Kornimate/medical-research-clean huggingface dataset:
reduction of pain following laparoscopic surgery: a double blind prospective randomized controlled trial

Conditions: Post-operative Pain

Summary: shoulder tip and abdominal pain following laparoscopic procedures are well recognized as causes of post-operative morbidity. this prospective, double-blind, randomized controlled trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by implementing a simple intra-operative technique. patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair will be recruited to the trial. patients will be randomized to either the current standard (control group) or to receive an intervention to remove residual co2. in the intervention group the pneumo-peritoneum will be removed, at the end of the operation, by placing the patient in the trendelenburg position and utilising a pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of 60 cm h2o. in the control group residual pneumo-peritoneum will be evacuated at the end of the procedure by passive decompression via the open operative ports.

this trial recruited 76 randomly assigned patients, 37 in the intervention group and 39 in the control group. the overall post-surgery pain scores, as analysed by two-way anova, were significantly lower in the intervention group (p=0.0019). on bonferroni post-tests both 12 hour (p\<0.01) and 24-hour (p\<0.01) pain scores were significantly lower in the intervention group.

Eligibility criteria:
inclusion criteria: * all patients were recruited from a single consultant's surgical clinic at the same district general hospital between august 2010 and february 2012. this study was approved by the local ethics committee (national research ethics service rec ref: 09/h0405/65) and informed consent was obtained from all patients after they had the opportunity to study information leaflets that were also given to them. the trial was designed as a prospectively randomized and double blind trial with a 1:1 (control:intervention) allocation. the inclusion criteria was all adults with an american society of anesthesiologists (asa) physical status grade 1 or 2, who were undergoing elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal preperitoneal procedure (tap). all procedures and data collection occurred at a district general hospital. exclusion criteria: the pre-operative exclusion criteria included patients younger than 18 years, those who refused to give consent, those that had an inability to understand the research questionnaire and pregnancy. patients who were found to require additional procedures, for example a conversion to open surgery, were excluded from the study prior to randomization. -

Keywords: laparoscopic pain prospective blinded trial
combined, intensified and modulated adjuvant therapy in prostate carcinoma

Conditions: Prostate Cancer

Summary: patients with high risk prostate cancer may benefit from radiotherapy after radical prostatectomy. the investigators postulated that adjuvant androgen deprivation therapy (adt), radiation dose escalation, and selective pelvic irradiation may improve outcome. a phase ii trial was designed to prove that combined-intensified-modulated-adjuvant (cima) treatment may improve 5-year biochemical relapse free survival (brfs) from 75% to 90% in high risk patients. the delivered dose to tumor bed and pelvic nodes was 64.8-70.2 gy and 45 gy (57% of patients), respectively, and 69% received adt.

prostate cancer patients at high risk of loco-regional recurrences may benefit from postoperative radiotherapy (rt) following radical prostatectomy (eortc trial 22911). however, despite an improvement in biochemical relapse-free survival (brfs), the risk of recurrences remained high for those patients. the investigators postulated that adjuvant androgen deprivation therapy (adt), radiation dose escalation, and selective pelvic irradiation for patients at risk for regional failures may improve the outcome. the combined-intensified-modulated-adjuvant (cima) as described may improve survival through a reduction of loco-regional and systemic failures. a phase ii trial was designed to test the hypothesis that cima treatment may improve 5-year brfs by 15%. patients less than 80 years old, with a histological diagnosis of prostate adenocarcinoma without distant metastases, stage pt2-4 n0-1, no previous treatments and an ecog performance status of 0-2 were selected. all patients had at least one of these pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle invasion. radiation dose to the tumor bed ranged from 64.8 to 70.2 gy. pelvic lymph nodes were treated to 45 gy in selected patients at risk of regional failures (57%). selected patients at risk for distant metastases (69.1%) received hormonal therapy.

Eligibility criteria:
inclusion criteria: * \< 80 years old * histological diagnosis of prostate adenocarcinoma * no distant metastases * stage pt2-4 * n0-1 * ecog performance status of 0-2 * one of these pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle invasion. extracapsular extension, positive surgical margins or seminal vesicle invasion, or positive lymph-nodes * no surgical complications such as pelvic infections or lymphocele, intraoperative rectal injury or severe urinary incontinence * preoperative and postoperative psa test, bone scan and ct-scan or mri of abdomen and pelvis prior to enrolment * normal bone marrow function exclusion criteria: * previously treated with radiotherapy * previously treated with androgen deprivation therapy * previously treated with chemotherapy for prostate cancer. they also had to be free

Keywords: adjuvant androgen suppressive therapy literature review phase ii prostate neoplasms radiotherapy
therapeutic equivalence study of generic brinzolamide vs azopt

Conditions: Glaucoma; Open Angle or Ocular Hypertension

Summary: the main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with azopttm

the main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with azopttm (brinzolamide ophthalmic suspension 1%) dosed three times daily in iop reduction in patients with poag or oh.

Eligibility criteria:
inclusion criteria: * male and females 18 years of age or older, * diagnosed with primary open-angle glaucoma or ocular hypertension. exclusion criteria: * patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma, * ocular hypertension.
detection of braf mutation on fnab from papillary thyroid carcinoma

Conditions: Papillary Thyroid Carcinoma

Summary: immunohistochemical detection of the braf-v600e mutation on pre-operative fine needle aspiration biopsy (fnab) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody ve1.

the braf mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (ptc). the mutation has been associated with poor prognosis and more advanced disease stage. therefore, pre-operative detection of the braf-v600e mutation may be of clinical interest in order to individualize treatment of patients with braf positive ptc. fnabs are performed immediately before the thyroid operation, and braf-v600e detection using ve1 is performed on clots. the ve1 stain is compared to the mutation status of the removed cancer or control tissue using the cobas test.

Eligibility criteria:
inclusion criteria: * bethesda system of reporting thyroid cytology (bsrtc) group 5-6 on pre-operative fnab from the nodule (\>1cm) * undergoing thyroid surgery (histology of index nodule) exclusion criteria: * not undergoing thyroid surgery
human papillomavirus (hpv) vaccination vs. placebo for the treatment of refractory cutaneous warts

Conditions: Warts

Summary: this double-blinded clinical trial randomly assigns participants with refractory cutaneous warts to receive either treatment with the human papillomavirus (hpv) vaccine or a placebo to assess the efficacy of hpv vaccination for the treatment of refractory cutaneous warts.

cutaneous warts are a common cause for medical office visits and are frequently encountered in dermatology practice. despite their benign nature, cutaneous warts can be painful, disfiguring, persistent and may be associated with significant morbidity. numerous therapeutic options are available, including local destruction, virucidal agents, topical and systemic antiproliferative medications, and immunotherapy. unfortunately, no single therapy is uniformly effective, and patients often receive multiple courses of treatment (cryotherapy, curettage, candida antigen injection, etc.) without improvement. an efficacious therapy for cutaneous warts is sorely needed and treatment with hpv vaccination is being increasingly reported. notably, individual cases and case series have reported complete resolution of multiple treatment refractory warts after treatment with the quadrivalent hpv vaccine. even more encouraging, a larger retrospective study of 30 patients found that up to 60% of patients had a complete or partial response after treatment with the hpv vaccine. additional benefits of treatment with hpv vaccination include ease of use, less tissue destruction and pain, and the potential for less frequent medical office visits. despite these promising preliminary data, a larger, randomized controlled study has yet to be performed. this will be a multi-center, double-blinded, randomized, placebo-controlled trial with 120 participants. enrolled participants will be randomized to treatment with either hpv vaccination or placebo. participants will receive injections with the 9-valent hpv vaccine or placebo at 0, 4, and 20 weeks and follow up until 24 weeks to determine their treatment response, quality of life and the safety and tolerability of hpv vaccination.

Eligibility criteria:
inclusion criteria: 1. must be able to understand and provide written informed consent 2. age 18 or older 3. clinical diagnosis of cutaneous warts 4. must have received prior treatment for cutaneous warts (such as curettage, cryotherapy, salicylic acid, intralesional candida antigen injection, etc.) exclusion criteria: 1. untreated cutaneous warts 2. anogenital warts 3. oral warts 4. treatment for cutaneous warts in the past 4 weeks 5. active acute illness 6. immunosuppression 7. known hypersensitivity to hpv vaccination 8. subjects may not receive any other investigational treatment 9. pregnancy or planned pregnancy during the study period

Keywords: refractory cutaneous warts human papillomavirus (hpv) vaccination hpv vaccine
hydration monitor validation in elderly

Conditions: Dehydration

Summary: the study will aim to determine normal daily variation of the individual hydration level in longitudinal study on elderly in assisted living facility and assess a range of variation of individual hydration baselines for elderly in a normal physiologically hydrated state.

the subject pool will be comprised of 100 elderly (over 65 years old), male and female subjects who are residing in assisted living center. all subjects will provide written informed consent before participation. for the day prior testing and all testing days subjects will be encouraged to follow standard hydration guidelines for older adults by consuming 1200-2400 ml/day depending upon the body weight of subjects. the application of the hm will follow specific protocol based on the prototype hm user manual for specific anatomic locations. triplicate measurements will be made for each time-point. all subjects will also be measured for bioelectrical impedance analysis (bia) and estimation of total body water using a leg-to-leg bia machine. to examine within-day and between-day variability and reliability of the hm a subgroup (n=25) of the 100 initial subjects will be selected. within-day reliability will be evaluated by taking multiple measurements (3) during the day. between-day reliability will include measurements (same time) for three consecutive days for the subgroup of 25 subjects. bia measures will also be included during each of the time points for both within-day and between-day.

Eligibility criteria:
inclusion criteria: * elderly ( above 65 years old) * male and female subjects who is residing in assisted living centers exclusion criteria: * open wounds or rashes on calf testing area * visibly detectable edema * active skin infection * subjects will be excluded from the study if they can't physically stand on both feet without assistance

Keywords: dehydration
oleuropein and muscle energy metabolism

Conditions: Muscular Fatigue

Summary: preclinical studies performed at nestlé research (nr) identified oleuropein as a novel activator of mitochondrial calcium import. this potentiated mitochondrial calcium uptake resulted in decreased phosphorylation of the enzyme pyruvate dehydrogenase (pdh), which is linked to its activation as a rate limiting enzyme for mitochondrial oxidation, as well as increasing mitochondrial oxygen consumption, resulting ultimately in decreases in muscle fatigue. in addition, nr demonstrated that during aging, mitochondrial calcium and oxygen consumption rates are decreased in isolated skeletal muscle fibers. the next step in the evidence development is to demonstrate efficacy of oleuropein for improved muscle energy and decreased physical fatigue in a healthy aging population.


Eligibility criteria:
inclusion criteria: 1. male 2. 50 to 70 years old 3. bmi 18.5-29.9 kg/m2 4. healthy as per medical history and investigator's/ physician's judgement 5. having given informed consent exclusion criteria: 1. allergy/intolerance to the study product 2. \>5% body mass change in the previous 3 months 3. hba1c ≥ 6.5% 4. blood pressure \>140/90 mmhg 5. participating in a structured (progressive) exercise program 6. smoking 7. diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes 8. diagnosed musculoskeletal disorders 9. chronic use of gastric acid suppressing medication 10. unauthorized concomitant medications such as calcium antagonists (e.g. valproate), oral corticosteroids, anything that will prevent subjects from safely completing the study according to the investigator or medications / drugs known interfering with the expected mechanism of action of ip or to affect the outcome parameters 11. alcohol (intake higher than 3 servings per day. one serving is 0.4 dl of alcohol, 1 dl of wine, or 3 dl of beer) or drug abuse 12. overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.) 13. subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol 14. any implants that would be a contra-indication for performing an mri scan. 15. participation in another study at the same time 16. blood donation in the past 2 months

Keywords: skeletal muscle energy and fatigue
ocular, vascular, and genetic findings in amd patients

Conditions: Age-Related Macular Degeneration

Summary: observation of findings associated with amd

explorational observation of ocular, vascular, and genetic findings in patients diagnosed with amd

Eligibility criteria:
inclusion criteria: 1. at least 55 years of age at the time of consent 2. able to understand and provide written informed consent 3. sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging 4. able to cooperate with ophthalmic visual function testing and anatomic assessments 5. diagnosed with late-stage amd in at least one eye. (if both eyes of an eligible subject meet inclusion criterion, the more advanced eye will receive primary eye assignment) 6. willing to have protocol specified genetic testing 7. willing to have head coil mri/a (with contrast if deemed necessary) exclusion criteria: ocular 1. history of any retinal disease other than amd in either eye 2. spherical equivalent refractive error demonstrating \>6 diopters of myopia or an axial length \>26 mm in the study eye 3. history of vitrectomy in the study eye 4. any intraocular surgery (including lens replacement surgery) in the study eye, within 90 days of enrollment 5. history of endophthalmitis 6. trabeculectomy or aqueous shunt or valve in the study eye 7. aphakia or absence of the posterior capsule in the study eye (note: previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet \[yag\] laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 90 days prior to enrollment) 8. presence of advanced guttae or visually significant keratopathy that would cause scattering of light or alter visual function in the study eye 9. history of idiopathic or autoimmune-associated uveitis in either eye 10. active inflammation or infection, including conjunctivitis, keratitis, or scleritis in either eye 11. ga secondary to a condition other than amd (e.g., stargardt's disease, cone rod dystrophy, or toxic maculopathies such as plaquenil maculopathy) in either eye non-ocular 12. use of any investigational product or investigational medical device (i.e., not approved by fda for the specific use) within 90 days prior to screening or anticipated use during the study 13. women of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study 14. acute or serious illness, in the opinion of the site investigator 15. history of kidney failure or gadolinium toxicity
acceptance and commitment therapy and test anxiety

Conditions: Therapy, Directly Observed

Summary: the aim of this study is to evaluate the effect of acceptance and commitment therapy-based psychoeducation on test anxiety, study skills and psychological flexibility on adolescents. test anxiety scale, study skills scale and psychological flexibility scale are data collection tools. the pretest-posttest is a randomized controlled trial. experimental and control groups were formed. a 6-week psychoeducation will be applied to the experimental group.

the aim of this study is to determine the effect of acceptance and commitment therapy-based psychoeducation given to adolescents on test anxiety, study skills and psychological flexibility.the research was designed as a randomized controlled study with pretest, posttest, experimental and control groups aiming to examine the results of acceptance and commitment therapy (act) based psychoeducation for test anxiety and study skills. the number of effects of the study was targeted by the randomization method among the adolescents who met the inclusion criteria and accepted the application. in the power analysis, the evaluation of the number of increase is aimed at 0.05 aggression level at the 95% confidence interval, and 52 adolescents, 26 experimental and 26 control groups, to reach 80% power. randomization methods were used so that individuals could be assigned to the experimental groups with equal chance, similar to the scores they obtained from the laboratory test anxiety periods. 52 adolescents who met the clinical research criteria for randomization were divided into 2 groups using the irregular numbers table, this group was named as the experimental and control groups by drawing lots. the group that came out first in the lottery at this stage was accepted as the experimental group. psychoeducation is planned to be held between december 2022 and february 2023.

Eligibility criteria:
inclusion criteria: * students' willingness to participate in research * students being 11th graders * getting a score of 50 or more on the test anxiety scale exclusion criteria: * any degree of cognitive decline or impairment * presence of depressive disorder * presence of serious psychiatric disorder * being under treatment for a psychiatric condition

Keywords: acceptance and commitment therapy test anxiety study skills psychological flexibility
whole-brain tumor burden metrics with inflammatory and molecular markers to predict postoperative neurocognitive decline in glioma

Conditions: Glioma; Glioma : Oligodendroglioma or Astrocytoma

Summary: although surgical resection improves overall survival in patients with diffuse low-grade gliomas (dlgg), it can also result in deterioration of neurocognitive function, which are poorly understood and lack effective predictive models. this study aims to develop a model using whole-brain tumor burden metrics, inflammatory and molecular markers for predicting high risk of neurocognitive decline (nd) postoperatively. the study involved 192 patients with left frontal dlgg. mri data were analyzed to derive whole-brain tumor burden metrics, including tumor radiomics, whole-brain cortical thickness, myelin content, and network characteristics. postoperative inflammatory and molecular markers were collected. postoperative follow-up neurocognitive function was assessed using the montreal cognitive assessment at 3 months and 1 year. machine learning models were constructed using pycaret.


Eligibility criteria:
inclusion criteria: 1. histopathologically proven dlgg based on 2021 who criteria 2. age ≥ 18 years, 3. karnofsky performance status ≥ 70%, 4. tumor involved unilateral left frontal lobe and did not reach the central sulcus. exclusion criteria: 1. with previous treatment before image acquisition, 2. presenting cognitive impairment pre-operatively based on the montreal cognitive assessment (moca) 3. survival of less than 3 months post-surgery 4. lack of compliance with neurocognitive assessments in 3-month and 1-year after surgery
biomarkers of insomnia and fatigue in hiv/aids (symptoms and genetics study)

Conditions: HIV Infections

Summary: the purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with hiv.

this study will characterize insomnia subtypes and identify genetic markers and metabolic parameters associated with these subtypes. the results will be useful in later developing interventions to improve sleep, reduce fatigue, and thereby enhance the quality of life of hiv-infected persons. a cross-sectional sample of 350 subjects will be recruited to describe relationships between biomarkers and insomnia subtypes. the initial assessment will include: * wearing a wrist actigraph for 72 hours * providing a fasting blood sample * measuring blood pressure, height, weight, neck, waist, hip, and thigh * completing questionnaires * urine screening depending on the results of the initial assessment, approximately 200 subjects will be followed every month by telephone to assess symptoms and every 3 to 6 months with study visits similar to the initial assessment. findings from this longitudinal part of the study will characterize the development of insomnia, fatigue, and daytime sleepiness over time in patients living with hiv.

Eligibility criteria:
inclusion criteria: * hiv infection * access to a telephone * able to read and write english exclusion criteria: * current use of illicit drugs * currently pregnant or within the previous 3 months * working nightshift * diagnosis of sleep apnea, narcolepsy, restless legs syndrome, or periodic limb movements, dementia, or psychotic illness

Keywords: sleep disorders genetics