Kornimate/medical-research-clean huggingface dataset:
navigation interventions to improve cascade genetic testing among relatives of patients with hereditary cancer syndromes

Conditions: Hereditary Malignant Neoplasm; Hereditary Neoplastic Syndrome

Summary: this clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to genetic testing for relatives of patients with hereditary cancer syndromes. between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. some kinds of cancer or certain cancers diagnosed in biological relatives may mean patients are more likely to have a genetic change. once a genetic change is identified in a family, other biological relatives can choose to undergo testing themselves to better understand their cancer risk. the uptake of genetic testing in other biological relatives once a genetic condition is identified is about 20% to 30%. the cascade genetic testing platform is a virtual tool that seeks to overcome barriers related to logistics of family communication and improve dissemination of genetic testing information which is clinically actionable for individuals at highest risk for cancer. using the cascade genetic testing platform may improve ways to share information about hereditary risk with biological relatives.

03jun2025- amendment was approved that shorten the study timeline from 12 to 6 months. we believe this is sufficient to capture our primary outcome (participation) and a shorter timeline may keep participants more engaged.

Eligibility criteria:
inclusion criteria: * probands: clinically confirmed autosomal dominant pathogenic germline variant (pgv) associated with a hereditary cancer syndrome * probands: previous evaluation by the university of michigan (u-m) cancer genetics clinic * probands: ≥ 18 years old * probands: able to speak and read english * probands: access to the internet * relatives: biological relative of proband * relatives: ≥ 18 years old * relatives: able to speak and read english * relatives: access to the internet * relatives: have not completed germline genetic testing, per self-report at baseline exclusion criteria: * relatives: prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider, per self-report at baseline
moderate to persistent asthma in the obese subject

Conditions: Asthma

Summary: obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ics). the investigators suggested that the addition of singular (montelukast)\[ltra\] to moderate doses of inhaled corticosteroids will improve asthma control. this cross over study will be treat subjects with moderate dose ics/ltra for 12 weeks and high dose ics with placebo for 12 weeks.

subjects will enter the 2-week run-in period after meeting eligibility criteria at the screening visit (visit 1). during run-in subjects will have all usual asthma medications discontinued and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (ltra wash-out). subjects will be monitored to rule out any acute infection or symptoms consistent with an exacerbation. the run-in period will be used to assess subject compliance and understanding of study related procedures. following the run-in, to be eligible for the randomization subjects must have an acq score \>1.25 on the juniper asthma control questionnaire.

Eligibility criteria:
inclusion criteria: * moderate persistent asthma as defined daily symptoms, nocturnal awakenings \>1 time/week but not daily, daily short-acting beta agonist usage * pre-bronchodilator force expiratory volume (fev1)\>55% but \<90%. * subjects must be on controller therapy for asthma with ics for at least one month prior to enrollment. * methacholine testing that causes a drop in the fev1 of 20% (8mg/ml off ics or 16mg/ml) on ics within 6 months prior to entry * physician diagnosis of asthma for at least one year prior to study enrollment. * obesity defined as bmi greater than 30. * subjects must have an asthma control questionnaire (acq) score \>1.25 on the juniper asthma control questionnaire (indicating poor asthma control), * require daily medications for asthma and be compliant with study related medications. exclusion criteria: * subjects must not have been intubated in the last 5 years or unstable asthma symptoms resulting in significant loss or work or school * upper or lower respiratory tract infection within 1 month of the study * use of antibiotics within 4 weeks of the study * use of oral glucocorticoids within 4 weeks * use of theophylline * smoking history greater than 10 pack years or any cigarette use within the past two years * significant non-asthma pulmonary disease or other medical problems * subjects planning to undergo gastric bypass surgery within 4 months of the enrollment date will be excluded since weight loss is a potential confounder of asthma control * pregnant women will also be excluded
wich is the best dressing in wounds by primary surgery of tha and / or tka?

Conditions: Occlusive Dressings; Nursing; Knee Surgery; Hip Surgery

Summary: surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier against external contamination. currently, in corporació pt after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. in many cases the appearance of blistering caused by the use of these conventional dressings is observed, which increases the risk of infection, pain and the final cost of the procedure. there are other types of dressings that could improve these aspects but comparative data are not currently available. main objective: to identify the dressing that better preserves the integrity of the skin. design: prospective randomized comparative study of 5 types of dressings used in total knee and hip arthroplasty surgical wounds (tka and tha). secondary objectives: to identify the dressing that provides greater advantages and minor inconveniences in tka and tha surgery. study population: patients older than 18 years undergoing fast track primary tka or tha. 110 patients


Eligibility criteria:
inclusion criteria: * patients older than 18 years * operated on primary tka and tha in the fast track circuit * adequate cognitive ability. exclusion criteria: * damaged skin * no self-care capacity or caregiver * inadequate cognitive ability to consent freely * patients who will not undergo "fast track" surgery
effects of different dialysis strategies on inflammation in covid-19 maintenance hemodialysis patients

Conditions: Covid19; Hemodialysis Complication; Inflammatory Response

Summary: in the course of coronavirus disease-19 (covid-19) uncontrolled inflammation has been related to disease severity and unfavorable outcomes. here, the investigators study the longitudinal changes of pro- and anti-inflammatory markers in a population of patients undergoing maintenance hemodialysis (hd) affected by covid-19, evaluating the potential modulating effects of two different dialysis approaches

for this prospective randomized study, the investigators recruit maintenance hemodialysis patients with confirmed covid-19 infection. after diagnosis, the patients are randomized to two different dialysis modalities, expanded hd (hdx), performed by use of a medium cut-off membrane, and standard treatment based on the use of a protein-leaking dialyzer (pld). the investigators collect clinical and laboratory data, including circulating pre and post-dialysis levels of interleukin-6 (il-6), interleukin-8 (il-8), interleukin-10 (il-10), soluble tlr4 (stlr4), and interferon-gamma (ifn-g). samples are collected at diagnosis (t0), and one and two weeks after the diagnosis (t7 and t14, respectively). moreover, lymphocyte and immune cell profiles are evaluated.

Eligibility criteria:
inclusion criteria: * patients undergoing maintenance hemodialysis * confirmed severe acute respiratory syndrome-coronavirus2 infection exclusion criteria: * acute kidney injury

Keywords: hemodialysis covid19 inflammation
decoding the extracellular vesicles-driven communication in the microenvironment of hairy cell leukemia to improve patient care management

Conditions: Hairy Cell Leukemia (HCL)

Summary: this is a national multi-centre, experimental, cross-sectional, non-profit study.

extracellular vesicles are small particles circulating in plasma and documented as key players of intercellular crosstalk thanks to their cargo of proteins, lipids, and nucleic acids. the driving hypothesis of this study is that in hairy cell leukemia-derived extracellular vesicles contribute to the maintenance of the tumor clone through regulation of selected key cells of the tumor microenvironment including immune cells and stromal cells, likely favoring immune evasion and marrow fibrosis. as a consequence, these circulating particles may be instrumental at identifying a biology-related, disease-specific and extracellular vesicle-based signature associated to outcomes.

Eligibility criteria:
inclusion criteria for patients: * who2022-defined diagnosis of hairy cell leukemia. * age ≥18 years. * signed informed consent. inclusion criteria for healthy donors: * age ≥18 years. * volunteers in general good health, free from any disease or serious illness. * signed informed consent. exclusion criteria - none
sw-imrt versus st-imrt in the treatment of head and neck cancer

Conditions: Swallowing Dysfunction

Summary: to clinically validate whether sw-imrt actually reduce the occurrence of swallowing dysfunction as compared to st-imrt.

patients are randomly assigned to either st-imrt or sw-imrt.

Eligibility criteria:
inclusion criteria: * patients with squamous cell carcinoma and requiring whole neck irradiation as a part of either definitive rt alone or in combination with chemotherapy or post-operative rt either alone or in combination with chemotherapy. exclusion criteria: * previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
study of biomarkers in dna samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia

Conditions: Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Adult Acute Promyelocytic Leukemia With PML-RARA; Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Acute Myeloid Leukemia; Childhood Acute Myeloid Leukemia in Remission; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia

Summary: this research study is looking at biomarkers in dna samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. studying samples of dna from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

primary objectives: i. collect dna samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease. ii. identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered. outline: previously collected dna samples are analyzed for polymorphisms at a variety of loci. gene expression and expression profiles are correlated with genotype and therapy outcomes.

Eligibility criteria:
inclusion criteria: * dna samples available from patients meeting the following criteria: * infants with acute lymphoblastic leukemia (all) or acute myeloid leukemia (aml) * patients with pre-b all, including responders vs non-responders in selected genotypes \[hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)\] and responders and non-responders regardless of genotype * pediatric patients with aml registered on pog-9421 * adult patients with all, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary aml * pediatric patients with relapsed all enrolled on cog-aall01p2 * pediatric patients enrolled on cog-9900 and other ccg or pog trials
post-marketing surveillance of children with chronic hepatitis c treated with intron a (vial or pen) and rebetol (study p04397)(terminated)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: the objective of the study is to assess the safety and efficacy of intron a (3 mio i.e./m2, 3 times per week) and rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in germany. the primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. the study will also evaluate the rates of eradication of the hcv virus. this study was terminated due to low enrollment. at the time of termination, 3 participants had enrolled. therefore, these 3 participants transferred into study p04538 (nct00727077) and will be included in the p04538 (nct00727077) data reporting.


Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c (serum hcv-rna-positive) * age 3 to 17 years * treatment-naïve * platelets \>= 100,000/mm\^3 * neutrophil counts \>= 1,500/ mm\^3 * tsh must be within normal limits * hemoglobin \>=12 g/dl (females); \>=13 g/dl (males) * women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. sexually active female subjects of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment. * sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment. exclusion criteria: * contraindications according to the spc and european approval * pretreatment of chronic hepatitis c * liver decompensation * hypersensitivity to the active substance or to any interferons or to any of the excipients * pregnant woman * woman who are breast feeding * existence of or history of psychiatric condition, in particular depression, suicidal ideation or suicide attempt * a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months * severe debilitating medical conditions, including patients with chronic renal failure or creatinine clearance \< 50 mllmin * autoimmune hepatitis or history of autoimmune disease * severe hepatic dysfunction or decompensated cirrhosis of the liver * pre- existing thyroid disease unless it can be controlled with conventional therapy * epilepsy and/or compromised central nervous system function * individual decision of physician if patient suitable for treatment (e.g., disturbance of growth)
a study to evaluate the pharmacokinetics and the safety after administration of "br1019" and co-administration of "br1019-3" and "br1019-2" in healthy volunteers

Conditions: Essential Hypertension; Type 2 Diabetes

Summary: the purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "br1019" and co-administration of "br1019-3" and "br1019-2" in healthy volunteers


Eligibility criteria:
inclusion criteria: * those have body mass index (bmi) within the range of 18.0 to 30.0kg/m2 at screening visit. * for men, those who weigh 50 kg or more * for women, those who weigh 45 kg or more * those who spontaneously decide to participate and sign written consent to comply with the subject's precautions during the clinical trial period after listening to and fully understanding detailed explanation of this clinical trial * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(except for hormone drugs) from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken etc, otc, oriental medicine, health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetic and pharmacodynamic properties such as interaction of investigational products, half-life) * those who have participated in bioequivalence tests or other clinical trials and administered their investigational products within 6 months prior to the first administration date. (however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * those who have a medical history of gastrointestinal surgery (except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs. * in the case of a female subject, pregnant woman, those suspected pregnancy or lactating woman.
diagnostic outcome trial in heart failure (dot-hf trial)

Conditions: Heart Failure

Summary: the dot-hf trial is an international, prospective, multi-center, randomized, controlled trial.

the study was designed with a control arm in order to adequately study the effect of early intervention triggered by the optivol® alert and/or sentrycheck™ monitor/patientlook™ indicator and evaluation using optivol® fluid status monitoring with cardiac compass. optivol® fluid status monitoring with cardiac compass features are available in the per clinical investigational plan specified medtronic products (crt, crt-d and icd devices)

Eligibility criteria:
inclusion criteria: * subjects of both genders with mild to severe hf as defined as nhya class ii to iv who also have an indication for device implant according to esc/aha guidelines as well as having a hf hospitalization or emergency department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no exclusion criteria, are eligible for this study. exclusion criteria: * subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year * subject received a coronary artery bypass graft or valve surgery in last 90 days * subject with a myocardial infarction (mi) in the last 40 days. * subject's life expectancy is less than one year in the opinion of the physician * subject has severe chronic obstructive pulmonary disease (copd), as determined by physician and documented in medical records * subject is listed for valve replacement/valve repair * subject has severe, primary pulmonary hypertension as determined by physician and documented in medical records * subject with serum creatinine ≥ 2.5 mg/dl measured within 14 days prior to enrolment * subject on chronic renal dialysis * subject on continuous or uninterrupted (≥ 2 stable infusions per week) infusion (inotropic) therapy for hf * subject has complex and uncorrected congenital heart disease

Keywords: heart failure, randomized, optivol® fluid status monitoring
evaluation of the effects of whole body vibration on the lung function of patients with stable copd

Conditions: COPD

Summary: the typical clinical progression of copd usually results in a decreased level of tolerable physical exertion for the patient. the avoidance of strenuous physical activity leads to a deteriorating level of physical fitness, which further decreases the patient's ability to undertake physical activities. recent research has shown that whole body vibration has the potential to improve physical fitness of participants, including such measures as the 6 minute walking distance. however, information concerning lung function is lacking. the goal of the study is to test whether the use of whole body vibration training has an effect on the lung function of patients with stable copd, or if the previously observed effects can be attributed to either pharmaceutical therapy or physical therapy interventions.


Eligibility criteria:
inclusion criteria: * stable copd (gold ii-iv) * signed understanding of participation * the patients must be able to understand and follow the requirements of participation (understanding of the german language) exclusion criteria: * acute thrombosis * hemoptysis * implants in the targeted training regions (joint implants) * acute joint inflammation, active arthrosis or arthropathy. * rheumatoid arthritis * acute tendinopathy in the targeted training regions * acute hernia * acute discopathy * fresh fracture in the targeted training regions * gall or kidney stones * wounds still in the process of healing * epilepsy * severe neurologic disorders (apoplexy, paralysis of upper and lower extremities) * severe circulatory disorders (cardiac insufficiency nyha \> or = iii, myocardial infarct less than one month prior, circulatory relevant rhythm disorders, idiopathic syncope) * tension pneumothorax * acute internal bleeding * current therapy with fluoroquinolone * alcohol/drug/medication abuse

Keywords: chronic obstructive pulmonary disease randomized controlled trial physical activity
outcome of ffr-guided intervention strategy

Conditions: Coronary Artery Disease

Summary: the investigator will evaluate the clinical outcomes of the patients in whom the treatment strategy for their coronary stenosis were determined by fractional flow reserve measurement.

inclusion criteria * coronary stenosis * successful measurement of fractional flow reserve clinical outcomes * death * cardiac death * target lesion revascularization * target vessel revascularization

Eligibility criteria:
inclusion criteria: * coronary stenosis * successful fractional flow reserve measurement exclusion criteria: * contraindication to adenosine * expected life expectance \< 1year

Keywords: coronary stenosis stent fractional flow reserve