Kornimate/medical-research-clean huggingface dataset:
the communication of genetic risk to adolescent daughters of women with breast cancer

Conditions: Breast Cancer; Counseling

Summary: the purpose of this study is to first understand how mskcc clinical genetics service doctors talk to women with breast cancer about any genetic risks they might carry, and if they help women to think about what they might say, in turn, to their relatives, especially their daughters. a second part of the study asks women for their opinions about when and how their daughters should be told about any genetic risks. all of this will help us develop teaching methods to help our doctors improve the way they talk about genetic risk when women with breast cancer have adolescent daughters.


Eligibility criteria:
inclusion criteria: * women seen in the msk cgs service who have a diagnosis of breast cancer or * a family history of breast cancer and * have biological daughter(s) in the age range 12-20 years will be eligible to participate in phase i \& ii. * women who were consented to phase i will automatically be eligible for phase ii. exclusion criteria: * women seen in the msk cgs service will be ineligible if they have no diagnosis of breast cancer and no family history of breast cancer, * do not have a biological daughter, * or have a biological daughter fewer than 12 or greater than 20 years(unless they were consented to phase 1). * women will be ineligible if they are not english speaking, * have intellectual or cognitive impairment, * or active mental illness rendering them incapable of giving informed consent, such as might occur with active psychosis.

Keywords: daughters communication genetic risk genetic counseling
e-bibliotherapy for informal caregivers of people with dementia

Conditions: Dementia; Caregiver Stress Syndrome; Psychological Well-Being

Summary: the objective of this study is to test the efficacy of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia as compared with a control group.

this project is a two-arm randomized controlled trial evaluating the effects of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia. one hundred and ninety-two informal caregivers of people with dementia will be recruited. participants in the intervention group will receive eight weekly e-bibliotherapy sessions. the control group will get access to the same e-bibliotherapy app but accept only general daily living knowledge. psychological well-being, caregiving appraisal, mental health, biomarker of stress, and health-related quality of life will be measured to test the effects of e-bibliotherapy immediately post-intervention, three months post-intervention, and six months post-intervention. focus group interviews will be conducted immediately post-intervention to explore caregivers' experiences participating in this study.

Eligibility criteria:
inclusion criteria: * primary caregivers aged 18 or above; * provide unpaid regular care to a person with mild to moderately severe dementia (measured by global deterioration scale, gds=4\~6); * have cared for the care recipient for at least six months; * assist with at least one of the care recipient's daily activities; * use a smartphone or tablet; * can read chinese. exclusion criteria: * caregivers with unstable physical or mental conditions; * have cognitive impairment; * are undergoing acute treatment or have not yet stabilized on their chronic medication; * are involved in another interventional study
testosterone therapy for pubertal delay in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: "observational study of clinical outcomes for testosterone treatment of pubertal delay in duchenne muscular dystrophy" is a single centre observational study that aims to follow the progress of 20 adolescents with duchenne muscular dystrophy (dmd) and delayed puberty who are treated by the newcastle muscle team, as they are treated with testosterone to induce puberty. the participants will all be treated with the standard stepwise regimen of testosterone injections every 4 weeks and data will be collected to help determine the effectiveness and tolerability of the current treatment regimen. the investigators will use the data to explore the effect of testosterone on pubertal development, growth, muscle strength and function, bone mineral density and body composition and characterise any side effects. semi-structured interviews will also be carried out to learn the boys' views on the tolerability of the regimen. the study will last up to a maximum of 27 months in total for each participant, but may be less if they are happy with pubertal development before this time. it is important to do this study because from the investigator's limited experience in this group, testosterone treatment seems to be well liked and tolerated but the best treatment regimen to use remains unknown and there is no current consensus. it is not currently part of the standard of care in dmd but it would be important to include it if this study can show that it is an effective treatment for pubertal delay.


Eligibility criteria:
inclusion criteria: * a molecular diagnosis of duchenne muscular dystrophy. * males aged between 12 and 17 years of age at time of first dosing * prepubertal (tanner stage 1, testicular volume \<4 mls, initial testosterone level of \<2.0 nmol/l) * subjects are receiving the standard of care for dmd as recommended by the northstar uk and treat-nmd guidelines * patients are capable of sitting upright in a wheelchair for at least an hour * patients have stable respiratory function. artificial ventilation with either bipap/continuous positive airways pressure (cpap) or tracheostomy is not a contraindication to the study. * informed consent/assent signed by the patient (or parent/guardian if under 16 years of age) exclusion criteria: * severe learning difficulties that would preclude them from cooperating with examination. * anticipated surgery during the study period. * symptomatic cardiac failure. * participants/families who may have emotional or psychological problems if recruited to a study * hypersensitivity to the active substance or to any of the excipients, including arachis oil or derivatives (including hypersensitivity and allergy to peanuts or soya.) * any contra-indication to receiving an intramuscular injection * any additional chronic disease that affects androgen production * anti-coagulant therapy * if participation in the study is not recommended in the opinion of the investigators

Keywords: testosterone pubertal delay
efficacy, safety, and tolerability of once daily oral administration of azd5004 versus placebo for 26 weeks in adults with type 2 diabetes mellitus.

Conditions: Diabetes Mellitus, Type 2

Summary: this is a phase iib, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of azd5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator.

this is a phase iib, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of azd5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator. the study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.

Eligibility criteria:
inclusion criteria: adults ≥ 18 years of age. diagnosed with t2dm for at least 6 months. hba1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an sglt2 inhibitor for at least one month prior to screening. body mass index of ≥ 23 kg/m2. stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change). exclusion criteria: type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma. history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment. have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. received medication for weight loss within the last 3 months prior to screening. clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper gi tract. previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier). history of acute or chronic pancreatitis.
bilateral and unilateral amblyopia treatment study

Conditions: Amblyopia

Summary: the purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to \<10 years old. specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.

the purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to \<10 years old. specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.

Eligibility criteria:
inclusion criteria: * age 3 to \< 10 years * subjects and their parent/guardian speak and understand english adequately to complete the study protocol and give informed consent. subjects have the ability to adhere to the study visit schedule. * all refractive error measures below will be determined by cycloplegic retinoscopy by one of the study investigators during the comprehensive eye exam. measures are in minus cylinder spectacle prescription format. inclusion criteria for bilateral amblyopia: the major eligibility criteria include: * best-corrected visual acuity of \<20/30 each eye. * for hypermetropia: * spherical equivalent \>+2.00 d each eye. * spherical equivalent difference between eyes \<1.25 d. * for astigmatism without hypermetropia criteria above or myopia criteria below: * \>1.75 d each eye * difference between eyes \<1.25 d * for myopia: * spherical equivalent \<-5.00. * spherical equivalent difference between eyes \<1.25 d. inclusion criteria for unilateral amblyopia: the major eligibility criteria include: * presence of anisometropia or constant unilateral strabismus. * best-corrected visual acuity in the amblyopic eye \<20/30; and interocular difference of best-corrected visual acuity at least two logmar lines. * for anisometropia: * spherical equivalent ≥ 1.00 d interocular difference * astigmatism \>1.75 d interocular difference * for constant unilateral strabismus where spectacle prescription is indicated. examples where spectacle prescription is indicated include esotropia caused at least in part by an accommodative component or where significant refractive error in either eye warrants spectacle prescription for improved vision. exclusion criteria: * history of spectacle wear * previous treatment for amblyopia * active amblyopia treatment planned other than spectacles at enrollment * prior intraocular or refractive surgery * ocular or systemic abnormalities that the examining investigator deems could impact prognosis for visual improvement. examples could include birth history that may have affected brain development, extremely low birth weight (\<1.5 lbs), seizure disorders, cerebral palsy, optic nerve hypoplasia, cranial nerve palsy. examples that would usually not exclude are off axis media opacity, low birth weight (2.0-3.5 lbs) without complication, mild limitation of extraocular muscle. cognitive impairment that prohibits accurate data collection

Keywords: amblyopia
serial coronary cta-based plaque progression detection for management of coronary heart disease

Conditions: Major Adverse Cardiovascular Events (MACE); Prevention; Coronary Artery Disease(CAD); CT Angiography

Summary: the primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (ccta) for patients with non-obstructive coronary artery disease can improve the ldl-c target achievement rate compared to a traditional management strategy without follow-up ccta, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.

patients with non-obstructive coronary artery disease have a high rate of adverse cardiovascular events, and currently, there is still a lack of effective management strategies for these patients in clinical practice. in the success study, investigator will compare follow-up ccta management with routine clinical management to assess the effectiveness of follow-up ccta in improving lipid control and reducing cardiovascular events in these patients. the success study is a single-center, randomized, parallel-controlled, interventional clinical trial that recruits patients with non-obstructive coronary artery disease identified on previous ccta (coronary artery stenosis of 20% to 70% or left main coronary artery stenosis of 20% to 50%). the experimental group is the ccta follow-up management group, and the control group is the routine clinical follow-up management group. all participants will be randomly assigned to the experimental and control groups in a 1:1 ratio. the experimental group will undergo management using follow-up ccta, while the control group will be managed using routine clinical and laboratory examinations. at the 1-year follow-up, all participants will undergo laboratory re-examination to observe the impact of follow-up ccta on lipid target achievement. after 3 years of follow-up, the differences in the occurrence of major adverse cardiovascular and cerebrovascular events (macce) between the two groups will be compared.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years old; 2. known patients with non-obstructive coronary artery disease (disease duration ≥2 years); 3. patients who agree to undergo follow-up ccta examinations and cooperate in completing follow-up observations. exclusion criteria: 1. patients who have experienced acs or pci/cabg; 2. patients who have experienced adverse cardiovascular and cerebrovascular events; 3. patients who have undergone follow-up ccta or dsa examinations before enrollment; 4. patients with severe hepatic and renal dysfunction; 5. patients with contraindications to ccta examinations; 6. patients with poor initial ccta image quality or data loss.
tesra: (treatment of emphysema with a gamma-selective retinoid agonist)

Conditions: Emphysema

Summary: this 2 arm study will investigate the efficacy, safety and tolerability of rar gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal copd therapy. following optimization of copd therapy (up to 6 weeks) patients will be randomized to receive either rar gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. following the double-blind treatment period, patients will enter a 4-week follow-up period. the anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * patients of \>44 years of age, with \>10 pack-year smoking history; * women not of child-bearing potential; * ex-smokers (must have stopped smoking for \>=12 months) with clinical diagnosis of emphysema; * willing to be switched to optimal copd therapy. exclusion criteria: * off oral steroids \>28 days prior to enrollment; * \>2 exacerbations of pulmonary symptoms requiring outpatient treatment, or \>1 exacerbation requiring hospitalization, within 12 months prior to screening; * exposure to synthetic oral retinoids in past 12 months; * history of allergy or sensitivity to retinoids.
safety and efficacy of exe844 otic suspension in otitis media at time of tympanostomy tube insertion (omtt)

Conditions: Otitis Media With Effusion in Children; Otitis Media Recurrent

Summary: the purpose of this study is to evaluate exe844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (eot).


Eligibility criteria:
inclusion criteria: * recurrent acute otitis media (raom) or chronic otitis media with effusion (come) and eligible for bilateral myringotomy and tympanostomy tube insertion. * suspected bacterial infection at time of surgery in at least 1 ear. * willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities. * legally authorized representative (lar) must read and sign the informed consent. * parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol. * other protocol-specified inclusion criteria may apply. exclusion criteria: * previous otologic or otologic-related surgery within the past 30 days or ongoing complications. * middle ear pathology in either ear other than otitis media. * current acute otitis externa (aoe), malignant otitis externa (moe) or other conditions which could interfere with evaluation of the study drug. * any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the investigator. * known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study. * other protocol-specified exclusion criteria may apply.
application of hyperoxygenated fatty acids in a surgical wound after laparoscopic cholecystectomy.

Conditions: Surgical Site Infection

Summary: title: application of hyperoxygenated fatty acids (prevomega) in a surgical wound of the umbilical trocar after laparoscopic cholecystectomy with placement of prostheses in patients with risk factors. objective: this study aimed to evaluate the effect of topical application of hyperoxygenated fatty acids (agho), prevomega, at the umbilical trocar level after laparoscopic cholecystectomy with prosthesis placement, regarding its non-application, on the infection rate. of the surgical site (isq) and eventration of the trocar orifice (eot), in patients with risk factors for isq and eot. methods: a prospective, double-blind, randomized study was performed in patients operated on for scheduled cholelithiasis, who also had any of the following risk factors that increase the appearance of ssi or oot: bmi\> 30kg / m2, diabetes mellitus, age\> 65 years and chronic obstructive pulmonary disease. group a was administered physiological saline (ssf) at the umbilical trocar level at the end of the intervention versus the administration of prevomega to group b. the study was carried out between january 2018 and january 2020 and is registered in the european database of clinical trials with the eudract code: 2018-002260-67.

this study aimed to evaluate the effect of topical application of hyperoxygenated fatty acids (agho), prevomega, at the umbilical trocar level after laparoscopic cholecystectomy with prosthesis placement, regarding its non-application, on the infection rate. of the surgical site (isq) and eventration of the trocar orifice (eot), in patients with risk factors for isq and eot.

Eligibility criteria:
inclusion criteria: patients with ages between 18 and 90 years who underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and who also presented any of the following risk factors for ssi or eot were included: * obesity with body mass index (bmi)\> 30kg / m2 * diabetes mellitus (insulin dependent or oral antidiabetic takers) * age (\> 65 years) * chronic obstructive pulmonary disease (copd in treatment with inhalers). exclusion criteria: * non-compliance with the inclusion criteria * conversion to laparotomy during the intervention * non-acceptance by the patient to participate in the study, * loss to follow-up.
effects of levothyroxine treatment on hemodynamic and renal functions in subclinical hypothyroidism

Conditions: Subclinical hypothyroïdism

Summary: renal and cardiovascular effects of subclinical hypothyroidism, defined by a high tsh and normal t4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies. the investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved. isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution.

animal experimental hypothyroidism is associated with renal and hemodynamic abnormalities. in human, exact measurements of gfr showed a decline in gfr after thyroidectomy and an increase in gfr and renal blood flow after hormone replacement. renal and cardiovascular effects of subclinical hypothyroidism, defined by a high tsh and normal t4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies. a retrospective study suggests that treatment of subclinical hypothyroidism may slow the degradation rate of renal function estimated by mdrd. however, the potential hemodynamic benefit of treatment has not yet been studied. the investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved. isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution. this open prospective study will include 16 patients in order to detect an increase of 1.2 standard deviation for the measured glomerular filtration.

Eligibility criteria:
inclusion criteria: * over 18 years * chronic kidney disease * subclinical hypothyroidism non-inclusion criteria: * insulin-dependent diabetes * dialysis