Kornimate/medical-research-clean huggingface dataset:
laparoscopic tap block during robotic assisted laparoscopic radical prostatectomy for improvement in postoperative pain

Conditions: Prostate Cancer

Summary: determine the impact of a laparoscopic-guided transversus abdominis plane (tap) block timing (at initiation or conclusion of procedure) on the postoperative pain experience in patients following robot assisted laparoscopic radical prostatectomy (ralp).

tap block involves the use of a local anesthetic agent injected between the internal oblique and transversus abdominis muscles for the goal of pain relief. often times these are performed under ultrasound guidance by the anesthesiology team preoperatively. the idea behind this is to provide a neurologic block to the sensory nerve fibers supplying the anterior abdominal wall, between the internal oblique and transversus abdominis muscles. more recently, this technique has been investigated in the setting of robot-assisted laparoscopic radical prostatectomy (ralp) with promising results. there is a lack of data comparing the benefits of the timing of tap block, and whether performing this at the initiation versus conclusion of the case provides superior results this is a prospective, randomized controlled trial of subjects undergoing early versus late tap block for the management of postoperative pain following ralp. subjects will be recruited through physician referral from private urology offices. potential subjects (patients scheduled for ralp procedure) will be approached by the study doctor prior to surgery, either in the study doctor's office or in the pre-operative area. subjects who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive early or late surgeon performed laparoscopic tap block. each patient will only receive one treatment (tap block) either at the initiation or conclusion of his procedure. for treatment delivery, subjects will receive 60 ml of 0.25 percent ropivacaine with 4 mg of dexamethasone either at the initiation of the procedure (immediately following placement of the robotic / laparoscopic camera port) or at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). study doctors will use laparoscopic / robotic camera visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.

Eligibility criteria:
inclusion criteria: 1. able to read, understand, and provide written, dated, informed consent prior to screening, complete study form(s) independently, comply with study protocol, and communicate with study personnel about clinically important information. 2. men ≥ 18 years of age. 3. pathologically confirmed diagnosis of prostate cancer 4. scheduled for routine ralp exclusion criteria: 1. chronic opioid use (daily for \&gt;3 months) 2. weight \&lt;40 kilograms 3. any condition that causes a lack of normal sensation to the abdomen or pelvis 4. current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation

Keywords: prostate cancer
eruption status of primary teeth in low birth weight children in comparison to normal birth weight childern

Conditions: Eruption Statues of Primary Teeth in LBW Children

Summary: determine the status of eruption of primary teeth and physical growth in children aged from 6 to 36 months with low birth weight in comparison to normal birth weight

timing of eruption of primary teeth is an urgent question for every mother especially in low birth weight children. although, the timing of eruption of primary teeth and their sequence of eruption shown to be under the genetic control , pre-natal maternal conditions, early childhood metabolic and nutritional factors along with socioeconomic states have been associated with the timing of eruption of primary teeth. many factors may affect the timing of eruption. literature showed that factors like gender, race and physical growth may influence emergence of tooth in child mouth but there is scarce information on egyptian children .

Eligibility criteria:
inclusion criteria: * healthy children. * children aged from 6 to 36 month. exclusion criteria: * refusal of participation from the parents. * medically compromised children. * major illness. * the child had special needs. * any systemic disease. * any congenital deformity that may affect teeth eruption.
phase 1 clinical trial of da-5207 in healthy adults

Conditions: Healthy

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of da-5207 transdermal delivery system in healthy adults


Eligibility criteria:
inclusion criteria: * health volunteers (age: 19\~55 years) * body weight: male≥55kg, female≥50kg * 18.5 ≤bmi≤ 25.0 exclusion criteria: * galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * allergy or drug hypersensitivity * clinically significant medical history * ast, alt\>upper normal range\*1.25, egfr\<60ml/min/1.73m² * heavy caffeine intake * heavy alcohol intake (more than 210g/week) * heavy smoker (more than 10 cigarettes/day)
confirmatory efficacy of the building a strong identity and coping skills program

Conditions: Chronic Stress; Anxiety; Depression

Summary: the goal of this clinical trial is to the efficacy of the building a strong identity and coping skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services. the aims of this study are to: (1) confirm the efficacy of basics by replicating previous findings, (2) examine the changes of coping mechanisms and symptom change over the course of the basics intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological "risk" and recalibration. cohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. participants enrolled in the intervention group will complete the basics program and participants enrolled in the no intervention group will not be enrolled in the intervention program. the basics program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (hpa) axis). researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and hpa reactivity profiles


Eligibility criteria:
inclusion criteria: * children ages 11-14 at intake * family income at or below 200% federal poverty level * child speaks english * parent speaks english or spanish exclusion criteria: * intellectual disability * autism spectrum disorder * high suicidal risk (score of 17 or more on the mini international neuropsychiatric interview for children and adolescents (mini-kid)) * severe depression (score of 19 or more on patient health questionnaire (phq).

Keywords: poverty discrimination stress coping
cephea transseptal mitral valve system fih

Conditions: Mitral Regurgitation

Summary: to assess the safety and performance of the cephea transseptal mitral valve system for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.


Eligibility criteria:
mvarc
adapted physical activity to promote quality of life, well-being and physical activity levels in pregnant women (well-done!study)

Conditions: Pregnant Women

Summary: the aim of the well-done! study is to co-design, using different professional figures (midwives, psychologists, master's degree in motor science) but also taking into consideration the pregnant women's point of view, an intervention of adapted physical activity for pregnant women, included in the birth accompaniment courses and conducted by midwives, and to evaluate its effectiveness in terms of quality of life, well-being, levels of physical activity and satisfaction with respect to the proposed intervention.

the primary objective is the evaluation of an integrated, co-designed intervention of adapted physical activity, included in the birth accompaniment courses, in order to improve the quality of life of pregnant women. * the secondary objective is the evaluation of the feasibility, efficacy and safety of the intervention in terms of general satisfaction with the proposed intervention, levels of physical activity practiced, physical performance, self-efficacy, sleep quality, anxiety and depression. * the tertiary objective is to translate, adapt and validate in italian a specific questionnaire to measure physical activity levels in pregnant women, pregnancy physical activity questionnaire (ppaq), through the use of actigraph accelerometers (actilife6 wgt3x-bt ).

Eligibility criteria:
inclusion criteria: * pregnant women between the 24th and 32th week. * pregnant women belonging to the birth accompaniment meetings organized by university hospital of bologna exclusion criteria: * alterations in communication skills and / or sensory functions so severe as to make it impossible to understand and / or execute the instructions given by the trainer (dementia, aphasia, blindness, deafness); * premature rupture of membranes (prom). * premature labor. * vaginal bleeding. * placenta previa after 28 weeks gestation. * pre-eclampsia * cervical incontinence * intrauterine fetal growth delay or arrest. * plurigemellarità * uncontrolled type i diabetes. * uncontrolled hypertension. * uncontrolled thyroid disease. * other severe cardiovascular, respiratory or systemic disorders. * any other condition the operator deems may contraindicate participation in a moderate intensity exercise program.
platinum-based chemotherapy with/without incmga00012, an anti-pd-1 antibody, in non-small cell lung cancer

Conditions: Metastatic Squamous Non-Small Cell Lung Cancer; Metastatic Nonsquamous Non-Small Cell Lung Cancer

Summary: the purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without incmga00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed nsclc (either nonsquamous or squamous) that is stage iv (ajcc v8). * no prior systemic treatment for the advanced/metastatic nsclc * able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy * measurable disease per recist v1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * life expectancy of at least 3 months. * willingness to avoid pregnancy or fathering children. * adequate organ function as indicated by protocol-specified laboratory values. - has been fully vaccinated against sars-cov-2 or is willing and able to be fully vaccinated against sars-cov-2 during the study by starting the vaccination process during screening. exclusion criteria: * clinically significant cardiac disease within 6 months of start of study treatment. * any major surgery within 3 weeks of the first dose of study treatment. * thoracic radiation therapy of \> 30 gy within 6 months of the first dose of study treatment. * history of peripheral neuropathy ≥ grade 2 ctcae v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel. * untreated central nervous system metastases and/or carcinomatous meningitis. * evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids. * active infection requiring systemic therapy or active tuberculosis. note: if required by country or local regulations to be tested for covid-19 during screening, a participant should be excluded if they have a positive test result for sars cov-2 infection until both the retesting result is negative and clinical recovery is obtained. * superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers. * has contraindications to chemotherapy agents used in the study. * has an active autoimmune disease that has required systemic treatment in past 2 years. * is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment. * has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug). note: while based on approved sars-cov-2 vaccines available worldwide, many vaccines are not live (mrna and adenovirus vaccines do not contain live virus), if a live vaccine against sars-cov-2 is the only available option, prior consultation with the medical monitor should be obtained. • has known active hbv or hcv (testing must be performed to determine eligibility)

Keywords: metastatic non-small cell lung cancer nonsquamous squamous pd-1 pd-l1
saturated fatty acids intake and mortality, diabetes, hypertension and overweight

Conditions: Morality; Diabetes; Hypertension; Overweight

Summary: the role of saturated fatty acids (sfas) intake in the development of total death, cardiovascular diseases, diabetes, hypertension and overweight are in great controversy but evidence from large population in china is scant.the investigators aim to use the data from the china health and nutrition survey to assess the long-term association of sfas intake with total mortality, diabetes, hypertension and overweight.

the role of saturated fatty acids (sfas) intake in the development of total death, diabetes, hypertension and overweight are in great controversy but evidence from large population in china is lacking.the investigators aim to utilize the data from the china health and nutrition survey. the investigators will calculate the cumulative average intake of sfas based on 3 consecutive 24-h dietary recalls in each round.sex-specific cox regression models will be used to estimate the relative risk.results from our work will be used to provide epidemiological evidence for improving recommendation on sfas intake for chinese in dietary guidelines.

Eligibility criteria:
inclusion criteria: * adults aged ≥20 with complete data on diet and follow-up time exclusion criteria: * cardiovascular diseases * diabetes (for analyses of diabetes) * body mass index ≥ 24 kg/㎡ (for analyses of overweight) * hypertension (for analyses of hypertension)

Keywords: saturated fatty acids chns
implementation of harmonized depression outcome measures in a health system

Conditions: Major Depression; Dysthymia

Summary: working with a health system, the investigators will recruit practices to participate in the pilot study, consent and enroll patients with major depressive disorder, and collect the phq-9 from those patients at three timepoints (baseline, 6 months post-enrollment, and 12 months post-enrollment). the phq-9 will be captured either at an office visit or directly from patients. the investigators will build and implement an open-source smart on fhir app to collect key data from the ehr, combine that data with the phq-9 results, and present the measurements back to the clinicians. the investigators will then obtain feedback from clinicians on the value and usefulness of the app.

the study is a longitudinal, observational pilot study that will assess the utility and value displaying the harmonized outcomes data to clinicians in the clinical workflow using an open-source, smart on fhir app. the app will connect with the site ehr, aggregate ehr and pro data, calculate the outcome measure results, and return the results to the ehr so that they are viewable within the clinician workflow. baseline data on patient characteristics, treatments, and symptoms will be combined with longitudinal data on outcomes during the study timeframe. all data will be collected from institution electronic medical records (emrs), pro portals, and other existing data sources, as needed.

Eligibility criteria:
inclusion criteria: * patients age 18 and older * diagnosis of major depression or dysthymia * willing and able to provide informed consent exclusion criteria: * there are no exclusion criteria for this study.
the effect of flexible thoracolumbar brace on spinal alignment, pain and quality of life in subjects with neuromuscular scoliosis

Conditions: Neuromuscular Scoliosis

Summary: in the initial evaluation, the degree of spine is measured quantitatively using cobb's angle and muscular dystrophy spine questionnaire (mdsq). the patients who had cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. after 12 months, whole spine x-ray was taken for the followed up the patient's status.


Eligibility criteria:
inclusion criteria: * 20-45' degrees of cobb's angle in the neuromuscular disease exclusion criteria: * patient's who had spinal surgery * less than 20 degree or more than 45 degree of cobb's angle * acute lumbar pain

Keywords: brace neuromuscular disease scoliosis
spp100 dose finding study in japan

Conditions: Hypertension

Summary: this study will evaluate the efficacy of spp100 in lowering blood pressure in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: 1. mild to moderate essential hypertension 2. age: ≥20 years old and \<80 years old (at time informed consent obtained) 3. sex: n/a 4. admission status: outpatient exclusion criteria: 1. pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant 2. patients having a mean sitting diastolic blood pressure of ≥110 mmhg and/or a mean sitting systolic blood pressure of ≥180 mmhg at either visit 2 or 3 3. patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension 4. patients suspected of having malignant hypertension

Keywords: hypertension, aliskiren
screening for primary aldosteronism in hypertension with 24-hour urinary aldosterone

Conditions: Hypertension; Primary Aldosteronism; Urine Aldosterone

Summary: this is an observational study compares the positivity rates of two tests for screening for primary aldosteronism: plasma aldosterone renin ratio and 24-hour urine aldosterone in patients with young-onset hypertension with or without other clinical features of primary aldosteronism.

plasma aldosterone and renin measurements are subject to significant intra-individual variability, including variation related to posture, time of day and sodium balance. aldosterone secretion is not constant and may be subject to diurnal variation. as such one-off testing of arr, does not consider the salt status of the individual necessitating repetition of tests to ensure false negative or false positive test results are ruled out. the value of accumulated aldosterone in a 24-hour sample has the advantage that it does not depend on circadian variation. this pilot observational study will help establish the positivity rates of both standard plasma aldosterone renin ratio and 24-hour urine aldosterone, and the degree to which they correlate but will help establish if untargeted screening in young-onset hypertension is feasible and test the robustness of current standard guidelines for primary aldosteronism screening and case confirmation.

Eligibility criteria:
inclusion criteria: * a patient will be eligible for inclusion in this trial only if all of the following criteria apply: * aged 18 years and above. * meets nice criteria for a diagnosis of hypertension with an age of onset of hypertension between 18-60 years. * for cohort 2 (suspected primary aldosteronism): resistant hypertension, and/or hypertension with spontaneous or diuretic-induced hypokalaemia, and/or hypertension. exclusion criteria: * • severe hypertension (sustained blood pressure of \>200/110 mmhg) or a history of known secondary hypertension other than pa. * contraindications to confirmatory testing with saline infusion or oral salt loading test as per standard clinical criteria such as known clinical diagnosis of heart failure, and/or chronic kidney disease stage 3b. * known pregnancy or breast feeding. * lack of informed consent. * any medical condition deemed unsuitable by investigator for participation in the study
cardiac rehabilitation and metabolomics in heart failure

Conditions: Heart Failure

Summary: this is a randomized controlled trial of participants with heart failure randomized into usual care plus integrated cardiac rehabilitation or usual care only. the rehabilitation protocol will comprise one month of thrice weekly sessions including supervised aerobic exercises and counseling, followed by two months of monitored home based exercises prescribed weekly. cardiopulmonary performance status, depression and quality of life will be assessed at enrollment and upon completion of the protocol using the 6-minute walk time distance test. plasma samples will be collected and bio-banked for metabolomic profiling and comparative outcome analysis.

integrated cardiac rehabilitation will comprise one month of thrice weekly sessions of supervised aerobic exercises and counseling, followed by two months of monitored home based exercises prescribed weekly. aerobic threshold (at) will be determined based on perceived rates of exertion as measured using a borg scale and target heart rate based on karvonen's formula. exercise intensity will be prescribed to achieve the earlier of moderate perceived exertion and 50-60% of their maximal target heart rate on a treadmill. intensity will be increased over the course of the 12 sessions to attain 70-80% of maximal target heart rate. duration of exercise will also be increased gradually over the 12 sessions in keeping with the study participants perceived rate of exertion. participants will be given pedometers and instructed to use these daily for the period of the study. at the end of the first four weeks, the participant's weekly steps will be averaged to establish a baseline weekly step target. starting in the 4th week,subjects will be instructed to continue exercises at home whilst maintaining a comparable activity level as will be measured by their weekly step counts. participants will be contacted weekly for the remaining 8 weeks and step targets will be prescribed based on 10% weekly increments.prior to the start of each exercise session, participants will receive a brief counseling module reflecting the primary goals of cardiac rehabilitation.

Eligibility criteria:
inclusion criteria: 1. nyha class ii or iii heart failure 2. owns a mobile telephone 3. can participate in supervised exercise three times a week 4. can read/ primary care giver can read in english or kiswahili exclusion criteria: 1. recent acute illness requiring hospitalization in the preceding 4 weeks. 2. limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced co morbidities. 3. known uncontrolled arrhythmia. 4. heart failure due to congenital heart disease. 5. pregnant patients as may be confirmed by patient report or urine pregnancy tests 6. heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis. 7. use of pacemakers.

Keywords: rehabilitation metabolomics