Kornimate/medical-research-clean huggingface dataset:
critical care anxiety and long-term outcomes management

Conditions: Anxiety

Summary: the aims of this study are to (1) test the benefits of a non-pharmacologic anxiety management approach with patients who are critically ill and/or traumatically injured during intensive care hospitalization and (2) test whether this approach reduces anxiety and improves engagement in rehabilitation therapies, shortens duration of hospitalization, and improves psychological and quality of life outcomes.


Eligibility criteria:
inclusion criteria: * 18 years or older * ability to read, write, and speak english * alert (best rass icu sedation score ≥-2) * current cam-icu test negative * expected icu stay ≥48 hours * anxiety visual analog scale (vas-a) score ≥30 * prescribed rehabilitation therapy at eligibility exclusion criteria: * inability to communicate (verbally, or via hand writing/gestures) * greater than 90% probability of mortality in hospital * anticipated discharge to hospice or transition to end-of-life care * pre-existing cognitive impairment (e.g., dementia, pervasive developmental disorder)

Keywords: anxiety intensive care unit critical care
reducing individual work stress in healthcare professionals through exchange of job resources

Conditions: Job Crafting

Summary: the present study focuses on prosocial job crafting as a novel strategy to reduce burnout and foster well-being among nurse professionals. specifically, we will examine whether prosocial job crafting enhances individual and team-level well-being by increasing own and others' resources.

below, we provide more information on the study design, study procedure, data collection, data management, and data analysis. study design: type: prospective, longitudinal, observational diary study. duration: 10 workdays of daily surveys with a baseline survey at the start (day 0). setting: online survey tool (castor), accessible via smartphones. study procedure: day 0 - baseline survey: collects demographic data and job-related information. days 1-10 - daily surveys: workday verification: confirmation of work on that day. in addition to the outcomes listed under primary and secondary outcome measures, daily surveys will include measures of: prosocial job crafting: 12 items adapted to measure crafting behaviors to benefit other team members, using the prosocial job crafting measure (psjcm). psychological capital: 12 items measuring hope, self-efficacy, optimism, and resilience, using a shortened version of the psychological capital questionnaire (pcq). day 11 - post-study survey: summary of results and feedback opportunity. data collection: survey platform: mobile-friendly (castor). questionnaire format: self-report measures adapted for daily context. data management: anonymity: participants are assigned anonymous codes for data matching. confidentiality: data is securely stored with access only for researchers on the project. statistical analysis: multilevel modeling will be used to analyze the nested nature of daily data and relationships between job crafting, resource exchange, and work outcomes.

Eligibility criteria:
eligibility criteria: * employees (nurse professionals) working in a team-based work environment (hospital setting). * participants must be able to complete daily surveys in the designated timeframe (end of each workday). exclusion criteria: * part-time workers with small contracts (less than 3 days a week) or individuals not engaged in team-based work. * participants who do not complete the baseline survey or a minimum of 5 daily surveys.

Keywords: job crafting work-related well-being healthcare nursing
treatment with high dose methotrexate in patients with eosinophilic fasciitis

Conditions: Fasciitis

Summary: evaluate the effect of high dose mtx on skin induration in patients with eosinophilic fascia.

eosinophilic fasciitis (ef)is a fibrosing skin disorder extensively involving the deep fascia. the aim of this pilot study is to evaluate the effect of high dose mtx on skin induration in patients with ef. in addition, we study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional ability, and pulmonary function. by administering high dose mtx intravenously every four weeks with a leukovorin rescue, we hope to induce a more pronounced and sustained effect on the involved skin with less (long-lasting) side effects.

Eligibility criteria:
inclusion criteria: * eosinophilic fasciitis as defined by clinical judgement of an expert, * histologically confirmed with a skin-fascia-muscle biopsy, and in additon: * either the presence of a modified skin score according to zachariae of 8 or higher (0-18), regarded as a generalised eosinophilic fasciitis or the presence of severe contractures due to eosinophilic fasciitis lesions. exclusion criteria: * age \< 18 yrs * contraindications to mtx: ast/alt level \> 2 times upper limit of normal, wbc count \ 130 micromol/l or clearance \< 50 ml/min, confirmed by two repeated tests within one month. * chronic liver disease, insulin dependant diabetes mellitus, alcohol abuse * restrictive pulmonary disease (total lung capacity or vital capacity \< 40% of predicted) or interstitial lung disease (kco \< 60% of predicted) * pregnancy or child bearing potential without adequate contraception * the presence of any serious co-morbidity or malignancy * use of other anti-folate drugs than mtx

Keywords: eosinophilic fasciitis, shulman's syndrome, methotrexate
fatigue and exercise training in patients with sarcoidosis

Conditions: Sarcoidosis; Fatigue

Summary: the aims of the current study is to explore if different exercise training protocols affect fatigue post-exercise, and if sarcoidosis-related fatigue and maximal and sub-maximal cardiopulmonary exercise test (cpet) variables change after a 4-weeks exercise training period.

this project aims to provide data on post-exercise fatigue after single exercise sessions with endurance training and muscle strength training, each with two different intensities. for endurance training; post-exercise fatigue will be assessed after one session of high intensity interval training, and one session with longer duration of moderate intensity. for muscle strength training, fatigue will be measured after one session with high loads/few repetitions and one session with low loads/many repetitions. in addition, changes in sub-maximal and maximal metabolic and ventilatory responses to a maximal cardiopulmonary exercise test on a treadmill (cpet) and association to sarcoidosis-related fatigue before and after a 4-weeks exercise training period will be studied.

Eligibility criteria:
inclusion criteria: * patients with sarcoidosis diagnosed according to the latest american thoracic society/european respiratory society/world association for sarcoidosis and other granulomatous disorders (ats/ers/wasog) statement on sarcoidosis who are attending a four weeks exercise based pulmonary rehabilitation program at lhl-klinikkene glittre. exclusion criteria: * patients with a concurrent and predominant diagnosis of another significant respiratory disorder (for example: asthma, chronic obstructive pulmonary disease (copd), cystic fibrosis, or lung cancer). * unstable cardiovascular disease. * not able to perform the required physical tests and exercise training sessions caused by co-morbidities.

Keywords: sarcoidosis fatigue exercise
virtual integrated environment in decreasing phantom limb pain

Conditions: Phantom Limb

Summary: the purpose of this study is to determine if observing a virtual arm decreases phantom limb pain (plp) in upper extremity amputees.

nearly all traumatic limb amputees will experience cognizance of a phantom limb and perceive a vivid impression that their lost limb is not only fully present, but also painful. the john hopkins university applied physics laboratory virtual integration environment (vie) is a highly flexible and adaptable virtual reality system that allows patients to observe movement of a 3d virtual arm. using the vie, recorded signals from the residual limb will be correlated to the desired motion of the phantom limb. we hope to correlate the consistency of these patterns with plp to determine if increased control of the phantom limb leads to decreased plp.

Eligibility criteria:
inclusion criteria: * male or female subjects, 18 to 65 years of age, active duty military, beneficiary, or retiree. * written informed consent and written authorization for use or release of health and research study information. * at least one upper-limb amputation (trans radial or trans humeral) at any time prior to enrollment. * no prior history of vertebral disk disease/condition, sciatica or radiculopathy. * normal neurological examination with the exception of limb amputation. * ability to follow study instructions and likely to complete all required visits. * experiencing plp at least 3 times a week at an intensity of at least 3 out of 10 at the time of enrollment. exclusion criteria: * presence of mild to severe traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening that is currently performed routinely on patients by the traumatic brain injury (tbi) program at walter reed national military medical center (wrnmmc) and noted in the patient's medical record. * known uncontrolled systemic disease * participation (either concurrently or in the 30 days prior to enrollment) in another study for treatment of plp * any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound study results, or interfere significantly with the subject's participation in the study. * significant axis i or ii diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study * subjects with lack of effort as determined by the neurologist or psychiatrist. subjects will be screened for effort using the test of memory malingering (tomm) in order to exclude those with blatant exaggeration or malingering. subjects who score lower than 42/50 on the tomm-2 will not continue in the study

Keywords: phantom limb amputation, traumatic electromyography visual analog pain scale
evaluation of 3 different doses of iv busulfan

Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia

Summary: albeit the safety of the stem cell transplantation procedure has been greatly improved, further refining the intensity of the conditioning is an important issue to explore, especially in patients with poor prognosis, the goal being to maintain the very favorable safety profile and improve the disease control. this is the goal our prospective trial; we aim to prospectively evaluate in a prospective multicenter trial the efficacy of different conditioning regimens in patients with high-risk myeloid malignancies. the study is a phase ii trial randomizing patients between a prospective active control arm (bx2) and two experimental arms (bx3 and bx4). a standard group was kept in this clinical trial in order to avoid the limitations induced by the comparison with historical controls in the context of continuously improving practice. each experimental arm will be conducted in parallel according to a standard phase ii trial design. in addition, this trial will associate four ancillary studies to the main clinical objective: 1/ a prospective assessment of the quality of life of the patients over a period of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study


Eligibility criteria:
inclusion criteria: 1. patients with poor prognosis myeloid malignancies: * myelodysplastic syndrome, * acute myeloid leukemia (aml) beyond complete response (cr1), * cr1 aml with poor risk cytogenetics 2. adult patients: aged ≥ 55 years up to 65 or \< 55 years not eligible for myeloablative conditioning regimen based on total body irradiation (tbi) or double alkylating agent combinations. 3. availability of a hla identical sibling or matched unrelated donor (10/10) 4. affiliation to social security 5. written informed consent exclusion criteria: 1. history of previous allo-hematological stem cell transplantation (hsct) 2. hiv positivity 3. signs of chronic active hepatitis b and/or c 4. evolutive psychiatric disease 5. concomitant neoplastic disease 6. pregnant or lactating woman or without contraception (for child bearing potential wom-en) 7. usual contra-indications for allo-hsct

Keywords: myelodysplasic syndrome acute myeloid leukemia
a novel blood test as a biomarker in mental health

Conditions: Depression - Major Depressive Disorder; Schizophenia Disorder; Psychosis; Mania (Neurotic); Alcohol Consumption; Anxiety Disorder (Panic Disorder or GAD); Substance Use Disorders; Alcohol Use Disorder

Summary: this longitudinal, observational study aims to assess whether the characteristics of a novel blood peripheral biomarker can serve as indicators for depression and schizophrenia in patients at the royal columbian hospital psychiatric clinics. the study will evaluate whether changes in these biomarker characteristics can help distinguish between depressed patients who do or do not respond to treatment and between individuals experiencing a single psychotic episode and those at risk of progressing to schizophrenia. to achieve this, blood samples and standardized mental health assessments will be collected across three study visits from up to 500 participants, grouped into two study arms based on their diagnosis: depression (dep) or psychosis/schizophrenia (psy).


Eligibility criteria:
inclusion criteria: i. age 19+. ii. informed consent by participant iii. any of the following situations: 1. suspected, new onset or established depression. 2. first episode of psychosis or suspected/established schizophrenia. iv. in the opinion of the investigator, the participant will likely be able to complete the standardized mental health questionnaires administered in each study visit. exclusion criteria: i. inability to provide informed consent. ii. currently enrolled in any other research study involving drugs or devices that may confound mental health treatment outcomes. iii. currently declared on extended leave under british columbia's mental health act.

Keywords: mental health biomarker depression schizophrenia psychosis sert
short-course trastuzumab, pertuzumab with taxanes in the adjuvant treatment of early her2-positive breast cancer

Conditions: Breast Cancer

Summary: the investigators plan to carry out a phase ii, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early her2-positive breast cancer, to explore whether 4 courses of dual her2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.


Eligibility criteria:
inclusion criteria: * histologically diagnosed unilateral primary invasive breast cancer patient with pt1, pn0, and m0 disease * her2-positive, ie. immunohistochemistry \[ihc\] 3+ or ihc 2+ and fluorescence in situ hybridisation \[fish\]-positive according to asco/cap 2018 guidelines * complete clinical pathological information * eastern cooperative oncology group \[ecog\] 0-1 * currently not pregnant or breast-feeding * fine organ function * have good compliance with planned treatment, understand the study process and sign a written informed consent exclusion criteria: * bilateral or metastatic breast cancer * receiving neoadjuvant treatment * other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer * severe systemic infections or other serious illnesses * hiv infection, active hepatitis b or c infection * known allergy to or intolerance to a therapeutic drug or its excipients * prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason * enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment * receiving live vaccine within 30 days prior to initial administration of the investigational treatment * history of mental illness or drug abuse that may affect compliance with the trial requirements * the researchers determine that the patients were not suitable for the study

Keywords: breast cancer pertuzumab her2 adjuvant
post-operative pain and opioid reduction trial after bunionectomy

Conditions: Hallux Valgus and Bunion

Summary: this is a phase 2b, randomized, double blind, placebo and active controlled study with an ascending dose stage and an optional dose expansion stage in subjects undergoing bunionectomy.

near the completion of surgery, a single dose of study drug (cpl-01, saline placebo, or ropivacaine hcl) will be infiltrated. subjects will remain in the hospital/research facility for a minimum of 72 hours after the start of study drug administration to undergo postoperative assessments. subjects will return to the study site on day 7 to complete follow up assessments, on day 28 for follow-up assessments including an x-ray, and on day 42 for the end-of-study (eos) visit.

Eligibility criteria:
inclusion criteria: * be willing and able to sign the informed consent form (icf) prior to study participation * in the medical judgment of the investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and asa class i or ii at the time of randomization * plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries * have a bmi ≤ 39 kg/m2 exclusion criteria: * previous unilateral simple bunionectomy * has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol * concurrent painful condition * active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery * known hypersensitivity or known allergy, as determined by the investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study * history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments * history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency * history or evidence of impaired liver function (e.g., alt \> 3 × upper limit of normal \[uln\] or total bilirubin \> 2 × uln), active hepatic disease, or cirrhosis * history or evidence of impaired renal function (e.g., creatinine \> 1.5 × uln) * history of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix * has or has had active covid-19 infection within 3 months prior to surgery
inflammatory markers in patients with active migraine headaches

Conditions: Migraine

Summary: the purpose of this study is to determine whether c-reactive protein (crp) is elevated in patients with active migraine headaches. secondary goal is to determine whether other inflammatory markers, such as calcitonin gene peptide (cgrp), vasoactive intestinal polypeptide (vip) or substance p (sp) are elevated in patients having a migraine headache.

a random selection of patients both male and female from a primary care practice with a diagnosis of having migraine headaches will be enrolled. thirty (30) patients will be recruited mainly from the primary care practice. recruitment will include males and females aged 21-65. the patients who meet the inclusion criteria will be enrolled. the patients who do not have migraine headaches will also be enrolled and function as controls. non-migraine patients will meet inclusion criteria 1, 2 and 3 and all of the exclusion criteria.

Eligibility criteria:
inclusion criteria: 1. subjects must sign a written informed consent. 2. enrollment population would include males and females 21 years of age to 65 years of age. 3. non-migraine subjects will be allowed in the control group 4. have episodic migraine headaches 5. patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed. 6. must be able to differentiate migraine headaches from other headaches exclusion criteria: 1. any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment. 2. basilar or hemiplegic migraine headaches. 3. pregnant woman or a nursing mother 4. history (within 1 year) or current evidence of drug or alcohol abuse. 5. more than 15 migraine headaches per month 6. chronic daily headaches 7. chronic use of nsaids 8. current participation in a research study or within the last 30 days.

Keywords: inflammatory markers migraine
gemcitabine and nabpaclitaxel in metastatic pancreatic carcinoma.

Conditions: Metastatic Pancreatic Cancer

Summary: retrospective, multicenter study including pts with metastatic pancreatic cancer who started first-line treatment with napaclitaxel plus gemcitabine between december 2013 and june 2015 according to the routine practice. overall survival (os) and progression-free survival (pfs) were assessed for the total sample and the exploratory subgroups based on treatment and clinical characteristics of the study pts.

this observational, retrospective, multicenter study included patients with metastatic pancreatic adenocarcinoma (either recurrent or de novo) from 20 spanish hospitals, who started first-line chemotherapy with nab-paclitaxel (abraxane®, celgene europe limited) plus gemcitabine between december 2013 and june 2015 according to routine clinical practice. the record included all adult patients (i.e., aged ≥ 18 years) with measurable metastatic disease at baseline in at least one dimension of the response evaluation criteria in solid tumors (recist), version 1.1,\[15\] who received at least one dose of combined treatment with nab-paclitaxel plus gemcitabine. data were retrieved from patients' medical records and lasted until death or the closure of the database on 16 march 2017. all patients signed the corresponding informed consent for their clinical data being used in this study, which was conducted in accordance with the local personal data protection law (lopd 15/1999). the study protocol was approved by the local independent ethics committee.

Eligibility criteria:
inclusion criteria: * histologically-confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma that is metastatic to distant sites. * other histologies such as neuroendocrine and acinar cell carcinoma are excluded. * no prior chemotherapy for metastatic pancreatic cancer. * participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral ct scan, mri, or calipers by clinical exam. * age greater than or equal to 18 years. * patient has signed a patient informed consent form. * patients should have received at least one cycle of gemcitabine and nabpaclitaxel exclusion criteria: * less than one cycle of gemcitabine/nabpaclitaxel administrated.

Keywords: metastatic pancreatic cancer real world data gemcitabine nabpaclitaxel efficacy safety