Kornimate/medical-research-clean huggingface dataset:
effect of spinae erector block (esp) and gabapentin on recovery and length of stay in adolescent spinal fusion patients

Conditions: Adolescent Idiopathic Scoliosis

Summary: a retrospective cohort study comparing time to ambulation (hours) between two groups of adolescent spinal fusion patients: a group who received intravenous multimodal analgesic strategy alone (mma group) and another group who received a multimodal analgesic strategy in combination with a preoperative esp block and oral gabapentin (mma-esp-g group).

one of the major challenges in postoperative care following posterior spinal fusion (psf) for adolescent idiopathic scoliosis (ais) is achieving adequate pain control. opioid-sparing multimodal anesthetic strategies are crucial for achieving effective postoperative pain control and facilitating early mobilization. the erector spinae (esp) block has been reported as part of various opioid-sparing strategies for spine surgery. perioperative oral gabapentin (in different dosing protocols) may contribute to reduce postoperative pain and opioid consumption. the primary aim of this retrospective study was to compare time to ambulation (hours) between two groups of adolescent spinal fusion patients: a group who received intravenous multimodal analgesic strategy alone (mma group) and another group who received a multimodal analgesic strategy in combination with a preoperative esp block and oral gabapentin (mma-esp-g group). the secondary aim was to compare intensive care length of stay, perioperative opioid requirements and time to urinary catheter removal between groups. this is a retrospective review of 34 consecutive adolescent spinal fusion patients during august-september 2023 at hospital italiano de buenos aires, argentina. the investigators compared two groups: 1) mma group received an intravenous multimodal analgesic strategy, 2) mma-esp-g group received an intravenous multimodal analgesic strategy in combination with a preoperative, ultrasound-guided, bilateral esp block (administration of a local anesthetic mixture of ropivacaine 0.375% and lidocaine 1%) and a 100mg dose of oral gabapentin 4 nights daily before surgery and 2 weeks postoperatively. both strategies were protocolized at our institution. data was analyzed for the primary outcome: median time to ambulation difference between groups. differences were considered statistically significant at p \< 0.05.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of adolescent idiopathic scoliosis (ais) and primary surgical indication between january 2018 and august 2023. * asa patients (american society of anesthesiology classification) i to iii. exclusion criteria: * patients who, at the end of the procedure, were transferred to the picu (pediatric intensive care unit) on mechanical ventilation. * patients undergoing corrective scoliosis surgery in combination with any other surgical procedure. * patients who received esp block postoperatively (group em-esp-g).
intravenous ferric carboxymaltose vs. oral iron substitution in patients with metastatic colorectal cancer (crc) and iron deficiency anemia: a randomized multicenter treatment optimization study.

Conditions: Metastatic Colorectal Cancer

Summary: iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. about 70% of these patients suffer from iron deficiency anemia (ida) which adds both physical and cognitive impediments to an already straining chemotherapy. moreover, a chronic disease like cancer often results in a reduced availability of iron for the body. in clinical practice iron substitution is usually administered orally. due to low resorption rates, frequent gastric side effects and thus poor patient compliance a parenteral substitution seems to be a better option in terms of efficacy. in the framework of a randomized multicenter clinical trial ('ferinject') a comparison of efficacy parameters of parenteral vs. oral iron substitution will now be conducted in order to identify the best treatment form for clinical practice in oncology. furthermore detailed quality of life-data (qol) will be collected in both treatment arms for effect comparison.


Eligibility criteria:
inclusion criteria: 1. metastatic or inoperable colorectal carcinoma. no curative therapy available. 2. current palliative chemotherapy. patients under conversion therapy must not be enrolled to this study. 3. iron deficiency anemia: hemoglobin ≤ 10.5 g/dl and transferrin saturation \< 20 % and/or serum ferritin \< 20 ng/ml 4. male and female patients aged ≥ 18 years; maturity 5. ecog ≤ 2 6. written informed consent 7. life expectancy \> 6 months 8. body weight ≥ 40 kg exclusion criteria: 1. oral or intravenous iron substitution within the last 4 weeks 2. age \< 18 years or body weight \< 40 kg 3. absorption dysfunction due to short bowel syndrome or after gastric resection 4. therapy with recombinant erythropoietin within the last 4 weeks 5. chronic diarrhea 6. chronic inflammatory bowel disease 7. ferritin \> 800 mg/dl at baseline 8. hypersensitivity or contraindication to ferric carboxymaltose or iron (ii) glycine sulphate complex 9. known vitamin b12 or folic acid anemia 10. necessary total parenteral nutrition 11. participation in another interventional study 12. pregnancy or lactation

Keywords: mcrc iron substitution iron deficiency anemia
targeting peroxisome proliferator-activated receptor-gamma in peritoneal dialysis patients - will it reduce inflammation, atherosclerosis, calcification and improve survival of peritoneal dialysis patients?

Conditions: Chronic Disease; Kidney Diseases; Cardiovascular Diseases

Summary: peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality and are related to the presence of accelerated atherosclerosis. our recent data showed that inflammation predicts mortality and cardiovascular death, independent of other cardiovascular risk factors in peritoneal dialysis patients. as a considerable proportion of peritoneal dialysis patients showed evidence of inflammation, it raises an important question as to whether anti-inflammatory treatment has any cardiovascular and survival benefit in these patients. the peroxisome proliferator-activated receptor-gamma (ppar-g) agonist is a class of drug with insulin sensitizing property. recent experimental and clinical studies demonstrated that this class of drug has anti-inflammatory and anti-atherosclerotic properties other than insulin sensitizing effect in type 2 diabetics. we therefore hypothesize that modulation of the ppar-g activity may be a novel therapeutic strategy for reducing inflammation and retarding the progression of atherosclerosis and possibly lowering mortality in our peritoneal dialysis patients.


Eligibility criteria:
inclusion criteria: * both prevalent patients or patients newly started on continuous ambulatory peritoneal dialysis with age between 20 - 75 with or without diabetes mellitus will be considered eligible for study entry. for patients newly started on continuous ambulatory peritoneal dialysis, they will be suitable for recruitment into the study after one month on continuous ambulatory peritoneal dialysis. exclusion criteria: * patients with underlying malignancy * patients with chronic liver disease or liver cirrhosis * patients with hepatitis b or c positive * patients with active infections * patients with other chronic active inflammatory disease such as systemic lupus erythematosus, rheumatoid arthritis * patients who refuse study participation * patients with underlying congenital heart disease or rheumatic heart disease * patients with poor general condition * patients with plans for living related kidney transplant within 2 years * female patients with pregnancy * patients with history of recurrent hypoglycemia * patients with class iii and iv congestive heart failure * patients already receiving glitazones treatment at the screening visit

Keywords: chronic kidney disease cardiovascular disease
the clinical trial on the use of umbilical cord mesenchymal stem cells in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: patients with amyotrophic lateral sclerosis (als) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. no treatment has changed its natural history. intrathecal injection of umbilical cord mesenchymal stem cells can secret trophic factors that keep the motorneurons functional. the investigators have designed a phase i/ii clinical trial to check the feasibility of this approach in humans.

a total of 30 diagnosed als patients. the patients would got these symptoms such as gait difficulty and tremor, hand incoordination or speech difficulties.

Eligibility criteria:
inclusion criteria: * diagnose established following the world federation of neurology criteria * more than 6 and less than 36 months of evolution of the disease * medullar onset of the disease * more than 20 and less than 65 years old * forced vital capacity equal or superior to 50% * total time of oxygen saturation \<90% inferior to 2% of the sleeping time * signed informed consent exclusion criteria: * neurological or psychiatric concomitant disease * need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube * concomitant systemic disease * treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months * inclusion in other clinical trials * unability to understand the informed consent

Keywords: als stem cell
understanding rebound pain after regional anesthesia resolution in healthy volunteers

Conditions: Regional Anesthesia Morbidity; Pain, Acute; Healthy

Summary: regional anesthesia decreases postoperative pain scores and opioid consumption, and may prevent chronic pain after surgery in patients undergoing surgery. however, some patients experience an increase of pain into the severe range when the nerve block wears off, also known as rebound pain. the investigators are studying if a nerve block (numbing injection) in the arm causes hyperalgesia (increased pain) when the nerve block is wearing off.

this is a prospective, randomized study in healthy volunteers who will undergo sensory testing using quantitative sensory testing (qst), complete psychosocial and pain questionnaires, and ultrasound-guided peripheral nerve block of the arm (axillary nerve block) in a supervised, monitored setting (bwh clinical investigation center). the investigators plan to assess the association between different qst modalities at different time points pre- and post-nerve block resolution. semi-structured interviews and qualitative analysis will be used to explore patient's experiences with nerve block placement.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, ≤ 65 years old * bmi \>18, \< 35 * able to speak and understand english * willingness to undergo psychophysical testing (e.g., qst, pain questionnaires) * willingness to have nerve block performed exclusion criteria: * ongoing acute or chronic pain in upper extremities * skin or tissue infection affecting upper extremities * previous hypersensitivity to mepivacaine or lidocaine * previous neuropathy (numbness, paresthesia, or motor weakness) in either upper extremity * loss of any limb * bleeding issues or bleeding disorder * history of alcohol or drug abuse * currently pregnant or breastfeeding * history of seizure or epilepsy

Keywords: healthy volunteer regional anesthesia rebound pain
asct in combination with c-car088 for treating patients with ultra high-risk multiple myeloma (mm)

Conditions: Multiple Myeloma

Summary: this is a phase i/ii, single-arm, open-lable study of autologous stem cell transplantation in combination with c-car088, an autologous bcma car-t cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line vrd-based treatment with or without the presence of multiple high-risk cytogenetic features.

patients with ultra high-risk multiple myeloma will undergo leukapheresis, stem cell mobilization and collection (could omit if collected before screening), conditioning, asct and c-car088 infusion. patients receive a single dose of c-car088 three days post-asct. two conditioning protocols and two dose levels of c-car088 will be used based on the investigator's discretion. patients will be evaluated closely for safety of efficacy during the first three months, then less frequently in the following months until 24 months post-asct.

Eligibility criteria:
inclusion criteria: * transplantation eligible patients, male or female, aged 18 to 65 years * ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line vrd-based treatment with or without the presence of multiple high-risk cytogenetic features * adequate liver, renal, bone marrow, and heart function * eastern cooperative oncology group (ecog) performance status 0-1. * male and female of reproductive potential must agree to use birth control during the study. exclusion criteria: * known allergies to the components or excipients of the c-car088 cell product * prior allogenic hsct, or asct * cns involvement * stroke or convulsion history within 6 months prior to signing icf * autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment * uncontrolled active infection; active hbv, hcv infection; hiv or syphilis infection * severe heart, liver, renal or metabolism disease * inadequate wash-out time for previous anti-tumor treatments prior to apheresis * previous car-t cell treatment, genetically modified t-cell therapies or bcma-directed treatment history * history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
azithromycin for preterm pre-labor rupture of membranes

Conditions: Preterm Pre-labor Rupture of Membranes

Summary: the preterm prelabour rupture of membranes is defined as the spontaneous rupture of the fetal membranes before 37 completed weeks. preterm prelabour rupture of membranes complicates up to 3% of pregnancies and is associated with 30-40% of preterm births. preterm prelabour rupture of membranes can result in significant neonatal morbidity and mortality, primarily from prematurity, sepsis, cord prolapse, and pulmonary hypoplasia. in addition, there are risks associated with chorioamnionitis and placental abruption the diagnosis of spontaneous rupture of the membranes is made by maternal history followed by a sterile speculum examination. if on speculum examination, no amniotic fluid is observed, clinicians should consider performing an insulin-like growth factor-binding protein-1 or placental alpha microglobulin-1 test of vaginal fluid to guide further management. one of the risks associated with preterm prelabour rupture of membranes is ascending infection leading to chorioamnionitis, and subsequent fetal and neonatal infection.


Eligibility criteria:
inclusion criteria: 1. gestational age is between 28 wks and 37wks 2. singleton living pregnancy. 3. confirmed premature pre-labor rupture of membranes (pprom). exclusion criteria: 1. previable rupture of membranes (\<23+6wks) 2. multiple gestations 3. macrolide allergy 4. patient receiving combination macrolide therapy 5. lethal fetal anomalies 6. contraindications to expectant management of pprom at time of diagnosis e.g. concurrent preterm labor, placental abruption, chorioamnionitis or non-reassuring fetal testing
epigenetic effects of a single bout of exercise on cardiovascular risk factors and the metabolome

Conditions: Obesity; Type 2 Diabetes; Cardiovascular Diseases; Acute Exercise

Summary: the purpose of this study is to determine the ability of acute exercise to regulate fat metabolism in muscle of overweight and obese people compared to lean people.

after being informed about the study details and possible risks and benefits, 15 overweight/obese and 15 lean participants gave written informed consent and were then screened and enrolled in the study. all participants then gave a muscle sample and ate a calorically controlled breakfast. participants completed \~1 hour of cycling exercise on a stationary bike and gave a second muscle sample 4 hours after eating breakfast.

Eligibility criteria:
inclusion criteria: * healthy males that completed a physical examination with a state licensed m.d. or d.o. within the past 2 years and completed a physical activity readiness questionnaire (parq), the international physical activity questionnaires (ipaq) and and a medical history questionnaire prior to the study exclusion criteria: * any participants that had not had a physical examination by a state licensed m.d. or d.o. within the past 2 years * persons not considered "healthy" (with any previous medical diagnoses) or not medically cleared by a m.d. or d.o. to perform physical activity/exercise * persons who are regularly physically active
study to evaluate the usability and value of integrated digital solutions in medical care of participants with multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the main purpose of this study is to assess the usability and value of the multiple sclerosis (ms) care management platform in terms of improved monitoring of people with ms (pwms) in clinical practice. this is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the ms care management platform.

the ms care management platform consists of: a) icobrain ms, a cloud-based artificial intelligence (ai) solution to quantify brain volume and brain abnormalities and changes thereof on magnetic resonance imaging (mri) scans and thereby providing insights into subclinical changes during disease progression in ms. b) icompanion ms, which consists of i) a free participant mobile application (app) and website to keep track of participant reported health and medications and prepare participants for the next consultation. ii) a web portal for healthcare professionals (hcps), which is accessible via web browser. the ms care team will be able to access the participants' data entered via the participant app (active linking of systems by the participant required), as well as their participants' mri images and icobrain ms volumetric brain reports automatically imported by the hospital picture archiving and communications system (pacs).

Eligibility criteria:
inclusion criteria: * able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. to use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (android version 5.0 or above, ios version 11 or above) * have a valid email address (for registration of icompanion ms) * have a definite diagnosis of rrms * time since ms diagnosis ≥1 year * medical history recorded for at least 1 year before enrollment * expanded disability status scale (edss) \<5.5 exclusion criteria: * any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion * inability to complete an mri * currently involved in an interventional trial * diagnosis of progressive ms (primary progressive multiple sclerosis \[ppms\] or secondary progressive multiple sclerosis \[spms\])

Keywords: icobrain icompanion multiple sclerosis medical device patient app digital care management magnetic resonance imaging (mri) deep learning artificial intelligence (ai) patient reported outcomes (pro)
single v dual-operator ultrasound technique for peripheral vascular access in the emergency department

Conditions: Patients With Difficult Vascular Access.

Summary: this is a randomized controlled trial comparing the success of us guided peripheral iv placement between single vs dual-operator technique among a convenience sample of patients with moderate or difficult vascular access in a tertiary care emergency department.

gaining intravenous (iv) access is a common and important procedure in the emergency department (ed). iv access is needed to deliver drugs, enable fluid resuscitation and sample blood, and delays in gaining access can lead to patient harm. ultrasound (us) is a commonly used tool in the ed, and the utility of ultrasound in the placement of ivs in patients with difficult access has been well described. this study aims to further guide the use of this evidence based tool by ed registered nurses. the focus will be comparing single-operator technique, in which the same provider manipulates the ultrasound probe while simultaneously placing the iv, to a dual-operator technique whereby a second provider manipulates the probe. any measured advantage has implications in guiding education and practice, as well as informing future ed policy.

Eligibility criteria:
inclusion criteria: * adult (18 years and older) patients predicted to require intravenous cannulas and identified at triage as having moderate or difficult access based on the following criteria: moderate: peripheral vein is visible or palpable but difficulty is expected based on patient characteristics both clinical and historical. difficult: no peripheral veins visible or palpable, or two failed attempts by traditional landmarking (lm). exclusion criteria: * exclusion criteria will include patients who have already undergone successful pre-hospital iv placement, patients with an indwelling vascular device, patients who are critically ill (canadian triage acuity score i) or objection to study enrolment by the attending md for any reason. if no suitable target vein can be identified with us the patient data will be collected and the patient will be excluded from the statistical analysis.