Kornimate/medical-research-clean huggingface dataset:
exploring the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia

Conditions: Pediatric ALL

Summary: the goal of this clinical trial is to explore the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. the main questions it aims to answer are: * the distribution of different volumes of ropivacaine after caudal anesthesia * the blockade level after caudal anesthesia with varying doses * the minimum effective concentration of ropivacaine among pediatric patients of different age groups researchers will inject different doses or concentrations of ropivacaine into the caudal canal to observe the drug's spread range, the level of blockade, and the duration of its effect. participants will: * undergo magnetic resonance imaging (mri) examinations before and after caudal anesthesia * will be detected the blockade level after caudal anesthesia

the activity of cyp1a2 in newborns and infants is lower than in adults, which may result in slower metabolism of ropivacaine. this might necessitate a reduction in the dosage or concentration of ropivacaine to prevent drug accumulation and toxicity. additionally, since the nervous system in children is still developing, excessively high concentrations of ropivacaine could have adverse effects. therefore, the lowest effective concentration of ropivacaine should be chosen to minimize the risk of adverse reactions. generally, the dosage of ropivacaine should be determined based on the patient's age, weight, and the type of surgery. however, there are currently no definitive dosage recommendations, and further research is needed to determine these guidelines. the goal of this clinical trial is to exploring the minimum effective concentration and volume of ropivacaine for sacral plexus anesthesia. using mri to investigate the distribution of different doses of ropivacaine after caudal anesthesia, and employing infrared imaging technology to detect the blockade level after caudal anesthesia with varying doses. participants will receive 0.5ml/kg, 1ml/kg and 1.5ml/kg ropivacaine, then undergo magnetic resonance imaging (mri) examinations to detect the distribution and optic nerve sheath diameter (onsd) before and after caudal injection. also, the blockade level will be detected 15min and 30 min after caudal anesthesia

Eligibility criteria:
inclusion criteria: bmi ≤ 30 kg/m²; lower limbs surgery; lower abdomen surgery; perineal region surgery; normal liver and kidney function; normal coagulation function; hemoglobin \> 70 g/l. exclusion criteria: abnormal coagulation function; allergy to local anesthetics; abnormal sacral anatomy; puncture site infection;

Keywords: caudal anesthesia children thermal imaging intraoperative mri
use of silodosin to treat moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome.

Conditions: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Summary: the primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. the secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.

a multi-center, double-blind, placebo-controlled investigation of silodosin in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome.

Eligibility criteria:
inclusion criteria: * male, at least 18 years of age * has a total nih-cpsi total score of 15 * has a nih-cpsi pain score of 8 * has had pain in the pelvic region for at least 3 months prior to screening exclusion criteria: * has previously participated in a watson study with silodosin * has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition * has experience ≥2 urinary tract infections within the previous 12 months * has any medical condition that in the opinion of the investigator precludes safe participation in the study * has any medical condition that could confound the efficacy evaluation * is receiving ketoconazole, or other known potent inhibitors of cytochrome p450 3a4 or any medication in the opinion of the investigator that precludes safe participation in the study * is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation * has participated in a study involving the administration of an investigational agent within the past 30 days

Keywords: prostatitis, chronic pelvic pain
assessing symptomatic clinical episodes in depression

Conditions: Major Depressive Disorder

Summary: randomized, double-blind, active-controlled study of axs-05 for mdd.

this study will evaluate the safety and efficacy of axs-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (mdd) experiencing an acute episode.

Eligibility criteria:
inclusion criteria: * currently meets dsm-5 criteria for mdd * body mass index (bmi) between 18 and 40 kg/m\^2, inclusive * agree to use adequate method of contraception for the duration of the study * additional criteria may apply exclusion criteria: * suicide risk * history of treatment resistance in current depressive episode * history of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months * pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study * additional criteria may apply

Keywords: axs-05 major depressive disorder mdd axsome depression dextromethorphan bupropion sigma-1 ndma ascend
the role of dietary fat on postprandial endotoxemia in healthy adults

Conditions: Endotoxemia

Summary: the purpose of this study was to determine the effect of different dietary fats (saturated or unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. the investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial endotoxemia.participants were recruited via email and randomized to treatment meal in this single-blind, cross-over study. each test session participants reported to the laboratory right away in the morning. an indwelling catheter was inserted into the participant non-dominant arm by a qualified nurse and a baseline blood draw was taken. the participant was then provided with one of four test meals (a porridge-type meal containing a different dietary fat), which they ate in entirety within 15 minutes. the participants remained in the laboratory for the next five and a half hours and were not allowed to consume any food or drink except water. during this time, further blood draws were taken at intervals of one hour for a total of five hours after the consumption of the test meal. collected blood was processed on-site and the serum fraction collected and tested for endotoxin, inflammatory biomarkers, and metabolites.


Eligibility criteria:
inclusion criteria: * aged between 18 and 40 years old; * willingness to eat test meals; * body mass index ≥ 19.9 ±0.8 and ≤ 24.9 ±0.8; * weight stable (\< 2 kilogram weight change in the previous 3 months) exclusion criteria: * presence of acute or chronic disease; * use of tobacco products; * consumes more than 21 units of alcohol per week; * use of anti-inflammatory medication; * history suggestive of macronutrient malabsorption

Keywords: inflammation endotoxemia lipopolysaccharide diet fat postprandial
pigtail catheter for drainage of (pneumothorax/simple effusion) is a effective procedure

Conditions: Pleural Effusion

Summary: assessment and evaluation of pigtail application in drainage of pneumothorax and haemothorax.

chest injuries are common following blunt and penetrating trauma. fewer than 10 per cent of blunt injuries and 15-30 per cent of penetrating injuries require surgical management1. most can be managed with tube thoracostomy to expand the lung (pneumothorax) or to drain blood (haemothorax)2. although tube thoracostomy is fairly effective, it can be associated with complications such as mispositioning, malfunction, or injury by insertion through the diaphragm or liver3-5. the standard tube size. has usuallybeen32-40fr.insertion of such a large -calibre tube requires a cut-down technique, can be traumatic, and is often associated with signiﬁcant pain and discomfort. pigtail catheters, originally used by cardiologists to drain chronic pericardial effusion6, were later modiﬁed and adapted for pleural drainage7. because of their small size and reduced trauma during placement, patients may experience signiﬁcantly decreased pain and discomfort. pigtail catheters are frequently used in the paediatric population8-10, as well as in adult, non-traumatic situations11-17 pigtail catheters inserted at the bedside have similar efﬁcacy to traditional chest tube.

Eligibility criteria:
inclusion criteria: * iatrogenic pneumothorax exclusion criteria: * age less than 18 years. * refused to participate. * unconscious. * spontaneous pneumothorax.
clinical evaluation of the "nicu clinical decision support dashboard" - mhsb

Conditions: Preterm Birth; Low; Birthweight, Extremely (999 Grams or Less); Neonatal Infection; Satisfaction; Stress; Chronic Lung Disease; Growth Acceleration; Adverse Event

Summary: this study evaluates the use of a nicu clinical integration system (dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. clinicians will be asked to follow their current standard of care practices with the aid of this technology. about half of participants will receive care in nicu rooms with the dashboard installed while the other half will receive standard care without the dashboard.

the current nicu environment can be stressful and overwhelming for parents of babies admitted and for clinicians caring for the babies. there is a wide range of monitors in a very clinical environment that does not take into account the comfort of neonates. the dashboard works in parallel with ehr and systems of record, and provides a cohesive view of the patient's status and planned clinical workflow in a single location for both parents and staff. accessories such as environmental sensors and cameras are used to ensure that the environment is comfortable and promotes optimal development of the baby. caregivers can educate and coach parents to facilitate integrating them into their infant's care. the nicu dashboard also supports a family view to facilitate education and assist the family in tracking core measures and developmental milestones.

Eligibility criteria:
neonates and their parents inclusion criteria: * admission to the nicu * at least one parent (biological, guardian, or adoptive) involved * one parent can understand and speak the english language * parent aged 18 years or older * parent with sufficient mental capacity to provide written informed consent as determined by a rn * signed informed consent from the parent exclusion criteria: * expected discharge from the nicu in \<48 hours clinicians interacting with the nicu dashboard inclusion criteria: * employee of institution with direct patient care in the nicu (e.g. physician, np, rn, therapist) * expected interaction with the nicu dashboard * signed informed consent exclusion criteria: * no interaction with the nicu dashboard

Keywords: nicu developmental care neuroprotective technology
immediate effect of two selected mulligan techniques in nonspecific low back pain

Conditions: Back Pain

Summary: to compare between immediate effect of snag and mulligan lion position in range of motion (rom) , pain, functional ability and kinesiophobia on patients with nonspecific low back pain.

low back pain (lbp) is a global health problem.orthopedic manual therapy (omt) is most commonly recommended form of treatment of lbp and it is also frequently used in clinical practice in various countries. mulligan introduced a new technique in manual therapy. mulligan has a great role in the treatment of lbp.general techniques of mulligan are mwm, snags and natural apophyseal glides (nags). lumber snag have immediate and short term on pain and function in treatment of patients with nslbp.mulligan has special techniques, one of them is modified lumbar snag (lion position) .it has short term effect in reducing pain and activity limitation. up to investigated knowledge, no previous studies comparing immediate effect of two techniques in range of motion (rom), pain, functional ability and kinesiophobia

Eligibility criteria:
inclusion criteria: 1. 3 to 7 on vas. 2. back pain duration of 6 week or more . 3. 20-40 years old . 4. patients of both sexes will be concluded . 5. body mass index (18.5-29.9 kg/m2). exclusion criteria: 1. fracture, osteoporosis, myelopathy, multiple adjacent radiculopathies, cauda equina syndrome, vertebral bone disease and bony joint instability . 2. infective conditions of spine, autoimmune disorders, pacemakers, malignancy . 3. history of surgery or injection at lumbar spine 1 year ago .

Keywords: mulligan lumbar sagittal mobility back pain
implementation strategy of bio-molecular techniques for early diagnose of congenital syphilis and chagas diseases

Conditions: Chagas Disease; Syphilis

Summary: chagas disease and syphilis are considered a mayor public health problem worldwide. both pathologies affect socio-economic vulnerable population and they are both transmitted congenitally, causing an alarming increasing number of infected newborns. the current diagnostic methods for these diseases are based on serology follow-up until 8 to 10 months from birth, which considering the population usually involved and their scarce resources, usually translates in loosing continuity in their controls and follow-up. chagas prevalence in pregnant women is 4% with an incidence of congenital chagas disease of 1500 annual cases. from those, only 1 third are diagnosed. in the investigators and other authors experience, the detection of dna of trypanosoma cruzi by pcr shows an elevation of parasitemia at birth, with a peak at the first month of life. syphilis is a re-emergent pathology, preventable and curable when diagnose is achieved early at the beginning of pregnancy.. the cost-effectiveness of performing screening for this infection is widely demonstrated, preventing high morbi-mortality for children when applied to pregnant women. for both syphilis and chagas diagnosis, there are some studies comparing pcr follow-up with conventional serology, but none were validated and there is still need to bring more evidence in order to modify current practice. the investigators propose a sequential study of pcr for tryipanosoma cruzi and treponema pallidum from birth, believing this will increase sensitivity of congenital chagas and syphilis diagnose and improve follow-up of these patients.


Eligibility criteria:
inclusion criteria: * child under 1 year of age, born from mother positive for syphilis not treated or inadequately treated during pregnancy * patients with acquired syphilis * child under 1 year of age, born from mother with positive serology test for chagas exclusion criteria: * patients who had received treatment for syphilis or chagas previously * patients who are not able to complete scheduled visits * other diseases that could difficult implementation of this protocol or results interpretation.

Keywords: congenital chagas disease congenital syphilis chagas pcr diagnose syphilis pcr diagnose children
efficacy and safety of jmt101 combined with afatinib (or osimertinib) in patients with non-small cell lung cancer

Conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary: this study is a phase ib, open label, multi-center study of to evaluate the safety and efficacy of jmt101 combined with egfr-tkis (afatinib or osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) harboring egfr exon 20 insertion mutations.

the objective of the trial is to evaluate the safety and efficacy of jmt101 combined with egfr-tkis (afatinib or osimertinib) in patients with locally advanced or metastatic nsclc with egfr exon 20 insertion mutations. this study consists of two parts (stage i and stage ii). stage i was a dose escalation study, and stage ii was a dose expansion study.

Eligibility criteria:
inclusion criteria: * pathologically or cytologically confirmed, locally advanced or metastatic nsclc, harboring an egfr exon 20 insertion mutation. ( non-irradiable, non-operable); * no previous treatment or first-line treatment failed nsclc; * at least 1 measurable lesion according to recist 1.1; * ecog score 0 or 1; exclusion criteria: * previously treated with egfr antibody; * symptomatic brain metastasis; * interstitial pneumopathy; * known hypersensitivity to any ingredient of jmt101, afatinib, osimertinib or their excipients; * receiving an investigational product in another clinical study within 4 weeks; * history of serious systemic diseases; * history of serious autoimmune diseases; * pregnancy or lactating women.
assessment of anterior cruciate ligament (acl) degeneratio mucosa treatment

Conditions: Anterior Cruciate Ligament Injuries

Summary: anterior cruciate ligament (acl) degeneratio mucosa is a condition resulting from mucoid degeneration of acl. exact etiology is unknown, however acl degeneratio mucosa impairs everyday functioning. in the literature there were some reports of treatment by acl excision and subsequent reconstruction, however such treatment brings risk of deteriorated function. in this study the investigator will evaluate the technique of acl "decompression" by the means of longitudinal incisions and evacuation of extrafibrous mucoid tissue.


Eligibility criteria:
inclusion criteria: * patients with acl degeneratio mucosa decided to undergo a surgical treatment * range of motion impairment caused by mucoid or cystic changes in acl confirmed by mri exclusion criteria: * non-adherence to the study protocol * active knee inflammation * range of motion impairment due to other extra- and intra-articular reasons
effect of sleep extension on overweight and learning in children

Conditions: Sleep Duration; Child Obesity; Child Development; Child Behavior

Summary: more2sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 300 school-aged children (6-9 years) who are mildly overweight or obese and habitually sleep for ≤ 9 h/night. data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). the collection of data is mainly related to the main study. however, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-i (metabolic mechanisms, n=60) and substudy-ii (learning mechanisms, n=150). the primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who are overweight or obese, and sleep less than recommended for their age.


Eligibility criteria:
inclusion criteria: * age: 6-9 years old (inclusive range). * weight status: modestly overweight or obese (equivalent adult bmi of 25 to 35 kg/m2) defined as a sex-specific bmi z-score between +1 and +3 (inclusive range) using reference standards from the world health organization. * sleep duration: sleeping ≤9 h/night on the basis of sleep diaries filled in by the children's parents, based on recommendations by the american academy of sleep medicine and the sleep health foundation. exclusion criteria: * any genetic or chronic condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit hyperactivity disorder, β-thalassemia, hypo-/hyper-thyroidism, type i diabetes). * any sleep-related disorder (for example: obstructive sleep apnea, parasomnias, narcolepsy, restless leg syndrome). * regular use of prescribed or over-the-counter medications that influence study out-comes. * irregular school schedule or not consistently sleeping in the same household during the school week. * participation in other research studies.

Keywords: sleep duration sleep quality overweight and obesity energy intake child development and behavior well-being cognitive function learning ability memory
diaphragmatic breathing exercises in total knee arthroplasty patients

Conditions: Anesthesia and Analgesia

Summary: rationale: while total knee replacements (tka) are one of the most commonly performed surgical procedures in the united states, this procedure can also be very painful. postoperative mobilization and rehabilitation is vital to a patient's recovery, but inadequate pain control can impede patients' progress. diaphragmatic breathing is an additional non-pharmacological and non-invasive tool with no adverse effects that could aid in recovery. this will serve as a pilot study for a possible larger controlled trials.

study population: patients (participants) undergoing total knee arthroplasty at keck usc hospital at hc3 study methodology: patients (participants) will be taught with the aide of a handout and instructional videos preoperatively and in the recovery room on how to perform diaphragmatic breathing exercises for post-operative pain control. patient (participant) pain levels will be assessed using the visual analog scale (vas). the investigators will then be comparing vas scores and daily opioid doses (morphine equivalents) between the study group and a control group. the control group will include prior patients (participants) over the past year who underwent tka at keck hospital and also had pain scores and opioid usage measured, but did not receive the breathing treatment. study endpoints: endpoints will include: pain levels via vas scale, anxiety levels via vas scale, and opioid usage (morphine equivalents).

Eligibility criteria:
inclusion criteria: * patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter exclusion criteria: * inability to perform or learn diaphragmatic breathing exercises or do not wish to participate in diaphragmatic breathing or study protocol * pregnant patients * patients without continuous peripheral nerve block catheter
safety and effectiveness of wavefront-guided lasik correction of hyperopic refractive errors

Conditions: Hyperopia

Summary: demonstrate that wavefront-guided lasik using measurements from the idesign system is safe and effective for the treatment of hyperopia.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the time of pre-operative exam * best spectacle corrected visual acuity (bscva) of 20/20 or better * demonstration of refractive stability * anticipated post-operative stromal bed thickness of at least 250 microns * willing and capable of returning for follow-up examinations for the duration of the study exclusion criteria: * women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study * concurrent use of topical or systemic medications that may impair healing * history of any medical conditions that could affect wound healing * history of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality * evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s) * known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Keywords: refractive errors