Kornimate/medical-research-clean huggingface dataset:
surgical prehabilitation of cancer patients undergoing colorectal resection.

Conditions: Colorectal Cancer

Summary: psychological distress is common among adults newly diagnosed with cancer and those awaiting cancer treatment(s). although preoperative psychological distress has been shown to be associated with poorer physical health and adverse treatments among colorectal cancer survivors, few psychological interventions have been developed to reduce distress, and improve physical health in the preoperative period. moreover, whether a preoperative psychological intervention, delivered in addition to a multimodal prehabilitation program can improve psychological and physical health remains unknown. therefore, the purpose of this pilot cohort study was to examine the impact of a structured psychological intervention, given in addition to standard prehabilitation, on preoperative psychological health and functional capacity in colorectal cancer patients awaiting surgery.

all participants will receive a multimodal prehabilitation program preoperatively for 4 weeks, composed of three elements: aerobic and strength training exercise program, nutritional counselling and psychological support. the exercise program will be three times per week and include a combination of home-based (twice per week) and supervised (once per week) sessions. participants' nutritional status and dietary intake will be assessed by a registered dietician/nutritionist, and a whey protein supplement (immunocal) will be prescribed to achieve a daily intake of 1.5 g protein/kg. psychological support will consist of a 90-minute interview/session at baseline and weekly in-person follow-ups before surgery aimed at reducing psychological distress and improving adherence to the exercise program and nutritional recommendations. perioperative care will follow the mcgill surgical recovery pathway, also called enhanced recovery program, which is an evidence-based care plan set up by the surgical recovery (sure) multidisciplinary committee of the mcgill university health centre.

Eligibility criteria:
inclusion criteria: * currently aged 18 years or older * diagnosed with non-metastatic, colorectal cancer * awaiting resection of malignant colorectal lesions * able to provide informed consent in english or in french exclusion criteria: - have health condition(s) interfering with ability to safely perform exercise at home or to complete testing procedures (e.g., non-ambulatory, dementia, severe end-organ disease, morbid obesity, cardiac abnormalities)

Keywords: psychological prehabilitation colorectal cancer functional capacity physical activity nutrition psychological counselling
unfractionated heparin in covid-19 and non-covid-19 patients

Conditions: Heparin Overdose of Undetermined Intent; COVID-19

Summary: the majority of icu patients with covid-19 show profound activation of coagulation, potentially resulting in thromboembolic events. in the treatment of these thromboembolic events it seemed that very high dosages of unfractionated heparin were necessary to achieve therapeutic values of aptt and anti-xa levels. the aim of this study is to explore whether heparin dosages are higher in covid-19 patients compared to non-covid-19 patients, to determine the correlation between aptt and anti-xa values and to explore possible causes for non-correlating aptt and anti-xa, including crp and at plasma levels.

covid-19 is a viral disease caused by sars-cov-2 virus that may affect many organ systems. patients with severe disease almost invariably have profound pulmonary inflammation and may require mechanical ventilation and prolonged icu admission. mortality in icu patients may be up to 50%. in the majority of patients with covid-19 in the icu, profound activation of coagulation is present as reflected by d-dimer levels up to 20.000 mg/l or higher. patients with proven pulmonary thrombosis are commonly treated with unfractionated heparin (ufh). typically, it seemed that very high dosages of ufh were necessary to achieve therapeutic values of aptt and anti-xa levels in covid-19 patients. though, the question remains whether dosages given in covid-19 patients were indeed extravagant compared to non-covid-19 patients and what potential causes of these high dosages might be. earlier research already implied that aptt, which is a primarily used parameter to dose ufh, is not accurate and rather anti-xa levels should be used. other potential reasons for the high doses are that covid-19 patients show signs of heparin resistance, possible due to high inflammation parameters. as overdosing of heparin can lead to serious bleeding complications, more understanding on heparin dosage, e.g. parameters to rely on and potential influencing factors, in covid-19 patients is needed. the primary objective of this study is to determine whether heparin dosages are higher in covid-19 patients compared to non covid-19 patients. the secondary objective is to determine the correlation between aptt and anti-xa values and to explore possible causes for non-correlating aptt and anti-xa, including crp and at plasma levels.

Eligibility criteria:
inclusion criteria covid-19 group: * covid-19 disease proven by pcr of nose- or airway sample * age ≥ 18 years * admitted to the icu from the 15th of march 2020 until 1st of january 2022 * treated with unfractionated heparin aiming at aptt 60-80 sec and/or anti-xa level 0.3-0.7 ie/ml inclusion criteria non-covid-19 group: * age ≥ 18 years * admitted to the icu between the 1st of january 2014 and 1st of january 2020 * treated with unfractionated heparin aiming at aptt 60-80 sec and/or anti-xa level 0.3-0.7 ie/ml exclusion criteria: - treatment with anticoagulants other than ufh or fibrinolytics
pleth variability index for predicting low blood pressure during maintenance hemodialysis

Conditions: Hypotension and Shock; Hemodialysis; End-Stage Renal Disease Requiring Haemodialysis; Intradialytic Hypotension

Summary: what is this study about? we are studying whether the pleth variability index (pvi)-a simple, non-invasive measurement from a pulse oximeter-can help predict low blood pressure (hypotension) during routine maintenance hemodialysis. low blood pressure during dialysis is a common and potentially serious complication. our goal is to find out if monitoring pvi can help identify patients at risk, so that early action can be taken. who can join? adults aged 18 to 80 years. patients who have been receiving maintenance hemodialysis regularly for more than 3 months. those who are willing and able to participate and sign an informed consent form. who cannot join? patients with severe heart rhythm problems, severe peripheral circulation problems, or swelling that makes pvi measurement unreliable. patients who are pregnant or breastfeeding. patients allergic to the dialysis filter or unable to cooperate with the study procedures. what will happen during the study? pvi measurement: your pvi will be checked with a simple fingertip device before starting dialysis and again 30 minutes after dialysis begins. blood pressure monitoring: your blood pressure will be closely watched throughout the dialysis session. data collection: information about your age, medical history, medications, lab results, dialysis settings, and other standard measurements will be recorded. what are the benefits and risks? benefits: by identifying patients at higher risk for low blood pressure during dialysis, the study may lead to safer and more comfortable dialysis treatment in the future. risks: all measurements used in this study are safe and non-invasive, with no extra risk compared to routine care. your rights and safety participation is completely voluntary-you may leave the study at any time without affecting your medical care. the study has been reviewed and approved by the hospital's ethics committee. your privacy and personal data will be strictly protected.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 80 years. * diagnosis of end-stage renal disease and undergoing maintenance hemodialysis for more than 3 months. * able and willing to provide informed consent and comply with study procedures. exclusion criteria: * severe cardiac arrhythmias or significant peripheral vascular disease that may interfere with pvi measurements. * local edema, skin lesions, or other conditions that prevent accurate pvi monitoring. * history of hemodynamic instability unrelated to dialysis. * pregnant or breastfeeding women. * known allergy or contraindication to materials used in the hemodialysis circuit. * unable to cooperate with study procedures. * participation in another interventional clinical study within the past 30 days.

Keywords: pleth variability index hemodialysis intradialytic hypotension blood pressure monitoring end-stage renal disease non-invasive monitoring predictive marker maintenance dialysis
kf stride to improve job interview skills

Conditions: Autism Spectrum Disorder

Summary: the goals of the current study are to evaluate the preliminary effectiveness and feasibility of kessler foundation-strength identification and expression (kf-stride) in an 8-week randomized controlled trial comparing the intervention to services as usual (sau).

this study will evaluate the acceptability and effectiveness of a strength-based intervention (kessler foundation strength identification and expression; kf-stride) that can enhance job interview skills and employment. despite possessing employable talents, the core social deficits of transition age youth with autism spectrum disorder (tay-asd) make it difficult for this group to articulate their individual strengths. this inability to identify and express one's strengths to a potential employer can negatively affect interview performance and lead to difficulty with job obtainment. thus, the current proposal will examine the effectiveness (aim 1), acceptability, usability, and feasibility (aim 2) of a novel strength-based intervention, kf-stride, which is designed to enhance the ability of tay-asd to identify personal strengths and effectively discuss them. the goals of the current study are to evaluate the preliminary effectiveness and feasibility of kf-stride in an 8-week randomized controlled trial comparing the intervention to services as usual (sau). the study will be performed at two private therapeutic schools. compared to a sau group, we hypothesize that the kf-stride group will: a) improve the ability to identify strengths (hypothesis 1), b) improve the ability to express strengths (hypothesis 2), c) improve other job interview skills (hypothesis 3) and finally c) improve ability to obtain employment 6-months following the intervention (hypothesis 4). in this way, the current study is in line with the nimh's experimental therapeutics model, as we will examine whether the intervention improves employment, as well as identify potential mechanistic targets that could affect outcome. in aim 2, we will also monitor fidelity, acceptability, usability, and feasibility of the strength-based intervention. the long-term goal of the current research is to collect pilot data that will lead to fully-powered effectiveness and implementation evaluations of kf-stride in other community settings.

Eligibility criteria:
inclusion criteria: * adolescents with autism spectrum disorder * live in the united states of america * ages of 14-26 * speak english fluently and at a 4th grade reading level exclusion criteria: * history of stroke, traumatic brain injury, or neurological injury or disease in the past (like brain tumor or epilepsy). * history of significant psychiatric illness * uncontrolled seizures or other unstable medical complications.
a trial of hrs-7085 tablet in healthy participants with and without food effect.

Conditions: Inflammatory Bowel Disease

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of hrs-7085.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial. 2. male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. 3. total body weight 45 kg\~100 kg (inclusive) at screening, and body mass index (bmi) between 18 and 32 kg/m2 (inclusive). 4. for healthy subjects, no clinically significant abnormalities. 5. men and women of childbearing potential (wocbp) must agree to take effective contraceptive methods exclusion criteria: 1. known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc. 2. severe injuries or major surgeries within 3 months before dosing. 3. subjects with infectious disease. 4. live/attenuated vaccine within 3 months prior to dosing or any vaccine during the trial. 5. blood donation or loss of ≥ 200 ml of blood within 1 month prior to dosing, or ≥ 400 ml of blood within 3 months prior to dosing; or receive a blood transfusion within 2 months prior to dosing. 6. clinically significant abnormalities in 12-lead ecg 7. more than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening, or positive cotinine test at screening or baseline. 8. positive urine drug at screening or baseline. 9. subject who cannot perform venous blood sampling. 10. known history or suspected of being allergic to the study drugs and their excipients. 11. use of prescription medicine within 2 weeks, or otc medicine, within 1-week or 5 half-lives prior to dosing. 12. history of alcohol abuse within 3 months prior to screening, or positive alcohol breath test at screening or baseline. 13. participation in clinical trials of other investigational drugs or medical devices within 1 month or 5 half-lives prior to dosing. 14. special dietary requirements that cannot follow the meal plan in the food effect study. 15. in the investigator's judgment, may increase the risk to the subject. 16. unwilling or unable to comply with the lifestyle guidelines detailed in this protocol.
study of dasatinib (bms-354825) in patients with accelerated phase chronic myeloid leukemia

Conditions: Chronic Myelogenous Leukemia

Summary: the purpose of this clinical research study is to learn if bms-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (cml) who are resistant to or intolerant to imatinib mesylate. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * subjects with philadelphia chromosome positive (ph+) or the fused gene bcr/abl positive (bcr/abl+) accelerated phase chronic myeloid leukemia (cml) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate. * subjects must have had prior exposure to imatinib. however, imatinib mesylate does not need to be their most recent cml treatment prior to coming on this study. * men and women, 18 years of age or older. * adequate hepatic function. * adequate renal function. * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized. exclusion criteria: * women who are pregnant or breastfeeding. * subjects who are eligible and willing to undergo transplantation during the screening period. * a serious uncontrolled medical disorder or active infection that would impair the ability of the subjects to receive protocol therapy. * uncontrolled or significant cardiovascular disease. * medications that increase bleeding risk. * medications that change heart rhythms. * dementia or altered mental status that would prohibit the understanding or rendering of informed consent. * history of significant bleeding disorder unrelated to cml. * concurrent incurable malignancy other than cml. * evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy. * prior therapy with dasatinib (bms-354825). * prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Keywords: chronic myelogenous leukemia (cml): accelerated phase
intraocular pressure control following one site versus two site combined phacoemulsification/iol and trabeculectomy

Conditions: Glaucoma; Cataracts

Summary: the purpose of this study is to compare the safety \& effectiveness of the two types of cataract and glaucoma surgeries. results from this study may improve the surgical and post surgical management and long term management of patients with these conditions in the future

the purpose of this study is to determine whether a two-site technique for the combined procedure for subjects with coexisting visually significant glaucoma \& cataracts will result in an improvement in iop control in both the immediate and longer term postoperative period as compared with the currently standard one site surgical technique for both glaucoma and cataracts. research and data indicate that the success rate of the glaucoma part of this operation may be improved if the incision for the cataract part of the operation is separated from the drainage hole created for the glaucoma part, the constant drainage through this hole is what lowers the intraocular pressure after surgery. using the two-site combined procedure the glaucoma incision(drainage hole) will still be created superiorly, under the upper lid. the cataract incision will be moved to the temporal side of the eye ball, away from the drainage hole for the glaucoma.

Eligibility criteria:
inclusion criteria: * meet the current criteria for combined procedure surgery: * a visually significant cataract(ie: an opacification of the crystalline lens resulting in a reduction of visual performance affecting daily living * open angle or mixed mechanism glaucoma inadequately controlled on current therapy, or requiring two or more medications for control, or with advanced visual field and optic nerve damage. exclusion criteria: * subjects with normal tension glaucoma(defined as those subjects in whom no iops greater than 21 mm hg\[preceding or during therapy\]have been recorded) * subjects with uveitis * subjects with neovascular glaucoma * severe conjunctival inflammation or scarring * subjects who have had previous incisional ocular surgery in the same eye * no subjects will have second eye operated on within 8 weeks of the first eye

Keywords: glaucoma cataracts phacoemulsification(iol) trabeculectomy
registry study of genesys hta for treatment of menorrhagia

Conditions: Menorrhagia

Summary: this is a clinical registry of an fda approved device system called the genesys hydro thermablatortm (hta) system (boston scientific). the hta system's intended use is to be inserted, by a trained physician, into the uterus, where it will fill and circulate fluid that is warm enough to change the characteristics of the uterine lining. this is done with the anticipated result of improving menstrual bleeding symptoms. the purpose of this fda-mandated registry is to obtain clinical experience on the use the genesys hta™ system, under normal clinical conditions, and document its safety and technical reliability.


Eligibility criteria:
inclusion criteria: * subject must meet the approved indication for use to be considered for this registry. exclusion criteria: * all subjects contraindicated for the treatment of the genesys hta system per the directions for use will be excluded: 1. the subject is pregnant or wants to be pregnant in the future 2. the subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia 3. the subject has active pelvic inflammatory disease or pyosalpinx 4. the subject has hydrosalpinx 5. the subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath 6. the subject has an anatomical condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium 7. the subject has an intrauterine device in place 8. the subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment

Keywords: menorrhagia
a prospective randomized study of medial patellofemoral ligament (mpfl) reconstruction

Conditions: Patella-Dislocation; Patellofemoral Osteoarthritis; Patellar Instability

Summary: the operative management of chronic patellar instability has been controversial. medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. the objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.

many of the previous studies on medial patellofemoral ligament (mpfl) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after mpfl reconstruction with medial reefing for chronic patellar instability. the distance between tibial tubercle and trochlear groove is measured on mri and corrected if it exceeds 17mm. primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. the second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.

Eligibility criteria:
inclusion criteria: * chronic patellar instability (more than 2 dislocations) * minimum 6 months nonoperative treatment exclusion criteria: * severe pf oa * acute patellar dislocation

Keywords: patella dislocation knee medial patellofemoral ligament