Kornimate/medical-research-clean huggingface dataset:
postoperative management of groin flaps for vascular coverage

Conditions: Functional Status After Sartorius Flap of the Groin; Wound Complication

Summary: this is a randomized controlled trial designed to analyze the impact of bedrest duration on return to functional independence at discharge following sartorius flap for coverage of vascular reconstruction in the groin.

this is a pilot prospective study with the purpose of evaluating the impact of bedrest duration on outcomes of groin muscle flaps used for groin coverage in patients undergoing open, infrainguinal vascular surgery. the investigators plan to target all patients undergoing groin muscle flaps for vascular groin coverage at ucsf. all patients undergoing groin flaps will be block randomized into two cohorts: cohort 1 - one day of bedrest (mobilize on post-op day 2) versus cohort 2 - 5 days of bedrest (mobilize on post-op day 6). the investigators perform approximately 50 infrainguinal muscle flaps per year. they aim to enroll 30 patients (15 per cohort). outcome measures include: surgical complication rates (including wound and lymphatic complications, readmissions, and reoperations), physical function, hospital length of stay, venous thromboembolism (vte), and rates of discharge to a skilled nursing facility. the investigators will also examine the impact of bedrest on patient reported outcomes one month following surgery. patient outcomes will be followed for 3 months post-operatively.

Eligibility criteria:
inclusion criteria: * all patients undergoing muscle flaps following infrainguinal, open vascular surgery. patients must be ambulatory at baseline. patients must be able to provide informed consent. exclusion criteria: * patients who are unable to provide informed consent. patients are non-ambulatory at baseline. patients' clinical status is not amenable towards early ambulation. enrollment is at the discretion of the vascular and plastic surgeons. * bilateral sartorius flaps
the team long-term cohort study (a sub-study of team(iii))

Conditions: Critically Ill; Mechanical Ventilation; Long Term Outcome

Summary: this study is a prospective cohort study to evaluate the long-term effects of early activity and mobilisation compared to standard care on disability, function and health status for patients at 1, 2 and 5 years after recruitment of patients randomised into the team phase iii rct (clinicaltrials.gov nct03133377). the primary outcome of the study will be the level of disability as measured by the world health organisation's disability schedule 2.0, 12 level (whodas) at 2 years after recruitment.

incomplete recovery following critical illness is a major public health problem in australia. each year around 150,000 australians are admitted to intensive care (icu). these critically ill patients require substantial resources and invasive, expensive interventions. approximately 10% die and many of the remaining patients who survive have delayed and compromised functional recovery. as many as 25% of the icu survivors who were living at home prior to icu are unable to return home due to impaired physical function. globally, the quality of survival following an icu admission has been identified as one of the largest health challenges for these patients. this study will address the quality of survival and long-term functional recovery for patients who require life support in icu. these patients account for 62% of the total bed-days in australian icus, with direct care costs of $2 billion per year. the long-term outcomes for these patients are very poor. in my australian cohort study, 50% of patients who survived hospital had disability

Eligibility criteria:
inclusion criteria: * enrolled in the team phase iii rct protocol. exclusion criteria: * there are no exclusion criteria.

Keywords: early activity and mobilization rehabilitation intensive care health status
the effect of reiki on the anxiety level of mothers

Conditions: Anxiety

Summary: the aim of this study is to determine the effect of reiki applied to mothers whose children were treated in the hospital on the anxiety level.

hypotheses 01; there was no difference between the anxiety score of the reiki group and the anxiety score of the control group. the study will be carried out in three different groups. the practice will start with meeting the women whose children were treated in the hospital. after the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. the random distribution of women to the study groups will be carried out using the block randomization method. the following applications will be made to the groups. reiki group the intervention will be applied to the reiki group to be applied in the hospital room. reiki therapy will be applied by a practitioner with a reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a week. anxiety level after 4 sessions will be recorded. placebo reiki will be applied to the participants in the group in the application hospital room. the practice will be carried out in the application laboratory for 30 minutes, with the participants sitting with their eyes closed. reiki life energy will not be transferred to participants in the placebo reiki group. since the participants' eyes are closed, they will not know that there is a transfer. placebo reiki application will be performed in the room 4 times during a week. placebo application will start, and the first anxiety scores will be recorded. after 4 sessions, anxiety scores will be recorded. control group; the first anxiety scores will be recorded. after a week later anxiety scores will be recorded.

Eligibility criteria:
inclusion criteria: * at least the 3rd day of hospitalization * their child has an acute or chronic disease * able to speak and write turkish and have no communication problems * no psychiatric history and not using medication * not drinking alcohol in the last 24 hours * those who have not received body-mind therapy (yoga, reiki, massage, meditation) in the last six months * mothers who volunteer to participate in the research will be included. exclusion criteria: reiki practitioner or who also has an instructor * having time and communication problems that cannot answer the questions asked * mothers who do not volunteer to participate in the study will not be included in the study.
cd19/22 bi-specific car-t cell therapy

Conditions: B Cell Malignancies

Summary: the purpose of this study is to assess the feasibility, safety and efficacy of anti-cd19/22 bi-specific car-t cell therapy in patients with cd19 and/or cd22 positive b cell malignancies. another goal of the study is to learn more about the safety and function of the anti-cd19/22 bi-specific car-t cells and their persistency in patients.

patients with refractory and/or recurrent b cell malignancies have poor prognosis despite complex multimodal therapy. despite impressive progress, more than 50% of patients treated with cd19-targeting chimeric antigen receptor t cells (car19) experience progressive disease. further, more than 40% patients with progressive large b cell lymphoma (lbcl) experienced reduced or lost expression of cd19 on the tumor cells after car19 treatment; low surface cd19 density before treatment was associated with progressive disease. therefore, novel curative approaches are needed. the investigation attempts to use genetically modified t cells to express a 4th generation lentiviral anti-cd19/22 bi-specific car (bi-4scar-cd19/22). the car molecules enable the t cells to recognize and kill tumor cells through the recognition of a surface antigen, cd19 or cd22, which is expressed at high levels on tumor cells but not at significant levels on normal tissues. to overcome tumor escape of single target antigen and enhance in vivo car-t efficacy, a novel bi-specific cd19/22 car-t therapy regimen is developed to include booster and consolidation car-t applications to target highly-refractory b cell cancer. the aim is to evaluate safety and long term efficacy of the bi-car-t therapy strategy in cd19 and/or cd22 positive cancer patients.

Eligibility criteria:
inclusion criteria: 1. age older than 6 months. 2. malignant b cell surface expression of cd19 or cd22 molecules. 3. the kps score over 80 points, and survival time is more than 1 month. 4. greater than hgb 80 g/l.5. no contraindications to blood cell collection. exclusion criteria: 1. accompanied with other active diseases and difficult to assess patient response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with hiv.4. active hbv or hcv infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed cd19 and cd22 car-t treatment.

Keywords: car-t b cell malignancies cd19 cd22
clinical evaluation of the combined use of apligraf® and the snap® pressure wound therapy system

Conditions: Diabetic Foot Ulcer

Summary: the primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of apligraf® and the snap® wound care system for the treatment of diabetic and venous stasis lower extremity ulcers.


Eligibility criteria:
inclusion criteria: * wound \< 10 cm in greatest diameter * wound age \> 4 weeks and patient shows \< 50% wound area healing after 4 weeks of treatment * patient \> 18 years of age * patient is willing and able to sign consent * patient is willing and able to complete study visits and comply with study dressing protocols exclusion criteria: * wound size reduction of \> 50% in last 4 weeks of treatment * patients with active wound infections, including cellulitis and osteomyelitis * patients with wounds not able to have eschar debrided * abi \< 0.65 or spp \< 30mmhg * patients with wounds in anatomic areas which preclude achieving an airtight seal for npwt * ulcers due to inflammatory conditions such as rheumatoid arthritis, lupus, scleroderma, vasculitis, calciphylaxis, etc. * patients with allergy to or intolerance of any of the wound dressing materials expected to be used during the trial. * pregnant patients * patients unable to tolerate npwt * patients with dialysis dependent esrd * index ulcer is on the plantar surface of the foot

Keywords: diabetes mellitus wounds ulcers
tear lipid layer thickness assessments with perfluorohexyloctane eye drops

Conditions: Dry Eye

Summary: the purpose of this study is to explore the tear lipid layer quantitatively and qualitatively before and after use of a perflurohexyloctane eye drop (novatears)

the tear lipid layer will be studied before and after the use of an over-the-counter eye drop (novatears, novaliq gmbh, heidelberg, germany) using a stroboscopic video color microscope, which is non-invasive.

Eligibility criteria:
inclusion criteria: * • age - at least 30 years * good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the pi) * ability to give informed consent * willing to spend time for the study; approximately one hour for a screening visit and 45 minutes for a data collection visit. * either gender * any racial or ethnic origin * tear lipid thickness ≤ 75 nm exclusion criteria: * active ocular inflammation * use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and restasis or xiidra) used within 14 days of the screening visit or started prior to the measurement visit(s). * currently having punctal plugs inserted in lacrimal puncta * current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to moderate or greater blepharitis and ocular allergy. clinically significant (active treatment) of blepharitis, sjogren's disease or other systemic disease that could influence mgd, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics, ssris, that could influence tear secretion, or sensitivity to any of the ingredient in the eye drop being tested, * past eye surgery, such as, but not limited to, refractive surgery. subjects who have had cataract removal surgery more than one year ago may be considered as potential subjects. * female subjects may not be pregnant or lactating. (subject will be asked to self-report these conditions.) * infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, hiv). (subjects will be asked to self-report these conditions.) * inability to complete the screening and examination * inability to provide analyzable data. for example, subjects who cannot keep their eye open during the entire measurement interval (due to early blinking) or provide a readable eye image (due to eyelid laxity) or cannot sit still for 1 minute.
culturally-targeted covid-19 communication and sars-cov-2 antibody testing evaluation and uptake

Conditions: SARS-CoV2 Infection

Summary: this disparities-focused study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary sars-cov-2 antibody testing among african americans residing in flint, michigan. this iteration will consider individuals recruited from the flint registry and assess willingness to participate in a drive-up saliva sample collection taking place at a central location in flint, michigan.

african americans develop and die from sars-cov-2 infection more than any other racial group in the united states, including in majority african american cities such as flint, michigan. addressing these disparities may be aided by sars-cov-2 antibody testing. however, african americans may be reluctant to partake in conventional antibody testing programs due to medical mistrust and experiences with racism. this study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary sars-cov-2 antibody testing. the central hypothesis is that african-americans will be more receptive to antibody testing when benefits and limitations are communicated in a culturally effective manner. our clinical trial aims are to 1) develop and compare effects of a general versus culturally-targeted video about antibody testing on african american and white flint residents' antibody testing attitudes and uptake; 2) identify and compare effects of a general versus culturally-targeted video on activation of medical mistrust and racism-related cognition among african americans when considering antibody testing. in collaboration with clinical and community partners, we have prepared and will evaluate general and culturally-targeted video tutorials about sars-cov-2 antibody testing. these brief videos will be distributed to the flint community through the flint registry - a highly visible local health resource exchange. we will furnish an opportunity to engage salivary antibody screening and measure willingness to participate. in this study iteration, we will consider willingness to participate in a drive-up saliva sample collection that is taking place at a central location in flint, michigan.

Eligibility criteria:
inclusion criteria: * african american or white, 18 or older, and enrolled in the flint registry exclusion criteria: * all who do not meet inclusion criteria.

Keywords: sars-cov-2 covid-19 health disparities health communication antibodies
cares: a mobile health program for alcohol risk reduction

Conditions: Alcohol Abuse

Summary: in this fast-track sttr, phase 1 will develop and test a mobile phone app among 40 adult community college students. the app is designed to reduce risky drinking behaviors and improve user safety. in phase 2 the app ("cares") will be tested with 200 adult community college students who drink alcohol. participants will be randomly assigned to the "cares" app or an alcohol education control condition and will use the app for 12 weeks. six month outcomes will assess changes in drinking related behaviors.

this sttr builds on our successful pilot that developed a text message-delivered alcohol intervention for, and in collaboration with ccs. phase i will develop and test a smart phone application (the "cares" app) incorporating the text message program with additional features and functionality requested by students in the pilot trial (aim 1.1). after obtaining user feedback (aim 1.2) programming will be completed in both ios and android languages. to ensure that the college alcohol risk education system (cares) is well positioned to get into the community college marketplace, it is critical to demonstrate efficacy. phase 2 will conduct an efficacy trial of cares compared to a competing alcohol education program that would be feasible for most community colleges to adopt, thus providing a real-world comparison with data suitable to support future efforts toward commercialization. this study will also identify the types of individuals for whom cares is more/less effective and identify how it might be improved.

Eligibility criteria:
inclusion criteria: * currently enrolled community college student * at least 2 heavy drinking episodes in past 2 weeks at recruitment * own smart phone exclusion criteria: * alcohol abuse disorder or currently in treatment for alcohol-related problems
temozolomide combine with intensity modulated radiation therapy with simultaneous integrated boost for non small cell lung cancer brain metastases

Conditions: Non Small Cell Lung Cancer Metastatic

Summary: with the improvement of systemic therapeutic effect(especially in the population with driver gene mutation), the incidence of brain metastases had significantly increased. conventional whole brain radiotherapy(wbrt) was less effective, the stereotactic radiosurgery(srs) technique had improve the local efficacy for 1-3 lesions, but the probability of intracranial recurrence was increased, intensity modulated radiation therapy with simultaneous integrated boost(sib-imrt) is a new radiotherapy technology, giving a standard radiation dose of whole brain ,at the same time can boost the high-risk region in target, so that it can significantly shorten the treatment time, at the same time can improve the local control rate of brain metastases. in the aspect of normal tissue protecting, sib was better than wbrt plus srs sequential treatment pattern. 30gy to the whole brain had a negative effects on cognitive function, the investigators previous study found that 25gy to the whole brain while the tumor bed simultaneous push to 50gy was safe and effective, while reducing the impact on cognitive function. hippocampus is a part of the brain located in the temporal lobe, mainly responsible for long-term memory storage conversion and orientation. many investigators point out that hippocampus is the main commander of neurocognitive function, reduce the dose of hippocampus can significant improve the neurocognitive function. temozolomide capsule is an anti-tumor alkylation agent for glioblastoma multiforme and anaplastic astrocytoma. in recent years, some researchers find that temozolomide capsules combine with radiotherapy such as srs, wbrt or the two combined, can improve objective response(or) and prolong the progress free survival(pfs),while with tolerable therapeutic toxicity. in order to better reduce the impact on cognitive function and improve the local control rate, the investigators present this trial, under the sib-imrt technique, the investigators want to explore the effect of temozolomide in brain metastasis of non-small cell lung cancer with the hippocampal protection technology.


Eligibility criteria:
inclusion criteria: 1. patients must have an estimated survival of at least 4 weeks 2. karnofsky performance status scale (kps) of 60-100. 3. patients' laboratory values had to meet these restrictions: hemoglobin\>8 g/dl, platelets\>70\*109/l, white blood cells\>4\*109/l. 4. patients must sign a study specific informed consent form prior to study entry exclusion criteria: 1. patients had major medical illnesses or psychiatric impairments which will prevent completion of the protocol therapy 2. had received previous brain irradiation 3. could not be regularly followed 4. with leptomeningeal involvement
subgingival microbiota following mechanical treatment and it's effect on peri-implant sub-mucosa in periodontitis patients

Conditions: Aggressive Periodontitis, Generalized

Summary: the investigators planed to observe the microbiome of an aggressive periodontitis patient, during mechanical treatment, surgery(if indicated) and implant placement. the investigators designed to observe the changes after mechanical treatment.then, the investigators will compare the sub-mucosa microbiome of implant and the subgingival community. the investigators expected a different community after treatment, and there could be similarity between implant and nature teeth.


Eligibility criteria:
inclusion criteria: 1. subjects were between 18-35 years old and diagnosed with generalized aggressive periodontitis (gagp) according to the 1999 international classification of periodontal diseases (armitage 1999); 2. at least 20 teeth in the first appointment and at least 3 teeth(other than first molars and central incisors)with a probing depth(pd) ≥ 6mm, clinical attachment level (cal)≥5mm; 3. the clinical diagnosis was confirmed by evidence of inter-proximal bone loss on full-mouth periapical radiographs; 4. family history of aggressive periodontitis. exclusion criteria: 1. uncontrolled systemic conditions including diabetes and hypertension; 2. pregnant or lactating; 3. smoking; 4. received periodontal treatment within the previous 6 months or antibiotic medication during the previous 3 months.

Keywords: mechanical treatment implant