Kornimate/medical-research-clean huggingface dataset:
study to evaluate exemestane with and without entinostat (sndx-275) in treatment of postmenopausal women with advanced breast cancer

Conditions: Breast Cancer; Estrogen Receptor-Positive Breast Cancer; Breast Cancer, Estrogen Receptor-Positive; ER+ Breast Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of entinostat in combination with exemestane in the treatment of advanced breast cancer.


Eligibility criteria:
inclusion criteria: * postmenopausal female patients * histologically or cytologically confirmed estrogen receptor positive (er+) breast cancer * relapsed or progressed on prior treatment with aromatase inhibitor (ai) * metastatic disease must be measurable * patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment * patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior ai * eastern cooperative oncology group (ecog) performance status: 0 to 1 * laboratory parameters: a)hemoglobin ≥ 9.0 g/dl; platelets ≥ 100.0 x 10\^9/l; absolute neutrophil count (anc ≥) 1.5 x 10\^9/l without the use of hematopoietic growth factors b)creatinine less than 2.5 times the upper limit of normal for the institution c)aspartate transaminase (ast) and alanine transaminase (alt) less than 2.5 times the upper limit of normal for the institution * able to understand and give written informed consent and comply with study procedures exclusion criteria: * relapse on treatment with non-steroidal ai after less than 12 months for patients in the adjuvant setting * progressive disease after less than 3 months treatment with most recent ai for patients with metastatic disease * rapidly progressive, life-threatening metastases * any palliative radiotherapy to the measurable lesion * previous treatment with sndx-275 or any other histone deacetylase (hdac) inhibitor including valproic acid * allergy to benzamides or inactive components of the study drug * a history of allergies to any active or inactive ingredients of exemestane * any concomitant medical condition that precludes adequate study treatment compliance * patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study * patient is currently receiving treatment with valproic acid, zolinza (vorinostat) or any other hdac inhibitor or deoxyribonucleic acid (dna) methyltransferase inhibitor or any systemic anticancer treatment (with the exception of lupron)

Keywords: breast neoplasms breast tumor mammary neoplasms
an observational study to collect information on safety and to document the drug utilization of fampyra (biib041) when used in routine medical practice

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific adverse events (aes) of interest from participants taking fampyra in routine clinical practice. the secondary objectives of this study are to characterize utilization patterns of fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of multiple sclerosis (ms) while taking fampyra and to assess the change over time in physician assessment of walking ability in participants taking fampyra (ms participants only).


Eligibility criteria:
key inclusion criteria: * ms patients with any disease subtype who are ≥18 years of age and must have been newly prescribed fampyra but not yet started the treatment. * patients who are willing and able to provide written informed consent. key exclusion criteria: * none note: other protocol-defined inclusion/exclusion criteria may apply.
study to demonstrate the lot-to-lot consistency and to evaluate the safety of an adjuvanted influenza vaccine candidate

Conditions: Influenza

Summary: the purpose of this phase iib study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to fluarix™ administered intramuscularly in elderly aged 60 years old and above.

the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * a male or female age 60 years or older at the time of the vaccination. * subjects who the investigator believes can and will comply with the requirements of the protocol * written informed consent obtained from the subject. * free of an acute aggravation of the health status as established by clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination. * history of hypersensitivity to a previous dose of influenza vaccine. * history of confirmed influenza infection within the last 12 months. * history of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * acute disease at the time of enrolment

Keywords: influenza influenza vaccine
(mo)betta trial in transwomen for optimization of art

Conditions: HIV Infections

Summary: the purpose of this study is to determine the safety and tolerability of a new hiv medication, bictegravir plus emtricitabine plus tenofovir alafenamide (b/ftc/taf, 3 hiv medications combined into one pill) in hiv-infected transgender women (tw).


Eligibility criteria:
inclusion criteria: * self-identified transgender woman (tw) * hiv infection * undetectable hiv viral load (hiv-1 rna \ /=24 weeks prior to entry. * current hiv treatment with ftc plus tdf or taf and a 3rd agent. * no changes in art in the 12 weeks prior to screening. * current female hormone therapy use. * ability and willingness of subject to provide informed consent. exclusion criteria: * current or planned use of prohibited medications (phenobarbital, phenytoin, carbamazepine, oxcarbazepine, rifampin, rifapentine, st. john's wort, echinacea, dofetilide, cisapride, atazanavir) * change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior to entry, or planned need for such therapy during the study period. * current use of androgen therapy. * intent to significantly modify diet or exercise habits, or to enroll in a weight loss intervention during the study period. * anticipated need to initiate or change doses of medications with anti-inflammatory properties within the study period. * screening laboratory values as follows: (anc \ 3x uln) * evidence of resistance to any component of the current art regimen (genotypic or phenotypic) * current use of bictegravir in another investigational setting * current use of other investigational agents that the participant could not receive unchanged, if needed, throughout the study period (unless approved by the study team) * any condition that the study investigator believes would make the candidate unsuitable for participation

Keywords: transgender women bictegravir
pulse oximeter test

Conditions: Hypoxia

Summary: assessment of spry health's loop oximetry accuracy in profound hypoxia


Eligibility criteria:
inclusion criteria: * good general health with no evidence of medical problems exclusion criteria: * smoking * anemia
6-minute stepper test and pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; 6-minute Stepper Test

Summary: the purpose of this study is to determine, if it exists, a relation between plateau heart rate from the last 3 minutes of the 6-minute stepper test and heart rate from first ventilatory threshold from cardiopulmonary exercise testing in order to individualise pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * age \> 18 ans ; * chronicle obstructive pulmonary disease stage i/ii (fev1 ≥ 50%) ; * chronicle obstructive pulmonary disease stage iii/iv (fev1 \< 50%) from may 2019 (ethical approvement granted) * weight ≤ 90kg ; * eligible for pulmonary rehabilitation. exclusion criteria: * pregnant woman or likely to be ; * patient under guardianship ; * contraindication to cardiopulmonary exercise testing ; * patient medically treated with heart rate modulator (excluding oral b2-agonist) ; * patient treated with pacemaker or defibrillator ; * history of lower limb impairment (i.e. peripheral artery disease, orthopedic disorder etc.).
evolution of the 6-minute walk test in patients treated with elexacaftor / tezacaftor / ivacaftor

Conditions: Cystic Fibrosis

Summary: the aim of the study is to identify a link between the new cftr modulators and physical activity in cystic fibrosis patients. the triple combination of cftr modulators (elexacaftor / tezacaftor/ ivacaftor) has recently changed the management of cystic fibrosis. this treatment has been shown to rapidly improve patients' respiratory function, with a gain in fev1 at 1 month ranging from 10.4% to 13.6%. it also reduces the number of respiratory exacerbations and improves the nutritional status and quality of life of treated patients. to date, there is limited data on the impact of these new therapies on physical activity. few studies have investigated changes in exercise or physical activity parameters under elexacaftor / tezacaftor/ ivacaftor. the 6-minute walk test is a validated field test used routinely to assess the exercise capacity of patients with chronic respiratory diseases, including cystic fibrosis.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 12 years with cystic fibrosis, heterozygous for the f508del mutation of the cftr gene, treated with elexacaftor/ tezacaftor/ ivacaftor. * patients followed in the respiratory diseases department of the renee sabran hospital * 6-minute walked test performed in the year preceding initiation of elexacaftor / tezacaftor/ ivacaftor * 6-minute walked test performed after treatment initiation (between the 3rd month and the 14th month) * no opposition to participation exclusion criteria: * - age \< 12 years * pregnancy * discontinuation or reduction in dosage of elexacaftor/ tezacaftor/ ivacaftor * patients objecting to the use of their data for research purposes

Keywords: cystic fibrosis cftr modulators 6-minutes walk test physical activity
risk factors of pocd in general anesthesia patients underwent noncardiac and non neurological procedures.

Conditions: Undergoing General Anaesthesia

Summary: the study was a prospective cohort study to assess the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery.

the study was a prospective cohort study, assessing the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery. the study used cognitive tests such as ravlt, tmt, and digit span tests. pocd definition is reduction in postoperative cognitive function by as much as 20% at a minimum of 2 cognitive tests.

Eligibility criteria:
inclusion criteria: * geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia * patient can do reading and writing * patient can speak in bahasa * signing informed consent exclusion criteria: * patient with cognitive impairment or psychiatric disorder such as delirium, amnesia, anxiety disorder, or depression. * patient under psychotropic drugs or narcotics. * patient with history of brain tumor, head injury or motoric disturbance and disability that can disturbed neurocognitive test

Keywords: postoperative cognitive dysfunction geriatrics general anaesthesia
ethyl glucuronide in urine samples of pregnant women within the hus ja phhyky area

Conditions: Fetal Alcohol Spectrum Disorders

Summary: in order to find how many women continue using alcohol during their pregnancies the plan is to anonymously test routine urine samples collected during pregnancies for ethylglucuronide (etg), a metabolite of ethanol that is detectable in urine up to several days after alcohol consumptions. altogether 600 samples are taken in the prenatal care units and the prenatal care units dedicated for the alcohol and drug abusing mothers both in the helsinki and lahti areas. test results are used to estimate and compare the prevalence of severe maternal drinking in the different populations.


Eligibility criteria:
inclusion criteria: * pregnant exclusion criteria: -
radiologic evaluation and breast density (read)

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether cessation of hormone replacement therapy for one or two months before a screening mammogram will improve its performance by decreasing breast density.

this randomized, controlled trial is designed to test whether short-term (1-2 months) hrt cessation will sufficiently lower breast density to decrease the proportion of women who receive a recommendation for additional evaluation following a screening mammogram, and to examine whether there is a trend by duration of cessation. the study is being conducted at group health cooperative, a managed health care organization in western washington state with an organized breast cancer screening program. we are recruiting 1,500 women and will randomize women to one of three hrt arms: 1) cessation two months before the screening mammogram; 2) cessation one month before; and 3) continued hrt use. we are using a computer-assisted method to measure mammographic breast density continuously. mammography recall rates are being determined from an expert radiologist review of the mammograms, blinded to hrt status.

Eligibility criteria:
inclusion criteria: * 1 or more prior screening mammograms at group health cooperative within the past 2 years * currently taking hrt * taking hrt at prior screening mammogram * due for a screening mammogram exclusion criteria: * bi-rads breast density of 1 (entirely fat) * previous cardiovascular events (heart surgery, catheterization, stent bypass, angioplasty, stroke, dvt) * previous breast cancer * history of breast implants * breast reduction since last mammogram * mastectomy * history of using tamoxifen or raloxifene * declined contact or use of data for research

Keywords: randomized controlled trial mammography health care setting hormone replacement therapy breast density mammography performance breast carcinoma
effect of inspiratory muscle training on exercise performance and quality of life in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with chronic obstructive pulmonary disease (copd) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.


Eligibility criteria:
inclusion criteria: * exsmokers * low pimax compared to reference values \[lower limits of normal: 80 cmh2o for patients less than or equal 54 years old; 71 cmh2o for patients' age between 55-64 years; and 65 cmh2o for patients 65 years old \]. * stable patients without history of exacerbation or hospitalization four weeks before starting the study. exclusion criteria: * lack of motivation and compliance. * patients with significant reversibility following bronchodilation defined as an increase in fev1 of more than 12% and 200 ml from the pre-bronchodilator value * unstable cardiac disease \[severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)\]. * uncontrolled hypertension * recent pneumothorax (within 6 weeks) * recent abdominal or thoracic surgery (within 6 weeks) * known progressive neuromuscular disorders * recent gastrointestinal bleeding (within 4 weeks) * current smokers * active cancer * patients with advanced liver diseases, or renal impairment. * known connective tissue diseases * significant endocrinal abnormalities

Keywords: copd inspiratory muscle training dyspnea quality of life
study using dexmedetomidine to decreases emergence delirium in pediatric patients

Conditions: Otitis Media

Summary: the purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium during general sevoflurane anesthesia in a pediatric population receiving pressure equalization tubes in one or more ear.

emergence delirium has been described as a dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent, inconsolably crying, moaning, kicking or thrashing. the children can run the gambit from restlessness and incoherence to combative and psychotic. the incidence of emergence agitation or delirium is 80% after a procedure with sevoflurane-induced anesthesia. dexmedetomidine has been shown to have sedative and analgesic effects. in the pediatric population, it has been shown to provide sedation for radiographic procedures. intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. the ability to administer a medication intranasally might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing myringotomy and tube placement.

Eligibility criteria:
inclusion criteria: * asa class 1 or 2 (healthy patient or acute illness) * parental willingness to participate * candidate for pressure-equalization tubes (pet) as determined by the ent department exclusion criteria: * asa class 3 or 4 (chronic illness or life-threatening illness) * parental refusal to participate * significant liver disease by history * allergy to dexmedetomidine or midazolam * nasal deformity * fever in the three days prior to surgery * nausea or vomiting * history of hypertension * history of cardiac dysfunction/disorder * diabetes mellitus

Keywords: dexmedetomidine pressure equalization tubes in the ear myringotomy sevoflurane
biofeedback and osteopathic procedures for daytime urinary incontinence

Conditions: Urinary Incontinence

Summary: the study will enroll 113 participants, randomly will be assigned to one of three groups will receive either group a will receive combined therapy of biofeedback training and osteopathy techniques, group b will receive biofeedback training, group c will receive osteopathy technique only over a period of 10 weeks, followed by an 8-week follow-up period. outcome measures will include the 24-hour pad test, pediatric lower urinary tract symptom score (plutss), and the bladder diary.

children (male and female) with functional daytime urinary incontinence, typically the urge type, who were referred for physical therapy by a urologist were recruited from mansoura urology and nephrology hospital at mansoura university. to participate in the study, participants had to be between 6 and 16 years old and have had functional daytime urinary incontinence for at least six months, with at least three episodes per week and a total of at least 60 ml of urine loss per week. certain exclusion criteria were applied, including not having other types of urinary incontinence, neurological disorders, previous operations on the urinary or bowel system, current use of certain medications that could interfere with study results or pose a risk to the participant's health, severe cognitive impairment or dementia, recent participation in another clinical trial, active urinary tract infection (uti), not having vascular disorders in the urinary system, and parental refusal to sign the written consent form.

Eligibility criteria:
inclusion criteria: * between 6 and 16 years old * have functional daytime urinary incontinence for at least six months * at least three episodes per week exclusion criteria: * neurological disorders, * previous operations on the urinary or bowel system * current use of certain medications that could interfere with study results * pose a risk to the participant's health * severe cognitive impairment or dementia

Keywords: biofeedback training osteopathic procedures 24-hour pad test functional daytime urinary incontinence
foreskin graft tubularized incised plate urethroplasty vs tubularized incised plate for primary hypospadias (fgtip-tip)

Conditions: Hypospadias

Summary: the purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. this study only included patients with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.

urethroplasty technique more used in the world for hypospadias repair is tubularized incised plate described by snodgrass in 1994. kolon and gonzales described a technical modification to the tip in 2000, which is called grafting foreskin. there are characteristics of the glans and urethral plate favoring the development of complications. in this study the researchers include patients with primary hypospadias, with these characteristics above, and compare two surgical techniques: tip vs fg-tip. the main aim is to determine the efficacy (functional and cosmetic) and safety (complications) of tip vs fg-tip. the study design is a randomized clinical trial, double blind (patient and evaluator), parallel groups. the sample size was calculated comparing two proportions, with a alpha 0.05, beta 0.2; 34 patients per group. the main outcome is complications.

Eligibility criteria:
inclusion criteria: * patients diagnosed with hypospadias without previous surgery * hypospadias with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate. exclusion criteria: * patients diagnosed with hypospadias and severe psychomotor development delay * patients with disorders of sexual development without gender assignment