Kornimate/medical-research-clean huggingface dataset:
patient priorities for survivorship care in older breast cancer survivors

Conditions: Breast Cancer Survivorship

Summary: the objective of this study is to adapt the patient priorities care (ppc) framework to breast cancer survivorship via a user-centered approach, through an iterative process in which patients and their physicians help to refine and modify the intervention. a second objective is to evaluate the feasibility and effectiveness of the adapted ppc framework in breast cancer survivorship for older adults.

in the proposed project, we will use a patient priorities care framework to explore older breast cancer survivors' priorities and health care preferences for high-quality breast cancer survivorship. the framework will include two components: (1) a health priorities identification session with a facilitator, and (2) an encounter with the oncology provider to discuss changes in the patient's care plan to align it with his/her priorities. our overall hypothesis is that prioritizing patients' priorities is feasible and facilitates individualized survivorship care for older women with breast cancer and multiple chronic conditions. an advisory panel composed of oncologists, geriatricians, and patient advocates will provide regular feedback throughout the refinement and adaptation of the patient priorities care framework to the breast cancer survivorship context and engage in an iterative process of development. after incorporating feedback from the stakeholder panel to create an adapted version of the framework, we will carry out a randomized quality improvement project with the objective of evaluating the feasibility of using the framework in the context of breast cancer survivorship and provide empirical estimates of treatment effect sizes by measuring treatment burden and quality of life at 3 months, adherence to basic and priorities driven survivorship care recommendations at 12 months. ultimately, the results of this project will provide initial direction for intended improvement, which will be verified in a larger, future trial.

Eligibility criteria:
inclusion criteria: * able to write and speak english * stage dcis/i/ii/iii breast cancer diagnosis * 3 months from active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment) up to 10 years since completing treatment * ≥3 documented comorbidities by chart review, or taking ≥10 medications, have ≥ 1 hospitalization over the past year, ≥ 2 emergency department visits over the past year, seen by \> 2 specialists over the past year * able to provide consent exclusion criteria: * currently on active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment)

Keywords: patient priorities survivorship care
submandibular gland stem cell transplantation

Conditions: Head and Neck Cancer

Summary: this study is a phase i safety and feasibility study to treat head and neck cancer patients with autologous salivary gland stem cell transplantation after postoperative (chemo)radiotherapy.


Eligibility criteria:
inclusion criteria: * squamous cell carcinoma (scc) originating from the mucosa of the oral cavity; * primary resection of tumour including an electively or therapeutic ipsilateral neck dissection (at least levels ib to iii, including the submandibular gland). * postoperative radiotherapy or chemoradiation, including prophylactic or therapeutic irradiation of the contralateral side of the neck (where the remaining submandibular gland is), including at least levels ib to iv), next to irradiation of the tumour bed and ipsilateral neck (current standard); * age ≥ 18 years; * who performance 0-2; * written informed consent; exclusion criteria: * primary (definitive) radiotherapy, with or without systemic treatment; * previous radiotherapy of the head and neck region (re-irradiation); * positive microbiological screening for human immunodeficiency virus type 1 and 2, hepatitis b and c virus and treponema pallidum. * presence of systemic disease known to affect salivary gland functioning (e.g., sjögren's syndrome); * known allergy to mice and gentamicin * history within the past five years of malignancies other than: * basal or squamous cell carcinoma of the skin * in situ carcinoma of the cervix; * females who are pregnant or lactating at entry.

Keywords: radiotherapy cell transplantation stem cell therapy
free hiv testing in private biological laboratories: a new offer to encourage hiv testing

Conditions: HIV Seropositivity; HIV Testing

Summary: the program " au labo sans ordo " aims to increase hiv testing coverage, in order to improve the first stage of the hiv care cascade in paris and the alpes-maritimes, areas facing a much higher hiv epidemic than the other regions in metropolitan france. both departments are engaged in the fast track cities initiative.

the program relies on the hypothesis that the opportunity to get tested for hiv for free (called vihtest) in any private laboratory (pl), without prior appointment nor prescription, combined with an intense targeted promotion and communication strategy, will significantly increase the testing coverage. this offer might remove some of the multiple barriers to hiv testing and ease the move to action, in particular within key affected populations which contribute to the largest part of the epidemic dynamic. this program offers a new access to hiv testing. it is developed jointly by local authorities, the health insurance and state regional health agencies, in response to the very low increase of hiv testing coverage despite a diversification of the testing supply and national recommendations for generalized and repeated hiv testing within key populations. the experimentation will be implemented for 12 months in all private laboratories in paris (164) and the alpes-maritimes (107), targeting a 15% increase in the total volume of tests performed outside of hospital settings. the evaluation process will focus on: axis 1 : the number of tests performed and the number of new hiv diagnosis considering the potential substitution effect towards the current testing provision through cegidd (free centers for information, diagnosis and testing) and community-based outreach testing programs. axis 2 : the linkage to care following an hiv positive test will be organized and documented and the characteristic of hiv+ population diagnosed after vihtest will be describe (also_parcours) axis 3: the characteristics of the program's users will be collected and compared 1) to those of pl attendants with a medical prescription for an hiv test and 2) to cegidd clients. axis 4: the feasibility and acceptability of the program by the pl's staff will be documented using detailed qualitative questionnaire; axis 5: the cost-effectiveness of scaling-up such a testing strategy and its budgetary impact will be assessed through a microcoasting evalutation.

Eligibility criteria:
axis 2 inclusion criteria: * major * being diagnosed hiv positive after a vihtest exclusion criteria: * minor

Keywords: hiv testing combined hiv prevention linkage to care implementation plan cost-effectiveness
effect of patient education on drinking behaviour and oral hygiene in patients undergoing bariatric surgery

Conditions: Obesity; Bariatric Surgery Candidate

Summary: the background for the study is that many bariatric surgery patients struggle with their oral health after bariatric surgery. this is probably related to both physiological changes and changes in eating and drinking patterns. in addition, many have reduced oral health even before surgery, and a significant proportion also have dental treatment anxiety, which also affects their ability to seek dental treatment. in sum, this is probably a patient group that may be at risk of oral pathology. participants in the study will be randomly allocated to different patient education programmes. the three interventions are: 1. customised information on a website 2. education delivered by a clinician 3. distribution of free samples relevant to dental hygiene the outcomes recorded are level of knowledge, drinking patterns, self-perceived oral health, and oral hygiene routines.

both caries and periodontitis are more prevalent among people with obesity. at the same time, we know that bariatric surgery is associated with poorer oral health expressed by caries, enamel erosion and short-term increased inflammation in the gums. although we do not yet have evidence to determine causality, we suspect that oral health in bariatric surgery patients is further impaired by both systemic effects (hyposalivation, altered oral microbiome, reflux and vomiting) and by altered eating and drinking patterns after surgery (acid exposure with subsequent demineralisation of tooth enamel). the patient's own diet and oral hygiene can be an opportunity to prevent or slow down such oral problems, but requires personal effort and must be a special focus in patient education. patient education is one of the hospital's statutory duties, but the quality of patient education is rarely systematically investigated. this project investigates the effect of three alternative educational interventions on patients' drinking habits, oral hygiene routines, knowledge level and oral health. the three interventions are a website with adapted patient information, group-based education given by healthcare professionals, and distribution of relevant product samples to maintain oral hygiene. patients are randomised between the different educational interventions.

Eligibility criteria:
inclusion criteria: * eligible for bariatric surgery at a norwegian hospital exclusion criteria: * insufficient language skills * lack of consent competency

Keywords: obesity oral health
an investigational immuno-therapy study of nivolumab compared to temozolomide, each given with radiation therapy, for newly-diagnosed patients with glioblastoma (gbm, a malignant brain cancer)

Conditions: Brain Cancer

Summary: the purpose of this study is to evaluate patients with glioblastoma that is mgmt-unmethylated (the mgmt gene is not altered by a chemical change). patients will receive nivolumab every two weeks in addition to radiation therapy, and then every four weeks. they will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.


Eligibility criteria:
inclusion criteria: * males and females, age ≥ 18 years old * newly-diagnosed brain cancer or tumor called glioblastoma or gbm * tumor test result shows mgmt unmethylated type * karnofsky performance status of ≥ 70 (able to care for self) exclusion criteria: * prior treatment for gbm (other than surgical resection) * any known tumor outside of the brain * recurrent or secondary gbm * active known or suspected autoimmune disease * biopsy with less than 20% of tumor removed other protocol-defined inclusion/exclusion criteria apply
home pt vs force pt

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine if unsupervised, home rehabilitation delivered by a web-based platform or paper manual is a safe and effective alternative to outpatient physical therapy after total knee replacement.


Eligibility criteria:
inclusion criteria: 1. any patient undergoing unilateral, primary tka exclusion criteria: 1. patients without access to the internet 2. patients without access to outpatient pt 3. revision or conversion tka 4. patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.
development of a computerized adaptive test (cat) for evaluation of sleep, fatigue and quality of life in patients with chronic pain

Conditions: Chronic Pain

Summary: the purpose of this study is to evaluate quality of life, sleep and fadigue in patients with chronic pain using an item-response theory methodology and also generating a computer adaptive testing system


Eligibility criteria:
inclusion criteria: be able to read portuguese be able to write portuguese being in treatment for chronic pain exclusion criteria: hearing impairment that impairs ability to respond to tests visual impairment that impairs ability to respond to tests physical impairment that impairs ability to respond to tests cognitive impairment that impairs ability to respond to tests
the very large database of lipids (vldl)

Conditions: Lipid Disorders and Lipid Measurement

Summary: closer examination of granular lipid data in a large population offers numerous opportunities to generate new knowledge, ranging from studies examining concordance between commonly used lipid parameters to phenotypic characterization of rare or extreme disorders of lipid metabolism, opening possibilities to better personalize future treatment of abnormal blood lipids. study population: the very large database of lipids (vldl) includes adults and children who were clinically referred for a vertical auto profile (vap). patient samples originated predominantly from outpatient primary care clinics in the u.s. (85%), along with specialty clinics and inpatient settings. lipid measurements: the vap test (vap diagnostics lab, birmingham, alabama, usa) directly measures cholesterol concentrations of low density lipoprotein, very low density lipoprotein, intermediate density lipoprotein, high density lipoprotein, their subfractions, and lipoprotein(a). triglycerides in the database are directly measured using the abbott architect c-8000 system (abbott park, illinois, usa). lipid distributions in the database closely match those from the population-representative national health and nutrition examination survey (nhanes). study procedures: this database was investigator-initiated. only de-identified data reach the investigational site. the master database is housed at the johns hopkins hospital in baltimore, maryland, and maintained by drs. jones and martin. the current database (2nd harvest) includes 5,051,467 patients whose laboratory samples were collected from october 1, 2015 and june 30, 2019. only electronic data, and not blood samples, are sent to hopkins. the academic investigators have unrestricted access to study data, take responsibility for the accuracy of analyses, and have authority over manuscript preparation and submission. variables: the variables currently in the vldl database are testing date, age, sex, fasting/nonfasting, and components of the vap test. from these primary variables, many additional variables were derived for inclusion in the master database. other analytes measured by validated assays in subsets of the vldl database include apolipoprotein b (apob), apolipoprotein a1 (apoai), high-sensitivity c-reactive protein (hscrp), homocysteine, uric acid, insulin, hemoglobin a1c, 25-hydroxy vitamin d, cystatin c, lipoprotein-associated phosphatase (lp-pla2), thyroid stimulating hormone (tsh), free t3 and t4, pro-brain natriuretic peptide (pbnp), direct bilirubin, creatine phosphokinase (cpk), creatinine and other components of the comprehensive metabolic panel, magnesium, and phosphate.


Eligibility criteria:
patients with age and lipid data are included in the master database. eligibility criteria are specific to each individual study.
biological sling allograft (uvt) for the treatment of urinary incontinence in women presenting with synthetic sling complications

Conditions: Female Stress Incontinence; Stress Urinary Incontinence

Summary: the purpose of this open, multi center trial is to evaluate a new biological replacement for synthetic slings in the treatment of female stress urinary incontinence.

it was estimated that more than 9 million french people are affected by urinary incontinence, of which 1% are treated surgically. indeed, if medical treatment or rehabilitation fails, surgical treatment must be considered. sling implantation is a commonly used surgical technique to treat stress urinary incontinence as it allows for a reduction in surgery time and morbidity and can be placed under local anesthesia. however, the risk of complications associated with the use of synthetic products is high and contributes to the recent decline of popularity of synthetic slings. as the demand for incontinence treatment remains high, fascia autograft surgeries are being proposed, even though they require an additional surgical procedure and expose the patient to complications at the donor site of the graft. the study product aims to address the growing need for a safer but equally effective implant to avoid autografting while keeping the standard surgical technique. the aim of this exploratory study is to evaluate a biological sling replacement to failed synthetic slings in the treatment of female stress urinary incontinence.

Eligibility criteria:
inclusion criteria: * women over 40 years of age and under 75 years of age. * failure of primary surgical technique with synthetic sling requiring its removal due to complications such as vaginal exposure or urinal tract erosion. * inclusion more than 3 months after primary surgery. * any fistula or abnormality of the urinary tract, any erosion or complication due to the synthetic sling placement must be repaired during surgery. in case of persistence of complication or limited possibility to insert the uvt due to major vesical or urethral lesion, the patient will not be included. * patients with controlled urinal tract infections. * patients who received the study information and provided consent. * patients who are members or the beneficiary of a national health insurance plan. exclusion criteria: * breast feeding women or women without effective contraception. in absence of effective contraception, a pregnancy test followed by an effective contraception are mandatories for non-menopausal women. * patients with mild cases treated by physiotherapy and pelvic floor exercises for urinary incontinence or without surgical complications. * patients with current urinary infection, severe anemia or other pathologies that counter-indicate surgery. * cystocele and rectocele not treated during the surgery. * persons under guardianship or confined by a judicial or administrative decision. * patients unable to have discernment for rehabilitation, unable to perform follow-up or unable to provide their consent.
orbicularis oris z-plasty modification of modified millard technique and the esthetic outcome of cleft lip repair

Conditions: Cleft Lip

Summary: this study aimed to evaluate the effect of orbicularis oris muscle z-plasty modification of modified millard technique on the esthetic outcome and length of the repaired lip

forty patients with a unilateral cleft lip will be enrolled in this randomized comparative study. the patients will be divided into two groups, the control (group a) who treated with the modified millard technique and the study group who repaired by orbicularis oris muscle zplasty modification of modified millard technique (group b).

Eligibility criteria:
inclusion criteria: * non-syndromic cleft lip patients. * primary, unilateral, complete or incomplete cleft lip. * the patient's age is younger than six months. * lip repair performed by one craniofacial surgeon exclusion criteria * syndromic cleft lip. * secondary lip treatment (previously operated cases) * bilateral cleft lip * patients are older than six months. associated cardiac anomalies. any systemic condition

Keywords: cleft lip chelioplasty modified millard orbicularis oris modification
influence of the implant connection on facial tissues maturation

Conditions: Bone Loss; Periodontal Bone Loss; Implant Tissue Failure

Summary: the substitution of a tooth with a fixture often induces undesired morphological changes, resulting in a deterioration of the aesthetic appearance. the purpose of this study is to compare the soft tissue behavior next to two different implant connections: 5° (group 1) and 35° hexed (group 2), conical, internal with switching platform design after 12 months of functional provisionalization


Eligibility criteria:
inclusion criteria: * missing teeth * good oral hygiene * good systemic health exclusion criteria: * lactation * pregnancy * heavy smoking (more than 20 cigarettes/day) * severe medical conditions that could affect periodontal health and peri-implant tissue response * use of drugs correlated to periodontal hypertrophy * bone volume that required bone augmentation procedures before implant placement as well as soft tissue graft or any kind of peri-implant tissue engineering
sensitivity of extended cultures in diagnosing urinary tract infections

Conditions: Overactive Bladder; Overactive Detrusor; Urgency-Frequency Syndrome; UTI

Summary: there is some evidence to suggest standard urine cultures may not be adequate in identifying patients with low grade urinary tract infections. therefore, there are patients with symptoms of frequency and urgency, being misdiagnosed with overactive bladder due to negative urine cultures. if this is true, could extended cultures be used to identify the false negative patients?

in 2014, hilt, evann et al published a study called "urine is not sterile," in which it was found via pcr and extended urine cultures, there is a microbiome that exists within the urinary bladder. in this study, 92% of the bacteria failed to be identified by a standard urine culture but 80% were identified with extended urine cultures. in further explorations of the significance of this microbiome, pearce, meghan et al. found that the female bladder consists of increased abundance of bacteria in patients with uui; including gardnerella and lactobacilus gasseri. then in 2015, a study by thomas-white, krystal et al. found that patients with urge urinary incontinence (uui) who responded to treatment with solifenacin had fewer and less diverse communities of bacteria when evaluated by pcr and extended urine cultures. the clinical significance of the bacteria identified is not well understood. however, these studies show that the presence of bacteria is being missed by standard cultures. dune et al. found that of patients with uti symptoms, 27.5% were standard culture negative but extended quantitative urine culture positive. this demonstrates that practitioners may be overlooking urinary tract infections in patients with frequency and urgency. therefore, if bacteria within the urine can be detected with extended cultures, can this technique be used to improve detection and treatment of urinary infections in patients with symptoms of frequency and urgency? the hypotheses states that extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency. the secondary hypothesis is that treatment of the uropathogen identified on extended urine cultures will improve patient symptoms.

Eligibility criteria:
inclusion criteria: * 18 y/o-70 y/o * able to consent * urgency /frequency * urge incontinence * puf score ≤ 4 * bother questionnaire #2 or #3 answered either "a moderate amount" or "a lot" exclusion criteria: * pregnant * pelvic radiation * chronic pelvic pain * urinary retention * greater than stage 2 prolapse * renal calculi * recurrent uti (2 in 6 months) * immunosuppressed * neurologic disorder * no antibiotics in the past 4 weeks

Keywords: overactive bladder overactive detrusor urgency-frequency urinary tract infection