Kornimate/medical-research-clean huggingface dataset:
clinical translational science institute (ctsi) brain hq modules vs. active controls for elderly survivors of icu

Conditions: Neurocognitive Disorders

Summary: the purpose of this project is to test whether an online cognitive rehabilitation program or online thinking exercises helps improve memory and thinking in elderly patients who survive a severe infection.

currently, over 50% of patients are estimated to develop an alzheimer's like disease following their hospitalization. this means they might have trouble remembering simple things or doing simple tasks. this can make returning to normal life difficult. this project will test whether online thinking exercises can help speed up patient's recovery.

Eligibility criteria:
inclusion criteria: 1. admitted to the intensive care unit (icu) at froedtert memorial lutheran hospital (fmlh) 2. diagnosis of sepsis 3. age 65 years or older 4. required mechanical ventilation or vasopressor therapy while in the icu 5. had delirium while in the icu exclusion criteria: 1. non-english speaking 2. severe dementia that would interfere with the ability to participate in the study activities 3. prior or current structural neurological injury that would confound study results 4. inability to communicate for any reason 5. current chemotherapy or radiation treatment 6. recent history of substance abuse 7. life expectancy \< 6 months 8. planned discharge to long term acute care facility or nursing home 9. lack reliable access to the internet either through a computer or smart device
a compassionate-focused intervention for older people with bipolar disorder

Conditions: Bipolar Disorder I or II

Summary: the aim of this study is to determine whether it is feasible to deliver a 9-session compassionate-focused therapy for older people with bipolar disorder. participants will be asked to complete baseline measures and at post-intervention follow-up (12 weeks and 24 weeks) to understand any potential clinical benefits of the therapy.

the present study will evaluate the feasibility of a compassionate-focused intervention targeting rumination that is specifically tailored for older people with bipolar disorder. in addition to evaluating its feasibility, the study will also investigate whether there are any clinical benefits associated with the intervention, namely, any potential reductions in negative rumination and feelings of guilt and shame. to date, there has been no research evaluating the feasibility of this type of intervention.

Eligibility criteria:
inclusion criteria: * adults aged 60 years and above. * have a nominated healthcare professional (i.e. gp/care coordinator) * meet the criteria for a diagnosis of bipolar disorder i or ii according to the mini. * score of \>57 on ruminative response scale (rrs) * be able to provide written informed consent. * be able to speak sufficient english to engage in the assessments and intervention. exclusion criteria: * currently in an episode of mania or hypomania according to the mini. * experiencing 'severe depression' according to the hamilton depression rating scale, which equates to a score of over 24. * moca score of \<22 to exclude for moderate and severe cognitive impairment. * currently receiving psychological therapy.

Keywords: compassion-focused therapy older adults rumination bipolar disorder guilt shame
preoperative chemoradiotherapy and transanal endoscopic microsurgery versus total mesorectal excision in t2-t3s n0, m0 rectal cancer

Conditions: Rectal Cancer

Summary: the standard treatment of rectal adenocarcinoma is total mesorectal excision (tme). the technique involves a low anterior rectal or colo-anal resection, very often associated with a protective stoma or abdominal-perineal resection with permanent colostomy. transanal endoscopic microsurgery (tem) allows access to tumors up to 20 cm from the anal margin, with minimal postoperative morbidity and mortality. recent studies of t1 rectal adenocarcinomas consider tem to be the technique of choice. however the treatment of t2 rectal cancers remains controversial. chemotherapy and radiotherapy (ct/rt) has achieved a concomitant reduction in local recurrence and an increase in survival. hypothesis: patients with rectal adenocarcinoma less than 10 cm from the anal margin and up to 4 cm in size, staged after endorectal ultrasound and mri as t2 or superficial t3 n0-m0-n0-m0, who underwent surgery after preoperative local chemoradiotherapy (tem), achieve effective results in terms of local recurrence similar to radical surgery (tme). objectives: primary: to compare the results of local recurrence at 2 years in patients treated with preoperative chemoradiotherapy and tem and in patients treated with conventional radical surgery (tme). secondary: to analyse the 3-year survival results in patients treated with ct/rt. methodology: multicenter clinical trial in a calculated sample of 173 patients.


Eligibility criteria:
inclusion criteria: 1. rectal adenocarcinomas located 10 cm or less from the inferior anal verge measured using a rigid rectoscope at the time of the eus. 2. preoperative staging by eus and pelvic mri of t2 or t3 superficial, n0. in case of disparity, the higher staging is considered as the definitive diagnosis. 3. tumours equal to or less than 4 cm of diameter maximum measured using colonoscopy, eus or mri. we use the highest score on both scores. 4. asa score iii or less. 5. absence of distance metastasis as shown on abdominal ct. exclusion criteria: 1. preoperative staging by eus or pelvic mri of t1, deep t3, t4 or n1. 2. presence of distance metastasis. 3. synchrony with other colorectal adenocarcinomas. 4. undifferentiated rectal adenocarcinomas or with presence of poor prognosis factors in preoperative biopsy. 5. patients with intolerance of preoperative chemotherapy or radiotherapy. 6. refusal to sign informed consent to enter the study.

Keywords: preoperative chemoradiotherapy transanal endoscopic microsurgery rectal cancer t2-t3s-n0
effectiveness of the iconic therapy for borderline personality disorder symptoms

Conditions: Personality Disorder, Borderline

Summary: borderline personality disorder (bpd) is the most prevalent personality disorder in young community population whose most severe complication is suicide. pharmacotherapy should not be used as the primary treatment for bpd as the benefits are unclear. psychotherapy is the main treatment for people with bpd and the current recommendation is adapting available comprehensive treatments to develop easier and briefer therapies that are also effective. iconic therapy is an innovative option whose good clinical results should be validated on a clinical trial.

borderline personality disorder (bpd) in the early adulthood is an increasing diagnosis among general population. first symptoms detection and early intervention might help prevent its aggravation and further bpd diagnosis. iconic therapy is an innovative manual-driven psychotherapy to specifically and intensively treat bpd symptoms. preliminary clinical results are good. the aim of the present study is to assess the effectiveness of the iconic therapy in comparison to a support structured therapy in an ecological setting (spanish public specialized mental health care). the study is planned as a randomized controlled prospective trial that will randomize 60 young people (15 to 25 years old) with suicidal ideation/self-injuring behaviour and borderline personality traits. participants will be randomly assigned to one of the two groups: iconic therapy or support structured therapy on a 1:1 basis. both the iconic therapy and the support therapy programs consist of 10-12 weekly sessions delivered by two trained psychologists for about 8-12 outpatients on group format. the primary outcome measure is the change of symptoms severity assessed by the borderline personality disorder list (bsl-23). secondary outcomes include suicidal ideation and behavior, non-suicidal self-injures maladjustment to the daily life and economic evaluation for health care. assessments will be performed at baseline after the intervention 6 and 12 months of follow-up. it is hypothesized that those attending the iconic therapy group will show a permanently reduction of the severity of symptoms as compared with those attending the structured support group. data will be analyzed using generalized estimating equations (gee) models.

Eligibility criteria:
inclusion criteria: * aged 15-25 years old * suicidal ideation and/or self-injuring behavior * bpd behavioural trends defined as the cut point for alarming bpd traits (\>38 score) on exploratory questionnaire of personality-iii-bpd (ceper-iii-bpd) * sufficiently proficient in spanish to follow the treatment exclusion criteria: * antisocial personality disorder as measured in the clinical interview for diagnostic and statistical manual (dsm-iv axis ii) (scid-ii) * substance or alcohol abuse * high suicidal risk * negative expectations to be enrolled in the study as measured \< 35 by the expectation of treatment scale (ets)

Keywords: terapia iconica bpd adolescence suicide
quantification of posterior capsule opacification in pediatric cataract

Conditions: Posterior Capsule Opacification

Summary: the purpose of this study is to quantify the opacity of posterior capsule in pediatric cataract comparing two intraocular lens materials.

the eye exam at the first appointment will consist of anamnesis, external motor, evaluating strabismus and nystagmus, visual acuity with and without correction, biomicroscopy, fundoscopy, binocular ultrasound biometry, pachymetry and specular microscopy. the surgery will be performed by a single surgeon under general anesthesia. all participants will receive primary intraocular lens implantation as the randomization process, or hydrophobic acrylic material or hydrophilic acrylic. the implanted intraocular lens differ primarily in the material. the lens of hydrophobic acrylic materials (acrysof sa60at, alcon lab) single, folding part, material acrylate / methacrylate with uv protection acrysof filter, optical diameter of 6.0 mm, total length of 13.0 mm, haptic angle of 0 degree with 360 degree double square edge, spherical convex earlier. the lens hydrophilic acrylic material (akreos adapt, bausch and lomb) single, folding piece with optical diameter 6.00 mm and length de10.7 mm aspheric convex in anterior and posterior with absorbent uv, haptic angle 0 degree angulation . it has 4 attachment points (haptics) with 360 degree square double edge.

Eligibility criteria:
inclusion criteria: * indication for cataract surgery exclusion criteria: * traumatic cataract * neurological diseases that do not allow the exams
comparing effect of opioid-sparing versus conventional anesthesia on quality of recovery after emergency laparotomy

Conditions: Anesthesia Recovery Period

Summary: aim of the work the investigators aim to compare lidocaine-based anesthesia versus conventional anesthesia in the presence of multimodal analgesia protocol in terms of early quality of recovery and analgesic efficacy. objectives to compare quality of recovery using the quality of recovery-15 (qor-15) score between lidocaine-based anesthesia in relation to conventional anesthesia in patients undergoing emergency laparotomy. hypothesis the investigators hypothesize that lidocaine-based regimen would be effective in reducing opioid use and provide superior quality of recovery compared to conventional opioid-routine anesthesia in emergency laparotomy.


Eligibility criteria:
inclusion criteria: * adult patients (18-65 years) * asa i-iii undergoing emergency laparotomy with midline incision. exclusion criteria: * severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions) and patients on beta-blockers * patients on vasopressor infusion, patients with high shock index (heart rate / systolic blood pressure \>1) * body mass index \ 35 kg/m2, * pregnant or lactating women,
impact of covid-19 on training for ent and cervico-facial surgery residents in france

Conditions: Cervico-Facial Surgery ENT Academic Medical and Surgical Training in France; Cervico-Facial Surgery ENT Medical Residency (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur Areas)

Summary: the impact of the covid-19 pandemic on medical education is real but little known. ent interns were directly affected by the management of covid-19 patients (performing surgical tracheostomies), many conferences and trainings were cancelled, their usual hospital activity deeply reshuffled. although each student has a personal story of the impact of covid-19 on their training, there is no doubt that the effects of covid-19 are felt at scale. this study aims to investigate the effect of the pandemic on the medical and surgical training of ent and cervico-facial surgery interns in france from november 2019 to may 2021 (auvergne-rhône-alpes, grand est, ile de france, nouvelle aquitaine and provence-alpes-côte d'azur areas). a questionnaire will be sent by mail to ent interns in france to assess the impact of covid-19 on the training of ent interns in france.


Eligibility criteria:
inclusion criteria: * age \> 18 years * ent residents in france (auvergne-rhône-alpes, grand est, ile de france, nouvelle aquitaine and provence-alpes-côte d'azur regions) during the period from november 2019 to may 2021. * informed of the objectives of the research and not objecting to the processing of their data exclusion criteria: - subjects in research year, on availability, or in off-track training

Keywords: covid 19 head and neck surgery residency medical training
an app-based instructional platform to improve eye drop recall

Conditions: Glaucoma

Summary: the goal of this interventional study is to assess whether an in-office, language-concordant instructional app improves drop regimen recall in a population of glaucoma patients who are on multi-drop regimens. participants will be divided into two groups -- those who use the app and those who do not. the app will have narrated information regarding the drop regimen, a quiz to test understanding of the regimen, and will enable a graphical printout of the eye drops and schedule. at one month, both groups will be assessed on their eye drop regimen recall.

specific aim: to investigate whether a language-concordant instructional application improves drop regimen recall in population of glaucoma patients at a 1-month follow-up period. app features 1. pictorial representation of drops (color-coded) and schedule. 2. quiz to assess understanding of the regimen. 3. narrated instructions (language-concordant) on how and when (frequency and eye laterality) to take each drop. 4. graphical print-out of the regimen. study design 1. study design: randomized study, two groups: (1) patients that use the app, and (2) patients that do not use the app. 2. study population: inclusion criteria: patients with primary open-angle glaucoma on at least 2 eye drops exclusion criteria: patients taking additional prescribed eye drops for other eye conditions; patients diagnosed within the last 3 months; patients unable to self-administer eye drops 3. intervention: use of an in-office app that has both graphical and verbal (language-concordant) instruction for how to use drops. 4. main outcome measure: ability to correctly identify drops/regimen

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of glaucoma (any type) * drop regimen of at least 2 pressure-lowering drops * languages supported at this time: english, spanish, cantonese exclusion criteria: * concurrent eye conditions necessitating additional eye drops * inability to self-administer eye drops * inability to engage with app (either visual or other barrier)
improved recovery of walking in acquired muscle weakness

Conditions: Critical Illness Myopathy; Critical Illness Polyneuropathy

Summary: the aim of re-walk-easy is to evaluate the effects of rehabilitation based on electrical stimulation on the motor performance of critically ill patients. the study will also investigate the pathophysiology of the two forms-the myopathic-predominant and the polyneuropathic-predominant variants-by examining the longitudinal progression of cip and cim and determining which form benefits more from electrical stimulation as a rehabilitative approach.

although rehabilitation is often recommended to patients with intensive care unit acquired weakness (icu-aw) to counteract the induced muscle weakness, systematic reviews failed to determine its efficacy. neuro muscular electrical stimulation (nmes) is part of clinical practice in icu-aw however its effects are still under debate. the investigators hypothesize that this uncertainty stems from the lack of distinction between the two forms of the condition-critical illness polyneuropathy (cip) and critical illness myopathy (cim)-which have distinct pathological features and disease trajectories. in addition, the investigators hypothesize that motivating patients by requiring voluntary muscle activation during the electrical stimulation (i.e. functional electrical stimulation - fes) will enhance rehabilitation. the study will test the following hypothesis through a longitudinal clinical trial aimed at determining: 1. which form will benefit the most from fes based-rehabilitation, 2. the biomarkers of walking recovery in icu-aw.

Eligibility criteria:
critical illness patient inclusion criteria: * clinical diagnosis of tetra/paraparesis of peripheral origin as disclosed by eng/emg examination; * be independent before the episode of critical illness critical illness patient exclusion criteria: * history of previous comorbidity for icu-aw; * previous known chronic polyneuropathy; * severe coagulopathy; * severe disorder of consciousness; * contraindications to electrical stimulation application healthy subjects exclusion criteria: * prosthetic implants * musculoskeletal, neurological, cardiovascular and pulmonary disorders that may alter the gait

Keywords: functional electrical stimulation acquired muscle weakness rehabilitation
pilot clinical trial of repeated doses of macimorelin to assess safety and efficacy in patients with cancer cachexia

Conditions: Cancer Cachexia

Summary: the purpose of this study is to evaluate the safety and efficacy of repeated oral administration of macimorelin at different doses daily for 1 week for the treatment of cancer cachexia.


Eligibility criteria:
inclusion criteria: 1. subjects ≥18 years of age with histological diagnosis of incurable cancer (solid tumor), 2. ecog performance status of 0-2, 3. presence of cancer-related cachexia defined as an involuntary weight loss of at least 5% of the pre-illness body weight over the previous 6 months, and 4. provide written informed consent prior to screening. exclusion criteria: 1. obesity (body weight \>140 kg); 2. recent active excessive alcohol or illicit drug use; 3. severe depression as determined by the investigator; 4. other causes of cachexia such as: liver disease (ast or alt \> 3x normal levels); renal failure (creatinine \>1.5 mg/dl), untreated thyroid disease, class iii-iv chf, aids, severe copd requiring use of home o2; 5. inability to increase food intake (e.g., esophageal obstruction, intractable nausea and vomiting); 6. any condition that would prevent the subject from performing the research procedures (e.g. unstable coronary artery disease); 7. use of growth hormone, megestrol, marinol, or any other anabolic agents, appetite stimulants (including corticosteroids other than dexamethasone at the time of iv chemotherapy administrations), tube feeding, or parenteral nutrition during the 1 month prior to entering the study; 8. recent administration (less than 1 week) of highly emetogenic chemotherapy (hesketh scale class 4-5); subjects may otherwise be undergoing chemotherapy. 9. being female and pregnant, breast-feeding or of childbearing potential. (note: lack of childbearing potential for female patients is satisfied by: a) being post menopausal; b) being surgically sterile; c) practicing contraception with an oral contraceptive, intra-uterine device, diaphragm, or condom with spermicide for the duration of the study; or d) being sexually inactive. confirmation that the patient is not pregnant will be established by a negative serum hcg pregnancy test at the time of enrollment. 10. co-administration of drugs that prolong qt interval, cyp3a4 inducers, qtc equal to or greater than 450ms at screening, or other investigational agents (a wash-out period of five times the half life of drugs that prolong qt will be allowed with approval of prescriber). 11. conditions that would preclude from successfully scanning subjects in mri: * claustrophobia (this would make lying in the scanner very uncomfortable); b. having a pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants; c. history of seizures d. history of head injuries resulting in loss of consciousness \> 10 minutes.
a cross sectional observational study on relation between oral manifestation and hepatitis c in egypt

Conditions: Hepatitis C; Oral Manifestations; in Egyptian Population

Summary: hepatitis c virus (hcv) is the major cause of chronic liver disease and has a long-term resultant complications4 and it considered as a major endemic medical health problem in egypt. it affects multiple organs and reflect various manifestations on oral cavity.the purpose of this study is to assess the prevalence of oral mucosa conditions, type of oral manifestation and gingival lesions in patients with hepatitis c

study design: it is a cross sectional observational study. sample size estimation: 100 patients (50 in each groups) a total of 100 adult participants of both genders above 18 years will be included in the study, patients was able and willing to participate in the study. 50 patients will be recruited for study group from consecutive patients previously diagnosed by hepatitis c regardless of the etiology of the condition and regularly attending at soad kafay hospital. participants with history of smoking and alcoholism that could affect their oral health status were excluded. the control group populations will be randomly recruited from the out-patient of dental diagnosis clinic in misr university for science \& technology university to include total 50 clinically healthy participants, with no history of liver disease, or any other chronic debilitating illness, or habit of smoking or drinking, , as well as history of an intervention or condition that could affect the oral mucosa (e.g., history of radiotherapy and/or not receiving any medication that could affect oral health. changes in the oral cavity was recorded on the entire mucosal surface recording signs, symptoms, and oral lesion absence or presence. all the information will be recorded and the data will be analyzed after the end of the study . the prevalence of various oral manifestations in hepatitis c patients will be documented.

Eligibility criteria:
inclusion criteria: * patients previously diagnosed with hepatits c, with education, ability and willing to participate in the study exclusion criteria: * patients with systemic diseases such as nutritional deficiency; cardiovascular, respiratory, metabolic, and endocrinal disorders; also smoking and alcoholism that could affect their oral health status were excluded. as well as history of an intervention or condition that could affect the oral mucosa (e.g., history of radiotherapy).