Kornimate/medical-research-clean huggingface dataset:
client centred 'tune-ups': do they enhance community reintegration after stroke?

Conditions: Stroke

Summary: once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation. there is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function. the purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.

the extent to which impairment (physical capacity) and function influence community reintegration is unclear. one of the challenges is that physical parameters change over time as does the person's awareness and perception of what activities are important to be able to engage in at the community level. interventions have led to gains in physical capacity, function and community reintegration, but the benefits have been shown to dissipate within three to six months. it has been suggested that maintenance therapy (tune-ups) for stroke survivors post-discharge could prevent or curtail decline in function of aging stroke survivors and enhance quality of life and well being; constructs that relate strongly to community reintegration. this study will determine whether tune-ups can alter the time course and magnitude of changes in physical capacity and function and their influence on community reintegration. stroke survivors discharged from rehabilitation will be followed for a 15 month period with laboratory or home assessments conducted at 3 month intervals. assessors will be blind to whether the subject is receiving a tune up. evaluations conducted after the tune-up at 9 months and 12 months post-discharge will allow us to determine if the tune-up effectively reduced physical impairment, improved function and resulted in better community reintegration compared to control.

Eligibility criteria:
inclusion criteria: * first major unilateral hemispheric stroke, * english speaking, * adequate verbal communication, * discharged home or residential care exclusion criteria: * serious comorbidities (eg. cancer, mobility limiting arthritis, leg amputation)

Keywords: mobility strength balance function reintegration community
assessing optimal xr-buprenorphine initiation points in jail

Conditions: Opioid Use Disorder

Summary: the goal of this study is to compare two approaches for commencing pharmacotherapy with injectable buprenorphine for opioid use disorder (oud) among jail inmates: (1) at the time of admission or (2) shortly before release. a sample of eligible inmates with sentences of less than 180 days will be randomly assigned to (1) initiating extended-release buprenorphine (xr-b) treatment at the time of admission (n=80), or (2) initiating xr-b treatment within 30 prior to their scheduled release date (n=80). the groups will be compared with regard to (1) how likely they were to participate in treatment, (2) levels of in-jail opioid use (via post-release interviews), (3) continuation of pharmacotherapy and other oud treatment in the community, and (4) levels of opioid use 4 and 12 weeks following discharge (self-report and incentivized voluntary urine tests).


Eligibility criteria:
inclusion criteria: 1. incarcerated adults able to provide written informed consent in english. 2. currently sentenced with pending release date between 3-7 months. 3. current moderate-to-severe opioid use disorder (dsm-5) 4. reasonable likelihood of completing 3-months or longer of community treatment (i.e., no plans to be transferred out of state or to another correctional facility) 5. willing to accept being randomized to initiating xr-b treatment at the time of jail admission or near the time of release. exclusion criteria: 1. severe medical or psychiatric disability making participation unsafe or regular follow-up unlikely, including patients with pre-existing moderate to severe hepatic impairment are not eligible to participate 2. pregnancy, planning conception, or breast-feeding 3. allergy, hypersensitivity or medical contraindication to either medication 4. chronic pain requiring opioid pain management 5. on methadone or buprenorphine (sl-b) maintenance prior to incarceration and intending to remain on methadone or buprenorphine maintenance upon return to the community.

Keywords: xr-buprenorphine sublocade medication for opioid use disorder (moud)
the use of artificial intelligence generated contours in radiation planning of the prostate brachytherapy

Conditions: Prostate Cancer

Summary: this study is investigating how ai can help doctors outline the prostate on an ultrasound image to make a custom radiation plan during a specialized type of radiation treatment for prostate cancer called brachytherapy.

this is a phase ii prospective study evaluating the standard u-net, a deep learning ai algorithm for auto-contouring of the prostate during hdr prostate brachytherapy with the needles in place by new learners. contouring will be done on trus. the study will be conducted with a randomized design. each patient will be assigned to a new learner and then randomized to manual versus ai-assisted contouring. the randomization will be stratified by new learner type: resident versus fellow/new attending. the hypothesis is that ai-assisted learner contours will have improved dice coefficients with respect to clinically approved contours compared with manual learner contours. all brachytherapy contours will undergo review by the treating radiation oncologist who is the experienced clinician for clinical approval prior to patient treatment. the experienced clinician will be blinded to the randomization.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * deemed suitable candidates for whole gland hdr prostate brachytherapy under general anesthesia as a monotherapy, boost or salvage treatment. exclusion criteria: * prior permanent seed ldr brachytherapy implant * prior transurethral resection of the prostate (turp) * presence or insertion of a rectal spacer * focal hdr brachytherapy treatment i.e. not whole prostate
living with long covid: longcovid-experience

Conditions: Long COVID; Experience, Life

Summary: background: one in ten people infected with covid-19 presents persistent covid, which consists of the presence of symptoms three months after the acute manifestations of covid-19 and their persistence for at least two months, without being explained by an alternative diagnosis. the characteristics and clinical approach to persistent covid syndrome are fairly well known, but not what the experience of people with persistent covid is in relation to their daily life, their work life, and their experience with the healthcare received. objective: to understand the experience of patients with persistent covid in relation to the disease, the health care received and re-entry into the world of work methods: qualitative, descriptive, phenomenological study, based on individual interviews. the study protocol will be registered in clinicaltrials.gov. people with persistent covid treated at the parc taulí hospital will be included. sampling will be by convenience, purposive and snowball and the sample size will be determined by data saturation. semi-structured individual or group interviews will be conducted and the data will be analyzed following a reflective thematic analysis (brawn and clarke). the preliminary report will be triangulated with some participants and with the results obtained from a scoping review carried out by the research team.


Eligibility criteria:
inclusion criteria: * women and men diagnosed with persistent covid between march '20 to the present according to who criteria (persistent symptoms three months after the acute manifestations of covid-19 and lasting at least two months and cannot be explained by an alternative diagnosis). * treated at the parc taulí hospital * from 18 to 65 years exclusion criteria: -people who do not understand or can communicate in catalan or spanish.

Keywords: post-acute covid-19 syndrome patient experience qualitative research
klotho gene polymorphism in dialyzed patients with hyperphosphatemia

Conditions: Chronic Kidney Disease; End Stage Renal Disease; Hyperphosphatemia; Renal Osteodystrophy

Summary: patients with chronic kidney disease (ckd) and those with end-stage renal disease (esrd) undergoing renal replacement therapies show elevated serum phosphate levels which predispose them to cardiovascular calcifications and high risks of death from cardiovascular diseases. however, in certain patients hyperphosphatemia is not related to dialysis insufficiency, excessive daily dietary phosphorus intake or high serum parathyroid hormone (pth) levels, suggesting that other mechanisms could be involved. transgenic mice lacking the klotho gene showed a phenotype which resembles that of dialyzed esrd patients, in the sense that they have hyperphosphatemia, vascular calcifications, and a short lifespan. this study will analyze whether functional polymorphisms or variants in the human klotho gene are associated with hyperphosphatemia in these patients.

the entire coding region of the klotho gene will be sequenced looking for functional variants and polymorphisms that differentiate two groups of adult dialyzed esrd patients, matched for age and gender, and with comparable values for dialysis dose and daily protein intake. these two groups consist of one group of 20 adult, dialyzed patients with serum phosphate levels \> 2.50 mm compared to another group of 20 adult, dialyzed esrd patients with serum phosphate levels \< 1.50 mm. the results of this study will allow to determine whether there is a relationship between extreme hyperphosphatemia and klotho gene polymorphisms in dialysed esrd patients.

Eligibility criteria:
inclusion criteria: group 1 * stable hemodialysis patients for at least 3 months * phosphatemia \> 2.5 mm * kt/v \> 1.2 * total weekly phosphate removal \> 75 millimoles group 2 * stable hemodialysis patients for at least 3 months * phosphatemia \< 1.5 mm * kt/v \> 1.2 * total weekly phosphate removal \> 25 millimoles exclusion criteria: * age \> 80 years * insufficient dialysis dose (kt/v \< 1.2) * total weekly phosphate removal \< 25 mm * problems with vascular access for hemodialysis (central catheter, arteriovenous \[a-v\] fistula dysfunction) * methods of dialysis different than the classical hemodialysis (peritoneal, hemofiltration, or hemodiafiltration with or without acetate) * intolerance or allergy to arylane m9 dialyzers * hypocalcemia \< 2.0 mmol/liter * hypophosphatemia \< 0.6 mmol/liter * daily protein intake \< 0.6 g/kg/j * parathyroidectomy at least 3 months prior to the study * evolutive neoplasia with or without secondary lytic bone lesions * intestinal malabsorption * alcoholism * corticotherapy * treatment by bisphosphonates, fluor or recombinant pth * malnutrition (body mass index \[bmi\] \< 15) * amputation of lower members (\> 10% of total body) * prolonged immobilization * secondary hyperparathyroidism (pth \> 1400 pg/ml) * vitamin d deficiency (25ohd3 \< 10 ng/ml)

Keywords: phosphate dialysis klotho hemodialysis
monoclonal antibody plus chemotherapy in treating patients with metastatic breast cancer that overexpresses her2

Conditions: Breast Cancer

Summary: rationale: monoclonal antibodies such as trastuzumab can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. drugs used in chemotherapy use different ways to make tumor cells stop dividing so they stop growing or die. combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of trastuzumab plus paclitaxel in treating patients who have metastatic breast cancer that overexpresses her2.

objectives: * determine the pharmacokinetics and pharmacodynamics of trastuzumab (herceptin) and paclitaxel in patients with her2-overexpressing metastatic breast cancer. * provide access to trastuzumab and paclitaxel for these patients. outline: patients receive trastuzumab (herceptin) iv over 30-90 minutes and paclitaxel iv over 1 hour weekly. patients receive trastuzumab alone during course 1 and then in combination with paclitaxel during subsequent courses. courses repeat every 4 weeks until patients achieve a sustained complete response of 8 weeks or disease progression occurs. projected accrual: a total of 55 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed metastatic breast cancer with her2 overexpression * radiographically or physically measurable disease that can be biopsied safely under local anesthesia * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * male or female menopausal status: * not specified performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * neutrophil count at least 1,000/mm\^3 * platelet count at least 75,000/mm\^3 hepatic: * bilirubin no greater than 3 times upper limit of normal (uln) * ast and alt no greater than 5 times uln renal: * not specified other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no prior trastuzumab chemotherapy: * not specified endocrine therapy: * at least 2 weeks since prior hormonal therapy * no concurrent hormone receptor therapy (e.g., tamoxifen or armidex) radiotherapy: * localized palliative external beam radiotherapy allowed surgery: * not specified other: * concurrent bisphosphonates allowed

Keywords: stage iv breast cancer male breast cancer
the effect of facial exercise on the appearance of aging

Conditions: Aging

Summary: this study seeks to evaluate the effects of facial exercises on aging of the face.


Eligibility criteria:
inclusion criteria: * aged 40-65 years * no significant medical illness * no chronic smokers * subject with mild to moderate facial atrophy * subjects who provide and interest and who understand the importance of consistently executing the program daily. * subjects with the willingness and ability to understand and provide informed consent. exclusion criteria: * under 40 years of age, over 65 years of age * pregnant or lactating * subjects who have ever had any invasive cosmetic procedure, including facelifts, neck lifts, laser resurfacing, dermabrasion, or liposuction * subjects who have non-invasive or minimally invasive cosmetic procedures, such a non-ablative lasers, medium-depth or deeper chemical peels, injectable neurotoxins or fillers, within the past year. * subjects who have used topical or oral retinoids within the past year.
aromatherapy for reducing labor pain

Conditions: Pain

Summary: pregnant women who eligible with inclusion criteria are random to two groups. aromatherapy group will receive the aromatherapy during labor along with standard pain control. non-aromatherapy group will receive standard pain control during labor


Eligibility criteria:
inclusion criteria: * singleton pregnancy * nulliparous * 37 complete weeks of gestation * cephalic presentation * no emergency obstetric complication * in labor exclusion criteria: * medical or obstetric complication preclude vaginal delivery * essential oil allergy * side effect of aromatherapy
penthrox in rezūm bph

Conditions: Pain; BPH

Summary: open-labeled, single-centre study

patients who have elected convective thermal therapy using rezūm system for the management of their bph and fulfilled inclusion and exclusion criteria will sign informed consent form for the study. patient will use methoxyflurane inhaler (penthrox™) on top of standard oral analgesia including oral lorazepam, oral percocet® (oxycodone and acetaminophen) or oxycodone immediate-release, and intra-urethral lidocaine gel (xylocaine®). intravenous propofol will be used as rescue analgesia.

Eligibility criteria:
inclusion criteria: * male subjects of ≥ 18 years of age * patient who has elected convective thermal therapy using rezūm system for the management of their benign prostatic hyperplasia. * no contra-indication on using methoxyflurane inhaler (penthrox™). * willing and able to accurately complete the required questionnaires. * willing and able to provide signed and dated informed consent. exclusion criteria: * ongoing use of analgesic agents for chronic pain. * concomitant use of nephrotoxic agents. * inr \> 4. * use of methoxyflurane inhaler (penthrox™) within the previous 3 months. * known allergy to lorazepam, percocet/ oxycodone, or xylocaine® gel. * known personal or familial hypersensitivity to methoxyflurane inhaler (penthrox™) or other halogenated anesthetics. * clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment. * an altered level of consciousness, due to any cause, including head injury, drugs, or alcohol. * known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives. * a history of liver dysfunction after previous methoxyflurane inhaler (penthrox™) use or other halogenated anesthetics.
evaluation of autonomic system before and after anticholinergic treatment in women with overactive bladder

Conditions: Overactive Bladder

Summary: the aim of the study is to evaluate changes in autonomic nervous system following treatment with anticholinergic medication for oab symptoms. heart variability as a measure of the functioning of the autonomic nervous system will be recorded before and three months following treatment with solifenacin succinate 10 mg daily.

30 women with clinical diagnosis of overactive bladder will be recruited for the study. an ecg strip for fifteen minutes at rest will be recorded through a 12-bit analog/digital data acquisition card (national instruments, austin tx) with a sampling frequency of 200 hz and stored in a computer for offline studies. the digitized ecg signals will than processed and analyzed via dedicated robust software to detect the r wave peaks. the r point of each qrs complex was defined and the interval between two consecutive r points (the r-r interval) was computed. all r-r intervals will be visually inspected and manually edited if necessary to exclude background noise and artifacts. the edited segments accounts for less than 1% in each patient. a "clean" 2-5-min segment (preferably unedited) will be used for the analyses. an autoregressive model with the order of 16 was will be used to estimate the power spectrum densities of hrv. the power spectra are quantified by measuring the area under the following frequency bands: low-frequency (lf) (0.04-0.15 hz) known to represents sympathetic activity, and high-frequency (hf) (0.15-0.4 hz) which represents parasympathetic activity.

Eligibility criteria:
inclusion criteria: clinical diagnosis of oab exclusion criteria: 1) stress urinary incontinence and voiding symptoms, 2) pregnancy, 3) pathological conditions that can interfere with the ans, (e.g. coronary heart disease, heart failure, or other cardiac conditions, hypertension, neurological diseases or diabetes , 4) medications that can interfere with the ans, including beta-receptor agonists or antagonists, antiarrhythmic agents or antihypertensive drugs, anticholinergic agents or adrenergic alpha-antagonists, tricyclic or serotoninergic antidepressants.

Keywords: heart rate variability, anti cholinergic medication
a clinic-based prevention program for families of depressed mothers

Conditions: Depression; Attention Deficit Disorder With Hyperactivity; Conduct Disorder

Summary: this study will assess the effectiveness of the "keeping families strong" program (kfs) in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

children of depressed mothers are at high risk for developing serious psychiatric disorders. while genetics can account for about 34% of cases of childhood psychiatric disorders, children of depressed parents are at an even greater risk of developing mental disorders. the "keeping families strong" program, or kfs, was built from evidence-based prevention programs. its goal is to provide educational, cognitive, and behavioral interventions. these interventions are meant to enhance understanding about depression and its effects on families, improve communication within families, enhance social support, increase positive and consistent parenting, and improve child coping. this will likely improve the children's mental health, as well as positively affect the short- and long-term outcomes of parents recovering from a depressive episode. this study will evaluate the effectiveness of the kfs program in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers. this 10-week, open-label program will involve 12 meetings, lasting 2 hours each. the parents and the children will attend separate meetings each week on the same nights. children are prone to take on their parents' responsibilities to prevent them from becoming depressed. in order to avoid this, the children's meetings will focus on clarifying role responsibilities. there will be two additional follow-up meetings in the 3 months following completion of the program. all caregivers are encouraged to participate, including depressed fathers.

Eligibility criteria:
inclusion criteria: * parent in treatment for depression * parent in maintenance phase of treatment exclusion criteria: * active substance abuse * substantial cognitive impairment * psychosis

Keywords: depression child disruptive behavior family functioning
therapy of metastatic breast cancer with paclitaxel and liposomal doxorubicin

Conditions: Metastatic Breast Cancer

Summary: today metastatic breast cancer is regarded as cureless. the treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.

breast cancer is the most common malignancy of females. in germany about 46,000 women come down with breast cancer yearly. present therapies cannot cure the metastatic disease, the main focus is improvement of quality of life and prolongation of life. it is therefore necessary to test new substances and/or new combinations and therapy concepts. among the most active cytotoxic agents used in advanced breast cancer are the anthracyclines. since conventional anthracyclines are often used as adjuvant or neoadjuvant therapy their cardiotoxicity restricts their use in the therapy of the advanced disease. liposomal encapsulated doxorubicin shows better activity than conventional doxorubicin combined with reduced cardiotoxicity. weekly applied cytotoxic agents show a better toxicity profile and hence the cumulative dosis can be increased. it is expected that the combination of liposomal encapsulated doxorubicin with paclitaxel given weekly shows improved results in the therapy of metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * women \>/= 18 years with histologically proven metastatic breast cancer * no prior chemotherapy in the advanced situation * ecog \</= 2 * adequate bone marrow reserve * left ventricular ejection fraction (lvef) \>/= 50, measured within 4 weeks before study treatment * existence of written informed consent exclusion criteria: * previous high dose therapy with stem cell support * prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² epirubicin, 300 mg/m² doxorubicin, 80 mg/m² mitoxantrone * concomitant hormon- or chemotherapy or radiation therapy * her2/neu overexpression * pregnancy or breast feeding