Kornimate/medical-research-clean huggingface dataset:
regional midazolam in quadratus lumborum block

Conditions: Postoperative Pain

Summary: midazolam has been used in regional anesthesia of brachial plexus block; it has offered accepted postoperative pain relief. this study will use it in as an adjuvant to bupivacaine 0.25% in quadratus lumborum block in caesarean section

it is vital to apply adequate postoperative analgesia following caesarean section (c-section), since it will affect the distinct surgical recovery requirements of the parturient. the ultrasound-guided quadratus lumborum block (qlb), first introduced by blanco r. in 2007, has been recognized as an effective abdominal wall block approach, in which local anesthetic injected from the posterior abdomen will spread around the quadratus lumborum muscle and block the intermuscular nerves. in addition, such block is also closely related to multiple sympathetic fibres and is connected to the thoracic paravertebral space. typically, qlb is found to be effective, which can provide satisfactory analgesic effect. midazolam is one of the clinically water-soluble benzodiazepines and effective to produce the analgesic effect through the neuraxial pathways. the organs and joints of humans have the benzodiazepine receptor, and midazolam is revealed to produce the analgesic effect through the gamma-aminobutyric acid receptors (gaba) in the spinal cord. previous studies have reported that the midazolam (75 μg/kg) through the intraarticular route can decrease the pain intensity for arthroscopic knee surgery. in addition, the intrathecal midazolam (2 mg) is reported to prolong the duration of analgesia without any adverse effects following knee arthroscopies. perineural midazolam has been also evaluated in brachial plexus block.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i or ii * age from 24 to 40 years old * weight from 50 to 80 kg, * normal singleton pregnancy with a gestation of at least 37 weeks exclusion criteria: * coagulopathy * maternal anatomic abnormalities in the block region * localized infection * incapable of comprehending or using the verbal rating pain scoring system * included medications allergy * history of chronic pain or regular opioid use.

Keywords: midazolam bupivacaine
a phase i/ii clinical trial of pepcan in head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: this study has been designed to evaluate the safety and efficacy of giving seven injections of pepcan or placebo over approximately a 24-month period in subjects with head and neck cancers who achieved remission. pepcan may prove to be beneficial in treating many stages of hpv-related malignancies starting from infection to cancer. safety, efficacy in terms of reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes will be assessed.

this is a phase i/ii study to evaluate the efficacy and safety of an hpv therapeutic vaccine called pepcan (hpv-16 e6 peptides) in adults over a two (2) year period. each subject will be receiving a total of 7 injections of pepcan (50 µg per peptide dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. subjects will receive one injection every 3 weeks until they receive 4 injections. then, subjects will receive one injection every 3 months until they receive a total of 7 injections. subjects will have 2 more visits approximately 6 months apart after the last injection. immunological assessment by enzyme-linked immunospot (elispot) assay will be made at 4 time points (visits 1, 5, 8, and 9), and by fluorescent activated cell sorter analysis will be made at times points at visits 1, 3, 5, 6, 7, 8, and 9. oral wash samples and stool samples will be collected at the screening visit, visit 5, visit 7 and visit 8 for microbiome diversity analysis.

Eligibility criteria:
inclusion criteria: 1. able to provide informed consent 2. male or female 18 years of age or older 3. squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) therapy within the previous 120 days 4. performance status of eastern cooperative oncology group (ecog) 0-2 5. no evidence of disease (ned) based on clinical and/or radiographic evaluations 6. vital signs recorded 1. blood pressure (≤160/95 mm hg acceptable) 2. heart rate (50-100 beats per min acceptable) 3. respiratory rate (≥ 12 ≤25 breaths per min acceptable) 4. temperature (≤100°f acceptable) 7. blood work done at screening visit 1. white count (≥3x109/l acceptable) 2. hemoglobin (≥ 7 g/dl acceptable) 8. willing and able to comply with the requirements of the protocol exclusion criteria: 1. positive urine pregnancy test for women of childbearing potential 2. being pregnant or attempting to be pregnant within the period of study participation 3. women who are breast feeding or plan to breast feed within the period of study participation 4. patients who are allergic to candin® or yeast 5. history of severe asthma requiring emergency room visit or hospitalization within the past 5 years 6. patients who have previously received pepcan 7. history of recurrence of squamous cell carcinoma of the head and neck 8. if in the opinion of the principal investigator or other investigators, it is not in the best interest of the patient to enter or continue in this study

Keywords: squamous cell carcinoma
adl and conut for predicting 1-year mortality risk in older adults after hip fracture

Conditions: All-cause Mortality

Summary: hip fracture has a serious impact on the quality of life and even the survival of older adults. the multidisciplinary management of hip fracture has been shown to be effective in improving patient outcome and cost-effective in international studies. as geriatricians and members of a multi-disciplinary team（mdt）, we are aware of various scores in predicting the 1-year mortality risk in hospitalized older adults with multimorbidity. however, given the need for a deeper understanding of the preoperative status of elderly patients who were suffering from pain, tension, anxiety, delirium,etc., we hope to explore a simple, quick, objective, and accurate method for assessing the status of elderly patients with hip fractures to predict their survival risk.

this was a single-center retrospective cohort study which were approved by the clinical research ethics committee of beijing tongren hospital, capital medical university (trec2023-ky026). demographic characteristics and medical parameters, such as age, gender, body mass index (bmi), comorbidities, hemoglobin , lymphocytes, c-reactive protein (crp), fasting blood glucose, creatinine, total protein, albumin, triglycerides, total cholesterol and american association of anesthesiologists (asa) were collected from the electronic medical record system. controlling nutritional status (conut) was calculated from 3 variables: serum albumin concentration, total cholesterol concentration, and lymphocyte count, as previously reported. all enrolled patients were followed-up in an outpatients setting. survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. the follow-up lasted for one year and the last follow-up was ended on december 31, 2022. all analyses were performed using spss version 19.0 (spss, chicago, il, usa).

Eligibility criteria:
inclusion criteria: 1. patients aged ≧65 years old; 2. patients diagnosed with hip fracture, including femoral neck fracture, femoral intertrochanteric fracture, and femoral subtrochanteric fracture; 3. patients whose injury was within 21 days of presentation. exclusion criteria: 1. patients aged \<65 years old; 2. patients with pathological fractures due to tumor metastasis or infection or inherited bone disorder; 3. patients with avascular necrosis of femoral head; 4. patients with periprosthetic fractures; 5. old fracture patients treated more than 21 days from injury; 6. patients with severe trauma or fracture in other parts; 7. patients and their families who could not bear the surgical risk and are unwilling to receive surgical treatment; 8. patients died in hospital.
nicotine and cotinine levels in smokers with schizophrenia and schizoaffective disorder - 2

Conditions: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder

Summary: nicotine dependence is very common among individuals with schizophrenia and schizoaffective disorder. cotinine is a chemical that is made by the body from nicotine. measuring levels of nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a person's body. the purpose of this study is to measure nicotine and cotinine levels in smokers with schizophrenia or schizoaffective disorder to determine if such individuals absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.

schizophrenic individuals have higher urinary cotinine levels compared to non-schizophrenic individuals with a similar smoking history. this suggests that schizophrenic individuals may absorb higher doses of nicotine. the purpose of this study is to determine whether smokers with schizophrenia or schizoaffective disorder have higher serum nicotine and cotinine levels in comparison to smokers without schizophrenic-related disorders. this observational, case-control study will enroll 150 participants, of which 100 will be smokers with schizophrenic-related disorders and 50 will be smokers without a mental illness. upon completing baseline assessments, participants will smoke a single cigarette. approximately two minutes following, 3 to 4 ounces of blood will be analyzed for nicotine and cotinine levels. an expired carbon monoxide reading will also be measured. this measurement correlates with the amount of smoke inhalation. individual participant studies will be completed in 1 to 2 hour-long sessions.

Eligibility criteria:
inclusion criteria: * meets dsm-iv diagnostic criteria for nicotine dependence and possibly schizophrenia or schizoaffective disorder * stable on current antipsychotic regimen(s) for participants with schizophrenia or schizoaffective disorder exclusion criteria: * at serious risk of suicide, including recent suicidal behavior or attempt within the thirty days prior to study entry * current use of clonidine, bupropion, or any other nicotine products (including nicotine patch, gum, inhaler, lozenge or nasal spray)

Keywords: nicotine dependence
characterizing recurrent thromboembolism, major bleeding and all-cause death in patients with cancer-associated thromboembolism treated with rivaroxaban

Conditions: Venous Thromboembolism

Summary: to estimate the real-world rates of recurrent venous thromboembolism (vte), major bleeding and all-cause mortality in patients with cancer-associated thrombosis (cat) treated with rivaroxaban


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years-of-age) with active cancer * patient with at least one index venous thromboembolism (vte ) * ≥6-months of continuous eligibility prior to the index vte event (baseline period). * newly initiated on rivaroxaban exclusion criteria: * patients with any medical claim for deep vein thrombosis (dvt) or pulmonary embolism (pe) during the 6 months pre-index date * patients with prescription claim for anticoagulation therapy during the 6-month pre-index vte period
cemented k-wire fixation vs open transfixion pinning

Conditions: Closed Fracture of Finger; Finger Fracture

Summary: to introduce a novel external-fixation technique using the combination of k-wires and cement, and the objective of this report is also to compare the technique with conventional open transfixion pinning.

shaft fractures of the middle phalanx are common injuries that are often difficult to treat. currently, fracture fixation is usually achieved by using k-wire, but pin configurations are controversial.the objective of this report is to introduce treatment of shaft fractures of middle phalanx with a novel external-fixation technique using combined k-wires and cement. for comparison, we also included another group of patients who were treated using open transfixion pinning.a total of 98 patients (98 fingers) with shaft fractures of middle phalanx were randomly allocated to group a (n=51) and b (n=47). fingers in group a were treated with cemented k-wire fixation, and fingers in group b were treated using conventional open transfixion pinning. time of bone healing, range of motion of the fingers, and joint motion were assessed. a p\<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * patient aged between 18 and 65 years; * acute fractures within 15 days; * closed fractures or fractures with small open wound less than 1.5 cm; * involvement of single middle phalanges of index to little fingers; * shaft fractures; at least 5 mm in length of the most distal and proximal fragments so that k-wires can be secured; * transversal, short oblique or spiral fractures; * comminuted fractures of middle third phalanx; * normal opposite hand for comparison. exclusion criteria: * patients younger than 18 years are excluded because of skeletal immaturity; * patients older than 65 years are excluded because of possible osteoporosis; * multiple finger involvement; severe open injury or crush injuries; * combined tendon or neurovascular injuries; involvement of articular surface; * old fractures exceeding 15 days because close reduction most likely became difficult; * combined tendon, nerve, or artery injuries or diseases; * diabetes, gout, ganglion; * osseous tumors, and other disease affecting bony structures and joint motion; * patients who declined to participate.

Keywords: reduction, fracture
organization of teratology information services (otis) autoimmune diseases in pregnancy project

Conditions: Pregnancy

Summary: the purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. this is an observational study only - no investigational product is used.

this pregnancy registry cohort study will be conducted by the organization of teratology information specialists (otis) which is a network of university and health department based telephone information centers serving pregnant women and health care providers throughout north america. participants in the first two cohorts are recruited concurrently from callers to otis centers, from health care providers and through direct to consumer marketing efforts. the source of historical controls is archived data on pregnancies that have been followed through the california teratogen information service's clinical research program located at the university of california san diego.

Eligibility criteria:
cohort 1 inclusion criteria: eligible subjects will be currently pregnant women residing in the us or canada who have had any exposure to etanercept for treatment of rheumatoid arthritis (ra), juvenile ra, ankylosing spondylitis (as), psoriatic arthritis (psoa) or psoriasis (pso) at any time during the first trimester of pregnancy which is defined as the period between first day of the last menstrual period (i.e., within two weeks of conception) up to and including the 12th week after the first day of the last menstrual period (lmp) - eligible subjects must have documentation of an exposure to etanercept during the first trimester of pregnancy. cohort 2 inclusion criteria: eligible subjects will be currently pregnant women residing in the us or canada who have not taken etanercept or any tnf antagonist for treatment of ra, jra, as, psoa or pso at any time in the current pregnancy or within two months prior to the first day of the last menstrual period (lmp). cohort 3 inclusion criteria: eligible subjects will be pregnant women who were residing in the us or canada who had not been diagnosed with ra, jra, as, psoa or pso and had not been exposed to a known human teratogen during the index pregnancy.

Keywords: pregnancy autoimmune disease
retrospective study on the outcome of cleft palate repair: comparing us surgical and ethicon suture materials

Conditions: Cleft Palate

Summary: investigator initiated retrospective chart review to study the effects of changing suture material on the healing and outcome of cleft palate surgery were.

this study aims to show what the effects of changing suture material were on the healing and outcome of cleft palate surgery. the study will be considered successful if we find that either there is an effect on the healing after surgery, one of the suture materials seems to promote better healing and final outcome, or that there is no difference between the suture materials.

Eligibility criteria:
inclusion criteria: * cleft palate repair performed at ucdmc between 1/1996 and 6/2006 exclusion criteria: * those who do not meet the inclusion criteria

Keywords: cleft palate suture materials
strive post-market registry study

Conditions: Emphysema

Summary: this is a single-arm, prospective, multi-center, registry study to evaluate the long-term safety and effectiveness of the spiration valve system (svs) for the treatment of severe emphysema in a post-market setting.

this post-market study is a single-arm, prospective, multi-center registry. it is designed to assess 36-month safety and effectiveness of this fda approved product in a post-approval setting, and to support the continued assessment of spiration valve system therapy for the treatment of severe emphysema in the united states. subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.

Eligibility criteria:
inclusion criteria: 1. adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation. 2. subjects must understand and voluntarily sign an informed consent form. exclusion criteria: 1. subjects who are not appropriate for svs therapy based upon the us fda-approved ifu requirements. 2. subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3. subjects who have incomplete screening or baseline data.

Keywords: emphysema chronic obstructive pulmonary disease (copd) spiration valve system
evaluation of biocompatibility and performances of 4 dialyzers in different mode treatments

Conditions: End Stage Renal Disease; Inflammation

Summary: prospective multicenter randomized cross-over study number of patients : 32 (8 patients per group) obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile. to evaluate the different hemodialyzers and judge their extraction performances in hd and post hdf. evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory status.

medical devices studied : * leoceed 21hx, hemodialyzer, high permeability ps membrane 2,1 m² , made by nx stage in germany * polypure 22s, hemodialyzer, high permeability ps membrane 2,2 m² , made by allmed in germany * vie 21a hemodialyzer, high permeability ps membrane 2,1 m² coated in vitamin e, made by asahi kasei medical in japan * rexsys 27h, hemodialyzer , high permeability pes membrane 2,7 m² , made by medica in italia these hemodialyzers are ec marked and are used in their own indications. schema details of the cross-over plan : 8 patients will be treated successively with the 4 hemodialyzers. patients will be treated with the dialyzer "test" for the two first sessions of the week. during the last dialysis session of each week, only their usual dialyzer will be used as wash-out. a randomization will define the order of use of the dialyzers in the 4 centers. this order will be identical in a center. number of patients : 32 (8 patients per center (4 centers)) duration : one week per dialyzer

Eligibility criteria:
inclusion criteria: * adult patient with chronic kidney disease dialyzed for at least one month and treated with the treatment mode that we will test * patient using post-dilution hdf mode have to use eudial volume guidelines (20-22l minimum) * patient treated before with high permeability membrane * patient with vascular access allowing a blood flow rate with a minimum of 300 ml/min * patient treated with a high surface area dialyzer ≥ 1,8 m² * patient covered by the social french health organism * patient informed of the study goals and having signed the informed consent exclusion criteria: * patient with a vascular access not allowing a blood flow rate minimum of 300 ml/min * patient with a fast progressive chronic disease * patient with an uncontrolled anemia * patient refusing to sign the informed consent * pregnant or nursing patient * pediatric patient * patient under tutorship
analysis of t cell metabolism in acute myeloid leukemia patients

Conditions: Acute Myeloid Leukemia

Summary: the objective of this study was to analyze the t cell metabolism and immune phenotype in aml patients during the course of the disease before and after allo-hct.

patients who experience relapse of acute myeloid leukemia (aml) after allogeneic hematopoietic cell transplantation (allo-hct) have a dismal prognosis. infusion of donor t cells can induce graft-versus-leukemia (gvl) effects, indicating the importance of intact t cell function for leukemia control. recent studies have shown the importance of metabolic fitness for an effective t cell response. in this study we have analyzed the t cell metabolism and immune phenotype in aml patients at different time points before and after allo-hct.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of aml * age ≥ 18 years * peripheral blood sample available * written informed consent * ability to understand the nature of the study and the study related procedures and to comply with them exclusion criteria: * age \< 18 years * lack of informed consent * patients that cannot be classified in one of the 3 groups