Kornimate/medical-research-clean huggingface dataset:
stratactx® as a steroid sparing device

Conditions: CTCL

Summary: the purpose is to determine if stratactx® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous t cell lymphoma (ctcl) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for ctcl, or chemotherapy/immunotherapy for solid/hematologic malignancies. subjects will have ctcl and are being treated with topical steroids, or being treated with chemotherapy/immunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.

topical steroids are the mainstays of treatment for many cutaneous reactions and disorders. steroids are known to cause many side effects and few effective pharmacologic alternatives exist. contact dermatitis is observed in 56% of patients with cutaneous t-cell lymphoma (ctcl) being treated with topical mechlorethamine gel. this usually requires chronic treatment with mid-to high-potency steroids. numerous chemo/immunotherapies are associated with cutaneous reactions including paronychia, hand and foot syndrome, and acneiform rash. skin toxicity often requires dose reduction of cancer therapies and a variety of skin directed therapies including topical antibiotics and topical steroids. cutaneous reactions are often the earliest manifestation of acute graft versus host disease. skin manifestations can be debilitating and treatment usually requires high potency topical steroids. additional therapies are needed for the treatment of disorders that rely on topical steroids.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * ability to sign informed consent document * patient with a diagnosis of ctcl who have contact dermatitis to topical mechlorethamine gel * patients with a diagnosis of ctcl who have intractable pruritis * patients with a diagnosis of ctcl who rely heavily on topical steroids for symptomatic relief * patients on chemo/immunotherapy with drug induced rash exclusion criteria: * patients currently undergoing radiotherapy * patients currently receiving oral steroids * patients who are unable to apply topical medications

Keywords: ctcl topical steroids stratactx® cutaneous steroid sparing
prevention of atrial fibrillation following valvular replacement with cardiopulmonary bypass: a prospective, randomized clinical study comparing oral caffeine with placebo

Conditions: Atrial Fibrillation

Summary: atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. many mechanisms have been implicated. among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via a2a receptors modulation. the effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality. the investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. the investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and a2a adenosine receptors modulation.


Eligibility criteria:
inclusion criteria: * age = 18 years * surgery valvular settled(adjusted) (plasties or aortic replacement, mitral, tricuspid or mixed), under cec * period of weaning in caffeine: limitation of the consumption of coffee(café), tea, chocolate, in a cup the day before the intervention * consent of the patients after information exclusion criteria: * pregnant or breast-feeding women * women taking an oral contraception (half-life of the caffeine increased until 3 times) * minors(miners) or adults under guardianship * persons staying in a sanitary or social establishment * not profitable persons of a national insurance scheme * private persons of freedom * persons requiring a surgery of replacement valvular as a matter of urgency * patients having been treated(handled) by papaverine, dipyridamole, corticoids, immunosuppressors or antibiotics during six weeks preceding the date of inclusion * weighty patient lower than 50 kg or upper to 100 kg or having a body mass index upper to 29 kg / m2 * presence of an active infection, a chronic inflammatory pathology, a lung arterial high blood pressure
single ascending dose study of bms-820132 in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: bms-820132 is an investigational new drug being developed by bms for treating type 2 diabetes. the purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile) * diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for at least 2 months * body mass index (bmi) of 18 to 40 kg/m2 * fasting glucose in the range of 100-250 mg/dl * hemoglobin a1c (hba1c) in the range of 6.5% -9.5% exclusion criteria: * clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression * past history of diabetic ketoacidosis and/or c-peptide \< 1.0 ng/ml, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia * any major surgery within 4 weeks of study drug administration * any gastrointestinal surgery that could impact upon the absorption of study drug * smoking more than 10 cigarettes per day * recent drug or alcohol abuse * women who are pregnant or breastfeeding * positive urine screen for drugs of abuse * positive blood screen for hepatitis c antibody, hepatitis b surface antigen, or hiv-1, -2 antibody
myeloid mutations register in r/r cml

Conditions: Chronic Myeloid Leukaemia Recurrent; Chronic Myeloid Leukemia, in Relapse

Summary: the aim of the study is to know the percentage of abl mutations in patients with chronic myeloid leukemia that relapsed or are refractory to tyrosine-kinase inhibitors measured with a myeloid mutations panel by ngs.


Eligibility criteria:
inclusion criteria: * cml diagnosis by the who 2016 criteria * failure to reach cytogenetic response of ph chromosome of 36 to 95% at 3 months or bcr/abl \<10% at 6 months of treatment with tki * progression or relapse of the disease after previous response to treatment with tki * validation of adherence to treatment * inform consent exclusion criteria: * lack of information to complete the register * failure to response achievement due lack of adherence to treatment

Keywords: chronic myeloid leukemia
symphony-pe study for treatment of pulmonary embolism

Conditions: Acute Pulmonary Embolism; Thromboembolism; Emboli, Pulmonary; Thrombosis; Thrombus; Embolism; Embolism; Cardiovascular Diseases; Vascular Diseases

Summary: evaluation of the safety and efficacy of the symphony thrombectomy system in the treatment of pulmonary embolism

symphony-pe is a pivotal study intended to assess the safety and efficacy of the symphony thrombectomy system to treat subjects with acute pulmonary embolism.

Eligibility criteria:
inclusion criteria: 1. cta evidence of acute pe within ≤14 days 2. clinical signs and symptoms consistent with acute pe. 3. systolic bp ≥90 mmhg with evidence of dilated rv with an rv/lv ratio \>0.9 (based on investigator's assessment of rv/lv ratio) 4. stable heart rate \<130 bpm prior to procedure 5. subject is between 18 and 80 years of age 6. subject is willing to sign an irb-approved informed consent form 7. subject is willing and able to comply with protocol follow-up exclusion criteria: 1. thrombolytic use within 14 days of baseline cta 2. international normalized ratio (inr) \>3 3. platelets \<100,000/µl 4. kidney dysfunction as confirmed by serum creatinine \>1.8 mg/dl or gfr \<45 ml/min 5. hematocrit \<28% or hemoglobin \<9 g/dl 6. systolic bp \<90 mmhg for 15 min or requirement of inotropic support to maintain systolic bp ≥90 mmhg any time after admission 7. experienced cardiac arrest 8. has left bundle branch block 9. known bleeding diathesis or coagulation disorder 10. presence of intracardiac lead in the right ventricle or right atrium 11. presence of intracardiac thrombus 12. major trauma within the past 14 days 13. cardiovascular or pulmonary surgery within last 7 days 14. known serious, uncontrolled sensitivity to radiographic agents 15. contraindication to anticoagulants, i.e., heparin or alternative 16. patient on extracorporeal membrane oxygenation (ecmo) 17. cancer requiring active chemotherapy 18. heparin-induced thrombocytopenia (hit) 19. pulmonary hypertension with peak pulmonary artery pressure \>70 mmhg by right heart catheterization. 20. history of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30% 21. life expectancy \<90 days as determined by investigator 22. pregnant or nursing 23. covid-19 positive at hospital admission 24. current participation in another investigational study 25. evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16f or 24f catheters).

Keywords: thrombectomy submassive pulmonary embolism right ventricle dysfunction
physical activity, motor competence, pulmonary function, and quality of life in children with severe spinal disease

Conditions: Scoliosis; Idiopathic, Infantile; Scoliosis; Juvenile; Scoliosis Neuromuscular; Scoliosis in Neurofibromatosis; Scoliosis; Congenital, Postural; Scoliosis in Skeletal Dysplasia; Scoliosis Associated With Other Conditions; Scoliosis; Congenital, Due to Bony Malformation; Scoliosis

Summary: observation study about physical activity, motor competence, pulmonary function, and health related quality of life in children, surgically treated for early onset scoliosis

early onset scoliosis (eos) defines patients who develop deformities of the spine and/or thorax in the embryologic development or in the early childhood. the exact prevalence of eos in norway is unknown, but it is assumed to be approximately 200-300 new eos patients every year. eos is a severe condition, whereby some of the most common and also most severe consequences of the deformity are severe pulmonary problems. the patients may require extensive orthopedic treatment from early childhood and until maturity to avoid serious consequences with severe pulmonary problems and shortening of life. eos' secondary problems, including severe consequences on the pulmonary function might contribute to enhanced inactivity. inactivity contributes to further negative impact on development of the musculoskeletal system, motor competence and pulmonary function. considering the severity of eos and children's reduced life expectancy, it is extremely important that eos children achieve the favorable impact of physical activity during their growth. insufficient level of activity might worsen the prognosis, thus counteracting the treatment's ambitions. the investigator's aim is to extend the knowledge about level of activity, motor competence, pulmonary function, and health related quality of life in norwegian children, surgically treated for eos.

Eligibility criteria:
inclusion criteria: * early onset scoliosis diagnosis * understand and speak norwegian * for physical activity test: walking ability * for motor competence test and/or pulmonary function test: ability to understand the test and cooperate exclusion criteria: * other spinal disease, not early onset scoliosis

Keywords: early onset scoliosis motor competence physical activity pulmonary function health related quality of life
hormonal regulation of body weight maintenance

Conditions: Obesity; Weight Loss; Weight Gain; Hormone Disturbance; Adipose Tissue; Insulin Resistance; Skeletal Muscle

Summary: the investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. the detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.


Eligibility criteria:
inclusion criteria: * bmi \> 27 kg/m2 (adults) exclusion criteria: * weight loss of more than 5kg in the last 2 months * pregnancy, breastfeeding * patients with: * severe heart failure * impaired hepatic or renal function * anaemia * disturbed coagulation (biopsies will not be taken in those subjects) * infection, malabsorption * severe hypertension * cancer within the last 5 years * eating disorders or any other psychiatric condition that would interact with the trial intervention * any other endocrine disorder * changes of smoking habits or diets within the last 3 months prior to study inclusion

Keywords: weight regain endocrine counterregulation
onlay and sublay mesh in treatment of ventral hernia

Conditions: Ventral Hernia

Summary: hernia is defined as aprotrusion of viscus or part of viscus usually within a peritonial sac through a defect in the abdominal wall. ventral abdomenal hernias include all the hernias occuring through the anterior abdominal wall excluding groin hernias ( incisinal hernia, epigastric hernias, paraumbilical hernias, umbilical and lumbar hernias)

ventral hernia can be categorized according to their characteristic into reducible, irreducible or incarcerated , strangulated and recurrant ventral hernia. the cause of a primary ventral hernia ia s far from completely understood, but it is undoubtedly multifactorial. familial prediposing play a role with increasing evidance of connective tissue disorders, they are considered as a leading cause of abdominal surgery and account for 2-10% of all abdomenal wall hernias . clinical data show that 52% of incisional hernias occur within 6 months postoperative as a result of excessive tension and inadeqate healing of aprevious incision. the history of prothetic repair in abdominal wall hernias began in 1844 within the use of silver wire coils placed in the floor of groin to induce an inflammatory fibrosis . meny prosthetic material have been tried in hernia repair, but the two most common in current use are polypropylene mesh and expanded polytetrafluoroethylene. the repair of ventral hernia varies from primary closure, primary closure with an onlay mesh reinforcement, sublay mesh placement, and intraperitonial mesh placement. primary closure techniques are usually performed for smal fascial defects less than 5 cm in the greaters diameter an onlay , usually of polyproptlene mesh is sutured to the anterior rectus sheeth after the fascial defect has been closed primary, thes type of repair has the potential advantage of keeping the mesh separeted from the abdomenal content by full abdominal muscle fascial wall thikness. the sublay (retrorectus) placement of mesh, became popular in 1990, the recurence rates with this repair have been stated to be less than 10%.

Eligibility criteria:
inclusion criteria: * ventral hernia patients exclusion criteria: * age below 18 years. * complicated hernia. * uncompensated heart or lung diseases, haemorrhagic disorders
benefit of elevation of hdl-c on cardiovascular outcomes in women

Conditions: Coronary Artery Disease

Summary: several risk factors including high cholesterol contribute to heart disease. we know that lowering triglycerides and raising hdl (protective cholesterol) in men reduces the risk for heart disease. we expect that women will share this same benefit because the combination of high triglycerides and low hdl appears to be a more important risk for heart disease in women. niacin reduces triglycerides and raises hdl. we also expect to see improvement in markers of inflammation and clot formation and blood vessel health, which we hypothesize should all confer a reduced risk of heart disease in women. women already taking lipid lowering statin will receive niacin therapy. we will measure blood lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood vessel reactivity. after 3 months of therapy we will repeat these measures.


Eligibility criteria:
inclusion criteria: * stable women on statin therapy with ldl-c between 90-135mg/dl and triglycerides \> 150mg/dl exclusion criteria: * history of mi, ptca or surgery within previous 3 months * currently on niaspan and unwilling to withdraw niaspan therapy or known intolerance to niacin * active or known gall bladder disease * pregnant or nursing women * significant comorbidity that precludes participation * significant liver disease, active alcoholism, or lft \>1.5x's uln at screening * diabetes or glucose \> 126 mg/dl at screening * pi perceived inability to comply with protocol

Keywords: women with and without cad
socal savvy: testing savvy caregiver in a racially and ethnically diverse sample in southern california

Conditions: Caregiver Burnout; Psychological Distress

Summary: the investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 english-speaking adults: savvy caregiver express™ (3-session, newly piloted in los angeles county for feasibility) and savvy caregiver program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months.

a number of epidemiological studies, systematic reviews, and consensus reports highlight the importance of non-pharmacological, sociobehavioural interventions to address the health, psychological, and social effects of caregiving for persons living with dementia, and the need for tangible information and resources. the investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 english-speaking adults: savvy caregiver express™ (3-session, newly piloted in los angeles county for feasibility) and savvy caregiver program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months. it is hypothesized that no differences (comparable effects) between the programs in their efficacy/effectiveness and moderating conditions. focus groups (\~25 participants) will be conducted to ascertain program acceptability and satisfaction. the analyses will include a multiple linear mixed-effects modeling for our trial outcomes, and thematic analyses for our focus group interview data.

Eligibility criteria:
inclusion criteria: * english- speaking women and men age 18 or older who care for or provide assistance to someone with dementia exclusion criteria: * caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity
diagnostic and prognostic prediction models for chinese patients with venous thromboembolism

Conditions: Venous Thromboembolism (VTE)

Summary: the objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with venous thromboembolism (vte) in china.

venous thromboembolism (vte), which clinically manifests as deep vein thrombosis (dvt) and pulmonary embolism (pe), is one of the leading causes of mortality that need to be accurately diagnosed and effectively managed. although a number of clinical decision rules in the domain of vte have been presented in the literature, such as the well-known prediction models developed by wells and colleagues, the prognostic models to assess vte recurrence risk in patients who suffered from a vte or the pulmonary embolism severity index (pesi) for short-term mortality risk in pe patients, and various other diagnostic models for both dvt and pe. they are few designed for chinese patients. the primary objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with vte in china.

Eligibility criteria:
inclusion criteria: 1. \> 18 years old 2. first episode of pe and/or dvt (diagnosed by pulmonary angiogram, chest computed tomography pulmonary angiography(ctpa), ventilation/perfusion (v/q) lung scan read as high probability by the radiologist, and/or (+) bilateral lower limb venous compression ultrasonography (ccus)) exclusion criteria: 1. patients with prior vte 2. cannot provide written informed consent 3. unable to read questionnaire in chinese or english 4. a record of pregnancy in the preceding 12 months
initial oral vinorelbine dosing schedules in clinical routine in germany and austria

Conditions: Non-Small-Cell Lung Cancer; Breast Cancer

Summary: the aim of this non-interventional study is to assess oral vinorelbine dose schedules (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of treatment under routine conditions in germany together with the underlying reasons for the respective chosen schedules.


Eligibility criteria:
inclusion criteria: * written informed consent of the patient with regard to the pseudonymized documentation and processing of his/her disease data * legally capable male or female nsclc patient or legally capable female mbc patient; in both situations: ≥ 18 years of age (no upper limit) * presence of any of the following two tumor entities: * advanced nsclc (stage iii or iv) * anthracycline- and taxane-resistant mbc (stage iv) in women * planned systemic chemotherapy and planned regimen with oral vinorelbine in any palliative setting (decision on treatment must have been made before inclusion in this study); included treatments: * monotherapy or any combination therapy with oral vinorelbine * inclusion of patients with hybrid-treatment involving i.v. and oral vinorelbine in one treatment cycle is allowed exclusion criteria: * presence of any contraindication with regard to oral vinorelbine treatment (and with regard to i.v. vinorelbine in case of hybrid-treatment) according to the respective summary of product characteristics (smpc) * oral vinorelbine based palliative treatment already ongoing or planned oral vinorelbine starting dose of \>60 mg/m2 * presence of a eastern cooperative oncology group (ecog) performance status (ps) \> 2 * simultaneous participation in an interventional clinical trial

Keywords: oral vinorelbine advanced non-small-cell lung cancer metastatic breast cancer