Kornimate/medical-research-clean huggingface dataset:
a trial to strengthen existential resiliency among women with metastatic breast cancer

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: the investigators group has piloted a 6-week psycho-educational program, growing resiliency and courage with cancer™ (grace), that bring together a variety of strategies and experiences from an inter-professional perspective to mitigate distress among patients with an advanced cancer diagnosis. grace is a six-session, empirically anchored intervention emphasizing a logotherapy (existential therapy) and cognitive-behavioral therapy approach involving psycho-education and process-oriented experiences. the curriculum includes themes illustrated via powerpoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.


Eligibility criteria:
inclusion criteria: * women with metastatic cancer with a minimum prognosis of 3 months * existential or spiritual concerns * reasonable medical stability as assessed by the evaluating physician * commits to attending 5/6 of the grace classes * english speaking * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * unstable psychiatric disorder that would detract from a group program (i.e. severe depression/anxiety not controlled medically, volatile personality disorders) * cognitive impairment or cognitive linguistic impairment (i.e., aphasia) that would interfere with a group program.

Keywords: logotherapy cognitive behavior therapy metastatic breast cancer
filling pressures of the left ventricle in patients with significant aortic stenosis

Conditions: Valvular Disease

Summary: left valvular heart disease has become one of the most common heart disease in western countries. this disease evolve over many years and are characterized by a long phase where the patient is "asymptomatic". it is characterized by discomfort lv filling may worsen and lead typically to a pressure increase of lv pressure and the left atrium (la) (1). the onset of symptoms is unpredictable and may occur at the stage of diastolic or systolic dysfunction. ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing that it is often very difficult to know if the patient is actually symptomatic. the onset of symptoms sign an intolerance to the increase in lv filling pressures and la , causing pulmonary hypertension . therefore, the study of the level of lv and la filling pressures , if possible by a noninvasive method, would identify patients apparently asymptomatic even though their condition is advanced. pressures filling pressures can be explored by two methods: * cardiac catheterization, which is a direct and invasive measurement method * echocardiography, which is an indirect measurement method which has the advantage of being non-invasive the goal of this research is to compare the two methods.


Eligibility criteria:
inclusion criteria: * older than 18 years; * patients hospitalized for a coarctation review, and has received or will be receiving during their stay a complete echocardiography and coronary angiography, and left and right catheterization exclusion criteria: * pregnant women * patients with a history of valve replacement surgery, * patients with other valvular\> grade 2 associated with the coarctation * patients known to have ischemic heart disease or in whom angiography showed significant coronary artery disease; * patients with chronic or paroxysmal atrial fibrillation * patients with a permanently pacemaker
observational study comparing home to office spirometry

Conditions: Cystic Fibrosis

Summary: this is a prospective, longitudinal multicenter observational study comparing home to office spirometry and home to office weight and height measurements. the aim of the study is to estimate the accuracy and variability of home spirometric measurements over time, and to assess the feasibility and acceptability of home measurements.

after successful completion of the run-in period, participants will have 3 in-person visits, at which office spirometry will be performed and weight and height measured. participants will perform home spirometry weekly during the study period. they will also electronically complete a weekly electronic patient reported outcome (epro) within one week of each in-person visit, they will measure height and weight at home and perform home spirometry with virtual coaching by site research staff. they will complete a brief epro every 4 weeks regarding acceptability and feasibility of home spirometry in research. within two weeks after study completion, a purposive subsample will complete an exit interview.

Eligibility criteria:
inclusion criteria: * documentation of a cf diagnosis * clinically stable * ≥6 years of age at screening visit * during the run-in period, performed acceptable home spirometry at least twice without virtually coaching and once with virtually coaching exclusion criteria: * history of lung transplantation * initiation of a highly effective modulator therapy within 2 months before screening visit

Keywords: telehealth spirometry cystic fibrosis cf telemedicine zephyrx
navadyn11 : hemodynamic impact of a new ventilatory support mode with diaphragmatic synchronization

Conditions: Invasive Ventilatory Support

Summary: despite spectacular advances since the 90s mechanical ventilation used in intensive care units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a significant morbidity and mortality. nava (neurally adjusted assist ventilation) ventilatory support, provides synchronous support, proportionate to patient's respiratory efforts. more "physiological", this mode would decline its efficacy on patient hemodynamic response. however, to date, no study has focused on hemodynamic impact of nava. this is precisely the purpose of navadyn11 study, which aims to assess nava efficacy on cardiac index in pediatric intensive care unit.


Eligibility criteria:
inclusion criteria: * servo-i with nava available at patient admission * sedation protocol compatible with nava functioning * parental consent non inclusion criteria: * digestive pathology incompatible with gastric tube. * deep sedation required defined by score comfortb \<11 (cranial traumatism...) * brain damage incompatible with spontaneous ventilation * duration of intubation too short for investigation exclusion criteria: * clinical worsening requiring treatment and/or management inconsistent with navadyn11 research (cpr, emergency surgery ...). however, the investigator is allowed to reiterate investigation when patient stabilized.

Keywords: nava hemodynamic cardiac index children with admission weight > 5kg
efficacy and safety of tildrakizumab in participants with moderate-to-severe chronic plaque psoriasis who are non-responders to dimethyl fumarate therapy

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to assess the efficacy, safety and tolerability of tildrakizumab in moderate-to-severe plaque psoriasis participants who are non-responder to dimethyl fumarate (dmf) at week 16. the study consists of two parts. part 1 will include the first 16 weeks of the treatment period and part 2 will include the last 24 weeks of the treatment period.


Eligibility criteria:
inclusion criteria: * provide signed written and dated informed consent given before any study related activity is performed * participants with at least 6 months history of chronic plaque psoriasis * participants diagnosed with moderate-to-severe plaque psoriasis at the screening visit * candidate for systemic treatment for plaque psoriasis at the screening visit exclusion criteria: * women currently pregnant, or intend to become pregnant or breastfeeding. unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary) * other forms of psoriasis than chronic plaque-type * participants with drug-induced psoriasis at the screening visit * participants with history or evidence of skin disease or conditions other than chronic plaque-type psoriasis * participants with history of hypersensitivity or allergy to the study drugs * concurrent malignancy, current relevant autoimmune diseases other than psoriasis * participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the screening visit * active infectious disease at the screening visit * participants positive test for human immunodeficiency virus or any other immunosuppressive disease * previous exposure to fumarate-based drug or a biologic systemic treatment * live vaccination within 4 weeks prior to the baseline visit * participant who intend to use any concomitant medication with immunomodulating or systemic corticosteroids * unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study

Keywords: dimethyl fumarate tildrakizumab moderate-to-severe plaque psoriasis chronic plaque psoriasis
study of ot-101 in treating myopia

Conditions: Myopia, Progressive

Summary: this is a phase iii, randomized, double-masked, placebo-controlled, parallel-group, multicenter safety, tolerability, and efficacy study of atropine sulfate 0.01% (ot-101) as an investigational treatment for myopia in pediatric subjects

this is a phase iii, randomized, double-masked, placebo-controlled, parallel-group, multi-center study to evaluate the safety tolerability and efficacy of ot-101 (atropine 0.01%) ophthalmic solution in treating the progression of myopia in pediatric subjects that will enroll approximately 678 pediatric subjects with myopia in total. subjects will be stratified by age and refractive error. this study consists of 11 visits over the course of approximately 4 years and can be broken down in the 3 stages: screening (days -14 to -1), stage 1 (day 1 to year 3), and stage 2 (year 3 to year 4). in stage 1, subjects will be randomized in a 2:1 manner to ot-101 ophthalmic solution: placebo. subjects will be dosed with one drop of study treatment per eye once daily at bedtime for 3 years. in stage 2, subjects will be re-randomization 1:1 will occur at visit 9 (month 36). at re-randomization, subjects who had been assigned to ot-101 ophthalmic solution will be randomized in a 1:1 ratio to continue on ot-101 ophthalmic solution or switch to placebo. subjects who had been assigned to placebo will continue with placebo.

Eligibility criteria:
inclusion criteria: * have refractive error by cycloplegic autorefraction at baseline (visit 1) in the study eye of: 1. myopia greater or equal to -1.00d of spherical equivalent 2. astigmatism less than or equal to 1.50dc 3. progression of at least -0.50d of spherical equivalent in the last 12 months; exclusion criteria: * have active or a history of chronic or recurrent episodes of ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye; * have undergone any myopia control treatment including orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed; * have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy \[prk\], laser in situ keratomileusis \[lasik\], laser-assisted sub- epithelial keratectomy \[lasek\]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (smile), cataract extraction, or any form of intraocular lens implantation;
analgesic benefit of preoperative vs. postoperative etoricoxib in total knee arthroplasty

Conditions: Postoperative Pain

Summary: evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (tka).

the investigators conducted a prospective randomized controlled study in 165 patients american society of anesthesiologists (asa) score i-iii scheduled for primary tka, divided in 3 groups: group a (etoricoxib 120 mg orally one hour before surgery), group b (etoricoxib 120 mg orally at the end of surgery) and group c placebo. surgery has been performed under spinal anesthesia. all groups received postoperative analgesia when numeric rating scale (nrs) over 3 with intravenous (iv) perfalgan and morphine on demand for the following 48 h. the effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at nrs \> 3, the total amount of morphine in the first 24 and 48 hours postoperative, the side effects and necessary amount of adjuvant medication.

Eligibility criteria:
inclusion criteria: * asa i-iii * weight (kilos) over 40 kg * height (centimeters) over 155 cm * non-anemic * indication for primary tka (total knee arthroplasty) exclusion criteria: * history of asthma * peptic ulcer * severe hepatic or renal dysfunction * neuropathies * bleeding disorders * uncooperative * drug abuse * sensibility to etoricoxib * paracetamol or morphine * long acting nonsteroidal antiinflammatory drugs (nsaid) in the last 4 days preoperative * cerebrovascular and peripheric vascular disease * arterial hypertension (hta) not adequately controlled * congestive heart failure.

Keywords: preemptive postoperative pain etoricoxib
safety study of oxi4503 (a vascular disrupting agent) given by 3 x weekly intravenous infusions to patients with advanced solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to establish the maximum tolerated dose (mtd) of oxi4503 given by weekly infusions to patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * histologically proven cancer. * written informed consent. * age \>/= 18 years. * life expectancy of at least 12 weeks. * world health organization (who) performance status of 0 or 1. * adequate hematological and biochemical indices to support investigational therapy. * all women of childbearing potential (wocbp) must have a negative serum pregnancy test. * wocbp and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication. * measurable and evaluable disease. * all toxic manifestations of previous treatment must have resolved. * able to undergo mri scanning. exclusion criteria: * radiotherapy, endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and mitomycin-c) prior to treatment. * pregnant and lactating women. * major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered. * patients which have active uncontrolled infections. * patients with any other condition that in the investigator's opinion would not make the patient a good candidate for the clinical trial. * patients known to be serologically positive for hepatitis b, hepatitis c or human immunodeficiency virus (hiv). * previous or ongoing cardiac conditions. * uncontrolled hypertension. * patients taking any drug known to prolong the qtc interval. * patients who have had any ischaemic or vascular damage from previous radiotherapy. * patients taking warfarin or heparin. * patients taking naproxen. * patients taking supplements or multivitamins containing vitamin c. * patients should not be taking any other investigational drug for the duration of the study. * patients with brain metastases or neurological tissue involvement of the spinal column.

Keywords: phase 1 oxi4503 oxigene cruk solid tumors vda vascular disrupting agent
vip: vascular imaging project. study on the progression of cardiovascular disease in renal transplant recipients

Conditions: Cardiovascular Disease

Summary: this is a prospective randomized study to compare the influence of area under the curve (auc)-monitored dual treatment with steroids in combination with either a calcineurin inhibitor (cni) or mycophenolate mofetil (mmf) on the progression of subclinical cardiovascular disease in renal transplant recipients. since cni have a detrimental effect on cardiovascular risk factors, it is the researchers' hypothesis that renal recipients after cni withdrawal will have more reduction of markers of cardiovascular disease.

stable renal transplant patients on maintenance immunosuppressive therapy with steroids, a calcineurin inhibitor (cni) and mycophenolate mofetil (mmf) will be randomized for auc-monitored withdrawal of either cni or mmf. the progression of cardiovascular markers will be assessed by yearly measurements of intima media thickness, pulse wave velocity and left ventricular hypertrophy in both groups. the duration of the study will be 3 years and the target sample size is 100 patients per arm

Eligibility criteria:
inclusion criteria: * patients, 18 years or older, on triple maintenance therapy with cyclosporine or tacrolimus , mmf and steroids * informed consent exclusion criteria: * calculated creatinine clearance \< 30 ml/min * multi-organ recipients * patients with a (historic) panel reactive antibody (pra) \>60% * third renal transplant or more. * patients receiving investigational drugs other than mmf in combination with cyclosporine or tacrolimus * solid malignancy, post-transplant lymphoproliferative disease.

Keywords: renal transplantation calcineurin inhibitor mycophenolate mofetil cardiovascular disease
nociplastic pain in patients with chronic shoulder pain

Conditions: Chronic Shoulder Pain

Summary: the aim of this study was to investigate predictors of nociplastic shoulder pain. factors of psychological distress, functionality, fitness, quality of life, quality of sleep, functioning of the parasympathetic system, and lifestyle will be examined. patients with nociplastic pain will be identified using the classification system proposed by the iasp.

the main part of the study will include patients with chronic shoulder pain who visit the hand surgery-upper limb and microsurgery department of the general hospital kat. the measurements will be performed in one session. once participants have been informed of the purpose and procedure of the study and given written consent, they will complete their demographics and a series of questionnaires and questions about their pain history. they will then be examined by a doctor and finally subjected to dynamometry, a functional test and two quantitative sensory tests.

Eligibility criteria:
inclusion criteria: * patients (men and women) with chronic shoulder pain (lasting more than 3 months, 3/10 numeric pain rating scale), * aged 18-65 years * mentally able to follow instructions or * healthy volunteers * aged 18-65 * who do not experience pain and have not received analgesic medication in the last trimester. exclusion criteria: * referred shoulder pain from different primary sources of pain (eg shoulder pain in women with mastectomy or stroke), * pain manifested by movements in the neck, * shoulder arthroplasty or fractures or dislocation of the shoulder, - * diagnosis of chronic pain syndrome such as fibromyalgia, chronic fatigue syndrome, chronic regional pain syndrome, cancer diagnosis, osteoporosis, rheumatic inflammatory diseases, * use of medication for neurological/psychiatric disorders, * the presence of gastrointestinal or renal disease * taking medication that may affect the assessment results, such as calcium channel blockers that could alter hrv, * pregnancy or childbirth before 1 year will be excluded from the study.

Keywords: chronic pain shoulder pain nociplastic pain predictors
cardiopulmonary effects of particulate exposure

Conditions: Respiratory Tract Diseases; Cardiac Diseases; Bronchitis

Summary: the aim of this study is to assess cardiac rate and respiratory responses and rhythm after workplace exposure to combustion particulates. a repeated measurement study is being performed on acute boilermakers (apprentices and journeymen). a stratified analysis is then done on those with and without chronic bronchitis, after adjustment for relevant covariates.

population-based epidemiologic studies of communities in the united states have revealed a consistent association between ambient particulate air pollution and increases in morbidity and mortality. the observed increases result from both respiratory and cardiovascular diseases. similar associations have been observed for rates of hospital admissions for respiratory and cardiovascular diseases for subjects over age 65. these ambient exposures are to low levels of particulates, many times lower than occupational exposures faced by workers in a variety of industries, including manufacturing, construction, transportation and electric-power generation. the objective of this proposal is to investigate the role of occupational exposure to particulates in the development of respiratory and cardiac responses in boilermakers. we will employ a detailed, continuous-exposure assessment to pm2.5 with repeated measures of biologic and physiologic markers of response. specific hypotheses to be tested will include: (1) occupational exposure to fuel-oil ash particulates induce airway inflammation as reflected in increased expired no, and airflow obstruction as reflected in decreases in peak flow (pefr) and fev1; (2) particulate exposure will result in acute changes in cardiovascular function, as reflected in changes in heart rate, heart-rate variability and blood pressure; (3) particulate exposures result in increased serum fibrinogen levels, a known risk factor for cardiovascular disease; and (4) chronic bronchitis predisposes particulate-exposed workers to changes in cardiac function. the results of this study will have important implications for preventive efforts aimed at reducing morbidity and mortality from occupational exposure to respirable particulates.

Eligibility criteria:
adults; over 18; boilermakers

Keywords: particulates air pollution cardiopulmonary disease lung inflammation
pgtai results for embryos cultured in sequential versus single step media

Conditions: Infertility; Aneuploidy Rate; Mosaicism

Summary: a prospective cohort study undergoing icsi at a private fertility center in egypt

purpose: to evaluate pgtai results for embryos cultured in sequential versus single step media. method: injected oocytes will divided between continuous single culture-nx media (csc- nx) with 10% sss the first group (irvine, usa) and the other group will be cultured in sequential cleavage and blastocyst media with 10% sps (sage, denmark). all blastocytes with 4bb quality and better according to gardner's criteria 1999 will go through pgta procedures with pgtai confirmation.

Eligibility criteria:
inclusion criteria: * female age ≤37 years with ≥ 8 mature oocytes * male partner had normal semen parameters according to who 2010 * pgt-a was done at the blastocyst stage exclusion criteria: * sperm or oocyte donor * severe male factors according to who 2010

Keywords: pgt-a mosaicism single step media sequential media