Kornimate/medical-research-clean huggingface dataset:
saphenous nerve block for partial meniscectomy

Conditions: Pain, Joint; Pain, Procedural; Meniscectomy

Summary: partial meniscectomy and meniscus repair are two of the most common orthopedic surgery procedures. as these procedures are being increasingly performed in ambulatory surgical centers, there has been a shift towards providing improved analgesia to ensure timely discharge, as well as preventing unwanted pain and side effects. as such, it has become common practice to use an intra-articular injection of local anesthetic to achieve post-operative pain control. however, these effects are short lived, requiring a multimodal approach to analgesia. to date, no optimal pain control strategy has been described for arthroscopic partial meniscectomy or meniscus repair. the purpose of this study is to examine the outcomes of subcutaneous saphenous nerve block with 0.5% ropivacaine at the medial femoral epicondyle/adductor hiatus plus portal 0.5% ropivacaine injection vs portal 0.5% ropivacaine injection alone for patients undergoing arthroscopic partial meniscectomy or meniscus repair.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * scheduled for arthroscopic meniscectomy or meniscus repair exclusion criteria: * multiple-ligament injury * primary acl reconstruction or acl revision reconstruction * articular cartilage restoration surgery * evidence of microfracture * history of allergy to local anesthetics * pre-existing saphenous neuropathy * unable to be prescribed opioids due to allergy or other reason
evaluation of telemedicine practices for contraceptive counseling during the covid-19 pandemic: a randomized controlled trial

Conditions: Family Planning Services; Telemedicine; Pregnant Women; Women's Health; COVID-19 Pandemic

Summary: the goal of this randomized clinical trial is to evaluate the telemedicine practices for contraceptive counseling given to pregnant women during the covid-19 pandemic. the main questions it aims to answer are: * does family planning counseling given to pregnant women by using telemedicine practices have an effect on the knowledge level about family planning? * is family planning counseling given to pregnant women by using telemedicine practices effective on satisfaction with family planning services? participants have attended to contraceptive counseling video call sessions provided via whatsapp application and they have the opportunity to see the consultant and her materials during these sessions. after these sessions (two weeks later), contraceptive counseling video call session has been repeated, and at the end of this second session, women have been asked to answer the questions in the "family planning knowledge level form" and the "family planning services satisfaction scale". there is a comparison group (a control group) in this study, and no intervention was made to the women in the control group other than the routine services given in primary care settings. researchers will compare the experimental group with control group to see if the telemedicine practices are effective in increasing the knowledge level of pregnant women about family planning and in the satisfaction of family planning services provided by primary health care settings.


Eligibility criteria:
inclusion criteria: * women in the third trimester of their pregnancy and who agreed to participate in the study have been included in this study. exclusion criteria: * women with psychiatric disorder have been excluded from this study.

Keywords: family planning services telemedicine pregnant women women's health covid-19 pandemic
the application of sling exercise training in people with chronic stroke

Conditions: Chronic Stroke

Summary: the purpose of this single-blinded, randomized controlled study aims to investigate the effects of sling exercise training (set) for core muscle on gait performance in people with chronic stroke.

background and purpose: balance and gait performance are often impaired in people post stroke. evidence showed positive correlations between trunk control and balance and walking ability. previous studies applying core muscle training reported positive effects on improving trunk control and sitting balance among patients with chronic stroke, but benefits on standing balance and gait performance remain undetermined. sling exercise training (set) has been suggested for improving core muscle stability and strength in people with stroke. however, studies about effects of set on gait performance in stroke populations are limited. therefore, the present study aims to investigate the effects of set for core muscle on gait performance in people with chronic stroke. methods: thirty-eight individuals with chronic stroke will be recruited and assigned to one of the two groups by randomization, sling exercise training group and conventional training group. the training is 30 minutes per session, 3 sessions per week for total of 4 weeks. gait performance is the primary outcome to include gait speed, stride length, single leg support time and temporal and spatial symmetry measured by gaitrite® system. secondary outcomes include balance, timed up-and-go (tug) test and trunk performance. all outcomes will be assessed before, after the 4-week training program and at 4-week follow-up.

Eligibility criteria:
inclusion criteria: * stroke after onset ≥ 6 months * trunk impairment scale (tis) score ≤ 21 at baseline * brunnstrome stage ≥ iv over the affected lower extremity * ability to independently walk for 10 meters with or without assistive devices * intact cognition with mini-mental state examination (mmse) ≥ 24 exclusion criteria: * any other significant musculoskeletal disorder, neurological disease or cardiovascular disease that may affect the participation in this study. * vision or language deficit that may affect participating in this study.

Keywords: core control sling exercise training gait chronic stroke
pooling of cohort studies on diet & coronary disease

Conditions: Coronary Arteriosclerosis; Cardiovascular Diseases; Heart Diseases

Summary: to quantify the role of dietary factors in the etiology of coronary heart disease by pooling data from 10 major prospective studies on diet and coronary heart disease.

design narrative: specific hypotheses tested included an adverse effect of saturated fat and carotenoids (alpha-carotene, lutein, and lycopene), flavonoids, folic acid, and vitamin b6. plausible biological interactions between nutrients, such as fatty acids of the n-6 and n-3 series were also explored. each participating center sent data on tape to the coordinating unit at the department of nutrition, harvard school of public health. the relations of dietary factors and coronary heart disease were first estimated within each study and compared for consistency. data were then combined to obtain the best overall estimates, taking into account the validity of dietary data collected at each center. members from study centers met annually to discuss the interpretation of findings. over 6,000 cases of myocardial infarction or coronary death were anticipated, which should have provided excellent precision in measuring associations, and allowed the comparison of extreme intakes that were poorly represented in individual studies. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
overcoming membrane transporters to improve cns drug delivery - improving brain antioxidants after traumatic brain injury

Conditions: Pediatric Traumatic Brain Injury

Summary: the overall purpose of this research study is to investigate the safety of pharmacological therapies that may potentially improve pediatric outcomes after traumatic brain injury. traumatic brain injuries are the leading cause of death and disability among children and young adults. hypothesis: combinational therapy with a membrane transporter and antioxidant are safe after tbi and can overcome barriers to the brain and synergistically improve bioavailability and efficacy the antioxidant content of the body and cns after tbi.

specific aim: define the capacity of the combination of probenecid and nac to safely and synergistically preserve levels of gsh and reduce oxidative stress in children with severe tbi. we will enroll 20 children age 2 to less than 18 years old (less than 216 months) after severe tbi in a randomized, controlled study of administration of the combinational therapy and test if the administration of these drugs is safe and if antioxidant reserve can be preserved within the serum and csf. probenecid (at the same dose that is used as an adjunct to antibiotic therapy) and nac (at the same dose that is used for acetaminophen-induced liver disease), or vehicles will be given for 3 days. the primary outcomes of the study will be the safety of drug administration and the csf and serum levels anti-oxidant reserve (aor), with the presumption that maintaining anti-oxidant levels within the brain may prove neuroprotective. other secondary outcomes (csf and serum probenecid, nac, gsh and phenytoin concentrations) will also be tested. adverse events occuring during treatment with these drugs after tbi will be monitored by a local data safety monitoring board.

Eligibility criteria:
inclusion criteria: * children (age 2 - 18 y) with severe tbi (gcs \< or = 8) with an externalized ventricular drain placed for measurement of intracranial pressure exclusion criteria: 1. brain dead on admission to icu 2. pregnancy 3. contraindications to enteral medications 4. contraindications to probenecid: * status epilepticus * blood dyscrasias * under 2 years-of-age * coadministration of salicylates * renal dysfunction or urate kidney stones * hypersensitivity to probenecid 5. contraindications to n-acetylcysteine: hypersensitivity to n-acetylcysteine 6. family unwilling to consent

Keywords: children brain injury trauma
pediatric obesity and the infant microbiome (beach)

Conditions: Pediatric Obesity

Summary: the impact of breastfeeding on the infant microbiome in vaginally and cesarean delivered offspring from obese and normal weight mothers.

design: normal weight (nw; pre-pregnant bmi \ 30.0 kg/m2), gestational diabetes (gdm), type 2 diabetes (t2d), and type 1 diabetes mothers during the 3rd trimester (34-36 weeks) of pregnancy that will be followed -along with their respective offspring- through the first 12 months of life will be recruited from the university of florida (uf) health shands hospital. stool, saliva, blood, vaginal swab, human milk, urine, body composition and clinical variables will be collected from mother and infant at 34-36 weeks of gestation (mom only), 2-weeks, 2-months, and 1-year at the uf clinical research center. infant body composition is the primary outcome and will be monitored via anthropometry. follow-up data points will be collected from electronic health records (ehr) and include but are not limited to wellness visits by 1 month, 2 months, 4 months, 6 months, 9 months, 12 months, 15 months, 18 months, 2 years, 2 ½ years, 3 years, and each year after that until 17.9 years. planned data analysis includes linear regression using the r statistical program. the primary data analysis will test maternal health status and human milk bioactive components for associations with the infant microbiome and pediatric outcomes collected by clinical visits and ehr. the study team will recruit equal samples of pregnant mothers in each the following groups (n=50 in each group; 1800 total participants): 1) nw vaginal deliveries; 2) nw c-section deliveries; 3) ob vaginal deliveries 4) ob c-section deliveries; 5) gdm vaginal deliveries; 6) gdm c-section deliveries; 7) t2d vaginal deliveries; 8) t2d c-section deliveries; 9) t1d vaginal deliveries; 10) t1d c-section deliveries. stool, saliva, and vaginal swab samples collected from participants may be used for animal studies whereby germ-free mice are inoculated with stool samples to evaluate a causal role of the microbiome in clinically relevant phenotypes (i.e. pediatric obesity).

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 45 years of age. * pre-pregnancy bmi is greater than 30 kg/m2 * pre-pregnancy bmi is less than 25 kg/m2 * at risk for gestational diabetes * pregnant and have type 1 diabetes (t1d) * pregnant and have type 2 diabetes (t2d) * pregnant and within the 3rd trimester (34-36 weeks of gestation)-you plan to deliver in the greater gainesville area * plan to deliver via vaginal or cesarean section * plan to exclusively breastfeed your infant for at least 2 months * child will receive their pediatric care through ufhealth exclusion criteria: * smoking * pre-eclampsia * history of pre-term delivery (\<35 weeks) * only one breast capable of lactation and milk production inadequate * age \ 45 yrs * any maternal antibiotics in the last 2 weeks during delivery * any alcohol consumption * drug use

Keywords: breastfeeding microbiome beach human milk pediatric obesity
study to examine the effects of multistem in ischemic stroke

Conditions: Ischemic Stroke

Summary: a study to examine the safety and potential effectiveness of the adult stem cell investigational product, multistem, in adults who have suffered an ischemic stroke. the hypothesis is that multistem will be safe and provide benefit following an ischemic stroke.


Eligibility criteria:
inclusion criteria: * male or female subjects between 18 and 83 years of age (inclusive) * clinical diagnosis of cortical cerebral ischemic stroke * occurrence of a moderate to moderately severe stroke exclusion criteria: * presence of a lacunar or a brainstem infarct * reduced level of consciousness * major neurological event such as stroke or clinically significant head trauma within 6 months of study

Keywords: ischemic stroke adult stem cells
clinical study of gpa33-specific pet/ct for the diagnosis of colorectal cancer

Conditions: Positron-Emission Tomography; Colorectal Neoplasms

Summary: in this study, we will first investigate the imaging safety and feasibility of \[68ga\]ga-nota-wwh347 and \[18f\]f-h3resca-wwh347 pet/ct in patients with primary and/or metastatic colorectal cancers. the second goal of the study is to preliminarily investigate the diagnostic efficacy (e.g., sensitivity and specificity) of \[68ga\]ga-nota-wwh347 and \[18f\]f-h3resca-wwh347 pet/ct in patients with primary and/or metastatic colorectal cancers. this study will provide a new method for the noninvasive target-specific diagnosis of colorectal cancer, and provide an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.


Eligibility criteria:
inclusion criteria: 1. be between 18 and 65 years of age and of either sex. 2. patients with colorectal cancer confirmed by puncture or surgical pathology. 3. written informed consent signed by the subject or legal guardian or caregiver. 4. willingness and ability to cooperate with all programs of this study. exclusion criteria: 1. severe hepatic or renal insufficiency; 2. targeted therapy before radiotherapy or pet/ct scan. renal function: serum creatinine less than or equal to the upper limit of the normal range; 3. liver function: bilirubin, ast(sgot)/alt(sgpt) less than or equal to the upper limit of the normal range. 4. history of serious surgery in the last month. 5. those who have participated in other clinical trials during the same period.
withdrawal of inhaled corticosteroids in patients with copd in primary care

Conditions: Chronic Obstructive Pulmonary Disease

Summary: guidelines recommend inhaled corticosteroids (ics) for patients with moderate to severe chronic obstructive pulmonary disease (copd). most copd patients are managed in primary care and receive ics long-term and irrespective of severity. the effect of withdrawing ics from copd patients in primary care is unknown.this randomised double-blind placebo-controlled trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with copd recruited from general practice. participants will have a clinical and spirometric diagnosis of copd and will have been prescribed inhaled steroids for the 6 months before entry to the trial. they will be randomised to taking a fixed dose steroid inhaler (flixotide accuhaler) or an identical placebo inhaler. patients will be monitored using diary cards for a year with 3 monthly follow-up visits at their general practice. the primary outcome measures will be exacerbation frequency and severity. other outcomes are time to first exacerbation, costs, health status, lung function and unscheduled care. we tested the hypothesis that withdrawal of ics in this population would lead to an increased number of exacerbations, earlier onset of exacerbation, and a worsening of symptoms.

to determine whether withdrawal of inhaled corticosteroids in patients with copd in general practice effects: * the frequency of exacerbations compared to a control group * differences in health status compared to a control group * differences in lung function compared to a control group * changes in unscheduled care compared to a control group * direct and indirect costs compared to a control group hypothesis the withdrawal of inhaled corticosteroids from patients with copd identified in primary care will cause an increase in frequency and severity of exacerbations and is not cost-effective.

Eligibility criteria:
inclusion criteria: * smoker or ex smoker of at least 10 pack years * age 40 or above * prior and current use of inhaled corticosteroids for at least 6 months duration (used for at least 75% of time on direct questioning) * fev1 \<80% of predicted, fev1/fvc ratio \<70%. * less than 15% change and \<200 mls change in fev1 20 minutes after 5 mg nebulised salbutamol. * 256 patients to be included in trial of which 196 must have had a precious exacerbation of copd in the last year exclusion criteria: * clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease * inability to give informed consent (severe mental illness, mental handicap or brain damage). * recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation) * classification as a never smoker * strongly positive skin allergy result (\>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)

Keywords: chronic obstructive pulmonary disease primary care randomised trials therapeutic interventions
evaluation of the effectiveness of tdcs in the management of perioperative pain

Conditions: Post-Operative Pain

Summary: the purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. the new technology is called transcranial direct current stimulation.

this study aims to evaluate the effectiveness of transcranial direct current stimulation (tdcs) in the management of postoperative pain. specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tdcs (compared to sham tdcs) delivered up to twice per day post-operatively. in addition to comparing the effects of real tdcs to sham tdcs, the present study will evaluate the interaction of dose (number and frequency of tdcs sessions) and surgery type.

Eligibility criteria:
inclusion criteria: * 18 years-75 years of age * surgery at medical university of south carolina * at least 2 days of post-operative stay exclusion criteria: * history of seizures or epilepsy * family history of seizures * taking any medications shown to lower seizure threshold * metal implants above the waist * pregnant * brain tumors or lesions * pacemaker
safety and activity study of psca-targeted car-t cells (bpx-601) in subjects with selected advanced solid tumors

Conditions: Metastatic Castration-resistant Prostate Cancer; Metastatic Prostate Cancer

Summary: the purpose of this study is to evaluate the safety and activity of bpx-601 car-t cells in participants with previously treated advanced solid tumors (prostate) expressing high levels of prostate stem cell antigen (psca). participants' t cells are modified to recognize and target the psca tumor marker on cancer cells.

the goal of this study is to characterize the feasibility, safety, and clinical activity of psca-specific car-t cells, bpx-601, administered with rimiducid to subjects with previously treated, psca-positive advanced solid tumors (prostate). bpx-601 car-t cells are genetically engineered to express a chimeric antigen receptor (car) to target the psca antigen and a rimiducid-inducible signaling domain which functions as a molecular "go-switch" to enhance activation and proliferation. phase 1: cell dose escalation to identify the maximum dose of bpx-601 administered with single or repeat doses of rimiducid. phase 2: indication-specific dose expansion to assess the safety, pharmacodynamics (including bpx-601 persistence), and clinical activity at the recommended dose identified in phase 1 in various psca-expressing solid tumors.

Eligibility criteria:
inclusion criteria: * metastatic castration-resistant prostate cancer (mcrpc), with progressive disease per pcwg3 criteria during or following the direct prior line of therapy. * measurable disease per recist v1.1 at baseline; subjects with mcrpc with bone only metastases must have measurable psa. * age ≥18 years. * life expectancy \> 12 weeks. * ecog 0-1 * adequate organ function. exclusion criteria: * prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of \> grade 2 hematuria within the previous 6 months. * prior car t cell or other genetically-modified t cell therapy. prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable. * symptomatic, untreated, or actively progressing central nervous system metastases. * impaired cardiac function or clinically significant cardiac disease. * pregnant or breastfeeding. * participant requires chronic, systemic steroid therapy. * severe intercurrent infection. * known hiv positivity.

Keywords: prostate stem cell antigen bpx-601 ap1903 car-t psca-car castration-resistant prostate cancer rimiducid prostate cancer psca crpc mcrpc