergy or contraindication to any of the study drugs

Keywords: lidocaine dexmedetomidine opioid free bariatric surgery
activity restrictions after inguinal hernia repair

Conditions: Inguinal Hernia

Summary: this research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following surgical repair of single-sided inguinal hernias. the researchers hypothesize that when given the autonomy to return to activity at the patient's discretion, convalescence will decrease in comparison to a control group given specific precautions to refrain from lifting and strenuous activity. specific aims include differences in convalescence and surgical outcomes for each group, i.e. rates of complications, hernia recurrence, physical activity assessments pre and postop, and quality of life outcomes.

this study will evaluate lifting restrictions in the postoperative period after inguinal hernia repair. patients will be consented to the study via in person and electronic methods. patients will be asked to answer a questionnaire regarding their current pre-operative activity levels in order to establish a baseline. patients will undergo surgery according to normal medical recommendations and patient preference. patients will be randomized into one of two groups: a control group told to practice standard of care at eastern colorado va with return to activity precautions (6 weeks for open surgery, 2 weeks for minimally invasive surgery) and a treatment group told to "return to activity as tolerated/comfortable and stop activity if pain present". patients will be observed in post-operative clinics and asked clinical questions, as well as questionnaires to assess their surgical experience, when they returned to activity, and overall quality of life. medical charts will be reviewed in order to compare differences in responses and behaviors between the two groups and these data points will be recorded in a password protected document for data analysis. this study aims to identify if lengthy recommendations for convalescence after inguinal hernia surgery are necessary and determine the impact of allowing the individual patient to have some autonomy in a recommendation to return to physical activity based on their own comfort level. this study could provide the surgical community with a more structured response after this common surgical procedure, as well as potentially reduce convalescence times for individual patients, leading to less economic burden on the individual and the community with returning to work precautions.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of unilateral inguinal hernia * must be undergoing surgery * must be able to consent exclusion criteria: * bilateral inguinal hernia * recurrent inguinal hernia * surgery scheduled with additional concomitant procedures

Keywords: hernia, recovery, surgery
intravenous acetaminophen for non-narcotic postoperative pain management following knee arthroscopy

Conditions: Pain, Postoperative

Summary: the purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (vnrs), are reduced with the administration of iv acetaminophen when compared to a control group. particular focus will be on the postoperative opioid consumption. in addition, we will ascertain if the total time the participant is in the pacu differs in those who receive the iv acetaminophen versus those who do not.

this is a randomized, placebo controlled, single blind study of intravenous (iv) acetaminophen in a postoperative arthroscopy patient population. although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. in this study all participants will be injected with a standard of care intra-articular dose of ropivacaine hcl, .2% (naropin) prior to transfer to the post anesthesia care unit (pacu). each will be randomized 1:1 to receive iv acetaminophen in 100ml of 0.9% ns (treatment group) or a 100 ml 0.9 % ns placebo (control). the pacu nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. all other pain medication or related treatment will be recorded. statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. further evaluation will examine if opioid consumption and total time in pacu differs between groups.

Eligibility criteria:
inclusion criteria: * is scheduled for knee arthroscopy with or without chondroplasty. * scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures. * has not received any acetaminophen (iv, pr, po) within at least 8 hours of the initiation of surgery. * is willing and able to sign an informed consent. exclusion criteria: * is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures * has self-reported and/or documented previous hypersensitivity to acetaminophen. * has self-reported and/or documented history of hepatic disease or impairment. * pre-operative calculated creatinine clearance (crcl) less than 40 ml/min. * has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day. * has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc...). may be self-reported or maybe per the judgment of the physician pi/sub-i.

Keywords: pain, postoperative ofirmev acetaminophen analgesics, non-narcotic arthroscopy
microcirculatory changes during magnesium sulphate infusion in sepsis

Conditions: Severe Sepsis; Septic Shock

Summary: during infections (sepsis) bloodflow in small vessels (microcirculation) becomes disturbed. restoration of bloodpressure and cardiac performance may not be sufficient to correct these alterations. magnesium is a potent vasodilator which may be used to open up the small vessels, in order to reduce organ failure.

in a single-center open label study we evaluated the effects of magnesium sulphate (mgs) infusion on the sublingual microcirculation perfusion in fluid resuscitated patients with severe sepsis and septic shock within the first 48 hours after icu admission. directly prior to and after 1 hour of magnesium sulphate (mgs) infusion (2 gram) systemic hemodynamic variables, sublingual sdf images and standard laboratory tests, were obtained.

Eligibility criteria:
inclusion criteria: * severe sepsis and septic shock exclusion criteria: * pregnancy * oral bleeding * age \< 18 years * liver cirrhosis * acute arrhythmias * advanced malignancy or a mean arterial pressure (map) \< 65 mmhg refractory to vasopressors

Keywords: microcirculation sdf magnesium sulfate
efficacy and safety of cdp870 versus placebo in the treatment of the signs and symptoms of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with cdp870 administered sc every 4 weeks compared to placebo in patients with active ra who had failed at least one dmard.


Eligibility criteria:
inclusion criteria: * male/female, 18-75 years old, inclusive * diagnosis of adult-onset ra * had active disease * had received methotrexate * on a stable dose of folic acid exclusion criteria: * contraindication for methotrexate or anti-tnf

Keywords: cdp870 certolizumab pegol
a prospective observational study on discontinuation of medication of shinbaro capsule

Conditions: Osteoarthritis

Summary: this study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.


Eligibility criteria:
inclusion criteria: * minimum 20- year-old patients diagnosed with osteoarthritis * within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the shinbaro capsule, celecoxib capsule and nsaids(non-steroidal anti-inflammatory drugs) * written consent form voluntarity exclusion criteria: * diagnosed with disease that may affect measurement of efficacy clinically * diagnosed with clinically significant phycological disorder, and taking medication * participated in a clinical trial within 4 weeks * pregnant or lactating woman * history of malignant disease within the previous 5 years * patients who seem not to participate in the study at investigator's discretion

Keywords: shinbaro capsule celecoxib osteoarthritis gcsb-5 discontinuation rate gastrointestinal adverse event nsaids oasis
international validation study of sentinel node biopsy in early cervical cancer

Conditions: Cervical Cancer

Summary: senticol iii is large prospective multicenter international randomized study designed to validate the sentinel lymph node (sln) mapping technique in early cervical cancer. this "validation study" will compare the outcome of patients with negative sln (experimental arm) vs patients with negative sln + pelvic lymph node dissection (pln)(reference arm). there will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, sln ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".


Eligibility criteria:
inclusion criteria: i 1. patient must be ≥ 18 years old, i 2. with squamous or adenocarcinoma or adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), i 3. stage ia1 with lymphovascular emboli, ia2, ib1 iia1, ib2 (clinical stage) of the 2018 figo classification (see appendix 1), i 4. maximum diameter ≤ 40 mm by clinical examination and/or magnetic resonance imaging (mri), i 5. no suspicious node on pelvic mri with an exploration up to the left renal vein (according to recist 1.1), i 6. ecog performance status 0-2 (see appendix 2), i 7. signed informed consent and ability to comply with follow-up, i 8. french subjects: in france, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category. exclusion criteria: e 1. pregnancy, e 2. previous pelvic or abdominal cancer, e 3. previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted), e 4. proven allergy to blue dye, isotope or indocyanine green (icg) e 5. other malignancy within the last 5 years except for treated cancer free of disease and treatment, e 6. patients with synchronous cancer
ifn-gamma-releasing assay based approach in patients with suspected tuberculous peritonitis

Conditions: Suspected Tuberculous Peritonitis

Summary: the diagnosis of tuberculous peritonitis (tbp) is still challenging, and largely dependent on invasive procedures such as laparoscopy. a recently developed rd-1 gene-based assay for diagnosing tbp shows has given promising results. the investigators thus created a 2-step algorithm using the blood/ascites elispot assays and adenosine deaminase (ada) in ascites for differentiation of tbp from other diagnoses (blood elispot ≥6 spots or ada ≥ 21 u/l' as a rule-out test and 'ascites/blood ratio ≥3' as a rule-in test). this study is the randomized controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic biopsy for the diagnosis of tbp in patients with suspected tbp.


Eligibility criteria:
inclusion criteria: * all patients with suspected tuberculous peritonitis * age 16 or more * formal informed consent exclusion criteria: * not specified

Keywords: tuberculosis peritonitis laparoscopy
genomic markers for measuring breast cancer response to neoadjuvant chemotherapy

Conditions: Breast Cancer; Breast Neoplasms; Cancer, Breast

Summary: the primary aim of the study is to identify genomic markers (circulating tumor cells (ctcs), circulating tumor dna (ctdna), transcriptomic markers) as biomarkers of response to neoadjuvant chemotherapy (nac) among patients with invasive breast cancer.

the study aims to evaluate genetic markers (i.e. ctcs and ctdna) in breast tumors to predict therapy response and metastatic risk. we aim to investigate genomic markers of treatment response and outcomes in breast cancer patients treated with neoadjuvant chemotherapy. the role of ctcs and ctdna in predicting response to nac will also be investigated.

Eligibility criteria:
inclusion criteria: 1. subjects must give appropriate written informed consent prior to participation in the study. 2. subjects must be women or men age 18+. 3. subjects must be receiving neoadjuvant chemotherapy for breast cancer. all chemotherapy types and regimens are acceptable (systemic therapy will determined by the overseeing medical oncologist). 4. biopsy-confirmed diagnosis of invasive breast cancer (i.e. er+/-, pr+/-, her2+/-). 5. stage i-iii disease according to the ajcc v7 criteria. exclusion criteria: 1. subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue. 2. subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety.

Keywords: circulating tumor cells ctc circulating tumor dna ctdna genomics transcriptomics
regional anesthesia for thyroidectomy

Conditions: Chronic Pain; Acute Pain

Summary: for more than 25 years, regional anesthesia has challenged anesthesiologists to determine whether it offers real benefits in terms of patient outcome from major surgery, compared with general anesthesia. although it is clear that regional analgesia in association with general anesthesia substantially reduces postoperative pain, the benefits in terms of overall perioperative outcome are controversial. the aim of this study is to evaluate the effect on short and long-term postoperative outcomes of adding regional analgesia to general anaesthesia in thoridetomic patients.

patients who are divided into two treatment groups: (a) a bilateral superficial cervical plexus group (group s) and a control group (group c).we performe bilateral superficial cervical plexus block (bscpb)with 0.25-0.75% ropivacaine10 ml to group s and 10ml nacl 0.9% to group c. all bscpb is performed by experienced anesthesia doctor after a standardized induction of general anaesthesia.eneral anaesthesia was induced by using intravenously with midazolam,propofol, fentanyl, cisatracurium is injected iv to facilitate orotracheal intubation. after a standardized induction of general anaesthesia, patients receive regional anesthesia at the discretion of the experienced anesthesiologist who was blinded to treatment. the patient is placed in a supine position with the head turned away from the side to be blocked, and then the sternocleidomastoid muscle (scm) is identified by slight head elevation. scpb is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the scm muscle and the needle is advanced just past the scm muscle.

Eligibility criteria:
inclusion criteria: -eligible patients fit an asa i or ii classification adult patients who will be scheduled for elective thyroid lobectomy under general anaesthesia. exclusion criteria: * hypersensitivity to any study drugs * long-term use of anticoagulant drugs: warfarin or heparin * the neck or systemic infection * communication disorder * refuse to accept this research subjects.

Keywords: chronic postsurgery pain acute pain
a phase 1, randomized, open-label, two-way crossover study to evaluate the steady-state effect of dimebon (pf 01913539) on the single-dose pharmacokinetics and pharmacodynamics of warfarin in healthy subjects

Conditions: Alzheimer's Disease; Huntington's Disease

Summary: this study will evaluate the potential drug-drug interaction of dimebon with the fda-recommended cyp2c9 substrate warfarin in healthy subjects. conformance with the guidance includes general study design using a randomized, open label, single-dose warfarin, steady-state dimebon, 2-sequence, 2-treatment, 2-period crossover design with a minimum 7-day washout period between treatments.


Eligibility criteria:
inclusion criteria: * healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). * prothrombin time (pt)/inr, and partial thromboplastin time (ptt). * plasma protein c and protein s activity (functional) within the normal reference range. exclusion criteria: * a known sensitivity or previous intolerance to dimebon or warfarin. * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening. * subjects receiving warfarin for treatment of active thromboembolic events (ie, pulmonary embolism, deep vein thrombosis), as well as subjects anticoagulated with prosthetic heart valves.

Keywords: dimebon warfarin drug-drug interaction
miglustat on gaucher disease type iiib

Conditions: Gaucher Disease

Summary: evaluate the combination therapy with miglustat and enzyme replacement therapy (ert) on gaucher disease

understand if miglustat (glucosylceramide synthase inhibitor) could improve neuropathy in patients with gaucher disease

Eligibility criteria:
case_miglustat inclusion criteria: 1. confirmed diagnosis of gaucher disease: blood test shown lack of beta- glucocerebrosidase, and found l444p homozygous on gba gene. 2. aged 6 years old or above. 3. already have regular ert (30-120 iu/kg/ every 2 weeks) at least a year; dosage and frequency of ert had not been changed in recent 3 months. exclusion criteria: 1. history of tremor and abnormal extremities perception ( pain, numbness, tingle etc.) 2. abnormal kidney function. 3. pregnant or plan to have a baby ( potentially pregnant patient need to be transferred to gynecologist for the test and promise to have proper contraception measures). 4. allergic to miglustat. control_normal inclusion criteria 1. age 6-18 years 2. no significant physical, mental, or psychiatric problems exclusion criteria 1. children with eye disease (not include myopia, hyperopia, astigmatism)

Keywords: enzyme replacement therapy miglustat gaucher disease