Kornimate/medical-research-clean huggingface dataset:
timely integration of palliative care in oncology care for patients referred for palliative radiotherapy on bone metastases: a randomized trial

Conditions: Bone Metastases in Subjects with Advanced Cancer; Radiotherapy

Summary: rationale: with improvements in systemic tumour-directed treatments for primary tumours, survival rates for patients with bone metastases are improving. however, individual illness trajectories become less predictable and more vulnerable to adverse events from treatments, negatively impacting a patient's quality of life (qol). palliative care is aimed at reducing symptoms and improving qol for patients with incurable diseases through early identification, thorough assessment, and effective management of physical, psychological, social, and spiritual challenges. early integration of specialist palliative care into oncology care has shown to reduce symptom burden and potentially inappropriate end-of-life care, and to enhance qol, yet it is often initiated late. objective: the primary objective is to evaluate the satisfaction with care and qol experienced by patients with bone metastases who are offered a consultation with the hospital palliative care consultation team (pcct) when referred for palliative radiotherapy compared to patients who receive standard of care. study design: a prospective, pragmatic, two-arm multicenter randomized controlled trial within the prospective evaluation of interventional studies on bone metastases (present+) cohort that follows the trials within cohorts (twics) design. study population: patients with bone metastases referred for palliative radiotherapy who have their treating physician in one of the participating centers and have not been in contact with the hospital pcct before. intervention: a consultation with the hospital pcct within two weeks after inclusion in present+. in the standard of care control group, no consultation with the pcct will be scheduled. they may have a consultation during follow-up if referring physicians may consider a consultation appropriate, or when patients themselves feel they want a referral. main study parameters/endpoints: satisfaction with care (affective behavior) four weeks after inclusion in present+.


Eligibility criteria:
inclusion criteria: 1. broad informed consent for present+ (i.e., consent for filling out questionnaires at regular intervals and randomization into future intervention studies), and 2. having their treating physician in the tipzo-rt study site (umc utrecht, radboudumc or lumc). exclusion criteria: 1. not able to understand the objective of the study (in dutch), 2. cognitive impairment or dementia, and 3. has been in contact with palliative care consultants of the hospital pcct before.

Keywords: palliative care bone metastases radiotherapy advanced cancer quality of life quality of care
taxus® element™ paclitaxel-eluting coronary stent system european post-approval surveillance study (te-prove)

Conditions: Coronary Heart Disease

Summary: the goal of the taxus™ element™ paclitaxel-eluting coronary stent system european post-approval surveillance study is to evaluate real world clinical outcomes data for the taxus™ element™ coronary stent system in unselected patients in routine clinical practice.

a prospective, open label, multi-center observational study with an all-comers enrollment approach of approximately 1000 subjects at up to 50 sites in europe.

Eligibility criteria:
inclusion criteria: * according to instructions for use exclusion criteria: * contraindications according to instructions for use

Keywords: drug eluting stents observational all-comers
practice experiences for school reintegration

Conditions: Suicide

Summary: this study is developing and refining a novel virtual reality (vr) supplement for inpatient treatment: the practice experiences for school reintegration (presr) program. the presr will provide immersive school experiences for inpatient adolescents (with suicidal-related admissions) to practice skills in real-world settings with the guidance of a trained clinician within the confines of a hospital. this pilot study follows a multiphase optimization strategy (most) to conduct a pilot optimization trial of the presr to inform the feasibility of training clinicians, the ability to recruit adolescent inpatient participants, and management of experimental conditions. this study is not powered to test hypotheses; however, in addition to assessing feasibility and acceptability, this pilot trial will assess candidate intermediary and outcome measures.

this study follows a multiphased optimization (most) research design; this clinical trial is considered to be a pilot optimization component of the most framework. for the present study, a prospective sample of adolescents hospitalized for suicidal thoughts and behaviors will be randomly selected into one of 8 experimental conditions (n=5-6 per group). although the intervention for the pilot optimization trial will be implemented by a member of research staff, this study will also aim to recruit 2-5 clinicians to deliver the full intervention to a separate sample of adolescent patients to inform acceptability and feasibility of the intervention within their clinical workflow.

Eligibility criteria:
inclusion criteria: adolescent participants: * current hospitalization for suicidal thoughts and behaviors * ages 13-18 * expected return to school following discharge * ability to speak, read, and understand english sufficiently to complete study procedures, * consent of a parent/legal guardian (in english or spanish; for minor participants) * adolescent assent or consent (in english) * clinician approval. hospital professionals: * works as a clinician at the hospital site who delivers treatment including cbt to hospitalized adolescents, * hospital professional consent (in english) * consent of patient's parent/legal guardian (in english or spanish; for minor participants) * adolescent patient assent or consent (in english). exclusion criteria: adolescent participants * evidence of active psychosis, * evidence of intellectual disability * risk for cyber-sickness (greater than or equal to 50th percentile as measured on the motion sickness susceptibility questionnaire)
treatment-related quality of life and patient-centred care with infertility

Conditions: Patient Centred Care; Compliance, Treatment; Infertility, Female; Quality of Life

Summary: this study was conducted in a cross-sectional descriptive type with 160 infertile women who were treated in the ivf clinic of a university hospital between july - october 2020 in order to evaluate the effect of patient-centered care approach in infertility on treatment-related quality of life. the data of the study were collected face to face through the "introductory information form" "patient centered care form for infertile women" and "fertiqol treatment module".


Eligibility criteria:
inclusion criteria: * diagnosed with infertility * has no commnunication problems exclusion criteria: * communication problems (e.g language) * diagnosed by diseases with reproductive problems but not infertility

Keywords: patient centred care fertiqol infertility quality of life nursing
evaluate the effects of patupilone on the pharmacokinetics and pharmacodynamics of warfarin in patients with advanced malignancies

Conditions: Advanced Malignancies

Summary: to evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.


Eligibility criteria:
inclusion criteria * age ≥ 18 years of age * life expectancy ≥3 months * histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist * agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study exclusion criteria * history of/or active bleeding disorders * known hypersensitivity to warfarin or related compounds * the use of vitamin k * central lines that require anticoagulant maintenance * the use of agents containing warfarin and heparin * known diagnosis of human immunodeficiency virus (hiv) infection, hepatitis other protocol-defined inclusion/exclusion criteria may apply

Keywords: cancer epo patupilone solid tumors advanced malignancies
pharmacokinetics of sildenafil orally disintegrating tablet formulation given with or without food.

Conditions: Erectile Dysfunction

Summary: this study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.


Eligibility criteria:
inclusion criteria: * otherwise healthy male subjects age 45 years or older with or without erectile dysfunction. * body mass index (bmi) of 17.5 to 32.5 kg/m2. * signed informed consent. exclusion criteria: * evidence or history of clinically significant abnormalities * have baseline orthostatic hypotension * positive drug screen, excessive alcohol and tobacco use

Keywords: bioavailability food effect oral dissolving tablet (odt)
the attenuex intravesical system for the treatment of female stress urinary incontinence

Conditions: Urinary Incontinence, Stress

Summary: over 11 million women in the united states suffer from stress urinary incontinence (sui), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing. sui affects women of all ages and can result in significant emotional distress. the purpose of this study is to evaluate a non-surgical, investigational treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.

a multicenter, prospective, randomized, single-blinded, two-arm longitudinal trial of the safety and effectiveness of the attenuex device in reducing incontinence. subjects randomized to the control arm will have the attenuex device inserted at the end of the 3-month control period. for those subjects who are randomized to the treatment group, the attenuex device will be inserted into the bladder on day 0, and replaced every 90 days by a new device for nine months. subjects randomized into the treatment group will be followed for a minimum of 12 months after receiving the attenuex device, while subjects randomized into the control group will be followed for 3 months without the attenuex device and a minimum of 12 months after receiving the attenuex device.

Eligibility criteria:
inclusion criteria: * female subjects ≥ 18 years of age * experienced stress urinary incontinence (sui) for at least 12-months and failed prior non-surgical treatment * vlpp ≥ 60cm h20 * stamey grade ≥ 1 * free of local skin infection, impassable urethral strictures, trauma or necrosis * provide written informed consent exclusion criteria: * pregnant or planning pregnancy * 3 or more urinary tract infections within previous year * intrinsic sphincter deficiency * incontinence surgery within previous 6-months * cystocele ≥ grade 3 * previous pelvic radiation therapy * presence of urethral abnormalities * recent urosepsis * history of interstitial or follicular cystitis * uncontrolled diabetes * biofeedback within previous 3 months * morbid obesity * use of anticoagulants other than aspirin
investigation of effectiveness of local antibiotic with platelet rich fibrin on third molar surgery outcomes in vivo

Conditions: Impacted Wisdom Tooth; Pain; Staphylococcus Aureus

Summary: the aim of this study was investigate the effectiveness of local antibiotic applications with platelet rich fibrin on third molar surgery outcomes in vivo and in vitro. the study included a total of 60 patients with impacted mandibular third molar. patients were evaluated in 3 randomly separated groups. for the first and second group, platelets rich fibrin+ local antibiotics were applied into the tooth socket. for the first group, amoxicillin was applied and for the second group, clindamycin was applied. there was a control group which only platelets rich fibrin was applied into the socket. the outcome variables were pain, swelling, the number of analgesics taken, and trismus. these variables were also assessed based on first, second, third, and seventh days following the operation.


Eligibility criteria:
inclusion criteria: * patient with no systemic diseases, no current infection, no smoke, no pregnancy exclusion criteria: * no inflammation

Keywords: local antibiotic comparison platelets rich fibrin
social deprivation and pregnancy

Conditions: Gestational Diabetes; High Blood Pressure; Prematurity; Fetal Growth Restriction

Summary: social deprivation during pregnancy is associated to adverse perinatal outcomes. however, prenatal screening of social deprivation by reliable measurement is not performed. prevalence of social deprivation is yet underestimated during pregnancy and vulnerable women are not being provided optimal prenatal care. our aim is to validate epices score during pregnancy.

the process of deprivation was defined first by j. wrezinski and p. townsend who also reported that deprivation is the main cause of inequalities in health. several studies have already shown an association between socioeconomic deprivation and adverse birth outcomes. epices score is the only one that measure individual deprivation. the epices score should be therefore included systematically in standard follow-up of pregnant women. descriptive analysis will assess women's characteristics and prevalence of social deprivation. two groups of women will be compared deprived women and non-deprived women. association between epices score and the adverse perinatal outcomes will be assessed by quantile regression.

Eligibility criteria:
inclusion criteria: * more than 18 years old * delivery at 2 maternity hospitals of clermont-ferrand area * fluent command of spoken and written french exclusion criteria: * terminations of pregnancy * protected women

Keywords: social deprivation adverse perinatal outcomes
rehabilitation intervention to prevent adverse events related to androgen-deprivation therapy (adt) in patients with metastatic prostate cancer (pca): a single arm feasibility study (recap study)

Conditions: Metastatic Prostate Cancer (PCa) in ADT; Rehabilitation

Summary: this is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility. the main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic pca patients undergoing adt. secondary aims are: to deepen the knowledge on other feasibility aspects (recruitment/retention), to monitor safety, to assess the effects in reducing the aes of adt (on loss of strength, loss of physical performance and fatigue, number of accidental falls and fractures), to monitor pain and the change in physical activity habits. the rehabilitation intervention will be led by a physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. this program will be adapted to single patient needs. every exercise session will last almost 60 minutes and patients will be supervised twice a week. one more exercise session per week will be self-managed by patients. at baseline a physiatrist will visit patients with bone metastasis and collect data on sites of bone metastasis, associated level of pain, and risk of pathological fractures. for all participants, the physiotherapist will assess muscle strength (hand grip strength-hgs), physical performance (short physical performance battery-sppb), level of fatigue (facit-f), and data collection on physical activity habits (international physical activity questionnaire-ipaq). the enrollment will be closed after 1 year from the activation of the study or when the target of patients will be reached, whichever occurs firstly. for each patient, data will be collected for 12 months. the duration of the study is expected to be around 2 years. follow-ups are scheduled at 12 weeks, 24 weeks and 12 months.


Eligibility criteria:
inclusion criteria: * diagnosis of prostatic adenocarcinoma; * metastatic disease candidate to adt treatment and adt free; * ecog ps 0-1. exclusion criteria: * physical conditions that may limit adherence to the study (heart failure nyha 3-4, pathologic fractures, previous disability limiting exercise, etc); * psychological/psychiatric conditions that may limit adherence to the study (moderate-severe cognitive impairment, psychiatric disorders, etc.) * other concomitant active malignancies

Keywords: rehabilitation feasibility adverse events
vortioxetine in patients with depression coexisting with general anxiety disorder (gad)

Conditions: MDD; Anxiety Disorders

Summary: this study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.

100 patients, recruited from psychiatrist outpatient clinics are planned for enrolment. approximately 50 of these patients will receive vortioxetine as a first treatment for the current major depressive episode (mde) (first treatment patients) and 50 patients will be switched to vortioxetine due to inadequate response to the current antidepressant medication treatment (switch patients).

Eligibility criteria:
inclusion criteria: * the patient has a primary diagnosis of mde, diagnosed according to dsm-5® confirmed using the mini international neuropsychiatric interview (mini). * the patient has had the current mde for \<12 months * the patient has current comorbid generalized anxiety disorder (gad) according to dsm-5®. the diagnosis was made prior to the current mde * the patient has a montgomery and åsberg depression rating scale (madrs) total score ≥ 22 at the baseline visit * the patient has a hamilton anxiety rating scale (ham-a) score ≥ 20 at the baseline visit exclusion criteria: * the patient has any current psychiatric disorder or axis i disorder (dsm-5® criteria), established as the primary diagnosis, other than mdd, as assessed using the mini international neuropsychiatric interview (mini) or another diagnostic interview. * the patient has a history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's opinion. other in- or exclusion criteria may apply
potential impact (benefit) of preventative treatment with topamax on the effectiveness of axert in the acute treatment of migraine

Conditions: Migraine; Classic Migraine; Common Migraine

Summary: the purpose of this study is to evaluate the impact of topiramate (migraine prevention medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating acute migraine headaches.

migraine afflicts greater than 28 million adults in the united states. acute treatments, such as almotriptan malate, target the symptoms of a migraine attack. preventive treatments, such as topiramate, primarily target the generation of attacks and may decrease use of acute treatments. preventive treatments, by a process of neurostabilization, may result in an additive effect on almotriptan malate to improve acute treatment intervention response during a migraine attack. this is a randomized, double blind, parallel group multicenter study that will enroll patients 18-65 years old with a history of 3-12 migraine headaches each month for the past 3 months. the total study duration will be approximately 32 weeks. the study is divided into 4 phases as follows: a screening phase that lasts one month; an open label phase where all patients will be treated with topiramate gradually dosed to 100mg a day lasting 6 weeks; a double blind phase lasting 19 weeks at which time patients will be randomized to stay on topiramate 100mg per day or switch to placebo topiramate (50:50 chance) and a taper/exit phase lasting 2 weeks. almotriptan malate will be used for all migraine headaches during the study as needed. the study hypothesis is that the combination of almotriptan malate and topiramate will have a better clinical response than the combination of almotriptan malate and placebo topiramate. migraine pain information will be collected from each patient with the use of a personal digital assistant (pda or palm pilot) throughout the study for each migraine attack. commercial topiramate will be gradually increased to 100mg/day in approximately 4-6 weeks. you will then be randomized to either topiramate or placebo, dosed at 100mg a day, for the remainder of the study (18 weeks). axert 12.5mg may be taken to treat migraine headaches during the study.

Eligibility criteria:
inclusion criteria: * have a history of migraine headaches for at least 6 months * experience 3-12 migraines per month * able to take oral medication * able to complete the electronic diary (personal digital assistant-pda). exclusion criteria: * you will not be able to participate in the study if you previously discontinued topiramate or almotriptan because it did not make you feel better or it made you feel different * have 15 or more headache days a month * experience migraine aura without a headache * already on a migraine preventative medicine.

Keywords: migraine headache topiramate, almotriptan malate
arrhythmic mitral valve prolapse detection using long-term ambulatory rhythm monitoring

Conditions: Mitral Valve Prolapse; Ventricular Arrythmia

Summary: mitral valve prolapse (mvp) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. this subgroup is referred to as amvp (arrhythmic mvp) and was recently defined using the following criteria: (1) presence of mvp), (2) ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (pvc) burden on holter) or complex (non-sustained ventricular tachycardia (nsvt), ventricular tachycardia (vt), or ventricular fibrillation (vf)), and (3) the absence of any other well-defined arrhythmic substrate. currently, diagnosis is often based on repeated 24-hour holter monitoring. however, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days). this pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with mvp as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * mitral valve prolapse diagnosed on previous echocardiography or cardiac mri * new york heart association classification ≥3 * willing and able to provide signed written informed consent * no contra-indication for long-term monitoring (known allergy to adhesives) exclusion criteria: * prior cardiac surgery, including previous mitral valve intervention * prior endovascular mitral valve repair (mitraclip) * previous catheter ablation of ventricular arrhythmias * patients not in sinus rhythm * patients on anti-arrhythmic drugs but betablockers * known alternative arrhythmic substrate, for example previous myocardial infarction * known allergy to adhesives